U.S. patent application number 11/102522 was filed with the patent office on 2005-08-18 for system and method for determining a reference baseline record.
Invention is credited to Bardy, Gust H..
Application Number | 20050182308 11/102522 |
Document ID | / |
Family ID | 27001238 |
Filed Date | 2005-08-18 |
United States Patent
Application |
20050182308 |
Kind Code |
A1 |
Bardy, Gust H. |
August 18, 2005 |
System and method for determining a reference baseline record
Abstract
A system and method for determining a reference baseline record
for use in automated patient care. One or more physiological
measures are retrieved. Each of the measures relates to individual
patient information recorded during an initial observation period
from a patient care record. One or more reference measures are
determined from the physiological measures. Each reference measure
is representative of at least one of measured and derived patient
information. The reference measures are stored into the patient
care record indicating a reference baseline patient status.
Inventors: |
Bardy, Gust H.; (Seattle,
WA) |
Correspondence
Address: |
LAW OFFICES OF PATRICK J.S. INOUYE
810 THIRD AVE
STE. 258
SEATTLE
WA
98104
US
|
Family ID: |
27001238 |
Appl. No.: |
11/102522 |
Filed: |
April 8, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11102522 |
Apr 8, 2005 |
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09860987 |
May 18, 2001 |
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09860987 |
May 18, 2001 |
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09476601 |
Dec 31, 1999 |
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6280380 |
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09476601 |
Dec 31, 1999 |
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09361332 |
Jul 26, 1999 |
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6221011 |
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Current U.S.
Class: |
600/300 ;
600/323; 600/324; 600/365; 600/485; 600/516; 600/549 |
Current CPC
Class: |
A61B 5/7282 20130101;
G16H 50/30 20180101; A61B 5/4884 20130101; G16H 10/60 20180101;
A61B 5/0002 20130101; G16H 40/67 20180101; A61B 5/7278 20130101;
G16H 70/00 20180101 |
Class at
Publication: |
600/300 ;
600/323; 600/324; 600/365; 600/485; 600/516; 600/549 |
International
Class: |
A61B 005/00; A61B
005/02; A61B 005/04 |
Claims
What is claimed is:
1. A system for determining a reference baseline record for use in
automated patient care, comprising: a database storing patient care
records with each record containing one or more physiological
measures relating to individual patient information recorded during
an initial observation period; and an analysis module determining
one or more reference measures, each representative of at least one
of measured and derived patient information, from the physiological
measures retrieved from one such patient care record and storing
the reference measures into the one such patient care record
indicating a reference baseline patient status.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This patent application is a continuation of U.S. patent
application, Ser. No. 09/860,987, filed on May 18, 2001, pending,
which is a continuation of U.S. Pat. No. 6,280,380, issued on Aug.
28, 2001, which is a continuation-in-part of U.S. Pat. No.
6,221,011, issued Apr. 24, 2001, the priority of filing dates of
which are claimed, and the disclosures of which are incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates in general to automated data
collection and analysis, and, in particular, to a system and method
for determining a reference baseline record for use in automated
patient care.
BACKGROUND OF THE INVENTION
[0003] A broad class of medical subspecialties, including
cardiology, endocrinology, hematology, neurology, gastroenterology,
urology, ophthalmology, and otolaryngology, to name a few, rely on
accurate and timely patient information for use in aiding health
care providers in diagnosing and treating diseases and disorders.
Often, proper medical diagnosis requires information on
physiological events of short duration and sudden onset, yet these
types of events are often occur infrequently and with little or no
warning. Fortunately, such patient information can be obtained via
external, implantable, cutaneous, subcutaneous, and manual medical
devices, and combinations thereof. For example, in the area of
cardiology, implantable pulse generators (IPGs) are medical devices
commonly used to treat irregular heartbeats, known as arrhythmias.
There are three basic types of IPGs. Cardiac pacemakers are used to
manage bradycardia, an abnormally slow or irregular heartbeat.
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). Finally, implantable cardiovascular monitors and therapeutic
devices are used to monitor and treat structural problems of the
heart, such as congestive heart failure, as well as rhythm
problems.
[0004] Pacemakers and ICDs, as well as other types of implantable
and external medical devices, are equipped with an on-board,
volatile memory in which telemetered signals can be stored for
later retrieval and analysis. 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 more than thirty
minutes of per heartbeat data. Typically, the telemetered signals
can provide patient device information recorded on a per heartbeat,
binned average basis, or derived basis from, for example, atrial
electrical activity, ventricular electrical activity, minute
ventilation, patient activity score, cardiac output score, mixed
venous oxygen score, cardiovascular pressure measures, time of day,
and any interventions and the relative success of such
interventions. In addition, many such devices can have multiple
sensors, or several devices can work together, for monitoring
different sites within a patient's body.
[0005] These telemetered signals can be remotely collected and
analyzed using an automated patient care system. One such system is
described in U.S. Pat. No. 6,312,378. The telemetered signals are
recorded by an implantable medical device, such as an IPG or
monitor, and periodically retrieved using an interrogator,
programmer, telemetered signals transceiver, or similar device, for
subsequent download. The downloaded telemetered signals are
received by a network server 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 is analyzed in an
automated fashion and feedback, which includes a patient status
indicator, is provided to the patient.
[0006] While such a system can serve as a valuable tool in
automated, remote patient care, the accuracy of the patient care,
particularly during the first few weeks of care, and the quality of
the feedback provided to the patient would benefit from being
normalized to a reference baseline of patient wellness. In
particular, a starting point needs to be established for each
individual patient for use in any such system in which medical
device information, such as telemetered signals from implantable
and external medical devices, is continuously monitored, collected,
and analyzed. The starting point could serve as a reference
baseline indicating overall patient status and wellness from the
outset of remote patient care.
[0007] In addition, automated remote patient care poses a further
challenge vis-a-vis evaluating quality of life issues. Unlike in a
traditional clinical setting, physicians participating in providing
remote patient care are not able to interact with their patients in
person. Consequently, quality of life measures, such as how the
patient subjectively looks and feels, whether the patient has
shortness of breath, can work, can sleep, is depressed, is sexually
active, can perform activities of daily life, and so on, cannot be
implicitly gathered and evaluated.
[0008] Reference baseline health assessments are widely used in
conventional patient health care monitoring services. Typically, a
patient's vital signs, consisting of heart rate, blood pressure,
weight, and blood sugar level, are measured both at the outset of
care and periodically throughout the period of service. However,
these measures are limited in their usefulness and do not provide
the scope of detailed medical information made available through
implantable and external medical devices. Moreover, such measures
are generally obtained through manual means and do not ordinarily
directly tie into quality of life assessments. Further, a
significant amount of time generally passes between the collection
of sets of these measures.
[0009] In addition, the uses of multiple sensors situated within a
patient's body at multiple sites are disclosed in U.S. Pat. No.
5,040,536 ('536) and U.S. Pat. No. 5,987,352 ('352). In the '536
patent, an intravascular pressure posture detector includes at
least two pressure sensors implanted in different places in the
cardiovascular system, such that differences in pressure with
changes in posture are differentially measurable. However, the
physiological measurements are used locally within the device, or
in conjunction with any implantable device, to effect a therapeutic
treatment. In the '352 patent, an event monitor can include
additional sensors for monitoring and recording physiological
signals during arrhythmia and syncopal events. The recorded signals
can be used for diagnosis, research or therapeutic study, although
no systematic approach to analyzing these signals, particularly
with respect to peer and general population groups, is
presented.
[0010] Thus, there is a need for an approach to determining a
meaningful reference baseline of individual patient status for use
in a system and method for providing automated, remote patient care
through the continuous monitoring and analysis of patient
information retrieved from an implantable medical device.
