Pacing systems and methods for control of the ventricular activation sequence

• US 5,174,289 A
• Filed: 09/07/1990
• Issued: 12/29/1992
• Est. Priority Date: 09/07/1990
• Status: Expired due to Term

• Current Assignee: Fred M. Cohen
• Original Assignee: Fred M. Cohen
• Inventors: Cohen, Fred M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/578,536
• Time in Patent Office: 844 Days
• Field of Search: 128/786 P, 128/419, 128/419 PG
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

Apparatus and methods for improving the ventricular activation sequence of the heart by pacing at an advantageous selected ventricular location to achieve shortening of the QRS complex or pacing at multiple advantageous selected ventricular locations, either simulataneously or with a programmed delay or delays between firings, to achieve shortening of the QRS complex in combination with producing a desirable and efficient ventricular motion. During a cardiac cycle initiated by intrinsic cardiac activity, stimulating impulses may be directed to advantageous selected locations of the ventricles by employing intrinsic cardiac signals to trigger the stimulating impulses, either simultaneously or with a programmed delay or delays between the sensed event or events and firing event or events, to provide improved mechanical and electrical ventricular function.

Claims

1. A method for improving the ventricular function of the heart of a patient comprising the steps of:

(a) monitoring the electrocardiogram of a patient to determine the duration of the patient'"'"'s ZRS complex;

(b) introducing a lead incorporating at least two electrodes of the same polarity thereon for electrical contact with ventricular muscle, each electrode electrically connected to a different lead terminal;

(c) manipulating said lead to position at least two of said electrodes in electrical contact with said ventricular muscle;

(d) electrically connecting all said lead terminals to an implantable pulse generator incorporating noninvasive means for selective pacing through each terminal from at least one output pole and electrically connecting at least one electrical group location, or polarity opposite to that of said electrodes, to the other pole of said pulse generator to complete each selected electrical circuit;

(e) providing pacing pulses from said pulse generator to at least two selected terminals, one at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(f) noninvasevely positioning the location of the pacing pulse by employing said pulse generator noninvasive means to select the one of said terminals that produces the minimum QRS duration with respect to said electrode locations on said lead;

(g) setting said implantable pulse generator at a desired predetermined time interval;

sensing intrinsic cardiac signals from at least one said terminal during a cardiac cycle; and

employing the first of said cardiac signal sin the electronic control circuit of said pulse generator to inhibit the deliverance of pacing pulses to said selected terminal upon occurrence of said first cardiac signal within said predetermined time interval and cause the deliverance of pacing pulses to said selected terminal upon the absence of any said cardiac signal with said predetermined time interval.

2. A method for improving the ventricular function of the heart of a patient comprising the steps of:

(a) monitoring the electrocardiogram of a patient to determine the duration of the patient'"'"'s QRS complex;

(b) introducing a lead incorporating at least two electrodes of the same polarity thereon for electrical contact with the ventricular muscle, each electrode electrically connected to a different lead terminal;

(c) manipulating said lead to position at least two of said electrodes in electrical contact with said ventricular muscle;

(d) electrically connecting each terminal to at least one output pole of a pulse generator and electrically connecting at least one electrical group location, of polarity opposite to that of said electrodes, to the other pole of said pulse generator in order to complete each electrical circuit;

(e) providing pacing pulses from said pulse generator to at least one selected terminal, one at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(f) analyzing said selected electrode positions to determine their respective resultant QRS durations and, if desired, further manipulating said lead to re-position said electrodes and analyzing such new positions to determine if a shorter resultant QRS duration is obtained;

(g) electrically connecting all said lead terminals to an implantable pulse generator incorporating noninvasive means for selective pacing through each terminal from at least one output pole and electrically connecting at least one electrical ground location, of polarity opposite to that of said electrodes, to the other pole of said implantable pulse generator to complete each selected electrical pacing circuit;

(h) providing pacing pulses from said implantable pulse generator to at least two selected terminals, one at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(i) noninvasively positioning the location of the pacing pulse by employing said implantable pulse generator noninvasive means to select the one of said terminals that produces the minimum QRS duration with respect to said electrode locations on said lead;

(j) setting said implantable pulse generator at a desired predetermined time interval;

sensing intrinsic cardiac signals from at least one said terminal during a cardiac cycle; and

(l) employing the first of said cardiac signals in the electronic control circuit of said pulse generator to inhibit the deliverance of pacing pulses to said selected terminal upon occurrence of said first cardiac signal within said predetermined time interval and cause the deliverance of pacing pulses to said selected terminal upon the absence of any said cardiac signal within said predetermined time interval.

