U.S. patent application number 09/789456 was filed with the patent office on 2001-07-05 for system and method for automated collection and analysis of patient information retreived from an implantable medical device for remote patient care.
Invention is credited to Bardy, Gust H..
Application Number | 20010007053 09/789456 |
Document ID | / |
Family ID | 46203620 |
Filed Date | 2001-07-05 |
United States Patent
Application |
20010007053 |
Kind Code |
A1 |
Bardy, Gust H. |
July 5, 2001 |
System and method for automated collection and analysis of patient
information retreived from an implantable medical device for remote
patient care
Abstract
A system and method for automated collection and analysis of
patient information retrieved from a medical device adapted to be
implanted in a patient for remote patient care is described. A set
of collected measures is periodically received from the medical
device adapted to be implanted over a communications link which is
interfaced to a network server. The collected measures set includes
individual measures which each relate to patient information
recorded by the medical device adapted to be implanted for an
individual patient. The collected measures set is stored into a
patient care record for the individual patient within a database
server organized to store one or more patient care records. Each
patient care record includes a plurality of the collected measures
sets. One or more of the collected measures sets in the patient
care record for the individual patient is analyzed relative to one
or more other collected measures sets stored in the database server
to determine a patient status indicator.
Inventors: |
Bardy, Gust H.; (Seattle,
WA) |
Correspondence
Address: |
PATRICK J S INOUYE P S
810 3RD AVENUE
SUITE 258
SEATTLE
WA
98104
US
|
Family ID: |
46203620 |
Appl. No.: |
09/789456 |
Filed: |
February 20, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09789456 |
Feb 20, 2001 |
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09324894 |
Jun 3, 1999 |
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Current U.S.
Class: |
600/300 |
Current CPC
Class: |
G16H 50/30 20180101;
A61B 5/4803 20130101; G16H 40/67 20180101; A61B 5/0205 20130101;
G16H 10/60 20180101; A61B 5/7465 20130101; A61N 1/3627 20130101;
Y10S 128/92 20130101; Y02A 90/10 20180101; G16H 40/63 20180101;
A61B 5/0031 20130101 |
Class at
Publication: |
600/300 |
International
Class: |
A61B 005/00 |
Claims
What is claimed is:
1. A system for automated collection and analysis of patient
information retrieved from a medical device adapted to be implanted
in a patient for remote patient care, comprising: a network server
interfaced to a communications link over which is periodically
received a set of collected measures from the medical device
adapted to be implanted, the collected measures set comprising
individual measures which each relate to patient information
recorded by the medical device adapted to be implanted for an
individual patient; a database server coupled to the network server
and storing the collected measures set into a patient care record
for the individual patient, the database server being organized to
store one or more patient care records which each comprise a
plurality of the collected measures sets; and an application server
coupled to the database server and analyzing one or more of the
collected measures sets in the patient care record for the
individual patient relative to one or more other collected measures
sets stored in the database server to determine a patient status
indicator.
2. A system according to claim 1, the application server further
comprising: a comparison module comparing an initial measure
selected from the one or more collected measures sets to a sibling
measure selected from the one or more other collected measures
sets, the initial measure and the sibling measure both relating to
the same type of patient information.
3. A system according to claim 1, the application server further
comprising: a derivation module determining an initial derived
measure using at least one measure selected from the one or more
collected measures sets and determining a sibling derived measure
using at least one measure selected from the one or more other
collected measures sets, the initial derived measure and the
sibling derived measure both relating to the same type of derived
patient information; and a comparison module comparing the initial
derived measure to the sibling derived measure.
4. A system according to claim 1, the application server further
comprising: a comparison module comparing an initial measure
selected from the one or more collected measures sets to a peer
measure selected from the one or more other collected measures
sets, the initial measure relating to a different type of patient
information than the peer measure.
5. A system according to claim 1, the application server further
comprising: a derivation module determining a peer derived measure
using at least one measure selected from the one or more other
collected measures sets; and a comparison module comparing an
initial measure selected from the one or more collected measures
sets to the peer derived measure, the initial measure relating to a
different type of patient information than the derived patient
information to which the peer derived measure relates.
6. A system according to claim 1, the application server further
comprising: a derivation module determining an initial derived
measure using at least one measure selected from the one or more
collected measures sets; and a comparison module comparing the
initial derived measure to a peer measure selected from the one or
more other collected measures sets, the initial derived measure
relating to a different type of derived patient information than
the patient information to which the peer measure relates.
7. A system according to claim 1, the application server further
comprising: a derivation module determining an initial derived
measure using at least one measure selected from the one or more
collected measures sets and determining a peer derived measure
using at least one measure selected from the one or more other
collected measures sets; and a comparison module comparing the
initial derived measure to the peer derived measure, the initial
derived measure relating to a different type of derived patient
information than the derived patient information to which the peer
derived measure relates.
8. A system according to claim 1, wherein the one or more other
collected measures sets are stored in the patient care record for
the individual patient for whom the patient care indicator has been
determined.
9. A system according to claim 1, wherein the one or more other
collected measures sets are stored in the patient care records for
a group of one or more other individual patients.
10. A system according to claim 1, further comprising: a collection
client communicatively interposed between the medical device
adapted to be implanted and the communications link, the collection
client retrieving the collected measures set and downloading the
collected measures set from the collection client into the network
server over the communications link.
11. A system according to claim 10, wherein the collection client
is selected from the group consisting of a programmer,
interrogator, recorder, monitor, telemetered signals transceiver,
personal computer, digital data processor, and combinations
thereof.
12. A system according to claim 1, the application server being
interfaced to a feedback communications link and further
comprising: a feedback client interfaced to the feedback
communications link over which automated feedback based on the
patient status indicator is provided to the individual patient from
the application server.
13. A system according to claim 12, the application server further
comprising: a feedback module providing tiered feedback comprising:
at a first level of feedback, communicating an interpretation of
the patient status indicator to the individual patient over the
feedback communications link; at a second level of feedback,
communicating a notification of potential medical concern based on
the patient status indicator to the individual patient over the
feedback communications link; at a third level of feedback,
communicating a notification of potential medical concern based on
the patient status indicator to medical personnel in local
proximity to the individual patient over the feedback
communications link; and at a fourth level of feedback,
communicating a set of reprogramming instructions based on the
patient status indicator to the implantable medical device over the
feedback communications link.
14. A system according to claim 12, wherein the automated feedback
comprises at least one of the group consisting of a peer group
status indicator, a historical status indicator, a trend indicator,
a medicinal efficacy indicator, and a wellness indicator.
15. A system according to claim 12, wherein the feedback
communications link comprises at least one of the following:
internetwork link, internetwork link, serial link, data telephone
link, satellite link, radio-frequency link, infrared link, fiber
optic link, coaxial cable link, television link, and combinations
thereof.
16. A system according to claim 12, wherein the feedback client is
selected from the group consisting of a personal computer,
facsimile machine, telephone instrument, network computer, wireless
computer, personal data assistant, television, digital data
processor, and combinations thereof.
17. A system according to claim 1, the application server further
comprising: an analysis module dynamically analyzing the one or
more of the collected measures sets in the patient care record for
the individual patient.
18. A system according to claim 1, the application server further
comprising: an analysis module analyzing the one or more of the
collected measures sets in the patient care record for the
individual patient in a batch comprising the one or more of the
collected measures sets in patient care records for a plurality of
individual patients.
19. A system according to claim 1, wherein the communications link
comprises at least one of the following: internetwork link,
internetwork link, serial link, data telephone link, satellite
link, radio-frequency link, infrared link, fiber optic link,
coaxial cable link, television link, and combinations thereof.
20. A system according to claim 1, wherein the database server
comprises at least one of the following: volatile storage,
non-volatile storage, removable storage, fixed storage, random
access storage, sequential access storage, permanent storage,
erasable storage, and combinations thereof.
21. A system according to claim 1, wherein the organization of the
database server comprises at least one of the following: flat file,
hierarchical database server, relational database server,
distributed database server, and combinations thereof.
22. A system according to claim 1, wherein the network server and
the application server are each selected from the group consisting
of a personal computer, minicomputer, mainframe computer,
supercomputer, parallel computer, workstation, digital data
processor, and combinations thereof.
23. A system according to claim 1, wherein the medical device is
selected from the group consisting of a pacemaker, implantable
cardioverter defibrillator, implantable heart failure monitor,
implantable event monitor, implantable cardiopulmonary monitor,
implantable metabolic monitor or device, endocrinology monitor or
device, hematology monitor or device, implantable neuromuscular
monitor or device, implantable gastrointestinal monitor or device,
genitourinary monitor or device, and combinations thereof.
