Note: Descriptions are shown in the official language in which they were submitted.
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MFDICAMENT PUMPS AND CONTROL SYSTEMS THEREOF
INCORPORATION BY REFERENCE
[0001] This application claims priority to U.S. Provisional Patent
Application Nos.
63/128,428, filed December 21, 2020; 63/167,563, filed March 29, 2021;
63/216,177, filed
June 29, 2021; 63/239,365; filed August 31, 2021; 63/169,112, filed March 31,
2021;
63/151,565, filed February 19, 2021; 63/261,290, filed September 16, 2021;
63/152,744,
filed February 23, 2021; 63/157,541, filed March 5, 2021; 63/152,716, filed
February 23,
2021; 63/168,203, filed March 30; 2021; 63/212,521, filed June 18, 2021;
63/139;210, filed
January 19, 2021; 63/238,670, filed August 30, 2021; 63/276,481, filed
November 5, 2021;
63/215,857, filed June 28, 2021; 63/183,900, filed May 4, 2021; 63/249,975,
filed
September 29, 2021; 63/194,126, filed May 27, 2021; 63/263,602, filed November
5, 2021;
and 63/264,645, filed November 29, 2021. This application claims priority
under 35 S.C.
365(a) to PCT Application No. PCT/US2021/072742, filed December 3, 2021. The
entire
contents of each application referenced in this paragraph are hereby
incorporated by
reference herein for all purposes and made part of this specification. Any and
all
applications for which a foreign or domestic priority claim, is identified in
the Application
Data Sheet as filed with the present application are hereby incorporated by
reference under
37 CFR, 1.57.
BACKGROUND
Technical Field
[0002] This disclosure relates to glucose control systems, including medical
devices that
provide glucose control therapy to a subject, glucose level control systems,
and ambulatory
medicament pumps that deliver medicament to the subject to control blood
glucose level in the
subject.
Description of Related Art
[0003] Sustained delivery, pump driven medicament injection devices generally
include a
delivery carmula mounted in a subcutaneous manner through the skin of the
subject at an
infusion site. The pump draws medicine from a reservoir and delivers it to the
subject via the
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cannula. The injection device typically includes a channel that transmits a
medicament from an
inlet port to the delivery cannula which results in delivery to the
subcutaneous tissue layer
where the delivery cannula terminates. Some infusion devices are configured to
deliver one
medicament to a subject while others are configured to deliver multiple
medicaments to a
subject.
SUMMARY
[0004] Blood glucose control system.s and ambulatory medical devices that
provide therapy to
a subject, such as blood glucose control, are disclosed, Disclosed systems and
devices can
implement one or more features that improve the user experience, such as
software update
techniques that avoid interrupting delivery of therapy, gesture-based control
of therapy
delivery, automatic resumption of therapy after a user-initiated pause,
improved alarm
management, display of autonomously calculated dosing recommendations, wide
area network
connectivity, and security features.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The systems, methods, and devices of this disclosure each have several
innovative
aspects, no single one of which is solely responsible for all of the desirable
attributes disclosed
herein. Details of one or more implementations of the subject matter described
in this
specification are set forth in the accompanying drawings and the description
below. The
drawings are provided to illustrate certain aspects of the subject matter
described herein and not
to limit the scope thereof.
[0006] FIG. 'IA illustrates an example blood glucose control system that
provides blood
glucose control via an ambulatory medicament pump.
[0007] FIG. I B illustrates another example blood glucose control system that
provides blood
glucose control via an ambulatory medicament pump.
[0008] FIG. 1.0 illustrates a further example blood glucose control system
that provides blood
glucose control via an ambulatory medicament pump.
[0009] FIG. 2.A shows a block diagram of an example blood glucose control
system.
[0010] FIG. 2B shows a block diagram of another example blood glucose control
system.
[0011] FIG. 2C shows a block diagram of another example blood glucose control
system.
[0012] FIG. 2D shows a block diagram of another example blood glucose control
system,
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[0013] FIG. 3 is a schematic of an example glucose control system that
includes an electronic
communications interface.
[0014] FIG. 4A shows a block diagram of an example blood glucose control
system in online
operation mode.
[0015] FIG. 4B shows a block diagram of an example blood glucose control
system in offlin.e
operation mode,
[001.6] FIG. 5A illustrates a perspective view of an example ambulatory
medical device.
[0017] FIG. 5B illustrates a cross sectional view of the ambulatory medical
device shown in
FIG 5A.
[0018] FIG. 6 illustrates different modules that may be included in an example
ambulatory
medical device.
[001.9] FIG. 7 illustrates various methods and links that AMD may establish a
connection with
a host computing system.
[0020] FIG. 8 is a flow diagram showing an example of a computer-implemented
method that
may be used by an AMD in order to detect and download an application update.
[0021] FIG. 9 is a flow diagram showing an example of a computer-implemented
method that
may be used by an AMD to install a down-loaded application update without
interrupting the
therapy provided to a subject.
[0022] FIG. 10 is a flow diagram showing an example of a computer-implemented
method
that may be used by an AMD to install a second update downloaded from a host
computing
system and switch control of the AMD from a first application to the second
application
without interrupting the therapy provided to a subject.
[0023] FIG. 11 is a flow diagram showing an example of a computer-implemented
method
that may be used by an AMD to install a second application downloaded from a
host computing
system, verify and switch control of the AMD from a first application to the
second application
without interrupting the therapy provided to a subject, when the second
application satisfies a
minimum set of operation conditions.
[0024] HG. 12 is a flow diagram showing an example of a computer-implemented
method
that may be used to respond to detection of an application fault during the
execution of a first
version of an application and switching control of the AMD to a second version
an application
installed on the AMD.
3
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[0025] FIG. 13 is a flow diagram showing an example of a computer-implemented
method
that may be used to respond to detection of an application fault during the
execution of a first
version of an application and switching control of the AMD to a second version
an application
installed on the AMD and/or downloading a third version of the application.
[0026] FIG. 14. is a block diagram, illustrating an example network
configuration wherein the
AMD is directly connected to a computing system and the computing system
shares the therapy
reports with one or more display systems and the AMD.
[0027] FIG. 15 is a flow diagram illustrating an example method that may be
used by a
computing system, to generate and share a therapy report based on encrypted
therapy data
received from an AMD.
[0028] FIG. 16. is a block diagram, illustrating an example network and data
flow
configuration wherein the AMD is directly connected to a computing system and
the computing
system generates and sends alerts to one or more display systems and the AMD.
[0029] FIG. 17 is a flow diagram illustrating an example method that may be
used by a
computing system, to generate and send an alert to one or more authorized
devices.
[0030] FIG. 18 illustrates the interconnection among modules and procedures in
AMD
involved in receiving, accepting and/or canceling therapy change request.
[0031] FIG. 19 is a flow diagram illustrating an example method that may be
used by an AMD
to allow a user to change the configuration of the ambulatory medicament
device using a touch
screen user interface.
100321 FIG. 20A is an illustration of the touchscreen display of an example
AMD after the
touch screen is waked/unlocked by a wake action of a user and before the first
user gesture is
received.
100331 FIG. 20B is an illustration of an example touchscreen display that may
prompt the user
to enter a predetermined series of inputs for the first gesture or second
gesture.
[0034] FIG. 20C is an illustration of an example therapy change user
interface.
[0035] FIG. 20D is an illustration of another therapy change user interface on
a touchscreen
display.
1003611 FIG. 21 is a flow diagram illustrating an example method that may be
used by an AMD
to generate an alarm status indicator.
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[0037] FIG. 22 is a flow diagram illustrating an example method that may be
used to cancel a.
therapy change using a touchscreen interface.
[0038] FIG. 23.A is an illustration of a touchscreen display alerting the user
that the delivery
of one or more medicaments will occur.
[0039] FIG. 23B is an illustration of a touchscreen display showing that a
medicament is
being delivered to the user,
[0040] FIG. 24 is a block diagram illustrating the interconnection among
modules and
procedures in AMD involved in receiving, accepting and/or canceling a therapy
suspension
request.
[0041] FIG. 25 is a flow diagram illustrating an example method for receiving
and
implementing a suspension request, which may be implemented by an AMD
[0042] FIG. 26 illustrates a plurality of screens that the ambulatory medical
device may
display when a user pauses therapy,
[0043] FIG. 27 is a flow diagram illustrating an example method of resuming a
suspended
therapy that may be implemented by an AMD.
[0044] FIG. 28 illustrates a plurality of screens that the ambulatory medical
device may
display when a user resumes therapy.
[0045] FIG. 29 is a block diagram illustrating the interconnection among
modules and
procedures in AMD involved in changing the settings of the AMD,
[0046] FIG. 30 is a flow diagram illustrating an example method that may be
used by an AMD
to allow a user to change a setting of the AMD using a user generated passcode
or an override
passcode.
[0047] FIG. 31 is a flow diagram illustrating an example method that may be
used by an AMD
to allow a user to change a setting of the AMD using a user generated passcode
or an override
passcode.
[0048] FIG. 32 is a schematic diagram illustrating the interconnection among
modules and
procedures in an AMD involved in monitoring the status of the AMD and/or the
subject and
generating alarms when an alarm condition is met.
[0049] FIG-. 33 is a flow diagram illustrating an example procedure that may
be used by the
alarm system of an AMD to annunciate an alarm condition upon receiving a
status information
that satisfies an alarm condition.
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[0050] FIG. 34 is a block diagram illustrating the interconnection among
modules and
procedures in AMD involved in monitoring the condition of the AMD and
generating alerts
when a device malfunction is detected.
[0051] FIG. 35 is a flow diagram illustrating an example procedure that may be
used by the
alert system of an AMD to monitor the operation of an AMD and generate alerts
when a device
malfunction is detected.
[0052] FIG. 36 is a schematic diagram illustrating an ambulatory medical
device that provides
the user with various options for providing medicament.
[0053] FIG. 37 is a flow diagram of a process for providing options for meal
dosage selection
on an ambulatory device.
[0054] FIG. 38 is another flow diagram of a process for providing options for
meal dosage
selection on an ambulatory device.
[0055] FIG. 39 is a series of screen displays showing a user initiating the
activation of meal
dosage on an ambulatory device.
[0056] FIG. 40 is a series of screen displays showing a user activating meal
dosage on an
ambulatory device.
[0057] FIG. 41 is a series of screen displays showing a user activating meal
announcement on
an ambulatory device.
[0058] FIG. 42 is a series of screen displays showing a user inputting the
total number of units
on an ambulatory device.
[0059] FIG. 43 is a series of screen displays showing an ambulatory medical
device delivering
the units and cancelling the delivery of the units.
[0060] FIG. 44 is a schematic illustrating a computer system that can be
implemented in
various embodiments of the described subject matter.
[0061] FIG. 45A is a schematic illustrating an example ambulatory medicament
pump that is
configured to maintain delivery of therapy to a subject after determining that
a possible
occlusion exists in a medicament delivery system.
[0062] FIG. 45B is a schematic illustrating an example occlusion detection
system.
[0063] FIG. 46A is a flow chart flow diagram illustrating an example method
that may be
used by an AMD to maintain delivery of therapy to a subject after determining
that a possible
occlusion exists in a medicament delivery system.
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[0064] FIG. 46B is a flow chart flow diagram illustrating an example method
that that may be
used by an occlusion detection system to maintain delivery of therapy to a
subject after
determining that a possible occlusion exists in a medicament delivery system.
[0065] FIG. 47 is a flow diagram illustrating an example procedure to activate
a Do Not
Disturb mode in an AMD.
[0066] FIG. 48 is a flow diagram illustrating another example procedure to
activate a Do Not
Disturb mode in an AMD,
[0067] FIG. 49 is a flow diagram illustrating an example procedure that may be
used by the
alarm system of an AMD to escalate non-urgent alarms.
[0068] FIG. 50 illustrates a plurality of screens that may be displayed on a
touch screen
display of an AMD for activating Do Not Disturb mode on the AMD
[0069] FIG. 51 illustrates a plurality of screens that may be displayed on a
touch screen
display of an AMD for deactivating Do Not Disturb mode on the AMD,
[0070] FIG. 52 is an illustration of a user interface provided on a touch
screen display for
viewing alarm notification details,
[0071] FIG. 53A and FIG. 53B are illustrations of a user interface provided on
a touch screen
display for accessing an alarm notifications screen when Do Not Disturb mode
is activated and
when the touch screen display is locked.
[0072] FIG. 54A and FIG. 54B illustrations of a user interface provided on a
touch screen
display for accessing an alarm notifications screen when Do Not Disturb mode
is activated and
when the touch screen display is unlocked.
[0073] FIG. 55 illustrates a user interface that may be displayed by an
ambulatory medical
device in a power saving mode.
[0074] FIG. 56 is a flow diagram illustrating an example procedure to activate
a power saving
mode of an ambulatory medical device.
[0075] FIG. 57 is a flow diagram illustrating an example procedure for tap
interaction in a
power saving mode of an ambulatory medical device.
[0076] FIG. 58 is a flow diagram illustrating another example procedure for
tap interaction in
a power saving mode of an ambulatory medical device.
[0077] FIG. 59 is a flow diagram illustrating another example procedure for
tap interaction in
a power saving mode of an ambulatory medical device.
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[0078] FIG. 60 is a flow diagram illustrating another example procedure for
tap interaction in
a power saving mode of an ambulatory medical device.
[0079] FIG. 61 is a flow diagram illustrating another example procedure for
tap interaction
with an ambulatory medical device.
[0080] FIG. 62 is a flow diagram illustrating an example procedure to control
an operation of
an ambulatory medical device pump based on motion detection.
[0081] FIG. 63 is a flow diagram illustrating an example procedure to control
an operation of
an ambulatory medical device pump after freefall motion has ended.
[0082] FIG. 64 is a flow diagram illustrating an example procedure to receive
an alarm
acknowledgement from a user,
[0083] FIG. 65 is a flow diagram illustrating an example procedure to unlock a
touchscreen of
an ambulatory medical device by motion.
[0084] FIG. 66 is a flow diagram illustrating an example procedure to enter a
gesture
password to unlock a touchscreen of an ambulatory medical device by motion,
[0085] FIG. 67 is a flow diagram illustrating an example procedure to deliver
medicament to a
subject by motion control.
DETAILED DESCRIPTION
[0086] Some embodiments described herein pertain to medicament infusion
systems for one
or more medicaments and the components of such systems (e.g., infusion pumps,
medicament
cartridges, cartridge connectors, lumen assemblies, infusion connectors,
infusion sets, etc.).
Some embodiments pertain -to methods of manufacturing infusion systems and
components
thereof. Some embodiments pertain to methods of using any of the foregoing
systems or
components for infusing one or more medicaments (e.g., pharmaceutical,
hormone, etc.) to a
subject. As an exemplary illustration, an infusion system may include an
infusion pump, which
can include one or more medicament cartridges or can have an integrated
reservoir of
medicament. An infusion system may include medicament cartridges and cartridge
connectors,
but not a pump. An infusion system may include cartridge connectors and an
infusion pump,
but not medicament cartridges. An infusion system may include infusion
connectors, a lumen
assembly, cartridge connectors, an infusion pump, but not medicament
cartridges or an infusion
set. A blood glucose control system can operate in conjunction with an
infusion system to
infuse one or more medicaments, including at least one blood glucose control
agent, into a
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subject. Any feature, structure, component, material., step, or method that is
described and/or
illustrated in any embodiment in this specification can be used with or
instead of any feature,
structure, component, material, step, or method that is described and/or
illustrated in any other
embodiment in this specification. Additionally, any feature, structure,
component, material,
step, or method that is described and/or illustrated in one embodiment may be
absent from
another embodiment.
[0087] Some embodiments described herein pertain to medicament infusion
systems for one
or more medicaments and the components of such systems (e.g., infusion pumps,
medicament
cartridges, cartridge connectors, lumen assemblies, infusion connectors,
infusion sets, etc.).
Some embodiments pertain to methods of manufacturing infusion systems and
components
thereof. Some embodiments pertain to methods of using any of the foregoing
systems or
components for infusing one or more medicaments (e.g., pharmaceutical,
hormone, etc.) to a
subject. As an exemplary illustration, an infusion system may include an
infusion pump, which
can include one or more medicament cartridges or can have an integrated
reservoir of
medicament. An infusion system may include medicament cartridges and cartridge
connectors,
but not a pump. An infusion system may include cartridge connectors and an
infusion pump,
but not medicament cartridges. An infusion system may include infusion
connectors, a lumen
assembly, cartridge connectors, an infusion pump, but not medicament
cartridges or an infusion
set. A blood glucose control system can operate in conjunction with an
infusion system to
infuse one or more medicaments, including at least one blood glucose control
agent, into a
subject. Any feature, structure, component, material, step, or method that is
described and/or
illustrated in any embodiment in this specification can be used with or
instead of any feature,
structure, component, material, step, or method that is described and/or
illustrated in any other
embodiment in this specification. Additionally, any feature, structure,
component, material,
step, or method that is described and/or illustrated in one embodiment may be
absent from
another embodiment.
100881 Some embodiments described herein pertain to medicament infusion
systems for one
or more medicaments and the components of such systems (e.g., infusion pumps,
medicament
cartridges, cartridge connectors, lumen assemblies, infusion connectors,
infusion sets, etc).
Some embodiments pertain to methods of manufacturing infusion systems and
components
thereof. Some embodiments pertain to methods of using any of the foregoing
systems or
components for infusing one or more medicaments (e.g., pharmaceutical,
hormone, etc.) to a.
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patient. A.s an exemplary illustration, an infusion system may include an
infusion pump, which
can include one or more medicament cartridges or can have an integrated
reservoir of
medicament. An infusion system may include medicament cartridges and cartridge
connectors,
but not a pump. An infusion system may include cartridge connectors and an
infusion pump,
but not medicament cartridges. An infusion system may include infusion
connectors, a lumen
assembly, cartridge connectors, an infusion pump, but not medicament
cartridges or an infusion
set. A glucose level control system. can operate in conjunction with an
infusion system to infuse
one or more medicaments, including at least one glucose control agent, into a
subject. Any
feature, structure, component, material, step, or method that is described
and/or illustrated in
any embodiment in this specification can be used with or instead of any
feature, structure,
component, material, step, or method that is described and/or illustrated in
any other
embodiment in this specification. Additionally, any feature, structure,
component, material,
step, or method that is described and/or illustrated in one embodiment may be
absent from
another embodiment.
[0089] Further, certain embodiments disclosed herein relate to a glucose level
control system
that is capable of supporting different operating modes associated with
different adaptation
ranges used to generate dose control signals for delivering medicament to a
subject. The
different adaptation ranges may be associated with a value or a change in
value of one or more
control parameters used by a control algorithm that controls the administering
of medicament
to a subject. In some non-limiting examples, the control parameter may be
associated with the
quantity of medicament, a delivery rate of medicament, a step-size or
graduation used to
modify the quantity of medicament between administrations of the medicament, a
timing of
supplying medicament to the subject, a glucose absorption rate, a time until
the concentration
of insulin in blood plasma for a subject reaches half of the maximum
concentration, a time until
the concentration of insulin in blood plasma for a subject reaches a maximum
concentration, or
any other control parameter that can impact a timing or quantity of medicament
(e.g., insulin or
counter-regulatory agent) supplied or administered to a subject.
[0090] Advantageously, in certain embodiments, supporting different operating
modes enables
a user (e.g., a healthcare provider, parent, guardian, the subject receiving
treatment, etc.) to
modify the operating mode of an ambulatory medicament device. In some cases,
the operating
mode may be modified automatically. Moreover, modifying the operating mode
enables
different dosing modes to be supported. Advantageously, supporting different
dosing modes
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enables an ambulatory medicament device to be used by different types of
subjects, and/or a
subject under different conditions (e.g., when exercising, before, during, or
after puberty, under
different health conditions, etc.).
[0091] Some embodiments described herein pertain to medicament infusion
systems for one
or more medicaments and the components of such system .s (e.g., infusion
pumps, medicament
cartridges, cartridge connectors, lumen assemblies, infusion connectors,
infusion sets, etc.).
Some embodiments pertain to methods of manufacturing infusion systems and
components
thereof. Some embodiments pertain to methods of using any of the foregoing
systems or
components for infusing one or more medicaments (e.g., pharmaceutical,
hormone, etc.) to a
subject. As an exemplary illustration, an infusion system may include an
infusion pump, which
can. include one or more medicament cartridges or can have an integrated
reservoir of
medicament. An infusion system may include medicament cartridges and cartridge
connectors,
but not a pump. An infusion system may include cartridge connectors and an
infusion pump,
but not medicament cartridges. An infusion system may include infusion
connectors, a lumen
assembly, cartridge connectors, an infusion pump, but not medicament
cartridges or an infusion
set. A blood glucose control system can operate in conjunction with an
infusion system to
infuse one or more medicaments, including at least one blood glucose control
agent, into a
subject. Any feature, structure, component, material, step, or method that is
described and/or
illustrated in any embodiment in this specification can be used with or
instead of any feature,
structure, component, material, step, or method that is described andlor
illustrated in any other
embodiment in this specification. Additionally, any feature, structure,
component, material,
step, or method that is described and/or illustrated in one embodiment may be
absent from
another embodiment.
[0092] Some embodiments described herein pertain to medicament infusion
systems for one
or more medicaments. Some embodiments pertain to methods of using infusion
systems for
infusing one or more medicaments (e.g., pharmaceutical, hormone, etc.) to a
subject. Some
embodiments pertain to methods of managing access to one or more therapy
settings of a
medicament infusion system. As an exemplary illustration, an infusion system
may include an
infusion pump, which can include one or more medicament cartridges or can have
an integrated
reservoir of medicament. An infusion system may include medicament cartridges
and cartridge
connectors, but not a pump, An infusion system may include cartridge
connectors and an
infusion pump, but not medicament cartridges. An infusion system may include
infusion
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connectors, a lumen. assembly, cartridge connectors, an infusion pump, but not
medicament
cartridges or an infusion set. A blood glucose control system can operate in
conjunction. with an
infusion system to infuse one or more medicaments, including at least one
blood glucose
control agent, into a subject. An infusion system may include a user interface
that allow
modifying one or more control parameters that control medicament delivery to a
subject. An
infusion system may include a wireless transceiver that allows data
communication between the
infusion system and one or more electronic devices.
[0093] Any feature, structure, component, material, step, or method that is
described and/or
illustrated in any embodiment in this specification can be used with or
instead of any feature,
structure, component, material, step, or method that is described and/or
illustrated in any other
embodiment in this specification. Additionally, any feature, structure,
component, material,
step, or method that is described and/or illustrated in one embodiment may be
absent from
another embodiment.
Blood Glucose Control System Overview
[0094] A blood glucose control system (BGCS) is used to control blood glucose
level in a
subject. Blood glucose control systems can include a controller configured to
generate dose
control signals for one or more glucose control agents that can be infused
into the subject.
Glucose control agents include regulatory agents that tend to decrease blood
glucose level, such
as insulin and insulin analogs, and counter-regulatory agents that tend to
increase blood glucose
level, such as glucagon or dextrose. A blood glucose control system configured
to be used with
two or more glucose control agents can generate a dose control signal for each
of the agents. In
some embodiments, a blood glucose control system can generate a dose control
signal for an
agent even though the agent may not be available for dosing via a medicament
pump connected
to the subject.
[0095] Glucose control agents can be delivered to a subject via subcutaneous
injection, via
intravenous injection, or via another suitable delivery method. In the case of
blood glucose
control therapy via an ambulatory medicament pump, subcutaneous injection is
most common.
An ambulatory medicament pump 100 is a type of ambulatory medical device,
which is
sometimes referred to herein as an ambulatory device, an ambulatory medicament
device,
ambulatory medical device, a mobile ambulatory device, or an AM]). Ambulatory
medical
devices include ambulatory medicament pumps and other devices configured to be
carried by a
subject and to deliver therapy to the subject. It should be understood that
one or more of the
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embodiments described herein with respect to one AMD may be applicable to one
or more of
the other AMDs described herein,
[0096] In some embodiments, the AMD can be a portable or wearable device
(e.g., an insulin
or hi-hormonal medicament pump) that provides life-saving treatment to a
subject by delivering
one or more medicaments (e.g., insulin and/or glucagon) to a subject. Some
AMDs may
continuously monitor the health condition of a subject (e.g., blood glucose
level) using a sensor
(e.g., a blood glucose level sensor that can measure values corresponding to
the blood glucose
level) and deliver therapy (e.g., one or more medicaments) to the subject
based on the condition
of the subject. Certain ambulatory medicament devices may be worn by subjects
constantly
(e.g., all day), or for a large portion of the day (e.g., during waking hours,
during sleep hours,
when not swimming, etc.) to enable continuous monitoring of the health
condition of the
subject and to deliver medicament as. In sonic embodiments, an AMD may be an
ambulatory
medicament device such as a medicament delivery pump. In some examples, an AMD
may be a
device that provides therapy in the form of electrical stimulation based on a
health condition of
a subject (e.g., heart rhythm or brain activity) determined using signals
received from one or
more sensors (e.g., heartbeat monitor or electrodes monitoring activity of the
brain). An
example of an electrical stimulation device is a cardiac pacemaker. A cardiac
pacemaker
generates electrical stimulation of the cardiac muscle to control heart
rhythms. Another
example of an electrical stimulation device is a deep brain stimulator to
treat Parkinson's
disease or movement disorders.
[0097] FIG-. IA.-FIG. IC show examples of blood glucose control systems that
provide blood
glucose control via an ambulatory medical device or AMD, such as a medicament
pump
connected to a subject. In FIG. 1A, the AMID 100 (medicament pump) is
connected to an
infusion site 102 using an infusion set 104. The AMD 100 (medicament pump) has
integrated
pump controls 106a that permit a user to view pump data and change therapy
settings via user
interaction with the pump controls 106a. A glucose level sensor 110 generates
a glucose level
signal that is received by the blood glucose control system.
100981 in FIG. 1B, the medicament pump 100 communicates with an external
electronic
device 108 (such as, for example, a smartphone or another remote device) via a
wireless data
connection. At least some of the pump controls 106a and 106b can be
manipulated via user
interaction with user interface elements of the external electronic device
108. The L4lucose level
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sensor 110 can also communicate with the ANID 100 (medicament pump) via a
wireless data.
connection.
[0099] In FIG. 1C, the AMD 100 (medicament pump) includes an integrated
cann.ula that
inserts into the infusion site 102 without a separate infusion set. At least
some of the pump
controls 106b can be manipulated via user interaction with user interface
elements of an
external electronic device 108. In some instances, pump controls can be
manipulated via user
interaction with user interface elements generated by a remote computing
environment (not
shown.), such as, for example, a cloud computing service, that connects to the
AMD 100
(medicament pump) via a direct or indirect electronic data connection.
[0100] Glucose control system.s typically include a user interface configured
to provide one or
more of therapy information, glucose level information, and/or therapy control
elements
capable of changing therapy settings via user interaction with interface
controls. For example,
the user can provide an indication of the amount of the manual bolus of
medicament from an
electronic device remote from the medicament pump. The user interface can be
implemented
via an electronic device that includes a display and one or more buttons,
switches, dials,
capacitive touch interfaces, or touchscreen interfaces. In some embodiments,
at least a portion
of the user interface is integrated with an ambulatory medicament pump that
can be tethered to
a body of a subject via an infusion set configured to facilitate subcutaneous
injection of one or
more glucose control agents. In certain embodiments, at least a portion of the
user interface is
implemented via an electronic device separate from the ambulatory medicament
pump, such as
a smartphone. In some embodiments, to protect patient privacy, the device
screen may include
a filter configured to have a predetermined viewing angle range such that
information cannot be
seen on the touchscreen when viewed from an angle outside of the predetermined
viewing
angle range.
[0101] FIG. 2A-FIG. 21) illustrate block diagrams showing example
configurations of a
glucose control system 200a/200b/200c/200d. As shown in FIG. 2A, a glucose
control system
200a can include a controller 202a having an electronic processor 204a and a
memory 210a that
stores instructions 208a executable by the electronic or hardware processor
204a. The
controller 202a can include a touchscreen controller. The controller 202a and
a pump 212 can
be integrated into an ambulatory medical device (AMD) 100. The AMD 100 can
have one or
more pumps 212. The pump 212 can be a regulatory agent pump and/or counter-
regulatory
agent pump. The AMD 100 can have one or more pumps 212, The AMD 100 can
include a
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transceiver or wireless electronic communications interface 214a for wireless
digital data.
communications with external electronic devices. When the instructions 208a
stored in memory
210a are executed by the electronic processor 204a, the controller 202a can
implement at least
a portion of a control algorithm that generates dose control signals for one
or more glucose
control agents based on time-varying glucose levels of the subject (e.g.,
received from a.
glucose level sensor 110 that is in communication with the AMD 100, e.g., a
medicament
pump) and one or more control parameters. The dose control signals, when
delivered to the
pump 212, result in dosing operations that control the blood glucose of a
subject. The pump
212 may be controlled by a pump controller. The pump controller receives the
dose control
signals and controls the operation of the pump 212 based on the received dose
control signals.
In some embodiments the pump controller may be integrated with the pump.
[0102] As shown in FIG. 2B, a glucose control system 200b can operate at least
partially via
execution of instructions 208b by an electronic or hardware processor 204b of
an external
electronic device 108 separate from the AMD 100, The external electronic
device 108 can.
include a transceiver 214b capable of establishing a wireless digital data
connection to the
AMD 100, and a controller 202b can implement at least a portion of a control
algorithm via
execution of instructions 208b stored in memory 210b. When the instructions
208b stored in
memory 210b are executed by the electronic processor 2041), the controller
202b can implement
at least a portion of a control algorithm that generates dose control signals
for one or more
glucose control agents based on time-varying glucose levels of the subject and
one or more
control parameters. The dose control signals, when delivered to the pump 212
(e.g., pump
controller of the pump 212), may result in dosing operations that control the
blood glucose of a
subject. In some embodiments, the dose control signals are transmitted from
the device
transceiver 214b to the AMID transceiver 214a over a short-range wireless data
connection 216.
The AMD 100 may receive the dose control signals and pass them to the pump 212
(e.g., pump
controller of the pump 212) for dosing operations.
101031 As shown in FIG. 2C, a glucose control system 200c can operate at least
partially via
execution of instructions 208c on an electronic processor or hardware 204c
integrated with a
remote computer or device 206, such as, for example, a cloud service. When the
instructions
208c stored in memory 210c are executed by the electronic processor 204c, the
controller 202c
can implement at least a portion of a control algorithm that generates dose
control signals for
one or more glucose control agents based on time-varying glucose levels of the
subject and one
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or more control parameters. The dose control signals, when delivered to the
pump 212, result in
dosing operations that control the blood glucose of a subject. In some
embodiments, the dose
control signals are transmitted from the remote computer WAN connection
interface 220c to
the AMD WAN connection interface 220a over an end-to-end wireless data
connection 218.
The AND 100 receives the dose control signals and passes them to the pump 212
for dosing
operations.
[0104] As shown in FIG. 2D, a glucose control system. 200d can have two or
more controllers
202a, 202b, 202c that cooperate to generate a dose control signal for dosing
operations by the
pump 212, In some examples, any one or any combination of controllers 202a,
202b, 202c can
include the touchscreen controller. A remote computer 206 can transmit or
receive data or
instructions passed through a WAN connection interface 220c via an end-to-end
wireless data
connection 218 to a WAN connection interface 220b of an external electronic
device 108. The
external electronic device 108 can transmit or receive data or instructions
passed through a
transceiver 214b via a short-range wireless data connection 216 to a
transceiver 214a of an
AMD 100, in some embodiments, the electronic device can be omitted, and the
controllers
202a, 202c of the AMD 100 and the remote computer 2.06 cooperate to generate
dose control
signals that are passed to the pump 212. In such embodiments, the AMD 100 may
have its own
WAN connection interface 220a to support a direct end-to-end wireless data
connection to the
remote computer 206.
[0105] As shown in FIG-. 3, in some embodiments, the glucose control system
200a includes
circuitry that implements an electronic communications interface (EU) 302
configured to send
and receive electronic data from one or more electronic devices. The ECI
includes a sensor
interface or glucose sensor interface 304 configured to receive a glucose
level signal from a
glucose level sensor 110 such as a continuous glucose monitor (CCM). Some CGMs
generate
the glucose level signal at fixed or periodic measurement intervals, such as
five-minute
intervals. The glucose level sensor 110 can be operatively connected to a
subject in order to
generate a glucose level signal that corresponds to a blood glucose estimate
or measurement of
the subject. The glucose level signal can be used by the controller 202a to
generate a dose
control signal. The dose control signal can be provided to a pump 212 via a
delivery device
interface or pump interface 306. In some embodiments, the sensor interface 304
connects to the
glucose level sensor 110 via a short-range wireless connection 308. In some
embodiments, the
pump interface 306 connects to the pump 212 via a short-range wireless
connection 310. In
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other embodiments, the pump interface 306 connects to the pump 212 via a local
data bus, such
as when the controller 202a, the ECI 302, and the pump 212 are integrated into
an AMD 100.
In addition, the pump 212 may be connected to a pump motor 312.
[0106] The controller can be configured to generate the dose control signal
using a control
algorithm that generates at least one of a basal dose, a correction dose,
and/or a meal dose.
Examples of control algorithms that can be used to generate these doses are
disclosed in U.S.
Patent Application Publication Nos. 2008/0208113, 2013/0245547, 2016/0331898,
and
2018/0220942 (referenced herein as the "Controller Disclosures"), the entire
contents of which
are incorporated by reference herein and made a part of this specification.
The correction dose
can include regulatory or counter-regulatory agent and can be generated using
a model-
predictive control (MPC) algorithm such as the one disclosed in the Controller
Disclosures. The
basal dose can include regulatory agent and can be generated using a basal
control algorithm
such as disclosed in the Controller Disclosures. The meal dose can include
regulatory agent and
can be gen.erated using a meal control algorithm such as disclosed in the
Controller
Disclosures. Additional aspects and improvements for at least some of these
controllers are
disclosed herein. The dose control signal can be transmitted to a pump
interface 306 via the
ECA 302 or can be transmitted to the pump interface 306 via an electrical
conductor when the
controller 202a is integrated in the same housing as the pump interface 306.
[0107] As shown in FIG-. 4A, the ambulatory medicament pump 212 can include
one or more
medicament cartridges or can have an integrated reservoir 408 of medicament.
The reservoir
408 may be integrated with the pump 212. A medicament stored in the reservoir
408 can be
delivered to the subject by operation of the pump 212.. In various
embodiments, the operation
of the pump 212 can be controlled by a controller 400. As shown in FIG. 4A,
the controller
400 can be configured to operate in "online mode" during time periods when the
controller
receives a glucose level signal 402 from a glucose level sensor 110. In online
mode, the control
algorithm generates a dose control signal 404 that implements regular
correction doses based
on values of the glucose level signal 402 and control parameters of the
control algorithm. The
pump 212 is configured to deliver at least correction doses and basal doses to
the subject
without substantial user intervention while the controller 400 remains in
online mode.
101081 As shown in FIG. 4B, the controller 400 can be configured to operate in
"offline
mode" during time periods when the controller does not receive a glucose level
signal 402 from
a sensor 110, at least during periods when the glucose level signal 402 is
expected but not
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received. In offline mode, the control algorithm generates a dose control
signal 404 that
implements correction doses in response to isolated glucose measurements 406
(such as, for
example, measurements obtained from the subject using glucose test strips) and
based on
control parameters of the control algorithm. The pump 212 is configured to
deliver basal doses
to the subject without substantial user intervention and can deliver
correction doses to the
subject in response to isolated 1_41ucose measurements 406 while the
controller 400 remains in
offline mode.
Example Ambulatory Medical Device (AMID)
[0109] In some embodiments, the ambulatory medicament device (AM)) can be a
portable or
wearable device (e.g., an insulin or hi-hormonal medicament pump) such as an
ambulatory
medicament pump (AMP) that provides life-saving treatment to a subject by
delivering one or
more medicaments (e.g., insulin and/or glucagon) to a subject. Some _ATVIDs
may continuously
monitor the health condition of a subject (e.g., blood glucose level) using a
sensor (e.g., a blood
glucose level sensor that can measure values corresponding to the blood
glucose level) and
deliver therapy such as one or more medicaments to the subject based on the
health condition
of the subject. For example, an ambulatory medicament pump (e.g., an insulin
pump or a hi-
hormonal pump) may monitor the blood glucose level in a subject using a
Continuous Glucose
Monitor (CGM) and adjust the dose or frequency of the medicament delivery
(e.g., insulin or
gluc,agon) accordingly. Certain ambulatory medicament devices may be worn by
subjects
constantly (e.g., all day), or for a large portion of the day (e.g., during
waking hours, during
sleep hours, when not swimming, etc.) to enable continuous monitoring of the
health condition
of the subject and to deliver medicament as desired. In some embodiments, the
AMD may be
an ambulatory medicament device such as a medicament delivery pump. In some
examples, the
AMD may be a device that provides therapy in the form of electrical
stimulation based on a
health condition of a subject (e.g., heart rhythm or brain activity')
determined using signals
received from one or more sensors (e.g., heartbeat monitor or electrodes
monitoring activity of
the brain).
[0110] FIG. 5A illustrates a three-dimensional (3D) view of an example
ambulatory medical
device 500 (e.g., an ambulatory medicament delivery pump such as an insulin
pump) including
a housing 502 with a wake button 506 and a touchscreen display 504. FIG. 5B is
an illustration
of a cross sectional view of the ambulatory medical device 500 shown in FIG.
5A. In this
example, all the electronic modules 508 are included inside the housing 502,
for example, as a
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single integrated electronic board. The wake button 506 may be any type of
button (e.g.,
capacitive, inductive, resistive, mechanical) that registers an input
generated by user interaction
with the wake button 506 to generate a wake signal, In some embodiments, the
wake signal is
generated by a sensor (e.g., a biometric sensor such as a fingerprint reader
or a retinal scanner,
an optical or RE proximity sensor, and the like), In various embodiments, the
wake signal may
be generated by user interaction with the touch screen display 504 or with an
alphanumeric pad
(not shown.).
[0111] The wake button 506 may be located at one edge of the AMD, more
specifically, at a
lower surface of the AMD for the user to conveniently interact (e.g., touch or
tap) while
holding or carrying the AMD. In some embodiments, there may be more than one
wake button
506.
[0112] in certain embodiments, a user may wake the AMD from a sleep state or
unlock the
AMD by interacting with the touch screen display 504 having via a wake
interface. When the
AMD is in a sleep state or other state/mode, the touchscreen controller may
not receive user
interaction or user interaction signals corresponding to user interaction
(e.g., via an
accelerometer or other motion sensors). As discussed herein, motion or motion
detection may
include all types of user gesture control inputs discussed herein, including
tapping the AMD
(including on the touchscreen), touching or other gesturing on the touchscreen
of the AMD,
shaking the AMD, moving of the AMD, or motioning proximate the AMD such as
handwaving
or other body part moving near, proximate, or in front of a motion sensor
(e.g., a camera) of the
AMD.
[0113] In certain cases, a single tap such as on the back of the AMD or
anywhere on the AMD
can correspond to wake touchscreen and/or snooze alarm control inputs as
discussed. Other
tapping for user gesture control inputs can include multi-tap such as double
or triple tapping
anywhere on the AMD, including the back of the AMD can correspond to wake
AMID, unlock
AMD, quick meal announcement (e.g., for bolus administration), confirmation of
control inputs
(such as when AMD is unlocked), and/or alarm acknowledgement control inputs as
discussed
herein. In some cases, multi-location-tap for gesture control inputs can be
utilized for
additional user gesture control inputs. For example, the AMID can generate a
user interface
with two dots on touchscreen; the two dots can be tapped or touched
simultaneously,
sequentially, or multi-tap to provide control inputs for various actions and
functions as
discussed herein. In some cases, the AMD can implement specific timing between
taps or
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touches or other gesture controls to register the control inputs as valid. For
example, there can.
be 100 to 600 milliseconds timing between taps. The timing between taps can be
adjusted by
the user.
[0114] In some embodiments, the user may wake the AMD by touching the wake
button 506
as the wake interface. In some cases, the wake button 506 may be incorporated
into the
alphanumeric pad. In some cases, the wake interface 3220 may be any one or
more keys of the
alphanumeric pad. In some cases, the wake interface may be a capacitive button
that detects a
change in capacitance. In some cases, a wake interface may have a computing
component for
interpreting and executing instructions from the signal processing component.
Thus, the wake
interface can follow a program that is dictated by the signal processing
component. In some
cases, a wake interface can include one or more additional user interfaces
mentioned above that
are configured to generate and provide a wake input (or wake signal) to the
CCM when
detecting a pre-set user interaction. Alternatively, or in addition, the wake
interface can be any
type of wake interface element of the AMD that a user can interact with to
wake at least a
feature (e.g., a touchscreen interface) of the AMD. In some cases, the wake
interface element
can be a physical button (e.g., a push button, a slide button, etc.), a
capacitive element, a
resistive element, or an inductive element. In some cases, the wake interface
element can be or
can include a biometric element, such as a fingerprint reader, an iris
scanner, a face detection
scanner, etc. In some cases, the AMD may wake in response to detection of a
particular
movement or motion. In some cases, the AMD may wake in response to detection
of a
particular movement or motion. For example, a determination that the
ambulatory medicament
device is being moved with a particular motion or within a line of sight or a
visual range of a
user may cause the AMD to awaken or cause the AMD to awake the touchscreen
interface of
the AMD. The AMD may determine that the AMD is being moved within a line of
sight of the
user based on the type of motion and/or the detection of a user's eyes via,
for example, an iris
scanner or a camera.
101151 in some examples, a wake signal may be generated based on facial
recognition or other
biornetric indicia. In some examples, the wake signal may be generated by a
wireless signal
such as a signal generated by an REID system or Bluetooth signals received
from an electronic
device or by detection of movement using one or more motion sensors such as an
accelerometer.
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[0116] The wake button 506, if touched, pressed, or held for a certain period
of time, may
generate a wake signal that activates the touchscreen display 504. In some
examples, touches
on the touchscreen display 504 are not registered until the wake button
activates the
touchscreen display. In some such examples, the Al\TD remains locked from
accepting at least
certain types of user interaction or settings modification until a gesture
(such as, for example,
any of the gesture interactions described with reference to any of the
embodiments disclosed
herein) is received after the touchscreen display 504 is activated by the wake
button. 506.
[0117] In some examples, after the touchscreen display 504 has been activated
by the wake
signal, a passcode may be required to unlock the touchscreen display.
[0118] FIG. 6 illustrates different modules that may be included in an.
example ambulatory
medical device 600. In some examples, all these modules may be integrated
together inside a
single housing (as shown in FIG. 5B), In some other examples, one or more
modules may be
individual modules contained in separate housings that communicate with the
main unit via a
wired or wireless communication links (e.g., Bluetooth). The modules included
in the AMD
may include a communication module 602, signal processing module 604, a
therapy delivery
module 606, a user interface module 608, and a control and computing module
610.
[0119] The control and computing module 610 may include one or more processors
614, a
main memory 616, a storage 618 that may include one or more non-transitory
memories and an
interface 612 that enables data and signal communication among the components
within the
control and computing module 610 as well as communication between the control
and
computing module and all other modules of the AM]). The main memory and the
storage each
may be divided into two or more memory locations or segments. The main memory
616 may
communicate with the other components of the control and computing module 610
as well as
other modules through the interface 612. Instructions may be transmitted to
the main memory
(e.g., from the storage) and the processor 614 executes instructions that are
communicated to
the processor through the main memory 616. The storage 618 may store data
while the control
and computing module 610 is powered or unpowered. The storage 618 may exchange
data with
the main memory directly or through the interface 612. The main memory 616 can
be any type
of memory that can store instructions and communicate them to the processor
614 and receive
executed instructions from the processor 614. Types of main memory include but
are not
limited to random access memory ("RAM") and read-only memory ("ROM"). The
processor
614 may be any type of general-purpose central processing unit ("CPU"). In
some
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embodiments, the control and computing module may include more than one
processor of any
type including, but not limited to complex programmable logic devices
("CPLDs"), field
programmable gate arrays ("FPG.As"), application-specific integrated circuits
(".ASICs") or the
like. The storage 618 can be any type of computer storage that can receive
data, store data, and
transmit data to the main memory 616 and possibly other modules of AMID. Types
of storage
618 that can be used in the control and computing module 610 include, but are
not limited to,
magnetic disk memory, optical disk memory, flash memory and the like. The
interface 612 may
include data transfer buses and electronic circuits configured to support data
exchange among
different components within the control and computing module 610. In some
examples, the
interface 612 may also support data an.d signal exchange among other modules
as well as data
exchange between an.y of the modules and the control and computing module 610,
[0120] The signal processing module 604 may include a plurality of
interconnected electronic
modules for signal conditioning and signal conversion (e.g., A-to-D and D-to-A
conversion)
configured to support communication and data exchange between different
modules, For
example, the signal processing module 604 may convert an analog signal
received from the
communication module 602 and convert it to a digital signal that can be
transmitted to the
control and computing module 610 (e.g., via the interface 612). As another
example, the signal
processing module may receive a digital control signal from the control and
computing module
610 and convert it to an analog signal that can be transmitted to the therapy
delivery module
606, for example, to control one or more pumps.
