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Patent 2960519 Summary

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Claims and Abstract availability

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(12) Patent Application: (11) CA 2960519
(54) English Title: MEDICATION DELIVERY SYSTEM AND METHOD
(54) French Title: SYSTEME ET PROCEDE D'ADMINISTRATION DE MEDICAMENTS
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61J 7/04 (2006.01)
  • H04W 84/18 (2009.01)
  • A61M 99/00 (2012.01)
  • G16H 20/10 (2018.01)
  • G16H 20/17 (2018.01)
  • G16H 40/67 (2018.01)
  • A61J 7/00 (2006.01)
  • H04L 12/16 (2006.01)
  • G16H 20/13 (2018.01)
  • G06F 19/00 (2011.01)
  • H04L 29/06 (2006.01)
(72) Inventors :
  • STARR, ERIC W. (United States of America)
  • UPDYKE, DUSTIN D. (United States of America)
  • KORCZYNSKI, SHERRY M. (United States of America)
(73) Owners :
  • MYLAN INC. (United States of America)
(71) Applicants :
  • MYLAN INC. (United States of America)
(74) Agent: OSLER, HOSKIN & HARCOURT LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2015-09-09
(87) Open to Public Inspection: 2016-03-17
Examination requested: 2020-07-16
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2015/049232
(87) International Publication Number: WO2016/040512
(85) National Entry: 2017-03-07

(30) Application Priority Data:
Application No. Country/Territory Date
14/483,572 United States of America 2014-09-11

Abstracts

English Abstract

A medication delivery system includes a medical server configured to send and receive and process data, a medication device configured to administer a preselected medication, a sensor circuit configured to detect selected parameters relating to medication delivery and transmit information, a transmission hub configured to communicate with the medical server and the sensor circuit. The transmission hub is configured to receive a signal from the sensor circuit and exchange the information. An application is configured to facilitate exchange of information between the sensor circuit and the medical server. The application has a preselected set of protocols. The application monitors usage of the medication device and location of the medication device by connecting to the medication device via the transmission hub.


French Abstract

L'invention concerne un système d'administration de médicaments comprenant : un serveur médical conçu pour envoyer, recevoir et traiter des données ; un dispositif de médication configuré pour administrer un médicament présélectionné ; un circuit de capteur configuré pour détecter des paramètres sélectionnés relatifs à l'administration de médicaments et transmettre des informations ; et un hub de transmission configuré pour communiquer avec le serveur médical et le circuit du capteur. Le hub de transmission est configuré pour recevoir un signal du circuit de capteur et échanger les informations. Une application est configurée pour faciliter l'échange d'informations entre le circuit du capteur et le serveur médical. L'application comprend un ensemble présélectionné de protocoles. L'application permet de surveiller l'utilisation du dispositif de médication et l'emplacement du dispositif de médication en se connectant au dispositif de médication par le biais du hub de transmission.

Claims

Note: Claims are shown in the official language in which they were submitted.



WHAT IS CLAIMED IS:

1. A medication delivery system, comprising:
a medical server configured to send and receive and process data;
a medication device configured to administer a preselected medication;
a sensor circuit configured to detect selected parameters relating to
medication delivery and transmit information;
a transmission hub configured to communicate with the medical server and
the sensor circuit, the transmission hub configured to receive a signal from
the
sensor circuit and exchange the information with the medical server, and;
an application configured to facilitate exchange of information between
the sensor circuit and the medical server, the application having a
preselected set
of protocols.
2. The medication delivery system of claim 1, further including at least
one
biometric device in communication with the transmission hub to transmit
patient-specific
biometric information to the transmission hub.
3. The medication delivery system of claim 1, wherein the transmission hub
is a mobile device configured to exchange information with the sensor circuit
using
Bluetooth technology and in communication with the server.
4. The medication delivery system of claim 1, wherein the sensor circuit is

attached to the medication device.
5. The medication delivery system of claim 1, wherein the sensor circuit 1s

provided on a medication carrier.
6. The medication delivery system of claim 4, wherein the sensor circuit
includes a temperature sensor configured to detect the temperature of the
environment
surrounding the medication device such that the sensor circuit transmits the
detected
temperature to the transmission hub and the application compares the detected
temperature to a selected temperature range.

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7. The medication delivery system of claim 4, wherein the sensor circuit
includes a location detector configured to provide information regarding the
location of
the medication device and attached sensor circuit and transmits location
related data to
the application.
8. The medication delivery system of claim 4, wherein the sensor circuit
includes a contact element provided on the medication device to facilitate
detection of
administration of medication from the device by the application.
9. The medication delivery system of claim 4, wherein the application is
provided on the transmission hub providing an interface to a user to input
information
into the application.
10. The medication delivery system of claim 1, wherein the transmission hub

is a tablet.
11. A method for remotely monitoring medication delivery at a medication
device, comprising:
detecting contact at the medication device using an element provided on
the medication device, in communication with a sensor circuit;
transmitting a signal from the sensor circuit to an application indicating
that contact has occurred at the medication device;
receiving the signal from the sensor circuit at a transmission hub;
determining that signal contains contact element information using the
application;
sending a signal from the transmission hub to a connected medical server
indicating that the medication has been accessed.
12. The method for remotely monitoring medication delivery at a medication
device of claim 11, wherein detecting contact at the medication device further
includes
using a contact element, provided on the medication device, in communication
with the
sensor circuit.

