Note: Descriptions are shown in the official language in which they were submitted.
CA 02836575 2013-12-12
TITLE
"CONTROL OF A WATER DEVICE VIA A DIALYSIS MACHINE USER
INTERFACE"
PRIORITY CLAIM
[0001] This application claims priority to and the benefit as a continuation-
in-
part application of U.S. Patent Application Serial No. 13/494,259, filed June
12, 2012,
entitled, "Dialysis System Including Multi-Heater Power Coordination", which
is a
continuation application of U.S. Patent Application Serial No. 13/030,909,
filed
February 18, 2011, entitled, "Dialysis System Including Multi-Heater Power
Coordination" (now U.S. Patent No. 8,216,452), which is a continuation
application of
U.S. Patent Application Serial No. 12/031,605, filed February 14, 2008,
entitled,
"Dialysis System Including Multi-Heater Power Coordination" (now U.S. Patent
No.
7,892,423), the entire contents of each of which are incorporated herein by
reference
and relied upon.
BACKGROUND
[0002] The present disclosure relates generally to renal therapy systems and
more specifically to systems and methods for controlling a water treatment
device
solely or only through a dialysis device.
[0003] Due to disease, insult or other causes, a person's renal system can
fail.
In renal failure of any cause, there are several physiological derangements.
The
balance of water, minerals and the excretion of daily metabolic load is no
longer
possible in renal failure. During renal failure, toxic end products of
nitrogen
metabolism (urea, creatinine, uric acid, and others) can accumulate in blood
and
tissues.
[0004] Kidney failure and reduced kidney function have been treated with
dialysis. Dialysis removes waste, toxins and excess water from the body that
would
otherwise have been removed by normal functioning kidneys. Dialysis treatment
for
replacement of kidney functions is critical to many people because the
treatment is life
saving. One who has failed kidneys could not continue to live without
replacing at
least the filtration functions of the kidneys.
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[0005] Hemodialysis and peritoneal dialysis are two types of dialysis
therapies
commonly used to treat loss of kidney function. Hemodialysis treatment uses
the
patient's blood to remove waste, toxins and excess water from the patient. The
patient
is connected to a hemodialysis machine and the patient's blood is pumped
through the
machine. Catheters or needles are inserted into the patient's circulatory
system to
connect the blood flow to and from the hemodialysis machine. Blood and
dialysate are
passed through a dialyzer in the hemodialysis machine. The dialyzer can
include a
semi-permeable membrane separating the blood and the dialysate. As blood
passes
through a dialyzer in the hemodialysis machine, the dialyzer removes the
waste, toxins
and excess water from the patient's blood. In particular, the toxins are moved
osmotically from the blood across the membrane into the dialysate. The
hemodialysis
machine returns the blood back to the patient. A large amount of dialysate,
for
example about one-hundred twenty liters, is used to dialyze the blood during a
single
hemodialysis treatment. The spent dialysate is then discarded. Hemodialysis
treatment lasts several hours and is generally performed in a treatment center
about
three or four times per week.
[0006] Peritoneal dialysis uses a dialysis solution or "dialysate", which is
infused into a patient's peritoneal cavity through a catheter implanted in the
cavity.
The dialysate contacts the patient's peritoneal membrane in the peritoneal
cavity.
Waste, toxins and excess water pass from the patient's bloodstream through the
peritoneal membrane and into the dialysate. The transfer of waste, toxins, and
water
from the bloodstream into the dialysate occurs due to diffusion and osmosis,
i.e., an
osmotic gradient occurs across the membrane. The spent dialysate drains from
the
patient's peritoneal cavity and removes the waste, toxins and excess water
from the
patient. This cycle is repeated.
[0007] There are various types of peritoneal dialysis therapies, including
continuous ambulatory peritoneal dialysis (-CAPD"), automated peritoneal
dialysis
and continuous flow peritoneal dialysis. CAPD is a manual dialysis treatment,
in
which the patient connects an implanted catheter to a drain and allows a spent
dialysate fluid to drain from the peritoneal cavity. The patient then connects
the
catheter to a bag of fresh dialysate and manually infuses fresh dialysate
through the
catheter and into the patient's peritoneal cavity. The patient disconnects the
catheter
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from the fresh dialysate bag and allows the dialysate to dwell within the
cavity to
transfer waste, toxins and excess water from the patient's bloodstream to the
dialysate
solution. After a dwell period, the patient repeats the manual dialysis
procedure.
[0008] In CAPD the patient performs several drain, fill, and dwell cycles
during the day, for example, about four times per day. Each treatment cycle
typically
takes about an hour. Manual peritoneal dialysis performed by the patient
requires a
significant amount of time and effort from the patient. This inconvenient
procedure
leaves ample room for improvement and therapy enhancements to improve patient
quality of life.
[0009] Automated peritoneal dialysis ("APD") is similar to CAPD in that the
dialysis treatment includes a drain, fill, and dwell cycle. APD machines,
however,
automatically perform three to four cycles of peritoneal dialysis treatment,
typically
overnight while the patient sleeps. The APD machines fluidly connect to an
implanted
catheter. The APD machines also fluidly connect to a source or bag of fresh
dialysate
and to a fluid drain.
[0010] The APD machines pump fresh dialysate from the dialysate source,
through the catheter, into the patient's peritoneal cavity and allow the
dialysate to
dwell within the cavity so that the transfer of waste, toxins and excess water
from the
patient's bloodstream to the dialysate solution can take place. The APD
machines then
pump spent dialysate from the peritoneal cavity, though the catheter, to the
drain.
APD machines are typically computer controlled so that the dialysis treatment
occurs
automatically when the patient is connected to the dialysis machine, for
example,
when the patient sleeps. That is, the APD systems automatically and
sequentially
pump fluid into the peritoneal cavity, allow for a dwell, pump fluid out of
the
peritoneal cavity and repeat the procedure.
[0011] As with the manual process, several drain, fill, and dwell cycles will
occur during APD. A "last fill" is typically used at the end of APD, which
remains in
the peritoneal cavity of the patient when the patient disconnects from the
dialysis
machine for the day. APD frees the patient from having to manually performing
the
drain, dwell, and fill steps.
[0012] For patients suffering from renal diseases, frequent dialysis is a way
of
life. Most peritoneal dialysis patients perform dialysis once a day.
Hemodialysis
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patients typically require dialysis several times a week. To allow patients to
continue
to live their lives as normally as possible, there has been an increased
desire to provide
home dialysis solutions.
Peritoneal dialysis is typically performed at home.
Hemodialysis and other blood treatment therapies, such as hemofiltration, are
performed largely in centers and clinics.
[0013] Performing dialysis, whether hemodialysis or peritoneal dialysis, at
home presents more challenges and complexities for patients. Typically,
dialysis is
performed using a dialysis device and a fluid source. The fluid source may be
provided in one or more prepared solution bag or be prepared online via a
water
treatment device and concentrated additives. In the case of the water
treatment device,
the dialysis machine and the water treatment device are operated at the same
time to
successfully perform a therapy. Operating two machines or devices can be
difficult,
especially for elderly patients or immobile patients who may not be able to
easily and
quickly observe and/or manipulate both devices. Viewing and/or entering
information
on or into the two devices may prove to be cumbersome. Both the dialysis
machine
and the water treatment device will produce data that may be desirable to
store for
analysis. The data should be accurate, timely and provide a sufficient level
of detail.
[0014] A need accordingly exists for a home dialysis system that integrates a
water treatment device with a hemodialysis machine, such that control of both
machines or devices is centralized, and such that data may flow readily to and
from
both machines or devices.
SUMMARY
[0015] The system and method of the present disclosure integrate the operation
of a dialysis machine and a water treatment device, such that the user in
essence
operates the water treatment device from the dialysis machine. That is, the
user
interface for the water treatment device is the user interface that controls
the dialysis
machine. The water treatment device can have its own small user interface but
primary control of the water treatment device is via the dialysis machine. It
is also
contemplated to transfer data from both machines to a central repository
maintained by
a therapy provider, provide reports of treatment data concerning both the
machine and
the device to clinicians, integrate with billing and ordering systems, track
consumables
usage and deliver consumables as needed, and service and maintain the machines
on a
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network of the system. To this end, in one embodiment the dialysis machine is
in data
fluid communication with the water treatment device via Ethernet or other
wired
communication. The dialysis machine is in turn in communication with the
system or
network. In this manner, data from the water treatment device can be sent via
the
dialysis machine to the network or system. The system or network can likewise
send
operating instructions and software upgrades via the dialysis machine to the
water
treatment device.
[0016] The dialysis machine includes a home therapy machine, such as, but not
limited to, a home hemodialysis ("1-ID") machine, a home peritoneal dialysis
("PD")
machine, a home hemofiltration (-HF-) machine, a home hemodiafiltration
("HDF")
machine, and a home continuous renal replacement ("CRRT") machine. While renal
therapy is one focus of the present disclosure, the present disclosure also
contemplates
the integration of any home fluid delivery therapy, such as in addition, a
home drug
delivery therapy or a nutritional therapy. In various embodiments, the home
therapy is
any type of therapy using a medical fluid that can be made online, or at the
time of use
beginning with a source of purified water, such as ultrapure water as that
temi is
understood in the art. For example, while PD has typically been performed
using
bagged dialysate, it is contemplated to instead make online PD solution
beginning with
the source of ultrapure or sterile water and adding PD concentrates, such as
dextrose or
glucose concentrate, as needed.
[0017] It is also contemplated that the home therapy is a nutritional therapy
in
which purified water from the water treatment device is used as the base for
preparing
a nutritional solution that is delivered to the patient. In any situation, all
the control of
the water treatment device is maintained through the same user interface that
is used to
control the home therapy machine, in one embodiment, be it a blood treatment
home
therapy machine, a PD home therapy machine or a nutritional home therapy
machine.
[0018] It is contemplated for the home medical device system to transfer
treatment prescriptions to the home therapy machine. A doctor's prescription
for a
renal or other type of home therapy is created. A clinician can remotely
select, based
upon the doctor's prescription, supplies to send to the patient's home,
including
supplies for both the home therapy machine and the water treatment device. The
clinician can also remotely set operating parameters for operating both the
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therapy machine and the water treatment device. The operating parameters for
both
the machine and device are sent to the home therapy machine. The operating
parameters for the home therapy machine are stored in the memory of the
therapy
machine. The operating parameters for the water treatment device are forwarded
from
the home therapy machine to the water treatment device and stored in the
memory of
the water treatment device.
[0019] The system and method of the present disclosure also allow for the
upgrading of filinware on the home therapy machine and the water treatment
device
via the home therapy machine. When upgraded firmware is generated, the
firmware is
sent to the home therapy machine. If the new firmware is meant for the home
therapy
machine, the new firmware is installed on the home therapy machine. If the new
firmware is meant instead for the water treatment device, the home therapy
machine
forwards the new firmware to the water treatment device, where it is
installed. In
certain jurisdictions, it may be required that the user accept the software
upgrade, be it
for either the home therapy machine or the water treatment device. In either
case, it is
contemplated to allow the user to accept the new firmware, for either the
machine or
the device, at the user interface for the home therapy machine.