24. A system according to claim 1, wherein the set of collected
measures comprises at least one of the following: atrial electrical
activity, ventricular electrical activity, time of day, activity
level, cardiac output, oxygen level, cardiovascular pressure
measures, pulmonary measures, interventions made, and combinations
thereof.
25. A system according to claim 24, the set of collected measures
further comprising derived measures selected from the group
consisting of linear measures derived from the set of collected
measures, non-linear measures derived from the set of collected
measures, and combinations thereof.
26. A method for automated collection and analysis of patient
information retrieved from a medical device adapted to be implanted
in a patient for remote patient care, comprising: periodically
receiving a set of collected measures from the medical device
adapted to be implanted over a communications link which is
interfaced to a network server, the collected measures set
comprising individual measures which each relate to patient
information recorded by the medical device adapted to be implanted
for an individual patient; storing the collected measures set into
a patient care record for the individual patient within a database
server organized to store one or more patient care records which
each comprise a plurality of the collected measures sets; and
analyzing one or more of the collected measures sets in the patient
care record for the individual patient relative to one or more
other collected measures sets stored in the database server to
determine a patient status indicator.
27. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: comparing
an initial measure selected from the one or more collected measures
sets to a sibling measure selected from the one or more other
collected measures sets, the initial measure and the sibling
measure both relating to the same type of patient information.
28. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: determining
an initial derived measure using at least one measure selected from
the one or more collected measures sets; determining a sibling
derived measure using at least one measure selected from the one or
more other collected measures sets, the initial derived measure and
the sibling derived measure both relating to the same type of
derived patient information; and comparing the initial derived
measure to the sibling derived measure.
29. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: comparing
an initial measure selected from the one or more collected measures
sets to a peer measure selected from the one or more other
collected measures sets, the initial measure relating to a
different type of patient information than the peer measure.
30. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: determining
a peer derived measure using at least one measure selected from the
one or more other collected measures sets; and comparing an initial
measure selected from the one or more collected measures sets to
the peer derived measure, the initial measure relating to a
different type of patient information than the derived patient
information to which the peer derived measure relates.
31. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: determining
an initial derived measure using at least one measure selected from
the one or more collected measures sets; and comparing the initial
derived measure to a peer measure selected from the one or more
other collected measures sets, the initial derived measure relating
to a different type of derived patient information than the patient
information to which the peer measure relates.
32. A method according to claim 26, the operation of analyzing the
one or more collected measures sets further comprising: determining
an initial derived measure using at least one measure selected from
the one or more collected measures sets; determining a peer derived
measure using at least one measure selected from the one or more
other collected measures sets; and comparing the initial derived
measure to the peer derived measure, the initial derived measure
relating to a different type of derived patient information than
the derived patient information to which the peer derived measure
relates.
33. A method according to claim 26, wherein the one or more other
collected measures sets are stored in the patient care record for
the individual patient for whom the patient care indicator has been
determined.
34. A method according to claim 26, wherein the one or more other
collected measures sets are stored in the patient care records for
a group of one or more other individual patients.
35. A method according to claim 26, further comprising: retrieving
the collected measures set into a collection client communicatively
interposed between the medical device adapted to be implanted and
the communications link; and downloading the collected measures set
from the collection client into the network server over the
communications link.
36. A method according to claim 35, wherein the collection client
is selected from the group consisting of a programmer,
interrogator, recorder, monitor, telemetered signals transceiver,
personal computer, digital data processor, and combinations
thereof.
37. A method according to claim 26, further comprising: providing
automated feedback based on the patient status indicator to the
individual patient over a feedback communications link configured
between the network server and a feedback client.
38. A method according to claim 37, further comprising: providing
tiered feedback comprising: at a first level of feedback,
communicating an interpretation of the patient status indicator to
the individual patient over the feedback communications link; at a
second level of feedback, communicating a notification of potential
medical concern based on the patient status indicator to the
individual patient over the feedback communications link; at a
third level of feedback, communicating a notification of potential
medical concern based on the patient status indicator to medical
personnel in local proximity to the individual patient over the
feedback communications link; and at a fourth level of feedback,
communicating a set of reprogramming instructions based on the
patient status indicator to the implantable medical device over the
feedback communications link.
39. A method according to claim 37, wherein the automated feedback
comprises at least one of the group consisting of a peer group
status indicator, a historical status indicator, a trend indicator,
a medicinal efficacy indicator, and a wellness indicator.
40. A method according to claim 37, wherein the feedback
communications link comprises at least one of the following:
internetwork link, internetwork link, serial link, data telephone
link, satellite link, radio-frequency link, infrared link, fiber
optic link, coaxial cable link, television link, and combinations
thereof.
41. A method according to claim 37, wherein the feedback client is
selected from the group consisting of a personal computer,
facsimile machine, telephone instrument, network computer, wireless
computer, personal data assistant, television, digital data
processor, and combinations thereof.
42. A method according to claim 26, further comprising: dynamically
analyzing the one or more of the collected measures sets in the
patient care record for the individual patient.
43. A method according to claim 26, further comprising: analyzing
the one or more of the collected measures sets in the patient care
record for the individual patient in a batch comprising the one or
more of the collected measures sets in patient care records for a
plurality of individual patients.
44. A method according to claim 26, wherein the communications link
comprises at least one of the following: internetwork link,
internetwork link, serial link, data telephone link, satellite
link, radio-frequency link, infrared link, fiber optic link,
coaxial cable link, television link, and combinations thereof.
45. A method according to claim 26, wherein the database server
comprises at least one of the following: volatile storage,
non-volatile storage, removable storage, fixed storage, random
access storage, sequential access storage, permanent storage,
erasable storage, and combinations thereof.
46. A method according to claim 45, wherein the organization of the
database server comprises at least one of the following: flat file,
hierarchical database server, relational database server,
distributed database server, and combinations thereof.
47. A method according to claim 26, wherein the network server and
the application server are each selected from the group consisting
of a personal computer, minicomputer, mainframe computer,
supercomputer, parallel computer, workstation, digital data
processor, and combinations thereof.
48. A method according to claim 26, wherein the medical device is
selected from the group consisting of a pacemaker, implantable
cardioverter defibrillator, implantable heart failure monitor,
implantable event monitor, implantable cardiopulmonary monitor,
implantable metabolic monitor or device, endocrinology monitor or
device, hematological monitor or device, implantable neuromuscular
monitor or device, implantable gastrointestinal monitor or device,
genitourinary monitor or device, and combinations thereof.
49. A method according to claim 26, wherein the set of collected
measures comprises at least one of the following: atrial electrical
activity, ventricular electrical activity, time of day, activity
level, cardiac output, oxygen level, cardiovascular pressure
measures, pulmonary measures, interventions made, and combinations
thereof.
50. A method according to claim 49, the set of collected measures
further comprising derived measures selected from the group
consisting of linear measures derived from the set of collected
measures, non-linear measures derived from the set of collected
measures, and combinations thereof.
51. A computer-readable storage medium holding code for automated
collection and analysis of patient information retrieved from a
medical device adapted to be implanted in a patient for remote
patient care, comprising: a network server interfaced to a
communications link over which is periodically received a set of
collected measures from the medical device adapted to be implanted,
the collected measures set comprising individual measures which
each relate to patient information recorded by the medical device
adapted to be implanted for an individual patient; a database
server coupled to the network server and storing the collected
measures set into a patient care record for the individual patient,
the database server being organized to store one or more patient
care records which each comprise a plurality of the collected
measures sets; and an application server coupled to the database
server and analyzing one or more of the collected measures sets in
the patient care record for the individual patient relative to one
or more other collected measures sets stored in the database server
to determine a patient status indicator.
52. A storage medium according to claim 51, the application server
further comprising: a comparison module comparing an initial
measure selected from the one or more collected measures sets to a
sibling measure selected from the one or more other collected
measures sets, the initial measure and the sibling measure both
relating to the same type of patient information.
53. A storage medium according to claim 51, the application server
farther comprising: a derivation module determining an initial
derived measure using at least one measure selected from the one or
more collected measures sets and determining a sibling derived
measure using at least one measure selected from the one or more
other collected measures sets, the initial derived measure and the
sibling derived measure both relating to the same type of derived
patient information; and a comparison module comparing the initial
derived measure to the sibling derived measure.
54. A storage medium according to claim 51, the application server
further comprising: a comparison module comparing an initial
measure selected from the one or more collected measures sets to a
peer measure selected from the one or more other collected measures
sets, the initial measure relating to a different type of patient
information than the peer measure.
55. A storage medium according to claim 51, the application server
further comprising: a derivation module determining a peer derived
measure using at least one measure selected from the one or more
other collected measures sets; and a comparison module comparing an
initial measure selected from the one or more collected measures
sets to the peer derived measure, the initial measure relating to a
different type of patient information than the derived patient
information to which the peer derived measure relates.