[0121] The therapy delivery module 606 may include one or more infusion pumps
configured
to deliver one or more medicaments to a subject. The medicaments may be stored
in one or
more medicament cartridges housed in the therapy delivery module 606. In some
examples, the
therapy delivery module may include electronic and mechanical components
configured to
control the infusion pumps based on the signals received from control and
computing module
610 (e.g., via the signal processing module 604).
[0122] The user interface module 608 may include a display to show various
information
about the AMD, medicament type and delivery schedule, software status, and the
like. Graphic
images and text may be shown by any display technology including, but not
limited to OLED,
LCD, or e-ink. In some embodiments, the AMD, may include a user interface
(e.g., an
alphanumeric pad) that lets a user enter information or interact with the AMID
to modify the
settings of the AMID, respond to request for certain actions (i.e., installing
a software) and the
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like. The alphanumeric pad may include a multitude of keys with numerical,
alphabetical, and
symbol characters. Keys of the alphanumeric pad may be capacitive or
mechanical. The user
may be a subject receiving medicament or therapy, or may be another user, such
as a clinician
or healthcare provider, or a parent or guardian of the subject. In some other
embodiments, the
AMD may include a touchscreen display that produces output and also accepts
input enabling a
two-way interaction between the user and the AMID. The touchscreen display may
be any input
surface that shows graphic images and text and also registers the position of
touches on the
input surface. The touchscreen display may accept input via capacitive touch,
resistive touch,
or other touch technology. The input surface of the touchscreen display can
register the
position of touches on the surface. In some examples, the touchscreen display
can register
multiple touches at once. In some embodiments, the alphanumeric pad is
displayed on the
touchscreen display. The touchscreen may present one or more user-interface
screens to a user
enabling the user to modify one or more therapy settings of the ambulatory
medicament device.
[0123] The communication module 602, may include one or more wireless
transceivers, one
or more antennas and plurality of electronic modules. Each transceiver may be
configured to
receive or transmit different types of signals based on different wireless
standards via the
antenna (e.g., an antenna chip). The transceiver tnay support communication
using a low power
wide area network (LPWAN) communication standard. In some examples, the
transceiver may
support communication with wide area networks such as a cellular network
transceiver that
enables 3G, 4G, 4G-LTE, or 5G. Further, the transceiver may support
communication via a
Narrowband Long-Term Evolution (NB-LTE), a NarroWband Internet-of-Things (NB-
IoT), or a
Long-Term Evolution Machine Type Communication (LTE-MTC) communication
connection
with the wireless wide area network. In yet other cases, the transceiver may
support Wi-Fi0
communication. In some examples, the transceiver may be capable of down-
converting and up-
converting a baseband or data signal from and to a carrier signal. In some
examples, the
communication module may wirelessly exchange data between other components of
the
ambulatory medical system (e.g., a sensor), a mobile device (e.g., smart
phone), a Wi-Fi
network, WLAN, a wireless router, a cellular tower, a Bluetooth device, and
the like. The
antenna chip may be capable of sending and receiving various types of wireless
signals
including, but not limited to, Bluetooth, LTE, or 3G. In some examples, the
communication
module may support direct communication between the AMID and a server or a
cloud network.
In some other examples the AMID may communicate with an intermediary device
(e.g., a smart
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phone). In some embodiments, the AMD may include an eSIM card that stores all
of the
information necessary to identify and authenticate a mobile subscriber. The
eSIM card may
allow the ambulatory device to transmit data on a very inexpensive TOT device
basis. In other
embodiments, the ambulatory medical device may be configured to transmit data
in a
narrowband communication protocol such as 2G or EDGE. Using the cellular
connection, the
ambulatory medical device may be paired with the mobile device at inception
and permit real-
time data access to the ambulatory medical device by a healthcare provider. In
certain
implementations, the ambulatory medical device may include a geolocation
receiver or
transceiver, such as a global positioning system (GPS) receiver.
Example Operation of the AMD
[0124] In some embodiments, the AMD may continuously, periodically, or
intermittently
receive information about one or more parameters that are correlated with a
health condition of
a subject (e.g., glucose level, glucose trend, heart rate, body movement
indicia, etc.). This
information may be encoded to a signal provided to AMD by a subject sensor 620
(e.g., a
wearable sensor that measured an analyte in the interstitial fluid) that is
connected to the
ambulatory medical device 600 main unit via a wired or wireless link (e.g.,
Bluetooth). In some
cases, the subject sensor 620can be any sensor that generates a signal or
status value associated
with one or more physiological indicators (or parameters) of a subject (e.g.,
heart rate, blood
pressure, body temperature, level of blood sugar, serum levels of various
hormones or other
analytes). In some such examples, the subject sensor can be a continuous
glucose monitoring
sensor (CGS). In some examples, the signal sent by the sensor may be received
by the
communication module 602 and transmitted to a signal processing module 604
that converts the
signal to a machine-readable signal (e.g., a digital signal). The signal
processed by the signal
processing module 604 may be transmitted to the control and computing module
610 where it is
analyzed to determine whether medicament should be delivered to the subject.
If it is
determined that medicament is needed, the control and computing module the
volume of the
medicament may calculate required dosage based on the information received
from the subject
sensor 620 and send a signal to the therapy module (e.g., via the signal
processing module) to
initiate the medicament delivery process to the subject.
[0125] All the procedures within the control and computing module 610 are
executed by the
processor 614 (or a plurality of processors) based on instructions provided by
one or more
software applications installed in one of the memories (e.g., the main memory)
of control and
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computing module 610. These procedures include, but are not limited to,
determining the need
for delivering medicament, determining the type of medicament and the required
dose,
determining the rate of delivery during a therapy session, providing
information (e.g., device
status, next delivery time, level of certain an.alytes in the subject's blood
and the like) via the
user interface module 608, processing the information received from a subject
sensor 620 via
the user interface module 608, and the like. In some embodiments, a first
software application
may control the AMD and may be installed on the main memory 616 while a second
software
application (e.g., different version) may be stored in the storage 618. In
some examples, the
first and second software applications may be both installed in the main
memory 616 but in
different locations or segments. In these examples, if needed, the control of
the device can be
switched from the first software application to the second software
application.
[0126] In some embodiments, the ambulatory medical device 600 may deliver
multiple types
of therapies that are selectable by a user or the control and computing module
610. For
example, the ambulatory medical device 600 may deliver the therapy of infusing
insulin into a
user and may also deliver the therapy of infusing glucagon into a user. In
some examples, the
user interface may include an option for the user to select an infusion of
insulin, glucagon, or
both insulin and glucagon. In other embodiments, other hormones, liquids, or
therapies may be
delivered. In some examples, the software application executed by the control
and computing
module 610, may determine the type of hormone that needs to be delivered, at
least partly
based on the information received from the subject sensor 620.
Communication and Networking
10127-1 FIG. 7 illustrates various methods and links that an ambulatory
medical device (e.g.,
the AMD 702) may use to establish a connection with a host computing system
704 in order to
obtain an application update. The host computing system 704 may be a server
706 or a
computing system within a cloud-based computing system 708 or other networked
computing
environment. The host computing system 704 may be part of a data center (e.g.,
the data center
of a health care provider).
101281 To obtain the application update, the A-N11) 702 may establish a
connection (e.g., using
its communication module) with the host computing system through an
intermediary device
710, such as a desktop computer, a mobile device (e.g., a smart phone, a
laptop, and the like).
In some examples, the intermediary device 710 can be an electronic device of a
user or the
subject (e.g., a computer in a clinic, a subject's home computer, a
smartphone, etc.) that has
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obtained a copy of the application update from the host computing system
directly or via
internet 714. In some other examples the AMID 702 may communicate with the
host computing
system 704 through a local area network 712 through a Wi-Fi connection.
Alternatively, or in
addition, the AMD 702 may establish a connection to the host computing system
704 via a
wide area network 716. Moreover, the communication connection established
between the
AMD 702 and the cloud computing service may be encrypted,
[0129] In some embodiments, the AMD 702 may establish a direct end-to-end
connection
over a wide area network 716 (e.g., a cellular network) with the host
computing system 704.
The method may include receiving a public key from the AMD 702. The public key
and a
private key stored in the host computing system 704 can be used to permit the
host computing
system 704 to decrypt data communications transmitted by the AMD 702. In some
implementations, establishing the direct end-to-end data connection includes
receiving a device
identifier associated with the AMD 702. The device identifier may be a unique
identifier
specific to the AMD 702. Further, establishing the direct end-to-end data
connection may
include determining that the AMD 702 is permitted to communicate with the
computing system
based at least in part on the device identifier. The device identifier may be
initially provided to
the networked-computing environment prior to provisioning of the AMD 702 to
the subject.
For example, the device identifier may be initially provided to the networked-
computing
environment as part of a manufacturing process for manufacturing the AMD 702.
The device
identifier may include or may be based on one or more of an Internet Protocol
(IP) address, a
Media Access Control (MAC) address, a serial number, or a subject identifier
of a subject that
receives therapy from the AMD 702. In some cases, the subject or a user
establishes or initiates
establishing the direct end-to-end data connection with the computing system.
In other cases,
the direct end-to-end data connection may be initiated or established without
action by the
subject or the user. For example, the direct end-to-end data connection may
occur automatically
at particular times or when the AMD 702. is in particular locations. This
automatic connection
may occur using information supplied to the AMD 702 at a time of manufacture,
shipment,
sale, or prescription to the subject. In some cases, the wide area network may
include, or may
communicate with, the internet 714.
[0130] In some embodiments, the ambulatory medical device (e.g., AMD 702) may
be
configured to communicate via the wide local area network 712 during
manufacture or prior to
being provisioned to the subject. For example, a manufacturer can register the
ambulatory
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medical device with a wireless wide-area network provider (e.g., T-Mobile or
Verizon) and
provide an International Mobile Equipment Identity (IMEI) number or serial
number for the
ambulatory medical device to the network provider. Moreover, any fees can be
negotiated or
paid between the manufacturer and the network provider or between the
subject's health
insurance and the network provider. Thus, the subject's ambulatory medical
device may be
configured to communicate via the network of the network provider without any
action by the
subject.
[0131] In some other examples, the ambulatory medical device may be pre-
registered or
authenticated with a computing network of the cloud services provider as part
of the
manufacturing process or before the ambulatory medical device is provided to
the subject. This
enables the ambulatory medical device to communicate over the wide area
network with the
computing system of the cloud services provider from day one without any or
with minimal
configuration by the subject. In sotne cases, a user, such as a healthcare
provider may register
or associate the ambulatory medical device with the subject at the computing
network of the
cloud services provider.
[0132] To enhance security, the ambulatory medical device may use a whitelist
that identifies
via a unique identifier (e.g., via an IP address, a MAC address, or a URL)
permitted cloud
servers or computing system of the cloud computing system. Further, the cloud
computing
service may have a whitelist that uses unique identifiers to specify
ambulatory medical devices
and/or other computing systems (e.g., remote display systems') that are
permitted to
communicate with the cloud computing system.
[0133] To enhance security, the ambulatory medical device may use a whitelist
that identifies
via a unique identifier (e.g., via an IP address, a MAC address, or a -URL)
permitted cloud
servers or computing system of the cloud computing system. Further, the cloud
computing
service may have a whitelist that uses unique identifiers to specify
ambulatory medical devices
and/or other computing systems (e.g., remote display systems) that are
permitted to
communicate with the cloud computing system. The whitelist may be stored in a
memory of the
ambulatory medical device. Further, the whitelist may be configured during
manufacture of the
ambulatory medical device. For example, the whitelist may be configured with
connection
information to establish communication with one or more computing systems of a
networked-
computing environment, Further, the ambulatory medical device may be
configured to execute
the specific computer-executable instructions to at least obtain an address of
the computing
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system from the whitelist and to establish a direct end-to-end data connection
to the computing
system of the networked-computing environment via a wireless wide area network
using the
address. Moreover, the ambulatory medical device may be configured to execute
the specific
computer-executable instructions to at least receive a public key from the
computing system of
the networked-computing environment,
Software Update of Ambulatory Medical Device
[0134] It is often the case that a computer application is updated after it is
released. In some
cases, the application is updated to patch bugs or vulnerabilities. In other
cases, the application
is updated or replaced with a new version to introduce new features or improve
existing
features, Regardless of the reason, it is often the case that an application
is shutdown or is not
executing while the application is updated. For most applications, there is
minimal to no harm
in shutting down or not executing an application while it is updated or
otherwise replaced. For
example, it is inconsequential that a video game, word processing, or
edutainment application
is not executing while it is updated,
[0135] However, it can be inconvenient, harmful, or, in some cases, life-
threatening to cause
an application on an ambulatory medical device to cease executing while it is
updated or
replaced by a new version of the application. If a subject or subject that is
receiving therapy
from the ambulatory medical device enters a state where therapy is desired or
needed while an
application or control software of the ambulatory medical device is being
updated or replaced,
harm may occur to the subject. For example, suppose the ambulatory medical
device is an
insulin pump, such as those that may be used by a type-1 diabetic. If the
insulin pump becomes
inoperative due to a software update process occurring at a time when a
subject's blood glucose
level exceeds a set-point or target range, the user may not receive a
necessary insulin -bolus
from the ambulatory medical device. Thus, it is desirable to modify reduce or
eliminate
disruption to subject care or therapy when updating applications, such as
control software, of
an ambulatory medical device.
[0136] in some embodiments, an ambulatory medical device includes a computer-
implemented method of updating an application executing on the ambulatory
medical device
without interrupting, or while causing minimal interruption, to therapy
provided by the
ambulatory medical device to a subject or subject. The method may generally be
performed by
a hardware processor, (e.g., a controller, and the like), included in an
ambulatory medical
device and based on a set of instructions that may be stored, for example, in
a non-transitory
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memory of the _AMD. The application update may be a new version of the
application, a
replacement or substitute application, or an application patch. In some
examples, the
application may be an older version of the application that has been used by
instances of the
ambulatory medical device for more than a threshold period of time and has
experienced less
than a threshold number of faults. The application update may be stored in one
or more host
computing systems. The application update may be pushed to the host computing
systems by a
company that manages or manufactured the ambulatory medical device or other
software
company that is authorized by the manufacturer or licensee of the device.
[0137] FIG. 8 is a flow diagram showing an example of a computer-implemented
method that
may be used by the AMD in order to detect and download an application update
from a host
computing system or other computer readable media in which a copy of the
application update
is stored. In certain aspects, an ambulatory medical device, such as a
medicament delivery
device or a medicament pump may receive an indication that an update is
available for an
application (block 802), such as control software or other software that
controls or facilitates
the operation of the ambulatory medical device. The software update may
include a binary
executable file for various processors of the ambulatory medical device. In
some embodiments,
the indication may be a determination made by a software or hardware module
included in an
ambulatory medical device of AMD. For example, the AMD may access a particular
host
computing system (e.g., using its communication module) to determine whether
an update is
available, based on set of update trigger conditions stored in a memory of
AMD. The set of
update trigger conditions may be defined/changed by a user and/or received by
AMD from a
host computing system. For example, a trigger condition may push the AMD to
periodically
search for an update at time intervals set by the user or received from a host
computing system.
Alternatively, or in addition, in response to a trigger (such as a user
command, the replacement
of medicament within the ambulatory medical device, the connecting to a
particular network, or
the connecting to a network using a particular communication transceiver
(e.g., Wi-Fi) or the
like), the ambulatory medical device may access a particular host computing
system to
determine whether an update is available to an application installed on the
AMD. The software
to be updated on the AMD may be currently executing on the ambulatory medical
device or
may be executed in future.
[0138] In some embodiments, the indication may a query received from the host
computing
system that may access the AMID to read and compare the software versions and
the hardware
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configuration (and warranty) to determine the eligibility of the ambulatory
medical device for a.
software upgrade. The serial number, the model number, and/or the software
version may be
used to determine software upgrade eligibility. In some embodiments, the
eligibility may be
determined based on the geoposition of the device and/or whether the device is
connected to a
local area network (such as for example, a Wi-Fi network) or a wide area
network (such as, for
example, a cellular network). In various embodiments, the ambulatory medical
device may
have an antenna that provides the device with GPS, text or picture messaging,
telephone
calling, and data transfer capabilities. Software update may be provided on a
limited release
with test groups of varying sizes, e.g., 1-100 or 1-1000 or 1-10000. There may
be a phase
rollout of the software updates. In some embodiments, the AMD may respond to
an upgrade
eligibility request with a version of the first software or a model
identification information of
the ambulatory medical device or a manufacturing date of the ambulatory
medical device.
[0139] If it is determined that an update is available to the application
executing on the
ambulatory medical device, the ambulatory medical device may establish a
connection 804 to a
host computing system that hosts the update to the application. Such
connection may be
established via one or more links or methods discussed above with reference to
FIG. 7.
[0140] Once a connection is established, at block 806, the ambulatory medical
device may
download the application update or application update from the host computing
system over the
connection. In some examples, the ambulatory medical device may download an
image of the
application update from the host computing system. While the application
update is being
downloaded, an existing version of the application on the ambulatory medical
device may
continue to execute. Thus, there is little or no interruption to therapy
provided by the
ambulatory medical device while the application update is being obtained by
the ambulatory
medical device.
[0141] Once the application update is obtained, the ambulatory medical device
(e.g., using its
control and computing module) may perform one or more operations to confirm
that the
application update was successfully downloaded from the application host
system and that the
download was not corrupted 808. For example, the ambulatory medical device may
calculate a
hash or checksum value from the downloaded application update. This hash or
checksum value
may be compared with one received from the application host system. If the
calculated hash or
checksum value matches the received hash or checksum value, then it may be
determined that
the download is both complete and not corrupt. Further, the ambulatory medical
device may
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use the checksum, a tag, a payload size, or any other method to confirm that
the download of
the application update is complete and not corrupt. If it is determined that
the download is
corrupt 808, the AMD discards the corrupt copy and downloads another copy of
the update
806. If it is determined that the download is complete and not corrupt, the
AMID may proceed
to the installation step 810 wherein the application update may be installed
on the AM[)
without interrupting the ongoing or upcoming therapy sessions.
[0142] FIG. 9-F1G. 11 are flow diagrams illustrating examples of computer-
implemented
methods that may be used by the AMID to install a downloaded application
update without
disrupting the therapy provided to a subject.
[0143] In the example method illustrated in FIG. 9, if it is verified that an
uncorrupted copy of
the update for an application is successfully downloaded 902 (e.g., using the
procedure
described above with reference to FIG, 8), the control and computing module
610 (CCM 610)
of the AMD may determine the amount of time required to install the
application update 904
and wait for a trigger signal 906 to initiate installation process. In some
examples, the CCM
may notify to the user 908 through a user interface (e.g., a touchscreen
display), that an update
is ready for installation. The notification may include the installation time
and information
about the update. In such examples, if a trigger is not received, CCM may send
one or more
notifications to the user indicating that a new update is ready for
installation. In some
examples, the trigger may be the confirmation that the application was
successfully
downloaded. Alternatively, or in addition, the trigger may be a user command
received based
on an interaction by a user or subject with a user interface that is part of
or that communicates
with the ambulatory medical device.
[0144] The installation time may be determined by the CCM based on data or
metadata
provided with the downloaded application update. For example, the application
update may
include a file (e.g., a text file or configuration file) that includes the
install time. The
installation time may be determined by the manufacturer of the ambulatory
medical device or
the publisher of the application update. For example, the developer of the
software update may
average the install time across several test devices to determine the install
time metadata that is
provided with the software update. General purpose computers have a wide
variety of
configurations and the performance of a general-purpose computer may vary
depending on the
applications executing at a particular time. Thus, the determination of
install time for an
application based on the measurement of install time on a test device is
typically unreliable,
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However, as an ambulatory medical device is often a special-purpose device
that is designed to
perform a specific function (e.g., provide insulin to a subject), an install
time determined
during testing by a manufacturer may in many cases be a reliable determination
of install time
on an ambulatory medical device of a subject. Alternatively, or in addition,
to determining the
install time based on testing by a manufacturer, the install time of an
application update may be
determined or estimated based on a size of the application update. In some
cases, the provided
or estimated install time may include a buffer. In other words, an additional
amount of time
may be added to the install time to account for variances in operating
condition of the
ambulatory medical device or inaccuracies in the estimated install time.
[0145] If a trigger is received 906, the CCM may check for any ongoing therapy
session 910.
If the no therapy is currently being administered, the CCM determines the next
therapy time
914 (or the time left until the next therapy session). If therapy is currently
being administered
the installation will be delayed 912 until the therapy session is compete.
Once the current
therapy session is complete, the CCM may determine the time remaining until
next therapy
session 914 (e.g., during which medicament, such as insulin is delivered to a
subject).
[0146] In some cases, the determination of the next time that therapy is to be
delivered may be
an estimate based on historical delivery of therapy, a present condition of
the subject (e.g.,
when a glucose level is of a subject is at the center of a desired range, the
next therapy delivery
time may be estimated to be further off than when the glucose level is at the
edge of the desired
range), and/or an indication provided by a user or subject (e.g., an
indication that the user is
planning to have a meal, to exercise, or to go to sleep). Alternatively, or in
addition, the
determination of the next time that therapy is to be delivered may be based on
a scheduled
delivery of therapy (e.g., every 5 minutes or every hour).
101471 As previously described, it is desirable to prevent disruption to
therapy during the
application update process. Thus, after the next therapy time is determined
914, the estimated
install time may be compared 916 to the determined or estimated next therapy
delivery time to
determine whether the installation of the application update can be completed
before the next
therapy delivery to the subject. If it is determined that the time left until
the next therapy
session is sufficiently longer than the determined time for completing the
installation,
installation of the application updated may be initiated 918. In some
examples, the determined
time to the next therapy session has to be longer than the determined
installation time by a
threshold value. Such threshold value may be different for different
application updates and/or
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the type of next therapy session. If it is determined that the application
installation cannot be
completed before the next therapy delivery (or the time left until the next
therapy is not larger
than that estimated installation time by a threshold value), the installation
of the application
may be delayed, regardless of receipt of the trigger. In this case, the CCM
may wait for the
next therapy to be completed and then determine a new therapy time 914. This
process may be
repeated until CCM determines that the update can be installed without
interrupting an
expected or scheduled therapy by the ambulatory medical device. In some
examples, a new
determination may be made before completion of the next therapy, to determine
whether
installation may be completed prior to a subsequent therapy time after the
next therapy time.
[0148] In some cases, a time when the application can be installed without
interrupting
therapy may not be identified. In some such cases, a user (e.g., a clinician
or other medical
provider, or a subject) may be provided with an alert that an application
update is available
and/or that the application update cannot be installed without interrupting
therapy. The user
may be provided with an. option as to whether to permit the update and/or when
to install the
application update. The option may include presenting the user with the
estimated install time
enabling the user to schedule the application update at a time when
interruptions to therapy
may be minimal or when an alternative source of therapy (e.g., injection
therapy) can be
[0149] In some embodiments, once it is verified that an uncorrupted copy of
the update for an
application is successfully downloaded 902, the AMD's control and computing
module (CCM)
may notify the user and wait for a trigger signal before determining the
installation time. Once
the trigger has been received, the CCM initiates the installation process of
the downloaded
copy of the application update without interrupting therapy provided by the
ambulatory medical
device to the subject. In such embodiments, the application update may be
installed in a
different memory location than the memory location where the original
application is installed
and executed.
[0150] FIG. 10 is flow diagram illustrating an example of a computer-
implemented method
that may be used by the AMD in order to install a second application that is
an update to a first
application executing on the ambulatory medical device, without disrupting the
therapy
provided to a. subject. In this example, once the control and computing module
610 (CCM 610)
of the AMD verifies that an uncorrupted copy of the second application is
successfUlly
downloaded 1002 (e.g., using the procedure described above with reference to
FIG. 8), the
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CCM may initiate the installation process of the second application 1004
without interrupting
the execution of the first application. The CCM may confirm 1006 the
successful installation of
the second application and wait for a trigger signal 1010 to initiate the
execution of the second
application in place of the first application. In some examples, the
installation of the second
application may be confirmed by sending a notification the user 1008 via a
user interface of the
AMD. In some examples, the CCM may determine the amount of time required for
switching
the control of AMID to from the first application to the second application.
The n.otification may
include information about the update and the time required for switching
between the
applications. In sonic examples, the trigger may be a user command received
based on an
interaction by a user or subject with a user interface that is part of or that
communicates with
the ambulatory medical device. In such examples, if a trigger is not received
the AMID may
send one or more notifications to the user indicating that a new update is
ready for installation.
If a trigger is received, the CCM may check for any ongoing therapy session
1012, If the no
therapy is currently being administered, the CCM determines the next therapy
time 1016 (or the
time left until the next therapy session). If therapy is currently being
administered the
installation will be delayed 1014 until the therapy session is compete. Once
the current therapy
session is complete, the CCM may determine the time remaining until next
therapy session
1016. The estimated next therapy delivery time may be compared to a set
threshold time to
determine whether the switching from the first application to the second
application can be
performed without interfering with the next therapy session. If it is
determined that the time left
until the next therapy session is longer than the set threshold time 1018, the
execution of the
second application will be initiated and the execution of the first
application will be halted
1020. In some examples, the set threshold time may be determined by the CCM at
least partly
based on the time required to execute of the second application and halt the
first application. In
some other examples, the set threshold time may be received from a host
computing system.
101511 in some embodiments, the performance of an application update may be
tested before
switching control of the AMD to the application update. FIG. 11 illustrate an
example method
that may be used by such embodiment. First the AMD verifies that an
uncorrupted copy of the
update for a first application, is successfully downloaded 1102 (e.g., using
the procedure
described above with reference to FIG. 8). Next the AMID may install 1104 and
execute 1106
the downloaded copy of the second application without interrupting the
execution of the first
application and therefore the therapy that might be provided by the ambulatory
medical device
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to the subject. In some examples, the second application update may be
installed to a separate
portion (e.g., a separate execution space or separate memory) from the portion
where the first
application is installed and is being executed. The Control and computing
module 610 (CCM
610) of the AMID may determine a minimum set of operating conditions 1108 and
then
determine whether the minimum set of operating conditions are satisfied by the
second
application 1110. In some cases, the minimum set of operating conditions may
relate to
maintaining therapy provided by the ambulatory medical device to the subject.
If at block 1110
it is determined that the minimum set of operating condition.s are not
satisfied by the second
application, the AMD may wait for an indication that a third application is
available 1112 and
repeat the procedure described above to evaluate the performance of the third
application, If it
is determined that the minimum set of operating conditions are satisfied by
the second
application, the AMID may check for an ongoing therapy session 1114. If it is
determined that
currently n.o therapy is provided to a subject, C(71\4. may switch the control
of the ambulatory
medical device from the first application to the second application 1118. if
currently therapy is
provided to a subject, the CCM may wait until the therapy session is competed
1116 and then
switch the control of the ArYID from the first application to the second
application.
10152-1 in some cases, the ambulatory medical device may be updated (or
downgraded) to add
(or remove) features from the ambulatory medical device. For example, the
ambulatory medical
device may initially provide only insulin therapy. At sonic point in time, the
ambulatory
medical device may be upgraded to include hi-hormonal control (e.g., to
provide both insulin
therapy and counter-regulatory agent (e.g., Glucagon) therapy). The upgrade
may be based on
newly available features and/or based on a decision by a user to purchase or
otherwise obtain
additional features. Similarly, a user may opt to downgrade therapy from hi-
hormonal to
insulin-only therapy. Alternatively, the upgrade or downgrade may be made
based on the
availability of medicament. In some examples, a first update can be a first
application version
including a first feature set (e.g., providing insulin therapy) and a second
update can be a
second application version including a second feature set (e.g., provide both
insulin therapy and
Glucagon therapy). In some such examples the first feature set may include a
subset of the
second feature set. In some other examples, the first feature set may include
a partially
overlapping set of features with the second feature set.
[0153] In some examples a computer-implemented method that may be used by the
AMID in
order to detect, download and install an update to an application executing on
the ambulatory
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medical device wherein the application includes one of a first application
version including a
first feature set or a second application version including a second feature
set. In some
examples, the first feature set may include partially overlapping set of
features with the second
feature set. In some other examples, the first feature set may include
partially overlappin.g set
of features with the second feature set. The AMD may receive an indication of
availability of
the application update, download the application update and verify that an
uncorrupted image
of the application update is successfully downloaded (e.g., using the
procedure described above
with reference to FIG. 8), Next, the control and computing module (CCM 610) of
the AMD
may initiate the installation process of the application update image without
interrupting the
execution of the application. In some examples, the indication received by the
AMD 802 (with
reference to FIG. 8), may include information about application update being
an update to the
first application version or to the second application version. In some such
examples, the CCM
610 may determine the version of the application update and download the
application update
image based on the determined version,
[0154] In some embodiments, any downloaded application update may be installed
to a
separate portion (e.g., a separate execution space or separate memory) from a
currently
executing version of the application. Once installation of the application is
complete and the
application is verified as being successfully installed, the active version of
the application can
be switched. For example, control of the ambulatory medical device can be
provided to the
updated application, the previously executing application can be ceased or
halted. The old
application can then be removed or kept as backup. Determining when to switch
which version
of the application is active may follow a similar process as previously
described for identifying
a next therapy delivery time and selecting a time to switch active versions of
the application
when there will not be an interruption to the therapy provided by the
ambulatory medical
device.
[0155] In some embodiments, the ambulatory medical device may be configured to
store
multiple instances of an application (e.g., ambulatory medical device control
software). For
example, the ambulatory medical device may have a current, or first, version
of the application
that it is installed in a first memory location (e.g., in the main memory 616)
and is executing to,
for example, control therapy provided by a subject. Further, the ambulatory
medical device
may include an updated, or second version of the application installed in a
second memory
location (e.g., in the main memory 616). The update of the second version may
have been
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downloaded and installed (e.g., in a prior to detection of the fault). In such
embodiments, when
a fault is detected during execution of the first version of the application,
the ambulatory
medical device may initiate the execution of the second version of the
application and then
switch control of the AMD to the second version of the application to maintain
therapy to the
subject.
[0156] In some examples, the second version of the application installed on
the AMD may be
a version older than the first version, or version that may not have track a
record of stability
and reliability. FIG. 12 is a flow diagram for such examples. Once an
application-fa.ult is
detected during execution of the first version 1202, the control and computing
module 610
(CCM) of the AMD may switch the control of the AMD to the second version of
the
application 1204 while establishing a connection with a host computing system
configured to
host a third update and download the third update 1206. The third version of
the application
may be a new version, a version prior to the first version, an update to the
first application that
addresses the detected application-fault or an older version that satisfies
the conditions to be
classified as a "safe version" (e.g., less than a threshold number or rate of
faults over a
minimum period of time). The second version (installed in the device) may
control the AMD
while the third version is being downloaded and installed 1208 without
interrupting the
therapy. Once the download of the third version is complete, the CCM may
initiate the
installation process of the downloaded copy of the third application and
switch control of the
ambulatory medical device form the second application to the third application
1210 without
interrupting therapy provided by the ambulatory medical device to the subject
[0157] in yet other embodiments, a "safe version" of the application may have
been installed
on the ambulatory medical device prior to detection of a fault. The safe
version of the
application may include a version of the application that has been used by
instances of the
ambulatory medical device for more than a threshold period of time and has
experienced less
than a threshold number of faults. For example, the safe version of the
application may be a
two-year old version of the application that has demonstrably had less than a
threshold number
of faults occur over the period of two years. This safe version of the
application may have less
features than the first or second version of the application. However, when a
fault is detected
during execution of the first or second version of the application, the
ambulatory medical
device may switch control of the device to the safe version of the application
to maintain
therapy to the subject.
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[0158] In some cases, if there is an issue installing an updated version of
the application, the
ambulatory medical device may revert to the current version or a safe version
installed on the
AMD.
[0159] In some other examples, the AMD may be triggered to establish a
connection with the
host computing system and search for the second version once a fault is
detected during
execution of the first version. In these examples, the ambulatory medical
device may revert to
the safe version (installed in the device) while downloading and installing
the second version
without interrupting the therapy.
[0160] FIG. 13 is a flow diagram illustrating yet another example of a method
of responding
to a. fault detection by the AMD. In this example, once an application-fault
is detected during
execution of the first version of an application 1.302, the control and
computing module 610
(CCM 610) of the AMD may look for a second version of the application 1304 in
the main
memory or the storage. If it is determined that the second version has been
already
downloaded, the CCM will determine 1306 whether the second version of the
application is
installed in a memory location and is ready to be executed. If it is
determined that the second
version of the application, is installed, the control of the AMD will be
switched to the second
version of the application 1308. With reference to block 1306, if CCM
determines that the
second version exists in the memory, but it is not installed, it will switch
the control of the
AMD to a safe version that may be already installed 1316 and then initiates
the installation
1318 of the second version. Once the installation of the second version is
complete, the CCM
may switch control of the AMD from the safe version of the application to the
second version
of the application. In some embodiments, after the control of the AMID is
switched to the
second version of the application, the CCM may search for a third version of
the application
1310 that may be an update to the previously downloaded second version. If a
third version is
found, the CCM may download and install the third version 1312 and switch the
control of the
AMD to the third version 1314. With reference to block 1304, if the CCM cannot
find a second
version of the application in a memory or storage location, it will switch the
control of the
AMD to a safe version of the application 1320 that may be installed in a
memory location (e.g.,
in the main memory or in the storage) and then search for a third version of
the application
1310. If a third version is found, the system may download and install the
third version 1312
and switch the control of the device to the third version 1314,
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[0161] In some embodiments, when an application-fault of an application
executing on the
ambulatory medical device is detected, the AMD may transmit an indication of
the application-
fault to the host computing system of a manufacturer or maintenance service of
the ambulatory
medical device. In some other embodiments, the .AMD may notify the user when
an
application-fault occurs through a user interface of the AMD or user interface
communicating
with the AMID.
Direct Network-Connected Medical Device Communication and Remote Viewing
[0162] An ambulatory medical device, such as an. ambulatory medicament device
(e.g., blood
glucose control system (e.g., an insulin pump or a bi-hormonal pump that
includes insulin and a
counter-regulatory agent), a pacemaker, or any type of medical device that may
be connected to
a subject to provide therapy to the subject, can generate a significant amount
of data related to
therapy provided to a subject (therapy data). This therapy data may be useful
for the subject, a
healthcare provider, or other users (e.g., parent or guardian) to actively
manage the subject's
health condition. For example, the therapy data may be useful to determine
whether a
modification to therapy may be desirable or to confirm that intended therapy
is being delivered
at the right time. In other examples the data may be used to generate an
alerts about the health
condition of the subject when therapy data indicates that immediate attention
is needed with
regards to subject' health condition,
[0163] Various aspects of accessing the therapy data or other types of data
stored in a memory
of the AMD needs proper management in order to provide uninterrupted, secure,
and easy
access to authorized users. As described above, the procedures and task
performed by an AMD,
including those associated with data transfer management, may be associated
with certain
computer-executable instructions stored and executed by the control and
computing module
610 of the AMD 600. As such, different AMD configurations used for various
data transfer
management tasks, may be configurations of the control and computing module
610 of the
AMD 600.
[0164] Accessing the data in the ambulatory medical device can be problematic
in some cases.
For example, accessing the data may require a user to connect the ambulatory
medical device to
a computer to upload the data. This places a burden on the user to remember to
connect the
ambulatory medical device. Further, during the period when the device is
connected to the
computer, the subject may not be receiving therapy from the ambulatory medical
device. In
some cases, the subject may not be capable of connecting the device to the
computer (e.g.,
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when the AMID is not within range of the local device) and may not have
someone available to
assist the subject. Thus, a direct end-to-end connection to a computing system
that (e.g.,
computing system of a healthcare provider) can safely share data (e.g.,
therapy data) with
authorized users may facilitate data management and access.
[0165] FIG. 14 is a block diagram illustrating an example network
configuration wherein the
AMD 1402 is directly connected to a computing system 1406. In some cases, the
AMD 1402
may receive data from one or more environmental sensors 1,404 and/or one or
more medical
sensors 1408 (e.g., a glucose sensor operatively connected to a subject. The
computing system
1406 may be part of networked computing environment 1412 (e.g., a data center,
networked
computing system), or cloud network 1410 or cloud computing system of a cloud
service
provider. The computing system may include one or more non-transitional
memories and one
or more hardware processors configured to execute the computer-executable
instruction.s stored
in one or more non-transitional memories. In some such examples, the
procedures performed
by the computing system may be associated with the execution of certain
computer-executable
instructions stored in a memory of the computing system by a hardware
processor of the
computing system.
[0166] In some examples, the direct end-to-end data connection may be
supported by one or
more transceivers in AMD's communication module 602. For examples, a direct
connection
may be established between the A.MD 1402 and the computing system 1406 over a
wide area
network (e.g., a cellular network) without using an intermediary system using
various wireless
standards and technologies (e.g., 4G, 5G and the like). In some examples, the
transceiver may
support communication via communication standards, including but not limited
to, low power
wide area network (LP-WAN), Narrowband Long-Term Evolution (NB-LIE),
Narrowband
Internet-of-Things (NB-loT), or Long-Term Evolution Machine Type Communication
(LIE-
MTC). In some cases, the transceiver is always on, and in other cases, the
transceiver may be
activated when a data transfer is scheduled, requested, or activated. In some
cases, the
capability of the ambulatory medical device 1402 to communicate with the
computing system
may be activated during manufacture or before providing the device to a
subject.
[0167] In some cases, the subject or a user establishes or initiates
establishing the direct end-
to-end data connection with the computing system. For example, the subject may
interact with
a user interface to cause the ambulatory medical device to communicate with
the cloud
computing service, In other cases, the direct end-to-end data connection may
be initiated or
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established without action by the subject or the user. For example, the direct
end-to-end data.
connection may occur automatically at particular times or when the ambulatory
medical device
is in particular locations. This automatic connection may occur using
information supplied to
the ambulatory medical device at a time of manufacture, shipment, sale, or
prescription to the
subject. Further, in some cases, the ambulatory medical device can communicate
with the
computing system without having access to a Wi-Fi network or a local area
network (LAN).
For example, the ambulatory medical device may communicate using a cellular or
other wide
area network. Further, in some cases, the interaction by the user with the
ambulatory medical
device may be relatively minimal or simple compared to traditional network
communication.
For example, a user may push a single button (e.g., an "upload" button) to
trigger establishing
of a connection with the cloud computing service arid causing data to be
provided from the
ambulatory medical device to the cloud computing service.
[0168] In some cases, the ambulatory medical device may be turned on and
paired with the
wireless wide area network (e.g., a cellular network) at the time of
manufacture, or prior to
being provided to a subject. Further, the ambulatory medical device may be
authenticated with
the networked-computing environment as part of the manufacturing process
[0169] Further, establishing the direct end-to-end data connection may include
determining
that the ambulatory medical device is permitted to communicate with the
computing system
based at least in part on the device identifier.
[0170] In some implementations, establishing the direct end-to-end data
connection may
include determining that the ambulatory medical device is permitted to
communicate with the
computing system based at least in part on a device identifier associated with
the ambulatory
medical device. The device identifier may be a unique identifier specific to
the ambulatory
medical device. The device identifier may include or may be based on one or
more of an
Internet Protocol (IP) address, a Media Access Control (MAC) address, a serial
number, or a
subject identifier of a subject that receives therapy from the ambulatory
medical device.
101711 Further, establishing the direct end-to-end data connection may include
determining
that the ambulatory medical device is permitted to communicate with the
computing system
based at least in part on the device identifier. The device identifier may be
initially provided to
the networked-computing environment prior to provisioning of the ambulatory
medical device
to the subject. For example, the device identifier may be initially provided
to the networked-
computing environment as part of a manufacturing process for manufacturing the
ambulatory
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medical device. The request may include a device identifier associated with
the ambulatory
medical device.
[0172] The ambulatory medical device may be configured to at least identify a
computing
system 1406 of a networked computing environment 1412 based on a whitelist of
one or more
approved computing systems. The whitelist may be stored in a memory of the AMD
1402 (e.g.,
a memory in the control and computing module of the AMD), Further, the
whitelist may be
configured during manufacture of the ambulatory medical device. For example,
the whitelist
may be configured with connection information to establish communication with
one or more
computing systems of a networked-computing environment. Further, the
ambulatory medical
device may be configured to at least obtain an address of the computing system
from the
whitelist and to establish a direct end-to-end data connection to the
computing system of the
networked-computing environment via a wireless wide area network using the
address. The
whitelist may include unique identifiers, such as MAC addresses or static IP
addresses that are
associated with computing systems of the cloud services provider,
[0173] To enhance security, the ambulatory medical device may use a whitelist
that identifies
via a unique identifier (e.g., via an IP address, a MAC address, or a URI)
permitted cloud
servers or computing systems in networked computing environment. Further, the
cloud
computing service may have a whitelist that uses unique identifiers to specify
ambulatory
medical devices and/or other computing systems (e.g., remote display systems)
that are
permitted to communicate with the cloud computing system.
10174-1 When the AMD communicates data over a network, there is a risk of a
data breach.
Thus, to improve security, all communication between the ambulatory medical
device and the
computing may be based on a secure data transmission method. For example, the
ambulatory
medical device may encrypt all data using an asymmetric key.
101751 in some examples, the therapy data may be encrypted before being
transferred to the
computing system. In these examplesõkMD may have a public key and a private
key stored in
one of its memories permitting the AMD to encrypt data communications
transmitted by the
ambulatory medical device to the computing system. In these examples, AMD may
transmit the
public key along with the therapy data to the computing system. The public key
provided by the
AMD and a private key stored on the computing system may permit the computing
system to
decrypt the data received from the ambulatory medical device In some such
cases, the public
key may timeout and a new public key may be obtained from the ambulatory
medical device to
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facilitate decrypting subsequent communications from the ambulatory medical
device. In some
cases, the public key may be associated with a time-to-live (ITL) value. In
some such cases,
the public key may timeout and a new public key may be obtained from the
ambulatory medical
device to facilitate decrypting subsequent communications from the ambulatory
medical
device.
[0176] Moreover, the secure data transmission may include generating a shared
secret based at
least in part on the public key and the private key. In some such cases,
decrypting the encrypted
data includes using the shared secret to decrypt the encrypted data. In some
examples, shared
secret may be established using public key exchange algorithm (e.g., Diffie-
Hellman key
exchange algorithm).
[0177] In some cases, the computing system may be configured to transfer the
data after
receiving a request to transfer data stored on the ambulatory medical device
to the computing
system over the direct end-to-end data connection via the wireless wide area
network.
Responsive to receiving the request to transfer data stored on the ambulatory
medical device to
the computing system, the computing system may be configured to receive, via
the direct end-
to-end data connection.
[0178] Once a connection is established and the therapy data is transferred to
the computing
system, the computing system may analyze the therapy data received from the
ambulatory
medical device and generate a therapy report. Further, the computing system
may detect an
alarm condition, based on therapy data analysis, and generate an alarm that
may be provided to
the subject, authorized user (e.g., healthcare provider). In some cases, the
therapy data may
trigger an automatic response by the computing system. For example, the AMD
may determine
that a medicament or another disposable is running low based on the received
data and may
automatically reorder the medicament or the disposable.
101791 In some cases, the computing system may periodically receive data from
the
ambulatory medical device based on a regular schedule. Alternatively, or in
addition, the data
may be received in response to a command or when the ambulatory medical device
determines
it is within a certain location. For example, when the ambulatory medical
device determines it
is within a subject's home or at a healthcare provider's office based on a
local area network
connection or based on a geolocation system (e.g., a global positioning system
(GPS)). In some
implementations, additional encrypted data is received from the ambulatory
medical device on
an intermittent basis. Alternatively, or in addition, additional encrypted
data is received from
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the ambulatory medical device on a continuous basis for at least a time
period. The ambulatory
medical device may be configured to transmit data as it is generated, or
shortly thereafter, (e.g.,
in real or near real-time (e.g., within a few millisecond, seconds, or minutes
of the data being
generated)), or in bulk at specified periods of time. Transmitting the data in
bulk at particular
time periods may extend battery life, but may provide for less up-to-date
analysis. Data can be
made available on-demand by keeping the transceiver always on, but this may
consume more
power. Thus, the scheduling of data transfer may be balanced based on
different considerations,
such as: (1) power consumption and (2) need to share information with
authorized users or
systems.
