WO2000070508A1

WO2000070508A1 - Disease management and exercise rehabilitation system

Info

Publication number: WO2000070508A1
Application number: PCT/AU2000/000447
Authority: WO
Inventors: Andrew Loch; James Edward Fitzgerald; Kim Norman Barnett; Bruce Richard Satchwell
Original assignee: Micromedical Industries Limited
Priority date: 1999-05-14
Filing date: 2000-05-15
Publication date: 2000-11-23
Also published as: AUPQ037599A0

Abstract

A portable physiological data acquisition, storage, display and communications device (11) adapted to provide patient specific, physician prescribed information as well as to provide real-time logging of objective clinical data on physical activity along with patient entered details on symptoms, signs and other influences on exercise performance, thereby to extend the influence of the physician into the patient's home environment and extend the physician's source of physiological data into the patient's home environment.

Description

Disease Management and Exercise Rehabilitation System

The present invention relates to a disease management and exercise rehabilitation system for a patient and, more particularly, to such a system adapted to provide continuity of care between a clinician and a patient undergoing rehabilitation for a specified condition. In particular, although not exclusively, the condition is a cardiac event.

BACKGROUND Heretofore, in the particular case of rehabilitation of patients following a cardiac event (such as a "heart attack') it has been known to provide the patient with an exercise regime in order to gradually, and in predefined steps, improve the patient's ability to tolerate cardiac stress. One such regime is described in Australian Patent 674188 to Geoffrey James Cornish, the disclosure of which is incorporated into this specification by cross reference.

The arrangement of Australian Patent 674188 includes the provision of a timing device to the patient which is adapted to communicate with the patient by means of an audible sound or otherwise when a predetermined time has passed since commencement of the exercise regime in order for the patient to determine whether the patient is following the regime at the correct rate . This arrangement, whilst helpful, does not allow, for example, the collection of information from the patient during the exercise regime m order to facilitate communication with the clinician responsible for the well being and cardiac rehabilitation of the patient.

Without such communication there is always the danger that the regime which the patient follows is not the regime desired by the clinician. There is also the danger that, even if the patient is following the regime set down by the clinician, that the regime is too stressful for the patient (with potentially serious consequences) and yet the only way of communicating undue stress from the patient to the clinician is by means of a second hand report some time after the exercise regime has been completed and then only by the patient and if the patient remembers.

It is an object of the present invention to overcome or at least ameliorate one or more of the abovementioned disadvantages .

BRIEF DESCRIPTION OF INVENTION

Accordingly, m one broad form of the invention there is provided a Disease Management and Exercise Rehabilitation System for a patient comprising A. a portable physiological data acquisition, storage, display and communications device; said device adapted to be in communication with: a. a patient physiological data acquisition transducer; b. said patient by means of patient communication means; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation regime,

B. a first database located at a first location and including : a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means; thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first database.

C. a second database located at a second location and including : a. background physiological data storage means, and b. background physiological data display means, thereby to provide said patient with a third category of information.

Preferably said patient physiological data acquisition transducer comprises an ECG transducer.

Preferably said patient communication means comprises a visual display. Preferably said patient input means comprises at least one patient operable switch operable so as to indicate a change in state between a first state and at least a second state to said portable physiological data acquisition, storage, display and communications device. Preferably said physiological data storage means comprises a mass storage device of a personal computer.

Preferably said physiological data interpretation means comprises said personal computer.

Preferably said physiological data and physiological information display means comprises a visual display unit of said personal computer.

Preferably said background physiological data storage means comprises a CD ROM or equivalent mass storage media. Preferably said background physiological data display means comprises a visual display unit of a second personal computer which is in communication with said background physiological data storage means . In a further broad form of the invention there is provided a Disease Management and Exercise Rehabilitation System for a patient comprising

A. a portable physiological data acquisition, storage, display and communications device; said device adapted to be in communication with: a. a patient physiological data acquisition transducer; b. said patient by means of patient communication means ; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation regime,

B. a first data base located at a first location and including : a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means; thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first data base.

