U.S. patent application number 15/703628 was filed with the patent office on 2018-01-11 for system and method for providing automatic setup of a remote patient care environment.
The applicant listed for this patent is Cardiac Pacemakers, Inc.. Invention is credited to Larry D. Canady, Kimberly S. Gerst, Bharat K. Jain, Benjamin L. Somberg.
Application Number | 20180011932 15/703628 |
Document ID | / |
Family ID | 39153074 |
Filed Date | 2018-01-11 |
United States Patent
Application |
20180011932 |
Kind Code |
A1 |
Gerst; Kimberly S. ; et
al. |
January 11, 2018 |
SYSTEM AND METHOD FOR PROVIDING AUTOMATIC SETUP OF A REMOTE PATIENT
CARE ENVIRONMENT
Abstract
A system and method for providing automatic setup of a remote
patient care environment. Connectivity to a centralized server over
a network connection is confirmed. Data reporting for a patient by
one or more monitoring devices that are wirelessly connectable is
induced through control provided through a user interface. Each of
the devices is registered as the device attempts to establish a
wireless connection and report the data conditioned on permission
for access. Upon granting of the permission for access, the device
is wirelessly connected and the data is subsequently received over
the wireless connection.
Inventors: |
Gerst; Kimberly S.; (Eden
Prairie, MN) ; Somberg; Benjamin L.; (Shoreview,
MN) ; Jain; Bharat K.; (Eden Prairie, MN) ;
Canady; Larry D.; (Ham Lake, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Pacemakers, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
39153074 |
Appl. No.: |
15/703628 |
Filed: |
September 13, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11516300 |
Sep 5, 2006 |
9773060 |
|
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15703628 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
H04W 12/0013 20190101;
G06Q 50/24 20130101; H04L 63/0428 20130101; H04L 69/40 20130101;
H04L 63/12 20130101; H04W 84/18 20130101; H04L 67/04 20130101; A61B
5/0002 20130101; G16H 40/67 20180101; G06F 19/3418 20130101; H04W
12/08 20130101; G06F 16/95 20190101; H04W 12/06 20130101 |
International
Class: |
G06F 17/30 20060101
G06F017/30; H04W 12/06 20090101 H04W012/06; A61B 5/00 20060101
A61B005/00; G06Q 50/24 20120101 G06Q050/24; G06F 19/00 20110101
G06F019/00; H04L 29/08 20060101 H04L029/08; H04L 29/14 20060101
H04L029/14 |
Claims
1. A system for providing automatic setup of a remote patient care
environment, comprising: one or more medical devices configured to
collect and report patient data; and a patient management device
configured to interface to the one or more medical devices, the
patient management device comprising: a configuration module
configured to establish an initial connection with each of the
medical devices by inducing data reporting by each medical device,
wherein the induced data reporting causes the configuration module
to execute an automated setup procedure enabling the initial
connection and subsequent connections between each of the medical
devices and the patient management device; a lookup module
configured to: register each of the medical devices on a list of
devices having permission for access during the automated setup
procedure, and look up each of the medical devices on the list of
devices having permission for access as each medical device
attempts to establish a connection subsequent to the initial
connection; and a storage device configured to receive the reported
patient data from the one or more medical devices when identified
as on the list of devices having permission for access.
2. A system according to claim 1, wherein one or more of the
medical devices are reconfigured by specifying operational
parameters to the device.
3. A system according to claim 2, wherein the operational
parameters are selected from the group comprising personal
identification number, service name, and time clock.
4. (canceled)
5. A system according to claim 1, wherein the registration of each
device is restricted by class.
6. (canceled)
7. (canceled)
8. A system according to claim 1, wherein at least one of patient
profiles and device configurations are retrieved by the patient
management device from a centralized server over a network
connection.
9. A system according to claim 1, wherein the patient management
device further comprises a reporting module to provide a status to
the centralized server of each device that has been granted the
permission for access.
10. (canceled)
11. (canceled)
12. A system according to claim 1, wherein at least one of the
devices to which permission for access has previously been granted
is wirelessly reconnected and further data is subsequently received
over the wireless connection.
13. A system according to claim 12, wherein the further data has
been temporarily stored due to an unsuccessful wireless
reconnection attempt.