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13. The method for remotely monitoring medication delivery at a medication
device of claim 11, wherein detecting contact at the medication device further
includes
using a magnetic field sensor, in communication with the sensor circuit.
14. The method for remotely monitoring medication delivery at a medication
device of claim 11, wherein detecting contact at the medication device further
includes
using a force pressure element, provided on the medication device, in
communication
with the sensor circuit.
15. A method for detecting the location of a medication device, comprising:

transmitting a Bluetooth signal from a sensor circuit provided on a
medication device or on a medication device carrier;
receiving the Bluetooth signal at a transmission hub if the signal is within
range;
initiating a signal from the transmission hub to a remotely connected
server providing the location of the transmission hub if the Bluetooth signal
is
received;
detecting the signal strength of the Bluetooth signal between the
medication device and transmission hub and comparing the signal strength value

to a preselected value;
initiating a signal from the transmission hub to a remotely connected
server if the Bluetooth signal strength value is less than a preselected value

thereby indicating that the medication device is not within a preselected
distance
from a user.
16. The method of claim 11, wherein detecting the location of a medication
device includes using a global positioning system application to determine
where the
transmission hub is located.
17. A medication delivery system, comprising:
a medical server configured to send and receive and process data;
a medication device configured to administer a preselected medication;
a sensor circuit configured to detect selected parameters relating to
medication delivery and transmit information;

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a transmission hub configured to communicate with the medical server and
the sensor circuit, the transmission hub configured to receive a signal from
the
sensor circuit and exchange the information with the medical server, and;
an application configured to facilitate exchange of information between
the sensor circuit and the medical server, the application having a
preselected set
of protocols, wherein the application monitors usage of the medication device
and
location of the medication device by connecting to the medication device via
the
transmission hub.
18. The
medication delivery system of claim 17, further including at least one
biometric device in communication with the transmission hub to transmit
patient-specific
biometric information to the transmission hub.

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Description

Note: Descriptions are shown in the official language in which they were submitted.