56. A storage medium according to claim 51, the application server
further comprising: a derivation module determining an initial
derived measure using at least one measure selected from the one or
more collected measures sets; and a comparison module comparing the
initial derived measure to a peer measure selected from the one or
more other collected measures sets, the initial derived measure
relating to a different type of derived patient information than
the patient information to which the peer measure relates.
57. A storage medium according to claim 51, the application server
further comprising: a derivation module determining an initial
derived measure using at least one measure selected from the one or
more collected measures sets and determining a peer derived measure
using at least one measure selected from the one or more other
collected measures sets; and a comparison module comparing the
initial derived measure to the peer derived measure, the initial
derived measure relating to a different type of derived patient
information than the derived patient information to which the peer
derived measure relates.
58. A storage medium according to claim 51, further comprising: a
collection client communicatively interposed between the medical
device adapted to be implanted and the communications link, the
collection client retrieving the collected measures set and
downloading the collected measures set from the collection client
into the network server over the communications link.
59. A storage medium according to claim 51, the application server
being interfaced to a feedback communications link and further
comprising: a feedback client interfaced to the feedback
communications link over which automated feedback based on the
patient status indicator is provided to the individual patient from
the application server.
60. A storage medium according to claim 59, the application server
further comprising: a feedback module providing tiered feedback
comprising: at a first level of feedback, communicating an
interpretation of the patient status indicator to the individual
patient over the feedback communications link; at a second level of
feedback, communicating a notification of potential medical concern
based on the patient status indicator to the individual patient
over the feedback communications link; at a third level of
feedback, communicating a notification of potential medical concern
based on the patient status indicator to medical personnel in local
proximity to the individual patient over the feedback
communications link; and at a fourth level of feedback,
communicating a set of reprogramming instructions based on the
patient status indicator to the implantable medical device over the
feedback communications link.
61. A storage medium according to claim 51, the application server
further comprising: an analysis module dynamically analyzing the
one or more of the collected measures sets in the patient care
record for the individual patient.
62. A storage medium according to claim 51, the application server
further comprising: an analysis module analyzing the one or more of
the collected measures sets in the patient care record for the
individual patient in a batch comprising the one or more of the
collected measures sets in patient care records for a plurality of
individual patients.
63. A system for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient, comprising: a medical device adapted to be implanted
in an individual patient and being interfaced to a communications
link, the implantable medical device periodically sending a set of
collected measures for the individual patient over the
communications link; a database organized into one or more patient
care records with each patient care record comprising a plurality
of the collected measures sets, each collected measures set
comprising individual measures which each relate to patient
information recorded by the implantable medical device; and a
server coupled to the database and interfaced to the communications
link and a feedback communications link, the server comprising: a
database module storing the collected measures set received from
the implantable medical device over the communications link into
the patient care record in the database for the individual patient;
an analysis module analyzing one or more of the collected measures
sets in the patient care record for the individual patient relative
to one or more other collected measures sets stored in the patient
care record of the individual patient; and a feedback module
sending feedback based on the analysis of the one or more collected
measures sets to the individual patient over the feedback
communications link.
64. A system according to claim 63, the analysis module further
comprising: a comparison module comparing at least one collected
measure selected from the one or more collected measures sets to at
least one other collected measure selected from the one or more
other collected measures sets, the at least one collected measure
and the at least one other collected measure both relating to the
same type of patient information.
65. A system according to claim 63, the analysis module further
comprising: a comparison module comparing at least one collected
measure selected from the one or more collected measures sets to at
least one other collected measure selected from the one or more
other collected measures sets, the at least one collected measure
and the at least one other collected measure both relating to
different types of patient information.
66. A system according to claim 63, the analysis module further
comprising: a derivation module determining at least one derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets; and a comparison module comparing
the at least one derived measure to at least one measure selected
from at least one of the one or more collected measures sets and
the one or more other collected measures sets.
67. A system according to claim 63, the analysis module further
comprising: a derivation module determining at least one derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets and determining at least one other
derived measure using at least one collected measure selected from
at least one of the one or more collected measures sets and the one
or more other collected measures sets; and a comparison module
comparing the at least one derived measure to the at least one
other derived measure.
68. A system according to claim 63, the feedback module further
comprising providing tiered feedback comprising: at a first level
of feedback, communicating an interpretation of the analysis of the
one or more collected measures sets to the individual patient over
the feedback communications link; at a second level of feedback,
communicating a notification of potential medical concern based on
the analysis of the one or more collected measures sets to the
individual patient over the feedback communications link; at a
third level of feedback, communicating a notification of potential
medical concern based on the analysis of the one or more collected
measures sets to medical personnel in local proximity to the
individual patient over the feedback communications link; and at a
fourth level of feedback, communicating a set of reprogramming
instructions based on analysis of the one or more collected
measures sets to the implantable medical device over the feedback
communications link.
69. A method for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient, comprising: organizing one or more patient care
records in a database with each patient care record comprising a
plurality of the collected measures sets, each collected measures
set comprising individual measures which each relate to patient
information recorded by a medical device adapted to be implanted
for an individual patient; receiving a set of the collected
measures periodically sent from the implantable medical device over
a communications link; storing the collected measures set into the
patient care record in the database for the individual patient;
analyzing one or more of the collected measures sets in the patient
care record for the individual patient relative to one or more
other collected measures sets stored in the patient care record of
the individual patient; and sending feedback based on the analysis
of the one or more collected measures sets to the individual
patient over a feedback communications link.
70. A method according to claim 69, the operation of analyzing
further comprising: comparing at least one collected measure
selected from the one or more collected measures sets to at least
one other collected measure selected from the one or more other
collected measures sets, the at least one collected measure and the
at least one other collected measure both relating to the same type
of patient information.
71. A method according to claim 69, the operation of analyzing
further comprising: comparing at least one collected measure
selected from the one or more collected measures sets to at least
one other collected measure selected from the one or more other
collected measures sets, the at least one collected measure and the
at least one other collected measure both relating to different
types of patient information.
72. A method according to claim 69, the operation of analyzing
further comprising: determining at least one derived measure using
at least one collected measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets; and comparing the at least one derived
measure to at least one measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets.
73. A method according to claim 69, the operation of analyzing
further comprising: determining at least one derived measure using
at least one collected measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets; determining at least one other derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets; and comparing the at least one
derived measure to the at least one other derived measure.
74. A method according to claim 69, the operation of sending
feedback further comprising: providing tiered feedback comprising:
at a first level of feedback, communicating an interpretation of
the analysis of the one or more collected measures sets to the
individual patient over the feedback communications link; at a
second level of feedback, communicating a notification of potential
medical concern based on the analysis of the one or more collected
measures sets to the individual patient over the feedback
communications link; at a third level of feedback, communicating a
notification of potential medical concern based on the analysis of
the one or more collected measures sets to medical personnel in
local proximity to the individual patient over the feedback
communications link; and at a fourth level of feedback,
communicating a set of reprogramming instructions based on analysis
of the one or more collected measures sets to the implantable
medical device over the feedback communications link.
75. A system for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient, comprising: a medical device adapted to be implanted
in an individual patient and being interfaced to a communications
link, the implantable medical device periodically sending a set of
collected measures for the individual patient over the
communications link; a database organized into a plurality of
patient care records with each patient care record comprising a
plurality of the collected measures sets, each collected measures
set comprising individual measures which each relate to patient
information recorded by the implantable medical device; and a
server coupled to the database and interfaced to the communications
link and a feedback communications link, the server comprising: a
database module storing the collected measures set received from
the implantable medical device over the communications link into
the patient care record in the database for the individual patient;
an analysis module analyzing one or more of the collected measures
sets in the patient care record for the individual patient relative
to one or more other collected measures sets stored in other
patient care records in the database; and a feedback module sending
feedback based on the analysis of the one or more collected
measures sets to the individual patient over the feedback
communications link.
76. A system according to claim 75, the analysis module further
comprising: a comparison module comparing at least one collected
measure selected from the one or more collected measures sets to at
least one other collected measure selected from the one or more
other collected measures sets, the at least one collected measure
and the at least one other collected measure both relating to the
same type of patient information.
77. A system according to claim 75, the analysis module further
comprising: a comparison module comparing at least one collected
measure selected from the one or more collected measures sets to at
least one other collected measure selected from the one or more
other collected measures sets, the at least one collected measure
and the at least one other collected measure both relating to
different types of patient information.
78. A system according to claim 75, the analysis module further
comprising: a derivation module determining at least one derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets; and a comparison module comparing
the at least one derived measure to at least one measure selected
from at least one of the one or more collected measures sets and
the one or more other collected measures sets.
