System and method for generating external counterpulsation reports

• US 6,858,012 B2
• Filed: 03/28/2003
• Issued: 02/22/2005
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: Renew Group Private Limited
• Original Assignee: Applied Cardiac Systems, Inc.
• Inventors: Manera, Alexandria, Burns, Kenneth L., Manera, Loren A.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/401,638
• Publication Number:
  US 20030216651A1
• Time in Patent Office: 697 Days
• Field of Search: 600/481, 600/483, 600/485, 600/490, 600492-496, 600/300, 600/301, 600500-502, 600/506, 600/508, 600/509, 600/513, 600/515, 601/152, 606/201, 606/202
• US Class Current: 600/483
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system for performing ECP and recording ECP system data, patient cardiac parameter data, and other data, and presenting the data in displays that are accessible to the operator in formats that assist in consistent treatment, interpretation of treatment data, and confirmation of therapeutic effect.

Claims

1. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patient'"'"'s blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data and ECP system parameters applicable to the patient;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and ECP system parameters of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control system'"'"'s operation of the inflation system in the trace data fields;

presenting substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to the entirety of a treatment session in the trace data fields in the second display;

wherein

the control system is further programmed to calculate a utilization percentage corresponding to the percentage of available compression time during which the system inflates the bladders and present the utilization percentage within the first display.

3. The system of claim 1 or 2 wherein the control system is further programmed to display a cursor in relationship to the trace data field and interpret operator manipulation of the cursor as input as to desired small time periods represented within the trace data field, and thereafter present a third display comprising an enlarged trace data field covering a time period consisting of the desired small time period.

4. The system of claim 3 wherein the control system is further programmed to present a plurality of cursors in logical proximity to the blood pressure trace, and interpret operator manipulation of the cursors as input as to operator determined systolic blood pressure, augmented diastolic blood pressure, and baseline blood pressure, and thereafter compute an augmentation ratio and display the augmentation ratio with the third display.

5. The system of claim 4 wherein the control system is further programmed to present a third display comprising a multi-session trend field:

and present a graph of augmentation ratio per therapy session.

6. The system of claim 4 wherein the control system is further programmed to present a third display comprising a summary data for multiple sessions, and present a table of augmentation ratio per therapy session.

7. The system of claim 1 or 2 wherein the control system is further programmed to present a plurality of cursors in logical proximity to the blood pressure trace, and interpret operator manipulation of the cursors as input as to operator determined systolic blood pressure, augmented diastolic blood pressure, and baseline blood pressure, and thereafter compute an augmentation ratio and display the augmentation ratio.

8. The system of claim 7 wherein the control system is further programmed to present a third display comprising a multi-session trend field:

and present a graph of augmentation ratio per therapy session.

9. The system of claim 8 wherein the control system is further programmed to present a session selection cursor within the fourth display and permit operator manipulation of the session selection cursor along the graph to locate the session selection cursor in logical relation to the therapy session numbers of the graph, and interpret operator manipulation of session selection cursor as selection of a particular session, and thereafter selectively present the second display or generate a fifth display comprising a graph of a cardiac parameter over time for the selected session.

10. The system of claim 7 wherein the control system is further programmed to present a third display comprising a summary data for multiple sessions, and present a table of augmentation ratio per therapy session.

11. The system of claim 10 wherein the control system is further programmed to present a session selection cursor within the fourth display and permit operator manipulation of the session selection cursor in the table to locate the session selection cursor in logical relation to the therapy session summary data, and interpret operator manipulation of session selection cursor as selection of a particular session, and thereafter selectively present the second display or generate a fifth display comprising a graph of a cardiac parameter over time for the selected session.

12. The system of claim 1 or 2 further comprising:

a central control system remotely locatable relative to the control system;

network means for transmitting cardiac parameters from the control systems to a central control system;

said central control system being operable to view the displays generated by the control system.

2. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patient'"'"'s blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data and ECP system parameters applicable to the patient;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and ECP system parameters of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control system'"'"'s operation of the inflation system in the trace data fields;

presenting substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to the entirety of a treatment session in the trace data fields in the second display;

wherein the control system is further programmed to display substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the second display in multiple display pages, with each display page displaying a portion of the single record; and

the control system is further programmed to calculate a utilization percentage corresponding to the percentage of available compression time during which the system inflates the bladders and present the utilization percentage within the second display.

13. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the legs and buttocks of the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patient'"'"'s blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data including patient identification, size and tightness of bladders applied to the patient, and location of electrodes placed on the patient;

fields for entry of patient reported symptoms of chronic heart disease;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and patient reported symptoms of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control systems operation of the inflation system in the trace data fields;

presenting substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the trace data fields in the second display;

wherein

the control system is further programmed to calculate a utilization percentage corresponding to the percentage of available compression time during which the system inflates the bladders and present the utilization percentage within the first display.