14. A system according to claim 1, wherein the initial and
subsequent connections are a Bluetooth connection.
15. A system according to claim 1, wherein the one or more medical
devices comprise one of implantable medical devices and external
medical devices.
16. A system according to claim 15, wherein the external medical
devices are selected from the group consisting of: external devices
that operate autonomously; external devices that operate under
patient, attendant, or caregiver control; and external devices that
include a user interface for receiving or providing subjective
feedback or communications.
17. A method for providing automatic setup of a remote patient care
environment, comprising: inducing data reporting by each of one or
more medical devices that are configured to collected and report
patient data, wherein inducing data reporting establishes an
initial connection with each of the medical devices, wherein the
induced data reporting causes the configuration module to execute
an automated setup procedure enabling the initial connection and
subsequent connections between each of the medical devices and the
patient management device; registering, by a lookup module, each of
the medical devices on a list of devices having permission for
access during the automated setup procedure; looking up each of the
medical devices on the list of devices having permission for access
as each medical device attempts to establish a connection
subsequent to the initial connection; and receive the reported
patient data from the one or more medical devices when identified
as on the list of devices having permission for access wirelessly
connecting with the device upon granting of the permission for
access and subsequently receiving the data over the wireless
connection.
18. A method according to claim 17, further comprising:
reconfiguring one or more of the devices by specifying operational
parameters to the device.
19. (canceled)
20. A method according to claim 18, wherein the operational
parameters are specified through at least one of the user interface
and the centralized server.
21. A method according to claim 17, further comprising: restricting
the registration of each device by class.
22. (canceled)
23. (canceled)
24. A method according to claim 17, further comprising: retrieving
at least one of patient profiles and device configurations from the
centralized server over the network connection.
25. A method according to claim 17, further comprising: providing a
status to the centralized server of each device that has been
granted the permission for access.
26. (canceled)
27. (canceled)
28. A method according to claim 17, further comprising: wirelessly
reconnecting with at least one of the devices to which permission
for access has previously been granted and subsequently receiving
further data over the wireless connection.
29. A method according to claim 28, wherein the further data has
been temporarily stored due to an unsuccessful wireless
reconnection attempt.
30. (canceled)
31. (canceled)
32. A method according to claim 17, wherein the external medical
devices are selected from the group consisting of: external devices
that operate autonomously; external devices that operate under
patient, attendant, or caregiver control; and external devices that
include a user interface for receiving or providing subjective
feedback or communications.
33. (canceled)
34. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 11/516,300, filed on Sep. 5, 2006, pending,
the disclosure of which is incorporated by reference, and the
priority filing date of which is claimed.
FIELD OF THE INVENTION
[0002] The invention relates in general to remote patient care and,
specifically, to a system and method for providing automatic setup
of a remote patient care environment.
BACKGROUND OF THE INVENTION
[0003] Remote patient management enables a clinician, such as a
physician, nurse, or other healthcare provider, to follow patient
well-being through homecare medical devices that can collect and
forward patient data without requiring the presence or assistance
of medical personnel. Remote patient management can be provided
over a data communications network, such as the Internet. One or
more medical devices per patient are remotely interconnected with a
centralized server via dedicated patient management devices, such
as repeaters, installed in patients' homes. The patient management
devices supplement traditional programmers that interrogate patient
medical devices in-clinic. This infrastructure allows patient
well-being to be continually monitored and centrally analyzed by
professional healthcare staff without the costs of office
visits.
[0004] Patient physiometry can be measured and recorded through
dedicated sensors or sensors incorporated into a medical therapy
device, such as a pacemaker or defibrillator. The recorded patient
physiometry is periodically uploaded to dedicated patient
management devices for local analysis and relay to the centralized
server. Thus, to effect remote patient management, each patient
management device must be able to interface remotely to the
centralized server and locally to the sensors and patient therapy
devices.
