Implantable stimulation device, programmer, and method for automatically evaluating interaction of the device with a patient's heart

• US 6,594,523 B1
• Filed: 09/14/2001
• Issued: 07/15/2003
• Est. Priority Date: 05/14/1996
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Levine, Paul A.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/953,466
• Time in Patent Office: 669 Days
• Field of Search: 607/4, 607/5, 607/9, 607/30, 607/32
• US Class Current: 607/30
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An implantable cardiac stimulation device, programmer, and method provides for automatically evaluating interaction of the implantable device with the patient'"'"'s heart. The evaluation of the interaction of the device with the patient'"'"'s heart is based upon analysis of a heart activity signal which may include event markers generated by the implantable device representing applied stimulation pulses and sensed physiological cardiac events. The heart activity signal is analyzed by the programmer and/or implanted device and the operation of the implantable device is automatically adjusted in response to the event heart activity signal analysis. The heart activity signal analysis is also used to determine final evaluation results and completion of the evaluation procedure. The programmer then provides recommendations to the physician as to device programming and/or performs these adjustments automatically.

Claims

1. A programmer for automatically evaluating interaction of an implantable stimulation device and a patient'"'"'s heart, the device comprising adjustable programmable parameters and a transmitter to transmit event markers representing heart stimulation pulses and sensed physiological cardiac events, the programmer comprising:

a telemetry circuit that transmits programmable parameters to the implantable device and receives the event markers from the implantable device;

a processor that analyzes the event markers received from the implantable device, automatically adjusts the programmable parameters in response to the event markers and in accordance with an automated evaluation procedure, and determines final evaluation results upon completion of the evaluation procedure; and

a display that displays the final evaluation results.

2. The programmer of claim 1 wherein the processor is programmed to adjust the programmable parameters of the stimulation device in a manner consistent with the final evaluation results.

3. The programmer of claim 1 wherein the final evaluation results include a recommended programmable parameter and wherein the processor is programmed to determine the recommended programmable parameter upon completion of the evaluation procedure.

4. The programmer of claim 3 wherein the processor is programmed to adjust the programmable parameter of the stimulation device to include the recommended programmable parameter.

5. The programmer of claim 3 wherein the automated evaluation procedure is an atrial sensing threshold evaluation procedure, wherein the stimulation device has a programmable atrial event sensing sensitivity, and wherein the processor is programmed to determine a recommended atrial event sensing sensitivity upon completion of the atrial sensing threshold evaluation procedure.

6. The programmer of claim 5 wherein the processor is programmed to adjust the programmable parameters of the stimulation device to include the recommended atrial event sensing sensitivity.

7. The programmer of claim 1 wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure wherein the stimulation device has a programmable atrial stimulation output, and wherein the processor is programmed to determine a recommended atrial stimulation output upon completion of the atrial capture threshold procedure.

8. The programmer of claim 7 wherein the processor is programmed to adjust the programmable parameters of the stimulation device to include the recommended atrial stimulation output.

9. The programmer of claim 1 wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter associated with retrograde conduction, and wherein the processor is programmed to determine a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure.

10. The programmer of claim 9 wherein the processor is programmed to adjust the programmable parameters of the stimulation device to include the at least one programmable parameter comprising the recommended state.

11. An implantable cardiac stimulation device comprising an evaluator that automatically evaluates interaction of the device with a patient'"'"'s heart, the device comprising:

a sensing circuit that senses physiological cardiac events;

an output circuit that generates stimulation pluses to the patient'"'"'s heart;

a signal generator that generates event markers representing applied stimulation pulses and sensed physiological cardiac events;

a processor that analyzes the event markers, automatically adjusts the operation of the sensing circuit and the output circuit in response to the event markers and in accordance with an automated evaluation procedure, and determines final evaluation results upon completion of the evaluation procedure;

wherein the final evaluation results include recommended operation of the device and wherein the processor is programmed to determine the recommended operation of the device upon completion of the evaluation procedure; and

a telemetry circuit that transmits the final evaluation results to a non-implanted receiver.

12. The device of claim 11 wherein the processor is programmed to adjust the operation of the stimulation device in a manner consistent with the final evaluation results.

13. The device of claim 11 wherein the processor is programmed to adjust the operation of the stimulation device to the recommended operation.