Preferably, such an approach would establish the reference baseline
through initially received measures or after a reasonable period of
observation. The reference baseline could be tied to the completion
of a set of prescribed physical stressors. Periodic reassessments
should be obtainable as necessary. Moreover, the reference baseline
should preferably be capable of correlation to quality of life
assessments.
[0011] There is a further need for an approach to monitoring
patient wellness based on a reference baseline for use in an
automated patient care system. Preferably, such an approach would
dynamically determine whether the patient is trending into an area
of potential medical concern, including indicating disease onset,
progression, regression, and status quo.
[0012] There is a further need for an approach to determining a
situation in which remote patient care is inappropriate based on a
reference baseline of patient wellness. Preferably, such an
approach would include a range of acceptance parameters as part of
the reference baseline, thereby enabling those potential patients
whose reference baseline falls outside those acceptance parameters
to be identified.
SUMMARY OF THE INVENTION
[0013] The present invention provides a system and method for
determining a reference baseline for use in an automated collection
and analysis patient care system. The present invention further
provides a system and method for monitoring a patient status using
a reference baseline in an automated collection and analysis
patient care system.
[0014] An embodiment of the present invention is a system and
method for determining a reference baseline record for use in
automated patient care. One or more physiological measures are
retrieved. Each of the measures relates to individual patient
information recorded during an initial observation period from a
patient care record. One or more reference measures are determined
from the physiological measures. Each reference measure is
representative of at least one of measured and derived patient
information. The reference measures are stored into the patient
care record indicating a reference baseline patient status.
[0015] A further embodiment of the present invention is a system
and method for applying a reference baseline record for use in
automated patient care. One or more reference measures are
retrieved from a patient care record indicating a reference
baseline patient status. The reference measures are each
representative of at least one of measured and derived patient
information and are determined from physiological measures relating
to individual patient information recorded during an initial
observation period. The reference measures are compared to
acceptance parameters corresponding to the same type of patient
information to which the reference measures relate.
[0016] The present invention provides a meaningful, quantitative
measure of patient wellness for use as a reference baseline in an
automated system and method for continuous, remote patient care.
The reference baseline increases the accuracy of remote patient
care, particularly during the first few weeks of care, by providing
a grounded starting assessment of the patient's health and
well-being.
[0017] A collateral benefit of the reference baseline is the
removal of physician "bias" which can occur when the apparent
normal outward appearance of a patient belies an underlying
condition that potentially requires medical attention. The
reference baseline serves to objectify a patient's self-assessment
of wellness.
[0018] The present invention also provides an objective approach to
humanizing the raw measures recorded by medical devices, including
implantable medical devices. Using known quality of life assessment
instruments, a patient can be evaluated and scored for relative
quality of life at a given point in time. The reference baseline of
the present invention provides a means for correlating the quality
of life assessment to machine-recorded measures, thereby assisting
a physician in furthering patient care.
[0019] Finally, the present invention improves the chronicling of
legal responsibility in patient care. A prescribed course of
treatment can be traced back to a grounded point in time
memorialized by the reference baseline. Thus, a medical audit trail
can be generated with a higher degree of accuracy and certainty
based on having an established originating point of reference.
[0020] 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
[0021] FIGS. 1A and 1B are block diagrams showing a system for
determining a reference baseline of individual patient status for
use in an automated collection and analysis patient care system in
accordance with the present invention;
[0022] FIG. 2 is a block diagram showing the hardware components of
the server system of the system of FIG. 1A;
[0023] FIG. 3 is a block diagram showing the software modules of
the server system of the system of FIG. 1A;
[0024] FIG. 4 is a block diagram showing the processing module of
the server system of FIG. 1A;
[0025] FIG. 5 is a database schema showing, by way of example, the
organization of a reference baseline record for cardiac patient
care stored as part of a patient care record in the database of the
system of FIG. 1A;
[0026] FIG. 6 is a database schema showing, by way of example, the
organization of a reference baseline quality of life record for
cardiac patient care stored as part of a patient care record in the
database of the system of FIG. 1A;
[0027] FIG. 7 is a database schema showing, by way of example, the
organization of a monitoring record for cardiac patient care stored
as part of a patient care record in the database of the system of
FIG. 1A;
[0028] FIGS. 8A-8C are flow diagrams showing a method for
determining a reference baseline for use in monitoring a patient
status in an automated collection and analysis patient care system
in accordance with the present invention; and
[0029] FIG. 9 is a flow diagram showing the routine for processing
a reference baseline for use in the method of FIGS. 8A-8C;
[0030] FIG. 10 is a flow diagram showing the routine for processing
quality of life measures for use in the method of FIGS. 8A-8C;
and
[0031] FIG. 11 is a flow diagram showing the routine for
reassessing a new reference baseline for use in the method of FIGS.
8A-8C;
[0032] FIGS. 12A and 12B are block diagrams showing system for
determining a reference baseline of individual patient status for
use in an automated collection and analysis patient care system in
accordance with a further embodiment of the present invention;
[0033] FIG. 13 is a block diagram showing the analysis module of
the server system of FIGS. 12A and 12B;
[0034] FIG. 14 is a database schema showing, by way of example, the
organization of a quality of life and symptom measures set record
for care of patients stored as part of a patient care record in the
database of the system of FIGS. 12A and 12B;
[0035] FIG. 15 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 FIGS. 12A and 12B;
[0036] FIG. 16 is a Venn diagram showing, by way of example, peer
group overlap between the partial patient care records of FIG. 15;
and
[0037] FIGS. 17A-17D are flow diagrams showing a method for
determining a reference baseline of individual patient status for
use in an automated collection and analysis patient care system in
accordance with a further embodiment of the present invention.
DETAILED DESCRIPTION
[0038] FIG. 1A is a block diagram showing a system 10 for
determining a reference baseline 5 of patient status for an
individual patient 11 for use in an automated collection and
analysis patient care system in accordance with the present
invention. An automated collection and analysis patient care system
suitable for use with the present invention is disclosed in U.S.
Pat. No. 6,312,378, the disclosure of which is incorporated herein
by reference. 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.
Alternatively, subcutaneous monitors or devices inserted into other
organs (not shown) without leads could also be used. 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.
[0039] For an exemplary cardiac implantable medical device, the
telemetered signals non-exclusively present patient information
recorded on a per heartbeat, binned average or derived basis and
relating to: atrial electrical activity, ventricular electrical
activity, minute ventilation, patient activity score, cardiac
output score, mixed venous oxygenation score, cardiovascular
pressure measures, time of day, the number and types of
interventions made, and the relative success of any interventions,
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 Gem line of ICDs, manufactured by Medtronic
Corporation, Minneapolis, Minn.
[0040] 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, muscular disorders, gastroenterology, urology,
ophthalmology, otolaryngology, orthopedics, and similar medical
subspecialties. One skilled in the art would readily recognize the
applicability of the present invention to these related implantable
medical devices.
[0041] The telemetered signals stored in the implantable medical
device 12 are retrieved upon completion of an initial observation
period and subsequently retrieved on a continuous, periodic basis.
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.
[0042] 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 14 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 internetwork 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.
[0043] 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.
[0044] 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.
[0045] The initial set of telemetered signals recorded during the
initial observation period is processed by the server system 16
into a set of reference measures and stored as a reference baseline
5 in the database 17, as further described below with reference to
FIG. 3. The purpose of the observation period is to establish a
reference baseline 5 containing a set of reference measures that
can include both measured and derived patient information. The
reference baseline 5 can link "hard" machine-recorded data with
"soft" patient-provided self-assessment data from which can be
generated a wellness status indicator. In addition, the reference
baseline 5 can be used to identify patients for whom remote patient
care may be inappropriate and for patient wellness comparison and
analysis during subsequent, on-going remote patient care. The
reference baseline 5 is maintained in the database 17 and can be
reassessed as needed or on a periodic basis.
[0046] Subsequent to the initial observation period, the patient is
remotely monitored by the server system 16 through the periodic
receipt of telemetered signals from the implantable medical device
12 via the internetwork 15. 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.
