U.S. patent application number 10/828545 was filed with the patent office on 2005-01-27 for medical device systems implemented network scheme for remote patient management.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Linden, Gregory J., Riff, Kenneth M., Smith, Kurt R..
Application Number | 20050021370 10/828545 |
Document ID | / |
Family ID | 27581170 |
Filed Date | 2005-01-27 |
United States Patent
Application |
20050021370 |
Kind Code |
A1 |
Riff, Kenneth M. ; et
al. |
January 27, 2005 |
Medical device systems implemented network scheme for remote
patient management
Abstract
A system and method for computer enabled network patient
management of medical devices used in chronic disease management.
Utilizing web site and push alert notification of alert level
physiologic data derived via analysis of continuous stream wireless
data transmissions from a patient, a full cycle improvement over
existing modalities is achieved. Proxy and medical device user
integration and access is enabled to achieve further contribution
to the technical advantages of the system.
Inventors: |
Riff, Kenneth M.; (Orono,
MN) ; Linden, Gregory J.; (Shorewood, MN) ;
Smith, Kurt R.; (Boulder, CO) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS
MN
55432-5604
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
27581170 |
Appl. No.: |
10/828545 |
Filed: |
April 20, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10828545 |
Apr 20, 2004 |
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09943193 |
Aug 29, 2001 |
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60228961 |
Aug 29, 2000 |
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60228674 |
Aug 29, 2000 |
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60228686 |
Aug 29, 2000 |
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60228685 |
Aug 29, 2000 |
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60228645 |
Aug 29, 2000 |
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60228699 |
Aug 29, 2000 |
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60228698 |
Aug 29, 2000 |
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60228697 |
Aug 29, 2000 |
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60228696 |
Aug 29, 2000 |
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Current U.S.
Class: |
705/2 ;
600/300 |
Current CPC
Class: |
G16H 40/67 20180101;
G06Q 40/08 20130101 |
Class at
Publication: |
705/002 ;
600/300 |
International
Class: |
G06F 017/60; A61B
005/00 |
Claims
What is claimed:
1. An internet-based method for a paid service to maintain data
connectivity of a remote medical device-configured patient to a
database network and to enable medical device data exchange and
processing, comprising the steps of: receiving in a substantially
continuous manner at a database network site first data inputs
uniquely representative of sensed physiologic information from a
specific medical device configuration of a patient using said
medical device configuration; enabling the database network site to
communicate with at least one web-enabled web-site and to receive
web-site originated signals requesting access to representations of
said first data inputs from said database; and monitoring data
packages to determine revenue for the service.
2. The service method of claim 1 further including the step of
providing said web-site and configuring said web-site with a user
interface which includes a sign-in input to enable access to said
database network site.
3. The service method of claim 1 in which the receiving step
includes receiving at least one signal carrying information
representing sensed physiologic status within the patient from at
least one medical device located on or at least partially in the
patient's body.
4. The service method of claim 1 in which the receiving step
includes receiving signals carrying information representing actual
physiologic phenomenon within the patient as sensed by at least one
medical device located on or at least partially in the patient's
body.
5. The service method of claim 1 in which the receiving step
includes receiving signals carrying information representing actual
physiologic phenomenon within the patient as sensed by a plurality
of medical devices located on or at least partially in the
patient's body.
6. The service method of claim 1 in which the enabling step
comprises providing a secure sign-in and validating an originator's
security-related action prior to allowing access of the originator
to the database information.
7. The service method of claim 1 in which the first data inputs
provides intermediate information to enable further production of
data representations enabling subsequent actions.
8. An internet-based method for a paid service to maintain
connection of a remote medical device configured patient to a
database network and for medical device data exchange and
processing comprising the steps of: providing a web-site in a
web-enabled system, the web-site having a user interface which
includes a sign-in input to enable access to a database network
site associated with said web-enabled system; receiving in a
substantially continuous manner at the database network site first
data inputs uniquely representative of sensed physiologic
information from a specific medical device configuration of a
patient using said medical device configuration; receiving at the
web-site second data inputs requesting access to representations of
said first data inputs available at said database; and enabling the
originator of said second data inputs to have access to the
database via the secure web site to view representations of said
first data inputs.
9. The service method of claim 8 in which the database network site
receiving step includes receiving at least one signal carrying
information representing sensed physiologic status within the
patient from at least one medical device located on or at least
partially in the patient's body.
10. The service method of claim 8 in which the database network
site receiving step includes receiving signals carrying information
representing actual physiologic phenomenon within the patient as
sensed by at least one medical device located on or at least
partially in the patient's body.
11. The service method of claim 8 in which the database network
site receiving step includes receiving signals carrying information
representing actual physiologic phenomenon within the patient as
sensed by a plurality of medical devices located on or at least
partially in the patient's body.
12. The service method of claim 8 in which the enabling step
comprises providing a secure sign-in and validating an originator's
security-related action prior to allowing access of the originator
to the database information.
13. The service method of claim 8 in which the first data inputs
provides intermediate information to enable further production of
data representations enabling subsequent actions.
14. An internet-based method for a paid service to maintain data
connectivity of a remote medical device-configured patient to a
database network and to enable medical device data exchange and
processing, comprising the steps of: receiving in a substantially
continuous manner at a database network site first data inputs
uniquely representative of sensed physiologic information from a
specific medical device configuration of a patient using said
medical device configuration; initiating processing of said first
data inputs to produce user accessible signals which represent the
first data inputs in a user accessible format to enable action
based on observations of the user accessible signals; and enabling
the database network site to communicate with at least one
web-enabled web-site and to receive web-site originated signals
requesting access to representations of said first data inputs from
said database.
15. The service method of claim 14 in which the step of initiating
processing includes initiating analysis of the first data inputs to
determine whether any sensed physiologic activity is abnormal.
16. The service method of claim 14 in which the step of initiating
processing includes initiating analysis of the first data inputs to
determine actual values for any sensed physiologic activity.
17. The service method of claim 14 in which the step of initiating
processing includes initiating analysis of the first data inputs to
determine whether any sensed physiologic activity is indicative of
a demonstrable or likely pattern of physiological activity.
18. An internet-based method for a paid service to maintain data
connectivity of a remote medical device-configured patient to a
database network and to enable rapid medical device data exchange
and processing of certain conditions, comprising the steps of:
receiving in a substantially continuous manner at a database
network site first data inputs uniquely representative of sensed
physiologic information from a specific medical device
configuration of a patient using said medical device configuration;
and enabling the database network site to communicate with at least
one web-enabled web-site to automatically deliver representations
of said first data inputs from said database when certain
conditions are met.
19. The service method of claim 18 in which the step of enabling
includes initiating automatic software analysis of the first data
inputs to determine whether any sensed physiologic activity is
abnormal.
20. The service method of claim 18 in which the step of enabling
includes initiating automatic software analysis of the first data
inputs to determine actual values for any sensed physiologic
activity.
21. The service method of claim 18 in which the step of enabling
includes initiating automatic software analysis of the first data
inputs to determine whether any sensed physiologic activity is
indicative of a demonstrable or likely pattern of physiological
activity.
22. A computer implemented method for improved data management in
the healthcare industry by increasing patient engagement with
recommended healthcare delivery modalities, comprising the steps
of: a. providing an implanted medical device configured for
automatic sensing of high relevance biologic data of the patient
and transmitting that data, or portions thereof, to an information
parser of the healthcare professional; b. configuring a patient
accessible electronic interface to receive signals representative
of sensed high relevance biological data of the patient; c.
providing selectively programmable computer implemented rapid
interpretations of the sensed high relevance biologic data and,
when indicated, electronically sharing with the healthcare
professional the details of the sensed high relevance biological
data without resort to personal contact or face to face meeting
between the healthcare professional and the patient; and d.
providing information flow paths for the healthcare professional to
further contribute to the knowledge database and patient engagement
by offering the patient and a patient's designated advocate direct
information about the high relevance biologic data thereby actively
engaging the patient in a highly content rich yet efficient
manner.
23. A computer implemented internet-based method for an improved
connect and monitoring service to rapidly connect remote persons to
a database network for medical device data exchange and analysis,
said method being characterized in that it comprises the steps of:
providing a web-site having a user interface wherein the user
interface includes a secure sign-in input to access a database
network site; receiving at the web-site automatic inputs associated
with a specific medical device and user of the device;
automatically confirming the identity of the medical device and the
user; enabling the user to access the database via the web-site to
use the service for real time monitoring of high relevance
physiologic data mined from all monitored data of the user; and
enabling the database network site to communicate with at least one
web-enabled web-site and to receive web-site originated signals
requesting access to the database.
24. The method of claim 23 wherein said web-site further includes a
proxy right access scheme to provide privileged access to a user's
data by friends or family as programmed.
25. A computer implemented internet-based method for improved user
compliance within a medical patient management system in which the
system automatically determines which connection protocols to
follow to rapidly connect one or more remote persons to a database
network for medical device data exchange and analysis under certain
conditions, said method being characterized in that it comprises
the steps of: providing a web-site having a user interface wherein
the user interface includes a secure sign-in input protocol to
access a database network site; receiving at the web-site automatic
inputs associated with a specific medical device and user of the
device; automatically confirming the identity of the medical device
and the user; performing computer implemented analyses to determine
which user groups to rapidly and selectively automatically access
the database via the web-site for receipt of high relevance
physiologic data mined from all monitored data of the user; and
enabling the database network site to communicate with at least one
web-enabled web-site and to receive web-site originated signals
requesting access to the database.