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MEDICATION DELIVERY SYSTEM AND METHOD
Field of Invention
[0001] Various exemplary embodiments disclosed herein relate
generally to a
configurable medication delivery system, and more particularly to medication
delivery
system having a smart sensor for remotely detecting and monitoring specific
parameters
related to the storage and utilization of a medication and/ or medication
device.
Description of the Related Art
[00021 Conventional medical systems related to medication delivery
are used
to monitor medication usage by a patient while the patient Is located at a
designated
health facility. Accordingly, such medical systems monitor or track the amount
of drug
administered to a patient. This information may be entered into the medical
system by the
medical practitioner, manually or automatically using devices such as scanners
and bar
codes. While such systems are suitable for their intended purposes of tracking
and
monitoring medication usage while the patient and/ or medication are both
located at the
medical facility, most systems do not provide extensive and accurate remote
real-time
monitoring of medication usage by a user once the user leaves the medical
facility.
Further most medical systems are incapable of tracking medication received by
a user at a
pharmacy or by mail.
[0003] The foregoing objects and advantages of the invention are
illustrative
of those that can be achieved by the various exemplary embodiments and are not
intended
to be exhaustive or limiting of the possible advantages which can be realized.
Thus, these
and other objects and advantages of the various exemplary embodiments will be
apparent
from the description herein or can be learned from practicing the various
exemplary
embodiments, both as embodied herein or as modified in view of any variation
that may
be apparent to those skilled in the art. Accordingly, the present invention
resides in the
novel methods, arrangements, combinations, and improvements herein shown and
described in various exemplary embodiments.
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SUMMARY
[00041 A brief summary of various exemplary embodiments Is presented
below. Some simplifications and omissions may be made m. the following
summary,
which is intended to highlight and introduce some aspects of the various
exemplary
embodiments, but not to limit the scope of the invention. Detailed
descriptions of an
exemplary embodiment adequate to allow those of ordinary skill in the art to
make and
use the inventive concepts will follow in later sections.
100051 Various exemplary embodiments relate to a medication delivery
system. The medication delivery system comprises a medical server configured
to send,
receive and process data, a medication device configured to administer a
preselected
medication, a sensor circuit configured to detect selected parameters relating
to
medication delivery and transmit the information, a transmission hub
configured to
communicate with the medical server and the sensor circuit. The transmission
hub is
configured to receive a signal from the sensor circuit and exchange the
information with
the server. The medication delivery system further includes an application
configured to
facilitate the exchange of information between the sensor circuit and the
medical server.
[0006] In further various embodiments of the medication delivery
system, the
transmission hub is a mobile device configured to exchange information with
the sensor
circuit using BluetoothTm or Bluetooth Low Energy Technology, and also in
communication with the server. The sensor circuit can be attached to the
medication
device or on a medication carrier.
100071 In further various embodiments, the sensor circuit includes a
temperature sensor configured to detect the temperature of the environment
surrounding
the medication device. The sensor circuit transmits the detected temperature
to the
transmission hub, and the application compares the detected temperature to a
selected
temperature range.
100081 In further various embodiments, the sensor circuit includes a
location
detector configured to provide information regarding the location of the
medication
device and attached sensor circuit and transmits location related data to the
application.
[00091 In further various embodiments, the sensor circuit includes a
contact
element provided on the medication device to facilitate detection of
administration of
medication from the device by the application. The application may be provided
on the
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transmission hub providing an interface for a user to input information into
the
application.
[00101 Further, various exemplary embodiments relate to a method for
remotely monitoring medication delivery at a medication device. The method
comprises
detecting contact at the medication device using a contact element provided on
the
medication device, in communication with a sensor circuit. Next, the method
step
comprises transmitting a signal from the sensor circuit to an application
indicating that
contact has occurred at the medication device. The method further includes
receiving the
signal from the sensor circuit at a transmission hub and determining that the
signal
contains contact element information using the application. The method further
comprises
sending a signal from the transmission hub to a connected medical server
indicating that
the medication has been accessed.
[00111 Further, various exemplary embodiments relate to a method for
detecting the location of a medication device. The method comprises
transmitting a
Bluetoothrm signal from a sensor circuit provided on a medication device or on
a
medication device carrier. The method further comprises receiving the
Bluetoothrm signal
at a transmission hub, if the signal is within range. The method further
comprises
initiating a signal from the transmission hub to a remotely connected server
providing the
location of the transmission hub if the Bluetoothrm signal is received. In the
event that the
signal is not in range of the transmission hub, the method comprises
initiating a signal
from the transmission hub to a remotely connected server indicating the sensor
circuit is
not within range of the transmission hub.
[00121 The method further comprises detecting an approximate distance
and/
or location the transmission hub is from the sensor circuit by sensing the
signal strength
of the Bluetooth transmission from the sensor circuit. Location the direction
of the
medication device can be done by displaying the strength of the signal as a
user moves
closer or away from the device.
100131 The method further comprises detecting the distance or
location of the
sensor circuit with the medical device by activating a button or signal at the
transmission
hub or application such that the sensor circuit emits a sound, vibration and a
LED. The
method further comprises detecting the location of a medication device using a
global
positioning system application to determine where the transmission hub is
located.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In order to better understand various exemplary embodiments,
reference is made to the accompanying drawings, wherein:
[0015] FIG. I illustrates an embodiment of a medication delivery
system
configured to remotely monitor medication usage and location, having a
transmission hub
in communication with a medication device, and smart sensor circuit;
[0016] FIG. 2 is a perspective view of an exemplary medication device
including a smart sensor circuit provided on the case, to facilitate
monitoring of the
location and usage of the medication device;
[0017] FIG. 3 is a flow diagram illustrating an embodiment of the
method of
monitoring the location of the medication device in the medication delivery
system of
FIG. 1;
[0018] FIG. 4 is a flow diagram illustrating an embodiment of the
method of
detecting medication usage.
100191 To facilitate understanding, identical reference numerals have
been
used to designate elements having substantially the same or similar structure
and/ or
substantially the same or similar fimction.
DETAILED DESCRIPTION
[0020] For simplicity and illustrative purposes, the principles are
shown by
way of examples of systems and methods described. In the following
description,
numerous specific details are set forth in order to provide a thorough
understanding of the
examples. It will be apparent however, to one of ordinary skill in the art,
that the
examples may be practiced without limitation to these specific details. In
other instances,
well known methods and structures are not described in detail so as not to
unnecessarily
obscure understanding of the examples.
[0021] The ability for a medical service provider to monitor and
track a
patient's medication usage in real-time, assists the medical service provider
in providing
immediate specialized services to the patient. Real-time tracking or
monitoring of a
patent's medication usage by the medical service provider may also provide
safety
advantages to the patient, such as preventing the patient from forgetting to
take his/ or her
medication, preventing the patient from overdosing on a prescribed medication,
and
providing real-time assistance to the patient during medication
administration. Real-time
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medication tracking further permits the patient or medical service provider to
locate
misplaced medication, as well as facilitate contacting emergency services or
personnel
upon usage of the medication.
[00221 Electronic devices, such as smart phones or similar
transmission hubs,
permit a user and/ or medical service provider to remotely communicate with a
medication device via Bluetoothirm, and simultaneously communicate with remote
data
servers and related networks via the internet, Wi-Fi or cellular. Accordingly,
it is
desirable to provide a medication delivery system providing a configurable
smart sensor
circuit and transmission hub in communication with a remote data server, to
monitor and
track the utilization of a selected medication and/ or medication device, and
further
facilitate the delivering of enhanced specialized medical services to the
patient.
[0023] Referring now to the drawings, wherein the illustrations are
for
purposes of describing one or more embodiments and not for the purposes of
limiting the
same, Fig. 1 illustrates an embodiment of the medication delivery system
generally
designated by the reference numeral 100. The medication delivery system 100,
in
communication with a smart sensor 102 or smart sensor circuit, facilitates the
monitoring
and tracking of key parameters associated with a patients usage and storage of
a selected
medication and/ or a medication device 104. Such medical devices may include
an auto-
injector Epipen0, or an auto-injector Epipen cap 112, an insulin pen,
transdermal patch,
metered dose inhaler, dry powder inhaler, Nebulizer, Glatitramer Acetate Pen,
for
example. Notably, it is contemplated that the smart sensor 102 may operate in
conjunction with any medical device used to distribute mediation, without
departing from
the scope of the invention.
[0024] The medication delivery system 100 includes a smart sensor
circuit
102. The smart sensor 102 may be configured to detect and facilitate the
exchange of
medication-specific information to and from the medication device 104, to a
remote
medical server 150 and associated networks. The smart sensor 102 may be
provided on
the medication device 104, in the cap portion 112 of the medication device
104, or on an
associated medication carrier 110, which may be a package, or container.
100251 As indicated, the medication delivery system 100 generally
includes a
medical server 150, and further includes a transmission hub 106, in remote
communication with the smart sensor 102 and medical server 150. The
transmission hub
106 facilitates the transmission and exchange of medication-specific
information detected
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by the smart sensor 102, between the remote medical server 150 and smart
sensor circuit
102. The medication delivery system 100 further includes a software
application 108. The
application 108 operates in cooperation with the medication delivery system
100
platform, and is configured to perform various functions related to
collecting, storing,
monitoring and remotely transferring medication-specific information between
the user
and/ or medical provider, the transmission hub 106 and the medical server 150.
[00261 The medication delivery system 100 may further include one or
more
biometric devices 120, for measuring patient-specific health related data and
transmitting
that information to the transmission hub 106 and/ or application 108. it is
contemplated
that the biometric device 120 is configured to transmit this information via
wireless and/
or Bluetooth.
[0027] The smart sensor circuit 102 may include one or more various
types of
sensors for detecting pre-selected parameters provided by the application 108.
The smart
sensor 102 may include a physical location sensor 122 configured for detecting

