Programming system having means for recording and analyzing a patient's cardiac signal

• US 5,421,830 A
• Filed: 08/27/1993
• Issued: 06/06/1995
• Est. Priority Date: 08/27/1993
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Levine, Paul A., Sholder, Jason A., Duncan, James L., Epstein, Andrew E.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/113,540
• Time in Patent Office: 648 Days
• Field of Search: 607/27, 607/28, 607/30, 607/31, 607/32
• US Class Current: 607/30
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A programming system is provided that allows a physician or medical personnel to optimize the settings of various arrhythmia detection criteria and/or parameters related to hemodynamic performance to be programmed into the implanted cardiac stimulating device. The cardiac stimulating device may be a pacemaker or cardioverter/defibrillator that detects heart arrhythmias by using various arrhythmia detection criteria. The cardiac stimulating device is capable of recording the patient'"'"'s cardiac signals and/or sensor data. The programming system may play back the recorded signals to test the detection criteria and hemodynamic performance and may simulate the response of the device to the cardiac signal. Alternatively, the programming system may play back an artificially created or previously stored cardiac signal for test purposes. As a result, the recorded signal may be played back repeatedly without unnecessarily stressing the patient'"'"'s heart. Additionally, the programmer may suggest specific arrhythmia detection criteria and therapies to a physician based on an analysis of a patient'"'"'s arrhythmia.

Claims

1. A programming system for programming and optimizing a plurality of programmed parameters for use in a cardiac stimulating device, the cardiac stimulating device being capable of applying a corresponding therapy to a patient'"'"'s heart based on the plurality of programmed parameters, the programming system comprising:

means for recording a patient'"'"'s cardiac signal for play back;

means for playing back the patient'"'"'s cardiac signal;

means for analyzing the response of the cardiac stimulating device to the played back cardiac signal based on the plurality of parameters, the analyzing means comprising means for determining optimal value for each of the plurality of parameters, wherein;

the plurality of parameters comprises a set of arrhythmia detection criteria;

the cardiac stimulating device is capable of detecting an episode of arrhythmia based on the set of arrhythmia detection criteria; and

wherein

the analyzing means further comprises means for adjusting the value of each parameter in the set of arrhythmia detection criteria until detection of the arrhythmia is optimized; and

means for generating a simulated cardiac signal.

2. The programming system of claim 1, wherein the analyzing means further comprises means for displaying a plurality of recommended values for the plurality of parameters in response to the determining means.

3. The programming system of claim 1, wherein the set of arrhythmia detection criteria comprises at least one of rate, rate stability, sudden onset delta, probability density function, morphology detection, slew rate, a specific number of intervals, signal amplitudes, frequency content and activation sequence.

4. The programming system of claim 1, wherein the recording means comprises means for recording an actual arrhythmia episode of the patient.

5. The programming system of claim 1, wherein the recording means comprises means for recording an induced arrhythmia episode of the patient.

6. The programming system of claim 1, wherein the generating means comprises:

means for selecting cardiac parameters; and

means for producing a simulated cardiac signal based on the cardiac parameters.

7. The programming system of claim 1, further comprising:

means for displaying the cardiac signal; and

means for editing the displayed cardiac signal.

8. The programming system of claim 1, wherein the analyzing means comprises an external cardiac simulating device for receiving the played back cardiac signal.

9. The programming system of claim 1, wherein the analyzing means comprises:

means for receiving the played back cardiac signal; and

means for simulating the response of the cardiac stimulating device to the played back cardiac signal.

10. The programming system of claim 1, wherein:

the recording means includes means for recording a hemodynamic sensor signal coincident with the patient'"'"'s cardiac signal;

the plurality of parameters comprises a set of hemodynamic parameters which cooperate to detect and control cardiac output;

the cardiac stimulating device is capable of detecting the hemodynamic state of the patient based on the set of hemodynamic parameters; and

the analyzing means comprises means for adjusting the value of each parameter in the set of hemodynamic parameters until the patient'"'"'s cardiac output is optimized.

11. The programming system of claim 1, wherein:

the recording means includes means for recording a hemodynamic sensor signal coincident with the patient'"'"'s cardiac signal; and

the analyzing means includes means for determining whether the cardiac signal is physiological or pathological based on the value of the sensor signal.

12. The programming system of claim 1, wherein:

the recording means includes means for recording a physiological sensor signal coincident with the patient'"'"'s cardiac signal;

the plurality of parameters comprises a set of rate-responsive parameters which cooperate to detect and control cardiac output during exercise;

the cardiac stimulating device is capable of detecting the exercise state of the patient based on the set of rate-responsive parameters; and

the analyzing means comprises means for adjusting the value of each parameter in the set of rate-responsive parameters until the patient'"'"'s cardiac output is optimized during exercise.