26. The computer implemented internet-based method for improved
user compliance of claim 25 further comprising: alerting a select
group of medical providers to an event using an event service; and
enabling the select group of medical providers to execute secure
access to the device user's database in a single sign-on action per
user in the group.
27. The method of claim 26, wherein said single sign-on action
includes authentication to a foreign web-site that is passed over
to access the secure device user's database.
28. The method of claim 25 further characterized by computer
implemented automatic formatting of automatically processed high
relevance data mined from all detected data, and electronically
pushing the formatted data to an electronic display of at least one
member of a group of medical providers whereby at least one of the
group of medical providers selectively provides commentary and then
directs a data transmission back via the web site to the user of
the medical device, to a designated advocate of the user of the
medical device, and, optionally, to another member of a medical
providers group.
29. A computer implemented patient management network configured
for automatically determining which connection protocols to follow
to rapidly connect one or more remote persons to a database network
for medical device data exchange and analysis, said network being
characterized in that it comprises: a web site having a user
interface wherein the user interface includes a secure sign-in
input protocol to access a database network site; said web site
providing for acceptance of automatic inputs to the web site
associated with a specific medical device and user of the device;
processing routines and module for automatically confirming the
identity of the medical device and the user; and processing
routines and module for performing computer implemented analyses to
determine which user groups to rapidly and selectively
automatically access the database via the web-site for receipt of
high relevance physiologic data mined from all monitored data of
the user. means for enabling the database network site to
communicate with at least one web-enabled web-site and to receive
web-site originated signals requesting access to the database.
30. A system for implementing a disease management service for a
remote chronic patient with an implantable medical device and/or
wearable device wherein the service includes multi-users of data
and information exchange systems cooperating to provide the service
for continuously managing the chronic patient's disease, health
care and medical devices comprising: a server hosting medical and
physiological data collected from the patient; a physician station
in data communications with the server; a health care system
information network being in a bi-directional communication with
the physician station and further having a data communication with
the server; a disease management organization in bi-directional
communications with said health care system information network;
said server including at least one set of database of information
concerning the patient wherein the database is structured to assist
the disease management organization to manage the patient for a
fee; and said server including means for enabling the database to
communicate with at least one web-enabled web-site and to receive
web-site originated signals requesting access to the database.
31. A system for implementing a disease management service for a
remote chronic patient with an implantable medical device and/or
wearable device wherein the service includes multi-users of data
and information exchange systems cooperating to provide the service
for continuously managing the chronic patient's disease, health
care and medical devices comprising: a server hosting medical and
physiological data collected from the patient; a physician station
in data communications with the server; a health care system
information network being in a bi-directional communication with
the physician station and further having a data communication with
the server; a disease management organization in bi-directional
communications with said health care system information network;
said server including at least one set of database of information
concerning the patient wherein the database is structured to assist
the health care system information network to manage the patient
for a fee; and said server including means for enabling the
database to communicate with at least one web-enabled web-site and
to receive web-site originated signals requesting access to the
database.
32. A system for implementing a disease management service for a
remote chronic patient with an implantable medical device and/or
wearable device wherein the service includes multi-users of data
and information exchange systems cooperating to provide the service
for continuously managing the chronic patient's disease, health
care and medical devices comprising: a server hosting medical and
physiological data collected from the patient; a physician station
in data communications with the server; a health care system
information network being in a bi-directional communication with
the physician station and further having a data communication with
the server; said server including at least one set of database of
information concerning the patient wherein the database is
structured to assist the health care system information network to
manage the patient for a fee; and said server including means for
enabling the database to communicate with at least one web-enabled
web-site and to receive web-site originated signals requesting
access to the database.
33. A system for implementing a disease management service for a
remote chronic patient with an implantable medical device and/or
wearable device wherein the service includes multi-users of data
and information exchange systems cooperating to provide the service
for continuously managing the chronic patient's disease, health
care and medical devices comprising: a server hosting medical and
physiological data collected from the patient; a physician station
in data communications with the server; a disease management
organization in bi-directional communications with said server and
said physician station; said server including at least one set of
database of information concerning the patient wherein the database
is structured to assist the disease management organization to
manage the patient for a fee; and said server including means for
enabling the database to communicate with at least one web-enabled
web-site and to receive web-site originated signals requesting
access to the database.
34. A data collection and transfer system for implementing a
chronic remote patient monitoring service for transmission of very
high relevance medical and physiological data from a person having
at least one implanted and/or wearable medical device, the service
comprising: a server hosting high relevance medical and
physiological data accessible via a remote monitor in data
communications with the server; at least one medical device
implanted or wearably located on a person being in data
communication with the remote monitor; the server being web-enabled
to host and provide multi-directional data collections from various
services including said person so that the collected data may be
re-transmitted for a fee provided by one or more recipients of the
data; and the server including means for enabling the database to
communicate with at least one web-enabled web-site and to receive
web-site originated signals requesting access to the database.
35. The service of claim 34 wherein said at least one implanted
and/or wearable medical device is in wireless communication with
the remote monitor to enable data communications when the person is
ambulatory.
36. The service of claim 34 wherein said server includes
programmable parameters to bill the person for services
rendered.
37. A system for implementing a computerized healthcare information
service network capable of collecting medical data from various
remote locations including a patient with a medical device, the
information service comprising: a server including a database
hosting medical and physiological data collected from a patient at
a remote location, said server being in data communications with a
remote monitor that collects highly relevant data from the patient
having at least one implanted and/or externally worn medical
device; the server including means for enabling the database to
communicate with at least one web-enabled web-site and to receive
web-site originated signals requesting access to the database; a
physician station; a health care system information network in data
communications with the server and the physician station; and a
billing service for the remote management of the patient's health
including a service of the performance of at least one implanted
and/or externally worn medical device communicating with the
physician station for expert opinion and advising the patient in
real time, to provide as to proper procedures to follow for therapy
and medical care.
38. A network-enabled system for implementing a chronic data
management and monitoring service for remote patients and medical
devices comprising: a server computer hosting high relevance data
transmitted from the remote patients and medical devices; a client
computer providing access to a plurality of users of the service;
and wherein said server computer provides a user interface whereby
said plurality of users are authenticated prior to accessing said
data; whereby the service is available via one of a secure Internet
channels to enable an authenticated user to access data pertaining
to a specific patient and/or medical device.
39. The service of claim 38 wherein said service utilizes billing
and collection systems consisting of one of: computer to computer
transactions, monthly statements, direct credit card transfer,
micro-payment-systems and business to business collection
systems.
40. An internet-based information network service for implementing
medical data transfer and exchange in a health care system
comprising: means for collecting medical data from multiple remote
sites including a database site; and interface means for accessing
said means for collecting by authorized agents; wherein said
interface means includes controls for authenticating a user for the
service and provides selection criteria and display at any one of
said multiple remote sites for the user; and means for enabling the
database network site to communicate with at least one web-enabled
web-site and to receive web-site originated signals requesting
access to the database.
41. An information system for generating medical device performance
data, in real time, to enhance product performance and adapt
businesses methods to provide a continuously improving service to a
chronic patient or other information users, the information system
comprising: a server hosting data transmitted from a remote
patient; a plurality of client computers providing access to the
server; and a medical device manufacturer computer being in data
communications with the server wherein device data is managed to
provide at least one functional group within a medical device
manufacturer with highly relevant information derived from the
medical device performance data for use in product or service
improvement actions.
42. The system of claim 41, in which the functional sub-group is
one of: research and development, product planning, post market
surveillance, and sales and marketing.
43. The system of claim 41, in which the other information users
include one of disease management organizations and healthcare
management organizations.
44. A system for implementing networked remote patient management
services comprising: a server hosting high relevance patient
management data for providing chronic monitoring of the remote
patients with chronic disease having implantable medical devices
and/or wearable devices; and said server being accessible via
client computers wherein said client computers include a
web-enabled system, a medical device manufacturer web-site, a
physician site, a health care information network site, and a
disease management organization; and each of said client computers
being in data communications with the server to import specific
data on which the patient management services billing schemes, for
at least one service, are implemented.
45. An internet-based method in a web-enabled system for a paid
service to connect a remote patient to a database network for
medical device data exchange and processing comprising the steps
of: providing a web-site in a web-enabled system, the web-site
having a user interface which includes a secure sign-in input to
access a database network site associated with said web-enabled
system; automatically receiving at the database network site first
data inputs uniquely associated with a specific medical device and
patient using said medical device; receiving at the web-site second
data inputs requesting access to representations of said first data
inputs; confirming the identity of the medical device, the patient,
and the originator of said second data inputs; and enabling the
originator of said second data inputs to have access to the
database to view representations of said first data inputs.
46. An internet-based method in a web-enabled system for a paid
service to connect a remote patient to a database network for
medical device data exchange and processing comprising the steps
of: providing a web-site in a web-enabled system, the web-site
having a user interface which includes a secure sign-in input to
enable access to a database network site associated with said
web-enabled system; periodically receiving at the database network
site first data inputs uniquely associated with a specific medical
device and patient using said medical device; receiving at the
web-site second data inputs requesting access to representations of
said first data inputs; confirming the identity of the medical
device, the patient, and the originator of said second data inputs;
and enabling the originator of said second data inputs to have
access to the database via the secure web site to view
representations of said first data inputs.
Description
RELATED APPLICATIONS
[0001] This application claims priority from Provisional
Application Ser. Nos. 60/228,961, 60/228,674, 60/228,686,
60/228,685, 60/228,645, 60/228,699, 60/228,698, 60/228,697 and
60/228,696, all filed on Aug. 29, 2000, and also from application
Ser. No. 09/935,019, filed Aug. 22, 2001, and is a continuation of
application Ser. No. 09/943,193, filed Aug. 29, 2001.