[0047] FIG. 1B is a block diagram showing a further embodiment of
the present invention in which the patient 11 is monitored by the
implantable medical device 12 while engaged in performing a
prescribed set of timed physical stressors during an initial
observation period or during a subsequent observation period if the
patient 11 is being reassessed. The stressors are a set of normal,
patient activities and cardiovascular and respiratory maneuvers
that allow consistent, reproducible physiological functions to be
measured by the implantable medical device 12. These maneuvers
include activities such as a change in posture, simple physical
exercises, breathing state, including holding breath and
hyperventilating, and oxygen challenges. By way of example, the
stressors include timed physical activities such as running in
place 6, recumbency 7, standing 8, sitting motionless 9, and
reprogramming at least one of pacing interventions and pacing modes
of the implantable medical device 12, as further described below
with reference to FIG. 5.
[0048] In a still further embodiment of the present invention, at
least one of pacing interventions and pacing modes of the
implantable medical device 12 is reprogrammed by the programmer 14
during the initial observation period or during a subsequent
observation period if the patient 11 is being reassessed. The
patient 11 is then monitored by the reprogrammed implantable
medical device 12.
[0049] FIG. 2 is a block diagram showing the hardware components of
the server system 16 of the system 10 of FIG. 1A. 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 intranetwork 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.
[0050] 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 device 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 device
measures sets in the appropriate patient care record.
[0051] The application server 35 operates management applications,
assimilates the reference measures into the reference baseline 5
(shown in FIG. 1A), 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.
[0052] The server system 16 also includes a plurality of individual
workstations 36 (WS) interconnected to the intranetwork 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.
[0053] 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 FIGS.
5-7.
[0054] 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 128MB RAM,
100GB hard drive capacity, data backup facilities, and related
hardware for interconnection to the intranetwork 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 64MB
RAM, 10GB hard drive capacity, and related hardware for
interconnection to the intranetwork 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.
[0055] 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
intranetwork 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.
[0056] FIG. 3 is a block diagram showing the software modules of
the server system 16 of the system 10 of FIG. 1A. 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 art. 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.
[0057] 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 processing module 56.
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 these
modules. The module functions are further described below beginning
with reference to FIGS. 8A-8C.
[0058] A reference baseline 5 is established at the outset of
providing a patient with remote patient care. The server system 16
periodically receives an initially collected device measures set
57. This set represents patient information which was collected
from the implantable medical device 12 (shown in FIG. 1A) during
the initial observation period, as further discussed below with
reference to FIG. 5. In addition, the server system 16 can also
periodically receive quality of life measures sets 60 recorded by
the patient 11, as further described below with reference to FIG.
6. Both the initially collected device measures set 57 and quality
of life measures set 60 are forwarded to the database module 51 for
storage in the patient's patient care record in the database 52.
During subsequent, on-going monitoring for remote patient care, the
server system 16 periodically receives subsequently collected
device measures sets 58, which are also forwarded to the database
module 51 for storage.
[0059] 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 device measures
sets 57, 58 and patient data maintained in those records. Exemplary
database schemes for use in storing the initially collected device
measures set 57, quality of life measures set 60, and subsequently
collected device measures sets 58 in a patient care record are
described below, by way of example, with reference to FIGS. 5-7.
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.
[0060] The processing module 56 processes the initially collected
device measures set 57 and, if available, the quality of life
measures set 60, stored in the patient care records in the database
52 into the reference baseline 5. The reference baseline 5 includes
a set of reference measures 59 which can be either directly
measured or indirectly derived patient information. The reference
baseline 5 can be used to identify patients for whom remote patient
care might be inappropriate and to monitor patient wellness in a
continuous, on-going basis.
[0061] On a periodic basis or as needed, the processing module 56
reassesses the reference baseline 5. Subsequently collected device
measures sets 58 are received from the implantable medical device
12 (shown in FIG. 1A) subsequent to the initial observation period.
The processing module 56 reassimilates these additional collected
device measures sets into a new reference baseline. The operations
performed by the processing module 56 are further described below
with reference to FIG. 4. The application server 35 (shown in FIG.
2) performs the functionality of the processing module 56.
[0062] The analysis module 53 analyzes the subsequently collected
device measures sets 58 stored in the patient care records in the
database 52. The analysis module 53 monitors patient wellness and
makes an automated determination in the form of a patient status
indicator 54. Subsequently collected device measures sets 58 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.
[0063] 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.
[0064] FIG. 4 is a block diagram showing the processing module 56
of the server system 16 of FIG. 1A. The processing module 53
contains two functional submodules: evaluation module 70 and
acceptance module 71. The purpose of the evaluation module 70 is to
process the initially collected device measures set 57 by
determining any derived measures and calculating appropriate
statistical values, including means and standard deviations, for
the reference measures set 59 in the reference baseline 5. The
purpose of the acceptance module 71 is to analyze the reference
measures set 59 against the acceptance parameters set 72. A patient
care record storing a reference measures set 59 substantially out
of conformity with the acceptance parameters set 72 could be
indicative of a patient for whom remote patient care is
inappropriate. Consequently, the acceptance module 71 identifies
each patient care record storing at least one reference measure
which is substantially non-conforming to a corresponding parameter
in the acceptance parameters set 72.
[0065] For instance, an acceptance parameter for heart rate might
be specified as a mean heart rate within a range of 40-90 beats per
minute (bpm) over a 24-hour period. However, a patient care record
storing a reference measure falling either substantially above or
below this acceptance parameter, for example, in excess of 90 bpm,
would be considered substantially non-conforming. The acceptance
parameters set 72 are further described below with reference to
FIG. 5.
[0066] The evaluation module 70 also determines new reference
baselines 73 when necessary. For instance, the new reference
baseline 73 might be reassessed on an annual or quarterly basis, as
the needs of the patient 11 dictate. Similarly, the new reference
baseline 73 might be reassessed for a patient whose patient care
record stores a subsequently collected device measures set 58
substantially out of conformity with the reference measures set 59
in the original reference baseline 5. The new reference baseline 73
would be assessed by the processing module 56 using subsequently
collected device measures sets 58 during a subsequent observation
period.
[0067] FIG. 5 is a database schema showing, by way of example, the
organization of a reference baseline record 75 for cardiac patient
care stored as part of a patient care record in the database 17 of
the system 10 of FIG. 1A. The reference baseline record 75
corresponds to the reference baseline 5, although only the
information pertaining to the set of reference measures in the
reference baseline 5 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). For
instance, during the initial observation period, the patient 11
maintains a diary of activities, including the onset of bedtime and
waking time, plus the time and dosing of any medications, including
non-prescription drugs. The observation period can be expanded to
include additional information about the normal range of patient
activities as necessary, including a range of potential anticipated
activities as well as expected travel times and periods away from
home. In addition, information from any set of medical records
could be included in the patient care record. The diary,
medication, activity, and medical record information and medical
test information (e.g., electrocardiogram, echocardiogram, and/or
coronary angiogram) is incorporated into the patient care record
and is updated with continuing patient information, such as changes
in medication, as is customary in the art.