3. The method of claim 2 wherein at least two of said electrodes on said lead are connected to one lead terminal.

4. The method of claim 2 wherein said step (c) of manipulating said lead includes positioning the end of said lead at a ventricular apex.

5. The method of claim 2 wherein said step (f) of analyzing said electrode positions includes manipulating said lead in an endocardial position within a ventricular chamber to position one electrode at a point to yield the minimum QRS duration possible as compared to QRS durations obtained when pacing at any other point.

6. A method for improving the ventricular function of the heat of a patient comprising the steps of:

(a) monitoring the electrocardiogram of a patient to determine the duration of the patient'"'"'s QRS complex;

(b) introducing a lead incorporating at least two electrodes of the same polarity thereon for electrical contact with ventricular muscle, each electrode electrically connected to a different lead terminal;

(c) manipulating said lead to position at least two of said electrodes in electrical contact with said ventricular muscle;

(d) electrically connecting all said lead terminals to an implantable pulse generator incorporating noninvasive means for selective pacing through any combination of said terminals or an individual terminal, from at least one output pole and electrically connecting at least one electrical ground location, of polarity opposite to that of said electrodes, to the other pole of said pulse generator to complete the electrical circuits selected and to provide simultaneous pacing pulses to said selected combinations of terminals;

(e) providing pacing pulses from said pulse generator to a selected individual terminal or any selected combination of terminals, one selection at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(f) noninvasively positioning the location of the pacing pulses by employing said pulse generator to select the combination of said terminals or individual terminal that produces the minimum QRS duration with respect to said electrode locations on said lead;

(g) setting said implantable pulse generator at a desired predetermined time interval;

(h) sensing intrinsic cardiac signals from at least one said terminal during a cardiac cycle; and

(i) employing the first of said cardiac signals in the electronic control circuit of said pulse generator to trigger the deliverance of pacing pulses to said selected terminals simultaneous with the occurrence of said first intrinsic signal within a predetermined time interval and cause the deliverance of simultaneous pacing pulses to said selected terminals upon the absence of any said cardiac signal within said predetermined time interval.

7. A method for improving the ventricular function of the heart of a patient comprising the steps of:

(a) monitoring the electrocardiogram of a patient to determine the duration of the patient'"'"'s QRS complex;

(b) introducing a lead incorporating at least two electrodes of the same polarity thereon for electrical contact with ventricular muscle, each electrode electrically connected to a different lead terminal;

(c) manipulating said lead to position at least two of said electrodes in electrical contact with said ventricular muscle;

(d) electrically connecting selected combinations of said terminals or individual terminals in turn to at least one output pole of a pulse generator and electrically connecting at least one electrical ground location, of polarity opposite to that of said electrodes, to the other pole of said pulse generator in order to complete the electrical circuits selected and to provide simultaneous pacing pulses to said selected combinations of terminals;

(e) providing pacing pulses from said pulse generator to a selected individual terminal or any selected combination of terminals, one selection at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(f) analyzing said selected electrode positions to determine their respective resultant QRS durations and, if desired, further manipulating said lead to re-position said electrodes and analyzing such new positions to determine if a shorter resultant QRS duration is obtainable;

(g) electrically connecting all said lead terminals to an implantable pulse generator incorporating noninvasive means for selective pacing through any combination of said terminals or an individual terminal, from at least one output pole and electrically connecting at least one electrical ground location, of polarity opposite to that of said electrodes, to the other pole of said implantable pulse generator to complete the electrical circuits selected and to provide simultaneous pacing pulse to said selected combinations of terminals;