FIELD OF THE INVENTION
[0002] The invention relates to medical devices implemented and
communicable through network systems such as the internet. More
specifically, the invention relates to patients wearing implantable
or externally mounted medical devices in which the devices are
communicable to remote healthcare professionals or expert centers
for a variety of purposes.
BACKGROUND OF THE INVENTION
[0003] Medical devices such as cardiac systems, drug delivery
systems, neurological products and similar other products are
implanted in patients for various clinical reasons. Some of these
devices may collect and document data on a continuous basis.
However, the state of the art is currently to ask patients to see
their doctors or other health professionals on a regular basis to
retrieve and check the physiological data collected in these
devices.
[0004] As medical devices become very sophisticated, in both
reliability and maintainability, the need for patients to visit
their doctors on a regular basis may not be required by coverage
plans or for other rationale. Various attempts to remotely engage
or monitor patients or medical devices/systems have been suggested,
such as for example those generally described in U.S. Pat. Nos.
6,261,230; 6,206,829; 6,221,011 B1; 6,203,495 B1; 6,250,309 B1;
6,168,563 B1; 6,108,635; 6,101,478; 6,050,940; 6,004,276;
5,987,519; 5,911,687; 5,781,442; 5,752,976; 5,633,910; 5,619,991;
5,544,661; and 5,508,912. However, for patients with chronic
disease, the management of the disease has become a critical aspect
which affects both the cost of health care and the quality of life
of the patient. Accordingly, patients with implantable medical
devices or externally mounted devices that monitor critical medical
data are either kept in hospitals or the patients are required to
visit their physicians on a very regular basis.
[0005] Accordingly, a data transfer and review system that enables
doctors and physicians to monitor patients on an as-needed basis
and as frequently as possible, while allowing patients to stay at
home, is a highly desirable service. Such a service would also
enable the patient to have access to their own personal data by
enabling real time data management and review by professionals as
well as the patient. Further, medical devices could be designed to
enable patients to be interactive with the devices that are
monitoring their physical and medical parameters such that the
patient could also be involved in managing their disease on a
day-to-day basis. More specifically, if patients are allowed to
have access both to the operation of their device and reports that
are stored in them, they may have sessions with their doctors and
will also be well-informed in managing their disease, thereby
becoming active partners in the management of their own disease.
Various economic opportunities may also arise from such
accomplishments.
[0006] Various online systems or data mining systems are also known
and described generally in U.S. Pat. Nos. 6,260,050; 6,253,193;
6,205,437; 6,192,114; 6,112,194; 5,819,092; and International
Publication WO 01/22265.
SUMMARY OF THE INVENTION
[0007] An internet- or equivalent-based system and method for a
service is disclosed which connects a remote patient to a database
network for medical device data exchange and review. The system and
method includes providing a web-site having a user interface
wherein the user interface includes a secure sign-in input to
access a medical device database network site, receiving at the
web-site inputs associated with a specific medical device and
patient, confirming the identity of the medical device and the
patient, and enabling the patient to access the database to use the
service. A further aspect of this system and method of doing
business is to connect remote users to a database network for
medical device data exchange and review by identifying authorized
users to access the database network and generating advantages,
including revenue streams of a type and quality not previously
possible.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a schematic representation of a patient with
exemplar implanted medical device components interfacing with a
remote patient management network.
[0009] FIG. 2 is a schematic diagram of the system and data flow of
the invention.
[0010] FIG. 3 is a schematic diagram of the system and data flow of
the invention.
[0011] FIG. 4 is a schematic diagram of the system and data flow of
the invention.
[0012] FIG. 5 is a decision making flow chart of the method of the
invention.
[0013] FIG. 6 is a schematic diagram of multiple embodiments of the
invention.
[0014] FIG. 7 is a schematic diagram of multiple embodiments of the
invention.
[0015] FIG. 8 is a schematic diagram of another embodiment of the
invention applied to medical procedural facilities.
DESCRIPTION OF THE INVENTION
[0016] Attempts to provide improved healthcare to patient
populations using technological methods have met with varying
degrees of success. Indeed, however, a very critical problem has
emerged in most such efforts. The patients and healthcare providers
alike risk increased isolation as the use of technology increases.
This isolation and sense of de-personalization in the healthcare
system is often a chief complaint of patients, as well as a source
of potential conflict which could actually impede the formation of
candid dialogue which is at the core of the best models of
patient-physician interface.
[0017] Another problem exists in that no actual system for
full-cycle healthcare enablement exists without substantial human
intervention for data handling. Although various patents suggest
systems and methods for either direct healthcare system improvement
or revenue generating systems and methods which might be useful in
healthcare providing (such as those noted above), these are
essentially inoperative or impractical schemes.
[0018] Assignee of the Applicants (Medtronic, Inc.) has developed
medical devices that are able to detect large amounts of valuable
patient specific information and process that information so as to
decide whether one or more specific actions is appropriate,
including for example whether applications of therapy or ongoing
diagnosis is merited. This is technology that has emerged in
application of implantable medical devices over the last several
decades, and has transformed many lives due to its use by Medtronic
and other companies. However, Applicants have now identified new
and improved mechanisms by which the technical means of harnessing
the ongoing and simultaneous revolutions in medical device
technologies and information technologies to achieve a new level of
patient and healthcare provider satisfaction, quality of care,
improved service, improved efficiencies and improved economics is
realized. This combination of new technical processes has overcome
the combined technical problems associated with: sensing highly
specific signals, parsing and validating high volumes of data,
power management of implanted medical devices, bandwidth allocation
to integrate all levels of a web-enabled network among multiple
foreign users, timing and structures of signals and processing,
accessibility and security, display limitations and demands, data
routing in multiple paths including wireless paths, partial user
unfamiliarity with technology, partial user incapacity, automatic
assessment and further handling of individual device user data,
non-integrated clinical guidelines, and other challenges. The
technical effect of the selected protocols along with the
application of advanced information technology has resulted in a
significant technical contribution to the art of integrated
network-based signal and resource management for programmable and
high relevance detected data signals.
[0019] Applicants have recognized that a remarkable innovation is
achieved in deeply utilizing the now very robust data collection
capabilities of various medical devices and integrating that
(explicit and/or implicit) information (either before, during or
after analyzing or processing the information) into a data network.
This causes integration of the patient and healthcare providers, or
others, into a collaborative effort resulting in patient-specific
healthcare improvement and very dynamic system efficiencies. This
is a pioneering effort in identifying a combination of historic
problems, applying technical methodology to combine the best
medical and information technologies resulting in a solution which
transforms the way resources are allocated, which in turn leads to
improvements for care of patients with various diseases and
conditions, particularly those having chronic conditions.
[0020] At one level, the contributions of this invention enable
economic functionality to attach to highly innovative technical
solutions. These technical solutions to patient care and chronic
monitoring yield data in seeming orders of magnitude greater in
quality and quantity than in just the recent past. For example,
Applicants' devices automatically sense, retrieve, transmit,
process, and store greater than 10.sup.10 heart beats (i.e. cardiac
rhythm elements) in a time of just a small number of hours,
continuously over an extensive patient population. When this data
is combined with data obtained and automatically processed during
cardiac procedures in operating or emergency rooms, then the volume
of this rich database is further enlarged. When this data is
analyzed, automatically, with software-based algorithms and other
tools, then the data is transformable to various knowledge-enhanced
value-added formats. Such formats may be of various types. For
example, signal structuring and data formatting (either prior to
and/or as a consequence of initial processing of transmitted
physiological data) may enable different users of the different
formats to have resultant data-based tools available for use in
numerous different applications or tasks. Examples include
different uses and/or formats of mined physiologic data to be used
with great advantage and economic value by: physicians, health care
systems, information networks (from which various laboratories
access high relevance information), Disease Management
Organizations (which enables very high quality patient interactions
use of point of care, instruments, and timely clinical guidelines),
internet users, (internet companies, health sites, patient advocacy
groups, clinical trial organizations, pharmaceutical companies and
individual patient web sites), retailers, and medical product or
device companies (for research and development, product planning,
post-market surveillance, sales and marketing, and clinical
database work). These users require many different tools, forms of
data, for individual and often interactive production of their
services and other products. Accordingly, a provider of high
relevance data-based products, either raw or rendered, creates
substantial value within numerous systems, each of which is subject
to its own economic rules and metrics. Regardless of any
differences or similarities among these data users, they each
receive a value-added product for their constituencies when the
information flow or mere availability of this data is enabled.
[0021] In addition to the data and the data flow, there are various
new uses for this physiologic data which occur as a result of the
underlying inventions disclosed herein, and which will be discussed
further below. Generally, these innovations create knowledge
enhanced value, integration enhanced value, and timing enhanced
value. These value enhancements in turn enable previously unknown
services and products to be provided to various consumers, such as
knowledge repositories; data mining tools; academic research tools;
surgical techniques; tools, and planning; device and
service-assisted outcomes monitoring and improvement; and mapping
or visualization tools. When previously inaccessible or non-useable
data of high relevance is rendered available and in appropriate
structure or format, then the above advantages are made possible.
As such, the technical advantages and contributions of Applicants
is realized.