C. a second database located at a second location and including : a. background physiological data storage means, and b. background physiological data display means. thereby to provide said patient with a third category of information. In yet a further broad form of the invention there is provided a Disease Management and Exercise Rehabilitation System for a patient comprising

A. A portable physiological data acquisition, storage, display and communications device; said device adapted to be in communication with: a. A patient physiological data acquisition transducer; b. said patient by means of patient communication means ; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation machine. B. A first database located at a first location and including: a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means; thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first database. C. A second database located at a second location and including : a. background physiological data storage means, and b. background physiological data display means. thereby to provide said patient with a third category of information. In yet a further broad form of the invention there is provided a method of executing an exercise regime with reduced health care professional -patient interaction. In yet a further broad form of the invention there is provided a portable physiological data acquisition, storage, display and communications device adapted to provide patient specific, physician prescribed information as well as provide real-time logging of objective clinical data on physical activity along with patient entered details on symptoms, signs and other influences on exercise performance, thereby to extend the influence of the physician into the patient's home environment and extend the physician's source of physiological data into the patient's home environment.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments of the invention will now be described with reference to the accompanying drawings wherein: Fig. 1 is an indicative block diagram of a physiological rehabilitation system according to a first embodiment of the invention,

Fig. 2 is a front view of the casing of a portable physiological data acquisition, storage, display and communications device useable with the system of Fig. 1,

Fig. 3 is an electrical block diagram of the functional components of the portable physiological data acquisition, storage, display and communications device of Fig. 2, Fig. 4 illustrates three possible display modes for a data display of the device of Fig. 2,

Fig. 5 is a logic flow diagram responsive to patient input for the device of Fig. 2, Fig. 6 is a VDU display derivable from a first database forming part of the system of Fig. 1,

Fig. 7 is a VDU display from a first database forming part of the system of Fig. 1,

Fig. 8 is a VDU display from a first database forming part of the system of Fig. 1,

Fig. 9 is a VDU display from a first database forming part of the system of Fig. 1,

Fig. 10 is a VDU display from a first database forming part of the system of Fig. 1, Fig. 11 is a VDU display from a first database forming part of the system of Fig. 1, and

Fig. 12 is a VDU display from a first database forming part of the system of Fig. 1.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to Fig. 1 there is shown a physiological rehabilitation system 10 according to a first embodiment of the invention comprising at least a first component in the form of a portable physiological data acquisition, storage, display and communications device 11 adapted to be, at least at predetermined times, m communication with a first database 12 located at a clinician's or health care provider's premises. In a particular form a second database 13 is locatable at the premises of a patient who is under the care of the clinician or health care provider.

The portable physiological data acquisition, storage, display and communications device 11 can be implemented, in one form, m accordance with the circuit diagram of Fig. 3 and can have an operational interface of the form illustrated in Fig. 2. The function of the communications device 12 requires that it be m communication with a patient physiological data acquisition transducer, in this case an ECG data acquisition transducer for input via ECG front end 14 to microcontroller 15.

The communications device 11 also requires for its functionality that it can communicate information to a patient by patient communication means which, in this instance, takes the form of an LCD display 16 which receives and displays data derived from the microcontroller 15.

In addition, also required for its functionality of the communications device 11 is patient input means whereby a patient can input data to the microcontroller 15, and wherein, in this instance, the patient input means comprises primarily first, second, chird and fourth push buttons 17, 18, 19, 20 respectively.

The combination of the patient physiological data acquisition transducer, the patient communications means and the patient input means results in a device which assists a patient to execute an exercise prescription with minimal staff-patient interaction whilst permitting efficient management of patient progression and ensuring compliance of the treatment regimen away from the physician's (or other health care provider's) office.

With reference to Fig. 2 push button 17 has a primary function of turning power on and off in a toggle manner. A first push of the push button 17 will turn the power on. A subsequent push will turn the power off. Push button 18 is utilised as an "event" button and is utilised as the primary patient input means by which the patient can signal a significant event directly to the device 11. As to the precise event and its significance this will depend upon the mode of operation of the device 11 at the time, as to be described in greater detail elsewhere in this specification. If, for example, the device 11 is operating in ECG monitor mode and, during exercise, the patient feels unusual or concerned the patient can depress the "event" button 18 and that portion of the ECG way form being recorded at that time will be marked so that it can be drawn to the attention of a health care provider during subsequent analysis .