79. A system according to claim 75, the analysis module further
comprising: a derivation module determining at least one derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets and determining at least one other
derived measure using at least one collected measure selected from
at least one of the one or more collected measures sets and the one
or more other collected measures sets; and a comparison module
comparing the at least one derived measure to the at least one
other derived measure.
80. A system according to claim 75, the feedback module further
comprising providing tiered feedback comprising: at a first level
of feedback, communicating an interpretation of the analysis of the
one or more collected measures sets to the individual patient over
the feedback communications link; at a second level of feedback,
communicating a notification of potential medical concern based on
the analysis of the one or more collected measures sets to the
individual patient over the feedback communications link; at a
third level of feedback, communicating a notification of potential
medical concern based on the analysis of the one or more collected
measures sets to medical personnel in local proximity to the
individual patient over the feedback communications link; and at a
fourth level of feedback, communicating a set of reprogramming
instructions based on analysis of the one or more collected
measures sets to the implantable medical device over the feedback
communications link.
81. A method for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient, comprising: organizing a plurality of patient care
records in a database with each patient care record comprising a
plurality of the collected measures sets, each collected measures
set comprising individual measures which each relate to patient
information recorded by a medical device adapted to be implanted
for an individual patient; receiving a set of the collected
measures periodically sent from the implantable medical device over
a communications link; storing the collected measures set into the
patient care record in the database for the individual patient;
analyzing one or more of the collected measures sets in the patient
care record for the individual patient relative to one or more
other collected measures sets stored in other patient care records
in the database; and sending feedback based on the analysis of the
one or more collected measures sets to the individual patient over
a feedback communications link.
82. A method according to claim 81, the operation of analyzing
further comprising: comparing at least one collected measure
selected from the one or more collected measures sets to at least
one other collected measure selected from the one or more other
collected measures sets, the at least one collected measure and the
at least one other collected measure both relating to the same type
of patient information.
83. A method according to claim 81, the operation of analyzing
further comprising: comparing at least one collected measure
selected from the one or more collected measures sets to at least
one other collected measure selected from the one or more other
collected measures sets, the at least one collected measure and the
at least one other collected measure both relating to different
types of patient information.
84. A method according to claim 81, the operation of analyzing
further comprising: determining at least one derived measure using
at least one collected measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets; and comparing the at least one derived
measure to at least one measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets.
85. A method according to claim 81, the operation of analyzing
further comprising: determining at least one derived measure using
at least one collected measure selected from at least one of the
one or more collected measures sets and the one or more other
collected measures sets; determining at least one other derived
measure using at least one collected measure selected from at least
one of the one or more collected measures sets and the one or more
other collected measures sets; and comparing the at least one
derived measure to the at least one other derived measure.
86. A method according to claim 81, the operation of sending
feedback further comprising: providing tiered feedback comprising:
at a first level of feedback, communicating an interpretation of
the analysis of the one or more collected measures sets to the
individual patient over the feedback communications link; at a
second level of feedback, communicating a notification of potential
medical concern based on the analysis of the one or more collected
measures sets to the individual patient over the feedback
communications link; at a third level of feedback, communicating a
notification of potential medical concern based on the analysis of
the one or more collected measures sets to medical personnel in
local proximity to the individual patient over the feedback
communications link; and at a fourth level of feedback,
communicating a set of reprogramming instructions based on analysis
of the one or more collected measures sets to the implantable
medical device over the feedback communications link.
87. A system for automated remote cardiovascular patient care using
cardiovascular patient information retrieved from a cardiovascular
monitoring device adapted to be implanted in a patient, comprising:
a telemetry transceiver retrieving on a substantially regular basis
a set of collected cardiovascular measures recorded by and stored
in the cardiovascular monitoring device adapted to be implanted and
periodically communicating the collected cardiovascular measures
set over a communications link to a centralized server; and a
centralized server comprising: a database storing the collected
cardiovascular measures set into a patient care record for the
individual patient, the database being organized into a plurality
of patient care records with each patient care record comprising a
plurality of the collected cardiovascular measures sets, each
collected cardiovascular measures set comprising individual
cardiovascular measures which each relate to patient information
recorded by a implantable cardiovascular monitoring device for an
individual patient; an analysis module analyzing one or more of the
collected cardiovascular measures sets in the patient care record
for the individual patient relative to one or more other collected
cardiovascular measures sets stored in the patient care records in
the database; and a feedback module sending feedback based on the
analysis of the one or more collected cardiovascular measures sets
to the individual patient over a feedback communications link.
88. A method for automated remote cardiovascular patient care using
cardiovascular patient information retrieved from a cardiovascular
monitoring device adapted to be implanted in a patient, comprising:
retrieving on a substantially regular basis a set of collected
cardiovascular measures recorded by and stored in the
cardiovascular monitoring device adapted to be implanted;
periodically communicating the collected cardiovascular measures
set over a communications link to a centralized server; storing the
collected cardiovascular measures set into a patient care record
for the individual patient in a database coupled to the centralized
server; organizing a plurality of patient care records in the
database with each patient care record comprising a plurality of
the collected cardiovascular measures sets, each collected
cardiovascular measures set comprising individual cardiovascular
measures which each relate to patient information recorded by the
cardiovascular monitoring device for an individual patient;
analyzing one or more of the collected cardiovascular measures sets
in the patient care record for the individual patient relative to
one or more other collected cardiovascular measures sets stored in
the patient care records in the database; and sending feedback
based on the analysis of the one or more collected cardiovascular
measures sets to the individual patient over a feedback
communications link.
Description
FIELD OF THE INVENTION
[0001] The present invention relates in general to automated data
collection and analysis, and, in particular, to a system and method
for automated collection and analysis of patient information
retrieved from an implantable medical device for remote patient
care.
BACKGROUND OF THE INVENTION
[0002] Implantable pulse generators (IPGs) are medical devices
commonly used to treat irregular heartbeats, known as arrhythmias.
There are two basic types. Cardiac pacemakers are used to manage
bradycardia, an abnormally slow or irregular heartbeat. Left
untreated, bradycardia can cause symptoms such as fatigue,
dizziness, and fainting. Implantable cardioverter defibrillators
(ICDs) are used to treat tachycardia, heart rhythms that are
abnormally fast and life threatening. Tachycardia can result in
sudden cardiac death (SCD).
[0003] Pacemakers and ICDs are increasingly being equipped with an
on-board, volatile memory in which telemetered signals can be
stored for later retrieval and analysis. Typically, the telemetered
signals provide patient device information regarding a trial
electrical activity, ventricular electrical activity, time of day,
activity level, cardiac output, oxygen level, cardiovascular
pressure measures, pulmonary measures, and any interventions made
on a per heartbeat or binned average basis. In addition, a growing
class of cardiac medical devices, including implantable heart
failure monitors, implantable event monitors, cardiovascular
monitors, and therapy devices, are being used to provide similar
stored device information. These devices are able to store
approximately thirty minutes of per heartbeat data. Telemetered
signals are also stored in a broader class of monitors and
therapeutic devices for other areas of medicine, including
metabolism, endocrinology, hematology, neurology, muscular,
gastrointestinal, genital-urology, ocular, auditory, and the
like.
[0004] Presently, stored device information is retrieved using a
proprietary interrogator or programmer, often during a clinic visit
or following a device event. The volume of data retrieved from a
single device interrogation "snapshot" can be large and proper
interpretation and analysis can require significant physician time
and detailed subspecialty knowledge, particularly by cardiologists
and cardiac electrophysiologists. The sequential logging and
analysis of regularly scheduled interrogations can create an
opportunity for recognizing subtle and incremental changes in
patient condition otherwise undetectable by inspection of a single
"snapshot." However, present approaches to data interpretation and
understanding and practical limitations on time and physician
availability make such analysis impracticable.
[0005] A prior art system for collecting and analyzing pacemaker
and ICD telemetered signals in a clinical or office setting is the
Model 9790 Programmer, manufactured by Medtronic, Inc.,
Minneapolis, Minn. This programmer can be used to retrieve data,
such as patient electrocardiogram and any measured physiological
conditions, collected by the IPG for recordation, display and
printing. The retrieved data is displayed in chronological order
and analyzed by a physician. Comparable prior art systems are
available from other IPG manufacturers, such as the Model 2901
Programmer Recorder Monitor, manufactured by Guidant Corporation,
Indianapolis, Ind., which includes a removable floppy diskette
mechanism for patient data storage. These prior art systems lack
remote communications facilities and must be operated with the
patient present. These systems present a limited analysis of the
collected data based on a single device interrogation and lack the
capability to recognize trends in the data spanning multiple
episodes over time or relative to a disease specific peer
group.
