Method and system for the selection of cardiac defibrillation shocks based on discomfort

• US 7,142,927 B2
• Filed: 09/04/2002
• Issued: 11/28/2006
• Est. Priority Date: 09/04/2002
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation), UAB Research Foundation (University of Alabama System)
• Original Assignee: UAB Research Foundation (University of Alabama System)
• Inventors: Benser, Michael E., Morris, Milton M., Ideker, Raymond E.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Kramer, Nicole R.
• Application Number:
  US10/234,624
• Publication Number:
  US 20040044370A1
• Time in Patent Office: 1,546 Days
• Field of Search: 607/7, 607/8, 607/63
• US Class Current: 607/63
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

Methods, systems and computer program products for selecting a shock profile for a defibrillator based on patient discomfort to a plurality of different defibrillating shocks include delivering a first defibrillating shock having an associated first shock profile to a patient, and measuring the associated physical displacement of a selected region in the patient. A second defibrillating shock having an associated second shock profile is delivered to the patient, and the associated physical displacement of the selected region in measured. One of the first or second shock profiles is selected based on which shock profile has the lesser amount of measured physical displacement.

Claims

1. A method of selecting a shock profile for a defibrillator based on patient discomfort to a plurality of different defibrillating shocks, comprising:

delivering a first defibrillating shock having an associated first shock profile to a patient;

measuring the physical displacement of a first selected region in the patient associated with the first shock during the first delivering step;

delivering a second defibrillating shock having an associated second shock profile to the patient;

measuring the physical displacement of a second selected region in the patient associated with the second shock during the second delivering step, wherein the second selected region is the same as or different from the first selected region; and

selecting one of the first or second shock profiles based on which shock profile has the lesser amount of associated measured physical displacement.

2. A method according to claim 1, wherein the first and second shock profiles comprise a shock vector and waveform profile.

3. A method according to claim 1, further comprising causing the defibrillator to operate with the selected defibrillating shock profile in position in the patient.

4. A method according to claim 1, wherein the measuring steps further comprises measuring peak thoracic acceleration.

5. A method according to claim 1, wherein the measuring and delivering steps are performed over a plurality of different patients selected to provide a statistically relevant predictive population, and wherein the selecting step is based on a statistically determined lesser amount of measured physical displacement over the population.

6. A method according to claim 1, wherein the measuring, delivering, and selecting steps are individually performed on each patient to establish a customized shock profile for each respective patient to thereby reduce a patient'"'"'s discomfort to administered defibrillating shocks.

7. A method according to claim 1, wherein the measuring steps comprises positioning an externally accessible 3-D accelerometer on the patient at the time of implantation and analyzing the signals generated by the accelerometer to establish the measurements.

8. A method according to claim 1, wherein the defibrillator comprises an accelerometer mounted in the implantable housing, wherein said method further comprises implanting the defibrillator in the patient, and wherein the measuring steps are carried out in vivo while the defibrillator is implanted in the patient.

9. A method according to claim 1, wherein said delivering, measuring, and selecting steps are performed to generate set-up operational parameters at initial implantation.

10. A method according to claim 1, further comprising administering an anesthetic to the patient during the delivering and measuring steps.

11. A method according to claim 1, further comprising assessing whether the selected defibrillating shock is clinically efficacious in terminating fibrillation and converting the cardiac rhythm to return to normal sinus rhythm.

12. A method according to claim 11, further comprising automatically altering the selected defibrillating shock if the shock is determined to be unsuccessful in terminating the fibrillation.

13. A method according to claim 2, wherein the first and second shock profiles differ in at least one of the shock vector and shock pulse waveform.

14. A method according to claim 1, wherein the first and second shock profiles are configured for atrial defibrillation.

15. A method according to claim 1, wherein the first and second shock profiles are configured for treating hemodynamically stable ventricular tachycardia.

16. A computer program product for assessing patient discomfort associated with selected defibrillation shocks, the computer program product comprising:

a computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code that obtains data associated with the physical displacement of the body of a subject in response to administration of a first defibrillation shock having an associated first shock profile;

computer readable program code that obtains data associated with the physical displacement of the body of a subject in response to administration of a second defibrillation shock having an associated second shock profile; and

computer readable program code that compares the data associated with the physical displacements for the first and second shock profiles.

17. A computer program product according to claim 16, further comprising computer readable program code that selects one of the first or second shock profiles based on which shock profile has the lesser amount of measured physical displacement.

18. A computer program product according to claim 16, wherein the first and second shock profiles comprise a shock vector and waveform profile.

19. A computer program product according to claim 17, further comprising computer readable program code that causes the defibrillator to operate with the selected atrial defibrillating shock profile in position in the patient.

20. A computer program product according to claim 16, further comprising computer readable program code that measures peak thoracic acceleration.