[0005] Ensuring the operability of remote and local interfaces is a
prerequisite to providing remote patient care. Existing remote care
environment setup requires manual configuration and testing of each
component and places the onus on the patient to ensure satisfactory
operation. Pragmatically, individual patients, particularly those
who are aged, infirm, or handicapped, are not necessarily
technically savvy and could be challenged if required to manually
set up a remote management environment. Nevertheless, a caregiver
must still ensure that each patient management device can connect
to both the centralized server and to each of the sensors and
patient therapy devices before beginning remote care and
establishing service. The caregiver must also address anomalies
occurring during setup. However, to minimize time, cost, and
resources expended, only those anomalies that result in a complete
failure of operation should be escalated.
[0006] Setup is only the first step in providing remote care. The
configurations and settings of the devices can change over time.
Existing devices may be removed or replaced and new devices may be
added. The operational parameters or firmware might respectively
require reprogramming or patching. Each change potentially entails
redoing the setup and requiring a patient to manually swap out
devices can be expensive, time-consuming, and impracticable.
[0007] Following successful setup, the patient, or attendant, where
applicable, must to be trained on the proper operation of the
patient management device and patient-operable sensors and medical
therapy devices. Effective training, as well as testing, requires
instruction and practice, but using live data can needlessly
consume resources or affect patient well being if incorrectly
performed.
[0008] Therefore, there is a need for facilitating transparent and
automated setup of a remote patient care environment for patients
that can support both initial and subsequent installation and
configuration of sensors, patient therapy devices, and patient
management devices.
SUMMARY OF THE INVENTION
[0009] A remote patient care environment is setup through an
automated sequence of operations that commence upon the initial
power up of a patient management device or at the initiative of a
patient or remote source, such as a centralized server or clients.
A connection to the centralized server is first established to both
confirm that the server connection is operable and to receive the
most up-to-date configurations and profiles. The patient management
device thereafter awaits requests to upload patient data from one
or more locally-situated medical devices, such as dedicated sensors
and medical therapy devices. Data reporting is induced to both
bootstrap and initialize connections from each medical device and
to help train the patient or attendant in the operation of the
patient management device and medical devices. As each medical
device attempts patient data upload, the patient medical device
establishes a secure connection and, as necessary, reconfigures the
sending medical device. Thereafter, remote patient management can
begin.
[0010] One embodiment provides a system and method for providing
automatic setup of a remote patient care environment. Connectivity
to a centralized server over a network connection is confirmed.
Data reporting for a patient by one or more monitoring devices that
are wirelessly connectable is induced through control provided
through a user interface. Each of the devices is registered as the
device attempts to establish a wireless connection and report the
data conditioned on permission for access. Upon granting of the
permission for access, the device is wirelessly connected and the
data is subsequently received over the wireless connection.
[0011] Still other embodiments will become readily apparent to
those skilled in the art from the following detailed description,
wherein are described embodiments of the invention by way of
illustrating the best mode contemplated for carrying out the
invention. As will be realized, the invention is capable of other
and different embodiments and its several details are capable of
modifications in various obvious respects, all without departing
from the spirit and the scope of the present invention.
Accordingly, the drawings and detailed description are to be
regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a functional block diagram showing, by way of
example, an automated patient management environment.
[0013] FIG. 2 is a block flow diagram showing, by way of example, a
hierarchy of tasks to be performed in a remote patient care
environment.
[0014] FIG. 3 is a process flow diagram showing automated setup of
the remote patient care environment of FIG. 1, in accordance with
one embodiment.
[0015] FIG. 4 is a process flow diagram showing data reporting in
the remote patient care environment of FIG. 1.
[0016] FIG. 5 is a process flow diagram showing server connectivity
confirmation in the remote patient care environment of FIG. 1.
[0017] FIG. 6 is a process flow diagram showing device registration
in the remote patient care environment of FIG. 1.
[0018] FIG. 7 is a process flow diagram showing patient management
device and server connection in the remote patient care environment
of FIG. 1.
[0019] FIG. 8 is a process flow diagram showing data transmission
in the remote patient care environment of FIG. 1.
[0020] FIG. 9 is a process flow diagram showing data transmission
and device reconfiguration in the remote patient care environment
of FIG. 1.
[0021] FIG. 10 is a functional block diagram showing a patient
management device for use in the remote patient care environment of
FIG. 1.