[0180] In some cases, the computing system may be used as a backup for the
ambulatory
medical device. For example, the ambulatory medical device can backup data to
the computing
system every night, when it is charging, or when it is in proximity to home or
a physician's
office (e.g., when subject is in waiting room., the device may upload data
that the physician can
then access). Moreover, if the ambulatory medical device is replaced (e.g.,
for a new model or
to replace a damaged device), the device can automatically synchronize with
the computing
system to obtain subject-specific configuration or therapy control data.
Therapy Data and Therapy Report
[0181] in sonic examples, the therapy data may include dose or dosage data
corresponding to
one or more doses of medicament provided by the ambulatory medical device to
the subject.
Further, the therapy data may include subject data corresponding to a medical
or physiological
state of the subject as determined by the ambulatory medical device.
[0182] In other examples, the data provided to computing system may include
any type of
data that may be measured or obtained by the ambulatory medical device and may
include a
record of therapy provided by the ambulatory medical device. For example, the
data may
include a time that therapy was provided, an amount of medicament provided as
part of the
therapy, a measure of one or more vital signs of the subject, a measure of
blood glucose levels
at different times for the subject, a location of the subject, and the like.
[0183] In some cases, the therapy data may be used to track the use of
disposables, such as
insulin or other medicament, or insulin pump site kits. In some cases, the
computing system
may automatically order or reorder disposables at a particular time based on
tracking the use of
the disposable. Alternatively, or in addition, the reordering of the
disposables may be initiated
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or performed from the ambulatory medical device (e.g., via a wireless wide
area network or via
a local connection through a separate electronic device).
[0184] In some cases, the data transferred to the computing systems may
include operation
data corresponding to operation of the ambulatory medical device.
Alternatively, or in addition,
the data may further include error data corresponding to an error in operation
of the ambulatory
medical device.
[0185] In some examples, the data, therapy data and/or the therapy report may
be stored in a.
memory of the computing system and/or at a storage of the networked-computing
environment.
[0186] In some cases, the method may include converting the therapy data from
one format to
another format. For example, the method may include converting the therapy
data from a.
format used to store and/or present data on ambulatory medical device to a
format that can be
stored or processed on the computing system. In sonic cases, the therapy data
is converted from
a machine-readable format to a human-readable format. The data may be stored
in a more
easily interpreted format that can be understood by different types of users.
For example, the
data may be presented in one format for a healthcare provider (e.g., sensor
readings), a
simplified format for a subject or parent of a subject, other data formats for
displaying data to
different types of users.
[0187] In some examples, the therapy data collected from different AMDs
associated with
plurality of subjects may be aggregated for a group of subjects based on their
association with
an institution or organization (e.g., a clinic, an insurance company, and the
like)
[0188] in some other examples, a therapy report based at least in part on the
therapy data may
be generated by the computing system. The therapy report may include time-
series therapy data
relating to the therapy delivered by the ambulatory medical device over a
particular time
period.
[0189] In some examples, the therapy report may be sent to ANTI) wherein the
subject can see
the report via a user interface (e.g., a touchscreen display).
[0190] in some cases, the ambulatory device data and/or data generated by the
computing
system based on the ambulatory device data can be viewed on a secondary
display system from
the computing system. For example, a clinician or parent can access the data
from their
personal device. The communication between the computing systems and the
viewing device
may be encrypted. Moreover, permission for sharing of end user data with a
'follower (e.g.,
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family member) or clinician may be granted or controlled by the end user
(e.g., the subject or a.
guardian).
[0191] An association between a subject, a clinic, and/or an ambulatory
medical device may
be performed by association of a device serial number of the ambulatory
medical device with
the subject and/or clinic. Further, a user (e.g., a subject, clinician, or
parent) can access
therapeutic recommendations through the cloud in case either the ambulatory
medical device
(e.g., an insulin pump) or the CGM sensor fails to function.
[0192] With reference to FIG. 14, in some cases, the computing system may be
configured to
at least receive a request from one or more display systems 1414 that are
separate from the
networked computing environment to access the therapy report, therapy data or
other data
received by or stored in the AMD. In some cases, the display system may be a
computing
system of a medical practitioner 1418 (e.g., such as a doctor, nurse,...), a
guardian of the
subject 1420 (e.g., subject's parents), a health care service provider 1424 an
authorized user
1422 (e.g., a user authorized by the subject such as spouse, relative, friend,
and the like) , or a
device of the subject 1416 (e.g., cell phone, personal computer, tablet and
the like).
[0193] In some examples, the display system can be a therapy data management
system that
analyses a therapy data associated with a specific type health problem (e.g.,
data associated
with managing diabetes) and provides useful information to the subject or an
authorized user to
monitor and manage the corresponding ailment.
[0194] The request may include an account identifier associated with a user
that generated the
request. In some examples, the account identifier may include a unique
identifier associated
with the subject. Alternatively, or in addition, the account identifier
includes a unique identifier
associated with a user that is authorized to access the therapy report. The
user may or may not
be the subject. In some aspects of the present disclosure, the method may
further include
associating the therapy data with the account identifier at a storage of the
networked-computing
environment. Further, the computing system may be configured to determine
whether an
account associated with the account identifier is permitted to view the
therapy report. In some
examples, account permissions may be granted and/or modified by the subject.
For example,
the subject can access an account at a networked computing environment 1412,
for example, a
cloud service provider associated with the subject, and provide one or more
identifiers
associated with one or more other users to give them permission to access the
subject's therapy
data or report stored on the computing system,
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[0195] Responsive to determining that the account is permitted to view the
therapy report, the
hardware processor may be configured to transmit the therapy report to the
display system over
an encrypted communication channel.
[0196] In some cases, the method may include receiving an identity or
identification
information of one or more users that are authorized to access therapy data
stored at the
networked-computing environment. For example, a user or subject may authorize
a clinician or
other healthcare provider, a parent or guardian, or other users that the
subject desires to have
access to the therapy data. The identity information of the one or more users
may include any
type of information that may identify the user or enable the user to be
authenticated. For
example, the identity information may include a name, unique identifier (e.g.,
social security
number), an email, an address, a phone number, account information for the
user at the
networked-computing environment, or any other identifying information.
[0197] FIG. 15 is a flow diagram that illustrates an example method that may
be used by
computing system 1406, to generate and share a therapy report based on
encrypted therapy data
received from an AMD 1402, In some examples, the AMD 1402 may generate the
encrypted
therapy data using a public key and a private key. The method may include
establishing a direct
end-to-end data connection 1502 to an ambulatory medical device, for example,
via a wireless
wide area network (WAN) using a Narrowband Long-Term Evolution (NB-LTE)
transceiver
included in the A.MD 1402. Once a direct end-to-end data connection between
the AMD 1402
and the computing system 1406 is established, the computing system may receive
a public key
1504 (e.g., associated with encrypted data), from the AMD 1402 over the
established
connection. Next, the computing system may receive a request from the AMD 1506
to transfer
data (e.g., therapy data) stored on the AMD 1402 to the computing system 1406
over the direct
end-to-end data connection. In some examples, the computing system 1406 may
use the device
ID associated with the AIVID 1402 to determine whether the AMD 1402 is
authorized to
transfer data to the computing system 1508. If, based on the device ID, it is
determined that the
AMD 1402 is authorized to transfer data to the computing system, the encrypted
therapy data
may be transferred 1512 to the computing system. If, based on the device ID,
it is determined
that the AMD 1402 is not authorized to transfer data to the computing system,
the request may
be denied 1510. The computing system may decrypt the encrypted therapy data
1514 using a
private key (e.g., stored in a memory of the computing system.) and a public
key received from
the AMD 1402, In some examples, the therapy data may be used to generate a
therapy report
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1516. In some examples, the decrypted therapy data and/or therapy report may
be stored in a.
memory of the computing system 1406,
[0198] The example method may further include receiving a request from a
display system
1114 that is separate from the networked computing environment, to access the
therapy report
1518, The request may include an account identifier associated with a user
that generated the
request. The method may include determining using the account identifier to
determine whether
the account associated with the account identifier is permitted to view the
therapy report 1520.
In the computing system determines that the account associated with the
received account
identifier does not have the required permission, the request will be denied
1524. Responsive to
determining that the account is permitted to view the therapy report, the
method may include
transmitting the therapy report to the display system 1522 over an encrypted
communication
channel.
[0199] In certain implementations, the method may further include determining
that the
therapy data or other data received from the AMD satisfy an alert threshold
condition. In these
implementations, when the computing system determines that the therapy data or
other data
received from the AMD satisfy an alert threshold condition, the computing
system may send an
alert to one or more display systems designated to receive alerts from the
computing system.
[0200] In some examples, alert threshold condition may be associated with the
health
condition of the subject. For example, alert threshold condition may include
subject's blood
sugar level is above or below a set value (hyperglycemia or hypoglycemia). In
some other
examples the alert threshold condition may be associated with the operation of
the AMD. For
example, alert threshold condition may include the rate of therapy (e.g., the
rate at which
insulin is provided to a subject) being above or below a set value.
[0201] in some other examples, alert threshold condition may be associated
with the temporal
behavior of therapy data over a period of time. For example, the alert
threshold condition may
include the fluctuations or variations of the subject's blood sugar level
being above a set value.
[0202] In some examples, the alert threshold condition may be defined or set
by health
provider. In some such examples, the health provider may change one or rnore
alert threshold
conditions based on the health condition of the subject.
[0203] FIG. 16 is block diagram, illustrating an example network and data flow
configuration
where an AMD 1602, which is directly connected to a computing system 1606
(e.g., computing
system within a cloud network 1610), may generate and send alerts 1616 (e.g.,
alert messages,
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alert signals, and the like) upon determining that data 1612 received from the
AMD satisfies a
threshold condition. The computing system 1606 may be part of networked
computing
environment 1614 (e.g., a data center, networked computing system), or cloud
network 1610 or
cloud computing system of a cloud service provider. The computing system may
include one or
more non-transitional memories and one or more hardware processors configured
to execute the
computer-executable instructions stored in one or more non-transitional
memories. The AMD
may receive data from one or more medical sensors 1608 (e.g., analyte sensor,
temperature
sensor, heartbeat sensor, and the like) and/or one or more environmental
sensors
(e.g., geolocation receiver, motions sensor, accelerometer, and the like.).
These sensors may be
included in the AMD unit or may be connected to the AMID via a wired or
wireless link.
[0204] in some cases, the display systems receiving the alert 1620, may be
display systems
that have already received therapy reports from the computing system 1606, In
other examples,
a group of display systems may be selected and authorized by the subject, who
is receiving
therapy from the AMD, to receive alerts 1620. The display system.s that may
receive alerts
1620 from the AMD may include: a medical practitioner 1624 (e.g., such as a
doctor, nurse,
etc.), a guardian of the subject 1626 (e.g., subject's parents), an emergency
service provider
1628, an authorized user 1630 (e.g., a user authorized by the subject such as
spouse, relative,
friend, and the like), a health care healthcare provider 1632, or a device of
a subject 1622 (e.g.,
cell phone, personal computer, tablet and the like). In some examples, when it
is determined
that received data 1612 the AMD satisfies a threshold condition, in addition
to sending a alerts
to one or more display systems 1618, the computing system 1606 may send an
alert 1616 to the
AMD 1602.
102051 in some examples, the AMD 1602 may be configured to establish a
connection to
support continuous data transfer to the computing system 1606 for a given
period of time (e.g.,
provided to the AMD by the subject), in order to capture any data that is
generated over that
period and satisfies an alert threshold condition. For example, the subject
may request a.
continuous connection between AMID and the computing system when going for
hike alone to
make sure that if his/her health condition deteriorate during the hike, an
alert is sent to
authorized display systems.
102061 in some examples, a geoloca.tion sensor (e.g., a Global Positioning
System (GPS)
receiver) and/or a proximity sensor can be used to enable location-activated
features such as
automatic upload of data at certain locations.
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[0207] In some cases, the ambulatory medical device may include or be
connected to an
accelerometer or a geolocation system. This velocity of the ambulatory medical
device may be
determined based at least in part on the accelerometer or geolocation system.
Using the data.
obtained 1612 from the ambulatory medical device 1602 including the location
and/or velocity
information, the computing system 1606 can provide intelligent alerts. For
example, if the data
indicates that a user is travelling at a high rate of speed (e.g., likely in a
car) and the user's
blood glucose level is low (e.g., below 55 m.gldi), the computing system may
automatically
alert emergency service provider 1628 that a subject is at risk of
hypoglycemia and may be
driving. Further, the computing system can provide a location of the subject
to the emergency
service provider 1628.
[0208] in some examples, the computing system can generate alerts based on a
trend of the
aggregated therapy data or based on therapy data that is an outlier to the
aggregate therapy data
or an outlier to a time-based average of the therapy data.
[0209] Further, the geolocation sensor and/or a motion sensor (e.g., an
accelerometer) can be
used to detect velocity of a subject to enable intelligent motion-sensitive
alerts. For example, if
the subject is moving at 60 mph and experiences low blood glucose, the system
may enable a
set of driving alerts and schedule possibly therapy in the future. The driving
alerts may inform
the subject to pull over immediately due to a risk of a hypoglycemic event.
Further, an
emergency responder may be informed of a subject location using based on
information
obtained from the geolocation sensor. If the subject is moving at 6-7 mph,
exercise alerts may
be enabled to, for example, alert the user to pause exercising and attend to
low blood sugar. If
the subject hasn't moved for 3 hours and has low blood sugar, the system can
enable automatic
notification to and emergency service provider 1628. Further, a determination
of the subject's
motion can be used to automatically adjust setpoint (e.g., raise setpoint
during exercise). The
activity level of the subject can be sensed and use to improve alerts and
therapy.
102101 Additionally, the cloud server can send a text message or call to a
follower's and/or
end user's phone or smart device in case the therapy data satisfies an alert
threshold. These
messages may be provided from the cloud computing system to a third-party
device in case
roaming or disabling of the data plan on the ambulatory medical device occurs
(e.g., no TCP/IP
available). Further, the cloud computing service may send a text message or
call 911 in case of
a detected emergency. The cloud server can track, for example, via GPS, the
end user's most
recent location and share that information with a follower and/or emergency
personnel.
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Moreover, the cloud computing system may enable an end user to order and re-
order medical
supplies directly from the viewing device.
[0211] Moreover, the computing system. can generate notifications (e.g.,
generate a message
when there is a risk of hypoglycemia). Further, more detailed processing in
the cloud can result
in improved recommendations (e.g., Tmax, setpoint, or other control
parameters)
[021.2] FIG. 17 is a flow diagram illustrating an example method that may be
used by
computing system 1606, to generate and send alerts (e.g., alert messages,
alert signals, and the
like) to one or more authorized devices and to the AMD. The method may include
establishing
a direct end-to-end data connection 1702 to an ambulatory medical device, for
example, via a.
wireless wide area network (WAN) using a Narrowband Long-Term Evolution (NB-
LTE)
transceiver included in the AMD 1602. in some examples, the direct end-to-end
connection
may be established for a given period of tirn.e set by the subject or an
authorized user (e.g., a
guardian of the subject). Once a direct end-to-end data connection between the
AMD 1602 and
the computing system 1606 is established, the computing system may receive a
public key
1704, from the AMD 1602 over the established connection. Next, at block 1706,
the computing
system may receive a request from the AMD 1602 to transfer data (e.g., therapy
data, medical
sensor data or environmental sensor data) generated by the AMD 1602 to the
computing system
1606 over the direct end-to-end data connection. In some cases, the request
may include a time
period during which AMD continuously transmits any data generated by the AMD
1602 or
obtained from one or more sensors (e.g., environmental sensors 1604 or medical
sensors 1608),
to the computing system 1606. In some such cases, the time period for
continuous data transfer
from the AMD 1602 to the computing system 1606, may be provided by the subject
or a
guardian of the subject to the AMD. At the decision block 1708, the computing
system 1606
may use the device ID associated with the AMD 1602 to determine whether the
AMD 1602 is
authorized to transfer data to the computing system 1606.
If the computing system
1606 determines that the AMD 1602 is authorized to transfer data to the
computing system
1606 (e.g., based on the device II)), at block 1712, the encrypted therapy
data may be
transferred to the computing system 1606. If, at the decision block 1708 the
computing system
1606 determines that the AMD 1602 is not authorized to transfer data to the
computing system,
the process may move to block 1710 and the request may be denied. At block
1714, the
computing system 1606 may decrypt the received data using a private key (e.g.,
stored in a
memory of the computing system 1606) and a public key received from the AMD
1602. At the
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decision block 1716 the computing system 1606 may determine whether the
received data (e.g.,
therapy data, medical sensor data or the environmental sensor data), satisfies
a threshold
condition. In some cases, the threshold condition may be provided to the AMD
by the subject
or an authorized user (e.g., a guardian of the subject). In some other
examples, the threshold
condition may be provided by a healthcare provider. In some such examples, the
threshold
condition may be stored in a memory of the AMID. If at the decision block 1716
the computing
system 1606 determines that the data satisfies a threshold condition, an alert
may be generated
and sent 1718 to one or more display systems 1618 that are authorized (e.g.,
by the subject or a
guardian of the subject) to receive alerts. In some examples, the subject or
the guardian may
authorize one or more display systems 1618 to receive alerts by providing the
account IDs of
the one or more displays systems to the computing system 1606 or the networked
computing
environment 1614.
Preventing Inadvertent Therapy Changes
[0213] As described above, the ambulatory medicament device may include a user
interface
(e.g., touchscreen interface or a non-touchscreen interface) that may present
one or more user-
interface screens to a user enabling the user to modify one or more therapy
settings of the
ambulatory medicament device, such as a quantity of medicament delivered when
a condition is
met or the condition that triggers the delivery of medicament to a subject.
The user may be a
subject receiving medicament or therapy, or may be another user, such as a
clinician or
healthcare provider, or a parent or guardian. For ambulatory medicament
devices that include a
user interface, there is a risk that a setting is accidentally modified or is
modified (intentionally
or unintentionally) by a user that does not fully comprehend his or her action
(e.g., a child or a
user with a reduced mental capacity). Further, ambulatory medicament devices
may
accidentally have settings modified by inadvertent interactions with a user
interface, such as
may occur when an ambulatory medicament device is worn against the body of a
subject.
[0214] This section relates to an ambulatory medicament device (AMD) to
prevent an
inadvertent modification in medicament deliver, for example, in the event of a
setting of the
AMID being accidentally modified by a user or inadvertent interactions with a
user interface.
[0215] As mention above, in some embodiments the user may modify the control
or
configuration the AMD using a user interface. There is a possibility that the
control or
configuration of the AILID is accidentally modified through the user
interface. For example, as
the user may transport the ambulatory medical device, there is a danger that
the user will
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inadvertently activate input in the ambulatory medical device that initiates a
therapy change
input (e.g., by applying pressure on the ambulatory medical device that may be
placed in the
jacket pocket of the user).
[0216] With reference to FIG. 18, in some such embodiments, the control and
computing
module (CCM) of the AMD may include a set of therapy change procedures 1818
implemented
to prevent therapy change inputs 1820 that are inadvertent. The therapy change
procedures
1818 may be implemented as instructions stored in a memory of CCM (e.g., the
main memory
616) and executed by the processor 614. The therapy change input 1820,
received from a user
1816, may be verified by the therapy change procedures 1818 before the
ambulatory medical
device 600 provides the therapy change delivery 1804. All the user
interactions with the user
interface module 1806 may be controlled and analyzed by the control and
computing module
610 (CCM) via one or more therapy change procedures 1818.
[0217] In these embodiments, the user 1816 may wake or unlock the AMD by
interacting with
a wake interface 1810. The wake interface 1810 can be any of the additional
user interfaces
mentioned above, configured to generate a wake input to the CCM when detecting
a pre-set
user interaction.
[0218] The therapy change input 1820 can be an input provided by the user 1816
to change a
therapy that is currently being delivered to the user 1816, In some
embodiments, the therapy
change input 1820 may cause the insulin or glucagon infusion pump to start
infusing an amount
of insulin or glucagon into the user 1816. Alternatively, the therapy change
input 1820 may
modify the rate of insulin or glucagon infusion into the user 1816. The
therapy change input
1820 may also cancel insulin or glucagon infusion into the user 1816 from the
insulin or
glucagon infusion pump.
[0219] When a wake action is detected by the wake interface 1810, a wake input
is sent to the
control and computing module 610 wherein it imitates a wake control procedure
1826 that
generates a wake signal to wake/unlock the user interface (e.g., a touch
screen display).
[0220] When in the wake and/or unlocked state, a user may interact with the
touchscreen
display 1812, alphanumeric pad 1814 or other types of user interfaces that may
be included in
the user interface module 1806, to obtain access to therapy change user
interface.
[0221] The therapy change user interface may be activated by a first user
interaction with the
user interface (e.g., touchscreen display 1812). When the first user
interaction is detected, the
user interface module user interface module 1806 sends an input signal to the
control and
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computing module 610 wherein it is analyzed by a therapy change control
procedure 1828, If it
is determined that the first user interaction satisfies a set of predefined
conditions, the therapy
change control procedure 1828 generates a signal to the user interface module
user interface
module 1.806 to activate the therapy change user interface.
[0222] In some embodiments, the therapy change user interface may be limited
based on the
first user interaction. For example, the therapy change control procedure 1828
may send one of
two signals to the user interface module user interface module 1806, The
therapy change user
interface may then unlock one of two different therapy change user interfaces
that result in
different options of therapy change selections for the user 1816, In an
implementation of this
example, a therapy change selection to make a significant therapy change, such
as dramatically
increase the rate of insulin or glucagon infusion rate, requires a first user
interaction that is
different from the first user interaction that would be required for an
insulin or glucagon
infusion at a normal or prescribed rate. In some examples, the first user
interaction may be a
simple interaction (e.g., a simple gesture) that unlocks a therapy change user
interface with
therapy change selections that are limited. Another first user interaction may
be a complicated
interaction (e.g., a series of complex gestures) that unlocks a therapy change
user interface with
therapy change selections that have no limits. An example of this
implementation may be
useful for child users. The child user may perform the first gesture that is
made up of a series of
simple inputs to unlock therapy change selections that are limited. An adult
user may perform
the first gesture that is made up of a series of complex inputs to unlock the
therapy change user
interface with therapy change selections that have no limits.
10223-1 Once activated, the therapy change user interface that may provide one
or more control
or configuration elements that enable the user to modify the control or
configuration of the
ambulatory medicament device. The control or configuration element may include
any type of
user interface screen on the touchscreen, or other type of user interface in
the non-touchsereen
context, that enables or permits a user to change a configuration of the
ambulatory medicament
device. This change in configuration of the ambulatory medicament device may
relate to a
change in the therapy provided or in the detection of a triggering event that
causes therapy
(e.g., medicament) to be provided to a subject. For example, the change in
configuration may
include a selection between one or more hormones that regulate blood sugar
level (e.g., insulin
or glucagon) of a user, an amount of the one or more hormones that regulate
blood sugar level
of the user.
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[0224] In some cases, a change to the configuration of the ambulatory
medicament device is
automatically and/or instantly recognized or implemented by the ambulatory
medicament
device, and/or transmitted to the ambulatory medicament device, In other
cases, a. confirmation
of the change may be required before the change is implemented by or
transmitted to the
ambulatory medicament device.
[0225] This confirmation may he entered based on a second user interaction
with a user
interface (e.g., touchscreen display 1812). When the second user interaction
is detected, the
user interface module user interface module 1806 sends an input signal to the
control and
computing module 610 wherein it is analyzed by a therapy change control
procedure 1828. If it
is determined that the second user interaction satisfies a set of predefined
conditions, the
therapy change control procedure 1828 implements the change to the
configuration of the
A.MD.
[0226] The first and/or second user interactions may include the selection of
an icon., a series
of taps or inputs, one or more gestures (e.g., a linear swipe, an arcuate
swipe, a circular swipe,
or other simple or complex movement across the touchscreen), performing a
pattern or
sequence on the touchscreen (e.g., drawing an image), a. multi-touch or multi-
input interaction,
a combination of the foregoing, or any other type of interaction with a
touchscreen, or portion
thereof. The series of inputs may be any combination of touch movements, touch
points,
numerical characters, alphabetical characters, and other symbols. Gesture
interactions can be
guided by visual indicia displayed or printed on the ANID. In some
embodiments, the visual
indicia can include animations that suggest or guide user interactions with a
touchscreen. For
example, the first user interaction can include an arcuate swipe around at
least a portion of a
generally circular icon or logo. In some examples, the first and/or second
user interactions may
include a predetermined sequence of numerical or alphabetical inputs. In some
examples, a
series of multiple inputs, the range of parameters for an input may be
dependent on other inputs
in the series. For example, required start position of a touch movement may be
dependent on
the position of the previous touch movement. The time that the series of
inputs are entered may
also be a part of the range of parameters. For example, a series of inputs may
need to be
entered in no less than 3 seconds or more than 3 seconds, and no more than 15
seconds or less
than 15 seconds.
[0227] Further, one or more of the interactions may include interacting with a
sensor as an
optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a
fingerprint or retinal
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scanner), a proximity sensor, a gyroscope, or a combination of accelerometer
and gyroscope,
and the like. Also, in an exemplary embodiment, the second user interaction
may be made
through a wireless signal such as RFID or Bluetooth. In some embodiments, the
second user
interaction may include receiving a selection of an indicator box that
correspond to either
insulin or glucagon and receiving a predetermined sequence of numerical inputs
in order to
deliver the therapy change selection,
[0228] The type of user interaction that unlocks the touchscreen, provides
access to a
configuration screen, and/or confirms a change to the configuration of the
ambulatory
medicament device may be the same or may differ.
[0229] In an exemplary embodiment, the system may have a time-out such that if
no
interaction occurs for a set period of time, the user interface will turn off
and the therapy
change request process has to start again in one implementation of the time-
out, if no
interaction occurs for more than 30 seconds after the system is waked/unlocked
before the
second user interaction is received by the user interface, the user interface
will be deactivated.
[0230] Once the configuration change is confirmed, implemented, or
transmitted, the
ambulatory medicament device may begin operating with the changed
configuration.
[0231] This operation may include triggering therapy based on the new
configuration or
providing therapy based on the new configuration, :For example, the ambulatory
medicament
device may generate a dose control signal based at least in part on the
modified configuration
or control parameter or may detect a trigger based at least in part on the
modified configuration
or control parameter that leads to the provisioning of therapy.
[0232] With continued reference to FIG. 18, in some embodiments, the changes
made through
the therapy change user interface are sent to CCM wherein the therapy change
control
procedure 182.8 in CCM transfers the changes to the device and subject
monitoring procedure
1824. The device and subject monitoring procedure 182.4 may be implemented in
the CCM 610
to monitor the status of the AMD (e.g., therapy delivery configuration) and
the health condition
of the user 1816 (or a subject). For example, the subject monitoring procedure
1824 may
receive information about a therapy change requested by a user 1816 through a
user interface (a
touchscreen display 1812 or alphanumeric pad 1814) or information about
glucose level in
subject's blood from the subject sensor 1808. Subsequently, the device and
subject monitoring
procedure 1824 may transmit the information pertaining a health condition of
the subject and/or
the AMD configuration, to the medicament dose control procedure 1822, In some
examples, the
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parameters in the medicament dose control procedure 1822 may be adjusted based
on the
changes and/or information captured by the device and subject monitoring
procedure 1824. The
medicament dose control procedure 1822, controls the medicament delivery
interface 1802 by
providing a medicament dose signal. The medicament does control may be
generated based
on detected conditions or physiological characteristics of the subject (e.g.,
provided by the
readings of the subject sensor 1808) and according to parameter values
received from the
therapy change control procedure 1828. The medicament delivery interface 1802
may provide a
therapy change delivery to the user according to the information received by
device and subject
monitoring procedure 1824.
[0233] In some examples, the dose control signals may be produced based on
time (e.g.,
medicament may be delivered on a periodic basis), one or more a command,
indication that the
subject is planning to engage or is engaging in a particular activity (e.g.,
eating a meal,
exercising, sleeping, fasting, etc.), or any other factor that may relate to
or cause the triggering
of therapy (e.g., medicament delivery).
[0234] FIG. 19 is a flow diagram illustrating an example method that may be
used by an AMD
to allow a user to change the configuration of the ambulatory medicament
device using a touch
screen user interface. The user may initiate the configuration change process
by
waking/unlocking the touch screen using a wake action. Once the wake action is
received by
the wake interface (block 1902), the wake interface sends a wake input to CCM
(block 1904).
At block 1906, the wake procedure generates a wake signal and at block 1908
that unlocks the
touch screen (block 1908). Next, in response to receiving a first gesture by
the user (block
1910), the therapy change user interface is unlocked (block 1912). Using one
or more therapy
control or configuration elements provided in the therapy change user
interface, the user may
change the therapy configuration (block 1914). The user may confirm the
changes made, by
providing a second gesture on the touch screen 1916. Once the confirmation is
received (block
1916) the requested changes will be implemented (block 1918), and the
ambulatory medicament device may begin operating with the changed
configuration. In some
examples, once the user confirms the changes made, a dose control signal may
be sent to the
medicament delivery interface 1802 that triggers a therapy change delivery to
the subject.
[0235] In some cases, the ambulatory medicament device, or a control device
that enables a
user to modify a configuration of the ambulatory medicament device, may have a
timeout
feature. The tirneout feature may cause the ambulatory medicament device or
the control device
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to enter a sleep or locked state after a period of time of inactivity by the
user. In some cases,
the timeout feature may cause the ambulatory medicament device or the control
device to enter
a sleep or locked state after a particular period of time regardless of
whether the user is
interacting with the ambulatory medicament device or control device. Thus, a
user may have a
limited period of time to modify he configuration of the ambulatory medicament
device.
[0236] In some examples, the therapy change made by a user may trigger the
delivery of a
medicament according. to the therapy change received and confirmed by a user.
This therapy
change delivery may occur after a set time from period from receiving the
confirmation.
[0237] In some embodiments of the AMID, an alarm status indicator may be
presented to the
user via the user interface. The alarm status indicator can be an alert
message or an alert
symbol. The alarm status indicator may be related to a configuration change
made by a user, a
change in the status of the AMD not related to a user input, or the condition
of the subject (e.g.,
detected by the subject sensor).
[0238] FIG. 20A is an illustration of the touchscreen display 2000 of an
example A.MD after
the touch screen is waked/unlocked by a wake action of a user and before the
first user gesture
is received. Even while the touchscreen display is locked, the touchscreen
display 2000 may
display any images, animations, text, or other graphics. The first gesture
prompt 2006 displays
to the user 1816 the input required to unlock the therapy change user
interface. Here, the first
gesture prompt 2006 shows the user 1816 that a touch movement that begins at
the greater-than
symbol and moves right across the "Unlock" text is the acceptable first
gesture. In addition to
the first gesture prompt, the refill status of the ambulatory medical device
600 is shown in a
graphic representation 2010. Here, the graphic representation 2010 shows that
the insulin
cartridge in the ambulatory medical device 600 is almost full. A current blood
sugar level 2016
is shown at the top of the touchscreen display 2000, which can inform the user
1816 of the need
for a hormone that regulates blood sugar levels. The touchscreen display 2000
also shows a
graphic representation of a cartridge of glucagon 2024. The graphic
representation of an alarm
2030 in the touchscreen display 2000 shows that an alert is set on the
ambulatory medical
device 600.
[0239] FIG. 20B is an illustration of an example touchscreen display 2038 that
may prompt
the user to enter a predetermined series of inputs for the first gesture or
second gesture. In
various embodiments, such as the embodiment shown in FIG. 20B, the touchscreen
display
2038 may display touchable number keys 2040. In various embodiments, the
touchscreen
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display 2038 prompts the user .1816 to enter the series of inputs that
complete the first gesture
or second gesture. The text Enter Code 2042 prompts the user 1816 to enter a
predetermined or
preselected numerical sequence as part of the first gesture or second gesture.
The numerical
sequence being typed by the user 1816 is displayed in field 2044 as it is
entered as an aid to the
user 1816, The input 2046 of the touchscreen. display 2038 shows that a touch
movement of a.
swipe right across the bottom of the screen is required to complete the
predetermined series of
inputs for the first gesture or second gesture. A Bluetooth connection symbol
2048 shows that
the ambulatory medical device 600 is paired or can be paired to another
electronic device.
[0240] FIG. 20C is an illustration of an. example therapy change user
interface (in this case a
touchscreen display 2002), The touch screen display may the user 1816 prompt
to select a
hormone that regulates blood sugar level. The touchscreen display 2002
presents the user 1816
with an option to select between two hormones. The touchscreen display 2002
aids the user
1816 by showing the selected hormone 2008 for the user 1816. The selected
hormone 2008 is
"insulin Only", The user 1816 is also given the options of selecting the
hormone Glucagon
Only button 2012 or both Insulin & Glucagon button 2004 to regulate blood
sugar level. Once
the user 1816 selects between the one or more hormones that regulate blood
sugar level. The
Next button 2014 may be selected to complete the therapy change selection or
select more
options. In one embodiment, to select more options, the therapy change user
interface prompts
the user 1816 to select an amount of the one or more hormones that regulate
blood sugar level
of the user 1816. In other embodiments, the user 1816 may be prompted to
select a blood sugar
level and the ambulatory medical device may choose the hormone and the amount
of the
hormone.
102411 FIG. 201) is an illustration of another therapy change user interface
on a touchscreen
display 2018. Here, the user 1816 is given a multitude of options. One or more
options in the
therapy change user interface allow the user 1816 to make a therapy change
selection. Other
options are related to the therapy change selection. A Deliver Hormone button
2036 allows the
user 1816 to select a therapy change that delivers a hormone that regulates
blood sugar to the
user 1816. A Test Blood Sugar button 2020 allows the user 1816 to test the
blood sugar level of
the user 1816. A Generate Report button 2022 generates a document that reports
the therapy
changes that have been delivered to the user 1816. A Refill Cartridge button
2026 allows the
user 1816 to fill a cartridge in the ambulatory medical device 600 with
medicament. An Upload
to Cloud button 2032 allows the user 1816 to transmit therapy change
information to a cloud-
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based server. A Sound Control button 2028 allows the user 1816 to control the
sounds emitted
by the ambulatory medical device 600. A. Settings button 2034 allows the user
_1816 to
manipulate other settings of the ambulatory medical device 600.
[0242] As mentioned above, in some embodiments of the AMD, an alarm status
indicator may
be presented to the user via the user interface to alert the user about a
change made or occurred
in the AMD configuration.
[0243] For example, with reference to FIG. 18, the user 1816 may provide a
therapy change
input 1820 using the user interface and based on the procedure illustrated in
FIG. 19, Once
therapy change control procedure 1828 implements the therapy change, the AMID
may alert the
user that a therapy change is implemented. The alert message or symbol may be
presented on a
user interface (e.g., touch screen display) before and/or during the therapy
change delivery
1804. For example, alarm indicator may inform the user 1816 that a therapy
change is about to
occur. Any number of details of the therapy change may be displayed as part of
the alert
message or symbol. In some cases, the alarm status indicator tnay appear after
the user unlocks
or wakes the user interface using a wake action.
[0244] FIG. 21 is a flow diagram illustrating an example method that may be
used by an AMD
to generate an alarm status indicator. In some embodiments the device and
subject monitoring
procedure (excused within CCM), may continuously monitor the status of the
AMID (e.g., the
user interface, different modules of the AMD and the like) as well as the
health condition of a
subject (e.g., using various subject sensors such as analyte sensors) 2102.
Once a status
information is received 2104, the device and subject monitoring procedure may
determine
whether the received status information satisfies an alarm condition 2106. If
the received status
information does not satisfy an alarm condition, no cation will be taken and
device and subject
monitoring procedure continuous monitoring the AMD and the subject. If it is
determined that
the received status information satisfies an alarm condition, the system
search for a wake signal
2108. If no wake signal is detected, the systems wait for or determine a wake
signal to be
received 2110. Once a wake signal is received via one or more user interfaces
or sensors, the
CCM may generate a display of a touchscreen lock screen interface 2112 and
display one or
more alarm status indicators 2114, corresponding to the detected alarm
condition, on the lock
screen.
102451 in some embodiments, the AMID may allow the user to provide a therapy
change and
then cancel the therapy change. FIG. 22 is a flow diagram illustrating an
example method that
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may be used to cancel a therapy change using a touchscreen interface. The user
may unlock the
touchscreen display 2202 using a wake action and get access to a therapy
change user interface
2204 (e.g., using a first gesture), where one or more therapy control elements
may be
displayed. Next, an indication of a modification to a therapy control element
may be received
2206 by the user interface followed by a confirmation of the modification made
2208 (e.g., a
second gesture). In response to receiving an indication and confirmation of a
modification to a
therapy control element, the corresponding control parameter may be changes
from a first
setting to a second setting 2210. In sonic examples, once the change is
implemented 2210, the
user may decide to cancel it, for example, after realizing that requested
change is erroneous. In
these examples the user may provide a third gesture 2212 on the touch screen.
In response to
receiving the third gesture from the user interface the therapy change
procedure may restore the
modified control parameter to the first setting 2214. In sonic examples the
third gesture may a
restore gesture. In some cases, the restore gesture may be a swipe gesture. In
some examples
the swipe gesture may be performed near or in a region of the therapy change
user interface
that is occupied by the therapy control element. An example of a restore swipe
gesture may be
performed from a starting swipe position to an ending swipe position located
closer to a left
edge of the touchscreen than the starting swipe position. In some embodiments,
the restore
gesture is received on a different user interface screen than a therapy change
user interface
wherein one or more therapy control element are provided. In various examples,
the restore
gesture is performed in the opposite direction from a therapy change
confirmation gesture that
confirms the modification to the therapy control element.
102461 in some examples, in order to cancel a therapy change request, the
restore gesture has
to be provided within a set time period after the confirmation gesture is
received by the user
interface. In some such examples, during the set time period one or more dose
control signals
may be provided to the medicament delivery interface resulting in one or more
therapy change
deliveries.
102471 in some cases, the system may allow the user, to modify a therapy
change before
confirmation. In these cases, the user may modify a therapy control element
for a second time
to change the corresponding control parameter from a second setting to a third
setting.
[0248] In some examples, the third setting may be the same as the first
setting. In some cases,
the first setting or the third setting may be a default setting. In some other
cases, the first
setting or the third setting may be a restore setting.
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[0249] FIG. 23A is an illustration of a touchscreen display 2300 alerting the
user that the
delivery of one or more medicaments will occur. The alert may be accompanied
by sound or
vibration effects. Here, the alert informs the user 1816 a delivery of
medicament will occur in 2
seconds 2302. The touchscreen display 2300 is further allowing the user 1816
to perform a
gesture to cancel the therapy change. The gesture to cancel the delivery is a
touch movement
that starts at the less-than symbol 2304 and swipes left across the "Cancel"
text. In the
embodiment shown in FIG. 23A., a single gesture by the user 1816 may cancel
the therapy
change. In an exemplary embodiment, input of the wake signal, the first
gesture, the therapy
change selection, and the second gesture are all required to cancel a therapy
that is being
delivered.
[0250] In some examples, the user may be able to cancel a therapy change
delivery triggered
based on therapy change made by the user. In these examples, the user may get
access to the
user interface using a wake action and provide a gesture to cancel the ongoing
therapy
corresponding to a therapy change delivery.
[0251] FIG.. 23B is an illustration of a touchscreen display 2306 showing that
a medicament is
being delivered to the user 1816. The text Delivering 2308 informs the user
1816 that a
medicament is currently being delivered to the user 1816. The progress bar
2310 is a graphic
representation of the progress of the delivery. In the example shown in FIG.
23B, the delivery
has just started and the progress indicates that no medicament has been
delivered yet. The
touchscreen display 2306 is allowing the user 1816 to perform a gesture to
cancel the delivery,
which includes interrupting and discontinuing the delivery if it had already
begun but has not
yet been completed. The gesture to cancel the delivery is a touch movement
that starts at the
less-than symbol 2312 and swipes left across the "Cancel" text. In an
exemplary embodiment
that is shown in FIG. 23B, the therapy change delivery 1804 may be canceled by
an input by
the user 1816. The input to cancel a therapy change delivery 1804 may be any
input such as a
wake signal input or a series of touch inputs such as a gesture.
[0252] Additional embodiments relating to interacting with an ambulatory
medicament device
that can be combined with one or more embodiments of the present disclosure
are described in
U.S. Provisional Application No. 62/874,950, which was filed on July 16, 2019
and is titled
"PREVENTING INADVERTENT THERAPY CHANGES ON AN AMBULATORY
MEDICAL DEVICE," the disclosure of which is hereby incorporated by reference
in its
entirety herein for all purposes, and in U.S. Provisional Application No.
62/874,954, which was
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filed on July 16, 2019 and is titled "CAPACITIVE TOUCH WAKE BUTTON FOR AN
AMBULATORY MEDICAL DEVICE," the disclosure of which is hereby incorporated by
reference in its entirety herein for all purposes.
Automatic Resumption of Medicament Delivery Following Manual Suspension
[0253] In some cases, it may be desirable to suspend operation of the
ambulatory medicament
device or to suspend at least the delivery of medicament by the ambulatory
medicament device
for a period of time. For example, it may be desirable to suspend an operation
associated with
the delivery of medicament when the medicament reservoir or cartridge in the
ambulatory
medicament device is empty or needs replacing. As another example, it may be
desirable to
suspend delivery of medicament when the ambulatory medicament device is
removed or is
being moved to another site on the subject. In yet another example, it may be
desirable to
suspend delivery of the medicament when the subject is taking or ingesting
another
medicament that may produce a contraindication with the medicament provided by
the
ambulatory medicament device. In some cases, when a subject suspends the
treatment delivered
by a medical device, the subject may forget to resume the treatment delivered
by the medical
device. In other cases, the health condition of the subject may deteriorate
during the suspension
period requiring therapy delivery prior to end of the suspension period. As
such, there is a need
for AMDs that allows subjects to safely suspend treatment for temporary
amounts of time.
[0254] In some embodiments, the AMD may support a therapy suspension and
resumption
procedure allowing a user to suspend all therapies or a subset of therapies
for a period of time
defined by the user as well as automatic resumption of one or more therapies
at the end of the
requested suspension period or when a threshold condition is met (e.g., a
threshold condition
associated with the health condition of the subject).
[0255] In AMDs that support therapy suspension, inadvertent activation and/or
resumption of
therapy delivery can be dangerous (e.g., when the AMD is an insulin and/or
glucagon infusion
device). In some examples to mitigate this risk, the AMD may be configured to
avoid
inadvertent suspension or resumption of therapies. For example, inadvertent
activations of
suspensions of medicament delivery may be prevented by requiring a user to
perform gestures
to activate suspension on the ambulatory medical device. In some cases, the
gestures may
activate a therapy suspension when entered at a particular prompt to.
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[0256] One particular application of the therapy suspension with automatic
resumption feature
in an. AMD can be in the field of diabetes drug delivery. For example, the may
need the ability
to suspend delivery of insulin during situations such as exercise, which has a
blood glucose
lowering effect. Suspension of insulin delivery can prevent a subject from
entering a
hypoglycemic state (extreme low blood glucose), which carries severe
complications. Once the
therapy is suspended the user many at the risk of entering a hyperglycemic
state (high blood
glucose that may result in complications suc.h as diabetic ketoacidosis or
neurovascular
complications) if the user forgets to reactivate the drug delivery after
exercise. Further, the
subject's blood glucose level may raise above or below a dangerous level
during the period of
exercise. In these situations, the automatic medicament delivery resumption
may improve the
health of the subject.
[0257] In certain cases, the AMD may suspend one or more therapy deliveries
when the AMD
receives an indication that therapy (e.g., delivery of medicament) is to be
suspended. The
indication that therapy is to be suspended may be a command from a user. Often
the user is the
subject, but the user may also include other users that may have a say or
interest in the care of
the subject. For example, the user may be a clinician or other healthcare
provider, or a parent or
guardian.
[0258] in some examples, the indication that the therapy or medicament
delivery is to be
suspended may be a command received via an interface of the ambulatory
medicament device
or from another device that provides the user with an interface to request
that medicament
delivery be suspended. For example, the device may be a smartwatch,
smartphone, laptop or
desktop, or other control device that can communicate via a wired or wireless
connection with
the ambulatory medical device.