21. A computer program product according to claim 17, further comprising computer readable program code that collects the data associated with the physical displacement of the body of a subject in response to defibrillation shocks over a plurality of different patients selected to provide a statistically relevant predictive population, and further comprising computer readable program code that selects a shock profile having a lesser amount of measured physical displacement based on a statistically determined lesser amount of measured physical displacement over the population.

22. A computer program product according to claim 17, further comprising computer readable program code that collects the data associated with the physical displacement of the body of a subject in response to defibrillation shocks individually on each patient to establish a customized shock profile for each respective patient to thereby reduce a patient'"'"'s discomfort to administered defibrillation shocks.

23. A computer program product according to claim 17, wherein the computer readable program code obtains data associated with the physical displacement of the body of a subject by analyzing the signals generated by an externally accessible 3-D accelerometer placed on the patient at the time of implantation.

24. A computer program product according to claim 17, wherein the computer program product is operatively associated with an defibrillator comprising an accelerometer mounted in the implantable housing.

25. A computer program product according to claim 17, further comprising computer readable program code that assesses whether the selected atrial defibrillating shock is clinically efficacious in terminating fibrillation and converting the cardiac rhythm to return to normal sinus rhythm.

26. A computer program product according to claim 17, further comprising computer readable program code that automatically alters the selected defibrillating shock if the shock is determined to be unsuccessful in terminating the fibrillation.

27. A computer program product according to claim 18, wherein the first and second shock profiles differ in at least one of the shock vector and shock pulse waveform.

28. A defibrillator comprising:

an implantable housing;

a power source held in the housing;

a controller held in the housing operatively associated with the power source;

shock generator held in the housing operatively associated with the power source and the controller, the shock generator being configured to deliver a plurality of different selectable shock profiles, each having a respective predetermined shock strength, waveform, and shock vector;

computer readable program code operatively associated with the controller for determining body displacement to estimate patient discomfort during the delivery of selected defibrillating shock profiles; and

computer readable program code operatively associated with the controller and the shock generator for selectively delivering a selected defibrillation shock profile that is associated with a reduced body displacement value for a particular patient to thereby reduce patient discomfort during use of the defibrillator in an individualized manner.

29. A defibrillator according to claim 28, wherein the plurality of shock profiles comprise at least a first shock profile and a second shock profile and wherein the computer readable program code further comprises:

computer readable program code that obtains data associated with the physical displacement of the body of a subject in response to administration of a first defibrillation shock associated with the first shock profile;

computer readable program code that obtains data associated with the physical displacement of the body of a subject in response to administration of a second defibrillation shock associated with the second shock profile; and

computer readable program code that compares the data associated with the physical displacements for the first and second shocks.

30. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that selects one of the first or second shock profiles based on which shock profile has the lesser amount of measured physical displacement.

31. A defibrillator according to claim 28, wherein the plurality of shock profiles comprises a shock vector and waveform profile.

32. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that causes the defibrillator to operate with the selected atrial defibrillating shock profile in position in the patient.

33. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that measures peak thoracic acceleration.

34. A defibrillator according to claim 28, wherein the computer readable program code further comprises:

computer readable program code that collects the data associated with the physical displacement of the body of a subject in response to defibrillation shocks over a plurality of different patients selected to provide a statistically relevant predictive population; and

computer readable program code that selects a shock profile having a lesser amount of measured physical displacement based on a statistically determined lesser amount of measured physical displacement over the population.

35. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that collects the data associated with the physical displacement of the body of a subject in response to defibrillation shocks individually on each patient to establish a customized shock profile for each respective patient to thereby reduce a patient'"'"'s discomfort to administered defibrillation shocks.

36. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that obtains data associated with the physical displacement of the body of a subject by analyzing the signals generated by an externally accessible 3-D accelerometer placed on the patient at the time of implantation.

37. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that assesses whether the selected atrial defibrillating shock is clinically efficacious in terminating fibrillation and converting the cardiac rhythm to return to normal sinus rhythm.

38. A defibrillator according to claim 28, wherein the computer readable program code further comprises computer readable program code that automatically alters the selected defibrillating shock if the shock is determined to be unsuccessful in terminating the fibrillation.

39. A defibrillator according to claim 28, wherein the plurality of shock profiles differ in at least one of the shock vector and shock pulse waveform.

40. A system for analyzing patient discomfort to defibrillation shocks, comprising:

a processor;

means for measuring physical displacement of a selected region a patient during the delivery of an defibrillation shock to estimate patient discomfort;

means for selecting a defibrillation shock pulse for operational output to a patient that provides reduced discomfort based on measured physical displacement data;

means for selecting an defibrillation shock pulse for operational output to a patient that is clinically efficacious and provides reduced discomfort based on measured physical displacement data.

41. A system according to claim 40, wherein the means for measuring physical displacement is an accelerometer.

42. A system according to claim 40, wherein the means for selecting comprises a computer readable program code for comparing the physical displacement associated with a first shock profile and the physical displacement associated with a second shock profile and selecting one of the first or second shock profiles based on which shock profile has the lesser amount of associated measured physical displacement.