DETAILED DESCRIPTION
Automated Patient Management Environment
[0022] Automated patient management encompasses a range of
activities, including remote patient management and automatic
diagnosis of patient health, such as described in commonly-assigned
U.S. Patent application Pub. No. US2004/0103001, published May 27,
2004, pending, the disclosure of which is incorporated by
reference. Such activities can be performed proximal to a patient,
such as in the patient's home or office, centrally through a
centralized server, such from a hospital, clinic or physician's
office, or through a remote workstation, such as a secure wireless
mobile computing device. FIG. 1 is a functional block diagram
showing, by way of example, an automated patient management
environment 10. In one embodiment, a patient 14 is proximal to one
or more patient monitoring or communications devices, such as a
patient management device 12, which are interconnected remotely to
a centralized server 13 over an internetwork 11, such as the
Internet, or through a public telephone exchange 22, such as a
conventional or mobile telephone network. Other patient monitoring
or communications devices are possible. In addition, the
internetwork 11 can provide both conventional wired and wireless
interconnectivity. In one embodiment, the internetwork 11 is based
on the Transmission Control Protocol/Internet Protocol (TCP/IP)
network communication specification, although other types or
combination of networking implementations are possible. Similarly,
other network topologies and arrangements are possible.
[0023] Each patient management device 12 includes a user interface
23 and is uniquely assigned to a patient under treatment 14 to
provide a localized and network-accessible interface to one or more
medical devices 15-18, either through direct means, such as wired
connectivity, or through indirect means, such as induction or
selective radio frequency or wireless telemetry based on, for
example, "strong" Bluetooth or IEEE 802.11 wireless fidelity "WiFi"
and "WiMax" interfacing standards. Other configurations and
combinations of patient data source interfacing are possible.
[0024] The medical devices 15-18 collect and forward the patient
data 22 either as a primary or supplemental function. Patient data
includes physiological measures, which can be quantitative or
qualitative, parametric data regarding the status and operational
characteristics of the patient data source itself, and
environmental parameters, such as the temperature or time of day.
Other types of patient data are possible.
[0025] The medical devices 15-18 include, by way of example,
medical therapy devices that deliver or provide therapy to the
patient 14, medical sensors that sense patient physiometry, and
measurement devices for collecting environmental and other data
occurring independent of the patient 14. Each medical device 15-18
can generate one or more types of patient data and can incorporate
one or more components for delivering therapy, sensing
physiological data, measuring environmental parameters, or a
combination of functionality. Medical therapy devices include
implantable medical devices (IMDs) 15, such as pacemakers,
implantable cardiac defibrillators (ICDs), drug pumps, and
neuro-stimulators, and external medical devices (EMDs) 16. Medical
sensors include implantable sensors 17, such as implantable heart
and respiratory monitors and implantable diagnostic multi-sensor
non-therapeutic devices, and external sensors 18, such as
thermometers, heart rate monitors, Holter monitors, spirometers,
weight scales, and blood pressure cuffs. External medical devices
and sensors can operate autonomously or under patient, attendant,
or caregiver control; and can include a user interface for
receiving or providing subjective feedback or communications.
[0026] Prior to commencing remote patient care, the environment 10
must be setup to ensure that the patient management device 12 is
usable by the patient and can reliably communicate with both
locally-situated medical devices 15-18 and the remotely-located
centralized server 13. Additionally, any changes to the
configurations of the patient management device 12 or medical
devices 15-18 should be addressed to avoid further unnecessary
interruptions or delays in starting remote care. Accordingly, on
initial power up or at the initiative of a patient 14 or other
source, such as the centralized server 13 or clients 20, the
patient management device 12 executes an automated setup procedure
that sets up and tests each device connection and applies any
changes to device configurations, as further described below
beginning with reference to FIG. 3. Following successful setup,
patient data 22 is collected by the medical devices 15-18 for
forwarding to a patient management device 12, which can analyze
and, in turn, also forward the patient data 22 to the centralized
server 13.