102591 in some cases, the indication that the therapy or medicament delivery
is to be
suspended may be received from the ambulatory medicament device itself. For
example, if the
quantity of medicament available to the ambulatory medicament device drops
below a
threshold (e.g., the cartridge or reservoir is empty or below a minimum dosage
amount), a
signal may be generated to suspend medicament delivery. In some embodiments,
suspension of
therapy occurs based on a loss of a sensor signal, such as the loss of a
glucose level signal.
[0260] FIG. 24 illustrates the interconnection among modules and procedures
involved in
receiving, accepting and/or canceling a therapy suspension request, in an
example AMD. In
some embodiments, a request for suspending one or more therapies (e.g.,
delivery of one or
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more medicament to the subject) can be made by a user 2414 by providing a user
input 2418
(e.g., the start and stop time for therapy suspension, selecting the type of
therapy that should be
suspended, and the like), through a therapy suspension user interface provided
by the user
interface module 2404. The therapy suspension user interface sends the
suspension request
along with the corresponding information to CCM wherein the therapy suspension
control
procedure 2426 implemented in CCM, processes and sends a therapy suspension
signal to the
device and subject monitoring procedure 2422. To prevent therapy suspension
request user
inputs 2418 that are inadvertent, the therapy suspension control procedure may
include a
therapy suspension request verification procedure to verify the therapy
suspension request,
[0261] The device and subject monitoring procedure 2422 may be implemented in
the control
and computing module 2416 to monitor the status of the AMD (e.g., therapy
delivery
configuration) and the health condition of the user 2414 (or a subject). For
example, when the
device and subject monitoring procedure 2422 receives the request for therapy
suspension, it
may send a signal to the medicament dose control procedure 2420 indicating
that no does
control signal should be send to the medicament delivery interface 2402 during
the period
request by the user 2414. In some cases, if during the suspension period,
certain pre-set
conditions are satisfied, the device and subject monitoring procedure 2422
automatically
resumes the therapy delivery by sending a signal to the medicament dose
control procedure
2420. For example, if during the suspension period the subject sensor 2406
detects an elevation
of the level of one or more analytes in subject's blood and/or interstitial
fluid beyond a set
threshold, it may resume the medicament delivery to the user 2414 by a sending
a dose control
signal to the medicament delivery interface 2402.
[0262] In order to prevent inadvertent activation of a suspension, the user
may initiate a
therapy suspension request starting with a wake action (e.g., received by the
wake interface
2408 and processed by the wake control procedure 2424), that activates the
user interface
module 2404. Using a first interaction with a user interface (e.g., a
touchscreen display 2410 or
alphanumeric pad 2412) the user may unlock a therapy suspension user interface
where the
information pertaining therapy suspension is provided. Next, the user may
confirm the
requested therapy suspension using a second interaction with the user
interface. In some
examples, the system may allow access to the therapy suspension user interface
and accept the
suspension request, when the first and second interaction with the user
interface are verified by
the therapy suspension control procedure 2426,
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[0263] In some examples, the therapy suspension control procedure 2426 may
receive the
request for suspension and suspension information from another device
connected to the
ambulatory medical device 600 (e.g., through the communication module).
[0264] The suspension information provided by the user may include a set of
parameters
needed for a suspension. For example, the suspension information may include
the dates and/or
times for starting and ending the therapy suspension, threshold values needed
to define a
threshold condition that may trigger an early resumption of the therapy
delivery, and the like,
In some other examples, suspension information may indicate that the
suspension of therapy
should happen at a particular time or after a particular event (e.g., after
the next dose of
medicament is delivered or after the condition of the subject reaches a
particular state, such as
the middle of a desired blood glucose range). In some examples, the threshold
values may be
associated with input provided by the subject sensor 2406 or other types of
sensors that may be
used to monitor one or more parameters associated with the health condition of
the user 2414.
[0265] The parameters for a suspension may include the start and stop
conditions for a
suspension. The start condition for a suspension may be a condition that, when
met, activates a
suspension, In some such examples, the start condition is met when. a timer
runs out. Similarly,
the stop condition is a condition that, when met, ends the suspension. In one
example, the stop
condition is met when a timer runs out. In another example, the stop condition
is met when a
threshold is met. A threshold may be related to a measurement taken by
ambulatory medical
device (e.g., by a subject sensor 2406), such as a glucose concentration of
the blood of a
user. The threshold may be met if the glucose concentration goes above, goes
below, or
matches a set concentration. Multiple conditions may be set by the suspension
request interface
component. For example, a time condition and a threshold condition may be set
simultaneously. A user may specify that a suspension will end after a set
time. However, the
suspension may end sooner than the set time if the glucose concentration of
the user meets a
threshold.
[0266] In some cases, the request to suspend therapy may include an indefinite
suspension
period. In other words, the request may not include a time period specified by
a user or an
identity of a resumption condition. In some other cases, the indication may
include a request to
temporarily suspend delivery of therapy for a defined period of time or until
a further
interaction or event occurs Thus, the resumption condition can include an
expiration of time or
an active event (e.g., a command or a determined condition of a subject).
Further, the therapy
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to be suspended may include any type of therapy. For example, the therapy to
be suspended
may be the suspension of the delivery of medicament, which may include
insulin, counter-
regulatory agent (e.g., Glucagon), or both insulin and a counter-regulatory
agent. In some
cases, the ambulatory medicament device may be capable of and/or configured to
administer
multiple medicaments (e.g., both insulin and a counter-regulatory agent). In
some such cases,
the request to suspend therapy may include a request to suspend one (e.g.,
insulin or the
counter-regulatory agent) or both of the medicaments.
[0267] The interactions with the user interface may include the selection of
an icon, a series of
taps or inputs, one or more gestures (e.g., a swipe or other simple or complex
movement across
the touchscreen), performing a pattern or sequence on the touchscreen (e.g.,
drawing an image),
a multi-touch or multi-input interaction, a combination of the foregoing, or
any other type of
interaction with a touchscreen., or portion thereof. The series of inputs may
be any combination
of touch movements, touch points, numerical characters, alphabetical
characters, and other
symbols. In some examples, the first and/or second user interactions may
include a
predetermined sequence of numerical or alphabetical inputs. In some examples,
a series of
multiple inputs, the range of parameters for an input may be dependent on
other inputs in the
series. For example, required start position of a touch movement may be
dependent on the
position of the previous touch movement. The time that the series of inputs
are entered may
also be a part of the range of parameters. For example, a series of inputs may
need to be
entered in no less than 3 seconds or more than 3 seconds, and no more than 15
seconds or less
than 15 seconds. In some cases, a visual guide may assist the user in
generating the user
interaction. For example, one or more arrows or images may be presented to the
user to guide
the user in providing the command to suspend the delivery of therapy.
[0268] Further, one or more of the interactions may include interacting with a
sensor as an
optical sensor (e.g., visible light or IR sensor), biometric sensor (e.g., a
fingerprint or retinal
scanner), a proximity sensor, a gyroscope, or a combination of accelerometer
and gyroscope,
and the like. Also, in an exemplary embodiment, the second user interaction
may be made
through a wireless signal such as RFID or Bluetooth. In some embodiments, the
second user
interaction may include receiving a selection of an indicator box that
correspond to either
insulin or glucagon and receiving a predetermined sequence of numerical inputs
in order to
deliver the therapy change selection.
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[0269] The type of user interaction that unlocks the touchscreen, provides
access to a therapy
suspension user interface, or confirms a suspension request may be the same or
may differ,
[0270] In an exemplary embodiment, the system may have a time-out such that if
no
interaction occurs for a set period of time at each step during the therapy
suspension request
process, the user interface will turn off and the therapy suspension request
process has to start
again. In one implementation of the time-out, if no interaction occurs for
more than 30 seconds
after the system is waked/unlocked before the second user interaction is
received by the user
interface, the user interface will be deactivated.
[0271] FIG. 25 is a flow diagram illustrating an example method for receiving
and
implementing a suspension request, which may be implemented by an AMD. In this
example
the user tnay use a touchscreen interface to request and confirm a therapy
suspension. Once the
user activates the touchscreen using a wake action 2502, the AMD may wait for
a first gesture
on the touchscreen. After the user provides the first gesture and the gesture
is verified by the
therapy suspension control procedure 2426, a therapy user interface may be
activated 2506
where the user can request a therapy suspension and provide 2508 the
suspension information
(e.g., a start day/time and stop day/time and/or a resumption condition).
Next, the AMD may
wait for second gesture on the user interface 2510. If the second gesture is
received and
verified by the therapy suspension control procedure 2426, the therapy
delivery will be
suspended 2512. If the second gesture is not received or not verified by the
therapy suspension
control procedure 2426, the therapy suspension control procedure 2426, may
determine if a set
time has passed since receiving the therapy suspension request 2514. If it is
determined that a
set time has passed since receiving the therapy suspension request, the
request will be canceled,
and the touch screen will be locked 2516. If it is determined that time from
receiving the
therapy suspension is less than a set time the AMD may wait for the second
gesture to be
received.
[0272] in some examples, once a wake action is received 2502, the ANID may
automatically
activate a therapy suspension user interface 2506, without the need for a
first gesture 2504. In
these examples, once the request for therapy suspension is received 2508, a
gesture (e.g., a first
gesture) may be required to verify the request. In some such examples, once
the therapy
delivery is suspended, a second gesture may stop a suspension before any of
the conditions of
the stop parameter are met. This allows the user the versatility of being able
to modify a
suspension that has been activated,
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[0273] FIG. 26 is an illustration of a plurality of screens 2600 that the
ambulatory medical
device may display when a user activates a therapy suspension user interface.
Screen 2602
shows a user interface that an ambulatory medical device may display to a user
2414. The
display may be a touchscreen. display 2410 that can accept input that includes
the first and
second gestures. The therapy suspension system (ambulatory medical device 600)
is not limited
to the displays shown in FIG, 26. Various displays may communicate, to the
user 2414, the
same information shown in FIG, 26. The screen 2602 allows the user 2414 to
select various
functions. The pause button 2612, shown on screen 2602 is a function that
suspends the
delivery of a medicament to the user 2414. When the pause button. 2612 is
selected, the user
2414 is treated to the pause screen 2604. The pause screen 2604 allows the
user 241 4 to select a
duration of the medicament suspension. The ambulatory medical device 600 may
display
various interfaces to allow the user 2414 to select a duration of the
medicament suspension.
The pause screen 2604 shows a simple interface, giving the user 2414 one of
two duration
options.
[0274] When the user 2414 has made a selection of the duration of the
medicament suspension
on the pause screen 2604, the pause screen 2606 shows the user 2414 the
duration 2614 that the
user 2414 selected (e.g., in the figure the user 2414 selected 1 hour. Thus,
the medicament
delivery is suspended for 1 hour after the suspension begins). The pause
screen 2606 has a
prompt 2608 for the user to make a gesture to confirm the requested suspension
before the
medicament suspension begins. As shown by the prompt 2608, the user 2414 is
being prompted
to swipe right across the bottom of the screen. Once the user 2414 performs
the gesture to
begin the medicament suspension, the suspension screen 2610 is displayed on
the touchscreen.
The suspension screen 2610 informs the user 2414 that the medicament is
paused. The user
2414 has the option of performing another gesture to unlock the ambulatory
medical device.
The prompt 2616 for the user 2414 to unlock the device forces the user to
perform another
swipe to execute more functions on the ambulatory medical device 600.
102751 Suspending the medicament delivery may occur by not generating a dose
control signal
to deliver a dose of medicament. Alternatively, or in addition, suspending the
medicament
delivery may occur by sending a signal to the medicament pump to cease
providing therapy or
medicament to the subject.
[0276] In some cases, the ambulatory medicament device may not immediately
suspend
therapy upon receiving a command to suspend therapy. For example, if the
ambulatory
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medicament device is in the process of delivering medicament or determines
that a condition of
the subject indicates that medicament may soon be required to maintain the
subject's condition
(e.g., blood glucose) within a particular state (e.g., within a desired blood
glucose range), the
suspension of therapy may be delayed until at least such time that medicament
is not being
delivered, is predicted to not be required during the suspension period, or
the next therapy has
been delivered. In some such cases, the ambulatory medicament device may
inform that user
that the suspension of therapy is being delayed. Further, the ambulatory
medicament device
may indicate the reason for the delay. In some cases, the user may be able to
override the delay
and request immediate suspension of therapy. For example, if the user is
replacing the
medicament cartridge, the user tnay override an indication that the suspension
of therapy
should be delayed. In some cases, the requested start time may be overridden
by a determined
condition of the subject.
[0277] The suspension of therapy or the suspension of the delivery of
medicament may
continue until a resumption condition occurs. In certain cases, when a
resumption condition is
met, the suspension period may automatically end without action by the user or
subject.
[0278] The resumption condition may include the expiration of a time period, a
command
from a user (e.g., the subject), detection that the ambulatory medicament
devise satisfies a
condition (e.g., that medicament has been refilled), that the condition of the
subject meets
certain criteria (e.g., the subject's blood glucose level drops below a
threshold range or rises
above a threshold range), or any other condition that may satisfy the reason
for suspension of
therapy or that overrides the request for suspension of therapy. For example,
the drug delivery
device may be configured to automatically resume drug delivery when a glucose
threshold is
reached or exceeded. This threshold could be set to 300mg/d1 for example. The
resumption
condition may include detection of an impending risk of hypoglycemia or
hyperglycemia, or a
hypoglycemia or hyperglycemia event. Further, the resumption condition may
include a meal
announcement, or an "exercise concluded announcement," a motion sensing event,
a pause of
other administered medicament, a conclusion of an undefined suspension length
(e.g., during
cartridge change), a speed-based resumption event, a location-based
resumption, a remote
resumption in case of an emergency (e.g., commanded from caregiver admin
software or
clinician), or any other type of resumption event. In some cases, the
resumption condition can
include a combination of criteria.
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[0279] In some cases, automatically resuming therapy may include discontinuing
the
suspension of therapy before the expiration of the suspension period. For
example, if a
condition that caused therapy to be suspended is resolved prior to the
expiration of the
suspension period, therapy may be resumed.
[0280] In some cases, when a resumption condition (provided by the user) is
met, the
ambulatory medicament device may confirm that one or more additional
conditions of the
ambulatory medicament device are satisfied before therapy is resumed. For
example, if the
ambulatory medicament device determines that medicament has not been refilled
or if there is a
problem with the refill (e.g., cartridge is incorrectly installed), the
ambulatory medicament
device may continue to maintain the suspension of therapy despite the trigger
to resume
therapy.
[0281] In sonic examples, a therapy suspension may be ended if a third
interaction with a user
interface (e.g., a gesture) is detected. The third user interface interaction
may be detected by
the user interface module 2404 and sent to the therapy suspension control
procedure 2426. If
the therapy suspension control procedure 2426 verifies that third interaction
with the user
interface is a predetermined third user interface interaction, it may send a
signal to the device
and subject monitoring procedure 2422 to activate the medicament dose control
procedure
2420. This allows the user the versatility of being able to end a suspension
that has been
activated, during the suspension period set by the user before the
confirmation (second
interface with the user interface). In some cases, a user may decide to end a
therapy suspension
to modify one or more suspension conditions set prior to activation of the
current therapy
suspension. In some other examples, user may decide to end a therapy
suspension due to
change in user's health condition not included in one or more therapy
resumption conditions
provided before activating the current therapy suspension.
[0282] FIG. 27 is a flow diagram illustrating an example method of resuming a
suspended
therapy that may be implemented by an AMD. Once a therapy suspension has been
requested
and confirmed by a user (e.g., using the procedure illustrated in FIG. 10)
2702, the AMID
suspends one or more therapies selected for suspension 2704 at suspension
initiation time
received as part of the suspension information. For example, therapy
suspension control
procedure 2426 deactivates the medicament dose control procedure 2420 using
the device and
subject monitoring procedure 2422, During the suspension period, the therapy
suspension
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control procedure 2426 continuously monitors the system clock and the subject
and device
condition (e.g., using medicament dose control procedure 2420).
[0283] If the therapy suspension control procedure 2426 determines that the
time passed since
the suspension initiation is less than the requested suspension time period
2706 and none of
condition for resumption has been met 2708, the therapy suspension continues.
[0284] If the therapy suspension control procedure 2426 determines that the
time passed since
the suspension initiation is equal to the requested suspension time period
2706, or one or more
resumption conditions have been met 2708, it may check other ANID or subject
conditions (not
included in the therapy suspension information), in order to determine whether
the therapy
delivery can be safely resumed 2710. If it is determined that the therapy
delivery cannot be
safely resumed, an alert message will be sent to the user interface to inform
the about the
reason for such determination 2714. If it is determined that the therapy
delivery can be safely
resumed, the one or more suspended therapies will be resumed 2712.
[0285] FIG. 28 is an illustration 2800 of a plurality of screens that may be
displayed, for
example, on a touchscreen display when a user 2414 resumes a suspended
therapy. Screen 2802
informs the user that the delivery of medicament is currently in a suspended
mode. The screen
2812 also shows the user 2414 the current glucose concentration of the blood
of the user 2414.
The ambulatory medical device 600 may display various vital measurements that
are useful to
the user 2414. In one implementation, the medicament suspension ends if the
glucose
concentration of the blood of the user meets or passes a threshold.
[0286] The interface screen 2804 allows the user 2414 to select and execute
various functions
on the ambulatory medical device 600. The resume button 2814 is a function
that ends a
medicament suspension. When the resume button 2814 is selected, the ambulatory
medical
device 600 displays a resume screen 2806. The resume screen 2806 has a prompt
2816 that
prompts the user 2414 to perform a gesture, in the examples shown, the user
2414 receives a
prompt 2816 in the resume screen to swipe right across the bottom of the
resume screen 2806.
The requirement to perform the gesture to resume medicament delivery prevents
the user 2414
from inadvertently resuming medicament delivery in the ambulatory medical
device 600.
[0287] Once the user 2414 performs the gesture to resume medicament delivery,
the
medicament suspension ends. The resumption screen 2808 shows the user 2414
that the regular
medicament delivery has resumed. Once the resumption screen 2808 has been
displayed to the
user 2414 for a sufficient amount of time to inform the user 2414 that the
suspension is ending,
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the ambulatory medical device 600 may display a lock screen 2810. The lock
screen 281.0
prevents the user 2414 from inadvertently executing more functions on the
ambulatory medical
device 600.
[0288] In one embodiment, the ambulatory medical device 600 may end the
suspension before
the one or more conditions to end the suspension are met, when it receives a
second gesture.
The purpose of the second gesture is to ensure that the user 2414 does not
inadvertently end the
suspension. Like the first gesture, the second gesture may be simple or
complex.
[0289] With reference to FIG. 24, once the AMD device is instructed to resume
therapy and/or
determines that therapy is to be resumed, the ambulatory medicament device may
determine
whether a dose of medicament should be supplied to the user based on a control
algorithm used
by the ambulatory medicament device to control the provisioning of medicament
to the subject.
For example, the therapy suspension control procedure 2426 may determine a
resumption
condition has been satisfied or receive a user input from the user interface
module 2404 (a third
interaction with a user interface) indicating that therapy suspension should
be ended.
Subsequently the therapy suspension control procedure 2426 may send a signal
to the device
and subject monitoring procedure 2422 to activate the medicament dose control
procedure
2420. If medicament is to be supplied, the medicament does medicament dose
control
procedure 2420 may generate and send a dose control signal to the medicament
delivery
interface 2402.
[0290] In some cases, the ambulatory medicament device may alert the user
and/or the subject
that therapy is being resumed. This alert may occur before generating a dose
control signal
and/or after a resumption condition is satisfied (e.g., a suspension time
expires). In some cases,
the user may request that the suspension of therapy end early. The user may
request the early
resumption of therapy be interacting with the aforementioned user interface
using one or more
of the previously described interaction methods (e.g., gestures or taps).
[0291] Additional embodiments relating to suspending medicament delivery to a
subject that
can be combined with one or more embodiments of the present disclosure are
described in U.S.
Provisional Application No. 62/910,970, which was filed on October 4, 2019 and
is titled
"METHOD FOR SU- SPENDING DELIVERY OF A DRUG INFUSION DEVICE WITH
AUTOMATIC RESUMPTION OF DELIVERY," the disclosure of which is hereby
incorporated by reference in its entirety herein for all purposes.
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AMD with Security Functionality
[0292] An ambulatory medicament device (AMD), such as, but not limited to, an
insulin
pump, that provides lifesaving treatment to subjects or subjects based on the
condition of the
subject, may include a user interface (e.g., a touchscreen display) that lets
a user to modify the
settings of the ambulatory medicament device. The setting may include, but not
limited to, a
condition that triggers the delivery of medicament to a subject, the quantity
of medicament
delivered when a condition is met, type of the medicament and the like. The
setting may also
include features of the AMD that may not be directly related to the medicament
delivery (e.g.,
the screen brightness, an alarm sound, and the like), hi sonic examples, it is
desirable to
manage access to various settings of AMD in order to avoid inadvertent changes
while enabling
changes that may be necessary for uninterrupted and proper operation of the
AMID. For
example, it may be desirable to limit the access to sonic settings to certain
authorized users
(e.g., a healthcare provider) while enable access to some other settings other
authorized users
(e.g., the subject, a guardian or parent of the subject).
[0293] In many cases, a healthcare provider can modify the settings of the
ambulatory
medicament device. However, it is often desirable that a non-healthcare
provider modify at
least some settings of the ambulatory medicament device. For example, when the
ambulatory
medicament device runs out of or has below a threshold amount of medicament,
it is often
desirable that a user be able to refill or change a medicament cartridge
without visiting a
healthcare provider. In some cases, changing the medicament cartridge may
include interacting
with a user interface and/or one or more settings of the ambulatory medicament
device.
Another example of when it is desirable for a non-healthcare user (e.g., a
subject, parent, or
guardian) to modify settings of the ambulatory medicament device is when the
initial settings
of the ambulatory medicament device are not providing the desired effect
(e.g., sufficient
medicament, too much medicament, providing the medicament too slowly or too
fast, etc.). In
some cases, normal maintenance of the ambulatory medicament device and/or
subject may
require interaction with the ambulatory medicament device settings and/or
controls. For
example, negative consequences may begin to occur when an ambulatory
medicament device
remains connected to a subject at the same site for more than a threshold
period of time (e.g.,
for more than 2-3 days, more than 5 days, more than a week, etc.). Thus, the
ambulatory
medicament device may need to be periodically moved from one site on the
subject to another
site on the subject (e.g., from left-side to right-side, from arm to leg, from
stomach to back,
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etc.). The change in site location may require interaction with settings of
the ambulatory
medicament device (e.g., pausing operation until the site change is
completed).
[0294] Although, as explained above, there are a number of reasons it is
desirable to enable a
user other than a healthcare provider (e.g., the subject receiving therapy, a
parent, or a
guardian) to have access to at least some user settings of an ambulatory
medicament device, it
is also desirable to regulate access to at least some of the ambulatory
medicament device
settings. For example, it is generally undesirable that a child (subject or
otherwise), or a user
below a particular age, have access to ambulatory medicament device settings
that could cause
harm to the subject if modified. Further, it may be undesirable for certain
subjects who have
diminished mental capacity regardless of age to have access to at least some
ambulatory
medicament settings.
[0295] The user may be a subject receiving medicament or therapy, or may be
another user,
such as a clinician or healthcare provider, or a parent or guardian of the
subject. In some
examples, the passcode required for changing one or more setting via an
intermediary device
may be different that the passcode required for changing the sam.e settings
directly using the
A NID s user interface.
[0296] One solution to regulating access to settings of the ambulatory
medicament device is to
implement a lock feature to require that a user provide a passcode, a
passcode, or other
information before the user is permitted to modify a setting of the AMD, such
as a control
parameter. To simplify discussion, the disclosure will describe using a
passcode. However, it
should be understood that the passcode can be substituted for a passcode or
any other type of
secret or semi-secret information. In some examples, when the AIVID is in the
locked state, it
may continue delivering therapy to the subject at the same rate as unlocked
state.
[0297] The lock feature may be activated by default or may be activated by a
user. In some
examples, the lock feature can be enabled through a setting in a control menu
of the AMD
device provided on a user interface (i.e., touchscreen display). The setting
may include an
on/off toggle (e.g., a software interface element or a hardware interface
element) so when the
toggle is on, a passcode (e.g., 4 to 8 numeric digits) may be required. In
some cases, if the lock
feature is on, the passcode (e.g., a 4 to 8 numeric digit code) may be
required to turn the lock
feature off. When the lock feature is activated, the user may program the
ambulatory
medicament device with a user passcode selected by the user. Alternatively, or
in addition, the
user passcode may be set in response to a passcode change request. In some
cases, a user
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passcode may expire. In such cases, a user may be required to generate a new
passcode after
the previous passcode expires or before the previous passcode is permitted to
expire, In other
cases, the ambulatory medicament device may periodically generate a new
passcode (e.g., an
override passcode), or may generate the passcode at a time when a user
supplies the passcode,
[0298] In some cases, the user interface element used for accessing a user
interface that enable
changing one or more settings of the AMID may differ from the user interface
for modifying the
control parameters associated with that setting. For example, a keypad may be
used to enter a
passcode for unlocking a user interface for changing a control parameter and a
touchscreen may
be used to modify the control parameter.
[0299] When the lock feature is enabled, the user interface screen may look
and function the
same as if the lock feature were not enabled. If the lock feature is enabled,
when a visual guide
for unlocking the device (such as, for example, a linear unlock slider, an
arcuate unlock slider,
or another unlock user interface element) is activated, a passcode entry
interface (e.g., a keypad
user interface element) may be displayed. If either the user passcode or the
global override
passcode is entered, the user interface may proceed as normal. Otherwise, the
user interface
may revert back to the original lock screen.
[0300] in some examples, the user action that permits a user to change one or
more settings of
the AMD may be different from the wake action that activates a user interface.
For example, a
wake action may be used to activate a touchscreen display that may display a
plurality of user
selectable elements some of which may be accessible without a passcode. In
such examples, a
subset of the user selectable elements, for example those allowing the user to
change therapy
control parameters, may require a passcode. In some cases, access to each user
parameter
control element may require a different passcode. In some other examples,
providing a
passcode may to an AMD in locked state, may directly enable access to a subset
of control
parameter elements.
[0301] To help recall the passcode, the passcode may be set by the user
enabling the user to
select a passcode the user is more likely to remember. However, regardless of
who sets the
passcode, there is a risk that the user will not remember the passcode. Due to
the nature of the
device (e.g., a device that may provide life-saving treatment), it is
desirable that certain users
not be restricted from accessing particular settings of the ambulatory
medicament device, and
be able to quickly (e.g., within seconds, minutes, prior to a next therapy
event, or before harm
may occur to the subject) obtain access to the particular settings when
required. Thus, while
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some non-medical devices may implement lockout periods or other restrictions
to prevent a.
malicious user from trying to brute-force determine a passcode for a device,
such features are
generally undesirable for an ambulatory medicament device. Accordingly,
embodiments
disclosed herein include an ambulatory medicament device that includes an
override passcode
that enables access to the ambulatory medicament device (or control settings
thereof)
regardless of whether the user passcode is provided.
[0302] In some examples the passcode or the override passcode can be a series
of taps, series
of inputs, a complex or a simple gesture (e.g., a swipe or other movement
across the
touchscreen), The series of inputs may be any combination of touch movements,
touch points,
numerical characters, alphabetical characters, and other symbols. In some
examples, the time
that the series of inputs are entered may also be a part of the range of
parameters. For example,
a series of inputs may need to be entered in no less than 3 seconds or more
than 3 seconds, and
no more than 15 seconds or less than 15 seconds. One example of the complex
gesture is a
swipe.
[0303] In some other examples the passcode or the override passcode can be a
complex or a
simple gesture (e.g., a swipe or other movement across the touchscreen),
performing a pattern
or sequence on the touchscreen (e.g., drawing an image), a multi-touch
interaction, a
combination of the foregoing, or any other type of interaction with a
touchscreen, or portion
thereof. Another example of a complex gesture is entering a predetermined
sequence of
touches. In some cases, the passcode may include a quiz or set of questions,
[0304] in some examples, the ambulatory medicament device may be configured to
receive
therapy settings or modifications to therapy settings from an intermediary
device via a
communication connection. In some cases, this feature may be supported in
addition to
providing the user with option of modifying one or more settings with a user
interface of the
AMD. The communication connection between the intermediary device and the AMD
may be a
direct connection via, for example, Bluetooth , or a connection via a network,
such as over a
local area network or a wide area network. In some such cases, the ambulatory
medicament
device may include a wireless transceiver, such as an NB-LIE transceiver, a Wi-
Fi transceiver,
or a Bluetooth transceiver. The intermediary device, that provides the user
with a user interface
to modify settings of the AMD, include any type of device (e.g., a computing
device) that can
communicate with an ambulatory medicament device. For example, the
intermediary device
may be a laptop or desktop computer, a srnartwatch, a smartphone, or a
hardware control
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device that may be configured to interact with the ambulatory medicament
device.
Embodiments disclosed herein are applicable regardless of whether the user
interface for
modifying therapy settings or the configuration of the ambulatory medicament
device is
generated or presented by the ambulatory medicament device to the user or via
another device.
In some such cases, a user may provide a user-generated passcode or an
override passcode via
an interface of the computing device. The computing device may then provide
the user
generated passcode or the override passcode to the ambulatory medicament
device via the
network connection between the devices.
[0305] In some examples, even if the AMD is in locked state, certain
intermediary devices
may have access to user interfaces that may be used to change one or more
settings (e.g.,
therapy settings) of the AMD. For example, the smart phone of a guardian or a
parent of the
subject may be used to change one or more settings of the AMD while the AMD is
in the
locked state.
[0306] In some examples, the AMD may be configured to receive a passcode from
or via a
computing systems (e.g., a cloud computing system). In these examples, the AMD
may receive
passcode through a direct end-to-end connection (e.g., a wireless connection
over a wide area
network) stablished with the computing system. In some such examples, another
computing
device (e.g., a smartphone, a laptop, a personal computer, and the like)
connected to the
computing system, may send a passcode to the AMD and be able to change one or
more
settings of the AMD if the passcode is validated by the AMD.
[0307] in cases where the user cannot recall the user passcode, the user can
obtain access to
the user interface that permits modification of the control parameter by
supplying an override
passcode. In some examples, the override passcode may be a universal fixed
passcode (e.g., an
8-digit override passcode) that can be used instead of the user set passcode.
The override
passcode can be stored in the ambulatory medicament device at the time of
manufacture and
may be shared among multiple ambulatory medicament devices (e.g., a global
override
passcode), or may be unique to a particular ambulatory medicament device. The
override
passcode may be managed by the manufacturer or by a third-party service. To
obtain the
override passcode, the user may contact the manufacturer or passcode managing
service.
Generally, enabling the passcode may exist to prevent a user with a diminished
mental capacity
(e.g., a child) from modifying settings of the ambulatory medicament device.
Thus, security
may be less of a concern and any user can contact the manufacturer or passcode
managing
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service to obtain the override passcode. In some such cases, a single global
override may be
used for all devices produced by the manufacturer. However, in some cases, a
level of security
may be desired. In some such cases, it may be necessary for the user to
authenticate him or
herself. Further, the user may be required to provide a serial number of the
ambulatory
medicament device, In some cases, each model or each unit of the ambulatory
medicament
device may have a different override passcode. The user may provide
authorization information
and a serial number of the ambulatory medicament device to the manufacturer or
passcode
managing service to obtain the override passcode,
[0308] in some examples, may periodically generate a new override passcode or
may generate
an override passcode at a time when a user supplies the passcode. In these
examples, the
ambulatory medicament device may use the same parametric values to generate
the override
passcode as another device may use thereby ensuring a match between the
override passcodes.
Advantageously, in some cases, by using an algorithm to generate the override
passcode, the
override passcode can be obtained regardless of whether a user is able to
contact a
manufacturer or other passcode managing service. In sonic cases, the user may
generate the
override passcode without access to a network or phone using, for example, a
computing device
that can access a common parameter value as the ambulatory medicament device.
[0309] in sonic cases, the override passcode may change over time or be a
rotating passcode.
For example, in some cases, the override passcode may change every thirty
seconds, every
minute, every hour, etc. In some such cases, the override passcode may be
determined from an
algorithm executed by an application. The ambulatory medicament device may
store a copy of
the algorithm in a memory of the ambulatory medicament device and may execute
the
algorithm to determine the override passcode that is currently valid. A copy
of the algorithm
may be executed by another computing device accessible by the user. The output
of the
algorithm may be based on a value that is commonly accessible by the
ambulatory medicament
device and the copy of the algorithm accessible by the computing device. For
example, the
output of the algorithm may be generated based on a time, a user identifier, a
provided value, or
any other factor that may be used to repeatedly generate the same output. In
some cases, the
override passcode may be calculated based on a combination of factors. For
example, the
override passcode may be calculated based on a portion of a serial number or
model number for
the ambulatory medicament device and the time. The determination of the
override passcode
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may be calculated by the ambulatory medicament device, a computer server,
and/or an
application on a user device.
[0310] In some cases, the override code can be automatically received by the
ambulatory
medicament device, Thus, a user may not need to see or enter the override
code. In some cases,
the override code may be transmitted to another device of the user (e.g., a
smartphone or
laptop). For example, the override code can be texted to a user's smartphone.
In some cases,
the override code may be received in a coded manner that may not be
understandable by a child
or user with diminished mental capacity,
[0311] In some cases, the override passcode may be linked to a location. For
example, the
override passcode may be enterable at a healthcare provider's office or at the
subject's place of
residence. The determination of the location of the ambulatory medicament
device may be
based on a geolocation system (e.g., a Global positioning System (GPS))
available to the
ambulatory medicament device.
[0312] In some examples, at least for a subset of therapy settings, the
passcode may provide a
second level of security in addition to other interactions with the user
interface (e.g., a first and
a second gesture on a touchscreen display) that may be used to change the
therapy settings
and/or accept the change made to a therapy setting. In some other examples, at
least for a
subset of settings, the passcode may be used instead of other interactions
with the user interface
(described above).
[0313] As mentioned above, interacting with the user interface may cause the
ambulatory
medicament device, or other device that can modify a control of the ambulatory
medicament
device, to present a passcode input screen to the user. The user may enter the
passcode to
unlock additional user interface features including, for example, a user
interface that enables
the user to modify at least one control parameter of the ambulatory medicament
device. The
control parameter can be modified based on an interaction with a parameter
control element of
the user interface. Further, modification of the control parameter may cause
modification of the
generation of a dose control signal that is generated by a control algorithm
based at least in part
on the control parameter.
[0314] In some embodiments, the ambulatory medicament device may have an
advanced
therapy screen, or other user interface, that permits a healthcare provider,
or other user, to
obtain additional details relating to therapy provided by the ambulatory
medicament device.
Although the advanced therapy screen may generally be intended for a
knowledgeable user,
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such as a clinician, in some cases, any user may obtain access to the advanced
therapy screen.
The advanced therapy screen may permit the healthcare provider to modify
control parameters
that may not be modifiable by other users. For example, the healthcare
provider may be able to
control parameters that relate to the calculation of a rate of insulin
accumulation, the rate the
insulin diminishes within the blood of the subject, the setting of a glucose
setpoint, an
aggression level or factor of therapy relating to an amount of insulin
provided when the
subject's glucose level is outside the setpoint range, or when the insulin
reaches a point of
maximum concentration within the blood of the subject (e.g., Turdx).
[0315] Access to the advanced therapy screen may be limited by requirement of
a passcode,
which may be referred to as a clinician passcode to distinguish it from the
user-generated
passcode and/or the override passcode. This clinician passcode may or may not
be user-
generated. However, the clinician passcode may be a separate passcode from the
user-generated
passcode that permits access to the non-advanced therapy screen interface.
Further, the
clinician passcode may be separate from the override passcode that permits a
user to override
the user-generated passcode to obtain access to the non-advanced therapy
screen interface. In
some cases, the clinician passcode may be used as an override passcode. In
some example the
clinician passcode can be valid for period of time (e.g., set by a subject or
another authorized
user such as the guardian or apparent of the subject). For example, the
clinician passcode may
be valid for a day, a week, or a month. In some examples, the AMD may allow
certain
authorized users to terminate the clinician access at any time.
[0316] In some cases, access to the advanced therapy screen may be limited to
a particular
period of time. After the time period expires, the ambulatory medicament
device may
automatically restrict access to the advanced therapy screen. In some cases,
the window of
access may be extended. For example, if the healthcare provider is continuing
to interact with
the advanced therapy screen, the screen may remain accessible.
103171 in some cases, the advanced therapy screen may provide additional
features. For
example, while a user may be able to indicate that an amount of insulin
provided for a meal or
as a correction factor should be higher or lower, the healthcare provider may
be able to
specifically adjust the amount of insulin. Moreover, while a user's direction
may or may not be
followed depending, for example, if the request exceeds a threshold or may
cause blood
glucose to not satisfy a setpoint range, an indication provided via the
advanced therapy screen
may be followed regardless or may have a wider range or different threshold
that may control
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whether the instruction is followed. Further, the advanced therapy screen may
be used to
temporarily pause therapy and/or may prevent subject access.
[031.8] In some cases, the manufacturer of the ambulatory medicament device
may provide a
remote unlock signal that can be used to unlock access to the ambulatory
medicament device
and/or to an advanced therapy screen of the ambulatory medicament device.
[031.9] As described above, the passcode may be desired to prevent particular
users from
inadvertently changing certain control parameters of the ambulatory medicament
device.
However, features of the ambulatory medicament device that do not affect
therapy may remain
accessible to a user when the ambulatory medicament device is in a locked
state. For example,
a user may be able to access therapy history, screen brightness settings or
colors, or any other
feature that is unlikely to harm a subject if modified in a particular manner.
Further, as the
passcode feature is generally to prevent control parameter changes, the
ambulatory medicament
device may provide therapy and continue to provide therapy at the same rate
and under the
same condition, whether or not the ambulatory medicament device is locked or
unlocked.
[0320] When the ambulatory medicatnent device receives the user passcode or
the override
passcode, the ambulatory medicament device validates the passcode. The
passcode may be
validated by comparing the received passcode to a passcode stored in a memory
of the
ambulatory medicament device or generated by the ambulatory medicament device.
If the
passcode received from the user is successfully validated, the user may be
granted access to a
user interface to modify one or more control parameters. In some cases, the
user may be
requested to re-enter a passcode to confirm a change to a control parameter.
In some other
examples, the user may be requested to provide a gesture on a touchscreen to
confirm a change
to a control parameter.
[0321] If the passcode is not validated, the ambulatory medicament device, or
other control
device that can provide access to control parameters of the ambulatory
medicament device, may
prevent access to the user interface to modify the one or more control
parameters. In some
cases, the user interface that presents the user with the ability to enter the
passcode may permit
the user a particular number of tries or a particular number of tries within a
particular time
period to enter the user passcode. if the correct user passcode is not entered
within the provided
number of tries or within the particular time period, the user interface may
enter a lock state
(e.g., the screen will be turned oft) and prevent further attempts to enter a
passcode for at least
a period of time, In some cases, the user passcode option may be indefinitely
locked or
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blocked. In some such cases, the control parameters of the ambulatory medical
device may be
accessible when the override passcode is provided. Alternatively, or in
addition, a user
passcode of a different user may be used to provide access to the control
parameters of the
ambulatory medical device. In some examples, if the correct override passcode
is not entered
within the provided number of tries or within the particular time period, the
user interface may
block any attempt to change the override passcode for at least a period of
time.
[0322] In some cases, once the passcode is successfully entered or validated,
a user may
deactivate the passcode feature of the ambulatory medicament device.
Deactivating the
passcode feature may require use of a separate passcode or the override
passcode in addition to
the user passcode.
[0323] In some cases, the passcode may be optional or omitted based on the
computing device
connected to the ambulatory medicament device. For example, if the end-to-end
connection. is
established between a sma.rtplione registered to a particular user (e.g., a
parent of the subject),
the ambulatory medicament device may unlock automatically without requiring a
passcode. In
other cases, the smartphone, or other computing device, may automatically
provide the user-
generated passcode or the override passcode to the ambulatory medicament
device upon
establishing a connection. In some cases, the ambulatory medicament device may
automatically
be unlocked when connected to a charger or when in a particular geographic
area. For example,
a gee-fence may be configured in one or more locations, such as the subject's
house or the
clinician's office. When the ambulatory medicament device determines it is
within the geo-
fence, the ambulatory medicament device may automatically be unlocked.
Similarly, when the
ambulatory medicament device determines that it is not within the geo-fenced
region, it may
automatically be locked. The determination of the location of the ambulatory
medicament
device may be made based on a geo-location system, such as the Global
Positioning System
(GPS).
[0324] in some cases, after a certain number of unsuccessful passcodes are
entered (e.g., after
tries), the user interface screen may be turned off or may accept only the
global override
passcode.
Example AMD with Security Codes
[0325] FIG. 29 is a block diagram illustrating the interconnection among
modules and
procedures in AMID involved in changing the settings of the AMD. In some
cases, one or more
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settings of the AMD may be changed using a setting change input 2916 to one or
more
parameter control element parameter control elements 2930/2934/2938 presented
on one or
more setting user interface screens 2928/2932/2936 provided by the user
interface module
2902, In some examples, when the lock feature is activated, access to one or
more setting
control screens 2928/2932/2936 and/or one or more parameter control element
2930/2934/2938, may be protected by a passcode. In order to change a parameter
control
element 2930/2934/2938, the user may provide a passcode input 2918 (e.g., a
user generated.
passcode or an override passcode), via the user interface module 2902 (e.g.,
using a
touchscreen display 2906 or alphanumeric pad 2908), Alternatively, or in.
addition, the user
2910 may provide a passcode 2940 using an intermediary device (e.g., a laptop,
a smart phone,
and the like) that is connected to the AMD (e.g., via a wireless link). In
some examples, the
access to one or more setting user interface screens 2928/2932/2936 and/or
parameter control
element parameter control elements 2930/2934/2938, may be managed by setting
change
procedures 2912 stored in a memory in the control and computing module of the
AMD. A hard
processor may execute the machine-readable instructions associated with the
setting change
procedures 2912.
[0326] In some examples, the option to provide a passcode may become
available, when the
user 2910 performs a wake action on a wake interface 2904. In these examples
if the wake
control procedure 2922 of the CCM determines that a valid wake action is
performed, it may
present selectable elements associated with the setting user interface screens
2928/2932/2936,
for example, on a touchscreen display. In some other examples, the first
screen presented on
the touchscreen display, may provide other selectable elements including an
element to change
the settings of the AMD. In such examples, selecting element associated with
settings change
may activate a second screen that presents selectable elements associated with
the setting user
interface screens 2928/2932/2936. When the lock feature is activated, access
to any of the
setting user interface screens 2928/2932/2936 and/or parameter control element
2930/2934/2938 may require a passcode. In some examples, each one of the user
interface
screens 2928/2932/2936 and/or parameter control element 2930/2934/2938 may
require a
different passcode. In some other examples, one or more user interface screens
2928/2932/2936
and/or parameter control element 2930/2934/2938 may not require a passcode.
For example,
access to the fist user interface screen 2928 may require a first passcode,
the access to the
second user interface screen 2932 may require a second passcode and the access
to the third
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user interface screen 2936 may not need a passcode. In yet another examples,
all the user
interface screens 2928/2932/2936 may be presented without the need for
providing a passcode,
but access to the one or more control elements in a control screen may require
a passcode. For
example, the user may select the second user interface screen 2932 without
entering a passcode
but in order to select one or more parameter control element 2934 on that
screen, the user may
need to enter one or more passcodes.