[0020] It is contemplated to provide operating prescriptions and new firmware
with tags that designate which of the home therapy machine and the water
treatment
device is to receive the operating instructions or the firmware.
Alternatively, the
instructions and firmware may inherently look or have content that is peculiar
to either
the home therapy machine or the water treatment device. In this latter case,
the home
therapy machine can determine whether to itself accept the instructions or
firmware
upgrade or to forward same to the water treatment device based on the detected
inherent characteristics. No additional tag is needed here.
[0021] Based on the foregoing and following description, it should be
appreciated that it is an advantage of the present disclosure to provide an
improved
home therapy treatment using online purified water generation.
[0022] It is another advantage of the present disclosure to provide an
improved
hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis, drug
delivery, and
nutritional home therapy system and method.
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[0023] It is a further advantage of the present disclosure to provide an
improved system and method for sending operating parameters to multiple
machines
or devices of a home therapy system.
[0024] It is yet another advantage of the present disclosure to provide
clinicians, doctors and nurses with the ability to remotely review and monitor
data
produced by multiple machines or devices cooperating to provide a home
therapy.
[0025] It is yet a further advantage of the present disclosure to provide an
improved system and method for sending firmware upgrades to multiple machines
or
devices cooperating to provide a home therapy.
[0026] It is still another advantage of the present disclosure to ensure that
data
sent back and forth between a server and multiple machines or devices
cooperating to
provide a home therapy is performed in a reliable and secure manner.
[0027] It is still a further advantage of the present disclosure to prevent
data
from being delivered from a server to multiple machines or devices cooperating
to
perform a home therapy while the machines or devices are being operated.
[0028] Moreover, it is an advantage of the present disclosure to allow a user
to
control aspects of a treatment involving multiple machines or devices using
one user
interface.
[0029] Additional features and advantages are described herein and will be
apparent from the following Detailed Description and the figures.
BRIEF DESCRIPTION OF THE FIGURES
[0030] FIG. IA is a schematic block diagram of one embodiment of a home
medical device system of the present disclosure.
[0031] FIG. 1B is a block diagram of one embodiment of a computing device
used in the home medical device system of the present disclosure.
[0032] FIG. 2 is a block diagram of one embodiment of a dialysis machine
with a water purification unit in a home medical device system of the present
disclosure.
[0033] FIG. 3 is a schematic view of one embodiment of a subsystem including
a water treatment device in communication with a home therapy machine for a
home
medical device system of the present disclosure.
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[0034] FIG. 4 is a flowchart of an example process of the present disclosure
for
installing a water treatment device.
[0035] FIG. 5 is a flowchart of an example process of the present disclosure
for
making water with a water treatment device.
[0036] FIG. 6 is a flowchart of an example process of the present disclosure
for
starting up a home therapy machine and a water treatment device.
[0037] FIG. 7 is a flowchart of an example process of the present disclosure
for
updating a component in a water treatment device.
[0038] FIG. 8 is a flowchart of an example process of the present disclosure
for
shipping inventory and programming a therapy prescription for a home therapy
machine and/or a water treatment device based upon an approved treatment
prescription.
[0039] FIG. 9 is a flowchart of an example process of the present disclosure
for
upgrading firmware on a home therapy machine and/or a water treatment device.
[0040] FIG. 10A is a screen shot of an example dashboard screen for a clinic
of
the present disclosure.
[0041] FIG. 10B is a screen shot of an example legend for a dashboard screen
of the present disclosure.
[0042] FIG. 11A is a screen shot of an example treatment summary screen of
the present disclosure.
[0043] FIG. 11B is another screen shot of an example treatment summary
screen of the present disclosure.
[0044] FIG. 12 is a screen shot of an example patient usage report of the
present disclosure.
DETAILED DESCRIPTION
Home Medical Device System
[0045] Referring now to the drawings and in particular to FIG. 1A, a home
medical device system 110 is illustrated. System 110 shows a home therapy
machine
100, which can be of any type including a home hemodialysis ("HD-), home
hemofiltration ("HF"), home hemodiafiltration ("HDF), home peritoneal dialysis
("PD"), home drug delivery, or nutritional home therapy machine. If home
therapy
machine 100 is a home hemodialysis machine, one suitable machine is set forth
in U.S.
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Patent Publication No. 2009/0101549, entitled, "Modular Assembly For A
Hemodialysis System", filed August 27, 2008, the entire contents of which are
incorporated herein by reference and relied upon.
[0046] While a single home therapy machine 100 is illustrated as
communicating with a connectivity server 118, system 110 oversees the
operation of a
plurality of home therapy machines 100, of the same type or of different
types. For
example, there may be M number of hemodialysis machines 100, N number of
hemofiltration machines 100, 0 number of hemodiafiltration machines 100, P
number
of peritoneal dialysis machines 100, Q number of home drug delivery machines
100,
and R number of nutritional home therapy machines 100 connected to server 118
and
operating with system 110. The numbers M through R may be the same or
different
numbers, and may be zero, one, or more than one.
[0047] In the illustrated embodiment, home therapy machine 100 receives at its
front end purified water from a water treatment device 10. One suitable water
treatment device 10 is set forth in U.S. Patent Publication No. 2011/0197971,
entitled,
"Water Purification System And Method-, filed April 25, 2011, the entire
contents of
which are incorporated herein by reference and relied upon. In one embodiment,
water
treatment device 10 outputs ultrapure water as that term is understood in the
art. The
ultrapure water may be passed through one or more filter, such as an
ultrafilter or a
dialyzer to make the water of or near an injectable or drug quality. The
injectable
quality water may then be mixed with one or more dry, liquid, or slurried
concentrate
to produce (i) an injectable substitution solution for HF or HDF, (ii) a PD
solution, (iii)
a drug for infusion or (iv) a nutritional solution for infusion.
[0048] System 110 illustrates that home therapy machines 100 operates with
other devices besides water treatment device 10, such as a blood pressure
monitor 104,
a weigh scale, e.g., wireless weigh scale 106, and a wireless tablet user
interface 122.
Home therapy machine 100 connects to server 118 wirelessly in one embodiment
via a
modem 102. Each of these components, including water treatment device 10, are
generally located within the patient's home, as demarcated by the dashed lines
in FIG.
1A. Any one, or more or all of components 10, 104, 106 and 122 may communicate
wired or wirelessly with home therapy machine 100. Wireless communication may
be
via BluetoothTM, WiFiTM, Zigbee0, Z-Wave , wireless Universal Serial Bus
("USB"),
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infrared, or any other suitable wireless communication technology.
Alternatively, any
one, or more or all of components 10, 104, 106 and 122 can communicate with
home
therapy machine 100 via wired communication.
[0049] In one embodiment, water treatment device 10 connects to home
therapy machine 100 via an Ethernet cable. Water treatment device 10 is
powered
under its own power in one embodiment. Home therapy machine 100 can request
water as needed from water treatment device 10. Water treatment device 10 is
sized
and configured to supply, on an online or batch basis, any amount of water
that
machine 100 needs.
[0050] Connectivity server 118 communicates with much of home medical
device system 110 via a home medical device system hub 120. System hub 120
enables data and information concerning each home therapy machine 100 and
water
treatment device 10 on system 110 to travel back and forth via the
connectivity server
118 between the machines 100 and the other clients connected to server 118. In
the
illustrated embodiment, system hub 120 is connected to a service portal 130,
an
enterprise resource planning system 140, a web portal 150, a business
intelligence
portal 160, a HIPAA compliant database 124, a product development team 128 and
electronic medical records databases 126a to 126n.
[0051] The electronic medical records ("EMR") databases 126a to 126n
contain electronic information about patients. The system hub 120 can send the
data
collected from log files of machine 100, described in detail below, to
hospital or clinic
databases 126a to 126n to merge or supplement that patient's medical records.
Databases 126a to 126n may contain patient-specific treatment and prescription
data
and therefore access to such databases could be highly restricted. The
enterprise
resource planning system 140 obtains and compiles data generated via the
patient and
clinician website access, such as complaints, billing information and life
cycle
management information. Web portal 150 enables patients and clinics 152a to
152n
treating the patients to access a publicly available website for system 110.
Business
intelligence portal 160 collects data from the system hub 120 and provides
data to
marketing 162, research and development 164, and quality/pharmacovigilance
166.
System Block Diagram
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[0052] A block diagram of one embodiment for the electrical systems of any or
more or all of the machines, devices or subsystems of the home medical device
system
(e.g., water treatment device 10, machine 100, modem 102, blood pressure
monitor
104, scale 106, server 118, system hub 120, user interface 122, service portal
130,
enterprise resource planning system 140, web portal 150, business intelligence
portal
160) is illustrated in FIG. 1B. System 110, including any or all of devices or
subsystems 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150, and 160,
includes a
main unit 170 which in one embodiment includes one or more processor 176
electrically coupled by an address/data bus 178 to one or more memory device
174,
other computer circuitry 172, and one or more interface circuit 180. Processor
176
may be any suitable processor, such as a microprocessor from the INTEL PENTIUM
family of microprocessors. Memory 174 may include volatile memory and non-
volatile memory. Memory 174 can store one or more software program that
interacts
with the other devices in the system 110 as described below. Memory 174 may
also
store digital data indicative of documents, files, programs, web pages, etc.
retrieved
from another computing device and/or loaded via an input device 194.
[0053] The interface circuit 180 may be implemented using any suitable
interface standard, such as an Ethernet interface and/or a USB interface. One
or more
input device 194 may be connected to the interface circuit 180 for entering
data and
commands into the main unit 170. For example, input device 194 may be a
keyboard,
mouse, touch screen, track pad, track ball, isopoint, and/or a voice
recognition system.
Interface circuit 180 may be connected to any type of network 182, such as an
Internet,
a local area network ("LAN"), a telephone network (POTS), and/or other
networks.
[0054] One or more displays, printers, speakers, and/or other output devices
192 may also be connected to the main unit 170 via the interface circuit 180.
Display
192 may be a cathode ray tube (CRT's), liquid crystal displays (LCD's), or any
other
type of display. Display 192 generates visual displays of data generated
during
operation of the device or subsystem 10, 100, 102, 104, 106, 118, 120, 122,
130, 140,
150, and/or 160. For example, display 192 may be used to display information
received from the system hub 120. The visual displays may include prompts for
human input, run time statistics, calculated values, data, etc.
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[0055] One or more storage device 190 may also be connected to the main unit
170 via the interface circuit 180. For example, a hard drive, CD drive, DVD
drive,
and/or other storage devices may be connected to the main unit 170.