[0027] In a further embodiment, data values can be directly entered
by a patient 14. For example, answers to health questions could be
input into a patient system 19, such as a personal computer with
user interfacing means, such as a keyboard, display, microphone,
and speaker. Such patient-provided data values could also be
collected as patient information. In one embodiment, the medical
devices 15-18 collect the quantitative objective physiological
measures on a substantially continuous or scheduled basis and also
record the occurrence of events, such as therapy or irregular
readings. In a further embodiment, the patient management device
12, patient system 19, or similar device record or communicate
qualitative subjective quality of life (QOL) measures that reflect
the personal impression of physical well-being perceived by the
patient 14 at a particular time. Other types of patient data
collection, periodicity and storage are possible.
[0028] In a further embodiment, the collected patient data can also
be accessed and analyzed by one or more clients 20, either
locally-configured or remotely-interconnected over the internetwork
11. The clients 20 can be used, for example, by clinicians to
securely access stored patient data 22 assembled in a database 21
and to select and prioritize patients for health care provisioning,
such as respectively described in commonly-assigned U.S. patent
application Ser. No. 11/121,593, filed May 3, 2005, pending, and
U.S. patent application Ser. No. 11/121,594, filed May 3, 2005,
pending, the disclosures of which are incorporated by reference.
Although described herein with reference to physicians or
clinicians, the entire discussion applies equally to organizations,
including hospitals, clinics, and laboratories, and other
individuals or interests, such as researchers, scientists,
universities, and governmental agencies, seeking access to the
patient data.
[0029] In a further embodiment, patient data 22 is safeguarded
against unauthorized disclosure to third parties, including during
collection, assembly, evaluation, transmission, and storage, to
protect patient privacy and comply with recently enacted medical
information privacy laws, such as the Health Insurance Portability
and Accountability Act (HIPAA) and the European Privacy Directive.
At a minimum, patient health information that identifies a
particular individual with health- and medical-related information
is treated as protectable, although other types of sensitive
information in addition to or in lieu of specific patient health
information could also be protectable.
[0030] Preferably, the server 13 is a server-grade computing
platform configured as a uni-, multi- or distributed processing
system, and the patient systems 19 and clients 20 are
general-purpose computing workstations, such as a personal desktop
or notebook computer. In addition, the patient management device
12, server 13, patient systems 19, and clients 20 are programmable
computing devices that respectively execute software programs and
include components conventionally found in computing device, such
as, for example, a central processing unit (CPU), memory, network
interface, persistent storage, and various components for
interconnecting these components.
Task Hierarchy
[0031] From a usability perspective, setup and data reporting
involve distinct yet related sets of tasks. FIG. 2 is a block flow
diagram showing, by way of example, a hierarchy of tasks 30 to be
performed in a remote patient care environment 10. The tasks 30 can
be grouped into installation 33, training 32, and use 31.
Installation 33 is potentially the most-involved set of tasks,
which includes configuring the patient medical device 12 and
possibly one or more of the medical devices 15-18. The wide range
of device types and configurations implies a host of physical
device combinations and operational characteristic settings.
Installation 33 further includes ensuring that the connection to
the centralized server 13 and to each of the medical devices 15-18
is properly configured and operable. Other installation-related
tasks are possible.
[0032] To a lesser degree, training 32 includes those tasks
necessary to enable a patient or attendant to both gain familiarity
with and be able to preferably perform limited troubleshooting of
the patient management device 12 and those medical devices 15-18
with patient-operable features. Training 32 can include learning to
navigate device menus and options, operating device controls, and
properly obtaining patient data measurements, such as positioning a
blood pressure cuff to take a correct reading. Other
training-related tasks are possible.
[0033] Finally, use 31 simply entails the day-to-day measuring,
recording, analysis, and relay of patient data between the medical
devices 15-18, patient management device 12, and centralized server
13. Tasks falling within use 31 can overlap with those previously
performed during training 32 and installation 33. Other use-related
tasks are possible.
Automated Setup
[0034] The tasks performed during training 32 and installation 33
can be automated. FIG. 3 is a process flow diagram showing
automated setup 40 of the remote patient care environment 10 of
FIG. 1, in accordance with one embodiment. During automated setup
40, the patient management device-to-centralized server connection
and individual medical device-to-patient management device
connections are automatically established and, where applicable,
devices are reconfigured.