[0022] In one example, patients having advanced cardiovascular
disease (and their care givers) may utilize one aspect of this
invention to great advantage. Using one or more medical devices 14,
such as the implantable cardiac-related devices known as either the
Medtronic Chronicle device or the GEM III DR device, shown in
patient 20 of FIG. 1, a patient's cardiac system is closely
monitored. This figure also illustrates alternate examples of
device 14 which includes neurologic device 14 and drug infusion
device 14 as well. The invention may utilize a device such as those
noted above which is implanted for sensing directly in a cardiac
chamber 25, and which may have more data acquisition capability and
processing power than any other known implantable on earth, or even
a more limited capability device. Such a powerful data acquisition
platform is able to store a wealth of information regarding cardiac
and overall patient physiologic data in the onboard RAM of the
device that can be uploaded through wireless technology, such as
radio frequency (RF) telemetry, telemetry B or C, or the like.
Following acquisition of this medical data from inside the body,
then advanced information and communication technologies are
utilized to format and communicate this information to other
locations or users in a manner which eliminates or virtually
obviates human intervention for various levels of processing of the
physiologic data.
[0023] In one embodiment, another device, shown in representative
manner as device 44 in FIG. 1, is arranged to be near the patient
and to obtain the information from the implanted device and
transmit the data to a remote network. Device 44 may be alternately
described as a remote interrogator or by other terminology, which
is not meant to limit its actual technical characteristics in any
way, but rather to identify a data communication device for use
with medical devices as generally described herein.
[0024] As shown in FIGS. 1-7, a secure transmission of the
physiologic data from the patient then occurs, with the data
flowing to a robust network where it can be stored, processed,
analyzed and presented for viewing via a web browser or other
interfaces. These technologies have been combined and improved with
the specific purpose of providing a reliable, scalable, secure and
accessible system for worldwide real-time use of the patient's
data. This is an extraordinary, full cycle, breakthrough over known
limited systems for disease and patient management. Indeed, this
invention re-organizes and prioritizes patient care in a manner not
previously known along a new model of data and human interaction.
In the cardiac example above, information about the patient's heart
is online and accessible at all times. The system provides the
physician and others with a continuous, longitudinal record of
cardiac status rather than the snapshot, or limited view, that is
received when the patient comes into a clinic. This is also
real-time and continuous, rather than reactively responsive and
subject to any specific event or to known monitoring device
availability or limitations. Physicians and other users may then
utilize this new system and methods to implement timely, systematic
therapeutic regimens for their patient--as well as for other
purposes. It is recognized that either the virtual or the physical
locations of certain elements of this system, and methods of
performing the services and advantageous steps of the invention,
may be optionally determined to occur in either one or more
jurisdictions depending on the element, step, signal, perspective
or advantage enabled. In addition, appropriate data use and other
security authorizations or measures are fully contemplated, and may
be relevant to judging the utilization and scope of challenges
successfully overcome by this invention.
[0025] Using this invention, the patient, and optionally the
patient's friends, family, and others, become active participants
in the management and/or progression of the patient's health. This
enables the patient to be empowered as a collaborator through the
system's patient portal, where he or she can access individualized
educational, monitoring and self-care programs at any time from
virtually any location. Although a deep and rich variety of data is
acquirable, data having the most relevance for the specific patient
may be designated for sensing, e.g. a patient's monitored signals
may include intracardiac pressures, heart rate, physical activity,
or other signals having the most utility for the patient. This
process of continuous data collection is then supplemented by the
uploads of all or some of the data to an external proximate device
(i.e. in home, office or car) for transmission of the critical
physiologic data securely to a healthcare management network.
Physicians or others can access the network via a Web site at any
time and review screens that present summary information from the
latest upload, trend information accumulated over time, and/or
detailed records from specified times or problem episodes.
[0026] The invention has the potential to dramatically transform
the management of chronic diseases like heart failure and cardiac
arrhythmias, neurologic conditions, or conditions requiring drug
infusions, and other health needs relating to particularly
long-term health conditions. It will improve the quality of care by
providing the physicians with real-time data about their patients'
physiological (and maybe other) conditions so that corrective
actions may be taken in a timely manner, if appropriate. This
invention will improve the quality of life for the patients,
enabling them to remain in their homes or travel as desired without
the same level of constant worry concerning an emergency
hospitalization. The invention will result in dramatic lowering of
the cost of managing chronic disease by reducing unnecessary
hospitalizations and clinic visits. Perhaps more importantly, this
system and methodology will help restore the close bond of the
patient-physician relationship through the power of direct
connectedness and the proliferation of high relevance
understandable knowledge to all participants in the process. For
example, the system and methodology makes personalized health
information, even detailed information on the performance of a
patient's own heart, available to the patient and loved ones (or
other advocates of the patient) through an interactive web or
mobile portal. Other users of patients' data are now fully enabled
to utilize this data for individual patient and systemic healthcare
improvements, as authorized. Analyses of this system have already
observed many of these very positive effects, synergies and
impacts.
[0027] In addition to the profound implications for quality of
care, standard of care, and related issues in relation to this
invention, the financial and business impact of this system and
methodology is quite revolutionary. The system is designed to more
successfully manage people with chronic diseases by leveraging the
Internet or similar communication medium that allows continuous or
near continuous real-time data access. The interaction with
clinical researchers of users of this invention is also valuable.
This degree of interaction allows for more rapid and in-depth
clinical analysis of disease symptoms and treatments, thereby
reducing the overall costs of such efforts. Such real-time access
to patient data also facilitates administration of drug and other
therapy in a more responsive and economical fashion. The
involvement of the patient and the patient's advocate(s) promotes
improved communication and outcomes. Combining this with the known
patient desire for greater convenience and a closer connection to
the physician, then the advantages of this invention are many.
[0028] FIG. 2 is a schematic representation of a portion of system
50 designed for interacting and managing care for a patient 16
having at least one interactive medical device, such as for example
an implanted cardiac, neurologic, infusion or other device. It is
recognized that partially implanted or external devices may also be
incorporated into the full scope of this disclosure, provided such
devices or components are capable of operating in the robust data
environment of this invention. FIG. 2 illustrates the relation
between patient 16, an electronically accessible patient management
database 63, and a web-based site 70. Patient management database
63 is configured for receipt, storage, processing, and other
transmission and handling of information related to the healthcare
status of patients administered by system 50, including patient 16.
Physiologic data 77 is uploaded via wireless 82 or other
transmission means from devices in or in communication with devices
in or on patient 16, and is of a content and format designed to
selectively provide essential high relevance information regarding
all manner of monitored disease etiology and system functionality.
This information is automatically uploaded via path 82 to the
database 63, possibly in response to interrogation routines, and
subject to power management, disease stage, and other
considerations. Data 77 is then registered or otherwise processed
as appropriate and transmitted in various form to at least one
web-based site 70, configured to allow access by the patient and
others, as will be further discussed below, and as depicted in path
94 with one or more secure sign-in protocols included. It is
recognized that patient medical device data 88 may also flow from
web-based site 70 back to patient management database 63.
[0029] FIG. 3 depicts web-based or equivalent site 70 as a platform
which is accessible via secure sign-in 101 by a first medical
provider 106 such as a nurse or other type of provider responsible
for the care and first stage monitoring of patient 16. A variety of
interactions are enabled by this relationship, including use of
web-based site 70 as a destination for secure access to provide and
receive information pertinent to the care of patient 16, including
unique and high relevance physiologic data 77 detected from within
one or more patients and transmitted via patient management
database 63. In the event of physiologic data 77 containing
information meeting certain criteria, such as activating triggers
or set points based upon certain analytics, differentials or
algorithmic metrics, then the patient management database 63 and
the web-based site 70 may be configured to provide an automatic
event notification service signal 112 to a display or other data
receiving device of one or more medical providers, such a first
medical provider 106. In one example, automatic event notification
service signal 112 may be pushed via an SMTP.net message, shown for
example as signal format 115, to medical provider 106 computer or
other display. These displays, and others contemplated herein, may
also include an automatic pushed signal via electronic mail, pager,
cellular phone, WAP cellular phone, telephone call, facsimile,
mobile wireless device, stylus tablet, or others. This automatic
event notification service signal 112 may be used to alert provider
106 of a health related signal anomaly or other indication which
may require prompt action to assist the patient, and is likely not
necessarily a secure message but rather a rapid message, which may
be more preferable. Accordingly, in one embodiment, the rapid
automatic event notification service signal 112 includes a link
accessible by the medical provider to rapidly access the data of
interest from the web-site 70, and which requires a response by the
recipient. Such signal 112, and others herein, may also activate an
automatic time notated archival feature for later reference for
various purposes. As in much of this invention, this path may
require a security validation or authentication, depending on
system, patient service, and legal requirements. Various biometric
or other cipher-like technologies may be utilized, although a smart
card or other intelligent and convenient tool may be preferred. For
example, one embodiment of a smart card may be able to record
medical updates of the patient's health record whenever it is used
for access authentication, and thus provide an element of
redundancy to the medical record.
[0030] First medical provider 106, or others described herein, may
be granted secure single sign in rights to facilitate rapid access
for the designated individual to the various elements of this
system and architecture. This feature may also be transportable as
that professional traverses among electronic links in order to
ensure connectivity during the response to a detected event, or the
access may be a graded access according to an event severity
algorithm or other grading technique.