15. The system of claim 13 or 14 wherein the control system is further programmed to display a cursor in relationship to the trace data field and interpret operator manipulation of the cursor as input as to desired small time periods represented within the trace data field, and thereafter present a third display comprising an enlarged trace data field covering a time period consisting of the desired small time period.

16. The system of claim 13 or 14 wherein the control system is further programmed to present a plurality of cursors in logical proximity to the blood pressure trace, and interpret Operator manipulation of the cursors as input as to operator determined systolic blood pressure, augmented diastolic blood pressure, and baseline blood pressure, and thereafter compute an augmentation ratio and display the augmentation ratio.

17. The system of claim 15 wherein the control system is further programmed to present a plurality of cursors in logical proximity to the blood pressure trace, and interpret operator manipulation of the cursors as input as to operator determined systolic blood pressure, augmented diastolic blood pressure, and baseline blood pressure, and thereafter compute an augmentation ratio and display the augmentation ratio with the third display.

18. The system of claim 13 or 14 wherein the control system is further programmed to present a fourth display comprising a summary data for multiple sessions, and present a table of augmentation ratio per therapy session.

19. The system of claim 18 wherein the control system is further programmed to present a session selection cursor within the fourth display and permit operator manipulation of the session selection cursor in the table to locate the session selection cursor in logical relation to the therapy session summary data, and interpret operator manipulation of session selection cursor as selection of a particular session, arid thereafter selectively present the second display or generate a fifth display comprising a graph of a cardiac parameter over time for the selected session.

20. The system of claim 13 or 14 further comprising:

a central control system remotely locatable relative to the control system;

network means for transmitting cardiac parameters from the control systems to a central control system;

said central control system being operable to view the displays generated by the control system.

14. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the legs and buttocks of the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patient'"'"'s blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data including patient identification, size and tightness of bladders applied to the patient, and location of electrodes placed on the patient;

fields for entry of patient reported symptoms of chronic heart disease;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and patient reported symptoms of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control systems operation of the inflation system in the trace data fields;

presenting substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the trace data fields in the second display;

wherein

the control system is further programmed to display substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the second display in multiple display pages, with each display page displaying portion of the single record; and

the control system is further programmed to calculate a utilization percentage corresponding to the percentage of available compression time during which the system inflates the bladders and present the utilization percentage within the second display.

21. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the legs and buttocks of the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patient'"'"'s blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data including patient identification, size and tightness of bladders applied to the patient, and location of electrodes placed on the patient;

fields for entry of patient reported symptoms of chronic heart disease;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and patient reported symptoms of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control systems operation of the inflation system in the trace data fields;

present substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the trace data fields in the second display;

wherein the control system is further programmed to present a plurality of cursors in logical proximity to the blood pressure trace, and interpret operator manipulation of the cursors as input as to operator determined systolic blood pressure, augmented diastolic blood pressure, and baseline blood pressure, and thereafter compute an augmentation ratio and display the augmentation ratio.

22. The system of claim 21 wherein:

the control system is further programmed to display substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the second display in multiple display pages, with each display page displaying portion of the single record.

23. A system for performing multiple sessions of external counterpulsion therapy on a patient and recording and presenting data relative to the therapy to an operator, said system comprising:

one or more inflatable bladders adapted to compress the legs and buttocks of the patient;

and inflation system for inflating the inflatable bladders;

a blood pressure monitoring system operable to continuously detect the patients blood pressure and transmit blood pressure data;

ECG monitoring system operable to continuously detect the patient'"'"'s ECG and transmit ECG data;

a computerized control system operable to control the inflation system, receive and record ECG data from the ECG monitoring system, receive and record data from the blood pressure monitoring system;

said control system programmed to operate the inflation system in response to the ECG data;

wherein the computerized control system is further programmed to;

present a first display comprising;

fields for entry of patient data including patient identification, size and tightness of bladders applied to the patient, and location of electrodes placed on the patient;

fields for entry of patient reported symptoms of chronic heart disease;

wherein for sessions subsequent to an initial session, the display is presented in a form containing values of patient data and patient reported symptoms of a prior session;

record cardiac parameters for substantially the entirety of each treatment session;

present a second display comprising one or more trace data fields and present an ECG trace generated from the ECG data, a blood pressure trace generated from the blood pressure data, and an inflation/deflation data trace corresponding to the control systems operation of the inflation system in the trace data fields;

present substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the trace data fields in the second display;

wherein the control system is further programmed to present a third display comprising a summary data for multiple sessions, and present a table of augmentation ratio per therapy session.

24. The system of claim 23 wherein:

the control system is further programmed to display substantially continuous ECG data, blood pressure data, and inflation/deflation data corresponding to entirety of treatment session in the second display in multiple display pages, with each display page displaying portion of the single record.