[0056] It should be appreciated that the disclosed methods and procedures
described herein may be implemented using one or more computer programs or
components. These components may be provided as a series of computer
instructions
on any conventional computer-readable medium, including random access memory
("RAM"), read only memory ("ROM"), flash memory, magnetic or optical disks,
optical memory, or other storage media. The instructions may be configured to
be
executed by a processor, which when executing the series of computer
instructions
performs or facilitates the performance of all or part of the disclosed
methods and
procedures.
Data Transfer For The Water Treatment Device
[0057] In one embodiment, home therapy machine 100 performs a home
treatment, such as home hemodialysis on a patient at the patient's home and
then
reports the results of that treatment to clinicians, doctors and nurses who
are
responsible for managing the health and well-being of that patient. The
results of the
treatment include data that is supplied from water treatment device 10 to home
therapy
machine 100. Water treatment device 10 data can include, for example, total
volume
of water delivered, quality of water delivered (e.g., chlorine content), how
many
different times water treatment device 10 delivered water to therapy machine
100 over
the course of a treatment (this data could be monitored by device 10 or
machine 100),
average flowrate of the water delivered, any alarms or alerts that water
treatment
device 10 experienced over a treatment, and/or an amount of time or number of
cycles
performed over the course of a treatment, e.g., for component replacement
information.
[0058] Home therapy machine 100 writes log files using, e.g., a LinuxTM,
operating system. The log files again document pertinent home therapy machine
100
data and pertinent water treatment device 10 data over the course of a
treatment. The
log files may include any one or more of Extensible Markup Language ("XML"),
comma-separated values ("CSV") or text files. The log files are placed into a
file
server box of the software of home therapy machine 100. It is contemplated to
store
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data at water treatment device 10 that is not sent to machine 100. Such data
may
otherwise be obtained via the Ethernet data connection to water treatment
device 10 or
downloaded through other data connections or storage media. For example, a
service
person can access additional data via a laptop connected to water treatment
device 10
via the Ethernet connection. Or, the additional data may be retrieved remotely
from
water treatment device 10, with home therapy machine 100 serving as the data
transfer
liaison between water treatment device 10 and authorized system clients as
described
herein.
[0059] Home therapy machine 100, e.g., via the Internet, uses a connectivity
service to transfer data, including water treatment device 10 data, between
modem 102
and system hub 120. In one embodiment, a dedicated line is provided at each
patient's
home for connecting the home therapy machine 100 to the connectivity server
118 via
modem 102. Home therapy machine 100 in one embodiment accesses the Internet
using a separate, e.g., 3G, 4G or 5G, modem 102. Modem 102 uses an Internet
Service Provider (-ISP"), such as VodafoneTM. In one implementation, a
connectivity
agent 114 developed by a connectivity service provider (e.g., provider of
connectivity
server 118) is installed onto the home therapy machine 100 and run on primary
control
processor (-ACPU") 112. One suitable connectivity service is provided by
AxedaTM.
The connectivity service provides a secure managed connection 116 between
medical
devices and the connectivity server 118.
[0060] The connectivity agent 114 allows the home therapy machine 100 to
connect to connectivity server 118 and transfer data, including water
treatment device
data, to and from the connectivity server 118. The connectivity service
operating
via agent 114 and server 118 ensures that the connection with machine 100 is
secure,
ensures that the data correctly passes through machine 100's firewalls, checks
whether
there has been a data or system crash and checks whether and ensures that the
connectivity server 118 is communicating with the correct home therapy machine
100.
[0061] In one embodiment, home therapy machine 100 can only connect to the
connectivity server 118 when connectivity agent 114 is turned on. During
treatment
and post-treatment disinfection, while machine 100 and water treatment device
10 are
functioning, connectivity agent 114 is turned off This prevents the home
therapy
machine 100 from communicating with any entity and sending or receiving data
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during treatment and disinfection or when machine 100 is live or running. When
the
home therapy machine 100 is idle, e.g., after treatment and post-disinfection
is
complete, ACPU 112 turns connectivity agent 114 on. In one
embodiment,
connectivity agent 114 is off only during treatment (including pretreatment).
Connectivity agent 114 then retrieves the log files from the home therapy
machine 100
and transfers data, including water treatment device 10 data, to the
connectivity server
118 using the connectivity service. The connectivity service routes data
packets to
their proper destination but in one embodiment does not modify, access, or
encrypt the
data.
[0062] In system 110 of FIG. 1A, the connectivity service via connectivity
server 118 can communicate data to various places via a system hub 120, a
service
portal 130 and a web portal 150. Connectivity server 118 allows service
personnel
132a to 132n and/or clinicians to track and retrieve various assets across the
network,
such as appropriate home therapy machines 100 and 3G, 4G or 5G modem 102, and
their associated information, including machine or modem serial numbers. The
connectivity server 118 can also be used to receive and provide firmware
upgrades,
approved by a director of service personnel 134 and obtained remotely via
service
portal 130, to authorized home therapy machines 100 and their associated water
treatment devices 10.
[0063] In one embodiment, a connectivity agent 114a (not illustrated) may also
be installed on the water treatment device 10 in addition to being installed
on the home
therapy machine 100. If the home therapy machine 100 cannot communicate with
the
system hub 120, and system hub 120 needs to communicate with the water
treatment
device 10, the water treatment device 10 may then directly communicate with
the
system hub 120 via the connectivity agent 114a. Alternatively, connectivity
agent
114a may be installed on a separate device or unit (not illustrated), which
can be
selectively connected to the water treatment device 10, so that water
treatment device
can be converted so as to communicate directly with the system hub 120 again,
for
example, if home therapy machine 100 loses communication with system hub 120.
Servicing The Water Treatment Device
[0064] In one embodiment, home therapy machine 100 may be operated in a
service mode for service personnel to access, diagnose and troubleshoot both
home
14
CA 02836575 2013-12-12
therapy machine 100 and water treatment device 10 on site and/or remotely. For
example, if water treatment device 10 encounters a problem, or if a component
of
same, e.g., a chemical pack, becomes spent, the patient may be able to call a
service
personnel or technician. The patient and/or service person can then place
water
treatment device 10 via the home therapy machine 100 into a service mode that
allows
the service technician to remotely verify device 10 settings and functionality
for
various components of the water treatment device 10. In one embodiment, system
110
prevents treatment while the service technician is connected to machine 100 to
enhance safety. For example, the service person may be able to logon onto
device 10
via machine 100 while treatment is paused. Alternatively, machine 100 must be
in an
idle state, or even powered down, for the service person to be able to access
the
machine 100 and/or device 10. Further alternatively, the machine 100 need only
be
disconnected from the patient for the service person to be able to access the
machine
100 and/or device 10.
[0065] Once accessed, the service technician can remotely investigate and
retrieve the log files stored on the home therapy machine 100 for the water
treatment
device 10 to determine a cause of an error occurring on the water treatment
device 10.
The service person may also be able to toggle valves and actuate a pump, for
example,
to see if a related sensor, e.g., pressure sensor, of the water treatment
device 10 is
operating properly and/or if a valve or pump of the water treatment device 10
is
operating properly. The service person does so by sending a command to home
therapy machine 100. Home therapy machine 100 recognizes that the command is
for
water treatment device 10 and passes along the command to the processing and
memory of the water treatment device 10, which in turn causes the appropriate
action
to occur on water treatment device 10. Water treatment device 10 sends
response data
back to home therapy machine 100, which relays the information back to the
appropriate service person.
[0066] Requests sent from the service person can either be structured so that
machine 100 inherently knows whether the request is for home therapy machine
100 or
water treatment device 10. Alternatively, the request can be tagged. For
example, the
valves for home therapy machine 100 may be numbered consecutively starting
from
the number one, while the valves for water treatment device 10 may be numbered
CA 02836575 2013-12-12
consecutively starting from the number one-hundred (assuming home therapy
machine
100 has less than one-hundred valves). Here, it is inherently known to pass a
request
to toggle valve one-hundred-eleven along to water treatment device 10.
Alternatively,
the valves for both home therapy machine 100 and water treatment device 10 may
be
numbered consecutively starting from the number one, but wherein the requests
are
coded, e.g., "A- for home therapy machine 100 and "B" for water treatment
device 10.
Here, ACPU 112 of home therapy machine 100 knows to keep a request to toggle
valve AV4 and to pass along a request to toggle valve BV4 to water treatment
device
10.
Control Via One User Interface
[0067] In one embodiment, the control processor (ACPU 112) and user
interface 122 of home therapy machine 100 walk the patient through the entire
treatment process and instruct, on a step-by-step basis, as to how treatment
should be
initiated and performed, including instructions for operating water treatment
device 10.
In one embodiment, the user interface 122 is a tablet that runs a custom,
secure
interface that only allows access to the home therapy machine 100. In one
implementation, tablet 122 operates wirelessly. Tablet 122 here can plug into
home
therapy machine 100 initially for pairing the tablet 122 with the home therapy
machine
100 and for performing software (e.g., firmware) upgrades for the tablet 122.
Tablet
122 may also plug into home therapy machine 100 to power or charge the tablet
122.
Connectivity between tablet 122 and home therapy machine 100 may be via a
serial
data connection, over a universal serial bus ("USB") connection, parallel
connection or
via another suitable data transfer interface. Once the tablet 122 is paired to
the home
therapy machine 100, the tablet 122 communicates wirelessly (e.g., using
BluetoothTM
or WiFiTM) with the home therapy machine 100.
[0068] User interface 122 can alternatively be connected to or tethered to
machine 100, for example, as shown and described in U.S. Patent Publication
No.
2009/0114582, the entire contents of which are incorporated herein by
reference and
relied upon. A connected or tethered arrangement for user interface 122 is
accordingly
discussed below, as illustrated in FIG. 3.
[0069] In one embodiment, the user can send data to and receive data from
machine 100 via tablet 122. Data entered into the user interface 122 is
securely sent to
16
CA 02836575 2013-12-12
the home therapy machine 100 and processed in ACPU 112, which controls machine
100 or forwards commands to be processed by water treatment device 10, which
in
turn controls some operation of the water treatment device 10. In one
embodiment, no
treatment data is stored in tablet 122. Storing no treatment data in the
tablet 122 is
advantageous because if the tablet 122 is disconnected or lost, no sensitive
or
important data is lost.
[0070] Because user interface 122 of home therapy machine 100 is also used to
enter and display data related to water treatment device 10, water treatment
device 10
does not need and in one embodiment does not provide anything more than a
simple
display, which may be provided with a few electromechanical buttons, such as
membrane switches, and an on/off switch. The simple display may be a small
liquid
crystal display (-LCD") or light emitting diode ("LED") display, which
provides a
single line or few lines of text. The electromechanical buttons allow for
emergency
control of water treatment device 10 in case tablet 122 is lost or
communication
between home therapy machine 100 and water treatment device 10 is broken.. The
electromechanical buttons alternatively or additionally allow installation or
service of
the water treatment device 10 in the absence of the home therapy machine 100.