The "up" button 19 and "down" button 20 can be utilised to toggle or step between different modes of operation of the device 11.

The "multifunction" buttons 21, 22 are utilised in association with indicia appearing upon the LCD display 16 and forming, in this instance, a primary form of patient communication means.

Typically, in use indicia will appear on display 16 at a location immediately above the respective function buttons 21, 22. The respective indicia 23, 24 will indicate the intended function to be performed, from time to time, by actuation of the respective buttons 21, 22. These multifunction buttons 21, 22 represent important secondary forms of patient input means to the device 11.

With particular reference to Fig. 3 physiological data acquisition into microcontroller 15 can also be effected by connection through a universal communications port line driver which takes the form, in this instance of an RS232 line driver (such as, for example, MAX 3221 or MAX 3222) . The line driver/receiver 25 can connect, for example, to a universal ECG interface device such as is described in co- - Im ¬

pending International Patent Application PCT/AU98/00014 to Micromedical Industries Limited, the disclosure of which is incorporated herein by cross-reference. Mechanical connection is made via connector 26. In addition the line driver/receiver 25 can also be utilised for connection to other communication devices and including a personal computer (not shown) whereby data acquired by microcontroller 15 and stored m memory 27 can be downloaded to the personal computer for subsequent analysis by a physiological data analysis program such as, for example, described m International Patent Application PCT/AU97/00821 to Micromedical Industries Limited, the disclosure of which is incorporated herein by cross reference. W th reference to Fig. 1 the personal computer can be located at a second location 28 to which the device 11 has been transported from its first location 29 and can, more particularly, be a personal computer 30 located at a health care provider's premises and which is loaded with software which allows it to act as a first data base 12. Analysis of data thus obtained from device 11 may be analysed and represented as a video output 31 as exemplified m the displays of Figs. 6 through to Fig. 12. These outputs will be described in greater detail elsewhere m this specification. Additional components comprising the portable physiological data acquisition, storage, display and communications device 11 include a power supply 32 (for example MAX 757 or MAX 778/ , random access memory m the form of memory 27 which can take the form of, for example, static RAM. Further components can include an audio output device such as speaker 33 and support devices including real time clock 34 (which can be, for example, a Seiko S-3520CF) and an external clock oscillator with counter 35 which can provide the main system clock to microcontroller 15 and sampling interrupts (for example a type 74HC4060) . The microcontroller 15, itself, can be a Hitachi H8/3337FY type device which includes an 8 bit CPU, 60KB of flash memory, 2KB of RAM, 3 timers, some 10 bit A/D converters, 2 UARTs, 1 synchronal serial bus, a non-multiplexed address/data bus interface, a watchdog timer, a PWM output and a reasonable quantity of general purpose input/output lines.

Functionally the device 11 has the microcontroller 15 programmed to achieve at least the following functions: 1. Provide doctor prescribed exercise protocols (output via LCD display 16) ; 2. Monitor exercise ECG and heart rate information (via either ECG front end 14 or the line driver/receiver 25) ; 3. Log essential data on daily exercise performance, regimen compliance, symptom variation and trends

(stored m memory 27) ;

4. Capture abnormal cardiac rhythm (either via comparison with pre-stored "normal" rhythms in the manner described m applicant's co-pending European Patent Application No. 93907648.5, the disclosure of which is incorporated herein by cross-reference) or via patient actuation of event button 18 upon the occurrence, during exercise or other monitored activity, of what the patient perceives to be an abnormal feelmg/situation.

5. Download data to a first data base 12 at a first location (typically at the healthcare provider's premises) via the universal input/output form in the form of line driver/receiver port 25. Sufficient memory is incorporated into device 11 to permit at least the following functions:

1. Record up to one hour of a single lead ECG; 2. Record up to 30 minutes of a six lead ECG;

3. Monitor heart rates via direct chest application or using dry electrodes; 4. Records 2 minute "event" ECGs - 1 minute per event, 1 minute post event ECG, storing up to 8 ECG event recordings ;

5. Recording an abnormal ECG symptom, "straddling" it for 2 minutes whenever the event button 18 is pressed, 8 such events capable of being stored;