conditions related to the physical location of the medication device 104. The
physical
location sensor may incorporate features such as Global Positioning Systems
GPS 190 to
provide location specific information as to where the medication device 104 is
located.
This feature may be advantageous in circumstances that the medication is
misplaced, or a
medical service provider needs to locate the patient with the medication.
[0028] The smart sensor circuit 102 may be an integrated circuit,
including
additional sensors for detecting parameters such as temperature with a
temperature sensor
124, pressure via a pressure sensor 126, mass air flow via a sensor 128,
magnetic field
(Hall Effect) electrical conductivity detector 130, electrical impedance with
a sensor 132,
strain and sound via sound detector 134, colorimetric sensor 136 for detecting
the color of
the medication, among many other parameters.
[0029] The temperature sensor 124, provided with the sensor circuit
102, may
be configured to continuously measure the real-time temperature of the
medication and/
or the storage location of the medication. As the temperature sensor 124
provides
temperature readings via the sensor circuit 102 to the application 108, the
information
may be relayed to, and processed by the medical server 150. Such temperature
information may be compared to approved storage temperatures for the
medication by the
application 108 and/ or server, and alerts may be sent to the patient via the
transmission
hub 106, when the medication is located in undesirable conditions. As such,
the
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application 108 in communication with the temperature sensor 124 and sensor
circuit 102
can further measure the time frame in which the medication device 104 and
medication
are located in unapproved temperatures, indicating possible medication
degradation.
100301 For example, with respect to a medication such as Epinephrine,
the
approved temperature range is approximately 15-30 degrees C. As such, in
circumstances
that the temperature sensor 124 detects that the temperature of the medication
is reading
is outside of a pre-selected approved range, an indicator 170 prompted by the
application
108, may sound an alarm, alert, or message via an interface provided on the
transmission
hub 106, or external device provided on the medication device 104 or carrier
110.
[00311 The smart sensor circuit 102 may further include a
microcontroller
142, which may be a small computer including a processor core 144, memory 146,
and
programmable input/output peripherals 148. For detection of parameters that
require an
analog sensor it is contemplated that the smart sensor circuit 102 may include
an analog
to digital converter 140 ("ADC") for converting signals received from the
analog sensor
to digital signal, such as a Texas Instruments 8/16/32 bit MCU, for example.
The memory
146 may be provided on the microcontroller 142. Memory 146 may be provided in
the
form of a NOR flash or OTP ROM, as well as a RAM. Further, the microcontroller
142
may be configured to receive embedded applications, such that the medication
monitoring
application 108 may be stored on the smart sensor circuit 102.
100321 The smart sensor circuit 102 may further include, or be in
communication with, a transmitter 116 such as a BluetoothTm Low Energy Radio
("BTLE"), or infrared transmitter, for example, for transmitting data and/or
information
detected by the smart sensor circuit 102 and the other aforementioned sensors
to the
transmission hub 106. It is contemplated that in place of a ("Bluetooth TM Low
Energy")
BTLE Radio transmitter 116 and microcontroller 142, a module 118 which
incorporates
all functionality of a BTLE radio 116 and microcontroller 122 with an ADC 140,
may be
provided. The microcontroller 122 may one similar to that manufactured by
Microchip,
for example. It is further contemplated that the sensor circuit 102 may
incorporate other
forms of communication such as, RFID, NFC, or other forms of wireless
communications
to communicate with the transmission hub 106, or directly with the medical
server 150.
Each sensor circuit 102 may have a unique radio number, which may be
transmitted to
the transmission hub 106 and application 108 during communication. This unique