[0031] A further feature may include a link or other access to a
database 118 or other medium having an electronic medical health
record 122 of the patient who is the source of the automatic event
notification service signal 112. In this manner the patient's
pertinent medical history may be presented along with the new data
which caused the medical alert, thereby allowing the medical
provider to have proper perspective and accuracy as to the specific
patient. In one embodiment, electronic medical health record 122 is
a data rich format such as that known as Extended Markup Language
(XML), although various data formats may be utilized to provide the
advantages and data contemplated. Moreover, in one embodiment, a
single page format is preferred but not required, in order to allow
the efficiencies of a template that may be efficiently structured
for a single screen display of the most critical information to a
final decision maker. This may include a summary, a waveform, a
differential diagnosis analysis, coding options, trending graphs,
overlays of patient history versus current data, or other high
relevance formatted data appropriate to that patient or patient
class. Rapid augmenting/updating of that formatted information is
also possible, when desired, due to the configuration of this
system and the rich data mining capabilities it enables.
[0032] FIG. 4 illustrates a further aspect of the invention in
which a second medical provider 135 receives either the automatic
event notification service signal 112 or, preferably, another form
of notification signal 144 which has been generated by another
medical provider, such as first medical provider 106. Notification
signal 144 is shown as a post-triage type of notification, i.e.
after the initial analysis of the high relevance physiologic data
has occurred by a first medical provider. The second medical
provider may be a more specialized or more highly qualified
provider, such as a cardiologist, surgeon or other type of
physician. In one embodiment, notification signal may include
recommendations or commentary from the first medical provider, and
may be in the form of a secure asynchronous XML message, although
various formats may be acceptable or preferred, including for
example that necessary to enable the above described single page
formatted communication. The notification signal 144 may also be
formatted for display on a mobile or stationary device of medical
provider 135, such as a handheld or other form of personal digital
assist device. In this manner, even if the second medical provider
is in the process of another activity, it may be possible to have
the information observed or otherwise understood from the display
and for the second medical provider 135 to direct appropriate
medical care in the form of instructions to the patient and other
care givers. In one embodiment it is contemplated for the second
medical provider 135 to observe the emergent conditions of patient
16 and then dictate a secure voice message 152 (for example, a WAV
file attachment or the like) for transmission back to a web-enabled
site, such as web-site 70, for merger with the original data and
automatic event notification service signal 112 for subsequent
transmission to the patient 16. Of course, this information in the
form of a combined signal of both the patient's physiologic data
and the medical provider's interpretation and care recommendation
may also be transmitted to a proxy or other patient advocate 159,
as well as to automatic clinic appointment scheduler prompting
mechanisms or the like.
[0033] Notification of patient 16 that a health-related message is
waiting for review may also be sent to the patient advocate 159,
such as a close relative of the patient, to ensure that the patient
reviews, understands, and complies with the advice of the medical
provider(s). This may be a sequence such as receipt of an
electronic mail message urging activation of a link to the web-site
70 with automatic routing to message 152. In addition to the
various communication options noted herein above, it is possible to
have a dedicated channel, optional pop-up alert channel, webTV-like
device, or dedicated internet service or portal available to the
patient or patient advocate. This may be a service provided by
existing or new communication service providers as a fee
subscription or other revenue generating mechanism which is able to
emerge and possibly block other communications until cleared by the
recipient.
[0034] FIG. 5 is a high level logic flow chart representative of
one embodiment of the computer implemented steps of the invention
and the flow of information. It is recognized that alternate flow
paths may be implemented within the scope of this invention while
still achieving the novelty, inventiveness, and technical
contribution that the inventors are merited. Step 193 represents
the detect and store features of the medical device that is
monitoring the patient or user of the device. Step 197 represents
the interrogate function to query and receive physiologic data from
the medical device which is likely implanted within a patient. It
is recognized that this function step may be obviated for a device
which is external in view of different power management options.
Step 203 represents the transmission of data to a remotely located
patient management database 210 for storage and processing of the
received physiologic data. Step 217 represents the analysis and set
point computation steps necessary to determine whether the data
received comprises particularly high relevance data that
necessitates an alert. If an alert is not warranted then at step
219 the data is routed to a web site for instantaneous presentation
upon authorized access by either the patient, a proxy or a
healthcare professional. If an alert is warranted, then at step 221
a formatting process is implemented, and at step 225 a signal is
sent to web-site 231 notification routine causing a non-secure
alert signal 240 to be transmitted in a push fashion according to
pre-set protocol to healthcare providers. These providers in turn
query the web site by rapid return link activation 248 in either a
secure or non-secure manner which permits transfer of content rich
rendered and formatted signal 256 to the healthcare providers via
the web site, and with the signal comprising the high relevance
physiologic data necessary for rapid analysis and comment/action by
the healthcare providers, leading to transfer to the patient and
proxy 264 again via the web site at step 267 with such
comment/action recommendations riding thereon.
[0035] FIG. 6 discloses another embodiment of the invention in
which patient 350 is shown in a home setting and having one or more
of an implanted medical device 14. These devices may include
pacemakers, defibrillators, neurological devices, drug pumps,
implantable monitors, or any other type of device which can act as
a source of physiologic and medical device data that can be
suitably transferred from the device out of the body. Where there
exists a plurality of devices associated with one patient,
[0036] the devices may also communicate between one another. The
data communicated can be of several types. It may be data about the
status of the device itself, such as battery status, programmable
parameters, or device performance. It may be data which is sensed
by the device such as electrical data or other data from
specialized sensors. The transmitted data may also be processed or
refined data such as prediction of an upcoming event.
[0037] Transmission 360 signifies transmission of data from the
implanted device 14 to external remote monitoring instrument 44.
This may be a single or a multi-step process. For example, in a
single-step process, data is transmitted directly from the
implanted device into a monitor which is connected to a
communication system such as a telephone 365, which is only shown
in representative rather than mandatory fashion. In a multi-step
process, the implanted device transmits data to an intermediate
device such as a transponder which then subsequently sends the data
to a device connected to a communication system. Any portion of
this system could either be hardwired or wireless. The wireless
system could use any type of wireless technology, including but not
limited to radio frequency or infrared communication. In addition,
any portion of the system could also do additional data synthesis
or processing either for compression, prediction, correlation, or
any other reason for data analysis. In addition, the remote monitor
could capture data from sources other than the implanted device
such as other external instrumentation, or any other source of data
in that environment, if desired. The connections to these other
data sources could be either hardwired or wireless. The data could
be combined in the remote monitor, processed, or transmitted
separately.
[0038] It should be recognized that server 405 represents a
networked computing system which may consist of additional hardware
and software including databases, operating systems, communications
channels, and all other necessary components required to receive
large volumes of data from large numbers of users around the world
and to be able to store, refine, analyze, and retransmit data. The
communications network employed could be either private networks,
virtual private networks, or public networks like the internet. It
is to be understood that the server may also be connected to other
computers on either private or public networks and the implanted
device data could be aggregated or otherwise combined with other
data or services in the server.
[0039] Accordingly one embodiment of the invention is a system or
method of service or alternatively a business method by which is
provided a system for automatic implementation of a chronic remote
patient monitoring service. The service transmits high relevance
data of a medical and physiologic type from a patient having at
least one implanted and/or wearable device. The system to provide
this service product 471 comprises a server 405 hosting medical and
physiological data accessible via a remote monitor in data
communications with the server. At least one medical device 14 is
implanted in a patient 350 or wearably located on a patient being
in data communication with the remote server, and the server is
web-enabled to host and provide multi-directional data collections
from various services including the patient. In one embodiment the
at least one implanted and/or wearable medical device is in
wireless communication with the remote monitor to enable data
communications when the patient is ambulatory. The service provided
also includes programmable parameters to bill the patient, or
others, for the services provided.
[0040] FIG. 6 further illustrates data 479 flowing from server 405
to a physician 483 or other clinician such as a paraprofessional or
nurse who wishes to view the implanted device data or any of the
other aggregated data available on the server. As discussed herein
above, the physician or other clinician would have a password (or
other access control) which would grant access to the specific
data, and access could be granted either by the patient or by other
appropriate authentication authority. The data 479 could flow from
server 405 to the physician through a variety of means, including
private or public networks such as the Internet. To maintain
security, the server is presumably protected by a variety of
security mechanisms such as a firewall or other mechanisms which
control access. If the data moves over a public network like the
Internet, it is anticipated that the data would be encrypted. It is
also anticipated that other services may be provided along with the
data to the physician, such as scheduling services, updates in
medical information, or any of a large variety of physician office
services. In return for access to this high relevance data 479
and/or the services, it is possible that the physician or clinician
or clinic employing the physician or clinician would pay a fee for
the data or services. Any of a number of billing and collection
mechanisms can be envisioned for this fee. The fee could be single
use; that is, fee for each data view, or a fee for each service
used. Alternatively, the fee could cover a given time period such
as a monthly access charge or the like. The services could be
versioned in multiple versions ranging in complexity and richness
and correspondingly having different prices. The billing and
collections process could be done in any number of ways, including
direct computer-to-computer transaction, monthly statements, direct
credit card transfer, or any other mechanism commonly used for
business-to-business billing and collection transactions.
[0041] Accordingly, a valuable service is enabled by use of the
inventive full-cycle information system by which the system is
network-enabled to implement a chronic data management and
monitoring service for remote patients and medical devices. The
system includes: a server computer such as that shown and
represented by server 405 which is configured for hosting data
transmitted from the remote patients and medical devices; a client
computer providing access to a plurality of users of the service
such as, for example, clinician-based computer 483. In this manner,
and with the stream of high relevance patient and service data
available, the server computer provides a user interface whereby
the plurality of users are authenticated prior to accessing the
data, and the service is available via one of a secure web-based
channels to enable an authenticated user to access data pertaining
to a specific patient and/or medical service. Various billing and
collection systems may be employed with this system, including, for
example, services by which are utilized computer to computer
transactions, monthly statements, direct credit or debit
card/account transfers, micro-payment-systems and
business-to-business systems. It may be possible for
query-generated service revenue to be integrated as well, for
example, responsive to various user inquiries as discussed
herein.