6. Transtelephonic transfer or recordings (for example as per the mechanisms described in applicant's co- pending International Application PCT/AU97/00821, the disclosure of which is incorporated herein by cross-reference . By way of non-limiting example the device 11, in use, may be operated as follows :

As outlined with reference to Fig. 4 the device 11 is turned on by pressing button 17 following which the screen displays as indicated in Fig. 4 with the title screen 36 being displayed for 2 seconds followed by any reminders screen 37 requiring attendance followed by the default time and date screen 38. If patient cables are connected via front end 14 then the ECG screen will be displayed (allowing display of ECG way forms of the type illustrated in Fig. 12) .

To access the main menu a user presses the left multifunction button which has immediately above it indicia 23 reading, in this instance "menu" . In the default mode the indicia position 24 remains blank.

With reference to Fig. 5 the various user menus available comprising menus 39a, 39b, 39c, 39d, 39e, 39f, 39g, 39i.

Prior to starting an exercise regime (as previously prescribed by the health care provider) the patient steps through the screens by depressing the left multifunction button 21 and selecting the "start exercise" option of Fig. 39b.

The patient then inputs his/her weight at screen 39c, then blood pressure at screen 39d and then provides requested data entry regarding medication change and any symptoms at screens 39e and 39f following which the patient is ready to begin the exercise regime at screen 39g. Progression forward through the screens is performed by depressing the left multifunction button 18 to achieve "next" as indicated by the left most indicia 23 in display 16 as opposed to depressing the right most multifunction button 22 to go "back" as indicated by the right most indicia 24 in display 16.

Once the patient initiates "begin" screen 39i is displayed giving an indication of heart rate, speed and distance travelled. As previously described, during the exercise regime, any unusual feelings or similar can be marked by the patient by pressing the event button 18.

All of the data obtained during an exercise session and as input by the patient before or during the session is retained m memory 27 for subsequent communication to first data base 12 at first location 28 for subsequent analysis, feedback and, if appropriate, revision of the programming of the device 11.

It will be observed that the device 11 includes the following relevant features :

• on-the-spot information for the patient, as required or appropriate, on their exercise prescription & everyday health endeavours such as medication regimen, appointment reminders, etc. via the splash screen.

• Acquisition of objective date on daily exercise performance, regimen compliance, symptom variation and trends. The patient directly enters and downloads data to the management clinic. Capturing and downloading data m this manner contains otherwise expensive labour intensive costs on behalf of the health professional involved. This feature can reduce carers travelling time whilst delivering improved objective clinical data to improve outcomes . • Immediate feedback to the patient on performance relative to health targets. The patient is more informed and hence more compliant.

• Patient ownership of a continuing record of accomplishments for their Live-every-day program and better health future. Feedback encourages and motivates the patient to participate regularly to improve or maintain their current health status.

• Connectively for transmitting the patient's data entries into relevant records & reports of treating personnel.

Utilisation of today' s technology provides time efficient delivery of critical information to the health professional overseeing the management of a patient's care. Reports provide the physician changes to medications since the last visit .

• Compliance m treatment regime. This feature eliminates inefficient use of the physician's time and enhances the quality of the consult with the patient .

• The program manager is alerted when a patient is beyond the prescribed boundaries. Patients are followed up in order of clinical priority. Continuity m care is therefore networked within the system. With reference to Figs. 6-12 it will be observed that the first data base 12 has the ability to store the patient records of a plurality of patients (Fig. 6), to add records for new patients (Fig. 7) and, for each patient to store and display relevant data for each patient obtained from usage of the device 11 and subsequently downloaded to the first data base 12 on personal computer 30 and including:

• graphs of heart rate against time (Fig. 8) ;

• graphs of heart rate statistics for each exercise session (Fig. 9, Fig. 10, Fig. 11); and

• ECG way forms for each patient (Fig. 12) .

In addition the first database 12 can include rehabilitation management software and cardiac outcome measurement, evaluation and tracking software thereby to provide the following features:

• Direct download of exercise performance data.

• Automated generation of reports for the clinician.

• Review of patient's EKG, related activities and symptomatology.