The
electromechanical buttons may also allow a service person to enter a service
mode
directly from the small keypad, e.g., by pressing and holding a hidden button
for a
certain number of seconds.
[0071] In one embodiment, the user may power and depower home therapy
machine 100 and/or water treatment device 10 from common user interface 122. A
user may send a command to water treatment device 10 from common user
interface
122. The command may for example request that water treatment device 10
provide
an estimate of how much time exists before a consumable component of water
treatment device 10 needs replacement. For example, water treatment device 10
may
include a carbon filter, a sediment removal cartridge, softening filter,
reverse osmosis
("RO-) membrane or metallic catalyst filter, which each needs to be replaced
after a
certain number of hours of use. Like before, the command from tablet 122 may
be
inherent to water treatment device 10, so that ACPU 112 has no choice but to
forward
the command to water treatment device 10. Or, the command may be provided with
a
17
CA 02836575 2013-12-12
code that ACPU 112 recognizes, upon which ACPU 112 responsively forwards the
command to water treatment device 10.
[0072] One goal of the present disclosure is to prevent the user from having
to
look at two different user interfaces when performing the home therapy
treatment
under system 110. Besides allowing user interface 122 to be a common user
interface,
it is contemplated to make water treatment device 10 require as little user
interaction
as possible. For example, water treatment device 10 can be configured such
that it
remains powered indefinitely with no ill affect to the water treatment device
10. Or,
home therapy machine 100 and water treatment device 10 can be configured such
that
water treatment device 10 receives power whenever home therapy machine 100 is
powered. In a similar manner, many commands to home therapy machine 100 may
carry over or have an automatic secondary affect on water treatment device 10.
For
example, a PAUSE or STOP input from user interface 122 to home therapy machine
100 may likewise cause home therapy machine 100 to automatically issue a PAUSE
or
STOP command to water treatment device 10. In another example, if home therapy
machine 100 enters an alarm state while receiving purified water from water
treatment
device 10, home therapy machine 100 can cease pumping water from water
treatment
machine 10.
[0073] Operating parameters for home therapy machine 100 may also dictate
operating parameters for water treatment device 10. For example, in the
hemodialysis
realm, dialysis fluid or dialysate tlowrate entered as an operating parameter
into home
therapy machine 100 can dictate the flowrate at which water treatment device
10 is
commanded to produce purified water, which is used to make the dialysis fluid
or
dialysate. This leader/follower operating parameter arrangement can be carried
out in
a plurality of different ways. In one way, ACPU 112 of home therapy machine
100
calculates or finds via a look-up table the operating parameter for water
treatment
device 10 based on the corresponding operating parameter for home therapy
machine
100. For example, ACPU 112 may store that purified water flowrate is to be set
to 1.2
times the dialysate flowrate. ACPU 112 calculates and adjusts on the fly a
purified
water flowrate knowing the current actual or currently commanded flowrate of
dialysate for home therapy machine 100. In one embodiment, ACPU 112 may adjust
the purified water flowrate if ACPU 112 determines that the patient needs a
bolus of
18
CA 02836575 2013-12-12
fresh solution. One suitable method for providing the patient with a bolus of
fresh
solution is set forth in U.S. Patent Publication No. 2009/0124963, entitled,
"Balanced
Flow Dialysis Machine", filed November 9, 2007, the entire contents of which
are
incorporated herein by reference and relied upon.
[0074] In a second way, the control processor of water treatment device 10
calculates or finds via a look-up table the operating parameter for water
treatment
device 10 based upon the corresponding operating parameter for home therapy
machine 100 sent by the home therapy machine 100 to the water treatment device
10.
For example, the control processor of water treatment device 10 may store that
purified water flowrate is to be set to 1.2 times the dialysate flowrate. ACPU
112
sends current dialysate flowrate periodically to water treatment device 10,
which in
turn calculates and adjusts on the fly a purified water flowrate knowing the
current
actual or currently commanded flowrate of dialysate for home therapy machine
100.
[0075] In a third way, the control processor of water treatment device 10 runs
off of a prescription just like home therapy machine 100. Discussed below is a
process
by which home therapy machine 100 receives one or more machine operating
prescriptions from a doctor or clinician remotely via the server 118 and
system hub
120 discussed above. When a machine operating prescription is installed onto
ACPU
112 of home therapy machine 100, the prescription comes with a set of
instructions or
secondary prescription that is forwarded from ACPU 112 to the -control
processor of
water treatment device 10. When that prescription for the home therapy machine
100
is then recalled by the user for treatment via home therapy machine 100, the
corresponding set of instructions or secondary prescription is recalled for
use with
water treatment device 10. In this third way, updating data during treatment
between
home therapy machine 100 and water treatment device 10 can be reduced or
eliminated.
[0076] A fourth way works on a batch or volume basis. Home therapy
machine 100 can include a dialysate holding tank. ACPU 112 can be configured
to
make dialysate when tank volume falls to a certain level and stop making
dialysate
when tank volume rises to a certain level. Here, water treatment device 10 is
tasked
with providing enough water to raise the low dialysate tank volume to the high
dialysate tank volume as opposed to being concerned with dialysate flowrate to
the
19
CA 02836575 2013-12-12
dialyzer. When tank volume hits the low level, ACPU 112 activates water
treatment
device 10 and the dialysate mixing pumps of home therapy machine 100 to
produce
dialysate and attempt to fill the dialysate holding tank. Water treatment
device 10 and
the dialysate mixing pumps remain activated until the designated high tank
volume is
reached. It is contemplated to maintain different dialysate production rates
for water
treatment device 10 and the dialysate mixing pumps, so that if the water
treatment
device 10 and the dialysate mixing pumps cannot meet demand at a lower rate of
production, they can be raised to a higher rate of dialysate production. As
ACPU 112
raises or lowers the dialysate production rate, the water treatment device 10
and the
dialysate mixing pumps are both adjusted accorsdingly.
[0077] While dialysate flowrate/purified water tlowrate and/or volume control
has been used to illustrate the leader/follower operating parameter
arrangements, it is
expressly contemplated to use the arrangements with other parameters, such as
parameters relating to the pressure, temperature and/or purity level of the
water exiting
water treatment device 10.
[0078] Referring now to FIG. 2, an example dialysis machine 100a includes a
water purification unit 10a, a dialysate preparation unit 224, a dialysate
delivery unit
2-30 and a disinfection unit 226. Controller 232 in one embodiment includes a
plurality
of controllers, each including processing and memory. Controller 232 can for
example
include a master or supervisory processor that controls a plurality of
delegate
processors, each of which are dedicated to various functions related to
dialysis
machine 100a. Controller 232 can also include redundant processing, such as a
safety
processor which ensures that each of the other processors is performing its
function
correctly.
[0079] Controller 232 can control any one or more of water purification unit
10a, dialysate preparation unit 224 and disinfection unit 226 in addition to
controlling
heater 234, pumps 236, valves 238 and sensors 240. Home therapy machine and
water
treatment device are shown as being separate in FIG. 1A, but they may be in
the same
housing as shown in FIG. 2. In one embodiment, the same user interface 122 may
be
used to control the controller 232, which may control any one or more of the
various
units, e.g., home therapy machine as well as water treatment device. The
dialysis
CA 02836575 2013-12-12
machine 100a may be powered by branch power 212 and/or supplemental power
supply 214.
Data Connection
[0080] Referring now to FIG. 3, FIG. 3 illustrates a subsystem 50 of system
110 between water treatment device 10 and home therapy machine 100. For
reference,
the simple display and electromechanical buttons discussed previously for
water
treatment device 10 are illustrated by display 20 and electromechanical
buttons 22.
Alternatively, water treatment device 10 only includes display 20 and provides
only
rudimentary input devices. The display on the water treatment device 10 may
augment
the user interface 122. The control processing and memory for water treatment
device
is illustrated by processing and memory 24. Also, as mentioned above, user
interface 122 of home therapy machine 100 is illustrated as being tethered or
connected to the home therapy machine 100. User interface 122 is alternatively
an
untethered tablet as has been described herein.
[0081] As illustrated in FIG. 3, a data communication link 32, e.g., Ethernet
or
wired communication, is provided to transmit data between processing and
memory 24
of water treatment device 10 and ACPU 112 of home therapy machine 100. In one
example, water treatment device 10 uses link 32 to send to the home therapy
machine
100 state or status information, component life information, sensor levels or
readouts,
self test results, alert and alarm information and hardware and/or software
version
information. The water treatment device 10 can also indicate information about
the
water flow between the water treatment device 10 and the home therapy machine
100
including flowrate information, water temperature information and line
connection
disinfection information.
[0082] As further illustrated in FIG. 3, data communication link 32 may also
be used to transmit data between ACPU 112 of home therapy machine 100 and
processing and memory 24 of water treatment device 10. As discussed above, or
in
addition to above, home therapy machine 100 can send to the water treatment
device
10 data regarding state change requests, commands (e.g., RUN, PAUSE or STOP),
status queries, flowrate change requests, software upgrades or downgrades,
and/or file,
e.g., device prescription, transfers.
21
CA 02836575 2013-12-12
[0083] As discussed herein, user interface 122 indicates information about the
water treatment device 10 to user 12. For example, the user interface 122 may
display
to user 12 information such as an alarm or an alert notice, water treatment
device
performance information, trouble shooting help, task guidance and/or action
requests.
For example, user 12 via user interface 122 can ask water treatment device 10
to
identify itself to ensure data connection 32 between machine 100 and device 10
is
functioning properly and to verify compatibility, such as hardware version and
software version compatibility, between device 10 and machine 100. If so,
device 10
can itself make an audible beep or answer and/or send a confirming message
back to
user interface 122, e.g., l am here-. The user 12 can then take appropriate
action,
either via user interface 122 or by performing some task indicated by the user
interface
122. To do so, user 12 need only interact with common user interface 122. In
this
way, user 12 can have minimal interaction with water treatment device 10, such
as to
perform a hard power-on and off, make physical data and power connections,
perform
filter changes and/or take manual measurements, while ensuring that water
treatment
device 10 is functioning properly and in communication with machine 100.
[0084] In addition to the data connection 32 between home therapy machine
100 and water treatment device 10, there is a water feed line 34 running from
water
treatment device 10 to home therapy machine 100. Water feed line 34 sends
water at a
specified level of sterility, flowrate, pressure and/or temperature to home
therapy
machine 100. Water sent from the water treatment device 10 to the home therapy
machine 100 is maintained typically at between about 5 C and 35 C. Line 34 may
in
one embodiment be used to return unused water product from home therapy
machine
100 to water treatment device 10.
[0085] In one embodiment, processing and memory 24 of water treatment
device 10 operate as a slave or delegate processor to the programmed ACPU 112
of
home therapy machine 100. The water treatment device 10 can inform the home
therapy machine 100 of its status, such as an alarm situation, and send any
other
pertinent data to ACPU 112. Home therapy machine 100 stores and acts upon the
data, e.g., decides whether to raise an alarm. Home therapy machine 100 thus
controls
the behavior of water treatment device 10.