13. The programming system of claim 12, wherein the rate-responsive parameters comprises at least one of pacing rate, sensor gain, slope, threshold, minimum rate, maximum rate, reaction time, recovery time, A-V delay, and hysteresis.

14. A programming system for optimizing a set of arrhythmia detection criteria for use in a cardiac stimulating device, the cardiac stimulating device being capable of detecting an episode of arrhythmia based on the set of arrhythmia detection criteria, and of applying a corresponding antiarrhythmia therapy to a patient'"'"'s heart, the programming system comprising:

means, within the cardiac stimulating device, for recording a patient'"'"'s cardiac signal;

means for playing back the cardiac signal; and

means for analyzing the response of the cardiac stimulating device to the played back cardiac signal and determining a set of optimized arrhythmia detection criteria, wherein the analyzing means comprises means for adjusting the value of each parameter in the set of arrhythmia detection criteria until detection of the arrhythmia is optimal; and

means for simulating the response of the cardiac stimulating device to the played back cardiac signal.

15. The programming system of claim 14, wherein the set of arrhythmia detection criteria comprises at least one of rate, rate stability, sudden onset delta, probability density function, morphology detection, slew rate, a specific number of intervals, signal amplitudes, frequency content and activation sequence.

16. The programming system of claim 14, further comprising:

means for displaying the cardiac signal; and

means for editing the displayed cardiac signal.

17. The programming system of claim 14, further comprising:

means for producing a default cardiac signal; and

means for displaying the default cardiac signal when desired.

18. The programming system of claim 17, further comprising:

means for selecting cardiac parameters; and

means for producing a simulated cardiac signal based on the cardiac parameters.

19. The programming system of claim 14, wherein the simulating means comprises an external cardiac simulating device having means for receiving the played back cardiac signal.

20. The programming system of claim 14, wherein:

the recording means includes means for receiving a recorded sensor signal coincident with the cardiac signal; and

the analyzing means includes means for determining whether the cardiac signal is physiological or pathological based on the value of the sensor signal.

21. The programming system of claim 14, further comprising:

means for analyzing the cardiac signal; and

means for creating recommended arrhythmia detection criteria responsive to the means for analyzing.

22. A method for optimizing a plurality of programmable parameters for use in a cardiac stimulating device, the cardiac stimulating device being capable of applying a corresponding therapy to a patient'"'"'s heart based on a plurality of programmable parameters selected, the method comprising the steps of:

recording a patient'"'"'s cardiac signal to play back;

playing back the cardiac signal;

analyzing the response of the cardiac stimulating device to the played back cardiac signal based on the plurality of programmable parameters selected;

producing a default cardiac signal; and

displaying the default cardiac signal when desired.

23. The method of claim 22, wherein the plurality of parameters comprises a set of arrhythmia detection criteria and wherein the cardiac stimulating device is capable of detecting an episode of arrhythmia based on the set of arrhythmia detection criteria, wherein the analyzing step comprises the step of:

adjusting the value of each parameter in the set of arrhythmia detection criteria until detection of the arrhythmia is optimal.

24. The method of claim 23, wherein the adjusting step comprises the step of:

adjusting the value of at least one of rate, rate stability, sudden onset delta, probability density function, morphology detection, slew rate, a specific number of intervals, signal amplitudes, frequency content and activation sequence.

25. The method of claim 22, wherein the step of recording comprises the step of:

recording an actual arrhythmia episode of the patient as sensed by a cardiac stimulating device.

26. The method of claim 22, wherein the step of recording comprises the step of:

recording an induced arrhythmia episode from a cardiac stimulating device.

27. The method of claim 22, further comprising the step of editing the cardiac signal.

28. The method of claim 22, further comprising the steps of:

selecting cardiac parameters; and

producing a simulated cardiac signal based on the selected cardiac parameters.

29. The method of claim 22, wherein the step of analyzing comprises the step of transmitting the played back cardiac signal to an external cardiac stimulating device.

30. The method of claim 22, wherein the step of analyzing comprises the steps of:

receiving the played back cardiac signal; and

simulating the response of the cardiac stimulating device to the played back cardiac signal.

31. The method of claim 22, further comprising the steps of:

analyzing the cardiac signal; and

creating recommended arrhythmia detection criteria in response to the analyzing of the cardiac signal.

32. The method of claim 22, wherein the plurality of parameters comprises a set hemodynamic responsive parameters, and wherein the cardiac stimulating device is capable of affecting the patient'"'"'s cardiac output based on the adjustment of the set of hemodynamic responsive parameters, wherein the analyzing step comprises the step of:

adjusting the value of each parameter in the set of hemodynamic responsive parameters until the patient'"'"'s cardiac output is optimized.