[0006] A prior art system for locating and communicating with a
remote medical device implanted in an ambulatory patient is
disclosed in U.S. Pat. No. 5,752,976 ('976). The implanted device
includes a telemetry transceiver for communicating data and
operating instructions between the implanted device and an external
patient communications device. The communications device includes a
communication link to a remote medical support network, a global
positioning satellite receiver, and a patient activated link for
permitting patient initiated communication with the medical support
network.
[0007] Related prior art systems for remotely communicating with
and receiving telemetered signals from a medical device are
disclosed in U.S. Pat. Nos. 5,113,869 ('869) and 5,336,245 ('245).
In the '869 patent, an implanted AECG monitor can be automatically
interrogated at preset times of day to telemeter out accumulated
data to a telephonic communicator or a full disclosure recorder.
The communicator can be automatically triggered to establish a
telephonic communication link and transmit the accumulated data to
an office or clinic through a modem. In the '245 patent,
telemetered data is downloaded to a larger capacity, external data
recorder and is forwarded to a clinic using an auto-dialer and fax
modem operating in a personal computer-based
programmer/interrogator. However, the '976 telemetry transceiver,
'869 communicator, and '245 programmer/interrogator are limited to
facilitating communication and transferal of downloaded patient
data and do not include an ability to automatically track,
recognize, and analyze trends in the data itself.
[0008] Thus, there is a need for a system and method for providing
continuous retrieval, transferal, and automated analysis of
retrieved implantable medical device information, such as
telemetered signals, retrieved in general from a broad class of
implantable medical devices and, in particular, from IPGs and
cardiovascular monitors. Preferably, the automated analysis would
include recognizing a trend and determining whether medical
intervention is necessary.
[0009] There is a further need for a system and method that would
allow consideration of sets of collected measures, both actual and
derived, from multiple device interrogations. These collected
measures sets could then be compared and analyzed against short and
long term periods of observation.
[0010] There is a further need for a system and method that would
enable the measures sets for an individual patient to be
self-referenced and cross-referenced to similar or dissimilar
patients and to the general patient population. Preferably, the
historical collected measures sets of an individual patient could
be compared and analyzed against those of other patients in general
or of a disease specific peer group in particular.
SUMMARY OF THE INVENTION
[0011] The present invention provides a system and method for
automated collection and analysis of patient information retrieved
from an implantable medical device for remote patient care. The
patient device information relates to individual measures recorded
by and retrieved from implantable medical devices, such as IPGs and
monitors. The patient device information is received on a regular,
e.g., daily, basis as sets of collected measures which are stored
along with other patient records in a database. The information can
be analyzed in an automated fashion and feedback provided to the
patient at any time and in any location.
[0012] An embodiment of the present invention is a system, method,
and computer-readable storage medium holding code for automated
collection and analysis of patient information retrieved from a
medical device adapted to be implanted in a patient for remote
patient care. A set of collected measures is periodically received
from the medical device adapted to be implanted over a
communications link which is interfaced to a network server. The
collected measures set includes individual measures which each
relate to patient information recorded by the medical device
adapted to be implanted for an individual patient. The collected
measures set is stored into a patient care record for the
individual patient within a database server organized to store one
or more patient care records. Each patient care record includes a
plurality of the collected measures sets. One or more of the
collected measures sets in the patient care record for the
individual patient is analyzed relative to one or more other
collected measures sets stored in the database server to determine
a patient status indicator. The patient status indicators are then
triaged and prioritized for an appropriate level of alert and
interaction.
[0013] A further embodiment of the present invention is a system
and method for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient. One or more patient care records are organized in a
database with each patient care record including a plurality of the
collected measures sets. Each collected measures set include
individual measures which each relate to patient information
recorded by a medical device adapted to be implanted for an
individual patient. A set of the collected measures periodically
sent from the implantable medical device over a communications link
is received. The collected measures set is stored into the patient
care record in the database for the individual patient. One or more
of the collected measures sets in the patient care record for the
individual patient are analyzed relative to one or more other
collected measures sets stored in the patient care record of the
individual patient. Feedback based on the analysis of the one or
more collected measures sets is sent to the individual patient over
a feedback communications link.
[0014] A further embodiment of the present invention is a system
and method for automated remote patient care using patient
information retrieved from a medical device adapted to be implanted
in a patient. A plurality of patient care records is organized in a
database with each patient care record including a plurality of the
collected measures sets. Each collected measures set includes
individual measures which each relate to patient information
recorded by a medical device adapted to be implanted for an
individual patient. A set of the collected measures periodically
sent from the implantable medical device over a communications link
is received. The collected measures set is stored into the patient
care record in the database for the individual patient. One or more
of the collected measures sets in the patient care record for the
individual patient is analyzed relative to one or more other
collected measures sets stored in other patient care records in the
database. Feedback based on the analysis of the one or more
collected measures sets is sent to the individual patient over a
feedback communications link.
[0015] A further embodiment of the present invention is a system
and method for automated remote cardiac patient care using
cardiovascular patient information retrieved from a cardiac
monitoring device adapted to be implanted in a patient. A set of
collected cardiovascular measures recorded by and stored in the
cardiac monitoring device adapted to be implanted is retrieved on a
substantially regular basis and the collected cardiovascular
measures set are periodically communicated over a communications
link to a centralized server. The collected cardiovascular measures
set is stored into a patient care record for the individual patient
in a database coupled to the centralized server. A plurality of
patient care records is organized in the database with each patient
care record including a plurality of the collected cardiovascular
measures sets. Each collected cardiovascular measures set includes
individual cardiovascular measures which each relate to patient
information recorded by the cardiac monitoring device for an
individual patient. One or more of the collected cardiovascular
measures sets in the patient care record for the individual patient
is analyzed relative to one or more other collected cardiovascular
measures sets stored in the patient care records in the database.
Feedback based on the analysis of the one or more collected
cardiovascular measures sets is sent to the individual patient over
a feedback communications link.
[0016] The present invention facilitates the gathering, storage,
and analysis of critical patient information obtained on a routine
basis and analyzed in an automated manner. Thus, the burden on
physicians and trained personnel to evaluate the volumes of
information is significantly minimized while the benefits to
patients are greatly enhanced.
[0017] Still other embodiments of the present invention will become
readily apparent to those skilled in the art from the following
detailed description, wherein is described embodiments of the
invention by way of illustrating the best mode contemplated for
carrying out the invention. As will be realized, the invention is
capable of other and different embodiments and its several details
are capable of modifications in various obvious respects, all
without departing from the spirit and the scope of the present
invention. Accordingly, the drawings and detailed description are
to be regarded as illustrative in nature and not as
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a block diagram showing a system for automated
collection and analysis of patient information retrieved from an
implantable medical device for remote patient care in accordance
with the present invention;
[0019] FIG. 2 is a block diagram showing the hardware components of
the server system of the system of FIG. 1;
[0020] FIG. 3 is a block diagram showing the software modules of
the server system of the system of FIG. 1;
[0021] FIG. 4 is a block diagram showing the analysis module of the
server system of FIG. 3;
[0022] FIG. 5 is a database schema showing, by way of example, the
organization of a cardiac patient care record stored in the
database of the system of FIG. 1;
[0023] FIG. 6 is a record view showing, by way of example, a set of
partial cardiac patient care records stored in the database of the
system of FIG. 1;
[0024] FIG. 7 is a flow diagram showing a method for automated
collection and analysis of patient information retrieved from an
implantable medical device for remote patient care in accordance
with the present invention;
[0025] FIG. 8 is a flow diagram showing a routine for analyzing
collected measures sets for use in the method of FIG. 7;
[0026] FIG. 9 is a flow diagram showing a routine for comparing
sibling collected measures sets for use in the routine of FIG.
8;
[0027] FIGS. 10A and 10B are flow diagrams showing a routine for
comparing peer collected measures sets for use in the routine of
FIG. 8; and
[0028] FIG. 11 is a flow diagram showing a routine for providing
feedback for use in the method of FIG. 7.
DETAILED DESCRIPTION
[0029] FIG. 1 is a block diagram showing a system 10 for automated
collection and analysis of patient information retrieved from an
implantable medical device for remote patient care in accordance
with the present invention. A patient 11 is a recipient of an
implantable medical device 12, such as, by way of example, an IPG
or a heart failure or event monitor, with a set of leads extending
into his or her heart. The implantable medical device 12 includes
circuitry for recording into a short-term, volatile memory
telemetered signals, which are stored as a set of collected
measures for later retrieval.