14. The device of claim 11 wherein the automated evaluation procedure is an atrial sensing threshold evaluation procedure, wherein the stimulation device has a programmable atrial event sensing sensitivity, and wherein the processor is programmed to determine a recommended atrial event sensing sensitivity upon completion of the atrial sensing threshold evaluation procedure.

15. The device of claim 14 wherein the processor is programmed to adjust the programmable atrial event sensing sensitivity of the sensing means to the recommended atrial event sensing sensitivity.

16. An implantable cardiac stimulation device comprising an evaluator that automatically evaluates interaction of the device with a patient'"'"'s heart, the device comprising:

a sensing circuit that senses physiological cardiac events;

an output circuit that generates stimulation pluses to the patient'"'"'s heart;

a signal generator that generates event markers representing applied stimulation pulses and sensed physiological cardiac events;

a processor that analyzes the event markers, automatically adjusts the operation of the sensing circuit and the output circuit in response to the event markers and in accordance with an automated evaluation procedure, and determines final evaluation results upon completion of the evaluation procedure;

wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure, wherein the output circuit has a programmable atrial stimulation output, and wherein the processor is programmed to determine a recommended atrial stimulation output upon completion of the atrial capture threshold evaluation procedure; and

a telemetry circuit that transmits the final evaluation results to a non-implanted receiver.

17. The device of claim 16 wherein the processor is programmed to adjust the programmable atrial stimulation output of the output circuit to the recommended atrial stimulation output.

18. An implantable cardiac stimulation device comprising an evaluator that automatically evaluates interaction of the device with a patient'"'"'s heart, the device comprising:

a sensing circuit that senses physiological cardiac events;

an output circuit that generates stimulation pluses to the patient'"'"'s heart;

a signal generator that generates event markers representing applied stimulation pulses and sensed physiological cardiac events;

a processor that analyzes.the event markers, automatically adjusts the operation of the sensing circuit and the output circuit in response to the event markers and in accordance with an automated evaluation procedure, and determines final evaluation results upon completion of the evaluation procedure;

wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter relating to retrograde conduction, and wherein the processor is programmed to determine a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure; and

a telemetry circuit that transmits the final evaluation results to a non-implanted receiver.

19. The device of claim 18 wherein the processor is programmed to adjust the at least one programmable parameter relating to retrograde conduction to the recommended state.

20. A method evaluating the interaction of an implantable cardiac stimulation device with a patient'"'"'s heart, the method comprising:

sensing cardiac events of the patients heart;

generating stimulation pulses to the patient'"'"'s heart as a function of the sensed cardiac events;

generating event markers whenever applied stimulation pulses and sensed cardiac events occur;

analyzing the event markers;

automatically adjusting the sensing of cardiac events and the generation of stimulation pulses in response to the event markers and in accordance with an automated evaluation procedure;

determining final evaluation results upon completion of the evaluation procedure;

determining a recommended adjustment of the sensing of cardiac events and/or the generation of stimulation pulses upon completion of the evaluation procedure; and

displaying the final evaluation results.

21. The method of claim 20 including the further step of adjusting the sensing of cardiac events and the generation of stimulation pulses of the stimulation device in a manner consistent with the evaluation results.

22. The method of claim 20 including the further step of adjusting the sensing of cardiac events and/or the generation of stimulation pulses to the recommended adjustment.

23. The method of claim 20 wherein the automated evaluation procedure is an atrial sensing threshold evaluation procedure, and wherein the method further includes recommending an atrial event sensing sensitivity upon completion of the atrial sensing threshold procedure.

24. The method of claim 23 including the further step of adjusting the atrial event sensing sensitivity to the recommended atrial event sensing sensitivity.

25. A method evaluating the interaction of an implantable cardiac stimulation device with a patient'"'"'s heart, the method comprising:

sensing cardiac events of the patient'"'"'s heart;

generating stimulation pulses to the patient'"'"'s heart as a function of the sensed cardiac events;

generating event markers whenever applied stimulation pulses and sensed cardiac events occur;

analyzing the event markers;

automatically adjusting the sensing of cardiac events and the generation of stimulation pulses in response to the event markers and in accordance with an automated evaluation procedure;

wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure and wherein the method further includes the step of determining a recommended atrial stimulation output upon completion of the atrial capture threshold evaluation procedure;

determining final evaluation results upon completion of the evaluation procedure; and

displaying the final evaluation results.