33. The method of claim 32, wherein the adjusting step comprises the step of:

adjusting the value of at least one of sensor gain, slope, threshold, minimum rate, maximum rate, reaction time, recovery time, A-V delay, hysteresis, and rate.

34. A method for optimizing a set of arrhythmia detection criteria for use in a cardiac stimulating device, the cardiac stimulating device being capable of detecting an episode of arrhythmia in a patient based on the set of arrhythmia detection criteria, and of applying a corresponding antiarrhythmia therapy to a patient'"'"'s heart, the method comprising the steps of:

recording the episode of arrhythmia as a cardiac signal;

receiving the recorded cardiac signal;

playing back the cardiac signal;

analyzing the response of the cardiac stimulating device to the played back cardiac signal based on the set of arrhythmia detection criteria;

analyzing the cardiac signal; and

creating recommended arrhythmia detection criteria accordingly.

35. The method of claim 34, wherein the analyzing step comprises the step of:

adjusting the value of each parameter in the set of arrhythmia detection criteria until detection of the arrhythmia is optimal.

36. The method of claim 35, wherein the adjusting step comprises the step of:

adjusting the value of at least one of rate, rate stability, sudden onset delta, probability density function, morphology detection, slew rate, a specific number of intervals, signal amplitudes, frequency content and activation sequence.

37. The method of claim 34, wherein the analyzing step comprises the steps of:

receiving the played back cardiac signal; and

simulating the response of the cardiac stimulating device to the played back cardiac signal.

38. The method of claim 37, further comprising the step of editing the recorded cardiac signal.

39. The method of claim 34, wherein the recording step comprises the step of recording an actual cardiac signal of the patient.

40. The method of claim 34, wherein the recording step comprises the step of recording the cardiac signal during an episode of induced arrhythmia.

41. The method of claim 34, further comprising the steps of:

producing a default cardiac signal; and

displaying the default cardiac signal when desired.

42. The method of claim 34, further comprising the steps of:

selecting cardiac parameters; and

producing a simulated cardiac signal based on the cardiac parameters.

43. The method of claim 34, wherein the analyzing step comprises the step of receiving the played back cardiac signal with an external cardiac stimulating device.

44. A programmer for programming a cardiac stimulating device with arrhythmia detection criteria, the cardiac stimulating device being capable of detecting an episode of arrhythmia based on the set of arrhythmia detection criteria, the cardiac stimulating device applying a corresponding antiarrhythmia therapy to a patient'"'"'s heart, the programmer comprising:

a control unit for implementing a programming system;

a telemetry head connected to the control unit for communicating with the cardiac stimulating device via telemetry;

a program storage unit connected to the control unit for storing programs and data;

an input interface connected to the control unit for receiving commands from a user;

a display connected to the control unit, the control unit playing back a cardiac signal that is representative of an intracardiac electrogram of an episode of arrhythmia to test the response of the cardiac stimulating device;

means for receiving a recorded cardiac signal from a cardiac stimulating device; and

means for simulating the response of the medical device to the recorded cardiac signal based on the set of arrhythmia detection criteria.

45. The programming system of claim 44, wherein:

the receiving means includes means for receiving a recorded sensor signal coincident with the recorded cardiac signal; and

the control unit includes means for determining whether the cardiac signal is physiological or pathological based on the value of the sensor signal.

46. The programming system of claim 45, wherein:

the cardiac stimulating device is capable of increasing stimulation rate based on a set of rate-response parameters; and

the control unit further includes means for adjusting the value of each parameter in the set of rate-response parameters until the stimulation rate is optimized during exercise.

47. The programmer of claim 46, further comprising:

means for selecting cardiac parameters; and

means for simulating the cardiac signal based on the cardiac parameters.

48. The programmer of claim 47, further comprising:

means for receiving the simulated cardiac signal; and

means for simulating the response of the cardiac stimulating device to the simulated cardiac signal based on the set of arrhythmia detection criteria.

49. The programmer of claim 44, further comprising:

means for producing a default cardiac signal; and

means for simulating the response of the cardiac stimulating device to the default cardiac signal based on the set of arrhythmia detection criteria.

50. The programmer of claim 44, further comprising:

means for editing the cardiac signal prior to playing back the cardiac signal; and

means for displaying the edited cardiac signal on the display.

51. The programmer of claim 44, further comprising:

means for analyzing the cardiac signal; and

means for creating recommended arrhythmia detection criteria according to the means for analyzing.

52. The programmer of claim 51, wherein the analyzing means comprises:

means for adjusting the value of each parameter in the set of arrhythmia detection criteria until detection of the arrhythmia is optimized.

53. The programmer of claim 52, wherein the set of arrhythmia detection criteria comprises at least one of rate, rate stability, sudden onset delta, probability density function, morphology detection, slew rate, a specific number of intervals, signal amplitudes, frequency content and activation sequence.