(h) providing pacing pulses from said implantable pulse generator to a selected terminal or any selected combination of terminals, one selection at a time, at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(i) noninvasively positioning the location of the pacing pulses by employing said implantable pulse generator noninvasive means to select the combination of said terminals or an individual terminal that produces a desired QRS duration with respect to said electrode locations on said lead;

(j) setting said implantable pulse generator at a desired predetermined time interval;

sensing intrinsic cardiac signals from at least one said terminal during a cardiac cycle; and

(l) employing the first and said cardiac signals in the electronic control circuit of said pulse generator to trigger the deliverance of pacing pulses to said selected terminals simultaneous with the occurrence of said first intrinsic signal within a predetermined time interval and cause the deliverance of simultaneous pacing pulses to said selected terminals upon the absence of any said cardiac signal within said predetermined time interval.

8. The method of claim 7 wherein said step (i) of noninvasively positioning includes selecting the combination of terminals that produces the minimum QRS duration with respect to the electrodes'"'"' locations on the lead as determined by said monitoring step (a).

9. The method of claim 7 wherein said step (l) of employing said cardiac signals comprises employing the first of said cardiac signals in the electronic control circuit of said pulse selected electrodes upon occurrence of said first cardiac signal with said predetermined time interval and cause the deliverance of simultaneous pacing pulses to said selected electrodes upon the absence of any said cardiac signal within said predetermined time interval.

10. The method of claim 7 wherein said step (c) of manipulating said lead includes positioning a first said electrode in an area of said ventricular muscle where early activation is desired and positioning at least one other said electrode in an area or areas of the ventricular muscle where avoidance of late activation is desired, as determined by the QRS interval resulting from said analyzing step (f).

11. The method of claim 7 wherein said step (c) of manipulating said lead includes positioning certain electrodes at positions to produce a more desirable ventricular motion.

12. The method of claim 7 wherein said step (c) of manipulating said lead includes positioning said electrodes within a ventricular chamber.

13. The method of claim 12 wherein said step (f) of analyzing said electrode positions includes positioning two of said electrodes in contact with ventricular muscle to produce a QRS duration that is shorter than the QRS duration obtained by pacing at any individual point in the ventricular muscle.

14. The method of claim 12 wherein said step (c) of manipulating said lead includes positioning one electrode at the ventricular apex and another electrode at a midseptal position.

15. The method of claim 14 wherein said step (c) of manipulating said lead includes positioning at least one additional electrode in a septal position between said two previously positioned electrodes, to produce a more desirable ventricular motion.

16. The method of claim 7 wherein said step (l) of employing the first of said cardiac signals comprises delivering a pacing pulse to a second terminal at a programmed time delay interval from the occurrence of said first cardiac signal at a first terminal within said predetermined time interval and delivering a pacing pulse to said first terminal upon the absence of said first cardiac signal at said first terminal within said predetermined time interval followed by a second pacing pulse delivered to said second terminal at expiration of said delay interval.

17. The method of claim 16 wherein said delayed pacing pulses are inhibited by intrinsic cardiac activity occurring at the second terminal within the delay interval.

18. The method of claim 17 wherein the electrical power delivered to each terminal and sensitivity of each terminal are independently and noninvasively adjustable.

19. The method of claim 17 wherein said implantable pulse generator is simultaneously connected to at least two ground locations of the same polarity.

20. The method of claim 19 wherein at least one of said ground locations is on the lead and outside of a ventricular chamber.

21. The method of claim 20 wherein said implantable generator incorporates noninvasive means for selection of said ground locations or location during pacing.

22. The method of claim 21 wherein said implantable generator incorporates noninvasive means for selection of said ground locations or location during sensing.

23. The method of claim 17 wherein the programmed time delay interval is adjustable from about 0 to about 75 msec.

26. The method of claim 17 wherein said lead incorporates at least two of said electrodes electrically connected to one of said lead terminals.

27. The method of claim 26 wherein said lead incorporates at least two terminals each electrically connected to at least two

28. The method of claim 16 wherein at least two delays are employed between at least three terminals.

29. The method of claim 28 wherein the delayed pulse are inhibited by intrinsic cardiac activity occurring at their respective terminals within their respective delay intervals.

30. The method of claim 29 wherein the electrical power delivered to each terminal and sensitivity of each terminal are independently and noninvasevely adjustable.