[0327] In some examples, once a passcode or override passcode received from
the
intermediary device 2914 or the user interface module 2902, the passcode may
be transmitted
to the control and computing unit of the AMD where the setting change
procedures 2912
(therapy change control procedure 2920 and wake control procedure 2922)
determine the
validity of the passcode by comparing it to the one or more stored user
generated passwords
2926 or received or stored override passwords 2924 stored in a memory of the
CCM,
[0328] FIG. 30 is a flow diagram illustrating an example method that may be
used by an AMD
to allow a user to change a setting of the AMD using a user generated passcode
or an override
passcode. Once the AMD (e.g., the wake action procedure in the CCM) receives a
valid wake
action 3002, a user interface may be activated. In some example, the wake
action may directly
activate a setting change interface 3004 (e.g., a setting change screen
presented on a
touchscreen display). In some examples, a specific wake action may activate
the setting change
interface. On the setting change interface 3006, the AMD (e.g., the setting
change procedure in
the CCM) may request a passcode (e.g., by presenting a window to enter a
passcode). Once a
passcode is received, the AMD (e.g., the setting change procedure in the CCM.)
may determine
whether the passcode matches a user generated passcode 3008. If it is
determined the passcode
matches with a user generated passcode, the AMD may provide access 3010 to one
or more
control parameter elements associated with the received passcode. If the
received passcode
dose not match with any of the stored user generated passcode, the AMD may
determine
whether the passcode matches with an override passcode 3012. If it is
determined the passcode
matches an override passcode stored in a memory of AMD or a memory of an
authorized
computing device, the AMD may provide access 3014 to one or more control
parameter
elements associated with the received override passcode. If it is determined
the passcode does
not matches an override passcode, the AMD denies access 3016 to one or more
passcode
protected control elements,
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[0329] FIG. 31 is a flow diagram illustrating another example method that may
be used by an
AMD to allow a user to change a setting of the AMD using a user generated
passcode or an
override passcode. Once the AMD (e.g., the wake action procedure in the CCM)
receives a
valid wake action 3102, the AMD may provide a user interface (e.g., a
touchscreen display) on
which the user can provide a first gesture to activate a setting change
interface or screen. When
a first gesture is received from a user or subject 31.04, the AMD may activate
a setting change
interface 3106 or a screen. In some examples, the setting change interface or
a screen may
include one or more parameter control elements associated with one or more
settings of the
AMD. In some other examples, the setting change interface or a screen may
include one or
more selectable elements each associated with a setting change screen (e.g., a
screen provided
on a touchscreen display) that may include one or more control parameters.
When a request for
setting change is received 3108, the AMD may determine whether the requested
setting change
is passcode protected or not 3110. In some examples, the request for setting
change may
include selecting a parameter control element. In some other examples, the
request for setting
change may include selecting a list of parameter control elements (e.g.,
included in a separate
screen provided on a touchscreen display).
[0330] if the AMD determines that the requested setting change is not
protected by a
passcode, it may permit access to one or more parameter control elements
associated with the
requested setting change 3112. In some examples, once the changes are received
via parameter
control elements 3114, the user may need to provide a second gesture on the
user interface
(e.g., touchscreen display) to confirm the changes made. In response to
receiving the second
gesture 3116, the AMD may change one or more settings 3118 according to the
requested and
confirmed changes.
103311 If the AMD determines that the requested setting change is protected by
a passcode, it
may request a passcode 3120 via a passcode display (e.g., provided on a
touchscreen display).
In some examples, the request for the passcode may be presented on a display
but the passcode
may be received via a physical keypad. Once a passcode is received 3122 from
the user or
subject, the AMD may validate the passcode 3124 by comparing it with one or
more user
generated passcodes or an override passcode. If it is determined that the
passcode matches with
a user generated passcode or an override passcode, the AMD may activate 3126
one or more
parameter control elements associated with the requested setting change.
Subsequently, the
AMD may receive a setting change via the selected control parameter element
3128. In some
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examples, the user may need to provide a second gesture on the user interface
(e.g.,
touchscreen display) to confirm the changes made, In response to receiving the
second gesture
3130, the AMD may change one or more settings according to the requested and
confirmed
changes 3132.
AMID with Alarm System
[0332] In some cases, a condition may occur that impacts the operation of the
ambulatory
medicament device (AMT.)), This condition may be associated with the ability
of the
ambulatory medicament device to operate as intended by the manufacturer, a
subject receiving
therapy from the AMD, and/or user (e.g., healthcare provider, parent, or
guardian of the
subject). In some cases, the AMD device may be operating as intended, but the
condition of the
subject may not satisfy a desired level of health. In either case, it is
generally desirable to
generate an alarm to inform the subject and/or one or more users of the
condition of the AMD
and/or the subject. Moreover, it is desirable to track the alarm until the
condition that caused
the alarm is resolved. Further, it is desirable -to issue different types of
alarms for different
conditions to enable a subject or user to easily distinguish the severity of
the condition that
triggered the alarm. The user may be a subject receiving medicament or
therapy, or may be
another user, such as a clinician or healthcare provider, or a parent or
guardian.
[0333] This section of the disclosure relates to an AMD, such as an insulin
pump or a
combined insulin and counter-regulatory agent (e.g., Glucagon) pump,
configured to generate a
dose control signal configured to cause a medicament pump to infuse medicament
into a
subject. Moreover, the present disclosure relates to an ambulatory medicament
device
configured to detect a condition of the ambulatory medicament device and/or
the subject, and
to generate an alarm when it is determined that the detected condition
satisfies an alarm
condition.
[0334] As mentioned above, an ambulatory medicament device may include an
alarm system
configured to monitor the ambulatory medicament device and/or the subject, and
to generate an
alarm when it is determined that a condition has been detected that satisfies
an alarm
condition. In some examples, the alarm system may organize an alarm manager
list, notify a
user of these alarms, and/or allow the user to acknowledge alarms, mute,
and/or snooze the
alarms. In some examples, the alarm manager list may be a list of pending
alarm conditions
with which the user can interact using a touchscreen display of the AMD.
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[0335] In some embodiments, the alarm system may include a plurality of
sensors that
monitor the ANID or the subject, a monitoring system interface that receives
the data from
sensors, and alarm generation module that process the received data and
generate alarms when
an alarm condition is met. In some examples, the monitoring system interface
and the alarm
generation module are implemented using one or more hardware processors and
machine
readable. In some other examples, the monitoring system. interface and the
alarm generation
module are separate hardware modules. In implementations, the monitoring
system may
provide status information received from the plurality of sensors to the alarm
annunciation and
control system. In some examples, the status information may include one or
more status
values. In some examples, the status information may include device
information pertaining to
a condition of the AMD or subject information pertaining to a condition of the
subject. In some
such examples, the alarm annunciation and control system may be configured to
determine
based at least in part on the status information received from the monitoring
system, whether an
alarm condition is satisfied.
[0336] As noted above, the AMD may generate an alarm for various situations to
notify the
user, and further may request a user's acknowledgement to confirm that the
user is aware of the
current situation to be resolved. The alarm can be generated in various forms
to the user in a
way that the user can recognize the situation and condition of the alarm or
alarms, thus
allowing convenient communication between the user and the AMD.
[0337] With reference to FIG. 32, in some embodiments, an alarm system 3202
may
implement alarm control procedures in a control and computing module (CCM) of
the
AMD. The alarm system 3202 can be implemented as instructions stored in a
memory of the
CCM and executed by a hardware processor to generate an alarm upon detection
of a condition
of the ambulatory medicament device and/or the subject. In some cases, the
hardware processor
of the monitoring system may be a hardware processor of the ambulatory
medicament device
that controls medicament delivery. In some cases, the hardware processor of
the monitoring
system may be a separate hardware processor.
103381 in some examples, the alarm system 3202 may include a monitoring system
interface
3210 and an alarm annunciation and control system 3212. The alarm annunciation
and control
system 3212 may include sub-systems for determining the severity of an alarm
condition, user
notification processing, and receiving alarm control commands from the user
interface module
3218. The user interface module 3218 may include any type of user interface
controller for
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providing a user interface. The user interface may be provided on a display of
the AMD or may
be transmitted to a display of an electronic device in communication with the
AMD. In some
cases, the user interface controller may be a touchscreen controller that is
configured to output
display signals configured to generate one or more user interface screens on a
touchscreen,
Further, the touchscreen controller may be configured to receive user input
signals
corresponding to user interaction with the touchscreen. The monitorin.g system
interface 3210
may monitor the condition or status of the AMD and/or the subject at least
partially based on
signals or status values received from a set of device sensors 3208 and a set
of subject sensors
3216. In some examples, the device sensors 3208 may be configured to track the
status of the
components or the elements of the AMD, and the subject sensors 3216 can be
configured to
obtain measurements of one or more physiological characteristics of the
subject. In some
examples, the device sensor 3208 can include a motion sensor that detects
motion or
acceleration of the AMD or on the AMD (e.g., tapping or shaking gestures). The
motion sensor
can include an accelerometer, gyroscope, and/or other electrical or mechanical
motion sensors
that convert motion or acceleration into electrical signals.
[0339] In certain embodiments, the user 3226 may wake the AMD from a sleep
state or
unlock the AMD by interacting with a wake interface 3220. In certain
embodiments, the user
3226 may wake the A.MD from another state or mode, such as for example a power
saving
mode or low power mode, the AMD by interacting with a wake interface 3220.
When the AMD
is in a sleep state or other state/mode, the touchscreen controller may not
receive user input or
user input signals corresponding to user input (e.g., via a touchscreen
display 3222). When the
AMD is in a sleep state or other state/mode, the touchscreen controller may
not receive user
interaction or user interaction signals corresponding to user interaction
(e.g., via device sensors
3208 including an accelerometer or other motion sensors).
103401 Waking the AMD may include activating a touchscreen interface or
presenting a lock
screen to a user. Further, waking the AMD may include waking the touchscreen
controller such
that it can receive user input or user input signals corresponding to user
input. The wake
interface 3220 can include one or more of the additional user interfaces
mentioned above that
are configured to generate and provide a wake input (or wake signal) to the
CCM when
detecting a pre-set user interaction. Alternatively, or in addition, the wake
interface 3220 can
be any type of wake interface element of the AMD that a user can interact with
to wake at least
a feature (e.g., a touchscreen interface) of the AMD. In some cases, the wake
interface 3220
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element can be a physical button (e.g., a push button, a slide button, etc.),
a capacitive element,
a resistive element, or an inductive element. In some cases, the wake
interface element can be
or can include a biometric element, such as a fingerprint reader, an iris
scanner, a face detection
scanner, etc. In some cases, the AMD may wake in response to detection of a
particular
movement or motion. For example, a determination that the ambulatory
medicament device is
being moved with a particular motion or within a line of sight or a visual
range of a user may
cause the AMD to awaken or cause the AMD to awake the touchscreen interface of
the AMD
The AMD may determine that the AMD is being moved within a line of sight of
the user based
on the type of motion and/or the detection of a user's eyes via, for example,
an iris scanner or a
camera. In some cases, the AMD may wake in response to detection of a tapping
on the AMD,
such as a single tap or a double tap. In sonic embodiments, a single tap or a
double tap may
activate one or more elements of the user interface module 3218, such as for
example the
touchscreen display 3222. The touchscreen display can be a touch digitizer
that converts
analog interaction.s of the user (e.g., via electrical or mechanical
properties of the user) into
digital signals communicated to one or more controllers as discussed herein.
[0341] When in the wake and/or unlocked state, a user may interact with the
touchscreen
display 3222, alphanumeric pad 3224, or other types of user interfaces that
may be included in
the user interface module 3218. The user interface module 3218 may include any
combination
of one or more of the touchscreen display 3222, alphanumeric pad 3224, or
other types of user
interfaces.
[0342] In some examples, a device sensor 3208 may be a sensor that generates a
signal or
status value associated with the condition of modules, interfaces,
accessories, disposables of
the AMD. In some examples, a device sensor 3208 may generate a signal that
corresponds to a
parameter associated with a component in a module or interface. For example,
one device
sensor may record the voltage of a battery and another device sensor may
record the follow rate
of a pump the medicament delivery interface 3214.
[0343] In some examples, a subject sensor 3216 may be any sensor that
generates a signal or
status value associated with one or more physiological indicators (or
parameters) of a subject
(e.g., heart rate, blood pressure, body temperature, level of blood sugar,
serum levels of various
hormones or other analytes). In some such examples, the subject sensor can be
a continuous
glucose monitoring sensor (CGS). The device and subject monitoring system
interface 3210
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may continuously receive and analyze signals from device sensors 3208 and
subject sensors
3216 to determine the condition of the AMD, the subject, a sensor, and/or
other accessories.
[0344] In some cases, a single sensor may be used to monitor both the
condition of the subject
and the ambulatory medicament device or accessories and sensors connected to
AMD. For
example, a continuous glucose monitoring (CGM) sensor may be used to monitor
the condition
of the subject and may also be monitored to determine whether the condition of
the CGM
satisfies an alarm condition (e.g., to alarm a user that the CGM should be
replaced).
[0345] Although described as sensors of the AMID, one or more of the sensors
may be
accessories that may or may not be part of the AMD, but that may communicate
with the AMD.
[0346] In some examples, the alarm system. 3202 may implement procedures for
allowing the
user or subject to change the alarm settings and/or acknowledge an alarm
annunciation via the
user interface module 3218. In some examples, the user may be able to see one
or more alarms
annunciated on a user interface (e.g., as a list of alarms), even if the AMD
is in a locked state.
In these examples, the user may not be able to acknowledge or respond to
alarms when the
AMD is in the locked state.
[0347] in sonic such examples, the user or subject may access an alarm setting
screen or
acknowledge an alarm annunciation by providing a wake action or a wake action
followed by a
first gesture via, for example, the touchscreen display 3222. In some cases,
the first gesture
may be created by entering predetermined or particular characters on the
alphanumeric pad
3224. In some such examples, the user or subject may access an alarm setting
screen or
acknowledge an alarm annunciation by providing a single, double, or more tap
gestures on the
AMD. In some such examples, the alarm system 3202 may distinguish inadvertent
alarm
control inputs from intentional alarm control inputs. An inadvertent alarm
control input may be
an alarm acknowledgment input that was made without the intent of the user
3226 to
acknowledge the alarm that the ambulatory medical device is delivering to the
user. For
example, an inadvertent alarm acknowledgment may include one that was
accidentally
executed by the user 3226 by putting pressure on the AMD in a jacket pocket of
the user 3226.
103481 in some examples, the alarm system 3202 may implement processes for
determination
and categorization of an alarm condition based on its severity level (e.g., a
severity level
between 0 and 5, with for example 0 being least or nonurgent alarm conditions
and 5 being
urgent or most urgent alar conditions), according to information received
through the
monitoring system interface 3210. In some examples, once an alarm condition is
detected, the
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alarm annunciation and control system 3212 may place it in the appropriate
queue, for example,
based on severity or category. In one or more embodiments, a list of alarms
may be generated
wherein alarms may be sorted numerically in descending order with the highest
priority fault or
most urgent alarm condition displayed at the top.
[0349] In some examples, the alarm system 3202 may implement procedures for
controlling.
the annunciation of alarm conditions via the user interface module 3218, at
least partially,
based on their severity level, In some such examples, a user interface (e.g.,
a touchscreen
display) may be configured to allow the user 3226 to navigate directly to the
issue or fault for
which an alarm is being delivered and to address the fault causing the alarm
so that it may be
corrected, thereby stopping the alarm. Additional embodiments relating to
alarm condition
for an a.mbulatory medicament device that can be combined with one or more
embodiments of
the present disclosure are described in -U.S. Provisional Application No.
63/167,563, which was
filed on March 29, 2021 and is titled "AMBULATORY MEDICAMENT PUMPS WITH
SELECTIVE ALARM MUTING," the disclosure of which is hereby incorporated by
reference
in its entirety herein for all purposes.
Alarm Conditions
[0350] In some examples, the device and subject monitoring system interface
3210 may
provide a status information received from the device sensor 3208 and/or
subject sensor 3216
to the alarm annunciation and control system 3212. In some examples, the
status information
may include one or more status values. In some examples, the status
information may include
device information pertaining to a condition of the ambulatory medicament
device or subject
information pertaining to a condition of the subject. In some. such examples,
the alarm
annunciation and control system 3212 may be configured to determine based at
least in part on
the status information received from the monitoring system interface 3210,
whether an alarm
condition is satisfied.
[03511 Determining whether an alarm condition is satisfied may include
comparing one or
more status values associated with the AMD and/or the subject to one or more
alarm
thresholds, threshold amounts, or alarm conditions. In some cases, each alarm
threshold,
threshold amount, or alarm condition may be associated with an alarm profile.
In some such
cases, determining whether the alarm condition is satisfied may include
comparing the status
information to one or more alarm thresholds, threshold amounts, or alarm
conditions included
in one or more alarm profiles. In some examples, the alarm profile may be
stored in a memory
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of the AMD, In some such examples, at least some of the alarm profiles may be
provided by an
authorized user or the subject via a user interface or directly transferred
from another device to
the storage (e.g., from USB drive, a laptop, smart phone, PC, and the like).
In some examples,
at least some of the alarm profiles may be provided at the time of
manufacture.
[0352] Each of the alarm profiles may indicate the characteristics or status
of the AMID and/or
subject that triggers an alarm corresponding to the alarm profile. For
example, at least some
alarm profiles may indicate the threshold status values below or above which
an alarm should
be triggered, For example, one alarm profile may indicate that when a blood
glucose level of
the subject exceeds a particular threshold, a particular alarm is to be
generated and/or
annunciated. As another example, an alarm profile may indicate that when an
available amount
of medicament is below a particular threshold, a particular alarm is to be
generated and/or
annunciated. The type of alarm and/or the alarm frequency or intensity
associated with the
medicament level may differ from the alarm triggered based on the blood
glucose level.
Although the previous examples described a single condition associated with a
single alarm
profile, it should be understood that multiple conditions may be associated
with an alarm
profile. For example, a blood glucose level that exceeds an upper threshold Of
is below a lower
threshold may be associated with different alarm profiles Or the same alarm
profile. As another
example, a blood glucose level that is above an upper threshold or a
medicament pump that is
unable to supply insulin may be associated with the same alarm profile. On the
other hand, a
medicament pump that is unable to supply insulin due to an empty insulin
cartridge may be
associated with a different alarm profile than when the medicament pump is
unable to supply
insulin due to damage to the medicament pump. Advantageously, by having unique
annunciation patterns for at least certain alarm conditions, a user can
instantly know the stated
of the AMD and/or subject based on the annunciation pattern for the alarm.
[0353] When an alarm condition is satisfied, the alarm annunciation and
control system can
implement an annunciation pattern or alarm condition annunciation pattern
selected based at
least in part on the status information generated by and/or received from the
monitoring system.
The annunciation pattern may be selected from a plurality of annunciation
patterns based at
least in part on the alarm condition and/or the status information. The
annunciation pattern may
include one or more different text patterns or text information, auditory
alarms, visual alarms,
or haptic alarms.
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[0354] Some non-limiting examples of conditions of the AMID or of the subject
that may be
associated with an alarm profile include conditions relating to a battery
capacity (e.g., below a
threshold charge capacity or below a capacity associated with a particular
amount of operating
time (e.g., one day)), a battery condition (e.g., high temperature or low
voltage), a medicament
or drug delivery condition (e.g., medicament is empty or below a threshold,
motor is stalled,
catheter is occluded, etc.), subject sensor condition (e.g., blood glucose
sensor is expiring, or
signal was not received from sensor), calibration failure (e.g., CGM
calibration needed or
incomplete load sequence), high or low glucose levels, network (e.g..
Bluetooth or BN-LTE)
communication errors, haptic interface errors (e.g., motor failure), speaker
errors (e.g., noise or
low volume), medicament cartridge errors (e.g., empty cartridge, cartridge
detection error,
etc.), and the like. As explained below, each of these errors or conditions
may be associated
with different severity levels that cause the annunciation of different
alarms.
[0355] In some cases, each alarm profile may be associated with a severity
level or threshold
severity level of the alarm. The severity level or urgency level may be
associated with how
urgently the condition that triggered the alarm should be addressed or
resolved. Further, the
severity level may be associated with an amount of harm that may be caused to
a subject when
the condition that triggered the alarm is not resolved or is not resolved
within a particular time
period. The number of severity levels may vary based on the type of ambulatory
medicament
device. Generally, there is no limit to the number of severity levels.
However, there may be a
point of diminishing returns as the number of severity levels exceeds a
particular number
because, for example, it may be difficult for a user to distinguish between
the different numbers
of severity levels or to identify with which severity level a particular alarm
is associated. Thus,
the number of severity levels may be limited to a particular number, such as
0, 3, 5, 6, 9, or
some number in between. However, it is possible for there to be more than 10
severity levels.
103561 There may be multiple alarm profiles associated with a severity level.
Or each
condition of the AMID and/or subject that is associated with the same severity
level may be
associated with the same alarm profile.
103571 The AMD may determine a severity of an alarm condition based on the
condition of
the ambulatory medicament device and/or the subject that triggered the alarm
condition. In
some cases, the ambulatory medicament device may determine the severity of the
alarm
condition based at least in part on an alarm profile associated with the alarm
condition.
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[0358] Generally, when the alarm condition does not prevent the AMD from
providing
therapy, the AMD may continue to provide therapy. In some examples, when the
alarm
condition interferes with the delivery of therapy, operation of the AMD may be
suspended or
partially suspended, Generally, alarm conditions that interfere with the
provisioning of therapy
may be associated with a higher severity level. However, some alarm conditions
that interfere
with the provisioning of therapy may be associated with lower severity levels.
For example, a
determination that the AMD cannot supply insulin may normally be associated
with a highest
severity alarm. But when a user indicates that the site location is currently
in process of being
changed, the alarm condition may be associated with a lower severity level
(e.g., an
informational alarm reminding the user that insulin cannot be delivered during
site change). In
some examples, in response to determining that the severity level of the alarm
condition
matches an unsafe operation (e.g., a condition that may cause the AMD to
provide doses of the
medicament that are above or below certain values, or to unreliably determine
the subject's
condition), the AMD may suspend delivery of the medicament to the subject.
Once the
condition is resolved, the AMD may resume delivery of medicament to the
subject. When it is
determined that the alarm condition matches a safe operation severity level,
the AMD may be
configured to maintain delivery of medicament to the subject.
Alarm Annunciation
[0359] When an alarm condition is satisfied, the alarm annunciation and
control system can
implement an annunciation pattern or alarm condition annunciation pattern
selected based at
least in part on the status information generated by and/or received from the
monitoring system.
The annunciation pattern may be selected from a plurality of annunciation
patterns based at
least in part on the alarm condition and/or the status information. The
annunciation pattern may
include one or more different text patterns or text information, auditory
alarms, visual alarms,
or haptic alarms. Determining whether the alarm condition is satisfied may
include comparing
one or more status values associated with the ambulatory medicament device
and/or the subject
to one or more alarm thresholds, threshold amounts, or alarm conditions
associated with an
alarm profile.
10360] Upon verifying that an alarm condition associated with an alarm profile
or alarm
condition is satisfied, the alarm annunciation and control system annunciates
the alarm
condition. In some cases, at least some of the alarm conditions may be
associated with a unique
annunciation pattern. Advantageously, by having unique annunciation patterns
for at least
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certain alarm conditions, a user can instantly know the stated of the AMD
and/or subject based
on the annunciation pattern for the alarm.
[0361] In some cases, the AMD may have a wireless electronic communications
interface that
can be used to transmit an alarm signal, status information, alarm condition
data, and/or an
annunciation pattern to a remote electronic device. In some such cases, the
remote electronic
device may annunciate an alarm when an alarm condition is met. The remote
electronic device
may include any device that can receive alarm information or status
information from the
AMD. For example, the remote electronic device may be a smartphone,
smartwatch, smart
glasses, a laptop, a -tablet, or any other computing device.
[0362] In some examples, the alarm system may generate a list of pending alarm
conditions
that can, for example, be displayed on a touchscreen using alarm status
indicators. In these
examples, any time an alarm condition associated with an alarm profile is
satisfied, the alarm
system may update the list of pending alarm conditions by adding the new alarm
condition to
the list of pending alarm conditions, in some examples, the list of pending
alarm conditions
may include a list of elements (e.g., icons, text, and the like such as alarm
status icons) each
indicating an alarm condition (e.g., an alarm condition that has been
annunciated), in some
examples, the AMD may display an alarm status icon including a visual
indication of a count of
alarm conditions on the list of pending alarm conditions.
[0363] In certain embodiments, the alarm system may organize an alarm manager
list, notify a
user of these alarms, and allow the user to acknowledge or mute the alarms in
some examples,
the alarm manager list may be a list of pending alarm conditions with which
the user can
interact using a touchscreen display of the AMD.
[0364] In some examples, the list of pending alarm conditions may be sorted
according to the
severity level associated with the alarm conditions. In some examples, the
alarms are
categorized numerically in descending order with the highest priority fault
displayed at the top
of the list, in some examples, when the list of pending alarm conditions
contains multiple alarm
conditions of the same severity level, the alarm conditions of the same
severity level may be
displayed in chronological order. In some examples, a level 0 severity may be
for a trivial fault
that does not require any action by the user or may be for informational
purposes only, thus not
warranting an alert notification. Acknowledging the alarm condition may clear
the alarm. In
some examples, a level 1 severity may be a reminder notification that repeats
at a certain
frequency (e.g., every 5 minutes) until acknowledged by the user, which
results in it being
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cleared. The annunciation may include a brief vibration and a beep, for
example. In some
examples, a level 2 severity may be one relating to an imminent, though non-
urgent, loss of
system function. Such an annunciation may include I brief vibration and 1
beep, for example,
and repeating at a certain frequency (e.g., every 5 minutes). In various
embodiments, alarm
annunciation may include an alarm annunciation pattern that is aurally or
haptically
annunciated, The alarm may be snoozed for a period (e.g., 24 hours) when the
user
acknowledges the fault; however, the user would still need to address the
situation creating the
fault to completely stop the annunciation.
[0365] In some examples, a level 3 severity may be for when the system is no
longer fully
functional thus requiring user intervention to correct the issue. The
annunciation may begin
with a base level intensity with three brief vibrations and three audio beeps,
for example, and
repeating at a certain frequency (e.g., every 5 minutes). The annunciation
escalates at a second
frequency, e.g., every 30 minutes, up to a maximum intensity level. The
escalation may be a
change in vibration intensity and/or audio level, for example. The alarm may
be snoozed for a
period (e.g., 30 minutes) when the user acknowledges the fault; however, the
annunciation
when activated may be cleared when the underlying issue is resolved, e.g.,
glucose level is
raised. In some cases, an alarm condition may change severity levels. For
example, a level 3
severity may be maintained as a level 3 severity or may be lowered to a level
2 severity. In
some cases, when acknowledging the level 3 fault, the user may choose to
snooze for a short
period (e.g., 30 minutes) or a long period (e.g., 24 hours). When the user
selects to snooze for a
short period, the severity level may be maintained at level 3. When the user
chooses to snooze
for a long period, the severity level may be lowered to level 2. Such an alarm
condition may be
referred to as having a level 2.5 severity.
[0366] In some examples, a level 4 severity may be for when the system is no
longer
functional and not correctable by the user. The annunciation may begin with a
base level
intensity with three brief vibrations and three audio beeps, for example, and
repeating at a
certain frequency (e.g., every 5 minutes). The annunciation escalates at a
second frequency,
e.g., every 30 minutes, up to a maximum intensity level. The escalation may be
a change in
vibration intensity and/or audio level, for example. The audio and haptic
alerts may be cleared
when the user acknowledges the fault; however, the base alarm remains because
the underlying
condition persists. In some examples, a level 5 severity may be for high
priority alarms per IEC
60901-1-S. The annunciation may begin with a base level intensity with 5 brief
vibrations and 5
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audio beeps, for example, and repeating at a certain frequency (e.g., every 5
minutes). The
annunciation escalates at a second frequency, e.g., every 30 minutes, up to a
maximum
intensity level. The escalation rnay be a change in vibration intensity and/or
audio level, for
example. The alarm may be snoozed for a period (e.g., 30 minutes) when the
user
acknowledges the fault; however, the annunciation when activated may be
cleared only when
the underlyin.g issue is resolved, e.g., glucose level is raised.
[0367] In some examples, the alarm system may annunciate the alarm conditions
via one or
more user interfaces (e.g., a display, a touchscreen display, a speaker, and
the like). In some
such examples, an alarm may include an audio alarm, a text message, a
graphical message, a
text or graphical message with audio, vibrations, flashing light and any
combination of these.
In sotne examples, the alarm conditions may be transmitted to other devices
where, for
example, an authorized user (e.g., guardians or parents of the subject), the
subject, or an
emergency provider can view the alarm condition. In some examples, the alarm
system may
annunciate the alarm conditions via the user interface module 32.18 of the
ambulatory medical
device 600. For example, the alarm condition may be annunciated via one or
more user
interfaces (e.g., a display, a speaker, and the like). In some examples, the
alarm conditions
may be transmitted to other devices, via the communication user interface
module 3218 of the
AMD where, for example, an authorized user 3226 (e.g., guardians or parents of
the subject),
the subject or an emergency provider can view the alarm condition. In yet
other examples, the
alarm annunciation and control system 3212, may establish a direct end-to-end
connection with
a computing system (e.g., a cloud computing system) using the communication
module 3204
and send the alarm condition to the computing system through the end-to-end
connection.
103681 in some examples, auditory and haptic annunciation of lower urgency
alarms may be
muted so as to reduce risk of alert fatigue. Lower urgency alarms may be
alarms that do not
require urgent user attention and may include at least alarms with severity
levels 0, 1, 2, and 3.
In some examples, higher urgency alarms may be alarms that require urgent user
attention and
may not be muted, to protect subject safety. In some examples, each severity
level may be
predefined as low or high urgency. In some other examples, users may define
how low and high
urgency alarms are defined. In some examples, muting an alarm may include
suppressing or not
providing auditory and haptic annunciation of the alarm condition. In some
examples, the
alarm condition may be displayed, such as on a touch.screen display of the
AMD, while
auditory and haptic annunciation is not provided.
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[0369] Based on the severity of the alarm condition and/or the alarm profile
corresponding to
the alarm condition, an alarm may be generated and/or annunciated that is
associated with the
severity of the alarm condition and/or the type of alarm condition. Different
alarm conditions
and/or alarm profiles may result in different types of alarms or different
annunciations of the
alarm. For example, an alarm associated with the highest severity level may
include an auditory
alarm with a loudness that exceeds a particular decibel level (e.g., above 70
or 80 decibels), a
visual alarm (e.g., a flashing or steady light) with a luminance above a
particular luminance
value (e.g., a luminance between 105 or 106 candelas per square meter), and/or
a vibrational
alarm. Further, the alarm associated with the highest severity level may not
be snoozed or
dismissed, as such alarm conditions may require urgent user attention. In some
cases, the alarm
associated with the highest severity level may be snoozed for a shorter time
period than alarms
of lower severity levels (e.g., for 5 minutes, for 10 minutes, etc.). An alarm
associated with a
different severity level than the highest severity level may include a
different combination
of auditory, visual, and vibrational alarms. Not only may the existence of
auditory, visual, and
vibrational alarms differ for different severity levels, but so may the
characteristics of each of
the alarm types. For example, auditory alarms may have different sound
patterns, loudness,
frequencies, etc. Visual alarms may be of different intensity, color, pattern,
etc. Vibrational or
haptic alarms may be of different pattern, intensity, etc. Further, an alarm
with a different
severity level than the highest severity level may be permitted to be snoozed
or dismisses or
snoozed for a longer period of time, as such alarm conditions may not require
urgent user
attention. In some examples, the severity of the alarm condition may determine
the type of type
of the alarm generated (e.g., audio, text, graphical, or any combination of
these).
[0370] Further, the display of alarm conditions on the user interface may
include an icon for
each type of alarm condition corresponding to an alarm status indicator for
that alarm
condition. The user interface may display the number of alarm conditions
and/or the number of
alarm conditions of a particular type or severity level. In some cases, a
duplicate alarm may be
omitted from the alarm manager list. In some cases, a count of the occurrence
of alarms may be
increased to reflect the duplicate alarm. In some cases, a duplicate alarm may
result in the
annunciation of the duplicate alarm. In some cases, the duplicate alarm is
ignored. In some
cases, the occurrence of a duplicate alarm may cause an escalation of the
existing alarm. For
example, when an alarm condition that causes an annunciation of an alarm with
a first severity
level is detected as occurring a second time, the alarm may be annunciated
with a second
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severity level that indicates a greater degree of severity than the first
severity level. It should be
understood that an alarm occurring after an alarm condition is resolved may
not be considered a
duplicate alarm, but instead may be a reoccurrence of the alarm condition
and/or an indicator
that the resolution for the alarm condition failed (e.g., an insulin cartridge
replacement is faulty
or is empty). In some cases, an existing alarm may be escalated when left
unresolved for a
period of time. For example, a low battery alarm may initially be annunciated
with a first
severity level but may be annunciated at a higher severity level if the
battery is not being
charged after a certain period of time,
[0371] in some cases, the alarm manager list may be observed via a user
interface (e.g., a
touchscreen display) when the user interface is locked. In some such cases,
further details about
the alarrn.s may be accessible when the user interface is locked. In some
cases, in order to
access more details about the alarms and/or resolve the alarms, it may be
necessary to unlock
the user interface unlocked (e.g., by a wake action and/or a gesture).
[0372] Each of the alarm conditions, or information associated therewith, may
be added to an
indicator or user interface (e.g., a list, or other data structure or user
interface element) that
may be accessed by a user. This user interface may maintain the alarm
condition on the user
interface until the alarm condition is resolved. Further, the alarm conditions
may be sorted or
ranked based on the. severity level of the alarm condition, the time that the
alarm condition
occurred, whether the alarm condition relates to the subject or the ambulatory
medicament
device, any combination of the foregoing, or any other factor for sorting or
ranking the alarm
conditions.
[0373] In some cases where the alarm is presented on a display using for
example one or more
alarm status indicators, the displayed information may include details about
what caused the
alarm, the severity of the alarm, how to respond to or address the alarm, or
any other
information that may be informative regarding why the alarm was generated
and/or how to
respond to the alarm. In some cases, the information may provide a workflow or
instructions on
how to respond to the alarm. The instructions may include a link to a workflow
provided by a
manufacturer of the ambulatory medicament device or of another entity, such as
an entity that
provides medicament or site changing kits.
[0374] In some cases, different views of an alarm or different information
associated with the
alarm may be provided based on an identity of the user, or a role of the user,
viewing the alarm.
For example, a child may be instructed to contact a parent to address an
alarm. But a parent
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may be provided with information to resolve the alarm. The parent may receive
simplified
information (e.g., blood glucose level is high) about what caused the alarm,
but a healthcare
provider may receive more detailed information regarding the alarm (e.g.,
internal control
parameter values, insulin flow rates, curvature of insulin diminishment
predictions, etc.) that
facilitates the healthcare provider caring for the subject.
[0375] The alarm conditions may be displayed on a display of the AMID.
Alternatively, or in
addition, the alarm conditions may be displayed on a remote display that is
separate from the
ambulatory medicament device. The remote display may be a display that is
authenticated or
associated with a computing device that is authenticated to access data, such
as alarm
conditions, from the AMID. In some cases, the alarm manager list may be
presented on a mobile
device (e.g., a smartwatch or smartphone) or on a computing device (e.g., a
laptop or desktop)
that can obtain data directly or indirectly from the AMID.
[0376] In some cases, annunciating the alarm may include contacting a
manufacturer and/or
user (e.g., a healthcare worker, a parent or guardian, or other registered
user). Further, the
alarm may include instructions on repairing the ambulatory medicament device
and/or on
addressing the alarm condition. For example, the alarm may provide a user with
instructions to
replace the insulin cartridge and how to replace the insulin cartridge. As
another example, the
alarm may provide instructions on how to change the battery of the device or
on how to change
a site where the insulin pump connects to the subject. In some cases, the
alarm may include one
or more operations associated with the alarm. For example, the alarm may
trigger reordering of
insulin or may request that the user confirm a reorder request to reorder
insulin.
Resolving an alarm
[0377] Certain alarms, such as informational alarms, may be dismissible.
However, generally
the alarm may remain on the alarm list until the condition that caused the
alarm is resolved.
[0378] In some cases, a user may be able to acknowledge and/or snooze alarms
via a user
interface. In some examples, in order to acknowledge and/or snooze alarms, the
user may first
need to activate the user interface (e.g., by providing a wake action) and
then provide a gesture
to unlock the user interface. For example, the user may use the wake button to
activate a
touchscreen display and then provide a gesture on the screen to unlock
display. In some
example, the touchscreen display may be configured to allow the user or
subject to navigate
directly to the issue or fault for which an alarm is being delivered. This
capability provides the
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user with access to address the fault causing the alarm so that it could be
corrected thereby
stopping the alarm.
[0379] In some cases, a user may be able to acknowledge and/or snooze alarms
via motion
sensor. As described herein, the AMD may include a motion sensor that detects
motion or
acceleration of the AMD or on the AMD (e.g., tapping or shaking gestures). The
motion sensor
can include an accelerometer, gyroscope, and/or other electrical or mechanical
motion sensors
that convert motion or acceleration into electrical signals. In some examples,
the user may tap
on the AMD to acknowledge and/or snooze alarms. In some examples, the user may
acknowledge and/or snooze alarms via the motion sensor without the AMD
activating on.e or
more user interface modules such as the touchscreen display. In some examples,
the user may
acknowledge andJor snooze alarms via the motion sensor without activating the
user interface
(e.g., without providing a wake action). The motion sensor may be configured
to detect
different tap patterns (e.g., a single tap, a double tap, etc.). Each tap
pattern may be associated
with a different function. In some cases, the AMD can include a user
interaction sensor which
may include any motion sensor(s) and/or any one of the user interface modules
such as the
touchscreen or the wake interface. The user interaction sensor can convert
electrical or
mechanical properties of the user into electrical signals. The electrical
signals from the user
interaction sensor can be user interaction signals. In some cases, user
interaction signals can
encompass both user input via a touchscreen and user interaction via a motions
sensor as
discussed herein.
[0380] Resolving the alarm may include any action that addresses the condition
that caused
the alarm to be generated. For example, resolving the alarm may include
replacing an insulin
cartridge, changing a site where the ambulatory medicament device is connected
to the subject,
charging a battery of the ambulatory medicament device, providing insulin or a
counter
regulatory agent to the subject and/or the ambulatory medicament device, or
any other action
that may be performed to address an alarm condition. In some cases, the
resolution action may
be acknowledging the alarm. For example, when the alarm is informational
(e.g., to inform the
user that more insulin has been ordered), acknowledging the alarm may be a
sufficient
resolution action,
[0381] In some cases, whether the alarm condition is resolved may depend on an
identity of
the user, For example, when a child interacts with an alarm related to
reordering of insulin, the
alarm may remain until a parent or guardian acknowledges the alarm. However,
the child may
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be able to snooze the alarm. In some cases, a user interface that displays
alarms may differ
based on who is viewing the alarm. For example, a child may view the alarms,
but may not be
able to interact with the alarms, However, a parent or guardian may be able to
snooze or
dismiss an alarm. Further, a child may be instructed to bring the device to a
parent or adult to
address an alarm. In some cases, the child may be informed of how urgently to
contact the
parent (e.g., contact a parent immediately, within a day, within a week, etc).
Moreover, a
designated adult may separately be alarmed (e.g., via a text or email alarm).
The parent or
guardian may receive additional information not provided to the child or
subject (e.g., a link to
repair instructions or a workflow to address the alarm condition).
[0382] In some cases, certain conditions may self-resolve over time. For
example, a low
battery alarm may resolve as the battery is charged. In such cases, the alarm
may be cancelled
automatically as the battery charge level exceeds a particular threshold. In
another example, a
low blood glucose alarm may be resolved once the subject has a meal. The alarm
inay be
cancelled automatically as the subject's blood glucose level rises. Further,
in some cases, one
or more alarms and/or the alarm list can be viewed and/or accessed on a home
screen, a main
screen, or other non-alarm based user interface screen in addition to a user-
interface screen
designated for display alarms. The alarm list may be accessed from the
ambulatory medicament
device and/or a computing system in communication with the ambulatory
medicament device.
[0383] In some cases, the alarm condition may or may not be resolvable when
the ambulatory
medicament device is locked or in a locked state or mode. The alarm
acknowledgement signal
may be configured to be detected by the motion sensor and may be one of a
gesture input or a
touch input, as will be described hereinafter.
[0384] A user may interact with the alarms generated based on the alarm
condition. In some
cases, the user can interact with the alarms when the AMD and/or the user
interface is
unlocked. In some eases, the user can interact with the alarms to snooze them
or to obtain
further information, when the AMID is locked. However, the user may not be
able to dismiss the
alarm without unlocking the ambulatory medicament device. The user may not be
able to
dismiss the alarm without unlocking the ambulatory medicament device when the
alarm is
urgent and requires user attention. Interacting with the alarms may include
providing
information associated with the alarm to a user in response to the user
interacting with the
alarm, or an indicator representative of the alarm.
Example AMID with Alarm Management System
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[0385] FIG. 33 shows a flow diagram illustrating an example procedure that may
be used by
the alarm system of an AMD to annunciate an alarm condition upon receiving a
status
information that satisfies an alarm condition. In some examples, the alarm
system 3202
implements an annunciation process by execution of instructions by a processor
in CCM of the
AMD, where the instructions can be stored in the main memory, storage of the
AMID, or in a.
memory of a connected electronic device or computing system..
[0386] The alarm system 3202 may receive status information 3302 using the
monitoring
system interface 3210, one or more device sensors 3208 and/or one or more
subject sensors
3216. In some examples, the alarm. system 3202 determines whether the received
status
information satisfies an alarm condition 3304. In some examples, the alarm
condition may be
an alarm condition in an alarm profile. If the received status information
does not satisfy an
alarm condition, no action may be taken 3306. If the received status
information satisfies an
alarm condition, the alarm system may determine whether the alarm condition is
already
present in the list of pending alarm conditions or not 3308. If the alarm
condition is not present
in the list of pending alarm conditions, the alarm system may add the alarm
condition to the list
of pending alarm conditions 3310. Next the alarm system, may determine the
severity of the
alarm condition 3312. Based on the determined level of severity, the alarm
system 3202 can
select an annunciation pattern 3314 and annunciate the alarm condition using
the selected
annunciation pattern 3316. If the alarm condition is present in the list of
pending alarm
conditions, at block 3318, the alarm system may select an annunciation pattern
and annunciate
the alarm condition using the selected annunciation pattern 3320. In some
examples, the
annunciation pattern selected at block 3318, may be an annunciation pattern
that is different
than the previously used annunciation patterns for the alarm condition. In
some such examples,
the annunciation pattern selected at block 3318, may be selected based on
number of times that
the same alarm condition is satisfied by a received status information. The
process of the alarm
detection and control function may repeat each processing cycle so long as the
ambulatory
medical device is in use. In some examples, after an alarm is annunciated, the
alarm system
may wait for user acknowledgment of the alarm. If the user acknowledges the
alarm, the system
proceeds to perform alarm processing. However, if the user fails to
acknowledge the alarm, the
annunciation continues and may escalate depending on the level of the alarm.
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[0387] As mentioned above, the alarm conditions may be categorized based and
annunciated
based on their severity level. In some examples, the alarms are categorized
numerically in
descending order with the highest priority fault displayed at the top of the
list.
[0388] In some examples, a level 0 severity, may be for a trivial fault that
does not require
any action by the user thus not warranting an alarm notification, In some
other examples, a
level I severity may be an informational type notification that repeats at a
certain frequency
(e.g., every 30 minutes) until acknowledged by user which results in it being
reset. The
annunciation may include a brief vibration and a beep, for example. In some
examples, a level
2 severity, may be one relating to an imminent loss of system function. Thus,
such an
annunciation may include two brief vibrations and two beeps, for example, and
repeating at a
certain frequency (e.g., every 30 minutes). Thus, the user would still need to
address the
situation creating the fault to completely stop the annunciation. In some
other examples, a level
3 fault may be for when the system is no longer fully functional thus
requiring user intervention
to correct the issue. The annunciation may begin with a base level intensity
with three brief
vibrations and three audio beeps, for example, and repeating at a certain
frequency (e.g., every
minutes). The annunciation escalates at a second frequency, e.g., every 30
minutes, up to a
maximum intensity level. The escalation may be a change in vibration intensity
and/or audio
level, for example. The escalation may be cleared to base level when the user
acknowledges the
fault; however, the base alarm remains if underlying condition persists. Thus,
the user would
still need to address the situation creating the fault to completely stop the
annunciation. In
some examples, a level 4 severity, may be for when the system is no longer
functional and not
correctable by the user. The annunciation may begin with a base level
intensity with three
audio beeps, for example, and repeating at a certain frequency (e.g., every 5
minutes). The
annunciation escalates at a second frequency, e.g., every 30 minutes, up to a
maximum
intensity level. The escalation may be a change in audio level, for example.
The escalation may
be cleared when the user acknowledges the fault; however, the base alarm
remains because the
underlying condition persists. In some other examples, a level 5 severity, may
be for high
priority alarms per fEC 60601-1-8. The annunciation when activated may be
cleared when the
underlying issue is resolved, e.g., glucose level is raised.
[0389] Additional embodiments relating to determining a severity of an alarm
condition and
annunciating the alarm based at least in part on the severity of the alarm
condition that can be
combined with one or more embodiments of the present disclosure are described
in U.S.
