Methods for control of the ventricular activation sequence

• US 5,267,560 A
• Filed: 12/28/1992
• Issued: 12/07/1993
• Est. Priority Date: 09/07/1990
• Status: Expired due to Fees

• Current Assignee: Fred M. Cohen
• Original Assignee: Fred M. Cohen
• Inventors: Cohen, Fred M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/997,775
• Time in Patent Office: 344 Days
• Field of Search: 128/419 P, 128/419 PG
• US Class Current: 607/25
• 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 simultaneously 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 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 the same lead terminal;

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

(d) electrically connecting said terminal to an 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 circuit;

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

(f) analyzing said electrode contacting positions to determine their resultant 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 duration is obtainable;

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

(h) sensing intrinsic cardiac signals from said terminal during a cardiac cycle;

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

2. The method of claim 1 wherein said step (i) of employing said cardiac signals comprises employing the first of said cardiac signals in the electronic control circuit of said pulse generator to trigger the deliverance of a pacing pulse to said terminal simultaneous with the occurrence of said first cardiac signal within said predetermined time interval and cause the deliverance of a pacing pulse to said terminal upon the absence of any said cardiac signal within said predetermined time interval.

3. 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 an even number of electrodes with at least four electrodes thereon, the first of said electrodes being most distal from the site of lead introduction, the second of said electrodes proximal to said first electrode, the third of said electrodes proximal to said second electrode, the fourth of said electrodes proximal to said third electrode, the next odd numbered electrode of said electrodes being proximal to its preceding even numbered electrode, and the next even numbered electrode of said electrodes being proximal to its preceding odd numbered electrode with each odd numbered electrode for contact with ventricular muscle and said second electrode electrically connected to said third electrode with each following even numbered electrode electrically connected to its following odd numbered electrode, unless it is the highest numbered electrode on the lead;

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

(d) electrically connecting the first said electrode to an output pole of a pulse generator and electrically connecting the highest even numbered of said electrodes to the other pole of said pulse generator in order to complete the electrical circuit;

(e) providing pacing pulses from said pulse generator to said contacting electrodes at a constant rate determined to stimulate said ventricular muscle in the absence of ventricular fusion;

(f) analyzing said electrode contacting positions to determine their resultant 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 duration is obtainable;

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

(h) sensing intrinsic cardiac signals from said output pole during a cardiac cycle;

(i) employing the first of said cardiac signals in the electronic control circuit of said pulse generator to inhibit the deliverance of a pacing pulse to said output pole upon the occurrence of said first cardiac signal within said predetermined time interval and cause the deliverance of a pacing pulse to said output pole upon the absence of any said cardiac signal within said predetermined time interval.

4. The method of claim 3 wherein said step (i) of employing said cardiac signals comprises employing the first of said cardiac signals in the electronic control circuit of said pulse generator to trigger the deliverance of a pacing pulse to said output pole simultaneous with the occurrence of said first cardiac signal within said predetermined time interval and cause the deliverance of a pacing pulse to said output pole upon the absence of any said cardiac signal within said predetermined time interval.

5. A method for improving the reliability of delivering electrical impulses to the ventricular chambers of the heart and sensing intrinsic signals of ventricular origin from the heart, 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 lead terminals to an implantable pulse generator incorporating noninvasive means for selective pacing through any combination of said terminals 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 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 that produces a desired 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 two said terminals during a cardiac cycle;

(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;

(j) employing the use of at least two electrodes and the resultant electrical and mechanical separation of electrodes thus obtained to provide increased reliability of ventricular stimulation and sensing of intrinsic ventricular signals, from at least one electrode in the event that the sites of other electrodes are subsequently subject to cardiac disease processes or other factors which prohibit their intended functions.

6. The method of claim 5 wherein said step (f) of noninvasively positioning includes selecting the combination of terminals that produces the minimum QRS duration with respect to said electrode locations on said lead as determined by said monitoring step (a).

7. The method of claim 5 wherein said step (i) of employing said cardiac signals comprises 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 electrodes upon the occurrence of said first cardiac signal within 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 tim interval.

8. The method of claim 7 wherein said implantable pulse generator incorporates a rate adaptive sensor to automatically adjust said predetermined interval in response to physiologic indications of cardiac demand.

9. The method of claim 8 wherein said implantable pulse generator employs a number of terminals which are inversely proportional to the resultant predetermined interval with the addition or reduction of terminals occurring at programmed predetermined intervals.

10. The method of claim 5 wherein said step (i) 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 interval followed by a second pacing pulse delivered to said second terminal at expiration of said delay interval.

11. The method of claim 10 wherein said delayed pacing pulses are inhibited by intrinsic cardiac activity occurring at the second terminal within the delay interval.

12. The method of claim 11 wherein said implantable pulse generator incorporates a rate adaptive sensor to automatically adjust said predetermined interval in response to physiologic indications of cardiac demand.

13. The method of claim 12 wherein said delay interval is shorter following a paced event at said first terminal than following a sensed event at said first terminal and the delayed pulse is not inhibited by electrical activity within the delay interval following a paced event at said first terminal.

14. The method of claim 13 wherein said delay intervals are automatically adjusted in response to said physiologic indications of cardiac demand.

15. The method of claim 14 wherein said lead incorporates at least two electrodes connected to at least one said terminal.

16. 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 at least two of 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 pulses 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;

(k) 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 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.

17. 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 at least one other selected terminal simultaneous with the occurrence of said first intrinsic signal within a predetermined time interval and cause the deliverance of simultaneous pacing pulses to at least one selected terminal 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

(i) providing pacing pulses from said pulse generator to at least one other terminal to produce a shorter QRS duration than the patient'"'"'s intrinsic QRS duration.