[0035] Initially, the connection to the centralized server 13 is
confirmed (operation 41) upon the initial power up of a patient
management device 12 or at the initiative of the patient 14 or
other source, such as the centralized server 13 or clients 20. The
patient 14 might need to reconfirm that all components remained
working together if the patient management device 12 has been moved
to a new location. Similarly, the centralized server 13 might need
to revise the environment 10 based on knowledge of changes
applicable to the environment 10, such as the addition of a new
sensor. Other sources that trigger automated setup 40 are
possible.
[0036] For a network-based server connection, the patient
management device 12 attempts to establish a secure on-line
connection with the centralized server 13 over a wired or wireless
interface via the internetwork 11. For a telephone-based server
connection, the patient management device 12 attempts to establish
a dial-up connection to the centralized server 13 over a POTS
(Plain Old Telephone System) or cellular connection. Other types of
server connections are possible. Once the centralized server
connection is established, the patient management device 12
retrieves configurations and profiles, as further described below
with reference to FIG. 5.
[0037] Next, the patient management device 12 induces data
reporting by each device (operation 42), as further described below
with reference to FIG. 6. "Inducing" data reporting can include
requiring the patient to perform a particular action that enables
the medical device 15-18 to take a data measurement, such as
stepping on a weight scale or triggering a patient-initiated
interrogation of an implantable medical device. Other induced data
reporting actions can occur automatically without patient
participation or cooperation.
[0038] The induced data reporting provides each medical device
15-18 with a starting point for establishing an initial connection
with the patient management device 12. Each patient management
device 12 is uniquely assigned to an individual patient 14, yet
several eligible medical devices 15-18 may fall within the
operational range of the patient medical device 12. Accordingly,
each device must first register with the patient management device
12 (operation 43), which will only allow the device to subsequently
connect and transmit data (operation 44 and 45, respectively) if
the device has the proper permissions for access, as further
described below with reference to FIGS. 7 and 8.
[0039] Additionally, each medical device 15-18, as well as the
patient management device 12, can be reconfigured (operation 46) as
part of the automated setup process, as further described below
with reference to FIG. 9. Lastly, each device connection is closed
(operation 47). The patient management device 12 can also confirm
successful setup to the centralized server 13 to signal readiness
to the caregiver for beginning remote patient care. Other automated
setup tasks are possible.
Data Reporting
[0040] Each patient management device 12 periodically receives
patient data from the medical devices 15-18, which can be
optionally analyzed prior to being relayed to the centralized
server 13. FIG. 4 is a process flow diagram showing data reporting
50 in the remote patient care environment 10 of FIG. 1. Generally,
to minimize the processing, storage, and power consumption overhead
imposed on each medical device 15-18, patient data is only reported
(operation 51) at the initiative of the reporting patient medical
device 15-18, as a form of data push. Alternatively, the patient
management device 12 could periodically poll one or more of the
medical devices 15-18 to request stored patient data, as a form of
data pull. Other forms of data reporting are possible.
[0041] The patient data that has been reported to a patient
management device 12 can be either asynchronously reported to the
centralized server 13 as received from each medical device 15-18,
or can be periodically relayed in a batch to minimize network
resource consumption. Upon successful receipt of patient data, the
patient management device 12 attempts to connect to the centralized
server 13 (operation 52) using the server connection previously
established during automated setup. If successful in establishing a
connection, the patient management device 12 transmits the patient
data (operation 53) and returns to awaiting further patient data
reports (operation 51). Otherwise, if unsuccessful in connecting,
the patient management device 12 stores the patient data (operation
51) and returns to awaiting further patient data reports (operation
51). The patient management device 12 reattempts transmission of
the stored patient data during the next reporting cycle. Other
forms of data reporting are possible.
Detailed Setup Operations
[0042] During setup, the patient management device-to-centralized
server connection is first established. FIG. 5 is a process flow
diagram showing server connectivity confirmation 70 in the remote
patient care environment 10 of FIG. 1. The initial server
connection ensures that the patient management device 12 is
properly connected over the applicable connection medium and has
the most recent updates of operational parameters and code.