identifier may permit the application 108 and user to track multiple
medication devices
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104 simultaneously, and further permit the transmission hub 106 and circuit
102 to be
automatically paired.
[0033] The location of the sensor circuit 102 and medical device 104
can be
determined using intuitive guidance by sensing the signal strength of the
Bluetooth
transmission. Location the direction of the medication device 104 may be
achieved by
displaying the strength of the signal, at the transmission hub 106, as a user
moves closer
or away from the medication device 104. It is also contemplated that the
detection of the
distance, and/ or location of the sensor circuit 102 on medical device 104,
can be
accomplished by activating a button or signal at the transmission hub 106 or
application
108 such that the sensor circuit 102 emits a sound, vibration and a LED, such
that the
user can detect the location of the sensor circuit 102. Further, it is
contemplated that if the
transmission hub 106 or sensor circuit 102 and medication device 104, is
moving out of
range, or pairing is disconnected, the application 108 in cooperation with the
transmission
hub 106 may generate a notification to the user indicating that the sensor
circuit 102 and
device 104 is no longer in pairing range. The last detected location of the
device 104 may
be sent to the application 108 and server 150.
[00341 It is contemplated that a transmission hub 106 in range of the
sensor
circuit 102 may in real-time automatically upload location information to the
application
108 and server 150. It is further contemplated that whenever a user activates
a "locate"
command using the application, the server 150 and/ or application 108 will
provide the
medication devices 104 last detected location. As such, the application 108
can use G PS
and/ or the signal strength of Blue tooth to indicate the location of the
medication device
104. Further, upon reaching the location of the device 104, as previously
discussed, the
sensor circuit 102 emits a sound, vibration and a LED, such that the user can
detect the
location of the sensor circuit 102.
[0035] The medication device 104 may include one or more medications
and/
or drug delivery products for treating emergency and/ or other medical
conditions, such
as for example Epinephrine (EpiPen Auto-Injector), Glatiramer acetate
(Copaxone
auto-injector), Adalimumab (Humiraf.R) auto injector), Insulin (auto-
injector), Naxolone
(auto injector) and various respiratory medication delivery devices (metered
dose & thy
powder inhalers). In various exemplary embodiments, the medication device 104
may be
an auto-injector for administering a dose of epinephrine, metered dose & dry
powder
inhalers or other devices. Suitable autoinjectors and associated devices and
method are
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described by U.S. Patent Numbers 4,031,893; 4,226,235; 4,329,988; 4,394,863,
4,484,910; 4,640,686; 4,678,461; 4,795,433; 4,832,682; 5,085,641; 5,092,843;
5,102,393;
5,295,965; 5,354,286; 7,449,012; 7,794,432; and 8,048,035, all of which are
hereby
incorporated by reference in their entireties for all purposes.
[00361 The smart sensor circuit 102 is configured to detect
medication-
delivery related parameters, specified by the application 108, such as when
the
medication device 104 is being utilized or activated. Accordingly the smart
sensor 102
may further include a contact or frangible element 114. The contact element
114 is
configured to detect and generate a signal or indication when a surface is
contacted,
opened or closed. The contact element 114 may complete or break an electronic
circuit
when the medication device 104 is activated or packaging 110 is opened,
sending a signal
to the smart sensor circuit 102.
[00371 For example, the smart sensor circuit 102 in cooperation with
the
contact element 114 is configured to detect when an auto-injector packaging
lid 110 is
opened, and therefore when an injection of medication, such as epinephrine,
insulin,
naloxone or another drug, is about to be deployed, further indicating when an
injection is
underway by a user. Additionally, the smart sensor circuit 102 in cooperation
with a
contact element 114 provided on the medication device 104 is configured to
detect when
a needle of an Epipent is retracted or capped, and the injection is complete.
Such
detection may be facilitated using one or more contact elements 114. The use
of sensors
102 and contact elements 114 are operable with respect to other medication
device 104
embodiments. With respect to alternative medication delivery devices 104, such
as a dry
powder inhaler, for example, the smart sensor circuit 102 may be configured to
detect
various events with respect to delivery. In the case of a medication device
104, such as an
inhaler 104, for example, the sensor circuit 102 in cooperation with the
element 114
detects when a lid of the medication device 104 is removed from a dry powder
inhaler,
metered dose inhaler, nebulizer. .
[0038] Further the smart sensor circuit 102 may detect when the
medication
delivery device 104 is grasped by a person. Further, in cooperation with a
pressure sensor
126, the sensor circuit 102 may detect when pressure is increased inside or
around an
inhalation or nasal spray device 104 or when force is applied to a pressurized
device. In
such cases, generally pressure is needed in order to disperse medication from
the
medication device 104, such as a metered dose medication canister, thus the
sensor circuit
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102 detection of force applied to the pressurized device indicates that the
medication is in
the process of being delivered. This information can then be transmitted
remotely to the
application 108 and medical server 150.
[00391 With respect to a medication delivery device 104, such as
transdennal
delivery patch, for example, the sensor circuit 102 in cooperation with the
contact
element 114, is configured to detect when the packaging of a transdennal
delivery patch
104 is opened, as well as, when the patch is placed on the skin indicating
that medication
is being delivered.
[00401 The medication device 104 may be provided in a carrier 110 or
packaging, which may be imprinted with a variety of selected medication
information.
Such medication information may also be provided on the sensor circuit 102,
medication
application 108, or remotely stored in a medical server 150. For example,
medication
information may include the name of the medication, active ingredients,
dosage,
expiration date, lot ID, approved storage temperature and product
serialization number, as
well as other medication-specific related information. The medication
information may be
printed in a manner that is machine-readable. For example, the medicament
information
may be printed as a quick response (OR) code. The medication information may
also be
printed as text that is easily recognized using optical character recognition
(OCR). As an
alternative to storing all of this medication information within one of these
codes, the
code can be transmitted to a look-up table stored within the application 108,
or within the
server 150. The code can be used to remotely look-up the information assigned
to the
particular code. Code assignment can be done at the time of manufacturing or
packaging
by the manufacturer. Because this information may be stored remotely, the