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Provisional Application No. 62/911,017, which was filed on October 4, 2019 and
is titled
"ALARM SYSTEM AND METHOD IN A DRUG INFUSION DEVICE," the disclosure of
which is hereby incorporated by reference in its entirety herein for all
purposes.
Non-critical AMD Condition Management
103901 in some cases, a condition may occur that impacts the operation of the
ambulatory
medicament device. This condition may be associated with the ability of the
ambulatory
medicament device to operate as intended by the manufacturer, a subject
receiving therapy
from the ambulatory medicament device, and/or user (e.g., healthcare provider,
parent, or
guardian of the subject). In some cases, the condition or malfunction of the
ambulatory medical
device may prevent the ambulatory medical device from providing therapy to the
subject. In
other cases, the condition or malfunction may permit, at least for a period of
time, the
ambulatory medical device to continue providing at least partial therapy to
the subject. In either
case, it is generally desirable to generate an alert to inform the subject
and/or one or more users
of the condition of the ambulatory medical device and/or the subject.
Moreover, it is desirable
to track the alert until the condition that caused the alert is resolved.
Further, it is desirable to
issue different types of alerts for different conditions to enable a subject
or user to easily
distinguish the severity of the condition that triggered the alert.
[0391] in many cases, if the nature of the alert is non-critical, it may be
safer to continue the
underlying therapy and notify the user of the condition than to cease therapy.
In some such
cases, the best response to a problem with the device for a subject is to
notify the device
manufacturer, or other user that can address the problem, while the subject
continues to receive
therapy until a replacement device can be obtained or a repair can be made.
[0392] Additionally, alert fatigue can be an issue with medical devices due to
excessive alerts
which do not necessarily require user interaction. Alert fatigue can be
dangerous because it can
lead users to ignore serious alerts or alerts that require action in the short
term.
[0393] The method described herein may be performed by an AMD (e.g., by one or
more
processor of the AMD) to detect device malfunctions for the AMD and that can
generate alerts
corresponding to the ambulatory medical device and prioritize the alerts to
enable the subject or
user to quickly and easily determine whether the device malfunction will
impact therapy,
should be addressed in the short-term (e.g., immediately, in 1-2 hours, within
the day, etc.),
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and/or can be addressed at the subject's convenience (e.g., within a month, or
more). In some
cases, the method may be used by other systems.
[0394] In certain embodiments, the system disclosed herein can detect a
condition in which
the ambulatory medical device does not meet a manufacturer's specification
(e.g., a failure of a.
haptic annunciator, a Bluetootht radio malfunction, glucagon or insulin runs
out, there is a
medicament delivery malfunction, a touchscreen failure, etc.). In some cases,
there can be
several tiers of critical and/or non-critical faults. If it is determined that
the underlying
condition is not sufficient to stop therapy (e.g., delivery of insulin is not
stopped), the fault may
be deemed non-critical. In some cases, the fault may not be a fault of the
device, but may be
indicative of required maintenance (e.g., recharge battery indicator, order
more medicament
indicator, etc.). The condition may be annunciated to the user with
appropriate instructions
(e.g., call manufacturer for replacement medicament or parts) for addressing
the fault or issue.
[0395] After the annunciation is acknowledged, the alert may be re-annunciated
as a reminder
at some later period in tim.e (e.g., the alert may be re-annunciated daily at
4:00 PM or on
Saturdays at noon). The length of time between annunciations may depend on the
severity of
the fault. In some cases, the re-annunciation cannot be stopped by the user,
but may only cease
if the underlying condition is resolved.
[0396] The method may include detecting a condition of the ambulatory medical
device. The
condition of the ambulatory medical device may be determined by one or more
sensors of the
ambulatory medical device. Further, the condition of the ambulatory medical
device may be
determined by the presence or absence of one or more errors when performing
one or more
functions of the ambulatory medical device. For example, if the ambulatory
medical device
fails to establish a communication connection with a control system or a data
storage system, it
may be determined that there is a possible malfunction with the ambulatory
medical device. As
another example, if the ambulatory medical device fails to deliver medicament
or detects an
error when attempting to deliver medicament, there may be a malfunction with
the medicament
pump. In some cases, the condition of the ambulatory medical device may be
determined based
on one or more configuration values being outside a normal operating range.
For example, if
the speed of delivery of medicament is faster or slower than a configured
operating range, then
it may be determined that there is a malfunction with the medicament pump or a
connection
with a medicament delivery tube (e.g., a catheter).
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[0397] The method may include comparing the detected condition of the
ambulatory medical
device to a set of normal operating parameters. The set of normal operating
parameters may be
the specifications set by the manufacturer for when the ambulatory medical
device is operating
as intended by the manufacturer. In some cases, the normal operating
parameters may be
associated with a range of values, For example, the operating parameter for a
speed of
medicament delivery may be associated with a range of speeds, which may vary
based on user
settings, medicament type, site location of medicament delivery, or
manufacturing tolerances,
among other parameters. Comparing the detected condition of the ambulatory
medical device to
the set of normal operating parameters may include comparing each operating
parameter in the
specification to a corresponding detected operating parameter of the
ambulatory medical
device. The ambulatory medical device may generate a user alert based on the
determined
condition of the ambulatory medical device. For example, the AMD may generate
an alert
when the detected condition of the ambulatory medical device does not satisfy
a set of normal
operating parameters.
[0398] The method may further include determining whether the detected
condition satisfies a
minimum set of operating parameters. In some cases, the minimum set of
operating parameters
may match the normal operating parameters. However, typically the minimum set
of operating
parameters differ from the normal operating parameters. The minimum operating
parameters
may include the minimum specifications, minimum parameters, or minimum
condition required
by the ambulatory medical device to maintain or continue providing therapy to
the subject. In
other words, the minimum operating parameters are the operating parameters
sufficient to
provide therapy. However, the minimum operating parameters may not be
sufficient to enable
all features of the ambulatory medical device. For example, the minimum
operating parameters
may permit the ambulatory medical device to deliver insulin to the subject,
but may not be
sufficient to deliver the insulin at a normal delivery speed for the
particular ambulatory medical
device. As another example, the minimum operating parameters may permit the
delivery of
therapy, but may not be sufficient to track a log of therapy or to transmit a
therapy log to
another computing system. In some cases, the normal operating parameters
and/or minimum
operating parameters may be specified by a subject or healthcare provider
(e.g., the minimum
amount of medicament that is to be provided in each bolus may be specified by
a healthcare
provider). In some eases, the normal or minimum operating parameters may be
modified,
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[0399] When it is determined that the condition of the ambulatory medical
device satisfies at
least the minimum operating parameters, the ambulatory medical device may be
configured to
maintain delivery of therapy to the subject. Maintaining delivery of therapy
may include
maintaining therapy at the same rate, at a reduced rate (e.g., providing only
basal therapy and
therapy responsive to a meal announcement), or at a minimum maintenance rate
(e.g.,
providing only basal insulin). Advantageously, the ability of the ambulatory
medical device to
distinguish between a minimum set of operating parameters and a normal set of
operating
parameters enables an ambulatory medical device with a malfunction to continue
providing
therapy, which sometimes includes life-saving treatment, to a subject until
the ambulatory
medical device can be repaired or until the condition of the device worsens to
a point where the
minimum operating parameters cannot be maintained. In some cases, the
ambulatory medical
device may temporarily maintain delivery of therapy, Temporarily maintaining
therapy may
provide a subject time to address the issue that caused the ambulatory medical
device to not
satisfy the normal operating parameters before the subject loses access to
therapy. In some
cases, the ambulatory medical device temporarily maintains therapy until the
device condition
makes it no longer possible to maintain therapy.
[0400] FIG. 34 is a block diagram illustrating the interconnection among
modules and
procedures in AMD involved in monitoring the condition of the AMD and
generating an alert
when a device malfunction is detected. In some examples, the condition of AMD
may include
the status of the modules and components of the AMD, such as AMD modules and
sensors
3404 and/or operation of modules and procedures of the AMD. In some
embodiments, the alert
system may be implemented as a set of alert control procedures 3408 in the
control and
computing module 610 (CCM) of the AMD. The alert control procedures 3408, may
be
implemented as instructions stored in a memory of CCM (e.g., the main memory
616) and
executed by a hardware processor 614 to generate an alert upon detection of a
malfunction of
the ambulatory medicament device. In some cases, the hardware processor may be
a hardware
processor of the ambulatory medicament device that controls medicament
delivery. In other
cases, the hardware processor of the monitoring system may be a separate
hardware processor,
[0401] In some examples, the alert control procedures 3408 may include a
monitoring
interface 3414, an operation monitoring procedure 3412 and alert generation
procedure 3416.
The monitoring interface 3411 may monitor and evaluate the condition of the
AMD and/or the
subject at least partially based on the information received from the
operation monitoring
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procedure 3412 and device sensors 3410. In some examples, the device sensors
may be
configured to track the status of the components or the modules of the
ambulatory medicament
device and the operation monitoring procedure 3412 may be configured to
monitor the
operation of the modules and other procedures. In some examples, the detected
of the AMD
may be provided to the alert generation procedure monitoring interface. The
alert generation
procedure 3416 may compare the detected condition of the AMD with a set of
normal operating
parameter. In some examples, the alert generation procedure may also determine
whether the
detected condition of the AMD satisfies a minimum set of operating parameters.
In sonic
examples, if it is determined that the detection condition of the AMD does not
satisfy the
normal operating parameters, the alert generation procedure may generate an
alert in some
examples, the alert may be transmitted to the user interface module 3406 and
displayed on a
display of the AMD (e.g., a touchscreen display). In some other examples, once
an alert is
generated the AMD may establish a connection (e.g., a wireless connection)
with another
device. This other device may include a local device (e.g., a laptop,
sma.rtplione, or smartwatch
of the user) or a computing system of a cloud-based service. In some such
examples, the alert
may be transmitted by the communication module 3402 to the computing systems
where it may
be displayed on user interface associated with the computing system. In some
cases, the
additional device may receive data from the ambulatory medical device enabling
it to monitor
the condition of the ambulatory medical device.
[0402] The type of the alert, and the frequency at which the alert is
repeated, or whether an
alert is dismissible or not, may be determined by the alert generation
procedure based on the
detected condition of the AMID and the alert information stored in a memory of
the AMD. In
some examples, the alert information may be provided by the subject, an
authorized user, or a
healthcare provider. In some other examples, the alert information may be
stored in the AMD at
time of manufacturing.
104031 In some examples, upon determination that the detected AMD condition
does not
satisfy a set of normal operating parameters, the alert generation procedure
may cause the
medicament delivery interface, such as the therapy delivery module 606, to
stop therapy
delivery or modify one or more delivery parameters (e.g., therapy delivery
rate). In some
examples, upon determination that the detected ANID condition does not satisfy
a set of normal
operating parameters, but satisfies a set of minimum operating parameters, the
therapy delivery
may be maintained at a normal rate.
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[0404] The alert may include any type of alert. For example, the alert may be
a visual alert
(e.g., a light or changing light), an audible alert (e.g., a beep or series of
beeps), a haptic or
vibration alert, an email alert, a text alert, or any other type of alert.
Different device conditions
may be associated with or may trigger different alerts. Thus, the user alert
may enable the user
to determine the device condition of the ambulatory medical device based on
the alert, For
example, an indication that the ambulatory medical device failed to deliver a
medicament may
trigger one type of alert while an indication that the ambulatory medical
device has below a
particular level of medicament available may trigger a different alert. In
some cases, the user
alert is dismissible and/or may be snoozed by the user. In other cases, such
as when the
ambulatory medical device fails to satisfy a set of minimum operating
parameters, the user alert
may not be dismissible or cannot be snoozed,
[0405] A dismissible alert may be scheduled to repeat on a particular schedule
until an alert
modification condition occurs. The frequency with which the dismissible alert
repeats may
depend on the severity of the condition or the particular operating parameters
that do not satisfy
normal or minimum operating parameters. More urgent device conditions may
result in alerts
that repeat more frequently. Further, alerts may vary based on when the
condition was detected,
the time of day, or the detected activity of a subject (e.g., sleep, abnormal
activity, or elevated
activity, such as exercise). Similarly, the snooze options may vary for
different alerts or any of
the aforementioned conditions. In some cases; the ambulatory medical device
may escalate an
alert if it detects that the condition of the ambulatory medical device has
become more critical.
[0406] The alert frequency may be for a static time period (e.g., every 5
hours) or may ramp
towards more frequency (e.g., every 5 hours for l to 3 reminders, every 4
hours for 3 to 6
reminders, etc.), or may change based on time of day (e.g., snooze alerts
during sleeping hours
for non-urgent alerts), etc.
[0407] The alert modification condition may include any action that causes the
operating
parameters of the ambulatory medical device to return to normal operating
parameters. For
example, the alert modification condition may be a repair or replacement of a
faulty
component. In some cases, the alert modification condition may include an
acknowledgement
of the alert. In other cases, the alert modification condition may include a
worsening of the
ambulatory medical device condition. In such cases, the modification to the
alert may include
the substitution of the alert to a different alert that indicates a different
or more serious
condition of the ambulatory medical device. For example, an urgent condition
may become
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critical if the detected malfunction is addressed after generating certain
number of alerts. When
an urgent condition becomes critical, it may trigger a different alert type
(e.g., a louder sound,
or brighter image) and/or escalation in the alert frequency. For example, the
audible alert may
become louder and may be combined with a vibration alert from a haptic
annunciator,
Moreover, if the condition reaches a critical state, the ambulatory medical
device may cease
providing therapy to the subject.
[0408] In some cases, generating the alert may further include contacting a
manufacturer
and/or healthcare provider (e.g., clinician), Further, generating the alert
may include ordering
replacement parts. In some cases, the alert may instruct a subject or user on
how to repair the
ambulatory medical device.
[0409] Once the malfunction is addressed, the ambulatory medical device is
repaired, or the
condition that caused the alert is resolved, a user may permanently (or until
the next time a
device condition triggers the alert) dismiss the alert. Alternatively, or in
addition, the
ambulatory medical device may automatically dismiss the alert if it senses
that the device
condition that caused the alert has been resolved. In some cases, the
ambulatory medical device
may periodically recheck the device condition to determine whether the alert
condition has
been resolved.
[0410] In some cases, the manufacturer or healthcare provider may remotely
clear or stop an
alert using, for example, an NB-LIE connection. In some cases, only the
manufacturer and/or
healthcare provider can clear or stop the alert. Further, in some cases, a
manufacturer and/or a
healthcare provider may notify a user (e.g., a subject, or parent or guardian)
of an issue or
impending issue with the ambulatory medical device. The notification may be
received by the
ambulatory medical device via the NB- LIE connection. Alternatively, or in
addition, the
notification may be received via a computing device, such as a smartphone or
laptop.
104111 FIG. 35 is a flow diagram illustrating an example procedure that may be
used by the
alert system of an AMD to monitor the operation of an AMD and generate alerts
when a device
malfunction is detected. In some examples, the alert system continuously
monitors the status of
all modules and components associated with AMD as well as the operation of all
modules and
procedures of the AMD. When a device condition is detected 3502, the alert
system may
determine whether the detected device condition satisfies a set of normal
operating parameters
3504. If it is determined that the detected device condition satisfies a set
of normal operating
parameters, the alert system takes no action and continuous monitoring the
AMD, If it is
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determined that the device condition does not satisfy a set of normal
operating parameters, the
alert system determines whether the detected device condition satisfies a set
of minimum
operating parameters. If, at block 3506, it is determined that the device
condition does not
satisfy a set of minimum operating parameters, the alert system may send a
signal to the
therapy delivery module to stop delivery of therapy to the subject 3508, and
immediately
generate a critical user alert 3512 indicating that immediate action is
required. In some
examples, upon generation of a critical alert the alarm system of the AMD, may
contact a.
healthcare provider or certified user (e.g., parent or guardian of the
subject) and also send the
critical alert to one or more computing devices (e.g., laptop, cell phone,
personal computer, and
the like) of the healthcare provider or certified user. If, at block 3506, it
is determined that the
device condition satisfies a set of minimum operating parameters, the alert
system may
maintain the delivery of therapy to the subject 3510 and generate a user alert
3514. In some
such examples, the alert system may maintain the delivery of the therapy at
rate associated with
the detected condition of the AMD (e.g., normal rate or minimum maintenance
rate) until an
alert modification condition is detected 3516. Upon detection of an alert
modification condition
3516, the alert system may determine whether the new device condition
satisfies a normal set
parameters 3518. If, at block 3518, it is determined that the new device
condition satisfies a set
of normal operating parameters, the alert system may resume the normal
operation of the AMD
3520 (e.g., deliver the therapy at a normal rate). If at block 3518, it is
determined that the new
device condition does not satisfy a set of normal operating parameters, the
alert system may
determine whether the new device condition satisfies a minimum set parameters
3522. If, at
block 3522, it is determined that the new device condition satisfy a set of
minimum operating
parameters. The alert system may maintain or modify the rate of therapy
delivery according to
the new device condition 3526 and generate a user alert 3530 according to the
according to the
new device condition. If, at block 3522, it is determined that the new device
condition does not
satisfy a set of minimum operating parameters, the alert system may send a
signal to the
therapy delivery module to stop delivery of therapy to the subject block 3524,
and immediately
generate a critical user alert 3528 indicating that immediate action is
required. In some
examples, upon generation of a critical alert the alarm system of the AMD, may
contact a
healthcare provider or certified user (e.g., parent or guardian of the
subject) and also send the
critical alert to one or more computing devices (e.g., laptop, cell phone,
personal computer, and
the like) of the healthcare provider or certified user.
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Managing Doses of Glucose Control Agents
[0412] Ambulatory medical devices allow subjects the freedom to treat
themselves while
being mobile. Self-managed medical treatment comes with inherent risks to the
subject.
[0413] An automated blood glucose control system may automatically provide
insulin and/or
a counter-regulatory agent (e.g., Glucagon) to a subject to help control the
blood glucose level
of the subject. Generally, a control algorithm is implemented by an automated
blood glucose
control system (BGCS) to determine when to deliver one or more glucose control
agents and
how much agent to provide to the subject. Further, the control algorithm may
control both an
ongoing or periodic delivery of insulin (e.g., a basal dose), and a correction
bolus that may be
provided to adjust a subject's blood glucose level to within a desired range.
The control
algorithm may use blood glucose level readings obtained from a sensor, such as
a continuous
glucose monitoring (CGM) sen.sor, that obtained automated blood glucose
measurements from
the subject. Moreover, in sotne cases, the control algorithm may deliver a
bolus of insulin in
response to an indication of a meal to be consumed or being consumed by the
subject.
[0414] Insulin may be administered subcutaneously into blood of a subject.
There is often a
delay between. when the insulin is provided and when the amount of insulin in
the subject's
blood plasma reaches maximum concentration. This amount of time may vary based
on the type
of insulin and on the physiology of the particular subject. For example, with
a fast-acting
insulin, it may take approximately 65 minutes for a bolus of insulin to reach
maximum
concentration in the blood plasma of the subject. For some other types of
insulin, it may take
anywhere from 3-5 hours to reach maximum concentration in the blood plasma of
the subject.
Accordingly, the blood glucose control system may implement a predictive
algorithm that
implements a bi-exponential pharmacokinetie (PK) model that models the
accumulation of
insulin doses in the blood plasma of the subject. The blood glucose control
system may modify
its predictions based on the type of insulin, one or more blood glucose
readings, and/or
characteristics of the subject.
104151 in some cases, a subject may receive a manual bolus of insulin or
medicament. For
example, a user (e.gõ healthcare provider, parent, or guardian) or subject may
inject a dose of
insulin into the subject. As another example, the user or subject may manually
direct the
automated blood glucose control system to provide a bolus of insulin to the
subject.
[0416] it is generally undesirable to have too much insulin. An excess of
insulin can lead to
Hypoglycemia. As described above, it may take time for insulin to reach
maximum
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concentration in the blood plasma of the subject. Thus, a blood glucose level
reading from a.
sensor may not immediately, or even after a particular period of time, reflect
the amount of
insulin within a subject. Thus, a manual bolus of insulin may not be detected
by the automated
blood glucose control system. As a result, if the automated blood glucose
control system is
operating during delivery of a manual bolus or is configured to operate on the
subject prior to
blood glucose level readings reflecting the effect of the manual bolus on the
subject, the
automated blood glucose control system may unnecessarily administer additional
insulin to the
subject potentially leading to hypoglycemia,
[0417] The present disclosure relates to an automated blood glucose control
system
configured to provide automatic delivery of glucose control therapy to a
subject and receive
information about manual glucose control therapy provided to the subject.
Using the received
information about the manual glucose therapy, the automated blood glucose
control system can
adjust the blood glucose control algorithm to account for the manual dosing of
insulin (or
counter-therapy agents). The manual glucose control therapy may be provided by
injection
therapy, or it may be provided by an insulin pump.
[0418] in some cases, the automated blood glucose control system may receive
an indication
of insulin or medicament to administer to a subject in place of an
automatically calculated dose
of insulin. For example, the automated blood glucose control system may
receive an indication
that a subject is consuming or will consume a meal. The indication may include
a type of meal
to be consumed (e.g., breakfast, lunch, or dinner) and an estimate of the
quantity of food or
carbohydrates to be consumed (e.g., less than usual, a usual amount, more than
usual, 30-40
grams of carbohydrates, 45-60 grams of carbohydrates, etc.). Based on the
indication, or meal
announcement, the automated blood glucose control system may calculate an
amount of insulin
to administer to the subject. The calculation may be based on an insulin to
carbohydrate ratio
provided by a clinician and/or determined by the automated blood glucose
control system.
Moreover, the calculation may be based at least in part on a history of blood
glucose level
measurements for the subject when consuming particular meals.
104191 The calculated amount of insulin for the meal announced by the user may
be presented
to the user. The user (e.g., the subject) may modify the amount of insulin to
administer. For
example, the user may determine that for the size meal the subject is
consuming or planning to
consume, more or less insulin should be administered. In such cases, the user
may modify the
calculated insulin dosage to match the user's determination of the amount of
insulin to
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administer. In some cases, the automated blood glucose control system may
modify its control
algorithm based on the user's input. Thus, future meal announcements may
result in a
calculation of insulin that satisfies the subject's insulin needs and/or
preferences.
[0420] In some eases, the indication of an amount of a manual bolus may be
received by a
user entering a numerical value (e.g., an amount of insulin, a number of
carbohydrates, or
another calculation) associated with administering insulin. A.s described
above, the automated
blood glucose control system may automatically-calculate a meal dose of
insulin and present it
to a user via a user interface where a user may enter the manual bolus
information. At the time
of making the meal announcement, the user may have an option. to enter the
manual bolus. The
meal controller of the blood glucose pump can provide a recommendation against
the manual
entry if there is a prior history of online operation or a basis for making
the recommendation.
[0421] The information may be received from a user via a user interface. This
user interface
may be provided by the automated blood glucose control system. Alternatively,
or in addition,
the user interface may be generated by another device, such as a laptop or
desktop, a
smartphone, a smartwatch, or any other computing device that can communicate
via wired or
wireless communication with the automated blood glucose control system. The
information
may include one or more of: an indication of delivery of a manual bolus (e.g.,
via injection
therapy), an amount of the manual bolus, a type of the insulin (or other
medicament), a time
when the manual bolus was delivered, a general location that the manual bolus
was
administered to the subject (e.g., back, stomach, arm, leg, etc.), a reason
for the manual bolus
(e.g., a meal, a maintenance dose, a blood glucose level reading, in advance
of exercise, etc.),
and any other information that may be useable by the blood glucose control
system in
controlling the blood glucose level of the subject.
104221 Advantageously, in certain embodiments, providing manual dosing
information to the
automated blood glucose control system can help the blood glucose control
system maintain the
blood glucose level of the subject within a desired range when the automated
features of the
blood glucose control system are active or operational. For example, if the
automated blood
glucose control system determines from a CGM sensor reading that a subject's
blood glucose
level is high, the automated blood glucose control system might normally
administer a bolus of
insulin. However, if the automated blood glucose control system receives an
indication that a
manual bolus of insulin was administered recently (e.g., within the past
thirty minutes), the
automated blood glucose control system may reduce or not administer a bolus of
insulin,
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thereby preventing a Hypoglycemic event, In some such cases, the automated
blood glucose
control system may continue monitoring the blood glucose level of the subject
and may
administer additional insulin at a later time if the blood glucose level
readings do not reflect an
expected blood glucose level based on the reported manual bolus of insulin.
[0423] In some cases, it may be unnecessary to receive an indication of the
manual bolus
because, for example, a user may cause the automated blood glucose control
system to provide
the manual bolus. In such cases, the automated blood glucose control system
may track the
amount of insulin delivered and the timing of the administering of the bolus.
To track the
manual bolus, the automated blood glucose control system may store the
information associated
with the manual bolus in a therapy log. Accordingly, when the automated blood
glucose control
system is operating in an automatic mode, the automated blood glucose control
system can
access the therapy log to determine whether any manual bolus were administered
and, if so, the
timing arid amount of the manual bolus.
[0424] In some cases, the automated blood glucose control system may model the
diminishing
of insulin, or other medicament, in the blood plasma over time based on the
information
associated with the manual bolus. Modeling the diminishing of medicament over
time may be
used to estimate a future effect of the medicament previously administered. In
some cases, the
model may account for previously administered medicament by the automated
blood glucose
control system. Further, in some cases, the model may account for
physiological characteristics
of the subject, such as the subject's weight or an input parameter related to
the subject's weight
(e.g., body mass index). Moreover, the model may account for perfusion over
time of the
medicament -bolus from a subcutaneous infusion site into the blood plasma of
the subject.
Further, the automated blood glucose control system may model an accumulation
of insulin,
model time course of activity of insulin, or model a finite rate of
utilization of insulin.
[0425] Based on the model, the automated blood glucose control system may
adjust the
automated administering of insulin, or other medicament when operating in an
automatic mode.
Further, the automated blood glucose control system may operate the
administering of
medicament (e.g., by controlling a medicament pump) based on a glucose level
of the subject
and the modeled concentration of medicament in the subject.
[0426] in some cases, the automated blood glucose control system may confirm
that the
manual bolus was delivered to the subject. The confirmation may be determined
based at least
in part on whether blood glucose level readings by the CGIN.4 sensor match or
are within a
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threshold level anticipated by the automated blood glucose control system
based on the manual
dosing information. Alternatively, or in addition, the automated blood glucose
control system
may request, via a user interface, that a user confirm that the manual bolus
was delivered. In
cases where the manual bolus in delivered by the automated blood glucose
control system, a
user may be requested to confirm the administering of the manual bolus by
using a particular
gesture or sequence of interactions with a user interface (e.g., a
touchscreen) of the automated
blood glucose control system or of a device (e.g., laptop or smartphone, etc.)
that
communicates with the automated blood glucose control system.
[0427] As previously described, in some cases, the information relating to the
manual bolus
may include an amount of insulin and a reason the manual bolus was
administered (e.g., for a
meal of a particular size). In some such cases, the automated blood glucose
control system may
determine an amount of insulin the automated blood glucose control system
would administer
in an automatic operating mode based on the manual dosing information if the
manual bolus
had not been supplied. If the automated blood glucose control system
determines it would have
supplied a different quantity of the medicament, and if the difference exceeds
a threshold, the
automated blood glucose control system may adjust a blood glucose control
algorithm to
account for the difference. For example, the automated blood glucose control
system may
change the operating setpoint or range of insulin the automated blood glucose
control system
attempts to maintain in the subject. As another example, the automated blood
glucose control
system may supplement the manual bolus with additional insulin to account for
an under-
administering of insulin or may reduce a subsequent dosage of insulin to
account for an over-
administering of insulin.
104281 As previously indicated, the automated blood glucose control system may
maintain a
therapy log of manual insulin therapy. This therapy log may be maintained
based on the use of
the automated blood glucose control system to provide a manual bolus or based
on information
provided by the user based on manual administering of insulin (e.g., via
injection). The manual
boluses may be supplied when the automated blood glucose control system is not
operating, is
not operating in an automatic mode, or is not connected to the subject. Once
the automated
blood glucose control system is connected to the subject and is configured in
automatic mode,
the automated blood glucose control system may determine therapy, if any, to
provide to the
subject based on a combination of the therapy log and the glucose control
algorithm
implemented by the automated blood glucose control system.
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[0429] The automated blood glucose control system may generate a dose control
signal based
on the determined therapy, This dose control signal may be supplied to a
medicament pump,
which may control delivery of the medicament (e.g., insulin) to the subject.
[0430] In some cases, a user may control whether the automated blood glucose
control system
is operating in a manual mode or an automatic mode by interacting with a user
interface of the
automated blood glucose control system or of a device that communicate with
the automated
blood glucose control system. The user interaction may include any type of
user interaction
with a user interface. For example, the user interaction may include
interaction why physical
buttons or interactions with a touchscreen including gestures or taps on the
touchscreen.
[0431] Additional embodiments relating to managing meal medicament doses and
manual
dosing that can be combined with one or more embodiments of the present
disclosure are
described in U.S. Provisional Application No. 62/911,143, which was filed on
October 4, 2019
and is titled "SYSTEM AND METHOD OF MANAGING MEAL DOSES IN AN
AMBULATORY MEDICAL DEVICE," the disclosure of which is hereby incorporated by
reference in its entirety herein for all purposes.
[0432] A system of one or more computers can be configured to perform
particular operations
or actions by virtue of haying software, firmware, hardware, or a combination
of them installed
on the system that in operation causes or cause the system to perform the
actions. One or more
computer programs can be configured to perform particular operations or
actions by virtue of
including instructions that, when executed by data processing apparatus, cause
the apparatus to
perform the actions. One general aspect includes a method including: providing
an option to a
user to select between receiving medicament using a manual delivery component
or an
automated delivery system. The method also includes receiving, by the
automated delivery
system, subjective information regarding the activity or action that may alter
the blood-glucose
level. The method also includes receiving, by the manual delivery component,
an amount of the
medicament to be infused. The method also includes storing a time and the
amount of
medicarnent that is infused into the automated delivery system that controls
blood glucose
level. Other embodiments of this aspect include corresponding computer
systems, apparatus,
and computer programs recorded on one or more computer storage devices, each
configured to
perform the actions of the methods.
[0433] implementations may include one or more of the following features. The
method
where the automated delivery system modifies medicament delivery based on the
time and the
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amount of medicament that was received from either the manual delivery
component or the
automated delivery system. The method where the manual delivery component
includes a
keypad which allows the user to type in the dosage amount of the desired
medicament, The
method where providing the option to select is provided prior to a user
performing the activity
that may alter the blood-glucose level. The method where the activity that may
alter the blood-
glucose level includes of consuming food or exercising. The method where the
subjective
information regarding the activity of consuming food includes the approximate
relative size of
the food that is to be digested. The method where the approximate relative
size of the food is
compared to the recommended meal doses for the user and depending on whether
the
approximate relative size is the same, larger, or smaller than the recommended
doses, the
model predictive control component is able to determine the actions that is
required to regulate
the glucose level of the blood. The method where the subjective information
regarding the
activity of exercising includes the intensity and the duration of the
exercise. The method where
the intensity and the duration of the exercise is compared to the recommended
intensity and
duration, and depending on whether it is the same, larger, or smaller than the
recommended
intensity and duration, the automated delivery system is able to determine the
actions that is
required to regulate the glucose level of the blood. Implementations of the
described techniques
may include hardware, a method or process, or computer software on a computer-
accessible
medium.
[0434] One general aspect includes a system having a medical device configured
to provide an
option to a user to select between receiving medicament using a manual
delivery component or
an automated delivery system. The system also includes automated delivery
system configured
to receive subjective information regarding the activity that may alter the
blood-glucose level.
The system also includes a manual delivery component configured to receive an
amount of the
medicament to be infused. The system also includes where the medical device
storing a time
and the amount of medicament that is infused into an automated delivery system
that controls
blood glucose levels. Other embodiments of this aspect include corresponding
computer
systems, apparatus, and computer programs recorded on one or more computer
storage devices,
each configured to perform the actions of the methods,
[0435] Upon utilizing an ambulatory medical device to request for a therapy
change, users
may have different preferences. Therefore, it is desirable for modern
technology, specially the
ambulatory medical devices to be equipped with optimality features. These
optional ity features
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may fulfill the different preferences of the users and subjects. The
optionality features
may allow users to control the therapy changes more closely and may allow them
to be more
engaged with the medical assistance of the ambulatory medical device.
[0436] In order to fulfill the variety of preferences, an ambulatory medical
device needs to
provide options which allows the user to either manually request the amount of
the desired
medicament or chose an automated delivery system that automatically delivers
the right amount
of the medicament at the right time without further assistance. For the manual
component, the
user may personally input the desired amount on a keypad that is provided by
the medical
device. The medical device further confirms and delivers the requested
medicament. After the
medicament is infused through a manual delivery component, the data is stored
into a model
predicative control component which is further used to control and regulate
the blood glucose
level. However, if the user decides to use the automated delivery system, the
user must provide
subjective information regarding the activity or the action that may alter the
blood-glucose
level. For example, if the blood-glucose level changing activity is consuming
food, the user
must provide the time and the dosage amount of the food that is going to be
digested. This
information is tied to the automated delivery system, and the subjective
information is further
stored into a model predicative control component.
[0437] Embodiments described herein include an ambulatory medical device that
has a keypad
which allows a user to type in a dose of insulin or glucagon to be
administered to a user. A user
may wish to receive a single dose of insulin prior to consuming food and
decide how much
insulin need to be administered. In other embodiments, the user may choose to
receive a burst
of glucagon due to low blood sugar because of physical activities. Embodiments
may include
the options for manual inputs of medicament and automated delivery system of
medicament. In
various implementations, the automated delivery system of medicament is driven
by the blood
glucose level or related trends. Embodiments herein address a problem that may
arise when the
user has just received a manual dose and has switched on the automated
delivery system. In
such cases, the automated delivery system may be made aware of all manual
medicament
infusion amounts and the timing of such infusions. Accordingly, the manual
delivery
component may inform the automated delivery system upon delivering any
medicament the
type of medicament delivered, the amount of medicament and the timing of the
medicament
delivered. By having the above information, the automated delivery system may
determine the
amount of medicament that is the user's blood stream and adjust the automated
delivery of
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medicament and the timing of the automated delivery. Accordingly, embodiments
are directed
to allows for a risk-free transition from the manual delivery component and
the automated
delivery system,
[0438] Differences from other system may include that the manual delivery may
be tied to an
automated delivery system, the dose input from the user is then stored into
the MPC algorithm
(Model Predictive Control) instead of the meal delivery algorithm and is
handled by the MPC
algorithm. Other embodiments may include selection being able to have a
relativistic
algorithmically tuned value. Other embodiments may include a learning
algorithm that includes
a usual size meal or larger size meal or small size meal. Embodiments may
include correlating
the manual inputs to asking the user what the size of the meal was and
learning how the insulin
affects the user. Embodiments may include correlating the manual inputs to
asking the user
what activity the user performed and learning how the glucagon affects the
user for a particular
activity.
BGCS with Manual Dose Management
[0439] FIG. 36 illustrates a schematic of the therapy change delivery system
3600 in an
ambulatory medical device 3602 that allows the user the choice of receiving
manual delivery of
medicament or automated delivery of medicatnent. Moreover, the therapy change
delivery
system 3600 allow the user to transition between the manual mode and the
automated mode
with ease. The therapy change delivery system 3600 includes the ambulatory
medical device
3602, a signal processing component 3604, a user 3606, a therapy delivering
component 3608,
a therapy change input 3610, input components 3612, activity change component
3614, and a
therapy change delivery 3616. When the user intends to receive a therapy from
an ambulatory
medical device 3602, the user 3606 may initiate a therapy change input 3610 to
request the
manual or automated medicament.
[0440] The ambulatory medical device 3602 is any medical device that a user
3606 may carry
around and use with the approval of a medical professional. There are many
different types of
ambulatory medical devices 3602. In one embodiment, the ambulatory medical
device 3602 is
an insulin and/or glucagon infusion device for user 3606 that have type I
diabetes. Ambulatory
medical devices 3602 allow users 3606 the freedom to receive medical care in
any setting at
their convenience. However, the drawback of using an ambulatory medical device
3602 could
be the user 3606 making mistakes when the user is away from the medical
professionals. One
possible issue may be caused the user 3606 switches from a manual delivery
mode to an
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automated delivery mode when the automated delivery mode is unable to
determine the amount
of medicament in the user's blood stream. Embodiments are directed to the
manual medicament
delivery information being provided to the automated medicament delivery
system so that it
can adjust its operations based on the current and future medicament in the
user's blood stream.
In some cases, such as the embodiment where the ambulatory medical device 3602
is an insulin
and/or glucagon infusion device, doing automated delivery of medicament can be
problematic.
[0441] The ambulatory medical device 3602 includes a signal processing
component 3604, a
therapy delivering component 3608, and input components 3612. The signal
processing
component 3604, therapy delivering component 3608, and input components 3612
tnay be
physically connected, wirelessly connected, connected via a cloud-based
computer system, or
connected in any other way.
[0442] The signal processing component 3604 is a computing system that
performs the
computing functions for the ambulatory medical device 3602. The signal
processing component
3604 includes a processor, memory, and storage. The signal processing
component 3604 tnay
be a single computing system or may be made up of several computing systems.
The signal
processing component 3604 may perform the computing functions for a single
ambulatory
medical device 3602 or many ambulatory medical devices. The signal processing
component
3604 receives signals from the therapy delivering component 3608 and from the
input
components 3612. The signal processing component 3604 also transmits signals
to the therapy
delivering component 3608 and the input components 3612. Signals of the
therapy change input
3610, the therapy change delivery 3616, and all steps of the activity change
component 3614
may be received or transmitted by the signal processing component 3604.
[0443] The user 3606 is any individual that uses the ambulatory medical device
3602. In one
embodiment the user 3606 is an individual with diabetes that requires a
periodic infusion of
insulin or glucagon to maintain healthy blood sugar levels. In various
embodiments, the
ambulatory medical device 3602 infuses insulin or glucagon into the user 3606.
The user 3606
may transport the ambulatory medical device 3602. Thus, as the user 3606 moves
around, there
is a danger that the user 3606 will inadvertently activate input in the
ambulatory medical device
3602 that initiates a therapy change input 3610.
[0444] The therapy delivering component 3608 provides medicaments to the user
3606.
Signals received from the signal processing component 3604 are executed by the
therapy
delivering component 3608 to change therapy such as starting, modifying, or
stopping a
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therapy. The therapy delivering component 3608 may have a computing component
for
interpreting and executing instructions from the signal processing component
3604. Thus, the
therapy delivering component 3608 can follow a program that is controlled by
the signal
processing component 3604. In one embodiment, the therapy delivering component
3608 is one
or more infusion pumps. An infusion pump is capable of delivering fluids at
varying rates to a.
user 3606. The infusion pump may deliver any fluid, including medicaments. The
infusion
pump may be connected to a user 3606 through any means. In one example, the
infusion pump
is connected to the body through a cannula. In an exemplary embodiment, the
therapy
delivering component 3608 is an insulin infusion pump. Also, in an exemplary
embodiment, the
therapy delivering component 3608 is an insulin and glucagon infusion pump.
Signals received
from the signal processing component 3604 may be interpreted by an insulin and
glucagon
pump to start, stop, or change the rate of insulin and glucagon being
delivered into a user 3606.
[0445] In an exemplary embodiment, the therapy delivering component 3608 is an
electrical
stimulation device. An example of an electrical stimulation device is a
cardiac pacemaker. A
cardiac pacemaker stimulates the cardiac muscle to control heart rhythms.
Instructions received
from the signal processing component 3604 may be interpreted by a cardiac
pacemaker to start
stimulating a cardiac muscle, stop stimulating a cardiac muscle, or change the
rate of
stimulation of a cardiac muscle. Another example of an electrical stimulation
device is a deep
brain stimulator to treat Parkinson's disease or movement disorders.
Instructions received from
the signal processing component 3604 may be interpreted by the deep brain
stimulator to start,
stop, or modify the stimulation of the brain.
[0446] The therapy change input 3610 is an input provided by the user 3606 to
change a
therapy that is currently being delivered to the user 3606. The change of
therapy may be to start
a therapy, modify a therapy, or cancel a therapy. There are many types of
possible therapy
changes, and the types of therapy changes are dependent on the type of
ambulatory medical
device 3602. In one embodiment, the ambulatory medical device 3602 is an
insulin or glucagon
infusion device. However, there are many possible embodiments of ambulatory
medical devices
3602 for the disclosed subject matter. The therapy change input 3610 in an
insulin or glucagon
infusion device may be an instruction, that when executed, causes the insulin
or glucagon
infusion device to start infusing an amount of insulin or glucagon into the
user 3606.
Alternatively, the therapy change input 3610 may be an instruction to modify
the rate of insulin
or glucagon infusion into the user 3606. The therapy change input 3610 may
also be an
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instruction to cancel insulin or glucagon infusion into the user 3606 from the
insulin or
glucagon infusion device. In an exemplary embodiment, the ambulatory medical
device 3602 is
an electrical implant, that when operated, stimulates a part of the body. An
example is an
electrical brain implant for users 3606 with Parkinson's disease or for pain
management. The
implementation of the therapy change can be to modify the rate of electrical
stimulation to the
body.
[0447] The therapy change delivery 3616 is the performance, by the ambulatory
medical
device 3602, of the therapy change input 3610 that was verified by the 3614.
The therapy
change that is delivered by the therapy change delivery 3616 corresponds to
the therapy change
selection made by the user 3606. In one embodiment, the ambulatory medical
device 3602
alerts the user 3606 that it is performing a therapy change delivery 3616. In
an example of
various embodiments, the ambulatory medical device 3602 displays the therapy
change during
the therapy change delivery 3616. Any number of details of the therapy change
may be
displayed during the therapy change delivery 3616. As shown in FIG-. 43, a
simple message of
"Delivering" may be displayed during the therapy change delivery 3616.
Alternatively, more
exact details, such as "Delivering 2 units of insulin" or "Delivering insulin
at 2 units per
minute" may be displayed. In another example, the ambulatory medical device
3602 plays a
sound effect during the therapy change delivery 3616. In an exemplary
embodiment that is
shown in FIG. 43, the therapy change delivery 3616 may be canceled by an input
by the user
3606. The input to cancel a therapy change delivery 3616 may be any input such
as a wake
signal input or a series of touch inputs such as a gesture.
[0448] The input components 3612 allow the user 3606 to interact with and
control the
ambulatory medical device 3602. The amount of control that a user 3606 has may
vary based
on the type of ambulatory medical device 3602 and the user 3606. For example,
an ambulatory
medical device 3602 that delivers pain medication may allow the user more
control than an
ambulatory medical device 3602 that controls heart rhythms. In another
example. a user 3606
that is a young child (less than about 10, 11 or 12 years) may be allowed less
control over an
ambulatory medical device 3602 than a user 3606 that is a teen or an adult.
The input
components 3612 include a wake button 3626, a touchscreen. display 3628, and
an
alphanumeric pad 3630.
[0449] The wake button 3626 is activated by a user 3606 to create a wake
signal input to
unlock an ambulatory medical device 3602. The wake button 3626 may be any
input button. In
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one embodiment, the wake button 3626 is a capacitive button that detects a
change in
capacitance, The wake button 3626 may have a computing component for
interpreting and
executing instructions from the signal processing component 3604. Thus, the
wake button 3626
can follow a program that is dictated by the signal processing component 3604.
[0450] The touchscreen. display 3628 may display a therapy change user
interface for the user
3606 and receive user 3606 inputs on the touchscreen display 3628 input
surface. Inputs on the
touchscreen display 3628 may be registered by any touch technology including,
but not limited
to capacitive and resistive sensing. The touchscreen display 3628 may be a
part of a mobile
computing device, such as a cellular phone, tablet, laptop, computer, or the
like. The
touchscreen display 3628 may have a computing component for interpreting and
executing
instructions from the signal processing component 3604. Thus, the touchscreen
display 3628
can follow instructions that are directed by the signal processing component
3604. To receive
input, the touchscreen display 3628 may display buttons, alphanumeric
characters, symbols,
graphical images, animations, or videos. The touchscreen display 3628 may
display an image to
indicate when the ambulatory medical device 3602 is locked or inaccessible via
the touchscreen
display 3628. The touchscreen display may receive the series of inputs that
make up the first
gesture and the second gesture.