22
CA 02836575 2013-12-12
[0086] Water treatment device 10 may be in any one of several different
states,
such as "Installation-, "System Rinse, "Hibernate" or -Therapy". Home therapy
machine 100 is responsible in one embodiment for requesting that water
treatment
device 10 changes states, e.g., from -Hibernate- to "Therapy". In "Hibernate",
water
treatment device 10 is maintained in a minimum power usage state. In
"Therapy",
water treatment device 10 is brought to a fully capable power level. As
discussed
above, the present system and method contemplate many ways of pairing water
treatment device 10 to home therapy machine 100 upon a request for water by
the
home therapy machine 100. In each alternative, water treatment device 10
provides
water suitable for treatment, and in a suitable quantity or flowrate, to home
therapy
machine 100.
[0087] Water treatment device 10 may send information to be displayed on the
user interface 122 to prompt necessary user actions. Water treatment device 10
may
send status information to the home therapy machine 100 asynchronously or in
response to a status query. The water treatment device 10 may also send error
packets
to the home therapy machine 100 in case of an error or an alarm. The home
therapy
machine 100 can decide what actions need to be taken and whether the user 12
should
be notified via user interface 122. If the user 12 needs to provide any input
for
clearing the alarm, the user 12 can do so via user interface 122. Water
treatment
device 10 is responsible for notifying home therapy machine 100 about its
current
state. Water treatment device 10 is also responsible for notifying home
therapy
machine 100 about any alarms or alerts.
[0088] When water is required for therapy, home therapy machine 100 in one
embodiment discussed above specifies to the water treatment device 10 the
desired
flowrate of the water. The water treatment device 10 then provides water at
the
desired flowrate. Or, as discussed above, water treatment device 10 calculates
or looks
up its flowrate based upon a therapy fluid flowrate sent from home therapy
machine
100. Or, as discussed above, water treatment device 10 determines its flowrate
from
its own device prescription. Still further as provided above, water treatment
device 10
and home therapy machine 100 can instead cooperate on a volumetric basis.
[0089] It should be appreciated that using and controlling both water
treatment
device 10 and home therapy machine 100 from the user interface 122 increases
safety,
23
CA 02836575 2013-12-12
minimizes the complexity of operating multiple devices and reduces the burden
of
therapy on patients at home. The functioning of water treatment device 10 and
the
home therapy machine 100 is also streamlined via the master/delegate processor
arrangement.
Installing Water Treatment Device
[0090] It is contemplated under system 110 for water treatment device 10 and
home therapy machine 100 to work together in many different ways, facilitated
in
many instances by common user interface 122. Referring now to FIG. 4, for
example,
process 400 illustrates an example process for installing or initially setting
up water
treatment device 10 using user interface 122 of home therapy machine 100. Upon
starting process 400 at the start oval, a user 12 connects water treatment
device 10 to
the home therapy machine 100 as shown at block 402, e.g., makes data
connection 32
and water line connection 34 discussed above. User interface 122 upon sensing
the
data connection prompts the user 12 whether the user would like to be guided
through
installation of the water treatment device 10, as shown at block 404. If the
user 12
selects "No", process ends at the end oval near block 404. If the user 12
selects "Yes",
user interface 122 prompts the user 12 to first install an RO cartridge and
press
"Confirm" on user interface 122, as shown at block 406.
[0091] When the user 12 presses -Confirm", home therapy machine 100
queries water treatment device 10 as to whether the RO cartridge is detected
and
correctly installed, as shown at block 408. If the RO cartridge is not
detected or not
correctly installed, water treatment device 10 reports an error condition as
shown at
block 410, and displays an error message on user interface 122, as shown at
block 411.
If the RO cartridge is detected and correctly installed, water treatment
device 10
responds at user interface 122 that the RO cartridge is present and provides
cartridge
information to the home therapy machine 100, as shown at block 412.
[0092] Next, user interface 122 displays to the user 12, "Now install the
pretreatment cartridge and press Confii _____________________________ in", as
shown at block 414. When the user 12
installs the cartridge and presses "Confirm- at user interface 122, home
therapy
machine 100 queries the water treatment device 10 as to whether the
pretreatment
cartridge is present, as shown at block 416. If the pretreatment cartridge is
not present
or there is an error, the water treatment device 10 responds with a
pretreatment
24
CA 02836575 2013-12-12
cartridge error, as shown at block 418, in which case the user interface 122
displays a
message to the user 12 that the pretreatment cartridge is not installed
properly, as
shown at block 420. If the pretreatment cartridge is present, the water
treatment
device 10 responds that the pretreatment cartridge is present and provides
cartridge
information to the home therapy machine 100, as shown at block 422.
[0093] Next, user interface 122 displays a message to the user 12 to connect
the water treatment device 10 to feed water, turn on the feed water and press
"Confirm", as shown at block 424. When the user 12 presses "Confirm", home
therapy machine 100 queries water treatment device 10 as to whether the feed
water
has been connected and/or whether the feed water pressure is acceptable, as
shown at
block 426.
[0094] Next, user interface 122 prompts the user 12 to, "Place the drain line
into the drain, and ensure that an air gap is present", as shown at block 428.
Once the
user 12 confirms these steps, user interface 122 displays a message to the
user 12 that
the water treatment device 10 will begin rinsing and that rinsing may take
several
hours, as shown at block 430. The user interface 122 also displays a "Rinse"
button.
Once the user 12 presses the displayed "Rinse" button, water treatment device
10
begins rinsing, as shown at block 432. A separate "Rinse" button accordingly
need not
be provided on water treatment device 10, although one may be provided for
redundancy. In any case, water treatment device 10 changes its state to
"Rinsing" and
informs home therapy machine 100 of this change in state, as shown at block
434.
User interface 122 displays, "Rinsing. Press Stop to Pause Rinse process", and
displays a -Stop" or "Pause" button accordingly, as shown at block 436. Water
treatment device 10 may also report the state of its valves and pumps in
addition to its
overall system mode, as shown at block 438. When the rinsing is complete, user
interface 122 displays that rinsing has been completed, as shown at block 440.
A
change of state is also reported to home therapy machine 100, as shown at
block 442.
Process 400 then ends as illustrated at the end oval.
[0095] It should be appreciated that while the steps of process 400 involve
specific functions to be performed on water treatment device 10, the display
of
instructions and user inputs for same occur on the user interface 122. Thus,
the user
CA 02836575 2013-12-12
12 can focus solely on user interface 122 to install the water treatment
device 10 and to
run treatment on home therapy machine 100.
Making Water
[0096] FIG. 5 illustrates an example process 500 for making water with water
treatment device 10 using user interface 122 of home therapy machine 100. Upon
starting process 500 at the start oval, home therapy machine 100 instructs
water
treatment device 10 to become active or "wake up" and produce water at a
specified
flowrate (or until a specified volume of dialysate is reached in the dialysate
holding
tank), as shown at block 502. In one embodiment, the water treatment device 10
performs necessary functions prior to producing water. Upon becoming active or
waking up, home therapy machine 100 performs startup activities, such as self-
tests,
rinsing, and safety checks. When water treatment device 10 has completed the
activities required, the device "wakes-up" and is ready to produce water, as
shown at
block 506. Home therapy machine 100 continuously queries water treatment
device
10's status and displays such status on user interface 122, as shown at block
508.
When water treatment device 10 is finished waking up and is ready to produce
purified
water, if home therapy machine 100 is occupied, as shown at block 510, water
treatment device 10 waits for the home therapy machine 100 to draw water, as
shown
at block 512. Once home therapy machine 100 is ready, home therapy machine 100
begins to draw water, as shown at block 514. User interface 122 displays to
the user
12 that the home therapy machine 100 is drawing water from water treatment
device
10, as shown at block 516.
[0097] User interface 122 may also provide an option for the user 12 to change
the water preparation flowrate of water treatment device 10 or to pause or
stop
production of same. Or as discussed above, home therapy machine 100 may
instruct
water treatment device 10 to change the flowrate based upon instructions
stored in the
ACPU 112. Water treatment device 10 in one embodiment is configured to change
its
recovery ratio based on demand. The RO units of water treatment device 10
produce
reject water. The reject water can be reclaimed and fed back into the RO
units,
reducing water actually rejected to drain, but doing so can reduce the service
life of the
RO units because feeding the RO units with recycled reject water can cause
fouling to
occur. However, in the event that home therapy machine 100 is not using all of
the
26
CA 02836575 2013-12-12
available stream of purified water produced by water treatment device 10, the
rejected
water stream from the RO units can be mixed with the excess purified water,
creating a
solution that is functionally equivalent to tap water, and which will not
cause excessive
fouling of the RO units. In this way, the water treatment device 10 can adjust
the
amount of rejected RO water to be recycled based upon the availability of
unused
purified water that can be mixed with the reject stream prior to reentering
the RO
units.
[0098] When home therapy machine 100 is finished drawing water, home
therapy machine 100 instructs water treatment device 10 to hibernate, as shown
at
block 518. In hibernate, water treatment device 10 continues to communicate
with
home therapy machine 100 to wait for an eventual command to wake-up again.
Also,
in hibernate water treatment device 10 may periodically perform rinses of its
flow path
after set periods of stagnation to maintain its performance in the absence of
a
command to wake-up. Water treatment device 10 changes its state to hibernate
and
conveys its state to the home therapy machine 100 for display to user 12, as
shown at
block 520. Process 500 then ends as illustrated at the end oval.
Starting Up Home Therapy Machine And Water Treatment Device
[0099] FIG. 6 illustrates an example process 600 for starting up home therapy
machine 100 and water treatment device 10 using user interface 122 of home
therapy
machine 100. Upon starting process 600 at the start oval, user interface 122
walks the
user 12 through start-up tests related to water treatment device 10, as shown
at block
602. For example, user interface 122 can ask the user 12 to check and run self
tests for
the UV light intensity, RO rejection percentage and total organic carbon
("TOC")
level, each associated with water treatment device 10. Other self tests
associated with
water treatment device 10 include, for example, whether or not remaining
pretreatment
cartridge life is sufficient.
[00100] The
water treatment device 10 self tests may include a
chlorine/chloramines test. For
example, the ACPU 112 may decide that a
chlorine/chloramines test should be run. The user interface 122 may prompt the
user
to collect a water sample from water treatment device 10 for testing,
optionally by
pressing a button on user interface 122. A chlorine/chloramines test is
performed, as
shown at block 603, and the user interface 122 displays to the user
27
CA 02836575 2013-12-12
chlorine/chloramines test result options (e.g. Pass or Fail) and may prompt
the user for
a response, as shown at block 606.
Depending upon the result of the
chlorine/chloramines test, process 600 may either complete other self testing
for
device 10, return to home therapy machine 100 self testing or proceed with a
different
task for the water treatment device 10.