medication
information can also be accessed or modified.
[0041] The carrier 110 may also include inserts or cards included
therein. Any
information included on the medication device 104 may instead be located on
packaging
110. As will be discussed in further detail below, the medication information
may also be
digitally encoded in the memory 146 of the medication device 104 or smart
sensor 102,
permitting the information to be shared with the medication application 108
and the
medical server 150.
[00421 The transmission hub 106 may be configured to facilitate
communication between the smart sensor circuit 102, medication application 108
and the
remote medical server 150. The transmission hub 106 transmits information
detected by
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the smart circuit 102 and transmits the information to the medical server 150
or processor.
The transmission hub 106 may include a Smart Phone, such as an iPhoneTm, for
example,
a Personal Digital Assistant ("PDA"), a computer, tablet, such as an iPadTm,
for example,
or a hub, such as a BluetoothTM hub capable of transmitting information
remotely such as
a 2net Hub manufactured by Qualcomm, Inc.
100431 Multiple transmission hubs 106, or electronic devices may be
used to
track each medication device 104 along with its sensor circuit 102. This may
be
accomplished using a unique digital code that the manufacturers of radios
(Bluetooth,
Bluetootb Low Energy, RFID, NFC, etc.) assign to each specific radio chip or
sensor
circuit 102 during the manufacturing process. Accordingly, the unique digital
code
assigned to each corresponding radio/ chip or sensor 102 can also be assigned
to the drug
or medication device 104, providing each respective medication device 104 with
a
separate identity.
[00441 Identifying the medication device 104 may be accomplished
using the
transmission hub 106 that has the application 108 installed on the hub 106, or
remotely on
the server 150. Accordingly, device identification can be achieved using
multiple
transmission hubs 106 (phones, tablets, electronic devices) since the code may
be
assigned to and transmitted from the device sensor 102.
[0045] The medication application 108 is configurable to receive,
process and
transfer information related to the delivery of one or more selected
medications. The
application 108 may be stored or provided in the medical delivery system's
architecture,
on either/ or the transmission hub 106, the sensor circuit 102 or remotely on
the medical
server 150 or connected networks. The medication application 108 is configured
to
monitor a variety of parameters, and/ or attributes related to the delivery of
medication.
The application 108 provided on the transmission hub 106, such as a mobile
phone, may
provide pre-selected information in real-time to the user/patient, as well as
any other
authorized individuals accessing the mobile device 106.
[00461 The application 108 in communication with the sensor circuit
102 is
configured to detect the physical location of the medication device 104, such
as an
EpiPene, and provide status alerts and other information when the device 104
is in a
range of the transmission hub 106, and additionally when the device is out of
range of the
transmission hub 106. As such, the system 100 can detect the proximity the
device 104 is
to a patient, such as a child, and relay this information to a doctor or
parent.
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[0047] The application 108 is also in communication with one or more
biometric devices 120. The biometric device 120 provides patient-specific data
detected
and/ or collected when the user uses the biometric device 120. This
information is
transmitted to the transmission hub 106 in real-time and further transmitted
to the
application 108 and medical server 150. As such, a medical professional such
as a doctor
or nurse can monitor the patient's biometric data remotely and adjust
medication dosage
and prescriptions based on the biometric information. Further a medical
provider may
remotely program dosage release.
100481 The application 108 is further configured to provide a variety
of
configurable user settings, such as detection of medication of utilization.
The application
108 is further configured to receive a signal from the sensor circuit 102
detecting when
the packaging 110 lid is opened, and thus an injection of the medication (e.g.
epinephrine,
insulin, naloxone or another drug) is about to commence. The application 108
is
configured to process and exchange this information with the medical server
150. The
application 108 may be configured to monitor other events such as when an auto
injector
lid is opened, when an auto-injector needle is deployed and retracted, and/ or
when the
injection is completed. Such delivery-specific information may be stored by
the
application 108, as well as transmitted to the medical server 150. With
respect to the
other aforementioned medication devices, the application 108 is configured to
monitor
and transmit usage information remotely to the medication server 150.
[00491 As the medication usage event may be stored by the application
108
and/ or transmitted to the server 150, such processed usage data may be
provided in real-
time to the mobile device, or transmission hub 106. The application 108 may
provide, for
example a map to a medical provider or user, indicating when and where the
user has
administered the medication device 104 in the past. Additionally, the
application 108
could also present a real-time alert as to when the medication 104 has been
used,
including location information. The application 108 may also provide
historical data and
analysis of the medication device 104 usage events such as event listings and
graphs.
[0050] The application 108 is configured to exchange information with
the
remote medical server 150. The application 108 provides one or more prompts or
inputs,
permitting the user or medical provider to provide selected information, such
as
demographic information, geographic information, as well as user activities
such as for
example, exercise and meal entries. The application 108 may further interface
with other
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medical devices to exchange user medical and biometric information, such as,
for
example, a blood pressure monitor, a glucometer, pulse oximeter, a weight
scale, EKG,
and any other medical device configured to transfer medical related
information.
[00511 The medication delivery system 100 may include a cloud
computing
infrastructure capable of receiving a signal from the smart sensor circuit
and/ or
application 108 and remotely transmitting information to a processor or cloud
computer
server 150. The transmission hub 106 is in communication with the server or
group of
servers, which may be connected via a communication network 198 such as the
Internet,
an intra3net, a local area network (LAN), wide area network (WAN), cellular
196, Wi-Fi,
for example. The connected transmission hub 106 or application 108 provided on
the
transmission hub 106 or server 150 includes preselected permissions and
protocols
permitting communication and remote access to the medical server 150 by the
transmission hub 106.
[0052] Medical server 150 may be a server operated by a health care
provider,
health insurance provider, or government health agency. In addition to storing