[0451] The alphanumeric pad 3630 registers numerical inputs, alphabetical
inputs, and symbol
inputs. The alphanumeric pad 3630 includes a multitude of keys corresponding
to numerical,
alphabetical, and symbol inputs. The alphanumeric pad 3630 may have a
computing component
for interpreting and executing instructions from the signal processing
component 3604. Thus,
the alphanumeric pad 3630 can follow instructions that are dictated by the
signal processing
component 3604. The alphanumeric pad 3630 may be configured to provide haptic
feedback
from its keys. The alphanumeric pad or pads 3630 may have any number of keys
and any
number of characters and may span multiple screens that the user 3606 can
toggle between in
order to find all of their sought-after characters. In one embodiment, the
wake button 3626 is
incorporated into the alphanumeric pad 3630. In various embodiments, the wake
button 3626
may be any one or more keys of the alphanumeric pad 3630. In an exemplary
embodiment, the
alphanumeric pad 3630 is displayed as part of the touchscreen display 3628.
Characters from
the alphanumeric pad 3630 may be used as input for the wake signal input,
first gesture,
therapy change selection, and second gesture, In an exemplary embodiment, the
first gesture
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and/or second gesture are created by entering predetermined characters on the
alphanumeric
pad 3630.
[0452] The activity change component 3614 may be part of a specialized
software that is
executed on an ambulatory medical device or include a specialized hardware
that performs the
various functions described here. The activity change component 3614 may
receive inputs from
the user regarding weather the user is about to conduct activities that will
change the blood
glucose of the user. For example, the user may provide input using the input
components 3612
that the user is about to perform exercise that may lower their blood sugar or
eat a meal that
will increase their blood sugar. Upon receiving the activity change from the
input components
3612, the activity change component 3614 offers the user the option via the
mode controller
3620 to select between the automated delivery system. 3618 or the manual
delivery component
3622. As shown in FIG. 36, the manual delivery system may inform the automated
delivery
system 3618 and the model predictive control component 3624 regarding any
manual
medicament deliveries of insulin or glucagon.
[0453] In various embodiments, the user may choose the dosage amount, the drug
type
(insulin or glucagon; fast or slow acting) and the time of the delivery and
the manual delivery
component 3622 may receive such information and deliver the medicament(s)
accordingly. In
one embodiment, the manual delivery component 3622 may inform the automated
delivery
system 3618 and the model predictive control component 3624 regarding the drug
type (insulin
or glucagon; fast or slow acting) and the time of the delivery.
[0454] When the user activates the automated delivery system 3618, the data
from previous
manual medicament infusions can be readily available so that the automated
delivery system
3618 may be able to determine how much medicament is still in the user's blood
stream. The
automated delivery system 3618 may make that determination by tracking the
finite rate of
utilization of infused insulin by the subject based on the time and amount of
any manual
medicament infusions reported to the automated delivery system 3618.
[0455] FIG. 37 is a flow chart of a process 3700 detailing a medicament
selection process,
according to an exemplary embodiment. In step 3702, the medical device
provides an option to
a user to select between receiving medicament using a manual delivery
component or an
automated delivery system. By using the mode contro11er3620, the user can
select the method
for the therapy change request between manual delivery component and the
automated delivery
system.
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[0456] In step 3704, the medical device may receive subjective information
regarding the
activity or action that may alter the blood-glucose level. Subjective
information may include
the size of the meal and/or the type of physical activity. In step 3706, the
manual delivery
component may receive an amount of the medicament to be infused. The
medicament may be a
plurality of hormones, including but not limited to, glucagon or insulin. At
step 3708, the
medical device may store a time and the amount of medicament that was infused
into the
automated delivery component that controls the blood glucose level. The
systems that are
disclosed in FIG-. 36 will be utilized to accomplish each and every step from
steps 3702, 3704,
3706 and 3708.
[0457] FIG. 38 is another flow diagram of a process 3800 for providing options
for meal
dosage selection or physical activity of the user on an ambulatory device.
Embodiments
described herein include an ambulatory medical device that has a keypad which
allows a user to
type in a dose of insulin or glucagon to be administered to a user. A user may
wish to receive a
single dose of insulin prior to consuming food and decide how much insulin
need to be
administered. In other embodiments, the user may choose to receive a burst of
glucagon due to
low blood sugar because of physical activities. Embodiments may include the
options for
manual inputs of medicament and automated delivery system of medicament. In
various
implementations, the automated delivery system of medicament is driven by the
blood glucose
level or related trends. Embodiments herein address a problem that may arise
when the user has
just received a manual dose and has switched on the automated delivery system.
In such cases,
the automated delivery system may be made aware of all manual medicament
infusion amounts
and the timing of such infusions. Accordingly, the manual delivery component
may inform the
automated delivery system upon delivering any medicament the type of
medicament delivered,
the amount of medicament and the timing of the medicament delivered. By having
the above
information, the automated delivery system may determine the amount of
medicament that is
the user's blood stream and adjust the automated delivery of medicament and
the timing of the
automated delivery. Accordingly, embodiments are directed to allows for a risk-
free transition
from the manual delivery component and the automated delivery system,
[0458] At block 3802, the user may inform the activity change component 3614
that the user
is about to engage in activities that may alter the blood-glucose level of the
user. The mode
controller 3620 may be activated at decision block 3804 and ask whether the
user wants to use
the manual delivery component 3806 or the automated system 3810. If the user
chooses to use
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the manual delivery component 3806 and the user provides an input to infuse
medicament, the
ambulatory device 3602 may delivery the medicament to the user. Upon the
manual delivery
process completion, the manual delivery component 3806 may inform at least one
of the model
predictive control component 3808 and the automated delivery system 3810
regarding the type
of medicament, amount of medicament and the time when the medicament was
delivery. The
predictive control component 3808 and automated delivery system 3810 may track
these
manual infusions of medicament and determine that based on the rate of decay
or the half-life
of the medicament the total amount of medicament that remains in the user's
blood stream at a
particular time or a period of time. Accordingly, when the automated delivery
system 3810 is
activated by the user, the automated delivery system. 3810 may change its
medicament infusion
based on the medicament that remains in the user's blood stream. after a
manual infusion by the
user.
[0459] Differences from other system may include that the manual delivery may
be tied to an
automated delivery system, the dose input from the user is then stored into
the MPC algorithm
(Model Predictive Control) instead of the meal delivery algorithm and is
handled by the -MPC
algorithm. Other embodiments may include selection being able to have a
relativistic
algorithmically tuned value. Other embodiments may include a learning
algorithm that includes
a usual size meal or larger size meal or small size mean. Embodiments may
include correlating
the manual inputs to asking the user what the size of the meal was and
learning how the insulin
affects the user. Embodiments may include correlating the manual inputs to
asking the user
what activity the user performed and learning how the glucagon affects the
user for a particular
activity.
104601 FIG. 39 illustrates a plurality of screens 3900 that may be produced by
the ambulatory
medical device 3602. The plurality of screens 3900 demonstrates a process that
a user may take
in order to enter meal doses. When the activity change component 3614 is
activated, the enter
meal doses screen 3902 may be displayed. Once the screen 3902 is displayed, a
warning text
may be displayed for the user to ensure safety. The warning text states that
entering a dose may
be unsafe and the device will not adapt its meal doses. This warning text
cautions the user of
the risks that may be involved in the process of using the ambulatory medical
device 3602.
After a user acknowledges the warning sign and choses to proceed, a password
screen 3904
may be displayed_ Once the password screen 3904 is displayed, a keypad is
provided for the
user to enter a predetermined sequence of numbers to ensure that the user is
the actual
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registered user of the ambulatory medical device 3602. When the ambulatory
medical device
3602 receives the correct predetermined password from the user, the enter meal
doses official
screen 3906 and meal doses official screen 3908 may be displayed. The user may
decide to
access the advanced screen 3912, and upon doing so, the advanced screen 3912
will allow the
user to double check the CGM Insulin levels and change the speed of the of the
insulin pump.
In screen 3906 and screen 3908, the user is provided the option to have the
meal keypad on or
off. If the user selects to have the keypad on, then an option may be provided
for the user to
choose the max dose limit. If the user decides to choose the max dose limit,
the official max
dose limit screen 3910 is displayed, where the user may enter up to 10 units
of the dose. The
provided number of units is then stored in the model predictive control
component 116 for
further regulation of the blood glucose level.
[0461] FIG. 40 illustrates a plurality of screens 4000 that may be produced by
the ambulatory
medical device 3602 Upon activating the ambulatory medical device (e.g., the
ambulatory
medical device 500, 600, or 3602) the initial menu screen 4002 may be
displayed. In the menu
screen 4002, options regarding functionalities of the ambulatory medical
device 3602 is
provided. The list of functionalities may cover all the aspects of the
ambulatory medical device
3602. The user may access and control many aspects of the device by choosing
the setting
option. The setting option will allow the user to further assess and regulate
the adjustable
functionalities of the ambulatory medical device 3602. Upon selecting the
setting option, the
setting screen 4004 may be displayed and the user may select the advanced
setting option.
Upon selecting the advanced option, the advanced setting screen 4006 is
displayed, and the user
is provided the option to double check the CGM insulin levels and change the
speed of the of
the insulin pump. The user may speed up the process or slow down the process
depending on
the regulation stats that are provided by the model predictive control
component 3624.
[0462] FIG. 41 illustrates a plurality of screens 4100 that may be produced by
the ambulatory
medical device 3602. The plurality of screens 4100 is the process that a user
may take in order
to enter meal announcements. The home screen 4102 provides information and
stats regarding
the cartridge of the ambulatory medical device 3602. The user may select the
meal button with
or without an installation of a new cartridge. If a user selects the meal
button without installing
a new cartridge, the ambulatory device 3602 will display the warning screen
4106, where the
user is warned that the insulin cartridge is empty, and the device further
advises the user to
change the cartridge. However, if a new cartridge is already installed and the
food button is
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pressed, the ambulatory medical device 3602 will display the Garbs screen
4104, where the user
is provided the option to choose a meal dose option. The carbs screen 4104
allows the user to
provide subjective information regarding the food that is to be digested. This
subjective data.
provided by the user is further stored in the model predictive control
component 3624 for
further regulation of the blood glucose level.
[0463] FIG. 42 illustrates a plurality of screens 4200 that may be produced by
the ambulatory
medical device 3602. The plurality of screens 4200 demonstrates the process of
the user being
alerted about the empty cartridge and having the option to replace the
cartridge and further
enter the meal doses. Warning screen 4202 alerts the user that the insulin
cartridge is empty
and the fact that it needs to be replaced. Upon replacing the cartridge,
screens 4204 and 4206
will be displayed. Screen 4204 is initially displayed, and a user may enter a
specified dose for
each meal on a numerical pad. Upon inserting a numerical specified dose,
screen 4206 is
displayed where a next button is provided for the user to further complete the
therapy change.
The numerical specified dose is further stored in the model predictive control
component 3624
for further regulation of the blood glucose level,
[0464] FIG. 43 illustrates a plurality of screens 4300 that may be produced by
the ambulatory
medical device 3602. Upon selecting the delivery request, a user may cancel
the delivery of the
medicaments prior to the completion of the delivery. The ambulatory medical
device 3602
displays a countdown prior to delivery. The initial countdown screen 4302 is
proceeded by the
secondary countdown screen 4306. During these countdown screens, a cancel
button is
provided for the user to cancel the therapy change. During the initial
countdown screen 4302 or
the secondary countdown screen 4306, the user may cancel the delivery at any
time. By
swiping the cancel button, the user may officially stop the delivery of the
therapy change. If the
user does not cancel, the therapy change may be delivered successfully.
Furthermore, the time
and the amount of the therapy change delivery is stored in the model
predictive control
component 3624 for further regulation of the blood glucose level. However, if
the user decides
to cancel the delivery, the delivery will be canceled and the screen 4304 will
be provided. Once
the delivery cancelation is requested and the screen 4304 is displayed, upon
pressing the ok
button, the ambulatory medical device 3602 will display a lock screen 4308 and
take the time
to officially cancel the therapy change request.
[0465] FIG. 44 is a block diagram illustrating a computer system 4400 that may
be
implemented in the various embodiments in the described subject matter. The
computer system
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4400 includes a processor 4402 (e.g., electronic or hardware processor), main
memory 4404,
storage 4406, a bus 4408, and input 4410. The processor 4402 may be one or
more processors.
The processor 4402 executes instructions that are communicated to the
processor through the
main memory 4404. The main memory 4404 feeds instructions to the processor
4402. The main
memory 4404 is also connected to the bus 4408. The main memory 4404 may
communicate
with the other components of the computer system through the bus 4408.
Instructions for the
computer system 4400 are transmitted to the main memory 4404 through the bus
4408. Those
instructions may be executed by the processor 4402. Executed instructions may
be passed back
to the main memory 4404 to be disseminated to other components of the computer
system
4400. The storage 4406 may hold large amounts of data and retain that data
while the computer
system 4400 is unpowered. The storage 4406 is connected to the bus 4408 and
can
communicate data that the storage holds to the main memory 4404 through the
bus 4408.
[0466] The processor 4402 may be any type of general-purpose processor
including, but not
limited to a central processing unit ("CPU"), a graphics processing unit
("GPIi"), a complex
programmable logic device ("CPLD"), a field programmable gate array ("FPGA"),
or an
application-specific integrated circuit ("ASIC"). Some embodiments of the
computer system
4400 in the ambulatory medical device 102 features a CPU as the processor
4402. However,
embodiments may be envisioned for the computer system of the ambulatory
medical device 102
that incorporate other types of processors 4402.
[0467] The main memory 4404 can be any type of main memory that can
communicate
instructions to the processor 4402 and receive executed instructions from the
processor 4402.
Types of main memory 4404 include but are not limited to random access memory
("RAM")
and read only memory ("ROM"). In some embodiments, the computer system 4400
incorporates RAM as the form of main memory 4404 to communicate instructions
to the
processor 4402 and receive executed instructions from the processor 4402.
Other embodiments
may be envisioned that incorporate other types of main memory 4404 in the
computer system
4400.
104681 The storage 4406 can be any type of computer storage that can receive
data, store data,
and transmit data to the main memory 4404 via the bus 4408. Types of storage
4406 that can be
used in the computer system 4400 include, but are not limited to, magnetic
disk memory,
optical disk memory, and flash memory. In some embodiments, flash memory is
used as the
storage 4406 in the computer system. 4400 of the ambulatory medical device
102. Other
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embodiments that use other types of storage 4406 for the computer system. 4400
may be
envisioned.
[0469] The bus 4408 connects the internal components of the computer system
4400. The bus
4408 may include a multitude of wires that are connected to the components of
the computer
system 4400. The wires of the bus 4408 may differ based on the components of
the computer
system 4400 to which the bus 4408 connects. In various embodiments, the bus
4408 connects
the processor 4402 to the main memory 4404. In various embodiments, the
processor 4402 is
directly connected to the main memory 4404,
[0470] The input 4410 of the computer system 4400 may include a touchscreen
display 4412,
an alphanumeric pad 4414, and buttons 4416. The touchscreen display 4412 may
both produce
output and accept input. The touchscreen display can generate user input
signals corresponding
user input. A touchscreen controller can receive user the user input signals.
The touchscreen
display can display user interface screens generated by computer system 4400
as discussed
herein (for example, the critical status information interface illustrated in
FIG. 55), The bus
4408 may be coupled to the touchscreen display 441.2 to produce visual output.
The
touchscreen display 441 2 may also accept input via capacitive touch,
resistive touch, or other
touch technology. The input surface of the touchscreen display 4412 can
register the position of
touches on the surface. Some types of touchscreen display 4412. can register
multiple touches at
once. The alphanumeric pad 4414 may include a multitude of keys with
numerical,
alphabetical, and symbol characters. Signals from the alphanumeric pad 4414
may be
communicated by the bus 4408 to the main memory 4404. Keys of the alphanumeric
pad 4414
may be capacitive or mechanical. In some embodiments, the alphanumeric pad
4414 is
displayed on the touchscreen display 4412. Buttons 4416, such as the wake
button or interface,
may be capacitive, mechanical, or other types of input buttons. The wake
interface may include
one or more of the embodiments described herein with respect to the wake
interface 3220 of
FIG. 32.
[0471] The input 4410 may be a user interface module as disclosed with respect
to the user
interface module 3218 of FIG. 32. The user interface module may include any
type of user
interface controller for providing a user interface as discussed herein. The
user interface may
be provided on a display 4412 of the computer system 4400 (e.g., an AMID
1.00), or may be
transmitted to a display of an electronic device in communication with the
computer system
4400 (e.g., an ANID 100), In some cases, the user interface controller may be
a touchscreen
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controller that is configured to output display signals configured to generate
one or more user
interface screens on a touchscreen. Further, the touchscreen controller may be
configured to
receive user input signals corresponding to user interaction with the
touchscreen,
Occlusion Detection
104721 When a subject is receiving therapy, often there may be an occlusion
(e.g., a kink or
obstruction in the medicament delivery path). The occlusion may be detected by
a system
and/or the medicament pump. However, sometimes a false signal may be detected
that would
otherwise cause a system to slow and/or stop therapy delivery. Systems and
methods described
herein can be effective at reducing the likelihood of needlessly slowing
and/or stopping therapy
delivery by better detecting false occlusion signals. The systems and methods
can protect the
user from dangerous occlusions while minimizing false alarms of occlusions.
False alarms may
be the result of one or more signals, such as an electrical signal (e.g.,
increased current), an
increased friction within the system, or some other signal.
[0473] FIG. 45A. illustrates a schematic of an example ambulatory medicament
pump 4500
that is configured to maintain delivery of therapy to a subject after
determining that a possible
occlusion exists in a medicament delivery system. The medicament delivery
system can include
the ambulatory medicament pump 4500 and/or other components described herein,
such as
elements described with respect to FIG. 29, FIG. 33 (deleted), FIG. 34, and
FIG. 36. The
ambulatory medicament pump 4500 includes a medicament reservoir 4502, a pump
motor
4508, a non-transitory memory 4510, and an electronic hardware processor 4512.
The
ambulatory medicament pump 4500 can include a medicament passageway 4506
configured to
couple to a medicament delivery interface 4504. The medicament passageway 4506
may
include a delivery tube operatively coupled between the medicament reservoir
4502 and an
infusion site or a subcutaneous depot of the subject and may be configured to
deliver the
medicament through the skin of the subject. The medicament delivery interface
4504 may be at
the infusion site or a subcutaneous depot of the subject, and of the subject
where medicament is
delivered to the subject as therapy.
104741 The ambulatory medicament pump 4500 is any medical device that the
subject may
carry around and use with the approval of a medical professional. The
ambulatory medicament
pump 4500 may correspond to and/or share certain functionality with one or
more devices
described herein, such as the ambulatory medical device 3602 or therapy
delivering component
3608 described above with respect to FIG. 36. There are many different types
of ambulatory
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medicament pumps 4500. In one embodiment, the ambulatory medicament pump 4500
is an
insulin and/or glucagon infusion device for subjects that have type I
diabetes. Ambulatory
medicament pumps 4500 allow subjects the freedom to receive medical care in
any setting at
their convenience.
[0475] However, the ambulatory medicament pump 1500 could malfunction during
use by the
subject in the absence of a medical professional. For example, an interference
or occlusion may
develop within the ambulatory medicament pump 4500 and/or associated elements.
An
occlusion may develop in a variety of possible scenarios. For example, a tube
(e.g., the
medicament passageway 4506) may become kinked, the pump motor 4508 may become
jammed or obstructed (e.g., from sand or debris), the medicament reservoir
4502 may become
jammed or obstructed, etc. When an occlusion alert is identified, this could
be an indication of
an actual occlusion that requires attention and perhaps repair by a
professional. Additionally or
alternatively, the occlusion alert may suggest that there is an anomaly or
other condition in the
therapy delivery and/or functionality of the ambulatory medicament pump 4500
but not that an
occlusion is present. For example, the anomaly could correspond to a false
alarm. The false
alarm could be due to one or more conditions, such as an increase of pressure
in the
medicament reservoir 4502, an increased pressure on a pump piston operatively
coupled to
pump motor 4508, slippage of the piston, a spike or drop in electrical current
delivered to the
pump motor 4508, and/or something else.
[0476] The ambulatory medicament pump 4500 can include a wireless data
interface may be
physically connected with the ambulatory medicament pump 4500, wirelessly
connected,
connected via a cloud-based computer system, or connected in any other way.
[0477] The processor 4512 is part of a computing system that performs the
computing
functions for the ambulatory medicament pump 4500. The processor 4512 may be a
single
processor or may be made up of several processors. The processor 4512 may
perform the
computing functions for a single ambulatory medicament pump 4500 or many
ambulatory
medicament pumps. The processor 4512 receives signals from the pump motor 4508
and/or
from the wireless data interface. The processor 4512 also transmits signals to
the pump motor
4508 and/or from the wireless data interface.
[0478] The subject is any individual that uses the ambulatory medicament pump
4500. In
some embodiments the subject is an individual with diabetes that requires a
periodic infusion of
insulin or glucagon to maintain healthy blood sugar levels. In various
embodiments, the
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ambulatory medicament pump 4500 infuses insulin or glucagon into the subject.
The subject
may transport the ambulatory medicament pump 4500. Thus, as the subject moves
around,
there is a danger that the subject will be away from medical professionals who
can provide any
necessary therapy if an occlusion develops within the ambulatory medicament
pump 4500.
[0479] The ambulatory medicament pump 4500 can include therapy delivery
components,
such as the pump motor 4508. The therapy delivery components may include one
or more
elements of an infusion pump, such as the pump piston, a carmula, and/or other
components as
described herein. The therapy delivery components provide medicaments to the
subject. Signals
received from the processor 4512 are executed by the therapy delivery
components, such as the
pump motor 4508, to change therapy such as starting, modifying, or stopping a
therapy. The
therapy delivery components may include a computing component for interpreting
and
executing instructions from the processor 4512. Thus, the therapy delivery
components can
follow a program that is controlled by the processor 4512,
[0480] The therapy change delivery 3616 is the performance, by the ambulatory
medicament
pump 4500, of the therapy change input 3610 that was verified at the therapy
delivering
component 3608. The therapy change that is delivered by the therapy change
delivery 3616
corresponds to the therapy change selection made by the subject. In some
embodiments, the
ambulatory medicament pump 4500 alerts the subject that it is performing a
change in therapy
delivery. In an example of various embodiments, the ambulatory medicament pump
4500
displays the therapy change during the change in therapy delivery. Any number
of details of the
therapy change may be displayed during the change in therapy delivery, such as
shown in FIG.
43 and described above.
[0481] The ambulatory medicament pump 4500 may include a user interface, such
as a
graphical user interface. The user interface may be operatively coupled to the
ambulatory
medicarnent pump 4500 via, for example, the wireless data interface. The user
interface can
include a touchscreen display. The touchscreen display may display an
occlusion detection
interface for the subject and/or receive subject inputs on the occlusion
detection interface.
Inputs on the touchscreen display may be registered by any touch technology
including, but not
limited to capacitive and resistive sensing. The touchscreen display may be a
part of a mobile
computing device, such as a cellular phone, tablet, laptop, computer, or the
like. The
touchscreen display may have a computing component for interpreting and
executing
instructions from the processor 4512. Thus, the touchscreen display can follow
instructions that
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are directed by the processor 4512. To receive input, the touch.screen display
may display
buttons, alphanumeric characters, symbols, graphical images, animations, or
videos. In some
embodiments, the user interface is not a touch.screen display. The user
interface may include
one or more mechanical buttons. The user interface may include an alert
generator, such as a
light emitter) a speaker, a haptic feedback system, or other sensory alert
system.
[0482] The ambulatory medicament pump 4500 may be configured to detect
possible
occlusions and probable occlusions. A possible occlusion suggests that an
occlusion may exist
but that more information is needed to adequately determine that an occlusion
probably exists.
A probable occlusion suggests that the ambulatory medicament pump 4500 or
other system
element may take action based on the detection that a. probable occlusion
exists.
[0483] To determine whether an occlusion is possible or probable, the
ambulatory
medicament pump 4500 may undertake one or more of a variety of actions. For
example, the
system may be configured to detect one or more fluid delivery parameters
associated with the
medicament delivery system. The fluid delivery parameter can include an
electrical parameter,
such as a current supplied by the pump motor 4508, an electrical resistance
associated with the
pump motor 4508, or a voltage associated with the pump motor 4508. The fluid
delivery
parameter can include any other detectable parameter, whether via a sensor
(e.g., a pressure
sensor, a flow rate sensor, or the like) or via some other way. For example,
the fluid delivery
parameter can include a fluid flow rate and/or a fluid flow acceleration
through the cannula,
through the medicament reservoir 4502, through the medicament passageway 4506,
through the
medicament delivery interface 4504, or through some other portion of the
ambulatory
medicament pump 4500 or of the medicament delivery system. The fluid delivery
parameter
can include a pressure on the pump motor 4508, on the medicament reservoir
4502, on the
medicament passageway 4506, on the medicament delivery interface 4504, or on
some other
component or components of the medicament delivery system. In some cases, the
pressure on
or inside any components of the medicament delivery system may be obtained by
a pressure
sensor (e.g., a pressure sensor integrated with the component). For example,
the acceptable
pressure within the ambulatory medicament pump 4500 may be around 2-3 pounds
per square
inch (psi), and the fluid delivery parameter may be a pressure threshold of
any pressure above a
threshold pressure level (e.g., about 15 psi).
[0484] The ambulatory medicament pump 4500 may determine that a fluid delivery
parameter
satisfies an initial occlusion condition. The first initial occlusion
condition may indicate that a
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possible occlusion exists that interferes with delivery via the medicament
delivery system.
Because it may be advantageous to continue the delivery of medicament to the
subject when
only a possible occlusion exists (as opposed to a probable occlusion), in
response to the
determination that the fluid delivery parameter satisfies the initial
occlusion condition, the
ambulatory medicament pump 4500 can maintain delivery of therapy to the
subject.
Maintaining delivery of therapy can include providing therapy at the same rate
as prior to the
determination that the initial fluid delivery parameter satisfies the initial
occlusion condition. In
some embodiments, maintaining delivery may mean providing therapy at a
different rate from
prior to the determination. For example, maintaining delivery may include
providing delivery
at a different speed (e.g., half speed). In some embodiments, in response to
the determination
that the fluid delivery parameter satisfies the initial occlusion condition,
the ambulatory
medicament pump 4500 may modify an attribute of the delivery of therapy while
maintaining
delivery of the therapy to the subject. For example, the attribute may include
a delivery speed,
a delivery interval, a delivery pressure, or impulse, etc. In some examples,
the ambulatory
medicament pump 4500 can begin injecting the fluid slowly and then inject
quickly to invoke a
jerk. This may be helpful at clearing a possible occlusion. Other examples are
possible. For
example, the ambulatory medicament pump 4500 may pulse the delivery of
delivery of therapy
at regular and/or irregular intervals.
[04851 In some embodiments, maintaining delivery may include slowing delivery
and then
suddenly pushing hard (e.g., to invoke a jerk). Invoking a jerk may be helpful
in dislodging a
cause of the occlusion (e.g., a jammed piece of sand or other debris). In some
embodiments, the
ambulatory medicament pump 4500 may delivery the therapy slowly or faster in
an attempt to
clear the occlusion. In some embodiments, the ambulatory medicament pump 4500
may modify
(e.g., reduce) the pressure within the ambulatory medicament pump 4500 and/or
related system
parts. In response to the determination that the fluid delivery parameter
satisfies the initial
occlusion condition, the ambulatory medicament pump 4500 may pause delivery of
therapy for
a length of time. The length of time of the pause may be at least about 1
second, at least about 2
seconds, at least about 3 seconds, at least about 5 seconds, at least about 10
seconds, at least
about 15 seconds, at least about 30 seconds, at least about 1 minute, or any
length of time
therebetween or fall within a range of any time having endpoints therein. In
some
embodiments, in response to the determination that the verification parameter
satisfies the final
occlusion condition, the ambulatory medicament pump 4500 may increase delivery
of therapy
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to the subject after a passage of an amount of time. The amount of time may be
about 10
seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 1 minute,
at least about 2
minutes, about 3 minutes, about 5 minutes, or any amount of time therebetween
or fall within a
range of any time having endpoints therein.
[0486] The ambulatory medicament pump 4500 may be configured to receive a
verification
parameter associated with the possible occlusion. The verification parameter
can serve as a way
for the ambulatory medicament pump 4500 to determine whether the possible
occlusion is
actually a probable occlusion. The verification parameter may be a separate
indication that
tends to confirm the existence of the occlusion. For example, the verification
parameter may be
received from a glucose detector operatively coupled to the ambulatory
medicament pump
4500. The verification parameter can include a glucose level signal received
from the glucose
sensor configured to detect a glucose level of the subject. The glucose level
signal can include
one or more glucose parameters, such as a glucose level of the subject and/or
an indication of a
glucose trend indicating at least a predicted change in the glucose level of
the subject.
Additionally or alternatively, the verification parameter can include an
amount of time before
receiving another indication of the status of the possible occlusion. For
example, the
ambulatory medicament pump 4500 may wait about 10 seconds, about 30 seconds,
about I
minute, about 2 minutes, about 5 minutes, about 10 minutes, about 15 minutes,
about 30
minutes, about 45 minutes, about an hour, about 2 hours, about 3 hours, or any
amount of time
therebetween or fall within a range of any time having endpoints therein. In
some
embodiments, the verification parameter can include a result from an action
taken by the
ambulatory medicament pump 4500 in an attempt to further diagnose or otherwise
characterize
a possible occlusion (e.g., to support a determination that it is a probable
conclusion). Such an
action may include supplying a sudden increase in pressure by the pump motor
4508 or other
action.
[0487] The ambulatory medicament pump 4500 may determine that the verification
parameter satisfies a final occlusion condition. If the verification parameter
supports the
inference toward a probable occlusion, then this may suggest that the final
occlusion condition
is satisfied. The final occlusion condition indicates that a probable
occlusion exists in the
medicament delivery system. The final occlusion condition includes a glucose
level indicating
a threshold value of at least 150 mg/dIa of blood glucose concentration. Other
values are
possible. The initial occlusion condition and the final occlusion condition
can be based on
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different parameters. For example, the initial occlusion condition may be
based on a current
drawn by the pump motor 4508 while the final occlusion condition may be based
on a glucose
level signal of the subject. Other combinations are possible,
[0488] In response to the determination that the verification parameter
satisfies the final
occlusion condition, the ambulatory medicament pump 4500 can modify (e.g.,
reduce) delivery
of therapy to the subject. The modification of therapy may include providing
less than the
amount of therapy delivered during the maintaining of therapy. For example,
the modification
of therapy can include reducing and/or essentially stopping the delivery of
therapy. The
stopping of delivery may be temporary. In some examples, after stopping or
reducing delivery
for an amount of time (e.g., about 10 seconds, about 30 seconds, about 1
minute, etc.), the
ambulatory medicament pump 4500 may increase delivery of therapy to the
subject after a
passage of an amount of time. Because of the pause in therapy, in some
examples the
ambulatory medicament pump 4500 will increase delivery, at least temporarily,
at a greater rate
than the rate prior to the pause.
[0489] The ambulatory medicament pump 4500 can further generate a first user
alert based at
least in part on the determination that the fluid delivery parameter satisfies
the initial occlusion
condition. Additionally or alternatively, the ambulatory medicament pump 4500
can generate a
second user alert based at least in part on the determination that the
verification parameter
satisfies the final occlusion condition. The first and/or second user alert
can be displayed via
the user interface. The first and/or second user alerts can be a sensory
alert, such as a visual,
tactile, aural, or other sensory alert. The sensory alert may be an annoying
and/or loud tone or
voice, audible alarm, phone call, and/or other kind of sensory alarm. The
second user alert may
be provided to the subject receiving the therapy and/or another person or
persons. The second
user alert may be configured to wake a sleeping subject and/or caregiver.
[0490] In some embodiments, the ambulatory medicament pump 4500 may identify
an
intermediate occlusion condition and that the fluid delivery parameter
satisfies the intermediate
occlusion condition. In some cases, the intermediate occlusion condition may
be satisfied after
the determination of the initial occlusion condition. The ambulatory
medicament pump 4500
can determine that the fluid delivery parameter satisfies an intermediate
occlusion condition,
wherein the intermediate occlusion condition indicates that the possible
occlusion persists. In
response to the determination that the fluid delivery parameter satisfies the
intermediate
occlusion condition, the ambulatory medicament pump 4500 may modify an
attribute of the
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delivery of therapy. The attribute of the delivery of therapy that is modified
may include a rate
of delivery and/or a size of a bolus of therapy. The attribute may include a
delivery speed, a
delivery interval, a delivery pressure, or impulse, etc. The ambulatory
medicament pump 4500
may modify the attribute of the delivery of therapy in. order to invoke a jerk
or to otherwise
address a potential occlusion. In some examples, the attribute may relate to
an action taken by
the ambulatory medicament pump 4500 in an attempt to further diagnose or
otherwise
characterize a possible occlusion (e.g., to support a determination that it is
a probable
conclusion),
[0491] Some embodiments of an occlusion detection system are described with
reference to
FIG-, 45B. FIG. 453 is a schematic illustrating an example occlusion detection
system 4514.
The occlusion detection system 4514 can include a non-transitory memory 4516,
an electronic
hardware processor 4518, and a user interface 4520. The user interface 4520
may include an
interactive graphical user interface, such as a smartphone or another mobile
device.
[0492] The processor 4518 may execute instructions stored on the memory 4516
to perform
various functions. The occlusion detection system 4514 can receive a fluid
delivery parameter
associated with a medicament delivery system. The medicament delivery system
may include
an ambulatory medicament pump (e.g., the ambulatory medicament pump 4500)
and/or other
medicament delivery system components, such as describe above. The fluid
delivery parameter
may be the fluid delivery parameter described above. The occlusion detection
system 4514 can
determine that the fluid delivery parameter satisfies an initial occlusion
condition. The initial
occlusion condition may indicate that a possible occlusion exists in the
medicament delivery
system. The occlusion detection system 4514 can send an instruction to the
medicament
delivery system to maintain delivery of therapy to the subject in response to
the determination
that the fluid delivery parameter satisfies the initial occlusion condition.
Additionally or
alternatively, the occlusion detection system 4514 may generate a user alert
based at least in
part on the determination that the fluid delivery parameter satisfies the
initial occlusion
condition. The user alert may be generated via the user interface 4520.
104931 The occlusion detection system 4514 can also receive a verification
parameter
associated with the possible occlusion. The occlusion detection system 4514
can then determine
that the verification parameter satisfies a final occlusion condition. The
final occlusion
condition can indicate that a probable occlusion exists in the medicament
delivery system. The
occlusion detection system 4514 can. send an instruction to the medicament
delivery system to
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modify (e.g., reduce) delivery of therapy to the subject in response to the
determination that the
verification parameter satisfies the final occlusion condition. The occlusion
detection system
4514 can generate a user alert based at least in part on the determination
that the verification
parameter satisfies the final occlusion condition.
[0494] FIG. 46A. and FIG, 46B show methods for determining possible and/or
probable
occlusions. FIG. 46A is a flow chart flow diagram illustratin.g an example
method 4600 that
may be used by an ambulatory medical device to maintain delivery of therapy to
a subject after
determining that a possible occlusion exists in a medicament delivery system.
The method 4600
may be performed by a system. such as a medicament delivery system including
the ambulatory
medicament pump 4500. At block 4602, the system detects a fluid delivery
parameter
associated with the medicament delivery system. At block 4604, the system
determines that the
fluid delivery parameter satisfies an initial occlusion condition. The initial
occlusion condition
can indicate that a possible occlusion exists. At block 4606, the system
maintains delivery of
therapy to the subject in response to the determination that the fluid
delivery parameter satisfies
the initial occlusion condition. At block 4608, the system receives a
verification parameter
associated with the possible occlusion. At block 4610, the system determines
that the
verification parameter satisfies a final occlusion condition. The final
occlusion condition
indicates that a probable occlusion exists in the medicament delivery system.
At block 4612,
the system may modify (e.g., reduce) delivery of therapy to the subject. The
modification of
therapy may be based on the determination that the verification parameter
satisfies the final
occlusion condition.
[0495] FIG. 46B is a flow chart flow diagram illustrating an example method
4614 that may
be used by an occlusion detection system to maintain delivery of therapy to a
subject after
determining that a possible occlusion exists in a medicament delivery system.
The method 4614
may be performed by a system such as an occlusion detection system such as the
occlusion
detection system 4514. At block 4616, the system receives a fluid delivery
parameter
associated with a medicament delivery system. At block 4618, the system
determines that the
fluid delivery parameter satisfies an initial occlusion condition. The initial
occlusion condition
can indicate that a possible occlusion exists. At block 4620, the system sends
an instruction to
the medicament delivery system to maintain delivery of therapy to the subject
in response to
the determination that the fluid delivery parameter satisfies the initial
occlusion condition. At
block 4622, the system receives a verification parameter associated with the
possible occlusion.
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At block 4624, the system determines that the verification parameter satisfies
a final occlusion
condition. The final occlusion condition indicates that a probable occlusion
exists in the
medicament delivery system.. At block 4626, the system may send an instruction
to the
medicament delivery system to modify (e.g., reduce) delivery of therapy to the
subject. The
modification of therapy may be based on the determination that the
verification parameter
satisfies the final occlusion condition.
Example AMD with Alarm Muting
[0496] Alert fatigue can be an issue with medical devices due to excessive
alerts which do not
necessarily require user interaction. In many cases, an alarm condition may
occur that does not
require immediate user attention or may only be resolved by the manufacturer
of the AMD.
Persistent annunciation of such alarms may cause alert fatigue, which can be
dangerous
because it can lead users to ignore all alerts, including serious alerts or
alerts that require action
in the short term. Advantageously, the disclosed alarm system and methods may
implement a
Do Not Disturb mode which users may activate to mute non-urgent alarms. The
system and
methods described herein can suppress lower urgency alarms during user
selected periods. The
user-selected periods can include times when a user is sleeping or in a
meeting. These periods
of Do Not Disturb activation and deactivation can be controlled by the user.
The system and
methods can also provide for automatic or user preselected/scheduled
activation of the Do Not
Disturb mode during recurring time periods or intervals, such as during the
night when the user
is sleeping, with the Do Not Disturb mode being activated by the system during
the recurring
time period or interval. In some cases, a recurring time interval may include
a time interval
occurring every day (e.g., every day between 18:00 and 7:00, or between 20:00
and 6:00, or
other time intervals.)
[0497] in some cases, lower urgency alarms may include at least alarms with
severity levels 0,
1, 2, and 3, as disclosed herein. Higher urgency alarms (e.g., severity levels
3, 4, 5, etc.) may
not be muted, both during usual operation of the AMD and when Do Not Disturb
mode is
activated. In some cases, the user may define which severity levels are to be
considered urgent
in a Do Not Disturb session. It should be noted that severity level alone may
not be enough to
determine whether an alarm may be muted. in some cases, one severity level may
encompass
both mute-eligible and mute-ineligible alarms. For example, in some cases,
only some level 3
alarms may be muted. In such cases, when Do Not Disturb mode is activated,
only the mute-
eligible level 3 alarms may be muted during Do Not Disturb mode, while the
mute-ineligible
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alarms will be annunciated as urgent alarms. In some cases, mute-eligible
level 3 alarms may
include the level 2.5 alarms as described herein.
[0498] It should be noted that the alarm muting processes described herein may
mute but not
postpone detected alarm conditions. Though auditory and haptic annunciations
may be muted,
details relating to each detected alarm condition may be displayed on a list
of pending alarm
conditions in real time and can be viewed by the user at any time. U.S. Patent
No. 11,135,364
disclosing alarm status indication is incorporated by reference herein and
made a part of this
specification.
[0499] FIG. 47 shows a flow diagram illustrating an example procedure that may
be used by
the alarm system of an AMD to mute non-urgent alarm conditions or in
annunciating alarms.
The process 4700 begins at block 4702, when the device receives a request to
activate alarm
muting, or Do Not Disturb mode. As used herein, alarm muting may include
activation of the
Do Not Disturb mode and vice versa. For example, the request to activate Do
Not Disturb mode
may include alarm muting instructions. As described herein, alarm muting or
alarm muting
instructions may include silencing auditory and/or haptic annunciation of
alarms while
maintaining visual annunciation of the alarm condition (e.g. displaying the
alarm condition on a
list of pending alarm conditions). In some cases, the do not disturb mode of
the ambulatory
medicament device may be activated in response to determining that alarm
annunciation should
be muted in accordance with the alarm muting instructions. In some such cases,
at least some
alarm annunciation patterns may not be aurally or haptically annunciated.
105001 As described herein, a user may input various parameters as part of the
alarm muting
instructions when activating Do Not Disturb mode. In some cases, the user may
define a start
and end time between which alarm muting is to remain activated. In some cases,
the user may
define a length of time over which alarm muting is to remain activated. In
some other cases, the
user may set alarm muting to recur at regular intervals or time intervals,
such as every night
during a time frame the subject is typically asleep. If the defined Do Not
Disturb period does
not begin immediately, the system may annunciate alarms on an accelerated
schedule prior to
activation of Do Not Disturb mode. For example, snoozed alarms may have alarm
reminders
that are annunciated at regular or predetermined intervals until the alarm is
resolved. In such
cases, if a reminder annunciation is scheduled to annunciate during the Do Not
Disturb period
(e.g., user scheduled Do Not Disturb period), the system may annunciate the
reminder for the
unresolved alarm prior to the activation time of Do Not Disturb mode. In some
cases, the user
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may select which alarms to mute when activating Do Not Disturb mode. In some
cases, Do Not
Disturb mode may be activated with a default selection of alarms to be muted.
In some cases,
alarm muting instructions may include a recurring time interval indicating a
time interval
during which the do not disturb mode may be activated. In some examples, the
recurring time
interval may include a time interval (e.g., time between a start and an end
time) occurring
periodically (e.g., every day).
[0501] In response to the request, at block 4704, the system may activate
alarm muting in
accordance with the specified alarm muting instructions. At decision block
4706, the system
may check whether a request to deactivate Do Not Disturb mode has been
received, A request
to deactivate Do Not Disturb mode may be created manually by the user or may
be created
automatically by the system. For example, if the defined period lapses for a
Do Not Disturb
session, the system may automatically request to deactivate Do Not Disturb
mode. In some
cases, the user may manually terminate a Do Not Disturb session prior to the
scheduled
deactivation time, as described herein in relation to FIG. 51., In such cases,
the system may
receive a deactivation request when the user cancels the current Do Not
Disturb session. If a
request to deactivate Do Not Disturb mode has been received, the process 4700
may proceed to
block 4718. If a request to deactivate Do Not Disturb mode has not been
received, Do Not
Disturb mode remains active and the process 4700 may proceed to block 4708.
[0502] At block 4708, the system may detect an alarm condition. At decision
block 4710, the
system may determine whether the detected alarm condition is an urgent alarm
condition
requiring urgent user attention in the short term. In some cases, determining
whether the alarm
condition is urgent may include comparing the severity level of the alarm
condition against a
threshold severity level. If the severity level of the alarm condition exceeds
the defined
threshold severity level, the alarm condition may be considered an urgent
alarm requiring
urgent user attention. In some cases, the threshold severity level may be
predetermined. In
other cases, the threshold severity level may be defined by the user as part
of the alarm muting
instructions. Further details relating to determining alarm urgency is
described herein in
relation to blocks 4810 and 4812 of FIG. 48.
[0503] If the alarm condition is determined to be urgent, the process 4700
continues to blocks
4712 and 4714, and the alarm condition may be displayed on a list of pending
alarm conditions
5200 (FIG. 52) and annunciated in real time. After block 4714, the system may
loop back or
return to decision block 4706,
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[0504] The system may maintain an indication of the alarm condition on the
list of pending
alarm conditions 5200 until the alarm condition is resolved. In some cases,
the list of pending
alarm conditions may be an alarm manager list, and the user may interact with
each listed alarm
condition to view alarm details, acknowledge the alarm, snooze the alarm, or
otherwise resolve
the alarm. If the alarm condition is determined not to be urgent, the process
4700 proceeds to
block 4716, where the alarm condition is added to the alarm manager list, or
list of pending
alarm conditions, and the auditory and haptic annunciation associated with the
alarm condition
is muted. After block 4716, the system may loop back or return to decision
block 4706.
[0505] While Do Not Disturb mode is activated, all alarms may continue to be
raised, but
auditory and haptic annunciation of some alarms may be muted. Raised alarms
may be added to
the alarm manager list at the time of detection and displayed on a user
interface until the
condition that caused the alarm is resolved. Thus, although an alarm condition
may not have an
auditory or haptic alert, the user may still view the alarm condition
information and resolve the
alarm condition. Resolving the alarm condition may include, but is not limited
to, the user
taking action to correct the condition that caused the alarm, the user
acknowledging the alarm,
the user snoozing the alarm, or the device no longer detecting the alarm
condition (e.g., low
blood glucose condition is no longer present).