[0030] For an exemplary cardiac implantable medical device, the
telemetered signals non-exclusively present patient information
relating to: atrial electrical activity, ventricular electrical
activity, time of day, activity level, cardiac output, oxygen
level, cardiovascular pressure measures, the number and types of
interventions made, and the relative success of any interventions
made on a per heartbeat or binned average basis, plus the status of
the batteries and programmed settings. Examples of pacemakers
suitable for use in the present invention include the Discovery
line of pacemakers, manufactured by Guidant Corporation,
Indianapolis, Ind. Examples of ICDs suitable for use in the present
invention include the Ventak line of ICDs, also manufactured by
Guidant Corporation, Indianapolis, Ind.
[0031] In the described embodiment, the patient 11 has a cardiac
implantable medical device. However, a wide range of related
implantable medical devices are used in other areas of medicine and
a growing number of these devices are also capable of measuring and
recording patient information for later retrieval. These
implantable medical devices include monitoring and therapeutic
devices for use in metabolism, endocrinology, hematology,
neurology, muscularology, gastro-intestinalogy, genital-urology,
ocular, auditory, and similar medical subspecialties. One skilled
in the art would readily recognize the applicability of the present
invention to these related implantable medical devices.
[0032] On a regular basis, the telemetered signals stored in the
implantable medical device 12 are retrieved. By way of example, a
programmer 14 can be used to retrieve the telemetered signals.
However, any form of programmer, interrogator, recorder, monitor,
or telemetered signals transceiver suitable for communicating with
an implantable medical device 12 could be used, as is known in the
art. In addition, a personal computer or digital data processor
could be interfaced to the implantable medical device 12, either
directly or via a telemetered signals transceiver configured to
communicate with the implantable medical device 12.
[0033] Using the programmer 14, a magnetized reed switch (not
shown) within the implantable medical device 12 closes in response
to the placement of a wand 13 over the location of the implantable
medical device 12. The programmer 14 communicates with the
implantable medical device 12 via RF signals exchanged through the
wand 14. Programming or interrogating instructions are sent to the
implantable medical device 12 and the stored telemetered signals
are downloaded into the programmer 14. Once downloaded, the
telemetered signals are sent via an internet 15, such as the
Internet, to a server system 16 which periodically receives and
stores the telemetered signals in a database 17, as further
described below with reference to FIG. 2.
[0034] An example of a programmer 14 suitable for use in the
present invention is the Model 2901 Programmer Recorder Monitor,
manufactured by Guidant Corporation, Indianapolis, Ind., which
includes the capability to store retrieved telemetered signals on a
proprietary removable floppy diskette. The telemetered signals
could later be electronically transferred using a personal computer
or similar processing device to the internetwork 15, as is known in
the art.
[0035] Other alternate telemetered signals transfer means could
also be employed. For instance, the stored telemetered signals
could be retrieved from the implantable medical device 12 and
electronically transferred to the internetwork 15 using the
combination of a remote external programmer and analyzer and a
remote telephonic communicator, such as described in U.S. Pat. No.
5,113,869, the disclosure of which is incorporated herein by
reference. Similarly, the stored telemetered signals could be
retrieved and remotely downloaded to the server system 16 using a
world-wide patient location and data telemetry system, such as
described in U.S. Pat. No. 5,752,976, the disclosure of which is
incorporated herein by reference.
[0036] The received telemetered signals are analyzed by the server
system 16, which generates a patient status indicator. The feedback
is then provided back to the patient 11 through a variety of means.
By way of example, the feedback can be sent as an electronic mail
message generated automatically by the server system 16 for
transmission over the internetwork 15. The electronic mail message
is received by personal computer 18 (PC) situated for local access
by the patient 11. Alternatively, the feedback can be sent through
a telephone interface device 19 as an automated voice mail message
to a telephone 21 or as an automated facsimile message to a
facsimile machine 22, both also situated for local access by the
patient 11. In addition to a personal computer 18, telephone 21,
and facsimile machine 22, feedback could be sent to other related
devices, including a network computer, wireless computer, personal
data assistant, television, or digital data processor. Preferably,
the feedback is provided in a tiered fashion, as further described
below with reference to FIG. 3.
[0037] FIG. 2 is a block diagram showing the hardware components of
the server system 16 of the system 10 of FIG. 1. The server system
16 consists of three individual servers: network server 31,
database server 34, and application server 35. These servers are
interconnected via an internetwork 33. In the described embodiment,
the functionality of the server system 16 is distributed among
these three servers for efficiency and processing speed, although
the functionality could also be performed by a single server or
cluster of servers. The network server 31 is the primary interface
of the server system 16 onto the internetwork 15. The network
server 31 periodically receives the collected telemetered signals
sent by remote implantable medical devices over the internetwork
15. The network server 31 is interfaced to the internetwork 15
through a router 32. To ensure reliable data exchange, the network
server 31 implements a TCP/IP protocol stack, although other forms
of network protocol stacks are suitable.
[0038] The database server 34 organizes the patient care records in
the database 17 and provides storage of and access to information
held in those records. A high volume of data in the form of
collected measures sets from individual patients is received. The
database server 34 frees the network server 31 from having to
categorize and store the individual collected measures sets in the
appropriate patient care record.
[0039] The application server 35 operates management applications
and performs data analysis of the patient care records, as further
described below with reference to FIG. 3. The application server 35
communicates feedback to the individual patients either through
electronic mail sent back over the internetwork 15 via the network
server 31 or as automated voice mail or facsimile messages through
the telephone interface device 19.
[0040] The server system 16 also includes a plurality of individual
workstations 36 (WS) interconnected to the internetwork 33, some of
which can include peripheral devices, such as a printer 37. The
workstations 36 are for use by the data management and programming
staff, nursing staff, office staff, and other consultants and
authorized personnel.
[0041] The database 17 consists of a high-capacity storage medium
configured to store individual patient care records and related
health care information. Preferably, the database 17 is configured
as a set of high-speed, high capacity hard drives, such as
organized into a Redundant Array of Inexpensive Disks (RAID)
volume. However, any form of volatile storage, non-volatile
storage, removable storage, fixed storage, random access storage,
sequential access storage, permanent storage, erasable storage, and
the like would be equally suitable. The organization of the
database 17 is further described below with reference to FIG.
3.
[0042] The individual servers and workstations are general purpose,
programmed digital computing devices consisting of a central
processing unit (CPU), random access memory (RAM), non-volatile
secondary storage, such as a hard drive or CD ROM drive, network
interfaces, and peripheral devices, including user interfacing
means, such as a keyboard and display. Program code, including
software programs, and data are loaded into the RAM for execution
and processing by the CPU and results are generated for display,
output, transmittal, or storage. In the described embodiment, the
individual servers are Intel Pentium-based server systems, such as
available from Dell Computers, Austin, Tex., or Compaq Computers,
Houston, Tex. Each system is preferably equipped with 128 MB RAM,
100GB hard drive capacity, data backup facilities, and related
hardware for interconnection to the internetwork 33 and
internetwork 15. In addition, the workstations 36 are also Intel
Pentium-based personal computer or workstation systems, also
available from Dell Computers, Austin, Tex., or Compaq Computers,
Houston, Tex. Each workstation is preferably equipped with 64 MB
RAM, 10 GB hard drive capacity, and related hardware for
interconnection to the internetwork 33. Other types of server and
workstation systems, including personal computers, minicomputers,
mainframe computers, supercomputers, parallel computers,
workstations, digital data processors and the like would be equally
suitable, as is known in the art.
[0043] The telemetered signals are communicated over an
internetwork 15, such as the Internet. However, any type of
electronic communications link could be used, including an
internetwork link, serial link, data telephone link, satellite
link, radio-frequency link, infrared link, fiber optic link,
coaxial cable link, television link, and the like, as is known in
the art. Also, the network server 31 is interfaced to the
internetwork 15 using a T-1 network router 32, such as manufactured
by Cisco Systems, Inc., San Jose, Calif. However, any type of
interfacing device suitable for interconnecting a server to a
network could be used, including a data modem, cable modem, network
interface, serial connection, data port, hub, frame relay, digital
PBX, and the like, as is known in the art.
[0044] FIG. 3 is a block diagram showing the software modules of
the server system 16 of the system 10 of FIG. 1. Each module is a
computer program written as source code in a conventional
programming language, such as the C or Java programming languages,
and is presented for execution by the CPU as object or byte code,
as is known in the arts. The various implementations of the source
code and object and byte codes can be held on a computer-readable
storage medium or embodied on a transmission medium in a carrier
wave. There are three basic software modules, which functionally
define the primary operations performed by the server system 16:
database module 51, analysis module 53, and feedback module 55. In
the described embodiment, these modules are executed in a
distributed computing environment, although a single server or a
cluster of servers could also perform the functionality of the
modules. The module functions are further described below in more
detail beginning with reference to FIG. 7.
