System and method for myocardial revalidation and therapy by high rate pacing

• US 5,919,209 A
• Filed: 05/13/1996
• Issued: 07/06/1999
• Est. Priority Date: 05/13/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schouten, Vincent J. A.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US08/645,471
• Time in Patent Office: 1,149 Days
• Field of Search: 607/9, 607/14, 607/15, 607/2
• US Class Current: 607/2
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

There is provided a system and method for high rate pacing of patients for training, or revalidation of heart muscle. The system and method of this invention provide a therapy particularly directed for patients with CHF, to enable effective exercise of the cardiac muscle without requiring the patient to exercise. In another embodiment, an alternate high rate routine, or algorithm is provided for assisting a patient to exercise during at least some part of the high rate pacing routine. The high rate pacing therapy may be initiated either automatically, based upon the patient'"'"'s circadian rhythm; automatically by patient data sensed by a system of sensors; or may be initiated directly by the patient by use of a simple external programmer device. The pacemaker of the invention suitably stores a plurality of algorithms which can be selected, or which can be modified or replaced by an external programmer. Whether used by a CHF patient or a patient who does not have CHF but who is in danger of developing it, the exercise algorithms suitably provide for high rate pacing in the range of about 90-160 bpm. For a CHF patient, the high rate pacing is carried out for a duration in the area of about 20 minutes, preferably twice a day. The duration and frequency of therapy can be programmed to match patient needs, and may vary from only several minutes to much greater than 20 minutes, carried out 1, 2 or more times daily, or automatically based upon patient data.

Claims

1. A cardiac pacing system having a pacemaker with a pace pulse generator, and at least one lead for delivering pace pulses from said pacemaker to a patient'"'"'s heart, said pacemaker having rate control means for controlling the rate of pace pulses generated by said pace pulse generator, said rate control means comprising:

high rate means for controlling said generator to continuously generate said pace pulses at a high rate in a range of about 90-160 bpm and for a high rate episode of a predetermined duration, said high rate means further comprising algorithm means for controlling the rate variation and duration of a said high rate episode.

2. The system as described in claim 1, wherein said algorithm means has duration means for scheduling said high rate episode for a duration of at least about 10-20 minutes.

3. The system as described in claim 2, said high rate means further comprising de-activate means for de-activating operation of said high rate means, whereby a said episode lasts for the scheduled duration unless de-activated sooner.

4. The system as described in claim 1, wherein said duration means has means for scheduling said high rate episode for a duration of at least 20 minutes.

5. The system as described in claim 1, comprising at least one sensor for sensing a parameter reflective of the patient'"'"'s heart response to a said high rate episode, and wherein said high rate means comprises de-activate means for deactivating said episode as a function of said sensed parameter.

6. The system as described in claim 5, comprising a plurality of sensors for sensing respective parameters reflective of the patient'"'"'s heart response, and wherein said de-activate means comprises sensor algorithm means for determining from said sensed parameters whether said episode is to be de-activated.

7. The system as described in claim 1, comprising at least one sensor for sensing a parameter reflective of the patient'"'"'s heart response to a said high rate episode, and wherein said algorithm means comprises adjust means for adjusting the rate during said episode as a function of said at least one sensed parameter.

8. The system as described in claim 7, wherein said adjust means lowers the rate to a value below said high rate range in response to said at least one sensed parameter meeting predetermined conditions.

9. The system as described in claim 1, wherein said algorithm increases rate gradually to a rate within said range at the start of a said episode, and decreases rate gradually to a rate below said range at the end of a said episode.

10. The system as described in claim 1, wherein said high rate means further comprises automatic activate means for automatically activating an episode at least once a day.

11. The system as described in claim 10, wherein said activate means comprises programmable means for activating a plurality of said episodes in a day.

12. The system as described in claim 10, wherein said activate means comprises a clock, and timing means to activate a said episode as a function of the patient'"'"'s circadian rhythm.

13. The system as described in claim 1, comprising patient-activated means to activate and de-activate said high rate means.