[0043] Prior to initial power up, the patient or attendant
physically connects the patient management device 71 to the
appropriate physical medium, that is, a telephone line or network
connection. Thereafter, on initial power up or when requested by
the patient 14 or other source, the patient management device 71
attempts to send a confirmation message 72 to an assigned
centralized server 73. Upon receiving the confirmation message 72,
the centralized server 73 confirms that the requesting patient
management device 71 is authorized for access and, if valid, sends
a message in reply that contains the most up-to-date configurations
and profiles 74 for both the patient management device 71 and those
medical devices 15-18 that the centralized server 73 expects to
interface. Following successful receipt of the configurations and
profiles message 74, the server connection is fully established.
Other server connection-related operations are possible.
[0044] Medical device setup includes discovery, data exchange, and
optional reconfiguration. FIG. 6 is a process flow diagram showing
device registration 80 in the remote patient care environment 10 of
FIG. 1. In one embodiment, one or more of the medical devices 15-18
interface with patient management devices using the Bluetooth
wireless communication protocol. When a medical device needs to
communicate with a patient management device, a connection is
established using Bluetooth baseband procedures. Once a connection
has been established, a Bluetooth communication session begins.
Under this protocol, a master-slave model is used under which the
medical device 81 functions as a master and each patient management
device within range functions as a slave. Consequently, each
patient management device must passively wait for a medical device
to initiate a connection for patient data upload and medical device
reconfiguration.
[0045] Initially, the patient management device remains in a
powered down or standby state until patient data 88 is available
for upload from one of the medical devices. Each patient management
device 71, 83, 84 is maintained in a discoverable mode under which
the patient management device will respond to discovery requests.
The uploading medical device 81 accesses an internal device list 82
to determine the Bluetooth address for the patient management
device to which the medical device 81 last successfully connected
and performed data upload. If no Bluetooth address can be found,
the medical device 81 performs discovery by transmitting a discover
request 85a-c to those patient medical devices 71, 83, 84 within
range. Upon receiving the discovery request 85a-c, each receiving
patient management device 71, 83, 84 replies with a class of
service (COD) message 86a-c that identifies the class of service to
which the patient management device belongs. The medical device 81
will only connect to those patient management devices belonging to
the correct class of device. The Bluetooth addresses 87a-b of those
COD-matching patient management devices are stored into the device
list 82. The functions of master and slave can be interchanged
between the medical devices and patient management devices and
other forms of device discovery could be used to register
devices.
[0046] Patient management device-to-medical device connection
occurs upon the initiative of a medical device that is ready to
upload patient data. FIG. 7 is a process flow diagram showing
patient management device and server connection 90 in the remote
patient care environment 10 of FIG. 1. A secure connection 92 is
established between the patient medical device 81 and at most one
patient management device 71 belonging to the same class of
device.
[0047] Connection security is provided in three parts.
Authentication is provided through standard Bluetooth link layer
security, which uses a combination of a personal identification
number (PIN), the 24-bit class of device, and, optionally, a
service name to generate a unique link key. An integrity seal is
provided by the receiving application, either on the patient
management device or centralized server 13, which ensures that the
received patient data falls within expected bounds. Finally,
encryption is provided through standard Bluetooth link layer
security, which employs a 128-bit encryption key. Other forms of
data security are possible.
[0048] Patient data is conditionally sent from the medical device
to the patient management device. FIG. 8 is a process flow diagram
showing data transmission 100 in the remote patient care
environment 10 of FIG. 1. Each upload of patient data is sent in
two parts, which include a header packet followed by a data packet.
The data packet is specific to the sending medical device 81 and
type of patient data.
[0049] The medical device 81 sends the patient data 101 to the
securely connected patient management device 71. If only patient
data receipt and not reconfiguration is to be performed, the
patient medical device 71 replies with an acceptance message 102,
which acknowledges receipt of the patient data 101 and enables the
medical device 81 to erase the patient data from memory. However,
if patient data 103 is sent to a patient management device 84 for
which permission for access is not allowed, the patient medical 84
sends a rejection message 104, which signifies that the patient
management device 84 has refused the patient data. Each patient
management device receives medical device configuration
information, including model and serial numbers, type, Bluetooth
address, and, optionally, a proprietary personal identification
number. Additionally, a service name can be used. The medical
device configuration information is used by each patient management
device to determine whether patient data received for upload will
be accepted or rejected. Other forms of patient data upload
acceptance and rejection are possible.