[0045] For each patient being provided remote patient care, the
server system 16 periodically receives a collected measures set 50
which is forwarded to the database module 51 for processing. The
database module 51 organizes the individual patent care records
stored in the database 52 and provides the facilities for
efficiently storing and accessing the collected measures sets 50
and patient data maintained in those records. An exemplary database
schema for use in storing collected measures sets 50 in a patient
care record is described below, by way of example, with reference
to FIG. 5. The database server 34 (shown in FIG. 2) performs the
functionality of the database module 51. Any type of database
organization could be utilized, including a flat file system,
hierarchical database, relational database, or distributed
database, such as provided by database vendors, such as Oracle
Corporation, Redwood Shores, Calif.
[0046] The analysis module 53 analyzes the collected measures sets
50 stored in the patient care records in the database 52. The
analysis module 53 makes an automated determination of patient
wellness in the form of a patient status indicator 54. Collected
measures sets 50 are periodically received from implantable medical
devices and maintained by the database module 51 in the database
52. Through the use of this collected information, the analysis
module 53 can continuously follow the medical well being of a
patient and can recognize any trends in the collected information
that might warrant medical intervention. The analysis module 53
compares individual measures and derived measures obtained from
both the care records for the individual patient and the care
records for a disease specific group of patients or the patient
population in general. The analytic operations performed by the
analysis module 53 are further described below with reference to
FIG. 4. The application server 35 (shown in FIG. 2) performs the
functionality of the analysis module 53.
[0047] The feedback module 55 provides automated feedback to the
individual patient based, in part, on the patient status indicator
54. As described above, the feedback could be by electronic mail or
by automated voice mail or facsimile. Preferably, the feedback is
provided in a tiered manner. In the described embodiment, four
levels of automated feedback are provided. At a first level, an
interpretation of the patient status indicator 54 is provided. At a
second level, a notification of potential medical concern based on
the patient status indicator 54 is provided. This feedback level
could also be coupled with human contact by specially trained
technicians or medical personnel. At a third level, the
notification of potential medical concern is forwarded to medical
practitioners located in the patient's geographic area. Finally, at
a fourth level, a set of reprogramming instructions based on the
patient status indicator 54 could be transmitted directly to the
implantable medical device to modify the programming instructions
contained therein. As is customary in the medical arts, the basic
tiered feedback scheme would be modified in the event of bona fide
medical emergency. The application server 35 (shown in FIG. 2)
performs the functionality of the feedback module 55.
[0048] FIG. 4 is a block diagram showing the analysis module 53 of
the server system 16 of FIG. 3. The analysis module 53 contains two
functional submodules: comparison module 62 and derivation module
63. The purpose of the comparison module 62 is to compare two or
more individual measures, either collected or derived. The purpose
of the derivation module 63 is to determine a derived measure based
on one or more collected measures which is then used by the
comparison module 62. For instance, a new and improved indicator of
impending heart failure could be derived based on the exemplary
cardiac collected measures set described with reference to FIG. 5.
The analysis module 53 can operate either in a batch mode of
operation wherein patient status indicators are generated for a set
of individual patients or in a dynamic mode wherein a patient
status indicator is generated on the fly for an individual
patient.
[0049] The comparison module 62 receives as inputs from the
database 17 two input sets functionally defined as peer collected
measures sets 60 and sibling collected measures sets 61, although
in practice, the collected measures sets are stored on a per
sampling basis. Peer collected measures sets 60 contain individual
collected measures sets that all relate to the same type of patient
information, for instance, atrial electrical activity, but which
have been periodically collected over time. Sibling collected
measures sets 61 contain individual collected measures sets that
relate to different types of patient information, but which may
have been collected at the same time or different times. In
practice, the collected measures sets are not separately stored as
"peer" and "sibling" measures. Rather, each individual patient care
record stores multiple sets of sibling collected measures. The
distinction between peer collected measures sets 60 and sibling
collected measures sets 61 is further described below with
reference to FIG. 6.
[0050] The derivation module 63 determines derived measures sets 64
on an as-needed basis in response to requests from the comparison
module 62. The derived measures 64 are determined by performing
linear and non-linear mathematical operations on selected peer
measures 60 and sibling measures 61, as is known in the art.
[0051] FIG. 5 is a database schema showing, by way of example, the
organization of a cardiac patient care record stored 70 in the
database 17 of the system 10 of FIG. 1. Only the information
pertaining to collected measures sets are shown. Each patient care
record would also contain normal identifying and treatment profile
information, as well as medical history and other pertinent data
(not shown). Each patient care record stores a multitude of
collected measures sets for an individual patient. Each individual
set represents a recorded snapshot of telemetered signals data
which was recorded, for instance, per heartbeat or binned average
basis by the implantable medical device 12. For example, for a
cardiac patient, the following information would be recorded as a
collected measures set: atrial electrical activity 71, ventricular
electrical activity 72, time of day 73, activity level 74, cardiac
output 75, oxygen level 76, cardiovascular pressure measures 77,
pulmonary measures 78, interventions made by the implantable
medical device 78, and the relative success of any interventions
made 80. In addition, the implantable medical device 12 would also
communicate device specific information, including battery status
81 and program settings 82. Other types of collected measures are
possible. In addition, a well-documented set of derived measures
can be determined based on the collected measures, as is known in
the art.
[0052] FIG. 6 is a record view showing, by way of example, a set of
partial cardiac patient care records stored in the database 17 of
the system 10 of FIG. 1. Three patient care records are shown for
Patient 1, Patient 2, and Patient 3. For each patent, three sets of
measures are shown, X Y, and Z. The measures are organized into
sets with Set 0 representing sibling measures made at a reference
time t=0. Similarly, Set n-2, Set n-1 and Set n each represent
sibling measures made at later reference times t=n-2, t=n-1 and
t=n, respectively.
[0053] For a given patient, for instance, Patient 1, all measures
representing the same type of patient information, such as measure
X, are peer measures. These are measures, which are monitored over
time in a disease-matched peer group. All measures representing
different types of patient information, such as measures X, Y, and
Z, are sibling measures. These are measures which are also measured
over time, but which might have medically significant meaning when
compared to each other within a single set. Each of the measures,
X, Y, and Z, could be either collected or derived measures.
[0054] The analysis module 53 (shown in FIG. 4) performs two basic
forms of comparison. First, individual measures for a given patient
can be compared to other individual measures for that same patient.
These comparisons might be peer-to-peer measures projected over
time, for instance, X.sub.n, X.sub.n-1, X.sub.n-2, X.sub.0, or
sibling-to-sibling measures for a single snapshot, for instance,
X.sub.n, Y.sub.n, and Z.sub.n, or projected over time, for
instance, X.sub.n, Y.sub.n, Z.sub.n, X.sub.n-1, Y.sub.n-1,
Z.sub.n-1, X.sub.n-2, Y.sub.n-2, Z.sub.n-2, . . . X.sub.0, Y.sub.0,
Z.sub.0. Second, individual measures for a given patient can be
compared to other individual measures for a group of other patients
sharing the same disease-specific characteristics or to the patient
population in general. Again, these comparisons might be
peer-to-peer measures projected over time, for instance, X.sub.n,
X.sub.n', X.sub.n", X.sub.n-1, X.sub.n-1', X.sub.n-1", X.sub.n-2,
X.sub.n-2', X.sub.n-2". . . X.sub.0, X.sub.0', X.sub.", or
comparing the individual patient's measures to an average from the
group. Similarly, these comparisons might be sibling-to-sibling
measures for single snapshots, for instance, X.sub.n, X.sub.n',
X.sub.n", Y.sub.n, Y.sub.n', Y.sub.n", and Z.sub.n, Z.sub.n',
Z.sub.n", or projected over time, for instance, X.sub.n, X.sub.n',
X.sub.n", Y.sub.n, Y.sub.n', Y.sub.n", Z.sub.n, Z.sub.n', Z.sub.n",
X.sub.n-1, X.sub.n-1', X.sub.n-1", Y.sub.n-1, Y.sub.n-1',
Y.sub.n-1", Z.sub.n-1, Z.sub.n-1', Z.sub.n-1", X.sub.n-2,
X.sub.n-2', X.sub.n-2", Y.sub.n-2, Y.sub.n-2', Y.sub.n-2",
Z.sub.n-2, Z.sub.n-2', Z.sub.n-2". . . X.sub.0, X.sub.0', X.sub.0",
Y.sub.0, Y.sub.0', Y.sub.0", and Z.sub.0, Z.sub.0', Z.sub.0". Other
forms of comparisons are feasible.