[0068] The reference measures set 59 stored in the reference
baseline record 75 are processed from the initial collected device
measures set 57 (shown in FIG. 3), as further described below with
reference to FIG. 9. The implantable medical device 12 (shown in
FIG. 1A) records the initial collected device measures set 57
during the initial observation period. For example, for a cardiac
patient, the reference baseline record 75 stores the following
information as part of the reference measures set 59: patient
activity score 76, posture 77 (e.g., from barometric pressure),
atrial electrical activity 78 (e.g., atrial rate), ventricular
electrical activity 79 (e.g., ventricular rate), cardiovascular
pressures 80, cardiac output 81, oxygenation score 82 (e.g., mixed
venous oxygenation), pulmonary measures 83 (e.g., transthoracic
impedance, measures of lung wetness, and/or minute ventilation),
body temperature 84, PR interval 85 (or AV interval), QRS measures
86 (e.g., width, amplitude, frequency content, and/or morphology),
QT interval 87, ST-T wave measures 88 (e.g., T wave alternans or ST
segment depression or elevation), potassium [K+] level 89, sodium
[Na+] level 90, glucose level 91, blood urea nitrogen and
creatinine 92, acidity (pH) level 93, hematocrit 94, hormonal
levels 95 (e.g., insulin, epinephrine), cardiac injury chemical
tests 96 (e.g., troponin, myocardial band creatinine kinase),
myocardial blood flow 97, central nervous system injury chemical
tests 98 (e.g., cerebral band creatinine kinase), central nervous
system (CNS) blood flow 99, and time of day 100. Other types of
reference measures are possible. In addition, a well-documented set
of derived measures can be determined based on the reference
measures, as is known in the art.
[0069] In the described embodiment, the initial and any subsequent
observation periods last for about one 7-day period during which
time the patient 11 might be asked to perform, if possible,
repeated physical stressors representative of both relatively
normal activity and/or activities designed to test the response of
the body to modest activity and physiologic perturbations for use
as the baseline "reference" measures that might be recorded daily
for a period of one week prior to initiating fee-for-service
monitoring. Reference measures taken and derived from the
observation period are recorded, processed, and stored by the
system 10. The reference measures include both measured and derived
measures, including patient activity score 76, posture 77, atrial
electrical activity 78, ventricular electrical activity 79,
cardiovascular pressures 80, cardiac output 81, oxygenation score
82, pulmonary measures 83, body temperature 84, PR interval 85 (or
AV interval), QRS measures 86, QT interval 87, ST-T wave measures
88, potassium [K+] level 89, sodium [Na+] level 90, glucose level
91, blood urea nitrogen and creatinine 92, acidity (pH) level 93,
hematocrit 94, hormonal levels 95, cardiac injury chemical tests
96, myocardial blood flow 97, central nervous system injury
chemical tests 98, central nervous system (CNS) blood flow 99, and
time of day 100. Other combination and derivative measures can also
be determined, as known in the art.
[0070] An illustrative prescribed set of timed physical stressors
for a non-ambulatory patient 11 is as follows:
[0071] (1) Running in place 6: if possible, the patient 11 must run
in place for about five minutes;
[0072] (2) Walking (not shown): if possible, the patient 11 must
walk for about six minutes and the total distance walked is
measured;
[0073] (3) Ascending stairs (not shown): if possible, the patient
11 must ascend two flights of stairs;
[0074] (4) Recumbency 7: if possible, the patient 11 must recline
following about two minutes of motionless immobile upright posture.
Upon recumbency, the patient 11 must remain as immobile as possible
for about ten minutes;
[0075] (5) Standing 8: if possible, the patient 11 must briskly
assume an upright standing posture after the ten-minute recumbency
7 and must remain standing without activity for about five
minutes;
[0076] (6) Coughing (not shown): if possible, the patient 11 must
cough forcefully about three times when in an upright position to
record the cardiovascular pressures 80;
[0077] (7) Hyperventilation (not shown): if possible, the patient
11 must hyperventilate over thirty seconds with full deep and rapid
breaths to record ventilatory status;
[0078] (8) Sitting motionless 9: when a physician is complicit, the
patient 11 must, if possible, use an approximately 2.0 liter per
minute nasal cannula while transmitting data for about twenty
minutes while sitting to evaluate cardiopulmonary response;
[0079] (9) Program AAI and VVI temporary pacing interventions for
five minutes, at low and high rates, if applicable (e.g., 40 bpm
and 120 bpm) to evaluate cardiopulmonary response; and
[0080] (10) Test dual site or biventricular pacing modes, if
applicable, for approximately 20 minutes to evaluate
cardiopulmonary response.
[0081] These physical and pacing stimulus stressors must be
annotated with date and time of day 100 and correlated with
symptoms and the quality of life measures 110. Heart rate,
temperature, and time of day are directly measured while the
patient activity score and cardiac output score are derived. These
physical stressors are merely illustrative in nature and the set of
physical and pacing stimulus stressors actually performed by any
given patient would necessarily depend upon their age and physical
condition as well as device implanted. Also, during the observation
period, the temperature is monitored with QT interval shortening
and, if the patient is in atrial fibrillation, the patient 11 must
undergo an incremental ventricular pacing protocol to assess his or
her response to rate stabilization. Finally, a T-wave alternans
measurement (not shown) can be integrated into the reference
baseline 5 during rest and sinus rhythm activities.
[0082] In a further embodiment of the present invention, the
reference measures set 59 in the reference baseline 5 are
reassessed on an annual or, if necessary, quarterly, basis. In
addition, if the reference measures set 59 was recorded during a
period when the patient 11 was unstable or recovering from a recent
illness, the reference baseline 5 is reassessed when the patient 11
is again stable, as further described below with reference to FIG.
11.
[0083] As further described below with reference to FIG. 9, the
reference measures are analyzed against the acceptance parameters
set 72. The acceptance parameters are those indicator values
consistent with the presence of some form of chronic yet stable
disease which does not require immediate emergency care. In the
described embodiment, the acceptance parameters set 72 for the
reference measures 59 in the reference baseline record 75 are, by
way of example, as follows: cardiac output 81 falling below 2.5
liters/minute/m2; heart rate below 40 bpm or above 120 bpm; body
temperature 84 over 101.degree. F. and below 97.degree. F.; patient
activity 76 score of 1.0 or below; oxygenation score 82 of less
than 60% mixed venous saturation at rest; pulmonary artery
diastolic pressure greater than 20 mm Hg at rest; and minute
ventilation less than 10.0 liters/minute at rest.
[0084] FIG. 6 is a database schema showing, by way of example, the
organization of a reference baseline quality of life record 110 for
cardiac patient care stored as part of a patient care record in the
database 17 of the system 10 of FIG. 1A. A quality of life score is
a semi-quantitative self-assessment of an individual patient's
physical and emotional well being. Non-commercial, non-proprietary
standardized automated quality of life scoring systems are readily
available, such as provided by the Duke Activities Status
Indicator. These scoring systems can be provided for use by the
patient 11 on the personal computer 18 (shown in FIG. 1A) and the
patient 11 can then record his or her quality of life scores for
periodic download to the server system 16.
[0085] For example, for a cardiac patient, the reference baseline
quality of life record 110 stores the following information as part
of the reference measures set 59: health wellness 111, shortness of
breath 112, energy level 113, exercise tolerance 114, chest
discomfort 115, time of day 116, and other quality of life measures
as would be known to one skilled in the art. Using the quality of
life scores 111-116 in the reference baseline quality of life
record 110, the patient 11 can be notified automatically when
variable physiological changes matches his or her
symptomatology.
[0086] A quality of life indicator is a vehicle through which a
patient can remotely communicate to the patient care system how he
or she is subjectively feeling. When tied to machine-recorded
physiological measures, a quality of life indicator can provide
valuable additional information to medical practitioners and the
automated collection and analysis patient care system 10 not
otherwise discernible without having the patient physically
present. For instance, a scoring system using a scale of 1.0 to
10.0 could be used with 10.0 indicating normal wellness and 1.0
indicating severe health problems. Upon the completion of the
initial observation period, a patient might indicate a health
wellness score 111 of 5.0 and a cardiac output score of 5.0. After
one month of remote patient care, the patient might then indicate a
health wellness score 111 of 4.0 and a cardiac output score of 4.0
and a week later indicate a health wellness score 111 of 3.5 and a
cardiac output score of 3.5. Based on a comparison of the health
wellness scores 111 and the cardiac output scores, the system 10
would identify a trend indicating the necessity of potential
medical intervention while a comparison of the cardiac output
scores alone might not lead to the same prognosis.