[0042] FIG. 6 further demonstrates an information network 510
within a healthcare system. The healthcare system may be a clinic,
a multi-specialty clinic, a hospital, a hospital system, or an
integrated delivery network of multiple hospitals, clinics, and
outpatient facilities. Healthcare system information network 510
typically collects data from multiple sites within the healthcare
system such as, but not limited to, radiology results 519, clinical
laboratory results 526, or pathology results 530. Typically,
physicians or other clinicians working within the healthcare system
have access to this information network as shown by arrow 538
between the physician 483 and the healthcare system information
network 510. This highly interactive system is a valuable service
product which enables implementation of high relevance physiologic
data transfer and exchange. This alone as a real-time, virtual
real-time, or "archived" retrieval service is a product of
considerable importance and value, particularly when combined with
the high relevance source data that is coming from the patient's
device(s), and which may be further formatted or otherwise rendered
as discussed herein.
[0043] Accordingly an internet based information network service
for implementing medical data transfer and exchange in a health
care system is provided. This service comprises means for
collecting the medical data from multiple remote sites; and
interference means for accessing said means for said collecting by
authorized agents. Interface means includes controls for
authenticating a user for the service and provides selection
criteria and display at any one of said multiple remote sites for
the user. It is anticipated that this service will provide
substantial value to the users and is therefore subject to optional
payment systems as disclosed herein elsewhere.
[0044] FIG. 6 shows a further example of this unique data flow
system and methods of applying knowledge enhanced value to high
relevance data. The figure further demonstrates data or other
services flowing from server 405 to healthcare system information
network 510. It is envisioned that healthcare systems will import
data from the server to integrate with the other clinical data on
that patient within their respective healthcare system information
network 510. FIG. 6 shows arrow 552 between server 405 and
healthcare system information network 510, signifying both a
data/service path and a fee being charged for the healthcare system
information network to have access to the data and services on the
server. The data on the server represents important information
about the status of patient 350 or of the device 14 and would be
valuable to be integrated with other clinical data about the
patient who is followed within that healthcare system. The
healthcare system can provide either more effective or efficient
care by having data available from the server. For example, it is
less expensive for the healthcare system to check the status of an
implanted device by having the data transferred from a patient's
home than to have the patient come to the healthcare system and use
a clinic appointment to have the data interrogated. The value that
is created through this more efficient device follow up mechanism
is one basis of such a fee. Alternatively, the data may indicate
that the patient is deteriorating and it becomes less expensive to
anticipate this deterioration and treat it while the patient is at
home than to wait for the patient to get sicker and come into the
healthcare system. Similarly, this additional value may become the
basis for a fee. In either event, the healthcare system has an
economic and performance incentive to pay a fee to have access to
the high relevance data on the server. As in the case of the
physician or clinician, any of a variety of billing and payment
mechanisms can be envisioned. A fee could be charged for each time
the server is accessed. That could be weekly, monthly or yearly
access charges. There could be various versions of access differing
in richness, depth, or quantity of information presented or
transferred. There could be a variety of billing or collection
mechanisms, including direct computer-to-computer transfer,
billings statements, or any of a variety of other mechanisms.
[0045] Accordingly, a system for implementing computerized health
care information services is provided. This system is a network
capable of collecting medical data from various remote locations
including a patient with a medical device. The information service
comprises a server hosting medical and physiological data collected
from a patient at a remote location, with the server being in data
communications with a remote monitor that collects the data from
the patient having at least one implanted and/or externally worn
medical device. A physician's station is provided, and a health
care system information network in data communications with the
server and the physician's station is also provided. A billing
service for the remote management of the patient's health,
including a service of the performance of at least one implanted
and/or externally worn medical devices, also provides communicating
with the physician's station for expert opinion and advising the
patient in real-time, and to advise as to proper procedures to
follow for therapy and medical care.
[0046] FIG. 6 further shows a disease management organization 611
operating in association with a clinician 483 and a healthcare
system 510. Disease management organizations typically undertake
the responsibility of managing a patient's disease in its entirety
and may be contacted using a variety of mechanisms such as yearly
fees, risk sharing, or captivated/capitated payment. A disease
management organization can either exist as part of a healthcare
system or may be outsourced. Disease management organizations
typically exist to manage patients with chronic diseases such as
heart failure, diabetes, asthma, arthritis, and cancer, although
any disease could possibly be managed by a disease management
organization.
[0047] It is recognized that disease management organizations
typically attempt to capture and synthesize a variety of types of
information. The figure demonstrates information coming from
clinical guidelines 621, data from point of care instrumentation
629, and data from patient interactions 633, but many types of
information are used by disease management organizations to manage
a patient that are in addition to those shown for example. Arrow
648 between the disease management organization 611 and the
healthcare system information network 510 represents that the
disease management organization may use data and services in the
healthcare system information network 510 and may also source data
and/or services to the healthcare system information network.
[0048] Once again, FIG. 6 also demonstrates how data and/or
services may flow from the server 405 to the disease management
organization 611. The data 650 flowing from a server 405 becomes
another source of information which is used by the disease
management organization to manage the patient or function more
effectively as an organization. Similar to the case for the
healthcare system, it is envisioned that the data and/or services
that can be supplied by the server will allow the disease
management organization to treat the patient either more
efficiently or more effectively, saving money and improving care in
either case. In return for the data, the disease management
organization pays a fee to have access to the data/services. All of
the comments about billing and payment mechanisms discussed in the
healthcare system and clinician case also apply to the disease
management organization. In addition, various payments structures
can also be envisioned based on the way that the disease management
organization contract is written, including subscription fees, risk
sharing, or captivated/capitated fees.
[0049] What is provided, therefore, is a system for implementing a
disease management service in which a remote chronic patient with
an implantable medical device and/or wearable device(s) is
provided. The service includes multiple users of data and
information exchange systems cooperating to provide the service for
continuously managing the chronic patient's disease in a highly
efficient and value-added manner. In one embodiment, the system
comprises: a server hosting medical and physiological data
collected from the patient; a physician's station and data
communications with the server; and a health care system
information network being in a bi-directional communication with
the physician's station and further having a data communication
with the server; and a disease management organization in
bi-directional communications with the health care system
information network. The server includes at least one set of
databases of information concerning the patient, so that the
database is structured to assist the disease management
organization in the management of the patient. In addition to the
basic data, as discussed herein, particular formats and rendering
of the data is also available for a fee based access in order to
improve the utility of the high relevance data to the disease
management organization.
[0050] FIG. 6 further shows data and/or services 702 flowing from
server 405 to a medical device provider/manufacturer 715 (such as
Assignee of the invention, Medtronic, Inc.) and/or medical
product/service provider. It is envisioned that the data on the
server could be used by medical device manufacturer 715 in a
variety of valuable ways.
[0051] A first embodiment shows the data 702 flowing to a research
and development department 719. It is anticipated that having
access to large and highly relevant databases of patient physiology
and device performance, will be a valuable source of information in
the design of new devices.
[0052] A second embodiment shows the data 702 flowing to the
product planning department 729. Knowing how devices are
programmed, device longevity, and potential failure modes will be
usefully in planning new features and new devices. This is
information which is very valuable and available from data 702.
[0053] A third embodiment shows the data 702 flowing to the
department responsible for post market surveillance 739. Many
governmental entities, e.g., countries, require manufacturers to
perform post-market surveillance on their medical devices to
understand device performance and failure modes and mechanisms.
Having this data available through the server 405 will allow more
accurate, timely, and complete information capture; all of which is
highly valuable. Indeed, for this and other uses, the particularly
high volume of highly relevant data in a full cycle system
distinguishes this invention from others.
[0054] A fourth embodiment illustrates the data 702 flowing to a
sales and marketing department 749. The server data can help to
evaluate whether the implanted device is appropriate for the
patient's condition. For example, if the patient has an implanted
ventricular defibrillator that does not have any atrial
fibrillation therapy modalities, and the data demonstrates that the
patient is having episodes of atrial fibrillation, the sales and
marketing department could contact the physician to replace the
implanted device with a different device that is more effective in
treating all of the patients' conditions. This offers the
opportunity for cross-selling or up-selling, particularly at the
time of device replacement, and is a very good example of the
knowledge enhanced value of data/services represented as data
702.
[0055] A fifth embodiment demonstrates the data 702 flowing to
clinical databases 759. These clinical databases are envisioned to
be large collections of data captured from patients who send data
to the server and are maintained longitudinally over time. It is
envisioned that these could be very large databases involving tens
or hundreds of thousands of patients who are being followed for
long durations, including possibly, years. These databases would
offer information which is simply unmatched and unattainable in any
other way involving device performance and patient physiology on
very large numbers of patients over prolonged periods of time.
Using any of a variety of data mining mechanisms, some of which may
be known in the art, it is anticipated that new patterns and new
knowledge can be gained through the analysis and synthesis of these
novel databases. For example, it is anticipated that device
performance, failure modes, and longevity will be able to be
estimated and predicted with far better accuracy than is possible
today. In addition, it is anticipated that evaluating patient
physiology will allow patterns of disease and prediction of future
disease, rate of onset, or disease progression which are not
currently possible without this invention.