• Assessing patient compliance to prescribed treatment regimen. • Comparison of health, clinical, behavioural and economic outcomes, satisfaction, demographic and core data evaluation.

• Provision of benchmarking facilities for measurement of both individual and program accomplishments.

• Cumulative and collective data base.

At a second location 40, usually being the patient's home, a further personal computer 41 can be loaded with a second data base, in its simplest form derived from data contained on a CD-ROM 42, the second data base 13.

The patient's learning commences with counselling by the physician or allied health professional followed by their first session on the Leda CD-ROM media. There is a clear ordering of Leda text by subject. A text item can be as short as a paragraph or as long as three pages. Leda text is richly cross-referenced. Menus on the screen provide pointers to additional areas containing further or linked information if required. Headers, footers and pop-up notes enrich the text. A glossary assists with the meanings of medical and exercise terminology. Text items can be bookmarked for future recall .

The second database content is specific by the patient's clinical status and risk profile. The patient can easily navigate through the system according to their individualised needs. The patient, or a member of the physician's staff, can print any item, section or part. The patient keeps what they want as part of their personal Leda heart health record. All patient text is written at a 6-7 level grade.

The above describes some embodiments of the present invention and modifications, obvious to those skilled in the art, can be made thereto without departing from the scope and spirit of the present invention.

Substitute Sheet (Rule 26) ROAU

Claims

1. A Physiological Rehabilitation System for a patient comprising

A. a portable physiological data acquisition, storage, display and communications device; said device adapted to be m communication with: a. a patient physiological data acquisition transducer; b. said patient by means of patient communication means ; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation regime, B. a first database located at a first location and including : a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means;

thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first database. C. a second database located at a second location and including : a. background physiological data storage means, and b. background physiological data display means, thereby to provide said patient with a third category of information.

2. The system of Claim 1 wherein said patient physiological data acquisition transducer comprises an ECG transducer.

3. The system of Claim 1 wherein said patient communication means comprises a visual display.

4. The system of Claim 1 wherein said patient input means comprises at least one patient operable switch operable so as to indicate a change in state between a first state and at least a second state to said portable physiological data acquisition, storage, display and communications device.

5. The system of Claim 1 wherein said physiological data storage means comprises a mass storage device of a personal computer.

6. The system of Claim 1 wherein said physiological data interpretation means comprises said personal computer.

7. The system of Claim 1 wherein said physiological data and physiological information display means comprises a visual display unit of said personal computer.

8. The system of Claim 1 wherein said background physiological data storage means comprises a CD ROM or equivalent mass storage media.

9. The system of Claim 1 wherein said background physiological data display means comprises a visual display unit of a second personal computer which is in communication with said background physiological data storage means .

10. A Physiological Rehabilitation System for a patient comprising

A. a portable physiological data acquisition, storage, display and communications device; said device adapted to be in communication with: a. a patient physiological data acquisition transducer; b. said patient by means of patient communication means ; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation regime, B. a first data base located at a first location and including : a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means; thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first data base.

C. a second database located at a second location and includin : a. background physiological data storage means, and b. background physiological data display means, thereby to provide said patient with a third category of information.

11. A Physiological Rehabilitation System for a patient comprising

A. A portable physiological data acquisition, storage, display and communications device; said device adapted to be in communication with: a. A patient physiological data acquisition transducer; b. said patient by means of patient communication means; c. patient input means thereby to provide a patient with a first category of information directly during execution of a physiological rehabilitation machine. B. A first database located at a first location and including: a. physiological data storage means; b. physiological data interpretation means; c. physiological data and physiological information display means; thereby to provide a clinician with a second category of information following communication between said portable physiological data acquisition, storage, display and communications device and said first database . C. A second database located at a second location and including : a. background physiological data storage means, and b. background physiological data display means. thereby to provide said patient with a third category of information.

12. A method of executing an exercise regime with reduced health care professional-patient interaction.

13. A portable physiological data acquisition, storage, display and communications device adapted to provide patient specific, physician prescribed information as well as provide real-time logging of objective clinical data on physical activity along with patient entered details on symptoms, signs and other influences on exercise performance, thereby to extend the influence of the physician into the patient's home environment and extend the physician's source of physiological data into the patient's home environment.