[0087] FIG. 7 is a database schema showing, by way of example, the
organization of a monitoring record 120 for cardiac patient care
stored as part of a patient care record in the database 17 of the
system 10 of FIG. 1A. Each patient care record stores a multitude
of subsequently collected device measures sets 58 (shown in FIG. 3)
for each individual patient 11. Each set represents a recorded
snapshot of telemetered signals data which were recorded, for
instance, on a 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 subsequently
collected device measures set 58: atrial electrical activity 121,
ventricular electrical activity 122, minute ventilation 123,
patient activity score 124, cardiac output score 125, mixed venous
oxygen score 126, pulmonary artery diastolic pressure measure 127,
time of day 128, interventions made by the implantable medical
device 129, and the relative success of any interventions made 130.
In addition, the implantable medical device 12 would also
communicate device specific information, including battery status
and program settings 131. Other types of collected or combined
measures are possible as previously described. In addition, a
well-documented set of derived measures can be determined based on
the collected measures, as is known in the art.
[0088] FIGS. 8A-8C are flow diagrams showing a method 140 for
determining a reference baseline 5 for use in monitoring a patient
status in an automated collection and analysis patient care system
10 in accordance with the present invention. The method 140
operates in two phases: collection and processing of an initial
reference baseline 5 (blocks 141-149) and monitoring using the
reference baseline 5 (blocks 150-158). The method 140 is
implemented as a conventional computer program for execution by the
server system 16 (shown in FIG. 1A). 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
141).
[0089] The collection and processing of the initial reference
baseline 5 begins with the patient 11 being monitored by the
implantable medical device 12 (shown in FIG. 1A). The implantable
medical device 12 records the initially collected device measures
set 57 during the initial observation period (block 142), as
described above with reference to FIG. 5. Alternatively, the
patient 11 could be engaged in performing the prescribed set of
timed physical stressors during the initial observation period, as
described above with reference to FIG. 1B. As well, the implantable
medical device 12 could be reprogrammed by the programmer 14 during
the initial observation period, also as described above with
reference to FIG. 1B. The initially collected device measures set
57 is retrieved from the implantable medical device 12 (block 143)
using a programmer, interrogator, telemetered signals transceiver,
and the like. The retrieved initially collected device measures
sets are sent over the internetwork 15 or similar communications
link (block 144) and periodically received by the server system 16
(block 145). The initially collected device measures set 57 is
stored into a patient care record in the database 17 for the
individual patient 11 (block 146). The initially collected device
measures set 57 is processed into the reference baseline 5 (block
147) which stores a reference measures set 59, as further described
below with reference to FIG. 9.
[0090] If quality of life measures are included as part of the
reference baseline 5 (block 148), the set of quality of life
measures are processed (block 149), as further described below with
reference to FIG. 10. Otherwise, the processing of quality of life
measures is skipped (block 148).
[0091] Monitoring using the reference baseline 5 begins with the
retrieval of the subsequently collected device measures sets 58
from the implantable medical device 12 (block 150) using a
programmer, interrogator, telemetered signals transceiver, and the
like. The subsequently collected device measures sets 58 are sent,
on a substantially regular basis, over the internetwork 15 or
similar communications link (block 151) and periodically received
by the server system 16 (block 152). The subsequently collected
device measures sets 58 are stored into the patient care record in
the database 17 for that individual patient (block 153).
[0092] The subsequently collected device measures sets 58 are
compared to the reference measures in the reference baseline 5
(block 154). If the subsequently collected device measures sets 58
are substantially non-conforming (block 155), the patient care
record is identified (block 156). Otherwise, monitoring continues
as before.
[0093] In the described embodiment, substantial non-conformity
refers to a significant departure from a set of parameters defining
ranges of relative normal activity and normal exercise responses
for that patient. Relative normal activity is defined as follows.
Note the "test exercise period" refers to running in place,
walking, and ascending stairs physical stressors described
above:
[0094] (1) Heart rate stays within a range of 40-90 bpm without
upward or downward change in mean heart rate (1.0 standard
deviation (SD) over a 24 hour period;
[0095] (2) Wake patient activity score during awake hours stays
within a range of (1.0 SD without change in the mean activity score
over a 24 hour period with no score equal to the minimum activity
score noted during sleep;
[0096] (3) Sleep period activity score stays within a range of (1.0
SD of typical sleep scores for that patient for the six to ten hour
period of sleep with no score less than the minimum score observed
during normal awake behavior during the initial observation period
or during normal sleep;
[0097] (4) Minute ventilation 123 during normal awake hours stays
within a range of (1.0 SD without change in the mean score over a
24 hour period with no score equal to the minimum or maximum minute
ventilation 123 noted during the test exercise period or the
minimum or maximum minute ventilation 123 noted during the initial
observation period;
[0098] (5) Cardiac output score 125 during normal awake hours stays
within a range of (1.0 SD without change in the mean cardiac output
score over a 24 hour period with no score equal to the minimum
cardiac output score noted during the test exercise period or the
minimum cardiac output score noted during the initial observation
period;
[0099] (6) Mixed venous oxygenation score 126 during normal awake
hours stays within a range of (1.0 SD without change in the mean
mixed venous oxygenation score over a 24 hour period with no score
equal to the minimum mixed venous oxygenation score noted during
the test exercise period or the minimum mixed venous oxygenation
score noted during the initial observation period;
[0100] (7) Pulmonary artery diastolic pressure measure 127 during
normal awake hours stays within a range of (1.0 SD without change
in the mean pulmonary artery diastolic pressure measure 127 over a
24 hour period with no score equal to the minimum or maximum
pulmonary artery diastolic pressure measure 127 noted during the
test exercise period or during the initial observation period;
[0101] (8) Potassium levels [K+] score during normal awake hours
stays within a range of (1.0 SD without change in the mean K+
levels over a 24 hour period with no score less than 3.5 meq/liter
or greater than 5.0 meq/liter noted during the test exercise period
or during the initial observation period;
[0102] (9) Sodium levels [Na+] score during normal awake hours
stays within a range of (1.0 SD without change in the mean Na+
levels over a 24 hour period with no score less than 135 meq/liter
or greater than 145 meq/liter during the test exercise period or
during the initial observation period;
[0103] (10) Acidity (pH) score during normal awake hours stays
within a range of (1.0 SD without change in the mean pH score over
a 24 hour period with no score equal to the minimum or maximum pH
score noted during the test exercise period or the minimum or
maximum pH scores noted during the initial observation period;
[0104] (11) Glucose levels during normal awake hours stays within a
range of (1.0 SD without change in the mean glucose levels over a
24 hour period with no score less than 60 mg/dl or greater than 200
mg/dl during the test exercise period or during the initial
observation period;
[0105] (12) Blood urea nitrogen (BUN) or creatinine (Cr) levels
during normal awake hours stays within a range of (1.0 SD without
change in the mean BUN or Cr levels score over a 24 hour period
with no score equal to the maximum BUN or creatinine levels noted
during the test exercise period or the maximum BUN or Cr levels
noted during the initial observation period;
[0106] (13) Hematocrit levels during normal awake hours stays
within a range of (1.0 SD without change in the mean hematocrit
levels score over a 24 hour period with no score less than a
hematocrit of 30 during the test exercise period or during the
initial observation period;
[0107] (14) Troponin, creatinine kinase myocardial band, or other
cardiac marker of myocardial infarction or ischemia, level during
normal awake hours stays within a range of (1.0 SD without change
in the mean troponin level score over a 24 hour period with no
score equal to the maximum troponin level score noted during the
test exercise period or the maximum troponin level scores noted
during the initial observation period;
[0108] (15) Central nervous system (CNS) creatinine kinase (CK) or
equivalent markers of CNS ischemia or infarction levels during
normal awake hours stays within a range of (1.0 SD without change
in the mean CNS CK levels over a 24 hour period with no score equal
to the maximum CNS CK levels score noted during the test exercise
period or the maximum CNS CK levels scores noted during the initial
observation period;
[0109] (16) Barometric pressure during normal awake hours stays
within a range of (1.0 SD without change in the mean barometric
pressure score over a 24 hour period with no score equal to the
minimum or maximum barometric pressure noted during the test
exercise period or the minimum or maximum barometric pressure noted
during the initial observation period;
[0110] (17) PR interval (or intrinsic AV interval) of sinus rhythm
during normal awake hours stays within a range of (1.0 SD without
change in the mean PR interval over a 24 hour period with no score
equal to the minimum or maximum PR interval noted during the test
exercise period or the minimum or maximum PR interval noted during
the initial observation period;
[0111] (18) QT interval during normal awake hours stays within a
range of (1.0 SD without change in the mean QT interval over a 24
hour period with no score equal to the minimum or maximum QT
interval noted during the test exercise period or the minimum or
maximum QT interval noted during the initial observation
period;
[0112] (19) QRS duration during normal awake hours stays within a
range of (1.0 SD without change in the mean QRS duration over a 24
hour period with no score equal to the maximum QRS duration noted
during the test exercise period or the maximum QRS duration noted
during the initial observation period;
[0113] (20) ST segment depression or elevation during normal awake
hours stays within a range of (1.0 SD without change in the mean ST
segment depression or elevation over a 24 hour period with no score
equal to the maximum ST segment depression or elevation noted
during the test exercise period or the maximum ST segment
depression or elevation noted during the initial observation
period; and
[0114] (21) Temperature during normal awake hours stays within a
range of (1.0 SD without change in the mean temperature over a 24
hour period with no score equal to the minimum or maximum
temperature score noted during the test exercise period or the
minimum or maximum temperature noted during the initial observation
period.