31. The method of claim 30 wherein each delay interval is independently adjustable and the sum of the multiple delays is from about 0 to about 75 msec.

32. The method of claim 31 wherein said implantable pulse generator incorporates a rate adaptive sensor to automatically adjust said predetermined interval in response to physiologic indications of cardiac demand.

33. The method of claim 32 wherein said delay intervals are automatically adjusted in response to physiologic indications of cardiac demand.

34. The method of claim 31 wherein said lead incorporates at least two electrodes electrically connected to one of said lead terminals.

35. The method of claim 34 wherein said lead incorporates at least two terminals each electrically connected to at least two electrodes.

24. The method of claim wherein said implantable pulse generator incorporates a rate adaptive sensor to automatically adjust said predetermined interval in response to physiologic indications of cardiac demand.

25. The method of claim 24 wherein said delay interval is automatically adjusted in response to said physiologic indications of cardiac demand.

36. A lead adapted for connection to a pulse generator comprising at least two electrodes thereon for electrical contact with the endocardial surface of a ventricular chamber and a preformed curvature within the ventricular chamber, said preformed curvature beginning at the distal end of said lead, extending through an approximate arc of forth five degrees and having a radius of curvature of approximately one inch, for the purpose of facilitating the placement of said electrodes in desired locations by manipulation of said lead.

37. The apparatus of claim 36 further comprising a second preformed curvature proximal to said preformed curvature within the ventricular chamber.

38. An electrode for location on a cylindrical portion of a pacing lead in electrical contact with a ventricular chamber incorporating an outwardly curved contacting surface to improve said electrode'"'"'s pacing threshold and capability of sensing intrinsic cardiac signals.

39. Cardiac electrical stimulation apparatus comprising:

first means for sensing a first ventricular depolarization at a first ventricular location;

second means having output means and responsive to said first sensing means for providing a stimulating impulse to said first ventricular location upon the absence of said first depolarization within a predetermined time interval;

third means for sensing a second ventricular depolarization at a second ventricular location; and

fourth means having output means and responsive to said third means for providing a stimulating impulse to said second ventricular location upon the absence of said second ventricular depolarization within said predetermined interval and a delay interval.

40. Apparatus according to claim 39 wherein said first and second ventricular locations are on the endocardial surface of a ventricular chamber.

41. Apparatus according to claim 39 wherein said first ventricular location is on the endocardial surface of the ventricular chamber and said second ventricular location is on the epicardial surface of a ventricular chamber.

42. Apparatus according to claim 39 additionally comprising:

fifth means for sensing a third ventricular depolarization at a third ventricular location; and

sixth means having output means and responsive to said fifth means for providing a stimulating impulse to said third ventricular location upon the absence of said third ventricular depolarization within said predetermined interval and a second delay interval.

43. Apparatus according to claim 42 additionally comprising:

seventh means for sensing a fourth ventricular depolarization at a fourth ventricular location; and

eighth means having output means and responsive to said seventh means for providing a stimulating impulse to said fourth ventricular location upon the absence of said fourth ventricular depolarization within said predetermined interval and a third delay interval.

44. Apparatus according to claim 39 wherein said first means senses first ventricular depolarization at least two first ventricular locations and said second means for providing stimulating impulses to said first ventricular locations upon the absence of said first ventricular depolarization within said predetermined time interval.

45. Apparatus according to claim 44 wherein said third means senses second ventricular depolarizations at least two second ventricular locations and said fourth means for providing stimulating impulses to said second ventricular locations upon the absence of a second ventricular depolarization within said predetermined interval and said time delay interval.

46. Cardiac electrical stimulation apparatus comprising:

first means for sensing a first ventricular depolarization at a first ventricular location;

second means having output means and responsive to said first sensing means for providing a stimulating impulse to said first ventricular location upon the absence of said first depolarization within a predetermined time interval;

third means for sensing a second ventricular depolarization at a second ventricular location; and

fourth means having output means and responsive to said first and third means for providing a stimulating impulse to said second location at a programmed time delay interval from the occurrence of said first depolarization within said predetermined interval in the absence of said second depolarization within said delay interval and providing a stimulating impulse to said second ventricular location at said time delay interval from the absence of said first depolarization within said predetermined interval in the absence of said second ventricular depolarization within said delay interval.