[0055] FIG. 7 is a flow diagram showing a method 90 for automated
collection and analysis of patient information retrieved from an
implantable medical device 12 for remote patient care in accordance
with the present invention. The method 90 is implemented as a
conventional computer program for execution by the server system 16
(shown in FIG. 1). As a preparatory step, the patient care records
are organized in the database 17 with a unique patient care record
assigned to each individual patient (block 91). Next, the collected
measures sets for an individual patient are retrieved from the
implantable medical device 12 (block 92) using a programmer,
interrogator, telemetered signals transceiver, and the like. The
retrieved collected measures sets are sent, on a substantially
regular basis, over the internetwork 15 or similar communications
link (block 93) and periodically received by the server system 16
(block 94). The collected measures sets are stored into the patient
care record in the database 17 for that individual patient (block
95). One or more of the collected measures sets for that patient
are analyzed (block 96), as further described below with reference
to FIG. 8. Finally, feedback based on the analysis is sent to that
patient over the internetwork 15 as an email message, via telephone
line as an automated voice mail or facsimile message, or by similar
feedback communications link (block 97), as further described below
with reference to FIG. 11.
[0056] FIG. 8 is a flow diagram showing the routine for analyzing
collected measures sets 96 for use in the method of FIG. 7. The
purpose of this routine is to make a determination of general
patient wellness based on comparisons and heuristic trends analyses
of the measures, both collected and derived, in the patient care
records in the database 17. A first collected measures set is
selected from a patient care record in the database 17 (block 100).
If the measures comparison is to be made to other measures
originating from the patient care record for the same individual
patient (block 101), a second collected measures set is selected
from that patient care record (block 102). Otherwise, a group
measures comparison is being made (block 101) and a second
collected measures set is selected from another patient care record
in the database 17 (block 103). Note the second collected measures
set could also contain averaged measures for a group of disease
specific patients or for the patient population in general.
[0057] Next, if a sibling measures comparison is to be made (block
104), a routine for comparing sibling collected measures sets is
performed (block 105), as further described below with reference to
FIG. 9. Similarly, if a peer measures comparison is to be made
(block 106), a routine for comparing sibling collected measures
sets is performed (block 107), as farther described below with
reference to FIGS. 10A and 10B.
[0058] Finally, a patient status indicator is generated (block
108). By way of example, cardiac output could ordinarily be
approximately 5.0 liters per minute with a standard deviation of
.+-.1.0. An actionable medical phenomenon could occur when the
cardiac output of a patient is .+-.3.0-4.0 standard deviations out
of the norm. A comparison of the cardiac output measures 75 (shown
in FIG. 5) for an individual patient against previous cardiac
output measures 75 would establish the presence of any type of
downward health trend as to the particular patient. A comparison of
the cardiac output measures 75 of the particular patient to the
cardiac output measures 75 of a group of patients would establish
whether the patient is trending out of the norm. From this type of
analysis, the analysis module 53 generates a patient status
indicator 54 and other metrics of patient wellness, as is known in
the art.
[0059] FIG. 9 is a flow diagram showing the routine for comparing
sibling collected measures sets 105 for use in the routine of FIG.
8. Sibling measures originate from the patient care records for an
individual patient. The purpose of this routine is either to
compare sibling derived measures to sibling derived measures
(blocks 111-113) or sibling collected measures to sibling collected
measures (blocks 115-117). Thus, if derived measures are being
compared (block 110), measures are selected from each collected
measures set (block 111). First and second derived measures are
derived from the selected measures (block 112) using the derivation
module 63 (shown in FIG. 4). The first and second derived measures
are then compared (block 113) using the comparison module 62 (also
shown in FIG. 4). The steps of selecting, determining, and
comparing (blocks 111-113) are repeated until no further
comparisons are required (block 114), whereupon the routine
returns.
[0060] If collected measures are being compared (block 110),
measures are selected from each collected measures set (block 115).
The first and second collected measures are then compared (block
116) using the comparison module 62 (also shown in FIG. 4). The
steps of selecting and comparing (blocks 115-116) are repeated
until no further comparisons are required (block 117), whereupon
the routine returns.
[0061] FIGS. 10A and 10B are a flow diagram showing the routine for
comparing peer collected measures sets 107 for use in the routine
of FIG. 8. Peer measures originate from patient care records for
different patients, including groups of disease specific patients
or the patient population in general. The purpose of this routine
is to compare peer derived measures to peer derived measures
(blocks 122-125), peer derived measures to peer collected measures
(blocks 126-129), peer collected measures to peer derived measures
(block 131-134), or peer collected measures to peer collected
measures (blocks 135-137). Thus, if the first measure being
compared is a derived measure (block 120) and the second measure
being compared is also a derived measure (block 121), measures are
selected from each collected measures set (block 122). First and
second derived measures are derived from the selected measures
(block 123) using the derivation module 63 (shown in FIG. 4). The
first and second derived measures are then compared (block 124)
using the comparison module 62 (also shown in FIG. 4). The steps of
selecting, determining, and comparing (blocks 122-124) are repeated
until no further comparisons are required (block 115), whereupon
the routine returns.
[0062] If the first measure being compared is a derived measure
(block 120) but the second measure being compared is a collected
measure (block 121), a first measure is selected from the first
collected measures set (block 126). A first derived measure is
derived from the first selected measure (block 127) using the
derivation module 63 (shown in FIG. 4). The first derived and
second collected measures are then compared (block 128) using the
comparison module 62 (also shown in FIG. 4). The steps of
selecting, determining, and comparing (blocks 126-128) are repeated
until no further comparisons are required (block 129), whereupon
the routine returns.
[0063] If the first measure being compared is a collected measure
(block 120) but the second measure being compared is a derived
measure (block 130), a second measure is selected from the second
collected measures set (block 131). A second derived measure is
derived from the second selected measure (block 132) using the
derivation module 63 (shown in FIG. 4). The first collected and
second derived measures are then compared (block 133) using the
comparison module 62 (also shown in FIG. 4). The steps of
selecting, determining, and comparing (blocks 131-133) are repeated
until no further comparisons are required (block 134), whereupon
the routine returns.
[0064] If the first measure being compared is a collected measure
(block 120) and the second measure being compared is also a
collected measure (block 130), measures are selected from each
collected measures set (block 135). The first and second collected
measures are then compared (block 136) using the comparison module
62 (also shown in FIG. 4). The steps of selecting and comparing
(blocks 135-136) are repeated until no further comparisons are
required (block 137), whereupon the routine returns.
[0065] FIG. 11 is a flow diagram showing the routine for providing
feedback 97 for use in the method of FIG. 7. The purpose of this
routine is to provide tiered feedback based on the patient status
indicator. Four levels of feedback are provided with increasing
levels of patient involvement and medical care intervention. At a
first level (block 150), an interpretation of the patient status
indicator 54, preferably phrased in lay terminology, and related
health care information is sent to the individual patient (block
151) using the feedback module 55 (shown in FIG. 3). At a second
level (block 152), a notification of potential medical concern,
based on the analysis and heuristic trends analysis, is sent to the
individual patient (block 153) using the feedback module 55. At a
third level (block 154), the notification of potential medical
concern is forwarded to the physician responsible for the
individual patient or similar health care professionals (block 155)
using the feedback module 55. Finally, at a fourth level (block
156), reprogramming instructions are sent to the implantable
medical device 12 (block 157) using the feedback module 55.
[0066] Therefore, through the use of the collected measures sets,
the present invention makes possible immediate access to expert
medical care at any time and in any place. For example, after
establishing and registering for each patient an appropriate
baseline set of measures, the database server could contain a
virtually up-to-date patient history, which is available to medical
providers for the remote diagnosis and prevention of serious
illness regardless of the relative location of the patient or time
of day.
[0067] Moreover, the gathering and storage of multiple sets of
critical patient information obtained on a routine basis makes
possible treatment methodologies based on an algorithmic analysis
of the collected data sets. Each successive introduction of a new
collected measures set into the database server would help to
continually improve the accuracy and effectiveness of the
algorithms used. In addition, the present invention potentially
enables the detection, prevention, and cure of previously unknown
forms of disorders based on a trends analysis and by a
cross-referencing approach to create continuously improving
peer-group reference databases.
[0068] Finally, the present invention makes possible the provision
of tiered patient feedback based on the automated analysis of the
collected measures sets. This type of feedback system is suitable
for use in, for example, a subscription based health care service.
At a basic level, informational feedback can be provided by way of
a simple interpretation of the collected data. The feedback could
be built up to provide a gradated response to the patient, for
example, to notify the patient that he or she is trending into a
potential trouble zone. Human interaction could be introduced, both
by remotely situated and local medical practitioners. Finally, the
feedback could include direct interventive measures, such as
remotely reprogramming a patient's IPG.
[0069] While the invention has been particularly shown and
described as referenced to the embodiments thereof, those skilled
in the art will understand that the foregoing and other changes in
form and detail may be made therein without departing from the
spirit and scope of the invention.
* * * * *