[0115] For an exemplary, non-ambulatory patient with no major
impairments of the major limbs, reference exercise can be defined
as follows:
[0116] (1) Heart rate increases by 10 bpm for each one point
increase in activity score. Note that to be considered "normal
exercise," heart rate generally should not increase when the
activity score does not increase at least 1.0 SD above that noted
during the twenty-four hour reference period or greater than that
observed during any reference exercise periods. Heart rate should
decrease to the baseline value over fifteen minutes once activity
stops or returns to the baseline activity level;
[0117] (2) Patient activity score 124 rises at least 1.0 SD over
that observed in the mean activity score over a 24 hour period or
greater than that observed during any reference exercise
periods;
[0118] (3) Cardiac output score 125 rises at least 1.0 SD over that
observed in the mean cardiac output score over a 24 hour period or
within 0.5 SD of the two minute test exercise period. Cardiac
output score should increase 0.5 liters per minute with each 10 bpm
increase in heart rate period or greater than that observed during
any reference exercise periods;
[0119] (4) In conjunction with an increase in activity score and
heart rate, mixed venous oxygenation score 126 falls at least 1.0
SD below observed in the mean oxygenation score over a 24 hour
period or be less than any oxygenation score observed during the
reference exercise periods. Oxygenation score should decrease 5.0
mm Hg with each 10 bpm increase in heart rate or 1.0 SD increase in
cardiac output score during exercise;
[0120] (5) In conjunction with an increase in activity score and
heart rate, pulmonary artery diastolic pressure measure 127 rises
at least 1.0 SD over that observed in the mean cardiovascular
pressure score over a 24 hour period or is greater than that
observed during the reference exercise periods;
[0121] (6) In conjunction with an increase in activity score and
heart rate, minute ventilation 123 rises at least 1.0 SD over that
observed over a 24 hour reference period or greater than that
observed during any reference exercise period. Minute ventilation
should rise 1.0 liter per minute with each 10 bpm increase in heart
rate; and
[0122] (7) In conjunction with an increase in activity score and
heart rate, temperature should rise at least 1.0 SD over that
observed in the mean temperature over a 24 hour period or greater
than that observed during the reference exercise periods.
Temperature should rise 0.1.degree. F. with each 10 bpm increase in
heart rate.
[0123] Finally, if the time for a periodic reassessment has arrived
or the subsequently collected device measures sets 58 are
substantially non-conforming (block 157), the reference baseline 5
is reassessed (block 158) and a new reference baseline 73
determined, as further described below with reference to FIG. 11.
Otherwise, the routine returns.
[0124] In the described embodiment, the reference baseline 5 is
preferably reassessed on an annual or, if necessary, quarterly
basis. In addition, the reference baseline 5 might be reassessed if
physiological findings dictate that new interventions might be
indicated or if the patient 11 indicates a change in medications
and general health status. Other bases for reassessing the
reference baseline 5 are feasible.
[0125] FIG. 9 is a flow diagram showing the routine 147 for
processing a reference baseline 5 for use in the method 140 of
FIGS. 8A-8C. The purpose of this routine is to analyze the
initially collected device measures set 57 and create a reference
baseline 5, if possible. First, the acceptance parameters set 72
(shown in FIG. 3) is defined (block 160) and the reference measures
set 59 in the reference baseline 5, including any quality of life
measures, are analyzed against the acceptance parameters set (block
161), as described above with reference to FIG. 5. If the reference
measures in the reference baseline 5 are substantially
non-conforming to the acceptance parameters set (block 162), the
patient care record is identified (block 164). Otherwise, if
conforming (block 162), the baseline reference 72 is stored into
the patient care record in the database 17 (block 163). The routine
then returns.
[0126] FIG. 10 is a flow diagram showing the routine 149 for
processing quality of life measures for use in the method 140 of
FIGS. 8A-8C. The purpose of this routine is to process and store a
collected quality of life measures set 60 into the reference
baseline 5. Collected quality of life measures sets 60 are
periodically received by the server system 16 over the internetwork
15 or similar communications link (block 170). The quality of life
measures were previously recorded by the patient 11 using, for
example, the personal computer 18 (shown in FIG. 1A) and downloaded
onto the internetwork 15 or similar communications link. The
collected quality of life measures set 60 is stored into a patient
care record in the database 17 for the individual patient 11 (block
171). The collected quality of life measures set 60 is then
assimilated into the reference baseline 5 (block 172), as further
described above with reference to FIG. 9. The routine then
returns.
[0127] FIG. 11 is a flow diagram showing the routine 158 for
reassessing a new reference baseline 73 for use in the method 140
of FIGS. 8A-8C. The purpose of this routine is to reassess a new
reference baseline 5 periodically or when necessary. Similar to the
collection and assimilation of the initial reference baseline 5,
the routine begins with the patient 11 being monitored by the
implantable medical device 12 (shown in FIG. 1A). The implantable
medical device 12 records subsequently collected device measures
sets 58 throughout a subsequent observation period (block 180), as
described above with reference to FIG. 5. Alternatively, the
patient 11 could be engaged in performing the prescribed set of
timed physical stressors, as described above with reference to FIG.
1B. As well, the implantable medical device 12 could be
reprogrammed by the programmer 14 during the subsequent observation
period, also as described above with reference to FIG. 1B. The
subsequently collected device measures sets 58 are retrieved from
the implantable medical device 12 (block 181) using a programmer,
interrogator, telemetered signals transceiver, and the like. The
retrieved subsequently collected device measures sets are sent over
the internetwork 15 or similar communications link (block 182) and
periodically received by the server system 16 (block 183). The
subsequently collected device measures sets 58 are stored into the
patient care record in the database 17 for the individual patient
11 (block 184). Finally, the subsequently collected device measures
sets 58 are assimilated into the new reference baseline 73 (block
185), as further described above with reference to FIG. 9. The
routine then returns.
[0128] FIGS. 12A and 12B are block diagrams showing system for
determining a reference baseline of individual patient status for
use in an automated collection and analysis patient care system 200
in accordance with a further embodiment of the present invention.