[0506] At block 4718, Do Not Disturb mode may be deactivated. As described
herein, Do Not
Disturb mode may terminate automatically (e.g. the defined time period in the
alarm muting
instructions has lapsed) or may be manually deactivated. The user may override
Do Not Disturb
mode by manually cancelling Do Not Disturb mode at any point while alarm
muting is
activated. In sonic cases, the user may override a current Do Not Disturb
session by inputting
new alarm muting instructions. At block 4720, the system may annunciate the
most severe
alarm condition from the list of pending alarm conditions that has not yet
been annunciated.
The most severe alarm condition may be associated with the highest severity
level of the non-
urgent alarms on the list of pending alarm conditions. The other alarm
conditions on the list
may remain muted but may continue to be displayed on the list until the alarm
conditions are
resolved. Previously annunciated alarms (e.g. urgent alarm conditions) may not
be annunciated
again in response to deactivation of Do Not Disturb mode.
[0507] in an example application of the process described in FIG. 47, the
system may detect a
first alarm condition, a second alarm condition, and a third alarm condition
while in Do Not
Disturb mode. The system may first detect the first alarm condition at block
4708. At decision
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block 4710, the system may determine that the first alarm condition is an
urgent alarm
condition. As such, the first alarm condition may be both added to the list of
pending alarm
conditions and annunciated in real time, according to blocks 4712 and 1714.
The system may
then return or loop back to decision block 4706, Do Not Disturb mode may
remain active if the
system does not receive a request to deactivate alarm muting. Without
deactivating Do Not
Disturb mode, then, the system may detect the second alarm condition. At
decision block 4710,
the system may determine that the second alarm condition is not an urgent
alarm condition.
Thus, the second alarm condition may be added to the list of pending alarm
conditions without
auditory or haptic annunciation, according to block 4716, Returning again to
decision block
4706, Do Not Disturb mode may remain active if the system does not receive a
request to
deactivate alarm muting. Continuing to block 4708 without deactivating Do Not
Disturb mode,
the system may detect the third alarm condition. At decision block 4710, the
system may
determine that the third alarm condition is also a non-urgent alarm condition.
The third alarm
condition may have a severity level lower than the second alarm condition. At
block 4716, the
third alarm condition may be added to the list of pending alarm conditions
without auditory or
haptic annunciation. Returning or looping back to block 4706, the system may
then receive a
request to deactivate Do Not Disturb mode. The system may then deactivate Do
Not Disturb
mode, at block 4718. In response to the deactivation of Do Not Disturb mode,
the system may
annunciate the muted alarm with the highest severity level, at block 4720. In
this example, the
system would annunciate the second alarm condition, since the first alarm
condition was
already annunciated as an urgent alarm and the third alarm condition has a
lower severity level.
[0508] in some cases, the system may deactivate the Do Not Disturb mode upon
or in
connection with annunciating the above first alarm condition, as discussed
further below.
[0509] FIG. 48 is a flow diagram illustrating another example procedure in
annunciating
alarms or activating a Do Not Disturb mode in an AMD. The process 4800 begins
at block
4802, when the system receives a request to activate Do Not Disturb mode. In
response to the
request, the system may activate Do Not Disturb mode at block 4804. At
decision block 4806,
the system may determine whether a request to deactivate Do Not Disturb mode
has been
received. The process at blocks 4802, 4804, and 4806 may proceed according to
the disclosure
related to blocks 4702, 4704, and 4706 of FIG. 47. If a request to deactivate
Do Not Disturb
mode has been received, the process 4800 may proceed to block 4826. If a
request to deactivate
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Do Not Disturb mode has not been received, Do Not Disturb mode remains active
and the
process 4800 may proceed to block 4808.
[0510] At block 4810, the system may determine a severity level of the alarm
condition, The
severity level may be based on the underlying fault of the alarm condition.
For example, a low
battery warning may be assigned a low severity level (e.g. level 1), while an
extremely low
blood glucose measurement may be assigned a high severity level (e.g. level
5). At decision
block 4812, the system may determine whether the severity level of the first
alarm condition
exceeds a threshold severity level. The threshold severity level may be a
predefined severity
level, which if exceeded, may cause the system to determine that the alarm
condition is an
urgent alarm condition requiring urgent user attention in the short term. In
some cases, the
threshold severity level may be defined by the user as part of the alarm
muting instructions. For
example, the user may want to be immediately alerted of a,n.y alarms that are
level 2 or higher.
If the severity level of the alarm condition exceeds the defined threshold
severity level, then the
alarm condition is considered urgent and the process 4800 proceeds to block
4814. If the
severity level of the alarm condition does not exceed the defined threshold
severity level, the
alarm condition is not considered urgent and the process 4800 proceeds to
decision block 4820.
[0511] In block 4814, the system may automatically deactivate Do Not Disturb
mode in
response to detecting an urgent alarm condition. As described herein, in some
cases, the list of
pending alarm conditions may be arranged in order of severity. In some cases,
the alarm
condition with the highest severity level may be listed at the top of the list
of pending alarm
conditions and the rest of the alarm conditions would be listed in descending
order of severity
level. in blocks 4816 and 4818, the alarm condition may be displayed at the
top of the list of
pending alarm conditions 5200 as the alarm condition with the highest severity
level and
annunciated in real time. In some cases, the system may only annunciate the
urgent alarm
condition upon deactivation of Do Not Disturb mode. In some other cases, the
system may also
annunciate the second alarm on the list of pending alarm conditions (e.g. the
muted alarm
condition with the highest severity level).
105121 At decision block 4820, the system may determine whether the severity
level of the
detected alarm condition exceeds the severity level of the most severe alarm
condition currently
on the list of pending alarm conditions. If the severity level of the detected
alarm condition
exceeds the highest severity level on the list of pending alarm conditions,
the process 4800
proceeds to block 4822, where the alarm condition may be listed at the top of
the list of
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pending alarm conditions. After block 4822, the system may loop back or return
to decision
block 4806.
[0513] If the severity level of the alarm condition does not exceed the
highest severity level
on the list of pending alarm conditions at the time, the process 4800 may
proceed to block
4824, where the alarm condition may be added to the list of pending alarm
conditions in order
of severity level. If the severity level of the detected alarm condition is
equal to the severity
level of one or more other alarm conditions present on the list, the detected
alarm condition
may be added to the list of pending alarm conditions in chronological order
within its severity
level group. After block 4824, the system may loop back or return to decision
block 4806.
[0514] At block 4826, Do Not Disturb mode may be deactivated. As described
herein, Do
Not Disturb mode may terminate naturally (e.g. the defined time period in the
alarm muting
instructions has lapsed) or may be manually deactivated, At block 4828, the
system may
annunciate the first alarm condition from the list of pending alarm conditions
(e.g. the most
severe alarm condition). The other alarm conditions on the list may remain
muted but may
continue to be displayed on the list until the alarm conditions are resolved.
[0515] FIG. 49 is a flow diagram illustrating an example procedure that may be
used by the
system to escalate a non-urgent alarm when Do Not Disturb mode is activated.
The process
4900 begins at block 4902, where the system may activate Do Not Disturb mode.
Do Not
Disturb mode may be activated in response to alarm muting instructions. In
some cases, the
user may manually activate Do Not Disturb mode by inputting alarm muting
instructions for
immediate activation. In some cases, the user may input alarm muting
instructions to schedule a
Do Not Disturb session to begin at a later time. In such cases, the system may
automatically
activate Do Not Disturb mode at the scheduled recurring time. In some cases,
the user may
input alarm muting instructions to schedule recurring sessions and the system
may
automatically activate Do Not Disturb mode for each recurring session.
[0516] At block 4904, the system may detect an alarm condition. At block 4906,
the system
may determine that the alarm condition is not urgent (e.g. does not require
urgent user attention
in the short term). In response to a determination that the alarm condition is
not urgent, the
system may display the alarm condition on a list of pending alarm conditions,
at block 4908.
105171 At decision block 4910, the system may determine whether the time
elapsed from the
detection of the alarm condition has exceeded a threshold amount of time. In
some cases, the
threshold amount of time may be predetermined by the system. In some other
cases, the
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threshold amount of time may be defined by the user as part of the alarm
muting instructions or
through AMID settings. If the time elapsed since the detection of the alarm
condition has not
exceeded the threshold amount of time, the process 4900 may return to block
4908 and the
system may maintain the alarm condition on the list of pending alarm
conditions. In some
cases, maintaining the alarm condition on the list of pending. alarm
conditions may include
maintaining the order in which the alarm condition is displayed on the list.
In some cases,
maintaining the alarm condition on the list of pending alarm conditions may
include
maintaining the alarm condition details but adjusting the order of the alarm
condition as later
alarms are added to the list.
[0518] if the time elapsed since the detection of the alarm condition. exceeds
the threshold
amount of time, the process 4900 may proceed to block 4912 and the alarm
condition may be
escalated. Escalating an alarm condition may include increasing the severity
level of the alarm
condition (e.g. increasing the severity level of the alarm condition from
level 2 to level 3). It
should be noted that the alarm condition may be escalated by more than one
severity level at a
time (e.g. increasing the severity level of the alarm condition from level 1
to level 4 or starting
from any level (e.g., level 0) to be escalated to any other level (e.g., level
5)).
[0519] At decision block 4914, the system may determine whether the alarm
condition at the
new severity level is urgent. If the escalated alarm condition is not urgent,
the process 4900
may loop or return to block 4908 and maintain the alarm condition display as
disclosed herein.
If the escalated alarm condition is urgent, the process 4900 may proceed to
block 4916 and the
alarm condition may be annunciated. For example, if a level 2 alarm is
considered non-urgent,
it may be muted when the alarm condition is first detected. However, if the
alarm condition has
not been resolved after a period of time, the system may escalate the alarm
condition from level
2 to level 3. If level 3 alarms are considered urgent alarms requiring urgent
user attention, then
the alarm condition may be annunciated upon escalation. If level 3 alarms are
also considered
not urgent, then the alarm condition may remain muted.
[0520] FIG. 50 is an illustration of a plurality of screens 5000 that may be
displayed on a
touch screen display of an AMID for activating alarm muting (Do Not Disturb
Mode) on the
AMD. As illustrated, a home screen 5004 may include a menu icon 5002, an alarm
status icon
5006, and a pump operation field 5020. The pump operation field 5020 may be
automatically
updated at regular intervals to show high level subject information. The alarm
status icon 5006,
in this exemplary embodiment, may be shaped as an alarm bell. The alarm status
icon 5006
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may be updated to provide high level information about alarm conditions of the
AMD. In some
cases, the alarm status icon 5006 may be an alarm bell with a counter in the
middle indicating
the number of annunciated alarms. In some cases, if there are no detected
alarm conditions, the
alarm status icon 5006 may display "0" or may not display any number or text.
In some other
cases, the alarm status icon 5006 may be updated with "zzz" or other visual
cues to indicate
that alarm muting, or Do Not Disturb (DND) mode, is activated. In some other
cases, the alarm
status icon 5006 may be in a shape of a crescent moon to indicate that alarm
muting is
activated. In yet other cases, the alarm status icon 5006 may not be a
displayed icon. In such
cases, alarm status may be indicated by other form.s of notification, such as,
but not limited to,
auditory, haptic, or visual cues (e.g. a light on the device that flashes when
alarm conditions are
detected). Selecting the alarm status icon 5006 tnay provide the user with
access to the list of
pending alarm conditions 5200 (see FIG. 52). The menu icon 5002, when
selected, may display
a menu screen. 5008 through which the user may control operation of the A.MD.
The menu
screen 5008 may include an alarm muting button 5010. In some cases, the alarm
muting button
5010 may be shaped as an alarm bell with "zzz" to represent that the alarm
alerts are silenced
or snoozed.
[0521] Selecting the alarm muting button 5010 may display a Do Not Disturb
(DND) setup
screen 5012. The DND setup screen 5012 may display an alarm muting control
interface
through which the user may input alarm muting instructions (e.g. defining a
time frame for the
Do Not Disturb session). The alarm muting control interface may be controlled
via touchscreen
controller. In some cases, the alarm muting control interface may be a
dropdown or scroll.
through menu from which the user may select a length of time for which to
activate alarm
muting, as illustrated in FIG. 50. In some cases, the alarm muting control
interface may be a
time wheel, and the user may rotate the wheel to increase or decrease the
length of time for
which to activate alarm muting. In some cases, the alarm muting control
interface may include
one or more text boxes in which the user may enter the amount of time for
which to activate
alarm muting. In some cases, the alarm muting control interface may list time
periods at regular
increments, such as 15-minutes increments, 30-minutes increments, I-hour
increments, 2-hour
increments, or the like. In some other cases, the alarm muting control
interface may allow users
to input a start time and an end time for the Do Not Disturb session, rather
than inputting a
length of time. The start time can be in the future to allow the user to plan
or schedule a Do Not
Disturb session. In yet other cases, the alarm muting control interface may
have additional
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features to define recurring Do Not Disturb sessions. Once the user has input
the alarm muting
instructions, the user may select the Start button 5014. If Do Not Disturb
mode is set to begin
immediately, selection of the Start button 5014 will cause the system to
display a confirmation
page 5016 to inform the user that Do Not Disturb mode was activated. If Do Not
Disturb mode
is set to begin after a period of time, the confirmation page 5016 may display
Do Not Disturb
confirmation information, including, but not limited to, recurrence
information, defined start
time, defined end time, and total alarm muting time. For subject privacy,
after a period of
inactivity, the system may automatically lock the AMD and display a lock
screen 5018.
[0522] For subject safety, the system may include limitations on the
permissible length of
time over which alarms may be muted. In some cases, the system may include
limitations on
the number of consecutive hours or the total number of hours alarm muting is
activated within a
day, within a week, or other timeframe. For example, the user may be able to
activate Do Not
Disturb mode up to a typica.1 sleeping time but substantially less than a day.
In some cases, the
system may allow longer periods of Do Not Disturb based on safe access level.
Accordingly,
the system may monitor the number of hours that Do Not Disturb has been
active. Some a.larms
may include one set of limitations while other alarms may have a different set
of limitations,
including depending on the number of hours that Do Not Disturb has been
active. In some
cases, some types of alarms (e.g., audio annunciation) may be silenced, while
other alarms
haptic annunciation) may not be silenced. In some cases, the user may define
which types
of alarms are to be silenced.
[0523] As disclosed herein, Do Not Disturb mode may mute but not postpone
detected alarm
conditions. Though auditory and ha.ptic annunciations may be muted, the list
of pending alarm
conditions 5200 may be updated in real time and can be viewed by the user at
any time.
[05241 FIG. 51 is an illustration of a plurality of screens 5100 that may be
displayed on a
touch screen display of an AMD for deactivating alarm muting, or Do Not
Disturb mode, on the
AMD. As described herein, the home screen 5004 may include a menu icon 5002,
an alarm
status icon 5006, and a pump operation field 5020. As illustrated, the alarm
status icon 5006
may be the shape of an alarm bell with "zzz" or other text to indicate that
alarm muting is
activated. As described herein, the menu icon 5002, when selected, may display
a menu screen
5008 through which the user may control the AMID. The menu screen 5008 may
include an
alarm muting button 5010. Selecting the alarm muting button 5010 may display
the alarm
muting control interface. In some cases, while alarm muting is activated, the
alarm muting
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control interface may be updated to show a Do Not Disturb setting screen 5104.
In some cases,
the setting screen 5104 may show the time that the active Do Not Disturb
session will expire. If
the user changes the display time of the device, the remaining duration of the
Do Not Disturb
period may be maintained such that the end time is updated with the new device
display time.
Alternatively, or in addition, the setting screen 5104 may show how much
longer the Do Not
Disturb mode is set to last. A.s described herein, the user may override Do
Not Disturb mode by
manually cancelling Do Not Disturb mode at any point while alarm muting is
activated. The
setting screen 5104 may include a Cancel button 5106. Selecting the Cancel
button 5106 tnay
cause the system to deactivate alarm muting and display a cancellation
confirmation page 5102.
For subject privacy, after a period of inactivity, the system may
automatically lock the AMD
and display the lock screen 5018.
[0525] In some cases, the Do Not Disturb setting screen 5104 may include
additional options
to change the current alarm muting settings. The user may override the
existing alarm muting
settings by inputting new alarm muting instructions. Submitting new alarm
muting instructions
may terminate the existing session. The newly defined alarm muting
instruction.s may override
the existing Do Not Disturb parameters and begin a Do Not Disturb mode session
in
accordance with the newly defined alarm muting instructions, such that the new
Do Not Disturb
session does not add onto the currently defined period. In sonic cases, the
system may not have
a limit on the number of times which the user can initiate Do Not Disturb. For
subject privacy,
after a period of inactivity, the system may automatically lock the AMD and
display the lock
screen 5018.
[0526] FIG. 52 shows an example list of pending alarm conditions 5200 when Do
Not Disturb
mode is not activated. The list of pending alarm conditions 5200 may include
an alarm
notification icon 5202. As illustrated, the alarm notification icon 5202 may
be in the shape of
an alarm bell. In some cases, the alarm notification icon 5202 may be any
shape that matches
the alarm status icon 5006 displayed on the home screen 5004. In some cases,
the alarm
notification icon 5202 may be displayed when one or more alarm conditions have
been detected
without otherwise being displayed when no alarm conditions have been detected.
The list of
pending alarm conditions 5200 may display information regarding the alarm
conditions,
including, but not limited to alarm condition description., cause of alarm
condition, and date
and time of alarm condition. Each alarm condition may have an associated alarm
status
indicator 5204, 5206. The alarm status indicator 5204, 5206 may be updated to
reflect various
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annunciation patterns, For example, as illustrated, an exclamation mark in a
triangle may
represent an urgent annunciation pattern. As illustrated, an exclamation mark
in a circle may
represent a non-urgent annunciation pattern. In. some cases, low level alarm
conditions may be
represented by a letter "i" to indicate a notification-only or informational
alarm condition. In
some cases, urgent alarm conditions may be represented by multiple exclamation
marks in a.
triangle or circle. Each alarm condition in the list of pending alarm
conditions 5200 may be
selected to view further details about the alarm and to resolve the alarm. In
some cases, an
alarm status indicators, may indicate whether an alarm condition was
annunciated or muted.
[0527] In some examples, urgent alarms may not be muted or snoozed, even when
Do Not
Disturb mode is activated. In such cases, the alarm status indicator 5204 for
urgent alarms may
not change as Do Not Disturb mode is activated and deactivated. In some
examples, non-urgent
alarms may be muted or snoozed, either manually by the user or automatically
as defined by
alarm muting instructions during a Do Not Disturb session. In such cases, the
alarm status
indicator 5206 for non-urgent alarms may be updated to represent that the
alarm condition has
been muted or snoozed (FIG, 53A and FIG. 54A).
[0528] In some examples, the user may view an alarm using a user interface
provided on a
touchscreen display, both when the display is locked and when the display is
unlocked. FIG.
53A and FIG. 53B are illustrations of such a user interface for accessing the
alarm notifications
screen when the display is locked. As illustrated, the home screen 5004 may
include a lock
status icon 5302, an alarm status icon 5006, and a pump operation field 5020.
The lock status
icon 5302, as illustrated, may be in the shape of a padlock when the A.MD is
locked. In some
cases, the lock status icon 5302 may be updated when the AMID is unlocked. For
example, the
lock status icon 5302 may be changed to the shape of an open padlock or
replaced with the
menu icon 5002 when the device is unlocked. If there are existing alarm
conditions, the alarm
notification icon 5202 may also be displayed on the interface.
105291 FIG. 53A illustrates the user interface when there are detected alarm
conditions. The
alarm status icon 5006 may display the number of detected alarm conditions.
The user may
view the list of pending alarm conditions 5200 without unlocking the
interface. Thus, for
example, if the user selects the alarm status icon 5006 while there are
existing alarms in the
system, the list of pending alarm conditions 5200 may appear. However, the
user may not be
able to select the alarms (e.g., to see more information or interact with the
alarms) because the
device is locked. In such cases, the list of pending alarm conditions 5200 may
include the lock
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status icon 5302. If alarm muting is activated, muted alarms may be associated
with an alarm
status indicator 5206, which may be updated to represent that the alarm was
muted or snoozed
("zz" as illustrated). As described herein, urgent alarms may not be muted
while Do Not
Disturb mode is active, and thus the associated alarm status indicator 5204
for urgent alarms
may remain unchanged. If the alarm muting is deactivated while pending. alarms
are still on the
list of pending alarm conditions 5200, the alarm status indicator 5206 for non-
urgent alarms
may be updated to the usual alarm status indicator associated with the alarm
condition, even if
the alarm alert is not annunciated. For example, as illustrated, the "sensor
expiring soon" alarm
may not be annunciated even when Do Not Disturb mode is deactivated, if the
"battery alarm
24" alarm is a higher-severity non-urgent alarm. Nonetheless, the alarm status
indicator 5206
may be updated to an exclamation point or information symbol as discussed
herein, for
example, with reference to FIG. 51.
[0530] FIG. 53B shows the user interface when there are no detected alarm
conditions. The
alarm status icon 5006 may display "0" or may not display any number when
there are no
pending alarm conditions. In such cases, selecting the alarm status icon 5006
may cause the
system to display the display interface 5304 illustrated. The display
interface 5304 illustrated
may inform the user that there are no alarm conditions. In such cases, because
there are no
alarm conditions, the alarm notification icon 5202 may not be displayed. In
some cases, the
display interface 5304 illustrated may further include information as to
Whether Do Not Disturb
is activated.
[0531] In some examples, if the user unlocks the device, the home screen 5004
illustrated in
FIG. 54A and FIG. 54B may be displayed. FIG. 54A and FIG. 54B are
illustrations of a user
interface for accessing the alarm notifications screen when the display is
unlocked. As
illustrated, the home screen 5004 may include a menu icon 5002, an alarm
status icon 5006,
and a pump operation field 5020. Selecting the menu icon 5002 may allow the
user to update
AMID settings.
[0532] FIG. 54A illustrates the user interface when there are detected alarm
conditions. The
alarm status icon 5006 may display the number of detected alarm conditions.
Selecting the
alarm status icon 5006 may cause the system to display the list of pending
alarm conditions
5200. The user may then access alarm control functions by selecting an alarm
condition of
interest. If alarm muting is activated, muted alarms may be associated with an
alarm status
indicator 5206 for non-urgent alarms, which may be updated to represent that
the alarm was
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muted or snoozed ("zz" as illustrated). A.s described herein, urgent alarms
may not be muted
while Do Not Disturb mode is active, and thus the associated alarm status
indicator 5204 for
urgent alarms may remain unchanged. If the alarm muting is deactivated while
pending alarms
are still on the list of pending alarm conditions 5200, the alarm status
indicator 5206 for non-
urgent alarms may be updated to the usual alarm status indicator associated
with the alarm,
even if the alarm alert is not annunciated. For example, as illustrated, the
"sensor expiring
soon" alarm may not be annunciated even when Do Not Disturb mode is
deactivated, if the
"battery alarm 24" alarm is a higher-severity non-urgent alarm. Nonetheless,
the alarm status
indicator 5206 may be updated to an exclamation point or information symbol as
discussed
herein, for example, with reference to FIG. 51,
[0533] FIG. 54B illustrates the user interface when there are no detected
alarm conditions.
The alarm status icon 5006 may display "0" or may not display any number when
there are no
pending alarm conditions. In such cases, selecting the alarm status icon 5006
may cause the
system to display the display interface 5402 illustrated. The display
interface 5402 illustrated
may inform the user that there are no alarm conditions, In such cases, because
there are no
alarm conditions, the alarm notification icon 5202 may not be displayed. In
some cases, the
display interface 5402 illustrated may further include information as to
whether Do Not Disturb
is activated.
Example AMD with Power Saving Mode
[0534] The AMD may be operated in various modes to extend battery life. The
AMD may
operate in a sleep mode, a low power mode, and/or a power saving mode. It
shall be understood
that the described modes are merely illustrative and that the AMD may be
configured to operate
in other modes not described herein, which may also extend battery life of the
device.
[0535] The AM.D may operate in a power saving mode to save power and minimize
user
disturbances as discussed herein. In some cases, the power saving mode may be
activated by
the user via one or more user inputs or interaction as discussed herein. In
some cases, the
power saving mode can be entered or exited via a wake interface of the AMD as
discussed
herein, in some cases, the power saving mode can be entered or exited via a
tap or other
gestures on the AMD as discussed herein. In some cases, the power saving mode
may be
activated automatically by the AMD after the AMD does not receive one or more
user inputs or
interactions (e.g., via the motion sensor or touchscreen) for a predetermined
amount or period
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of time associated with a period of inactivity of a user not interacting with
the AMD or
providing user input to the AMD.
[0536] In some cases, the AMD may have an always on screen (which can be a
type of user
interface screen) that displays in the power saving mode certain desired or
predetermined status
information, including critical status information, that may be relatively
more important for
quick review during glucose control therapy without having to unlock or wake
the AMD. The
AMD can display the always on screen in the power saving mode. The critical
status
information may be part of the status information received by the AMD via the
monitoring
system interface as discussed herein. The status information can include
device information
pertaining to a condition of the ambulatory medicament device or subject
information
pertaining to a condition of a subject. Advantageously, an always on screen
displaying certain
status information in the power saving mode can allow a user to view the
important or critical
therapy and device information without having to turn on or wake the AMD. The
power saving
mode features discussed herein can reduce the number of times the user fully
wakes the AMID.
[0537] FIG. 55 illustrates an example AMD 5500 with an always on user
interface provided
on a display or touchscreen display 5502 while the AMD 5500 is in the power
saving mode.
The user interface may include certain critical status information as part of
the critical status
information interface screen displayed on the touchscreen display 5502 while
the AMD 5500 is
in the power saving mode. In some cases, while in the power saving mode, the
AMD 5500 may
turn off a backlight used to illuminate the touchscreen display 5502. In some
cases, while in the
power saving mode, the AMD 5500 may cause the touchscreen controller to not
receive or not
respond to user input signals. For example, the AMD 5500 may not respond to
any user inputs
on the touchscreen display 5502 via touching or otherwise motioning on the
touchscreen
display 5502. The touchscreen display 5502 can have a filter configured to
have a
predetermined viewing angle range relative to the touchscreen display such
that information
cannot be seen on the touchscreen when viewed from an angle outside of a
predetermined
viewing angle range relative to the plane of the display. The filter can be
part of the privacy
features of the AMD 5500 (e.g., privacy mode as discussed herein.)
[0538] In some cases, the critical status information interface screen may
display a glucose
level indicator 5504 as a critical status indicator. For example, as
illustrated in FIG. 55, the
glucose level of the subject as discussed herein may be 11.5 mg/dL. The
glucose level indicator
5504 can be considered to be a subject status indicator. The AMD 5500 can
determine whether
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a glucose level of the subject is within a predetermined glucose range and
generate a display of
a glucose interface screen (which may be a type or be part of user interface
screen). The AMID
can display on the touch.screen display 5502 the glucose level indicator via a
glucose interface
screen to prioritize displaying the status information corresponding to the
glucose level not
being within the predetermined glucose range.
[0539] In some cases, the critical status information interface screen may
display a glucose
trend indicator 5506 as a critical status indicator. For example, as
illustrated in FIG. 55, the
arrow may be flat to indicate that the glucose level is stable. In some
instances, an arrow
pointing up may indicate that the glucose level is rising. In some instances,
an arrow pointing
down may indicate that the glucose level is falling. The glucose trend
indicator 5506 can be
considered to be a subject status indicator,
[0540] In some cases, the critical status information interface screen may
display a therapy
status indicator 5508 as a critical status indicator. For example, as
illustrated in FIG, 55, the
therapy status indicator 5508 may be a circle that is animated (e.g.,
rotating) to indicate that the
AMD 5500 is operating and providing glucose control therapy. The therapy
status indicator
5508 may indicate when the delivery of medicament is paused or suspended.
.Another therapy
status indicator may indicate when glucose level is low. The therapy status
indicator 5508 can
be considered to be a medicament device status indicator.
[0541] in some cases, the critical status information interface screen may
display an alarm
status indicator 5510 as a critical status indicator. The alarm status
indicator 5510 can be
considered to be a medicament device status indicator and can also be a type
of alert status
indicator. As illustrated in FIG-. 55, the alarm status indicator 5510 may be
a bell or bell icon.
In some cases, the bell may include a number displayed on the -user interface
within the bell
indicating the number of alarms presently on, for example, the list of pending
alarms. The
alarm status indicator 5510 may be an alarm bell with a counter in the middle
indicating a
count of alarm conditions. In some cases, when there are no detected alarm
conditions, the
alarm status indicator 5510 may display "0" or may not display any number or
text as
illustrated in FIG. 55. In some cases, the alarm status indicator 5510 may not
include a counter
and, instead, a separate alarm state icon may be displayed to indicate the
count of alarm
conditions. In some cases, the alarm status indicator 5510 can include the
alarm state icon such
as the counter being displayed within the alarm status indicator 5510. In some
cases, the alarm
status indicator 5510 may be updated with "zzz" or other visual indicators or
icons to indicate
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that alarm muting, or Do Not Disturb mode, is activated or that one or more
alarms have been
snoozed. In some cases, the alarm status indicator 5510 may be in a shape of a
crescent moon
to indicate that alarm muting is activated.
[0542] In some cases, the critical status information interface screen may
display a remaining
medicament level indicator 5512 as a critical status indicator. For example,
as illustrated in
FIG. 55, the remaining medicament level of, for example, insulin is indicated
to presently be
full (e.g., a solid outline of an insulin cartridge). The medicament level
indicator 5512 can be
considered to be a medicament device status indicator and can also be a type
of alert status
indicator,
[0543] In sotne cases, the critical status information interface screen may
display a battery
level indicator 5514 as a critical status indicator. For example, as
illustrated in FIG. 55, the
battery le),Tel of the AMD 5500 is indicated to presently be at full charge
(e.g., a solid outline of
a battery). The battery level indicator 5514 can be considered to be a
medicament device status
indicator and can also be a type of alert status indicator. In some cases, the
AMID 5500
can determine that a power level of a battery of the AMD 5500 is below a
predetermined power
level threshold and generate a display of a battery status interface (which
may be a type or be
part of user interface screen). The AMD can display on the touchscreen display
5502 a battery
charging indicator on a battery status interface to prioritize displaying the
status information
corresponding to the power level being below the predetermined power level
threshold. The
battery charging indicator may include, but is not limited to, an image of a
battery charger for
the battery of the AMD 5500.
[0544] With continued reference to FIG. 55, the user interface may include
certain other status
information displayed on the touchscreen display 5502 while the AMD is in the
power saving
mode. The status information interface screen may include the critical status
information
interface screen. The indicators 5504, 5506, 5508, 5510, 5512, and/or 5514 may
considered
critical status information relative to other status information such
indicators 5516 and/or 5518.
The critical status information can include other information, icons, and/or
indicators important
or critical for user review while receiving glucose control therapy, including
while in the power
saving mode.
[0545] In some cases, the status information interface screen may display a
lock status
indicator 5516 as a status indicator. For example, as illustrated in FIG. 55,
the lock status icon
is displayed to be locked or closed to indicate that the AMD :5500 is
presently in a locked
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state/mode, including while in a power saving mode. While the AMD 5500 may
exit out of the
locked mode via a wake mode indicator/interface 5520 as discussed herein,
other user
interaction gestures such as tapping may cause the AMD 5500 to exit out of a
locked state,
where for example the lock status indicator 5516 is no longer displayed, The
lock status
indicator 5516 can be considered to be a medicament device status indicator.
The lock status
icon, as illustrated, may be in the shape of a padlock when the AMD 5500 is
locked. In some
cases, the lock status icon may be updated when the AMD 5500 is unlocked. For
example, the
lock status icon may be changed to the shape of an open padlock or replaced
with a menu icon
when the AMD 5500 is unlocked. When there are existing alarm conditions, the
alarm status
indicator 5510 may be updated -to indicate unresolved alarm conditions.
[0546] In some cases, the status information interface screen may display a
wake mode
indicator or message 5518 as a status indicator. For example, as illustrated
in FIG. 55, the wake
mode indicator or message 5518 indicates that user can tap the wake interface
or button 5520 of
the AMD 5500 to wake the screen and/or cause the AMD 5500 to exit the power
saving mode.
Waking the screen can include activating the touchscreen controller such that
the AMD 5500 is
responsive to user input on the touchscreen display. The wake mode
button/interface 5520 can
be considered to be a medicament device status indicator. The wake mode of the
AMD 5500
can be considered a full functionality mode of the AMD 5500 as described
herein, for example,
in reference to paragraphs [0094140108] and [0332[40384] with all functions
including the
touchscreen display fully active and functioning with minimal (e.g., certain
select) or no power
saving features active. The wake mode of the AMD 5500 can include a fully
functioning and
interactive touchscreen display that refreshes at desired rate, such as 60
hertz, and updates that
status icons and indicators at a desired standard rate. In some cases, the
refresh rate of the
touchscreen display can be greater than 60 hertz, such as for example, 120
hertz or greater. The
wake mode of the AMD 5500 can include a fully functioning motion sensor as
discussed
herein.
[0547] The user interface screen may include other wake mode indicator or
message 5518,
that indicate to the user what the wake mode button/interface 5520 is and/or
provides
information for activating the wake mode. When in the wake mode, the user
interacting with
the wake mode button/interface 5520 (e.g., pressing the wake mode
indicator/interface 5520)
can cause the AMD to enter or activate the power saving mode, including low
power mode or
sleep mode as discussed herein. The wake mode indicator or message 5518 may
correspond to
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and indicate the location of the wake interface, may be a message to interact
with the wake
interface to activate the wake mode, or both. The AMD 5500 can generate and
cause to display
a power saving interface screen that includes the wake mode indicator. The
power saving
interface screen can be or be part of the user interface screens discussed
herein. Once in the
wake mode, the AMID 5500 may not display or stop displaying the wake mode
indicator or
message 5518,
[0548] The user may interact with a wake mode button/interface 5520 to create
a wake request
signal to unlock the AMID 5500. In response to the wake request signal, the
AMD 5500 may
deactivate or exit power saving mode. In some cases, when the wake request is
received during
a predefined period of the day, the AMID can turn on or increase the
brightness of the backlight
as part of entering the wake mode. For example, the AMD can turn on or
increase brightness
the backlight between 8 PM and 7 AM (e.g., when it is dark or nighttime) in
response to
receiving a wake request. During other times (e.g., 7 AM to 8 PM), the
backlight can be turned
on or brightness increased by for example holding the wake mode
button/interface 5520 for a
first predetermined period of time (such as 1-2 seconds). By holding the wake
mode
button/interface 5520 for a first predetermined period of time, the A.MD 5500
can turn on or
increase brightness of the backlight to a dimmer state, such as 40-60%
brightness, relative to
maximum brightness. When the user holds the wake interface for a second
predetermined
period of time (such as 2-3 seconds), the A.MD 5500 can turn on or increase
brightness of the
backlight to maximum brightness. The A.MD 5500 can track or count a length of
time that the
user interacts with or presses the wake mode indicator/interface 5520. In the
wake mode, the
AMD may enter or reactivate the power saving mode when the user interacts with
the wake
mode button/interface 5520 as discussed herein.
[0549] The wake mode button/interface 5520 may include, but is not limited to,
a physical
button, a capacitive sensor, or an inductive sensor. In some cases, a wake
button may be
incorporated into the alphanumeric pad 3224. In some cases, the wake interface
may be any one
or more keys of the alphanumeric pad 3224. In some cases, the wake interface
may be a
capacitive button that detects a change in capacitance. The wake interface may
have a
computing component for interpreting and executing instructions from the
signal processing
component. Thus, the wake interface can follow a program that is dictated by
the signal
processing component.
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[0550] In some cases, the AMD 5500 in the power saving mode can refresh,
update, change,
or animate the status information screens, including the critical status
information screens, less
frequently or at a less frequent rate than updating the status interface
screens in a wake
mode. For example, the AMD 5500 can refresh, update, change, or animate the
status
information icons or indicators, including the critical status information
indicators or icons, less
frequently or at a less frequent rate than updating the status information
indicators or icons in a
wake mode. In some cases, certain critical status indicators may be updated at
different
rates. For example, some critical status indicators may be updated at a wake
mode refresh rate,
while other critical status indicator or other status indicators may be
updated at a less frequent
or power saving refresh rate, Certain status information may not be updated in
the power saving
mode. For example, the lock status indicator 5516 may not be updated until the
AMD 5500
changes modes from the power saving mode to the wake mode.
[0551] In some cases, the AMD 5500 in the power saving mode can lower a
refresh rate of the
touchscreen. to a lower refresh level relative to a maximum refresh rate of
touchscreen. The
lower refresh rate in the power saving mode can be for example 0.1, 0.5, 1,
1,5, 2, 2.5 3, 4, 5 or
more hertz. The lower refresh rate in the power saving mode is less than the
refresh rate of in
the wake mode of, for example, 60 hertz. In some cases, the AMD 5500 in the
power saving
mode can lower brightness or dim of the touchscreen display 5502. to a lower
brightness level
relative to a full brightness level of the display. For example, the
brightness may be 5, 10, 15,
20, 25, 30, 40, 50, or 60 % brightness relative to the full brightness of the
touchscreen display
5502.
[0552] In some cases, the AMD 5500 in the power saving mode can lower
brightness or dim a
backlight of the touchscreen display 5502 to a lower illumination level
relative to a maximum
illumination level of the backlight. For example, the brightness may be 5, 10,
15, 20, 25, 30,
40, 50, or 60 % brightness relative to the full brightness of the backlight.
The backlight can
illuminate the touchscreen display 5502 and have an adjustable brightness
separate from the
adjustable brightness of the touchscreen display 5502. While in the power
saving mode, the
AMID 5500 can display the critical status information interface screen while
using, for example,
5-10% additional electric current relative to electric current used with the
display turned off
(e.g., sleep mode as discussed herein) with the AMD 5500 operating (providing
glucose control
therapy). For example, the AMD 5500 can draw an additional 100-200 milliamps
of additional
current (5-10% more) without changes/updates to the screen on top of the 2-4
milliamps that
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the AMD 5500 may draw while delivering glucose control therapy without the
display being
on.
[0553] The combination of the AMD 5500 displaying certain critical status
information, less
frequent update of status indicators/icons, lower refresh rate of the display,
lower brightness of
the display, and/or lower brightness of the backlight (or turning of the
backlight) can be
considered to be a low power mode. For example, in low power mode, the AMD
5500 may
update the display less frequently compared to when in the wake mode. For
example, the AMD
may update the display every 1 minute, every 2 minutes, every 5 minutes, or
more. Between
updates, the display can be a static screen that draws minimal current to stay
on as discussed
herein.
[0554] The low power mode can be a variant of the power saving mode that for
example
allows display of certain critical status information as discussed herein. The
low power mode
can be a type of power saving mode. For example, the power saving mode can
include
displaying certain critical status information with an always on screen as
discussed herein.
When the AMD 5500 functions to achieve additional power savings via lower
frequency
refresh or updates, lower brightness, etc., this can be considered a low power
mode that helps
achieve the lowered 540% additional electric current draw relative to the
display being off.
[0555] When the display (as well as the backlight) is turned off while the AMD
5500
continues to provide glucose control therapy, this can be considered a sleep
mode. The sleep
mode can be a variant of the power saving mode that for example allows for
certain user
interaction such as tapping as discussed herein While the display and
backlight are off. The low
power mode can be a type of power saving mode. The sleep mode can be used
during the day
or at night while the subject sleeps. With the display and backlight off, the
AMD may achiever
further power savings relative to the lower power mode.
105561 in some cases, the AMD 5500 can have a privacy mode. The privacy mode
may be
activated by the user or the AMD 5500 can activate the privacy mode
automatically based on
time of day or geolocation. The user may activate the privacy mode via one or
more user
interface via a menu or icon selection as discussed herein. The AMD 5500 can
generate
a privacy mode interface screen and display on the privacy mode interface
screen one or more
status indicators corresponding to the status information without displaying
at least one of the
critical status indicators that may contain relatively sensitive information.
For example, the
critical status information interface screen or the privacy mode interface
screen may omit or not
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display the glucose level indicator, the therapy status indicator, or both, In
some cases, none of
the critical status indicators are displayed while privacy mode is active. For
example, the
critical status information interface screen may only show a lock symbol or an
indication that
privacy mode is activated.
[0557] In some cases, privacy mode can include activating the sleep mode such
that display is
off while the AMD 5500 delivery glucose control therapy. In some other cases,
the display may
be turned off while privacy mode is activated, Privacy mode may be activated
independently or
in conjunction with power saving mode. For example, the AMD 5500 may allow the
user to
configure the power saving mode to activate the privacy mode when the power
saving mode is
activated as discussed herein. In some cases, the AMD 5500 may allow the user
to configure to
activate the privacy mode after the power saving mode is activated. In some
cases, the AMD
5500 may allow the user to configure to activate the privacy mode without the
power saving
mode being activated. The privacy mode can be configured to be activated via a
wake interface
discussed herein.
[0558] FIG. 56 is a flow diagram 5600 illustrating an example procedure to
activate a power
saving mode in an AMD. As discussed herein, the AMD can activate the power
saving mode
upon receiving a request from the user 5602 (e.g., via a wake interface or
menu selection on the
touchscreen display). In some cases, when the AMD does not receive a user
request to activate
the power saving mode and the user is otherwise not interacting with the AMD
(e.g., selecting
through menus, reviewing alarms, reviewing information on the AMD, etc.), the
AMID can
activate the power saving mode after a predetermined amount of time has passed
5604
associated with a period of inactivity of a user not interacting with the AMD
or providing user
input to the AMD. Once the AMID has entered or begun entering into the power
saving mode,
the AMD can deactivate the touchscreen controller 5606 such that the
touchscreen controller
does not receive or does not react to user input signals corresponding to the
user input on the
touchscreen display. In some cases, when the backlight was on for example, the
AMD can
lower or dim the brightness or the backlight (e.g., lower or dim illumination
level of the display
relative to a maximum illumination level) or turn off the backlight 5608 to
achieve power
savings in the power savings mode. In some cases, the AMD may implement other
power
saving features as discussed herein, such as reduced refresh and update rates,
etc. The AMD
may receive status information, including critical status information, 5610 as
discussed
herein. The AMD may then display the status information, including critical
status information,
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56n as discussed herein. The AMD may utilize the always on screen
functionality, including
variation thereof, as discussed herein.
[0559] In some cases, the AMD may exit out of the power saving mode when the
user wakes
the device via a wake interface as discussed herein. In some cases, the AMD
may exit out of
the power saving mode via other user interactions or gestures. For example,
the AMD may exit
out of the power saving mode via a user interaction corresponding to a single
or double tap on
the AMD that the AMD determines via a motion sensor. In some cases, the user
may interact
with the AMD and command the AMD via user interaction with the AMD
corresponding to
taps or other gestures on the AMD while the AMD remains in the power saving
mode. For
example, the user may snooze alarms or toggle the display to turn on or off
without the AMD
exiting the power saving mode (e.g., without entering the wake mode).
Example AMD with Motion Sensor
[0560] As discussed herein, the AMD can have one or more user interaction
sensors. The user
interaction sensors can include motion sensors. The motion sensor can include
an
accelerometer, gyroscope, and/or other electrical or mechanical motion sensors
that convert
motion or acceleration into electrical signals. The electrical signals can be
sent to the one or
more controllers of the AMD as user interaction signals. In some cases, the
motion sensors can
be part of the device sensors 3208 as discussed herein. The motion sensor can
detect, for
example, a single tap or a double tap anywhere on the AMD, including on the
touchscreen
display. The motion sensor can detect and send user interaction signals
associated with any
number of taps, such as for example, a triple tap, a quadruple or more taps on
the AMD. In
some cases, other user interaction gestures detected by the motion sensor can
be used with the
AMD as discussed herein in combination with or in lieu of taps. For example,
other user
interaction gestures may include shaking the AMD, moving the AMD, tilting the
AMD, picking
up the AMD, and/or the like that may activate or initiate functionality of the
AMD as discussed
herein in reference to tapping.
[0561] FIG. 57 is a flow diagram 5700 illustrating an example procedure for
tap interaction in
a power saving mode of an AMD. The tap interaction can be a single tap. In
some cases, the tap
interaction for flow diagram 5700 as discussed below in reference to FIG. 57
can be a double
tap. In some cases, the user interaction with AMID for flow diagram 5700 can
be another user
interaction with the AMD as discussed herein.
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