47. Apparatus according to claim 46 wherein said first means senses first ventricular depolarization at at least two first ventricular locations and said second means for providing stimulating impulses to said first ventricular locations upon the absence of said first ventricular depolarization within said predetermined time interval.

48. Apparatus according to claim 46 wherein said implantable pulse generator is simultaneously connected to at least two ground locations of the same polarity.

49. Apparatus according to claim 46 additionally comprising fifth means for sensing a third ventricular depolarization at a third ventricular location;

and sixth means having output means and responsive to said first and fifth means for providing a stimulating impulse to said third location at a second programmed time delay interval from the occurrence of said first depolarization within said predetermined interval in the absence of said third polarization within said second time delay interval and providing a stimulating impulse to said third ventricular location at said second time delay interval from the absence of said first depolarization within said predetermined interval in the absence of said third ventricular depolarization within said second time delay interval.

50. Apparatus according to claim 49 wherein said first, second and third ventricular locations are on the endocardial surface of a ventricular chamber.

51. Apparatus according to claim 50 wherein said first ventricular location is at a ventricular apex, said second ventricular location is at a midseptal position and said third ventricular location is at a septal position between said first and second ventricular locations.

52. Apparatus according to claim 49 additionally comprising seventh means means for sensing a fourth ventricular depolarization at a fourth ventricular location;

and eighth means having output means and responsive to said first and seventh means for providing a stimulating impulse to said fourth location at a third programmed time delay interval from the occurrence of said first depolarization within said predetermined interval in the absence of said fourth polarization within said third time delay interval and providing a stimulating impulse to said fourth ventricular location at said third time delay interval from the absence of said first depolarization within said predetermined interval in the absence of said fourth ventricular depolarization within said third time delay interval.

53. Apparatus according to claim 46 wherein said first and second ventricular locations are on the endocardial surface of a

54. Apparatus according to claim 53 wherein said first ventricular location is at a ventricular apex and said second ventricular location is at a midseptal position.

55. Apparatus according to claim 46 wherein said implantable pulse generator incorporates a rate adaptive sensor to automatically adjust said predetermined interval in response to physiologic indications or cardiac demand.

56. Apparatus according to claim 55 wherein said delay interval is automatically adjusted in response to said physiologic indications of cardiac demand.

57. A method for improving the ventricular function of the heart of a patient, presenting with wide QRS complexes of intrinsic origin, comprising the steps of:

(a) monitoring the electrocardiogram of a patient to determine the duration of the patient'"'"'s QRS complex;

(b) introducing a lead incorporating at least two electrodes of the same polarity thereon for electrical contact with ventricular muscle, each electrode electrically connected to a different lead terminal;

(c) manipulating said lead to position at least two of said electrodes in electrical contact with said ventricular muscle;

(d) electrically connecting at least two of said individual terminals to at least one output pole of a pulse generator and electrically connecting at least one electrical ground location, of polarity opposite to that of said electrodes, to the other pole of said pulse generator in order to complete each electrical circuit;

(e) sensing intrinsic cardiac signals from at least one said terminal during a cardiac cycle;

(f) employing the first of said cardiac signals in the electronic control circuit of said pulse generator to trigger the deliverance of pacing pulses to selected terminals simultaneous with the occurrence of said first intrinsic signal within a predetermined time interval and cause the deliverance of simultaneous pacing pulses to said selected terminals upon the absence of any said cardiac signal within said predetermined time interval;

(g) providing pacing pulses from said pulse generator to at least one other selected terminal at a rate determined by intrinsic electrical activity in order to stimulate said ventricular muscle in the presence of ventricular fusion;

(h) analyzing said electrode positions to determine their respective resultant QRS duration as compared to the intrinsic QRS duration and, if desired, further manipulating said lead to re-position said electrodes and analyzing such new positions to determine if a shorter resultant QRS is obtained; and

(j) providing pacing pulses from said pulse generator to a desired combination of terminals that produces a shorter QRS duration than the patient'"'"'s intrinsic QRS.