[00101] Process
600 may accordingly interleave between steps 602 and
603 as shown by the dual direction arrows between steps 602 and 603. For
example, if
the water treatment device 10 does not pass the chlorine/chloramines test,
home
therapy machine 100 may signal to the water treatment device 10 that a
pretreatment
swap is required or that the sample needs to be retested to confirm a failure.
The water
treatment device 10 changes its system state to "Cartridge Swap" and confirms
the
state change to ACPU 112. User interface 122 displays to user 12 that water
treatment
device 10 requires a pretreatment cartridge swap. The user interface 122 then
walks
user 12 through the steps for swapping the pretreatment cartridge. Any errors
from the
water treatment device 10 are displayed to the user 12 via user interface 122,
or user
interface 122 may prompt the user for a response, as shown at block 606. Upon
completion of the steps for the pretreatment cartridge swap, the water
treatment device
changes its state and conveys its state to the home therapy machine 100 for
display
to user 12.
[00102] If all
the self tests associated with water treatment device 10
have positive results with no errors, user interface 122 transitions to
running self tests
for home therapy machine 100, as shown at block 604. Or, ACPU 112 may
alternate
self tests between home therapy machine 100 and water treatment device 10. In
other
words, it may not be desirable to run all of the home therapy machine 100 self
tests
first and then run the water treatment device 10 self tests, or vice versa, as
discussed
above. The self tests may be interleaved or run simultaneously. Process 600
may
accordingly interleave between steps 602, 603 and 604 as shown by the dual
direction
arrows between steps 602 and 603 and 602 and 604. At any time, the self test
for
either home therapy machine 100 or water treatment device 10 may display a
result to
or prompt user 12 for a response on user interface 122, as shown at block 606.
Such
interleaving of testing increases efficiency and saves time, while enabling
the user 12
to pay attention to a single user interface 122.
28
CA 02836575 2013-12-12
[00103] Process 600 ends as illustrated at the end oval, and may end
from any one of steps 602, 603 or 604, depending upon the results of the self
tests and
the order of interleaving between the self tests.
Performing Pre-treatment Cartridge/Membrane Swap
[00104] FIG. 7 illustrates an example process 700 for performing a
pre-
treatment cartridge swap in water treatment device 10 using user interface 112
of the
home therapy machine 100. Upon starting process 700 at the start oval, water
treatment device 10 checks whether the pre-treatment cartridge has completely
degraded, as shown at block 702. If the pre-treatment cartridge has not
completely
degraded, but needs to be changed soon, the water treatment device 10
transmits an
alarm over data connection 32 to the home therapy machine 100, as shown at
block
704. User interface 122 displays that the pre-treatment cartridge should be
changed
soon and presents options and selection buttons to user 12 as to whether the
user 12
wishes to change the pre-treatment cartridge now or later in one embodiment,
as also
shown at block 706. If the user selects, via user interface 122, to change the
pre-
treatment cartridge later, process 700 ends as illustrated at the end oval. If
the user
selects, via user interface 122, to change the pre-treatment cartridge now,
process 700
proceeds to step 712, described below.
[00105] If the pre-treatment cartridge has completely degraded and
needs to be changed immediately before water treatment device 10 can make
water,
water treatment device 10 transmits an alarm over data connection 32 to the
home
therapy machine 100, as shown at block 708, which causes user interface 122 to
display to the user 12 that the pre-treatment cartridge must be changed
immediately, as
shown at block 710.
[00106] If the user 12 elects at user interface 122 to change the
pre-
treatment cartridge now (in the case in which the pre-treatment cartridge is
not
necessary), or the pre-treatment cartridge must be changed immediately, the
user
interface 122 in one embodiment walks user 12 through the process of changing
the
pre-treatment cartridge, as shown at block 712. Instructions for user tasks
are
displayed on the user interface 122. Once the pre-treatment cartridge swap is
complete, water treatment device 10 changes its state, as shown at block 714,
which is
displayed to the user 12 via user interface 122, as shown at block 716. In
various
29
CA 02836575 2013-12-12
embodiments, process 700 may be used alternatively or additionally to perform
an RO
membrane swap. Process 700 then ends as illustrated at the end oval.
Setting Up And Using Supplies And Therapy Prescription
[00107] Medical products and drugs are shipped or delivered to a
patient's home for the home therapy machine 100 to use during treatment.
Typically,
only therapy products or drugs approved under a doctor's prescription can be
shipped
to the patient's home. In the U.S., such prescriptions typically last one
year, and
patients may have more than one prescription available to them at any given
time in
order to dynamically manage their condition. One or more prescription is
stored for
each patient in the system hub 120. Each home therapy machine 100 uses
supplies and
settings according to the prescription. If the patient's prescription changes
or if a
prescription is added, the patient's clinician uses web portal 150 to update
the settings
of home therapy machine 100 to change or add the prescription. If the home
therapy
machine 100 settings are updated, system hub 120 sends the updated settings to
home
therapy machine 100 via the connectivity service as discussed previously,
e.g., in one
embodiment, the home therapy machine 100 only communicates with system hub 120
when connectivity agent 114 is turned on.
[00108] Referring now to FIG. 8, process 800 illustrates an example
process for shipping inventory and programming a prescription for home therapy
machine 100 based upon a doctor's prescription for a particular patient. That
is, a
doctor associated with the clinic 152a to 152n can also access system hub 120
via web
portal 150 to deliver a therapy prescription for the patient (used for both
supplies and
machine operation) to the clinician. Upon starting process 800 at the start
oval, the
clinician retrieves an electronic prescription prescribed by a doctor using
the web
portal 150 as shown at block 802. At the web portal 150, the clinician selects
the
dialyzer, blood tubing set, acid, bicarbonate, needles, etc. and any other
supplies,
including possibly supplies for water treatment device 10, necessary to
fulfill the
prescription to run on home therapy machine 100. The selected dialyzer and
other
supplies will be shipped to the patient's home as shown at block 804.
[00109] At the same or different time, the clinician may remotely
access
the system hub 120 through the web portal ISO to program a prescription for
home
therapy machine 100, as shown at block 806. The system hub 120 holds the
therapy
CA 02836575 2013-12-12
prescription in one embodiment until the connectivity agent 114 on a home
therapy
machine 100 is turned on, as shown at blocks 820 to 824.
[00110] The clinician sets various treatment parameters used to
program
a prescription for the home therapy machine 100 as shown at block 808, such as
blood
flowrate, dialysate tlowrate, UF volume and heparin flowrate flush. In one
embodiment, the settings specified by the clinician include settings for
operating the
water treatment device 10 or may affect the parameters for water treatment
device 10,
as explained above, so separately setting parameters for water treatment
device 10 is
not necessary. Or, the clinician may separately set various treatment
parameters used
to program a prescription for the water treatment device 10, as shown at block
810.
[00111] The clinician also specifies allowed ranges for the various
settings as shown at block 812. That is, the patient may be allowed to pick
within a
range of values for certain parameters under the specified therapy
prescription. In this
manner, the patient has a certain amount of control over the treatment that is
performed. Dialysate temperature, for example, may be set within a range of
allowable values based upon patient preference and comfort. The clinician
further
specifies whether or not the patient will have the ability to modify the
settings at all as
shown at block 814. If the patient is allowed to modify parameter settings,
the setting
variability is within an allowed range, such that the patient picks a value
inside the
range specified by the clinician at block 812. The clinician then submits the
settings to
the system hub 120 as shown at block 816.
[00112] The system hub 120 then sends the therapy prescription to
the
connectivity server 118 as shown at block 818. When the connectivity agent 114
residing at home therapy machine 100 is next turned on or enabled as shown at
block
820, home therapy machine 100 checks the connectivity server 118 for a therapy
prescription as shown at block 822. If a therapy prescription is present at
the
connectivity server 118 for the home therapy machine 100, connectivity server
118
sends the therapy prescription to the home therapy machine 100 as shown at
block
824. Machine 100 prompts the patient to accept the therapy prescription. In
one
embodiment, the patient must accept the therapy prescription to continue using
the
home therapy machine 100, as shown at block 826.
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CA 02836575 2013-12-12
[00113] In one embodiment, the therapy prescription downloaded from
the connectivity server 118 may be a new or updated prescription, meant to
replace a
previous therapy prescription already on the machine 100. Before treatment
begins,
e.g., after disinfection the day before, ACPU 112 of home therapy machine 100
checks
whether the connectivity service via agent 114 has posted an updated therapy
prescription for that particular home therapy machine 100. To do so, in one
embodiment, the home therapy machine 100 and the system hub 120, through the
connectivity service, compare prescription version numbers to determine
whether
home therapy machine 100 has the most updated prescription. If not, the most
recent
prescription version is delivered to therapy machine 100. Machine 100 will not
run an
old therapy prescription if a new therapy prescription has been downloaded
from
connectivity server 118 and is present on machine 100. However, the new
therapy
prescription will not overwrite the old therapy prescription until the patient
accepts the
therapy prescription as shown at block 826. In this manner, the patient
confirms that
the patient knows that his or her treatment has changed. Upon accepting the
new
therapy prescription, the new therapy prescription is written into the memory
of
therapy machine 100. In an alternative embodiment, machine 100 can store
multiple
therapy prescriptions in memory so even when a new therapy prescription is
downloaded, the old therapy prescription is kept in memory. Machine 100 may be
able to store different types or categories of therapy prescriptions. Each
different type
of therapy prescription may provide a different treatment, e.g., to remove a
low
amount, medium amount, or large amount of ultrafiltration for dialysis. The
machine
100 may be able to store one therapy prescription in each category.
[00114] ACPU 112 receives the settings and separates the home
therapy
machine 100 settings from the water treatment device 10 settings and sends the
water
treatment device 10 settings over the data connection 32 to the water
treatment device
10, as shown at block 827. The settings may be flagged as being intended for
the
home therapy machine or the water treatment device 10. Or, the ACPU 112 may
recognize characteristics in the settings as inherent to the water treatment
device 10
and pass those settings to the water treatment device 10. The next time the
patient is
about to perform treatment, the connectivity agent 114 is turned off as shown
at block
828. The home therapy machine 100 as shown at block 830 now runs a treatment
32
CA 02836575 2013-12-12
using the therapy prescription specified at blocks 808 and/or 810. Home
therapy
machine 100 writes treatment data produced by the treatment to the log files
as shown
at block 832. Again, the log files document pertinent home therapy machine 100
data
and pertinent water treatment device 10 data over the course of the treatment.
In one
embodiment, the water treatment device 10 sends its own log tiles to the home
therapy
machine 100. The home therapy machine 100 appends the data from the water
treatment device 10 to the log files of the home therapy machine 100. The next
time
connectivity agent 114 is turned on, the combined log files stored in the home
therapy
machine 100 are sent to connectivity server 118.