The system 200 provides remote patient care in a manner similar to
the system 10 of FIGS. 1A and 1B, but with additional functionality
for diagnosing and monitoring multiple sites within a patient's
body using a variety of patient sensors for diagnosing one or more
disorder. The patient 201 can be the recipient of an implantable
medical device 202, as described above, or have an external medical
device 203 attached, such as a Holter monitor-like device for
monitoring electrocardiograms. In addition, one or more sites in or
around the patient's body can be monitored using multiple sensors
204a, 204b, such as described in U.S. Pat. Nos. 4,987,897;
5,040,536; 5,113,859; and 5,987,352, the disclosures of which are
incorporated herein by reference. One automated system and method
for collecting and analyzing retrieved patient information suitable
for use with the present invention is described in U.S. Pat. No.
6,270,457, the disclosure of which is incorporated herein by
reference. Other types of devices with physiological measure
sensors, both heterogeneous and homogenous, could be used, either
within the same device or working in conjunction with each other,
as is known in the art.
[0129] As part of the system 200, the database 17 stores patient
care records 205 for each individual patient to whom remote patient
care is being provided. Each patient care record 205 contains
normal patient identification and treatment profile information, as
well as medical history, medications taken, height and weight, and
other pertinent data (not shown). The patient care records 205
consist primarily of monitoring sets 206 storing device and derived
measures (D&DM) sets 207 and quality of life and symptom
measures (QOLM) sets 208 recorded and determined thereafter on a
regular, continuous basis. The organization of the device and
derived measures sets 205 for an exemplary cardiac patient care
record is described above with reference to FIG. 5. The
organization of the quality of life and symptom measures sets 208
is further described below with reference to FIG. 14.
[0130] The patient care records 205 also include a reference
baseline 209, similar to the reference baseline 5 described above,
which stores an augmented set of device and derived reference
measures sets 210 and quality of life and symptom measures sets 211
recorded and determined during the initial observation period.
Other forms of database organization are feasible.
[0131] Finally, simultaneous notifications can also be delivered to
the patient's physician, hospital, or emergency medical services
provider 209 using feedback means similar to that used to notify
the patient. As described above, the feedback could be by
electronic mail or by automated voice mail or facsimile. The
feedback can also include normalized voice feedback, such as
described in U.S. Pat. No. 6,261,230, the disclosure of which is
incorporated herein by reference.
[0132] FIG. 13 is a block diagram showing the analysis module 53 of
the server system 16 of FIGS. 12A and 12B. The peer collected
measures sets 60 and sibling collected measures sets 61 can be
organized into site specific groupings based on the sensor from
which they originate, that is, implantable medical device 202,
external medical device 203, or multiple sensors 204a, 204b. The
functionality of the analysis module 53 is augmented to iterate
through a plurality of site specific measures sets 215 and one or
more disorders.
[0133] As described above, as an adjunct to remote patient care
through the monitoring of measured physiological data via
implantable medical device 202, external medical device 203 and
multiple sensors 204a, 204b, quality of life and symptom measures
sets 208 can also be stored in the database 17 as part of the
monitoring sets 206. A quality of life measure is a
semi-quantitative self-assessment of an individual patient's
physical and emotional well-being and a record of symptoms, such as
provided by the Duke Activities Status Indicator. These scoring
systems can be provided for use by the patient 11 on the personal
computer 18 (shown in FIG. 1) to record his or her quality of life
scores for both initial and periodic download to the server system
16.
[0134] FIG. 14 is a database schema which augments the database
schema described above with reference to FIG. 6 and showing, by way
of example, the organization of a quality of life and symptom
measures set record 220 for care of patients stored as part of a
patient care record 205 in the database 17 of the system 200 of
FIGS. 12A and 12B. The following exemplary information is recorded
for a patient: overall health wellness 221, psychological state
222, chest discomfort 223, location of chest discomfort 224,
palpitations 225, shortness of breath 226, exercise tolerance 227,
cough 228, sputum production 229, sputum color 230, energy level
231, syncope 232, near syncope 233, nausea 234, diaphoresis 235,
time of day 91, and other quality of life and symptom measures as
would be known to one skilled in the art.
[0135] Other types of quality of life and symptom measures are
possible, such as those indicated by responses to the Minnesota
Living with Heart Failure Questionnaire described in E. Braunwald,
ed., "Heart Disease--A Textbook of Cardiovascular Medicine," pp.
452-454, W.B. Saunders Co. (1997), the disclosure of which is
incorporated herein by reference. Similarly, functional
classifications based on the relationship between symptoms and the
amount of effort required to provoke them can serve as quality of
life and symptom measures, such as the New York Heart Association
(NYHA) classifications I, II, III and IV, also described in
Ibid.
[0136] The patient may also add non-device quantitative measures,
such as the six-minute walk distance, as complementary data to the
device and derived measures sets 207 and the symptoms during the
six-minute walk to quality of life and symptom measures sets
208.
[0137] FIG. 15 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 200 of FIGS. 12A and 12B. Three patient care records
are again shown for Patient 1, Patient 2, and Patient 3 with each
of these records containing site specific measures sets 215,
grouped as follows. First, the patient care record for Patient 1
includes three site specific measures sets A, B and C,
corresponding to three sites on Patient 1's body. Similarly, the
patient care record for Patient 2 includes two site specific
measures sets A and B, corresponding to two sites, both of which
are in the same relative positions on Patient 2's body as the sites
for Patient 1. Finally, the patient care record for Patient 3
includes two site specific measures sets A and D, also
corresponding to two medical device sensors, only one of which,
Site A, is in the same relative position as Site A for Patient 1
and Patient 2.