[0056] FIG. 6 also illustrates selling or sharing the results of
this data mining from the clinical databases 759 (or other
sub-groups of entity 715) to a disease management organization 611,
as shown by arrow 778. Disease management organizations need to
understand disease progression and cost structures in order to be
able to profitably run their business. Such organizations must
estimate the costs that they will incur in taking care of patients
when they contract with a healthcare system. Better information
that allows more accurate prediction of costs is highly valuable to
these organizations. In return for this better predictive
information which is a result of the data mining of the high
relevance clinical databases, the disease management organization
pays a fee. This fee could be structured in any of a variety of
ways. For example, the disease management organization may want
data only on its own enrolled patients which are contained in the
clinical database and would pay either a subscription or access fee
to be able to estimate costs of their enrolled population.
Alternatively, disease management organization 611 may be
interested in population behavior that would allow it to better
estimate future costs. In this case, the fee could take the form of
intermittent updates, fees for algorithms, fees for analyst's
reports, or any of a variety of data product or data-service
related mechanisms. Any one of a number of billing and collection
mechanisms could be utilized including direct computer-to-computer
transfer, standard invoicing and payments, or any other mechanism
for billing and collection.
[0057] In similar fashion to that above, data and/or data-products
and/or data-services from the clinical database (or other sub-group
of entity 715) flow to the healthcare system information network
510 via arrow 788. In similar ways as those described for disease
management organizations, healthcare systems need to be able to
predict and anticipate operating costs, utilization, quality, and
other operating metrics. The information which is synthesized
through the data mining of the large clinical databases can be a
source of extremely valuable information to healthcare systems. For
example, a healthcare system could compare device failure or
malfunction rates within its healthcare system to population
statistics to determine quality of device implantation and follow
up. Alternatively, a healthcare system could compare the physiology
or complications from its patients to population statistics.
Healthcare systems could predict utilization of their services by
evaluating complication rates within large populations of patients
and extrapolating that data to their own population. Many other
valuable types of information can be envisioned, and particularly
when using high relevance and rapidly accessible high volume
data/information which is nowhere else found. In return for this
exceptionally unique information, the healthcare system would pay a
fee to entity 715. These fees could be structured in a variety of
ways depending on the type of information, frequency of interaction
and depth of richness and utility of information. Potential
mechanisms include time based subscriptions, single use access
fees, and multiple versions. Invoicing, billing and payment could
be carried out as well through a variety of mechanisms, including
direct computer-to-computer transfer, credit card billing, paper
invoicing and checks, or any of the multitude of ways of billing
and collecting in business.
[0058] This example shows an information system for generating
medical device performance data, in real-time, to enhance product
performance and adapt business methods to provide a continuously
improving service to a chronic patient. The information system
comprises a server hosting data transmitted from a remote patient;
a plurality of client computers providing access to the server; and
a medical device related entity computer being in data
communications with the server wherein device data is managed to
provide at least a certain quantity of information derived from a
sub-group of the medical device entity, for use by engineering
personnel and others in disease management organizations or health
care systems.
[0059] FIG. 6 further illustrates relationships and inventive
methods of performing tasks and of doing business involving
patients, consumers, and others using interrogated high relevance
implanted device data on the internet or web-enabled system 802.
This figure shows data being transferred from the server 405 to an
internet website 807 which is a customized website, similar to that
earlier described in relation to web-based site 70 of FIGS. 2-4.
Site 807 is representative of a plurality of various sites which
could be used in this application. This transfer could involve raw
data or synthesized or refined data, and is represented by arrow
815. The transfer of this data could either occur continuously or
intermittently depending on the application. The data, or refined,
synthesized, or analyzed data/signals could either reside on the
website 807 or the website could use the server as a source of data
when queried by the user.
[0060] A user may access website 807 and view the data supplied by
the server. This creates a complete loop of high relevance, fresh
information starting with the patient (or other entity)
interrogating the implanted device 14 with data flowing through the
remote monitor, through a communications channel such as a
telephone or other means, to a server 405 (or element functioning
as such), to a website 807 and subsequently back to the patient, as
shown via data/services arrow 825. This closed loop can serve as a
system by which the patient changes something in this environment
based on the information supplied by the interrogated device.
[0061] For example, the patient may change a dose of medicine,
alter their lifestyle, or diet, or any other aspect of his/her
medical care based on the updated information which is supplied
through website 807. It is anticipated that this website will
display the most recent data along with a longitudinal record of
the patient's data in the past. In addition, the patient's
individual data may be compared to population statistics which are
available on the server which would allow the patient to compare
his particular medical condition to larger numbers of patients with
similar problems. It is also anticipated that the patient will
interact with the website to supplement the data coming from the
server with additional user-entered information such as current
drug regimens, quality of life information, lifestyle information,
or any other information which could be useful when stored on
website 807 and aggregated with the implanted device data. This
further information seeking may also serve as a rating mechanism
for rating the relevance and value of the user's inquiries in
relation to the observed physiologic condition. This rating may
then be a factor in further actions, including fee related
actions.
[0062] It is contemplated that the user (whether patient or another
user) will pay a fee for the services available on website 807.
This fee might typically take the form of a monthly subscription
fee to allow the user to access the website and the personal data
residing at that site. Any of the methods used to bill and collect
payment on internet sites such as credit card billing or direct
billing could be used. It is also contemplated to provide multiple
versions of the service available, including basic versions which
may be lower priced or even ranging through richer and deeper
applications and service offerings which will be priced
accordingly. The financial transactions may be done using encrypted
data transmissions as is common on public computer network such as
the Internet: The data transmission and medical information
transmission can either be done using encryption or might also be
done in a non-encrypted format.
[0063] It is also anticipated that the patient will be able to
designate other users who can log on to the patient's account on
website 807 to view the patient's specific data and information.
These users might include family members, homecare givers, friends,
advocates or any other person that the patient designates such as
in a "friends and family" list. It is also anticipated that any one
of the friends or family could also pay for the patient's account
by billing a member of the "friends and family" list rather than
the patient himself. In addition, it is possible that there would
be access charges for the designated users which could range from
single transaction fees through monthly subscription fees.
Alternatively, charges might be adjusted according to health plan
providers in view of the positive economic impact to a health care
system when a patient and/or patient's friends or family are
actively involved in the patient care or monitoring. It is also
important to note that the hardware or software components of the
system which are required in the closed loop could be bundled with
the online service charges. For example, the remote interrogation
device, might be purchased directly by any one of the potential
users of the system, such as the patient, the physician, the
healthcare system, the disease management organization, or a friend
or family member. Alternatively, the cost of the remote monitor
could be included as part of the internet service fee charged or
accessed on website 807 in return for a subscription of minimum
length such as two or three years. Additionally, software upgrades
either to the remote monitor or the website could be purchased
directly by any of the users of the system or also could be bundled
within the overall Internet service offering. Again, although not
envisioned as the primary way of charging for this service, it is
possible that either the healthcare system, disease management
organization, or other healthcare entity may elect to pay for the
Internet service for the patient to ensure that the patient has
this service that ultimately will be of benefit to that healthcare
entity. As will be further discussed, website 807 is also connected
to other health sites who may extract value by having patients have
the customized website 807 service offering. It is conceivable as
well that one or more of these other websites could pay the access
fee for the patient to such a website 807.
[0064] FIG. 6 also shows links between website 807 and other
Internet health sites. There are currently many health sites on the
Internet with a variety of information, service, and revenue
models. Most of these sites benefit by having additional users log
onto their sites. Website 807 could structure business
relationships with these health sites whereby users on would become
aware of pertinent or relevant content on other health sites 820.
If a user transfers from website 807 to that other health site, the
other health site would pay a fee to website 807 for delivering a
user to their site. This communication and fee structure is shown,
for example, by arrow 825.
[0065] This figure also illustrates the connection between website
807 and the websites of pharmaceutical companies 831 on the
internet. It is anticipated that website 807 may contract with
pharmaceutical companies to make information about their products
available to users of website 807. If a user moves to the website
of a pharmaceutical company or uses the services of a
pharmaceutical company, it is anticipated that company would pay a
fee to the owner at website 807, indicated by data and revenue
arrow 835. Several different fee structures can be envisioned. For
delivering a patient to a pharmaceutical site, a "click through"
fee could be generated. If the patient purchases additional
services on the pharmaceutical site, a fee which could represent a
percentage of revenue or an additional one time fee could also be
generated. For example, if a user ends up getting a prescription
for a drug through their interaction with the pharmaceutical site,
the pharmaceutical company could pay a portion of that revenue back
to website 807. In addition, if the patient becomes a user of other
services which are offered by the pharmaceutical company such as
enrollment in a disease management program, then a portion of
related or attributable revenues would also be returned to website
807. Additionally, patient data could flow to the pharmaceutical
company if permitted by the patient. The pharmaceutical company may
have interest in evaluating patients responses to medications and
the high relevance data collected by the implanted device and
offered at website 807 may be valuable data to the pharmaceutical
company. In this case, a fee would be charged to the pharmaceutical
company for the data. This could either be one time access fees or
fees for access to data over more prolonged periods of time.
[0066] Also demonstrated is a connection between website 807 and a
clinical trial organization 841 such as a contract research
organization. Clinical trial organizations typically perform
clinical trials for manufacturers of pharmaceuticals or devices.
There are a number of different ways that internet based
interaction could occur. Website 807 could contract with a clinical
trial organization to identify patients who may set the criteria
for clinical trial enrollment. If a user of website 807 meets the
enrollment criteria, website 807 could inform the patient that they
could be eligible for a clinical trial and refer the patient to the
clinical trial organization for enrollment. This could be done
either by connecting them to the clinical trial organization
website or through more traditional means such as a phone number or
an office contact. The clinical trial organization would pay a fee
for referring the perspective enrollee. If the patient actually
enrolled in the clinical trial, one or more additional fee(s) could
be generated. Another interaction is that data collected at website
807 could be useful in the monitoring and management of the
clinical trial. In return for the clinical trial organization
having access to patient data at website 807, which may make the
clinical trial more effective, efficient, or faster, the clinical
trial organization would pay a fee for data access. These fees and
data-related products/services are represented by arrow 845.