medication-specific information, the medical server ISO may store, or have
access to,
patient-specific information. Accordingly, the medical server 150, in
communication with
the transmission hub 106 may provide patient-specific information to
authorized devices,
such as the transmission hub 106, an associated medication device control
center 180, as
well as emergency services providers 180.
[0053] As the medical server 150 may be configured to receive and
process
particular messages from the medication device 104, mobile device or
transmission hub
106, and control center 180. For example, medical server 150 may be configured
to verify
medications, prescriptions and order refills. The medical server 150 may
include a
processor 160 an& or controller which may me any suitable type of computer
processor,
such as a microprocessor, configured to perform calculations, determinations,
data
transmission or data reception, sending or receiving of control signals or
commands
processed. As used herein, the term "processor" will be understood to
encompass a
variety of devices such as, for example, microprocessors, field-programmable
gate arrays
(FPGAs), application-specific integrated circuits (ASICs), and other similar
processing
and computing devices.
100541 The medical server 150 has the processing power to tun an
application
108, store data, or perform any other computing task permitting a user to
access and run
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application 108 remotely as the medical server 150 as previously stated, is
also connected
to a network via the Internet or other connection platforms to be accessed
from anywhere.
MO551 Medical server 150 may be operated by a medicament
manufacturer or
other third party. It is contemplated that the medical server 150 may provide
the
application 108 in a downloadable a format for execution on the transmission
hub 106 or
may store application on the memory 152 or remotely. The medical server 150
may also
provide support for the downloadable application and/ or a web application.
The medical
server 150 may include a database of registered medicament information
provided by
patients who opt to register the medicament device 104. The medical server 150
may
provide various services accessible via the application. The medication server
150 in
cooperation with the medication application 108, may provide textual, or audio
and/ or
video instructions that may be downloaded or streamed to the transmission hub
or mobile
device 106.
[0056] The medical server 150 may provide information to the
application
108 and transmission hub 106 based on registration medication device 104
information.
For example, the medical server 150 may track expiration dates, medication
device usage
104 and provide notification of approaching expiration dates. As such, the
system 100 can
cue reorders when a medication is set to run out or expire in the device 104.
In various
embodiments, the medical server 150 may provide a tracking system, such as a
geo-
location tracking system, permitting a registered user to track the last known
physical
location of the medication device 104 or transmission hub 106 in communication
with the
device 104.
[0057] The medication system 100 in conjunction with the medication
server
150 may further include a storage device or memory 152 in communication with
the
medical server 150 to store data and information. The memory may be provided
on the
medical server 150 or be externally accessible by the medical server 150. The
memory
152 can be any suitable type of computer readable and programmable memory.
Examples
of computer readable media include a magnetic recording apparatus, non-
transitory
computer readable storage memory, an optical disk, a magneto-optical disk,
and/ or a
semiconductor memory (for example, RAM, ROM, etc.). Examples of magnetic
recording apparatus that may be used in addition to memory 152, or in place of
memory
152, include a hard disk device (HDD), a flexible disk (FD), and a magnetic
tape (MT).
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Examples of the optical disk include a DVD (Digital Versatile Disc), a DVD-
RAM, a
CD-ROM (Compact Disc-Read Only Memory), and a CD-R (R.ecordable)/RW.
[00581 Memory 152 may store information regarding the medication
device
104. Information stored by memory 152 may include the manufacture date,
expiration
date, medication, dose size, audio instructions, text instructions, other
instructions,
prescription information, re-order information, and contact information.
[00591 The sensor circuit 102 provided on the carrier 110 permits a
medical
provider to track the carrier for the purposes of reordering and/ or recycling
the carrier
110. As usage of the carrier 110 is completed, the sensor circuit 102 provided
on the
carrier 110 may transmit location information to the system 100 via the
transmission hub
106. To reduce cost and waste, the sensor circuit 102 may be tracked to a
return location
via a transmission hub provided at a medical provider's location. As such, the
medical
provider may detect the sensor circuit 102 once the carrier 110 is range,
prompting the
medical provider to reorder a replacement medication device 104 for the user.
[00601 In operation, the drug delivery system 100 in cooperation with
the
sensor circuit 102, transmission hub 106, application 108 and a remote medical
server
150 provide real-time monitoring of the medication device 104, which may
include the
temperature of the medication, the approximate location of the medication via
location
detection of the transmission hub 106, and further medication is
administration and usage
information.
[0061] As previously disclosed, the sensor circuit 102 is connected
or affixed
to the medication device 104, which may include connection to an EpiPent cap
112 , an
auto injector plastic case 110 or carrier 110. As shown in Fig. 3, in step 202
the sensor
circuit 102, using a contact element 114 detects when the auto-injector
packaging lid is
opened and drug usage is about to commence. The sensor circuit 102 may also
further
detect when the auto-injection needle is deployed and when the injection is
commencing
and further, when the needle is retracted.
100621 In step 204 and 206, once medication delivery is detected by
the smart
sensor circuit 102, the application 108 may access administration information
via the
application 108 and deliver that information containing a series of audios,
video or text
prompts to be sent to the transmission hub 106 or mobile device 106 in a pre-
selected
order. The administration information may be transmitted in accordance with a
related
protocol instructing the patient or user on how to use the medication device
104 properly
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and how to deliver the medication. The system 100 further detects the location
208 of the
transmission hub 106.
[0063] Additionally, in step 210 when the auto-injector or medication
device
104 is detected by the sensor circuit 102 as being opened, and/ or detects
that the
medication device 104 is deployed, the sensor circuit 102 may send a signal at
step 212 to
the application 108 prompting the user to determine if they want to the
transmission hub
106 or connected server 150, or associated network devices, to contact a first
responder,
caregiver, medical professional or an emergency number, such as 911.
[0064] Information regarding the medication device 104 and carrier
110, and
location may be sent to the server 150 via the application 108. This which may
be done
automatically once medication device 104 is in range of a transmission hub 106
or
manually into the application 108 at the transmission hub 106. The medication
delivery
system 100 in real-time continuously detects when the sensor circuit 102
provided
proximate to the medication device 104 is in communication with the
transmission hub
106, sending a signal detecting whether the sensor 102 is within range of the
transmission
hub 106. Medication device 104 detection generally depends on the range of
transmission
between the sensor circuit 102 and the transmission hub 106, which in the case
of
BluetoothTm, is approximately 150 ft. It is contemplated that the medication
device 104
may also be tracked using GPS chip or cellular communication with the sensor
circuit
102. Application 108 or transmission hub 106 may convert the device 104
detected GPS
coordinates to text message or audible speech command. As such, once the
emergency
provider receives the call, an audible speech command will alert the provider
of the need
for medical attention and the detected location of the medication device 104
and user.
[0065] As discussed the application 108 may detect the location of
the
medication device 106. When the BTLE signal is present, the application 108
may deduce
that the medication device 104 is within proximity of the transmission hub 106
and
therefore the patient has their medication nearby. This information can be
sent to the
cloud/medical server 150 and then relayed to caregivers (such as parents) that
the patient
has their medication on hand. When the BTLE signal is lost, deducing that the
medication
is most likely not nearby, the application 108 can send an alert to the
patient or caregiver
100661 Fig. 4 illustrates monitoring usage of the medication device
104. In
steps 405 and 410, multiple location signals may be exchanged between the
transmission
hub 106, sensor circuit 102 and application 108 to provide real-time
information with
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respect to the medication devices 104 and carrier's 110 proximate location. In
step 420
and 425, if the sensor circuit 102 leaves the range of detection by the
transmission hub
106, a message is sent to the user notifying the user. Further if the sensor
returns to range
or is reactivated in range of the transmission hub 106, a message is sent to
the user.
[00671 Using location information and usage information, the system
100 in
conjunction with the application 108 may utilize the transmission hub 106 or
mobile
devices location tracking service to locate the patient and in step 435, send
a message to
911 and/ or to a caregiver step 445 any time that an emergency medication such
as
naloxone, epinephrine or corficosteroid is delivered and a refill may be
ordered at step
455. The user can also configure additional contact preferences when a
medication
delivery event occurs.
[00681 The system 100 may further provide assistance with respect to
monitoring storage and usage and ordering. It is contemplated that once the
medication
device 104 is opened, the application 108 prompts the user to provide
information as to
whether they used the medication, and whether they would like to place a
reorder for
replacement/refill of medication
[00691 The patient's medication utilization can also be sent to the
medical
server 150 via the sensor circuit 102 and transmission hub 106 with a time-
stamp in order
to longitudinally plot medication adherence for maintenance drugs such as
insulin,
Copaxone.t, or a bronchodilator Combining medication delivery times and doses,