26. The method of claim 25 including the further step of adjusting the atrial stimulation output to the recommended atrial stimulation output.

27. A method evaluating the interaction of an implantable cardiac stimulation device with a patient'"'"'s heart, the method comprising:

sensing cardiac events of the patient'"'"'s heart;

generating stimulation pulses to the patient'"'"'s heart as a function of the sensed cardiac events;

generating event markers whenever applied stimulation pulses and sensed cardiac events occur;

analyzing the event markers;

automatically adjusting the sensing of cardiac events and the generation of stimulation pulses in response to the event markers and in accordance with an automated evaluation procedure;

wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter relating to retrograde conduction, and wherein the method further includes determining a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure;

determining final evaluation results upon completion of the evaluation procedure; and

displaying the final evaluation results.

28. The method of claim 27 further including the step of adjusting the at least one programmable parameter to the recommended state.

29. A programmer for automatically evaluating interaction of an implantable stimulation device and a patient'"'"'s heart, the device comprising adjustable programmable parameters and means for transmitting event markers representing heart stimulation pulses and sensed cardiac events, the programmer comprising:

receiving means for receiving the event makers from the implanted device;

analyzing means for analyzing the event markers received from the implantable device;

adjusting means for automatically adjusting the programmable parameters responsive to the analyzing means analyzing the event markers in accordance with an automated evaluation process; and

determining means for determining final evaluation results in accordance with the automated evaluation procedure.

30. The programmer of claim 29 further including display means for displaying the final evaluation results.

31. The programmer of claim 29 wherein the adjusting means further adjusts the programmable parameters of the stimulation device in a manner consistent with the final evaluation results.

32. The programmer of claim 29 wherein the final evaluation results includes a recommended programmable parameter and wherein the determining means further determines the recommended programmable parameter upon completion of the evaluation procedure.

33. The programmer of claim 32 wherein the adjusting means further adjusts the programmable parameters of the stimulation device to include the recommended programmable parameter.

34. The programmer of claim 29 wherein the automated evaluation procedure is an atrial sensing threshold evaluation procedure, wherein the stimulation device has a programmable atrial event sensing sensitivity, and wherein the determining means determines a recommended atrial event sensing sensitivity upon completion of the atrial sensing threshold evaluation procedure.

35. The programmer of claim 34 wherein the adjusting means further adjusts the programmable parameter of the stimulation device to include the recommended atrial event sensing sensitivity.

36. The programmer of claim 29 wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure, wherein the stimulation device has a programmable atrial stimulation output, and wherein the determining means further determines recommended atrial stimulation output upon completion of the atrial capture threshold evaluation procedure.

37. The programmer of claim 36 wherein the adjusting means further adjusts the programmable parameters of the stimulation device to include the recommended atrial stimulation output.

38. The programmer of claim 29 wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter relating to retrograde conduction and wherein the determining means further determines a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure.

39. The programmer of claim 38 wherein the adjusting means further adjusts the programmable parameter of the stimulation device to include the at least one programmable parameter comprising the recommended state.

40. An implantable cardiac stimulation device comprising means for automatically evaluating interaction of the device with a patient'"'"'s heart, the device comprising:

sensing means for sensing cardiac events;

output circuit means for generating stimulation pluses to the patient'"'"'s heart;

marker generating means for generating event markers representing generated stimulation pulses and sensed cardiac events;

analyzing means for analyzing the event markers;

adjusting means for adjusting the operation of the sensing means and/or the output circuit means responsive to the analyzing means analyzing the event markers in accordance with an automated evaluation procedure; and

determining means for determining final evaluation results in accordance with the automated evaluation procedure;

wherein the final evaluation results include recommended operation of the device and wherein the determining means further determines the recommended operation of the device upon completion of the evaluation procedure.

41. The device of claim 40 further including telemetry means for transmitting the final evaluation results to a non-implanted receiver.

42. The device of claim 40 wherein the adjusting means adjusts the operation of the stimulation device in a manner consistent with the final evaluation results.

43. The device of claim 40 wherein the adjusting means further adjusts the operation of the stimulation device to the recommended operation.