[0050] As a patient management device must passively wait for each
medical device to attempt patient data upload, the only opportunity
for reconfiguration occurs as part of the patient data upload
session. FIG. 9 is a process flow diagram showing data transmission
and device reconfiguration 110 in the remote patient care
environment 10 of FIG. 1. Assuming that a patient management device
71 agrees to accept a patient data upload, the patient management
device 71 replies with an acceptance and configuration mode message
111. The medical device 81 replies with a configuration request
message 112 that indicates that the medical device 81 has entered
into a configurable mode of operation. The patient management
device 71 then sends operational parameters 113, which can include
both device settings or code that is automatically applied or
installed by the medical device 81. Upon attempting
reconfiguration, the medical device 81 sends a configuration
acknowledgement message 114 that indicates success or failure.
Other forms of medical device reconfiguration are possible.
Patient Management Device
[0051] Each patient management device serves as the focal point for
forwarding collected patient data to the centralized server and for
reconfiguring the medical devices and the patient management device
itself. FIG. 10 is a functional block diagram showing a patient
management device 121 for use in the remote patient care
environment 10 of FIG. 1. In one embodiment, the patient management
device 121 executes a sequence of program or process steps, such as
described above beginning with reference to FIG. 3, implemented,
for instance, on a programmed digital computer or
micro-programmable device.
[0052] Each patient management device 121 includes a storage device
142 and can be configured to store medical device configurations
129, patient profiles 130, and patient data 131. Other types of
stored data are possible. Each patient management device 121 also
includes a local interface 122, remote interface 123, lookup module
124, configuration module 125, security module 126, reporting
module 127, and, in a further embodiment, an analyzer 128. The
local interface 122 provides an external interface by which medical
devices 15-18 can connect and perform secure communication sessions
using, for example, the Bluetooth wireless communication protocol.
Similarly, the remote interface 123 provides an external interface
by which the patient management device 121 can securely connect to
the centralized server 13 using, for example, a network- or
telephone-based communications medium. The lookup module 124
accesses a set of devices with permissions for access 141
maintained in a device list 143 and configurations 129 and patient
profiles 130 maintained in the storage device 142 in response to an
attempted upload of patient data 133. Authorized medical devices
having the correct COD and patient-specific credentials is
registered into the device list 143 as a device 141 with permission
for access. The lookup module 124 also sends reply messages 140 to
data reporting medical devices 15-18, such as class of device,
patient data acceptance, patient data rejection, and patient data
acceptance and configuration mode.
[0053] The configuration module 125 controls the initial and
subsequent configuration of the patient management device 121 and
reconfiguration of the medical devices 15-18. Upon initial power up
or when requested by the patient 14 or other source, the
configuration module 125 receives device configurations 134 and
patient profiles 135 from the centralized server, which are stored
into the storage device 142. The configuration module 125 then
induces data reporting by one or more of the medical devices 15-18
through control provided through a user interface 23. For example,
the patient 14 could be instructed to perform physical actions that
trigger data reporting. Upon receiving the induced data reports,
the configuration module 128 performs any configuration required of
the patient management device 121 or reconfiguration of the medical
devices 15-18 by sending the appropriate parameters and code 137.
The security module 126 performs the three-part protection of
patient data 133 received from authorized medical devices 15-18 and
further performs data protection for the patient data 138 being
forwarded to the centralized server 13. The reporting module 127
performs the actual reporting of device status 136 and patient data
138 to the centralized server 13. Device status 136 can include a
list of those devices 141, which have been granted permission for
access. In a further embodiment, the analyzer 128 locally evaluates
uploaded patient data 133 and, as appropriate, generates alerts
139, which are provided to the centralized server 13 and, if
appropriate, other recipients, such as the patient via the user
interface 23. An alert 139 might be generated locally to the
patient if, for instance, connectivity to the centralized server 13
cannot be confirmed. Other forms of patient management device
functionality are possible.
[0054] While the invention has been particularly shown and
described as referenced to the embodiments thereof, those skilled
in the art will understand that the foregoing and other changes in
form and detail may be made therein without departing from the
spirit and scope of the invention.
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