measured or keyed-in, with biometrics measured by the associated biometric
device 120
permits medical personnel that is managing the patient remotely to view
effects and side
effects such as changes in heart rate, respiration, blood pressure, oxygen
saturation and/
or body temperature from the patient's. The connected biometric device 120
further
permits a medical provider to compare variables such as dosage, diet and
exercise to the
patient's biometric changes.
100701 Although the various exemplary embodiments have been described
in
detail with particular reference to certain exemplary aspects thereof, it
should be
understood that the invention is capable of other embodiments and its details
are capable
of modifications in various obvious respects. As is readily apparent to those
skilled in the
art, variations and modifications can be effected while remaining within the
spirit and
scope of the invention. Accordingly, the foregoing disclosure, description,
and figures are
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for illustrative purposes only and do not in any way limit the invention,
which is defined
only by the claims.
-1 8-

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2015-09-09
(87) PCT Publication Date 2016-03-17
(85) National Entry 2017-03-07
Examination Requested 2020-07-16
Dead Application 2023-01-09

Abandonment History

Abandonment Date Reason Reinstatement Date
2022-01-07 R86(2) - Failure to Respond
2022-03-09 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $400.00 2017-03-07
Maintenance Fee - Application - New Act 2 2017-09-11 $100.00 2017-09-08
Maintenance Fee - Application - New Act 3 2018-09-10 $100.00 2018-08-28
Maintenance Fee - Application - New Act 4 2019-09-09 $100.00 2019-09-03
Request for Examination 2020-09-09 $800.00 2020-07-16
Maintenance Fee - Application - New Act 5 2020-09-09 $200.00 2020-09-02
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
MYLAN INC.
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Request for Examination 2020-07-16 4 90
Examiner Requisition 2021-09-07 6 345
Maintenance Fee Payment 2019-09-03 1 33
Abstract 2017-03-07 2 78
Claims 2017-03-07 4 189
Drawings 2017-03-07 4 102
Description 2017-03-07 18 1,362
Representative Drawing 2017-03-07 1 25
Patent Cooperation Treaty (PCT) 2017-03-07 2 80
International Search Report 2017-03-07 3 190
Declaration 2017-03-07 2 63
National Entry Request 2017-03-07 4 101
Cover Page 2017-05-01 2 50