44. The device of claim 40 wherein the automated evaluation procedure is an atrial sensing threshold evaluation procedure, wherein the sensing means has a programmable atrial event sensing sensitivity, and wherein the determining means further determines a recommended atrial event sensing sensitivity upon completion of the atrial sensing threshold procedure.

45. The device of claim 44 wherein the adjusting means further adjusts the atrial event sensing sensitivity of the sensing means to the recommended atrial event sensing sensitivity.

46. An implantable cardiac stimulation device comprising means for automatically evaluating interaction of the device with a patient'"'"'s heart, the device comprising:

sensing means for sensing cardiac events;

output circuit means for generating stimulation pluses to the patient'"'"'s heart;

marker generating means for generating event markers representing generated stimulation pulses and sensed cardiac events;

analyzing means for analyzing the event markers;

adjusting means for adjusting the operation of the sensing means and/or the output circuit means responsive to the analyzing means analyzing the event markers in accordance with an automated evaluation procedure; and

determining means for determining final evaluation results in accordance with the automated evaluation procedure;

wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure, wherein the output circuit means has a programmable atrial stimulation output, and wherein the determining means further determines a recommended atrial stimulation output upon completion of the atrial capture threshold evaluation procedure.

47. The device of claim 46 wherein the adjusting means further adjusts the programmable atrial stimulation output of the output circuit means to the recommended atrial stimulation output.

48. An implantable cardiac stimulation device comprising means for automatically evaluating interaction of the device with a patient'"'"'s heart, the device comprising:

sensing means for sensing cardiac events;

output circuit means for generating stimulation pluses to the patient'"'"'s heart;

marker generating means for generating event markers representing generated stimulation pulses and sensed cardiac events;

analyzing means for analyzing the event markers;

adjusting means for adjusting the operation of the sensing means and/or the output circuit means responsive to the analyzing means analyzing the event markers in accordance with an automated evaluation procedure; and

determining means for determining final evaluation results in accordance with the automated evaluation procedure;

wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter relating to retrograde conduction, and wherein the determining means further determines a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure.

49. The device of claim 48 wherein the adjusting means further adjusts the at least one programmable parameter relating to retrograde conduction to the recommended state.

50. A programmer for automatically evaluating interaction of an implantable stimulation device and a patient'"'"'s heart, the device comprising adjustable programmable parameters and a transmission system that generates and transmits a heart activity signal representing heart stimulation pulses and sensed physiological cardiac events, the programmer comprising:

a telemetry circuit that transmits programmable parameters to the implantable device and receives the heart activity signal from the implantable device;

a processor that analyzes the heart activity signal received from the implantable device, automatically adjusts the programmable parameters in response to the heart activity signal and in accordance with an automated evaluation procedure, and determines final evaluation results upon completion of the evaluation procedure; and

a display that displays the final evaluation results.

51. An implantable cardiac stimulation device comprising an evaluator that automatically evaluates interaction of the device with a patient'"'"'s heart, the device comprising:

a sensing circuit that senses physiological cardiac events;

an output circuit that generates stimulation pulses to the patient'"'"'s heart;

a signal generator that generates a heart activity signal representing applied stimulation pulses and sensed physiological cardiac events;

a processor that analyzes the heart activity signal, automatically adjusts the operation of the sensing circuit and the output circuit in response to the heart activity signal and in accordance with an automated evaluation procedure, and determines the final evaluation results upon completion of the evaluation procedure; and

a telemetry circuit that transmits the final evaluation results to a non-implanted receiver.

52. The device of claim 51 wherein the final evaluation results includes a recommended programmable parameter and wherein the processor is programmed to determine the recommended programmable parameter upon completion of the evaluation procedure.

53. The device of claim 51 wherein the automated evaluation procedure is an atrial capture threshold evaluation procedure wherein the stimulation device has a programmable atrial stimulation output, and wherein the processor is progammed to determine a recommended atrial stimulation output upon completion of the atrial capture threshold procedure.

54. The device of claim 51 wherein the automated evaluation procedure is a retrograde conduction evaluation procedure, wherein the stimulation device has at least one programmable parameter associated with retrograde conduction, and wherein the processor is programmed to determine a recommended state of the at least one programmable parameter relating to retrograde conduction upon completion of the retrograde conduction evaluation procedure.