[00115] Connectivity agent 114 is turned on as shown at block 834.
In
one embodiment, the home therapy machine 100 initiates the connection to the
connectivity service. In an alternative embodiment, the connectivity service
may
initiate the connection to the home therapy machine 100. At block 836, the log
files
are uploaded to connectivity server 118. Process 800 then ends as illustrated
at the end
oval.
[00116] In one embodiment, machine 100 can perform post treatment
procedures, such as a disinfection procedure that cleans the machine and the
disposables used for treatment for the next treatment. In one embodiment,
system 110
allows the connectivity agent to be turned on at block 834 after treatment but
while
post-treatment disinfection is taken place. Writing treatment data at block
832 can
also be done during disinfection. Alternatively, the home therapy machine 100
waits
to write data at block 832 or turn on the connectivity agent at block 834
until
disinfection is completed and the machine 100 enters an idle mode.
[00117] In the illustrated embodiment, because the connectivity
agent
114 turns off before treatment and does not turn on again until after
treatment, system
110 provides no real-time monitoring of a treatment. Events that occur during
a
treatment, including alarms and alerts, are not reported to the system hub 120
immediately. Such information is part of the log files that are sent to the
system hub
120 after treatment. In an alternative embodiment, the connectivity agent 114
may
remain on during treatment and may report information about the home therapy
machine 100 and the treatment in real-time.
Firmware Upgrades
33
CA 02836575 2013-12-12
[00118] From time to time, the software that ACPU 112 runs on home
therapy machine 100 and/or the software that runs on processing and memory 24
on
water treatment device 10, which may also be referred to herein as firmware,
may need
to be upgraded. The home medical device system 110 provides an efficient and
reliable manner for upgrading firmware that integrates the product development
team
128 and service personnel 132a to 132n (Fig. 1A).
[00119] FIG. 9 illustrates an example process 900 for upgrading
firmware on the home therapy machine 100. Upon starting process 900 at the
start
oval, a product development team 128 develops a firmware upgrade for home
therapy
machine or water treatment device 10, as shown at block 902. At block 904, the
product development team 128 uploads the firmware upgrade to the system hub
120.
The service portal 130 then allows a service personnel director or decision-
maker 134
to view and approve the upgrade. Upon approving the upgrade, director 134
uploads
the upgrade from system hub 120 to the connectivity server 118, as shown at
block
906. In the illustrated embodiment of FIG. 1A, director 134 is separate from
the
service personnel 132a to 132n that are responsible for servicing and
maintaining
home therapy machines 100 and water treatment devices 10, and for maintaining
relationships with the patients. Service personnel director 134 not only has
the
authority to finalize whether the upgrade is sent to the connectivity server
118, director
134 can also designate which machines 100 and/or water treatment devices 10
receive
the upgrade, if not all machines 100 or devices 10, and refuse the upgrade or
return it
to the product development team 128 for refinement. Once an upgrade is allowed
to
reach connectivity server 118, service personnel 132a to 132n, or designated
ones
thereof, can view the firmware upgrade through service portal 130 as
illustrated at
block 908. In one embodiment, the product development team 128 uploads the
firmware upgrade directly to the connectivity server 118, without going
through the
system hub 120.
[00120] As discussed above in connection with FIG. 1A, service
personnel I 32a to 132n manage the day-to-day relationship with the patients.
Service
personnel 132a to 132n are familiar with patient schedules and are in the best
position
to determine when a patient should receive the firmware upgrade. For example,
service personnel 132a to 132n will know the maintenance and activity schedule
for
34
CA 02836575 2013-12-12
the home therapy machines 100 and corresponding water treatment devices 10
that
they normally service. If the patient's machine 100 and/or water treatment
device 10
is scheduled to soon receive a part needed for the firmware upgrade, then the
service
personnel 132a to 132n can wait until the new part is installed before
upgrading the
firmware (which may, for example, need the new part) on the patient's home
therapy
machine 100 and/or water treatment device 10.
[00121] Each service personnel 132a to 132n selects which of its
designated home therapy machines 100 and/or water treatment devices 10 should
receive the firmware upgrade as shown at block 910. The next time connectivity
agents 114 on the selected home therapy machines 100 are turned on, as shown
at
block 912, connectivity server 118, waiting for the agents to be turned on,
sends the
upgrade to the selected home therapy machines 100 and/or water treatment
devices 10
as shown at block 914.
[00122] In one embodiment, the selected home therapy machines 100
and/or water treatment devices 10 may decide, based upon settings stored in
the ACPU
112 and/or processing and memory 24, whether or not to accept the upgrade, as
shown
at block 916. If the selected home therapy machines 100 and/or water treatment
devices 10 selects not to upgrade, process 900 ends as shown at block 916 and
the end
oval. If any of the selected home therapy machines 100 and/or water treatment
devices
accept the upgrade, the corresponding patients are prompted via user interface
112
as to whether they would like to install the upgrade, as shown at block 918.
If the
patients, via user interface 112, do not choose to upgrade the selected home
therapy
machines 100 and/or water treatment devices 10, the process 900 ends as shown
at
block 920 and the end oval. If the patients, via user interface 112, choose to
upgrade
the selected home therapy machines 100 and/or water treatment devices 10, the
upgrade(s) are performed, and the home therapy machines 100 inform the
patients, via
user interface 112 that the software has been upgraded as shown at block 922.
Some
countries require by law that patient approval must be obtained before
upgrading a
patient's firmware. In one embodiment, system 110 may require that only home
therapy machines 100 in countries that require patient approval prompt
patients to
accept the firmware upgrade at blocks 918 and 920.
CA 02836575 2013-12-12
[00123] Home therapy machines 100 may be allowed to retain the
ability
to revert back to a previous software version for either or both of machine
100 or
device 10. For example, if a firmware upgrade is con-upt, or if the firmware
on a home
therapy machine 100 or water treatment device 10 becomes corrupt, home therapy
machine 100 in an embodiment is allowed to revert back to a previous, non-
corrupt
software version. Alternatively, home therapy machine 100 cannot revert back
to a
previous software version. Here, if the software is or becomes corrupted, new
software is installed or home therapy machine 100 or water treatment device 10
is
swapped with a new home therapy machine 100 or water treatment device 10.
[00124] The connectivity service at server 118 documents all events
related to firmware upgrades, such as which patients have received upgrades,
and
which service personnel 132a to 132n have been involved in the upgrades. The
connectivity server 118 stores serial numbers, tracking numbers and software
versions
so the various steps in the upgrade process are documented and so that at any
given
moment the current software version of each machine 100 and device 10 on
system
110 can be readily obtained. At the end oval in FIG. 9, process 900 ends.
[00125] As discussed above, any software updates for the water
treatment device 10 can also be sent to the water treatment device 10 through
the home
therapy machine 100. Home therapy machine 100 can receive a combined software
upgrade that contains software upgrades for both the home therapy machine 100
and
the water treatment device 10. Or, the upgrades can be delivered separately.
The
ACPU 112 then analyzes and separates the software contents for the home
therapy
machine 100 from the software contents for the water treatment device 10. In
particular, the ACPU 112 can recognize which software contents are intended
for the
home therapy machine 100 and which software contents are intended for the
water
treatment device 10. For example, the software contents may inherently look or
include content that is particular to either the home therapy machine 100 or
the water
treatment device 10. Or, the software content may be flagged as being for the
home
therapy machine 100 or the water treatment device 10. The home therapy machine
100 then sends the software contents for the water treatment device 10 over
the data
connection 32 to the water treatment device 10.
36
CA 02836575 2013-12-12
[00126] Firmware upgrades may additionally be provided in the manner
described above for other home components of system 10, e.g., tablet 122,
blood
pressure monitor 104 and/or scale 106.
Clinician Dashboard With Rule-Evaluation
[00127] A clinician can view a list of the clinician's patients and
a file
for each patient showing how treatments for the patients have transpired. The
treatment files are derived from the log files in the home therapy machine
100,
including flowrates achieved, ultrafiltrate removal, ultrafiltration rates
achieved, blood
pressure over the course of therapy, weight, etc. The log files may also
include
treatment data for water treatment device 10 as described above. Stored
treatment data
for water treatment device 10 can include for example, total purified water
volume
delivered, average water temperature, average water pressure, number of
delivery
requests from machine 100, alerts and alarm information, chlorine/chloramines
levels,
and/or component use or replacement information.
[00128] A clinician can sort the list of patients by numerous
categories,
including the type of treatment they have received, e.g., hemodialysis (sub-
categorized
as for example short daily, nocturnal, every other day, and every other
night),
peritoneal dialysis (sub-categorized as continuous cycling peritoneal dialysis
(-CCPD"), tidal, for example), the supervising doctor, or by the notifications
described
below. A clinician can also view a patient snapshot and an overview for the
week,
month or other duration.
[00129] Web portal 150 provides a clinician dashboard having
notifications about events that occurred during treatment. In one embodiment,
the
notifications include colored flags, with different colors corresponding to
different
notification conditions. The clinicians can choose which events generate the
red or
yellow flags that appear on the dashboard. In one embodiment, the flag
settings are
clinic-specific, not patient-specific. Thus, choosing to be notified about
certain events
applies to all patients in the clinic or under the clinician's case. For
example, a
clinician may set a rule that a yellow flag should appear on the dashboard if
a
treatment lasted less than four hours. This rule would then apply to all
patients at that
clinic or under that clinician's care. The dashboard will indicate, e.g., with
yellow
flags, any patients who have undergone a treatment that lasted less than four
hours.
37
CA 02836575 2013-12-12
The flags may also pertain to water treatment device 10, e.g., post a flag
when a
disposable component of water treatment device 10 has less than ten hours of
service
left, or post a red flag if tested chlorine/chloramines reaches a certain
level.
[00130] FIG. 10A
illustrates an example dashboard screen 1000 for a
clinic on a clinician's display device 192. Dashboard
screen 1000 is in one
implementation the first screen a clinician sees upon logging into the web
portal 150.
Dashboard screen 1000 provides an overview of information about the patients
handled by that clinic, as well as how the treatments performed by home
therapy
machine 100 and water treatment device 10
[00131] The
patients are listed by name as shown at column 1002.
Dashboard 1000 may enable the clinician to apply filters as illustrated by
drop down
menu 1010. For example, the clinician in the illustrated embodiment can filter
information in the dashboard by patient type (not shown), by physician at
dropdown
menu 1012, or by the status of a patient (not shown). The clinician can also
filter
information in the dashboard to only show treatments for which there has been
no
communication using checkbox 1014, or to only show treatments for which a flag
has
been generated using checkbox 1016. The filters allow the clinician to hone in
on
particular, desired information.
[00132] Various
icons 1004, 1006 and 1008 indicate information about a
treatment performed by that patient on a specific date. Icons 1004, 1006 and
1008
may indicate different types of events. For example, icon 1004 may be used to
indicate that a treatment performed by the home therapy machine 100 and water
treatment device 10 has been performed successfully. Icon 1006 may be used to
notify
the clinician about events that are not critical and do not need immediate
action, but
need to be closely monitored in the future. Icon 1008 for example may be used
to
notify the clinician of events that need immediate action.