[0138] The analysis module 53 (shown in FIG. 13) performs two
further forms of comparison in addition to comparing the individual
measures for a given patient to other individual measures for that
same patient or to other individual measures for a group of other
patients sharing the same disease-specific characteristics or to
the patient population in general. First, the individual measures
corresponding to each body site for an individual patient can be
compared to other individual measures for that same patient, a peer
group or a general patient population. Again, these comparisons
might be peer-to-peer measures projected over time, for instance,
comparing measures for each site, A, B and C, for Patient 1,
X.sub.n.sub..sub.A, X.sub.n'.sub..sub.A, X.sub.n".sub..sub.A,
X.sub.n-1.sub..sub.A, X.sub.n-1'.sub..sub.A, X.sub.n-1".sub..sub.A,
X.sub.n-2.sub..sub.A, X.sub.n-2'.sub..sub.A, X.sub.n-2".sub..sub.A
. . . X.sub.0.sub..sub.A, X.sub.0'.sub..sub.A, X.sub.0".sub..sub.A;
X.sub.n.sub..sub.B, X.sub.n'.sub..sub.B, X.sub.n".sub..sub.B,
X.sub.n-1.sub..sub.B, X.sub.n-1'.sub..sub.B, X.sub.n-1".sub..sub.B,
X.sub.n-2.sub..sub.B, X.sub.n-2'.sub..sub.B, X.sub.n-2".sub..sub.B
. . . X.sub.0.sub..sub.B, X.sub.0'.sub..sub.B, X.sub.0".sub..sub.B;
X.sub.n.sub..sub.c, X.sub.n'.sub..sub.c, X.sub.n".sub..sub.c,
X.sub.n-1.sub..sub.c, X.sub.n-1'.sub..sub.c, X.sub.n-1".sub..sub.c,
X.sub.n-2.sub..sub.c, X.sub.n-2'.sub..sub.c, X.sub.n-2".sub..sub.c
. . . X.sub.0.sub..sub.c, X.sub.0'.sub..sub.c, X.sub.0".sub..sub.c;
comparing comparable measures for Site A for the three patients,
X.sub.n.sub..sub.A, X.sub.n'.sub..sub.A, X.sub.n".sub..sub.A,
X.sub.n-1.sub..sub.A, X.sub.n-1'.sub..sub.A, X.sub.n-1".sub..sub.A,
X.sub.n-2.sub..sub.A, X.sub.n-2'.sub..sub.A, X.sub.n-2".sub..sub.A
. . . X.sub.0.sub..sub.A, X.sub.0'.sub..sub.A, X.sub.0".sub..sub.A;
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, comparing comparable
measures for Site A for the three patients, X.sub.n.sub..sub.A,
X.sub.n'.sub..sub.A, X.sub.n".sub..sub.A, Y.sub.n.sub..sub.A,
Y.sub.n'.sub..sub.A, Y.sub.n".sub..sub.A, and Z.sub.n.sub..sub.A,
Z.sub.n'.sub..sub.A, Z.sub.n".sub..sub.A, or comparing those same
comparable measures for Site A projected over time, for instance,
X.sub.n.sub..sub.A, X.sub.n'.sub..sub.A, X.sub.n".sub..sub.A,
Y.sub.n.sub..sub.A, Y.sub.n'.sub..sub.A, Y.sub.n".sub..sub.A,
Z.sub.n.sub..sub.A, Z.sub.n'.sub..sub.A, Z.sub.n".sub..sub.A,
X.sub.n-1.sub..sub.A, X.sub.n-1'.sub..sub.A, X.sub.n-1".sub..sub.A,
Y.sub.n-1.sub..sub.A, Y.sub.n-1'.sub..sub.A, Y.sub.n-1".sub..sub.A,
Z.sub.n-1.sub..sub.A, Z.sub.n-1'.sub..sub.A, Z.sub.n-1".sub..sub.A,
X.sub.n-2.sub..sub.A, X.sub.n-2'.sub..sub.A, X.sub.n-2".sub..sub.A
Y.sub.n-2.sub..sub.A, Y.sub.n-2'.sub..sub.A, Y.sub.n-2".sub..sub.A
Z.sub.n-2.sub..sub.A, Z.sub.n-2'.sub..sub.A, Z.sub.n-2".sub..sub.A
. . . X.sub.0.sub..sub.A, X.sub.0'.sub..sub.A, X.sub.0".sub..sub.A,
Y.sub.0.sub..sub.A, Y.sub.0'.sub..sub.A, Y.sub.0".sub..sub.A, and
Z.sub.0.sub..sub.A, Z.sub.0'.sub..sub.A, Z.sub.0".sub..sub.A, Other
forms of site-specific comparisons, including comparisons between
individual measures from non-comparable sites between patients, are
feasible.
[0139] Second, the individual measures can be compared on a
disorder specific basis. The individual measures stored in each
cardiac patient record can be logically grouped into measures
relating to specific disorders and diseases, for instance,
congestive heart failure, myocardial infarction, respiratory
distress, and atrial fibrillation. The foregoing comparison
operations performed by the analysis module 53 are further
described below with reference to FIGS. 17A-17D.
[0140] FIG. 16 is a Venn diagram showing, by way of example, peer
group overlap between the partial patient care records 205 of FIG.
15. Each patient care record 205 includes characteristics data 250,
251, 252, including personal traits, demographics, medical history,
and related personal data, for patients 1, 2 and 3, respectively.
For example, the characteristics data 250 for patient 1 might
include personal traits which include gender and age, such as male
and an age between 40-45; a demographic of resident of New York
City; and a medical history consisting of anterior myocardial
infraction, congestive heart failure and diabetes. Similarly, the
characteristics data 251 for patient 2 might include identical
personal traits, thereby resulting in partial overlap 253 of
characteristics data 250 and 251. Similar characteristics overlap
254, 255, 256 can exist between each respective patient. The
overall patient population 257 would include the universe of all
characteristics data. As the monitoring population grows, the
number of patients with personal traits matching those of the
monitored patient will grow, increasing the value of peer group
referencing. Large peer groups, well matched across all monitored
measures, will result in a well known natural history of disease
and will allow for more accurate prediction of the clinical course
of the patient being monitored. If the population of patients is
relatively small, only some traits 256 will be uniformly present in
any particular peer group. Eventually, peer groups, for instance,
composed of 100 or more patients each, would evolve under
conditions in which there would be complete overlap of
substantially all salient data, thereby forming a powerful core
reference group for any new patient being monitored.
[0141] FIGS. 17A-17D are flow diagrams showing a method for
determining a reference baseline of individual patient status for
use in an automated collection and analysis patient care system 260
in accordance with a further embodiment of the present invention.
As with the method 140 of FIGS. 8A-8C, this method is also
implemented as a conventional computer program and performs the
same set of steps as described with reference to FIGS. 8A-8C with
the following additional functionality. As before, the method 260
operates in two phases: collection and processing of an initial
reference baseline 209 (blocks 261-149) and monitoring using the
reference baseline 209 (blocks 268-158). Thus, the patient care
records are organized in the database 17 with a unique patient care
record assigned to each individual patient (block 261).
[0142] Next, the reference baseline 209 is determined, as follows.
First, the implantable medical device 202, external medical device
203, or the multiple sensors 204a, 204b record the initially
collected device measures set 57 during the initial observation
period (block 262), as described above with reference to FIG. 5.
The initially collected device measures set 57 is retrieved from
the medical device (block 263) and sent over the internetwork 15 or
similar communications link (block 264) and periodically received
by the server system 16 (block 265). The initially collected device
measures set 57 is stored into a patient care record in the
database 17 for the individual patient 11 (block 266) and processed
into the reference baseline 209 (block 147) which stores a
reference measures set 59, as described above with reference to
FIG. 9. If the quality of life and symptom measures sets 211 are
included as part of the reference baseline 209 (block 267), the
quality of life and symptom measures sets 211 are processed (block
149), as described above with reference to FIG. 10. Otherwise, the
processing of quality of life and symptom measures is skipped
(block 267).
[0143] Monitoring using the reference baseline 209 involves two
iterative processing loops. The individual measures for each site
are iteratively obtained in the first processing loop (blocks
268-273) and each disorder is iteratively analyzed in the second
processing loop (blocks 274-278). Other forms of flow control are
feasible, including recursive processing.
[0144] During each iteration of the first processing loop (blocks
268-273), the subsequently collected measures sets for an
individual patient are retrieved from the medical device or sensor
located at the current site (block 269) 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 270) and periodically received by the server system 16
(block 271). The collected measures sets are stored into the
patient care record 205 in the database 17 for that individual
patient (block 272).
[0145] During each iteration of the second processing loop (blocks
274-278), each of the subsequently collected device measures sets
58 are compared to the reference measures in the reference baseline
209 (block 275). If the subsequently collected device measures sets
58 are substantially non-conforming (block 276), the patient care
record is identified (block 277). Otherwise, monitoring continues
as before for each disorder. In addition, the measures sets can be
further evaluated and matched to diagnose specific medical
disorders, such as congestive heart failure, myocardial infarction,
respiratory distress, and atrial fibrillation, as described in U.S.
Pat. No. 6,336,903; U.S. Pat. No. 6,368,284; U.S. Pat. No.
6,398,728; and U.S. Pat. No. 6,411,840, the disclosures of which
are incorporated herein by reference. In addition, multiple
near-simultaneous disorders can be ordered and prioritized as part
of the patient status indicator as described in U.S. Pat. No.
6,440,066, the disclosure of which is incorporated herein by
reference.
[0146] Finally, if the time for a periodic reassessment has arrived
or the subsequently collected device measures sets 58 are
substantially non-conforming (block 279), the reference baseline
209 is reassessed (block 158) and a new reference baseline 209
determined, as described above with reference to FIG. 11.
[0147] The determination of a reference baseline consisting of
reference measures makes possible improved and more accurate
treatment methodologies based on an algorithmic analysis of the
subsequently collected data sets. Each successive introduction of a
new collected device measures set into the database server would
help to continually improve the accuracy and effectiveness of the
algorithms used.
[0148] 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.
* * * * *