[0067] FIG. 6 also shows the interaction between website 807 and
various retailers 851 on the internet. These may be retailers
offering medical equipment, but could also include retailers
selling diverse items such as books, exercise equipment, or
virtually any item which may be of interest to the user of website
807. The operator of website 807 would contract with various
internet retailers to deliver patients to their sites based on
their interests and/or ratings as well as the data which is
acquired from the implanted device, all of which may be done
automatically based on the patient's physiological data or other
mechanisms. For example, if the data from the implanted device
indicated that the patient was having episodes of a particular type
of arrhythmia, the patient could be referred to a book retailer
with specific books on that arrhythmia. Fees would be generated
through a variety of mechanisms. The store would pay a fee for the
referral of the patient to the store website. If the patient
actually accesses and/or purchases items at that online store, a
percentage of the revenue would flow back to website 807. These
data services/products and fees are designated by arrow 855.
[0068] The figure further demonstrates the interactions between
website 807 and other major internet companies 861 such as major
portals, search engines, internet service providers, and the like.
Many of these companies generate revenue based on advertising,
which depends on user volume. Customized websites 807 could create
arrangements with other internet companies to refer patients to
those companies' websites if there is particularly relevant content
or services available at those sites. For example, based on the
implanted device data, a patient may be referred to a particular
search engine which is particularly powerful in searching sites
relating to that patient's particular problem. In return for the
referral to the site, a fee is generated, as indicated by data
services/products and fee arrow 865. In addition, if the patient
subsequently purchases additional services from that site as a
result of being routed to that site through website 807, a portion
of review would be returned to website 807.
[0069] Similar relationships may be possible with patient advocacy
groups 871, having valuable charters or missions which can have
considerable tangible and intangible value to healthcare services,
products, and decision makers. Such value may have a fee component,
which is shown here as data services/products and fee arrow
875.
[0070] Accordingly, a system for implementing a network remote
patient management services fee generating series of transactions
comprises a server hosting patient management data for providing
chronic monitoring of remote patients with chronic disease having
implantable medical devices and/or wearable devices. The system
further comprises a server being accessible via client computers
wherein the client computers include a web-enabled system, a
medical device entity website, a physician or other clinician site,
a healthcare information network site, and a disease management
organization. Each of the client computers are in data
communications with the server to import specific data on which the
patient management services billing schemes, for at least one
service, are implemented.
[0071] FIG. 7 illustrates a variation of a method of providing data
products and services, or alternatively methods of doing business,
as described hereinabove. This variation places or positions the
(patients' implanted device) server 405 at the center of the
patient information flow. FIG. 6 shows, for example, most data
flowing in one direction from server 405 to various users, which
are now shown in FIG. 7 as bi-directional arrows.
[0072] This indicates that data could be flowing in both
directions. The implanted data server 405, by being at the center
of all of these information flows, could act as an aggregator of
data and become the central repository of data about this
particular patient. For example, while interrogated device data
could flow from the server 405 to integrate what the healthcare
systems information network 510 contains as other data on the
patient, the data from the healthcare system information network
510 could flow back to the server 405. Similarly, rather than data
flowing only from the server 405 to the disease management
organization, data could also flow backward from the disease
management organization to server 405. With multiple information
flows coming to the server 405, it could become the central
repository of multiple data sources. In return for this data
access, the server 405 might generate payments to the sources of
data such as the healthcare system information network or the
disease management organization or alternatively process the
returned data as a product/service after revision algorithms or
updated databases for a further fee from the data providers.
Therefore, in the same way that the information flow arrows are now
two way, the revenue flow could also be bi-directional or
optionally remain one-way. Of course, by having an aggregated set
of the patient's data residing at the server, that data could then
be repackaged with further knowledge enhanced value and resold to
any of a variety of interested users beyond just the healthcare
systems, disease management organizations, or integrated delivery
systems, as may be agreed. Any of those organizations could also
subsequently pay a fee for access to the integrated and aggregated
data.
[0073] Accordingly, a personalized set of electronic web-based
health and mobile health services may be provided and tailored to
provide real-time and uninterrupted chronic patient management for
remote patients with a medical device. These services include a
billing scheme which is automatically implemented for services
rendered, with the billing scheme comprising a server computer
hosting the services accessible via client computers to a plurality
of potential users of the service; and with the client computers
being web-enabled to provide various service options to the user.
The services are available over the internet to assist a specific
user in locating and accessing a required service relating to the
patient.
[0074] The above described invention relates to a patient-focused
service of the highest order in which one or more implantable
medical devices are implanted in a patient, and wherein the devices
are adapted to connect the patients with caregivers for an
uninterrupted management of chronic disease. Specifically, the
invention also relates to a seamless flow of information between a
surgical suite where the devices are implanted, the availability of
support/expert systems, and improved availability of caregivers to
the patient's home.
[0075] As noted, the health care systems worldwide need to provide
better economic and lifestyle options for patients who suffer from
chronic disease. Further, there is a need to empower patients to
respond to their needs in a responsible way. Specifically, a system
that enables patients and physicians to better treat chronic
disease through the use of a remote monitoring communication and
therapeutic technologies, is highly desired. More importantly, a
total closed loop patient management system as well as support
entity improvement tools which enable a continuous communication
between patients, caregivers and physicians, will provide both
patients and physicians with the knowledge that they need to make
better treatment and organizational/resource management
decisions.
[0076] Application of the invention(s) herein will move care beyond
an episodic event to managing care over the course of one's
disease. For example, a disease management system that allows
physicians to select more appropriate treatment pathways in the
management of chronic pain would require a bi-directional
communication system between patients and remote physicians and
caregivers. Specifically, as it relates to chronic disease, a
system that enables patients and caregivers to have an
uninterrupted continuous communication between them, would assist
in the delivery of more effective and lower cost care for the
patient.
[0077] The invention thus relates to multiple types of technologies
integrated to support an infrastructure of networks for implanting
a medical device, managing the medical device operations and
performance, and chronic monitoring of patients while allowing them
to lead a normal life at home and away from the hospital.
[0078] The invention exploits a combination of traditional medical
technology with new advances in information and communication
technology, coupled with the biologic sciences to transform the
practice of medicine. More specifically, the invention creates
services that will connect patients with their caregivers. This
connectivity will allow connectivity to manage and especially
enhance the flow of information between caregivers and patients, in
order to provide the knowledge necessary to make informed decisions
about the patient's health care over an extended period of
time.
[0079] Another example of the integrated approach of the present
invention is further illustrated as, optionally, starting in the
Network Operating Room 962 (shown schematically in FIG. 8) where a
clinical knowledge delivery system provides the physician with
up-to-date information on the device to be implanted in the
prospective patient. Specifically, the physician will be provided
with complete care knowledge delivered in an environment that not
only meets, but also anticipates, the surgical team's every
requirement. The Network Operating Room 962 can, for example, bring
a clinical specialist directly into the operating room through a
virtual clinical support system.
[0080] It is anticipated that the specialist could be one who could
offer in-depth product knowledge and has a deep understanding of a
particular procedure so that technical service and support could be
given at the exact moment in surgery when it is required by the
physician. The network operating room also contains a high speed
information portal 975, a conduit to deliver the patient's most
relevant care information such as knowledge-enhanced radiographs,
physiologic monitoring and information of anatomic and functional
displays. All this, and similar functions, would be under the
physician's control. Video audio graphics, even highly realistic
holographic imagery could be delivered where the physician needs
it, when she needs it.
[0081] Further, an on-line consultation with physicians 979
remotely located from the operating room, could be initiated using,
for example, an expert on-call program. As the on-call physician
connects with the Network Operating Room, they are provided with a
summary of the surgical plan and reference similar procedures
using, for example, vast clinical data repositories 982 via server
988. Accordingly, the invention provides complete connectivity
between all care providers whose instantaneous availability
anywhere in the world to cover all aspects of care, is available in
the operating/emergency/procedures room. Further, a parallel
network of support systems 993 provides the patient in the home
with connectivity to the primary care physician and other health
care professionals via appropriate connectivity or communications
interfaces 995. Thus the service is focused entirely on the
patient, improving the physical condition and psychological outlook
of patients, and reducing the anxiety among patients and others
involved in healthcare.
[0082] The invention therefore provides a standards-based network
for procedural room support, chronic disease management and medical
device management services that are accessible to enable patients
and physicians to effectively manage chronic disease through remote
monitoring, communication, and data exchange on a continuous basis.
The present invention provides virtual support systems to enable
patients to lead a full life in spite of chronic disease, and
appropriate revenue savings and fee generation results so as to
encourage utilization of such a system. Connectivity may be via
electronic, mobile lines 997 of data transfer, as disclosed in
various embodiments herein.
[0083] This invention contemplates various systems and various
types of methods to enable substantial economic and medical
improvements to the business, art and science of healthcare. It is
believed that these innovations and technical contributions provide
a powerful combination of features and service advantages in view
of the previously stated challenges to real-time effective
management of certain classes of patient, such as those with
chronic cardiac disease, constant infusion of medicines, neurologic
stimulator requirements, or others, and that this has not been
accomplished or realistically contemplated before by others.
* * * * *