[00133] A user is
able to access a legend using link 1018. When a user
selects link 1018, a popup window or new screen 1050 appears. FIG. 10B
illustrates
an example legend screen 1050 on a clinician's display device 192 that
explains the
various icons that can appear on dashboard screen 1000. Icon 1004 indicates
that the
treatment performed by home therapy machine 100 and water treatment device 10
went "Ok." Icon 1008 indicates a high priority flag. Icon 1006 indicates a
flag of
38
CA 02836575 2013-12-12
normal priority. Icon 1010 indicates that there has been no communication with
the
home therapy machine 100 associated with that patient for a specific
treatment.
[00134] In one embodiment, the dashboard also displays information
collected by the water treatment device 10 in the water treatment device 10
log files.
FIG. 11A illustrates an example treatment summary screen 1100, which is part
of the
clinician dashboard or accessible via a link from the dashboard, on a
clinician's
display device 192. Treatment summary screen 1100 provides granulated details
about
a particular treatment performed on a patient by home therapy machine 110 and
water
treatment device 10 as collected in the log files as described above. FIG. 11A
shows
information about a treatment performed by home therapy machine 100 and water
treatment device 10 on July 31, 2010, as indicated at chart 1102. From
treatment
summary screen 1100, a clinician can see a description of the flag symbols at
chart
1101. The clinician can also view the date, start time and total dialysis time
at chart
1102, the prescribed device program at chart 1104 and overall treatment
summary log
in table format showing exact times for various treatment events for home
therapy
machine 100 and/or water treatment device 10 at chart 1106. The treatment
summary
screen 1100 also indicates information collected from water treatment device
10. For
example, item 1107 in chart 1106 indicates to a clinician that water treatment
device
registered a cold water alert at time 20:41:13. Any of the alerts or events
documented in the log files and displayed on the clinician dashboard may also
have
been communicated to the user 12 via user interface 122 during the therapy at
the time
the alert or event occurred.
[00135] The screen 1100, displayed on a clinician's display device
192,
is continued on FIG. 11B. As shown in FIG. 11B, a clinician can view fluid
management particulars at chart 1108, information about the treatment dose at
chart
1110, heparin particulars at chart 1112, dialyzer extended use data at chart
1114, blood
pressure at chart 1116, and pulse particulars at chart 1118. A clinician can
also view
information about pretreatment samples taken for comparison purposes at chart
1120,
including the time 1121 that a water sample was taken from water treatment
device 10.
A clinician can also view details about the prescribed device program at chart
1122.
The clinician can also view the device ID of the home therapy machine 100 and
the
39
CA 02836575 2013-12-12
software versions of the home therapy machine 100 as well as the water
treatment
device 10 at chart 1124.
[00136] FIG. 12 illustrates an example patient usage report 1200
that
may be presented to a clinician at web portal 150 on a clinician's display
device 192.
The example patient usage report 1200 allows a clinician to view the amount of
product or consumables utilized by home therapy machine 100 and water
treatment
device 10 in treating a specific patient over a specified time frame. In the
patient
usage report 1200, the clinician can view the treatment month 1202 as well as
information relating to usage by home therapy machine 100, such as the
dialyzer used
1204, the blood treatment set used 1206, the acid concentrate used 1208 and
the
bicarbonate concentrate used 1210. The clinician can also view information
relating to
usage by water treatment device 10, such as the water pre-filters used 1212
and the
water distribution loop used 1214. Thus, the clinician can view information
about the
usage of consumables over one or several treatments that relate to the home
therapy
machine 100 as well as the water treatment device 10.
Additional Aspects Of The Present Disclosure
[00137] Aspects of the subject matter described herein may be useful
alone or in combination with any one or more of the other aspect described
herein.
Without limiting the foregoing description, in a first aspect of the present
disclosure, a
home medical device system includes a home therapy machine for performing a
home
therapy on a patient; a user interface operably connected to the home therapy
machine,
the user interface receiving operator inputs; a water treatment device in
fluid
communication with the home therapy machine; and a data connection between the
home therapy machine and the water treatment device, wherein the home therapy
machine transmits data via the connection to the water treatment device for
control of
the water treatment device, the data provided based on at least one of the
operator
inputs received via the user interface.
[00138] In accordance with a second aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
water treatment device transmits to the home therapy machine at least one of
(i) state
information, (ii) component life information, (iii) self test results, (iv)
alert information
or (v) version information.
CA 02836575 2013-12-12
[00139] In accordance with a third aspect of the present disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
user interface displays at least one of (i) the state information, (ii) the
component life
information, (iii) the self test results, (iv) the alert information or (v)
the version
information.
[00140] In accordance with a fourth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
home therapy machine transmits to the water treatment device at least one of
(i) state
change requests, (ii) status queries, (iii) flowrate change requests, (iv)
software
upgrades or downgrades, or (v) file transfers.
[00141] In accordance with a fifth aspect of the present disclosure,
which may be used in combination with any one or more of the preceding
aspects,
wherein the user interface displays at least one of (i) the state change
requests, (ii) the
status queries, (iii) the flowrate change requests, (iv) the software upgrades
or
downgrades, or (v) the file transfers.
[00142] In accordance with a sixth aspect of the present disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
at least one operator input leading to the transmitted data concerns a water
treatment
device parameter.
[00143] In accordance with a seventh aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
at least one operator input leading to the transmitted data concerns a home
therapy
machine parameter, the transmitted data an automatic result of a change in the
home
therapy machine parameter.
[00144] In accordance with an eighth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, a
home therapy medical system includes a home therapy machine for performing a
home
therapy on a patient; a user interface operably connected to the home therapy
machine,
the user interface receiving operator inputs; a water treatment device in
fluid
communication with the home therapy machine; a server in data flow
communication
with the home therapy machine; and a data connection between the home therapy
machine and the water treatment device, wherein the home therapy machine
transmits
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data via the connection to the water treatment device, the data based on a
therapy
prescription sent from the server to the home therapy machine.
[00145] In accordance with a ninth aspect of the present disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
transmitted data is for control of the water treatment device.
[00146] In accordance with a tenth aspect of the present disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
therapy prescription specifies the data transmitted from the home therapy
machine to
the water treatment device.
[00147] In accordance with an eleventh aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
therapy prescription specifies an operating parameter for the home therapy
machine,
the transmitted data based on the specified operating parameter.
[00148] In accordance with a twelfth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
home therapy machine determines the transmitted data based on the specified
operating parameter.
[00149] In accordance with a thirteenth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
water treatment device uses the data to determine a corresponding operating
parameter
for the water treatment device.
[00150] In accordance with a fourteenth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding, the
server is
configured to send a software upgrade to the home therapy machine, the
software
upgrade if meant for the water treatment device forwarded by the home therapy
machine to the water treatment device.
[00151] In accordance with a fifteenth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
software upgrade is automatically installed on the water treatment device or
installed
upon acceptance by a user via the user interface.
[00152] In accordance with a sixteenth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
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server is in data communication with a service computer, the service computer
enabling a service person to access the water treatment device via the data
connection
with the home therapy machine to perform at least one service procedure.
[00153] In accordance with a seventeenth aspect of the present
disclosure, which may be used in combination with any one or more of the
preceding
aspects, upon startup, the home therapy machine is configured to determine if
the
water treatment device is in a hibernation mode and if so to perform a startup
procedure not involving the water treatment device.
[00154] In accordance with an eighteenth aspect of the present
disclosure, which may be used in combination with any one or more of the
preceding
aspects, the home therapy medical system is configured to enable a user via
the user
interface to run at least one self test for the home therapy machine and at
least one self
test for the water treatment device.
[00155] In accordance with a nineteenth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, a
home therapy medical system includes a home therapy machine for performing a
home
therapy on a patient; a user interface operably connected to the home therapy
machine,
the user interface receiving operator inputs; a water treatment device in
fluid
communication with the home therapy machine; a server in data flow
communication
with the home therapy machine; and a data connection device between the home
therapy machine and the water treatment device, wherein the water treatment
device is
configured to transmit data via the data connection to the home therapy
machine,
which forwards the data to the server.
[00156] In accordance with a twentieth aspect of the present
disclosure,
which may be used in combination with any one or more of the preceding
aspects, the
transmitted data includes treatment log data.
[00157] In accordance with a twenty-first aspect of the present
disclosure, which may be used in combination with any one or more of the
preceding
aspects, the transmitted data includes component usage or component
replacement
data.
[00158] In accordance with a twenty-second aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
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connection with FIG. I may be used in combination with any one or more of the
preceding aspects.
[00159] In accordance with a twenty-third aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 1A may be used in combination with any one or more of the
preceding aspects.
[00160] In accordance with a twenty-fourth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 2 may be used in combination with any one or more of the
preceding aspects.
[00161] In accordance with a twenty-fifth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 3 may be used in combination with any one or more of the
preceding aspects.
[00162] In accordance with a twenty-sixth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 4 may be used in combination with any one or more of the
preceding aspects.
[00163] In accordance with a twenty-seventh aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 5 may be used in combination with any one or more of the
preceding aspects.
[00164] In accordance with a twenty-eighth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 6 may be used in combination with any one or more of the
preceding aspects.
[00165] In accordance with a twenty-ninth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 7 may be used in combination with any one or more of the
preceding aspects.
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[00166] In accordance with a thirtieth aspect of the present
disclosure,
any of the structure and functionality illustrated and described in connection
with FIG.
8 may be used in combination with any one or more of the preceding aspects.
[00167] In accordance with a thirty-first aspect of the present
disclosure,
any of the structure and functionality illustrated and described in connection
with FIG.
9 may be used in combination with any one or more of the preceding aspects.
[00168] In accordance with a thirty-second aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 10A may be used in combination with any one or more of
the
preceding aspects.
[00169] In accordance with a thirty-third aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 10B may be used in combination with any one or more of
the
preceding aspects.
[00170] In accordance with a thirty-fourth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 11A may be used in combination with any one or more of
the
preceding aspects.
[00171] In accordance with a thirty-fifth aspect of the present
disclosure,
any of the structure and functionality illustrated and described in connection
with FIG.
I 1B may be used in combination with any one or more of the preceding aspects.
[00172] In accordance with a thirty-sixth aspect of the present
disclosure, any of the structure and functionality illustrated and described
in
connection with FIG. 12 may be used in combination with any one or more of the
preceding aspects.
[00173] It should be understood that various changes and
modifications
to the presently preferred embodiments described herein will be apparent to
those
skilled in the art. Such changes and modifications can be made without
departing from
the spirit and scope of the present subject matter and without diminishing its
intended
advantages. It is therefore intended that such changes and modifications be
covered by
the appended claims.