14. The system as described in claim 1, comprising memory for storing data, sensor means for obtaining data indicative of the patient'"'"'s cardiac responsiveness to rate changes, and means for selectively storing said data in said memory.

15. The system as described in claim 14, wherein said algorithm means comprises at least one stored algorithm for controlling rate variation, and comprising algorithm adjust means for adjusting said at least one algorithm as a function of said indicative data.

16. The system as described in claim 14, wherein said pacemaker is adapted to be implanted in said patient, and comprising a second device adapted to be implanted within said patient, said pacemaker having means for generating a control signal as a function of said stored data, and transmit means for transmitting said control signal to said second implanted device.

17. The system as described in claim 1, comprising program receive means for receiving programmed data, and programming means for programming said algorithm means in accordance with said programmed data.

18. The system as described in claim 1, comprising a plurality of sensors for obtaining data representative of patient cardiac responsiveness to high rate pacing, and means for adjusting a said episode in response to said data, and wherein said plurality of sensors includes sensors from a group which includes sensors for obtaining indications of ventricular pressure and ventricular volume.

19. The system as described in claim 1, wherein said high rate means comprises means enabled by said patient for initiating a said high rate episode following a start duration, and said algorithm means comprises an exercise rate algorithm which is designed to aid the patient to exercise, whereby the patient may initiate a high rate episode in anticipation of exercise.

20. The system as described in claim 19, wherein said algorithm comprises a start-up algorithm for increasing rate during said start duration in a manner to prepare said patient to undertake exercise during operation of said exercise algorithm.

21. The system as described in claim 19, comprising sensor means for obtaining a measure of patient activity during a said high rate episode, and wherein said high rate means comprises means for adjusting pace pulse rate during a said episode in response to said activity measure.

22. The system as described in claim 1, wherein said high rate means comprises means for obtaining a measure of patient exercise, and automatic means for initiating a said high rate episode as a function of said patient exercise measure.

23. The system as described in claim 22, further comprising an external device having a receiver and a display, and wherein said pacemaker has transmit means for transmitting data representative of patient performance to said external device for display to the patient.

24. A pacing system for providing pacing therapy to a patient, the system having a pace pulse generator and delivery means for delivering pace pulses to a patient'"'"'s heart, and comprising control means for controlling the rate of generation and delivery of said pace pulses, said control means comprising at least one algorithm for determining an episode of high rate pacing, said algorithm providing for increasing pacing rate to at least a predetermined high value for a duration calculated to exercise said patient'"'"'s cardiac muscle.

25. The pacing system as described in claim 24, comprising automatic means for automatically initiating said episode as a function of the patient'"'"'s circadian rhythm.

26. The pacing system as described in claim 24, comprising patient-initiated means for initiating a said episode of high rate pacing.

27. The pacing system as described in claim 24, comprising automatic means for automatically initiating a said episode as a function of time.

28. The pacing system as described in claim 24, comprising sensor means for obtaining data reflective of patient exercise history, and means for initiating a said episode as a function of said exercise history data.

29. A pacing system for providing pacing therapy to a patient, the system having a pace pulse generator and delivery means for delivering pace pulses to a patient'"'"'s heart, and comprising control means for controlling the rate of generation and delivery of said pace pulses, said control means comprising at least one algorithm for determining an episode of high rate pacing, said algorithm providing for increasing pacing rate to at least a predetermined high value for a duration calculated to exercise said patient'"'"'s cardiac muscle and to aid said patient in exercising during at least a portion of said duration.

30. A method of high rate pacing therapy, comprising determining a high rate pacing duration suitable for exercising a patient'"'"'s heart, and pacing said patient'"'"'s heart at a rate in the range of 90-160 bpm for said determined duration.

31. The method as described in claim 30, comprising pacing at a variable rate within said range.

32. The method as described in claim 30, comprising pacing at a substantially constant rate for at least a portion of said duration.

33. The method as described in claim 30, further comprising sensing cardiac activity of said patient, and controlling said pacing as a function of said sensed activity.

34. The method as described in claim 33, comprising indicating to said patient when he or she can undertake exercise.