System for providing hyperpolarization of cardiac to enhance cardiac function

• US 5,800,464 A
• Filed: 10/03/1996
• Issued: 09/01/1998
• Est. Priority Date: 10/03/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kieval, Robert S.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/720,834
• Time in Patent Office: 698 Days
• Field of Search: 607/5, 607/7, 607/9, 607/11
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• 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 1/36564 controlled by blood pressure

Abstract

An implantable system providing cardiac anodal stimulation (AS) as a system for effecting hyperpolarization of myocardial cells of a heart chamber to enhance the relaxation thereof in the diastolic phase and to thereby enhance cardiac function. The AS system is optimally timed to be delivered in an AS delivery interval following an AS delay interval timed from a preceding ventricular depolarization or pacing pulse to effect maximal cardiac relaxation. The sub-threshold AS pulse or train of pulses is increased in energy (amplitude) and/or decreased in energy to and from a peak energy level gradually rather than abruptly. The AS characteristics are optimized in an initialization process that determines the AS characteristics that provide the optimum blood pressure parameters and thereafter continually or from time to time in a confirmation process. Confirmation of the AS characteristics is determined by measuring one or more blood pressure parameter in the right atrium or ventricle reflecting the blood pressure in the heart chamber subjected to the AS pulses and comparing the measured blood pressure parameter to the corresponding optimum blood pressure parameter determined in the initialization process. The initialization process is repeated if the comparison shows a deterioration in cardiac function response to the AS. The AS pulse waveforms are preferrably delivered through a plurality of discrete AS electrodes distributed about the heart chamber or through or large surface area epicardial patch or endocardial AS electrodes.

Claims

1. A method of operating a medical device having electrode means adapted for placement about the heart of a living body for hyperpolarizing cardiac cells and characterized by having means to deliver anodal stimulation through said electrode means comprising the steps of:

detecting depolarizations of a chamber of a patient'"'"'s heart and providing a sense signal in response thereto;

timing an anodal stimulation delivery interval from the sense signal;

generating an anodal stimulation electrical pulse characterized by a waveform having a characteristic sufficient to hyperpolarize myocardial cells of the heart chamber, said waveform also having no characteristic sufficient to capture said cells;

delivering the anodal stimulation therapy to the heart chamber during a delivery interval timed in relation to the sensed signal.

2. The method of claim 1 wherein said timing step further comprises the step of:

establishing a delay interval between the sense signal and the commencement of the anodal stimulation delivery interval such that said anodal stimulation waveform reaches said heart electrode means during an intrinsic relaxation time between depolarizations of the cardiac cells.

3. The method of claim 2 wherein said timing step further comprises the step of:

establishing a delay interval between the sense signal and the commencement of the anodal stimulation delivery interval such that said anodal stimulation waveform reaches said heart electrode means during the intrinsic relaxation time between depolarizations of the cardiac cells that caused the generation of said sense signal.

4. The method of claim 1 wherein said generating step further comprises the step of:

delivering said anodal stimulation pulse waveform such that the waveform comprises a plurality of anodal energy pulses commencing with an initial pulse having an initial pulse energy level and terminating with a terminating pulse having a terminating pulse energy level, and wherein the intervening pulses have energy levels that are increased from said initial pulse energy level to a maximum pulse energy level and decreased from the maximum pulse energy level to said terminating pulse energy level in a manner so as to avoid depolarization of the myocardial cells.

5. The method of claim 1 wherein said generating step further comprises the step of:

establishing an anodal stimulation pulse waveform comprising a plurality of anodal energy pulses commencing with an initial pulse having an initial pulse energy level and terminating with a terminating pulse having a terminating pulse energy level, and wherein the intervening pulses energy levels are decreased from the maximum pulse energy level to said terminating pulse energy level sufficiently to avoid depolarization of the myocardial cells.

6. The method of claim 1 wherein said generating step further comprises the step of:

establishing an anodal stimulation pulse waveform comprising a plurality of anodal energy pulses commencing with an initial pulse having an initial pulse energy and terminating with a terminating pulse having a terminating pulse energy, and wherein the intervening pulses are increased from said initial pulse energy to a maximum pulse energy sufficiently to avoid depolarization of the myocardial cells in response to make excitation effects.

7. The method of claim 1 wherein said generating step further comprises the step of:

establishing an anodal stimulation pulse waveform commencing with an initial pulse energy and terminating with a terminating pulse energy, and wherein the intervening pulse energy is increased from said initial pulse energy to a maximum pulse energy and decreased from the maximum pulse energy to said terminating pulse energy sufficiently to avoid depolarization of the myocardial cells in response to make and break excitation effects.

8. The method of claim 1 wherein said generating step further comprises the step of:

establishing an anodal stimulation pulse waveform commencing with an initial pulse energy and terminating with a terminating pulse energy, and wherein the intervening pulse energy is decreased from the maximum pulse energy to said terminating pulse energy sufficiently to avoid depolarization of the myocardial cells in response to break excitation effects.

9. The method of claim 1 wherein said generating step further comprises the step of:

establishing an anodal stimulation pulse waveform commencing with an initial pulse energy and terminating with a terminating pulse energy, and wherein the intervening pulse energy is increased from said initial pulse energy to a maximum pulse energy sufficiently to avoid depolarization of the myocardial cells in response to make or break excitation effects.

10. The method of claim 1 further comprising the steps of:

measuring a physiologic function of the body; and

modifying the anodal stimulation therapy characteristics to optimize the measured function such that as the steps of claim 1 are iteratively operated, said measured physiologic function converges on a predetermined optimum level of said measured physiologic function.

11. A cardiac pacemaker, having anodal stimulation generating means adapted to deliver anodal stimulation pulses comprising:

timing means for determining the timing of pacing pulses to at least one chamber of a patients heart,

sensing means to detect depolarizations of a chamber of a patient'"'"'s heart and providing a sense signal in response thereto;

escape interval means for maintaining and initiating an escape interval upon delivery of a pacing pulse to the heart chamber or in response to a sense signal and for generating an escape interval time-out signal when one said escape interval times out;

pacing pulse delivery means to provide said pacing pulses to the heart chamber at the time out of one of said pacing escape intervals said pacing pulses being capable of depolarization of the heart chamber;

means for timing an anodal stimulation delivery interval from a sense signal or a pacing pulse;

means for generating an anodal stimulation pulse having pulse characteristics insufficient to elicit a depolarization of myocardial cells of the heart chamber;

means for delivering the anodal stimulation pulse to the heart chamber during an anodal stimulation delivery interval.

12. Apparatus for hyperpolarizing cardiac cells employing anodal stimulation comprising:

means for detecting depolarizations of a chamber of a patient'"'"'s heart and providing a sense signal in response thereto;

means for timing an anodal stimulation delivery interval from the sense signal;

means for generating an anodal stimulation pulse having a characteristic sufficient to hyperpolarize myocardial cells of the heart chamber said stimulation pulse also having no characteristic sufficient to capture said cells;

means for delivering the anodal stimulation pulse to the heart chamber during the delivery interval to effect maximal cardiac relaxation of the myocardial cells of the heart.

13. The apparatus of claim 12 wherein said timing means further comprises:

means for establishing a delay interval between the sense signal and the commencement of the anodal stimulation delivery interval to ensure application of the anodal stimulation therapy during intrinsic relaxation time between depolarizations of the cardiac cells of the heart.

14. The apparatus of claim 12 wherein said generating means further comprises:

means for establishing an anodal stimulation pulse waveform comprising a plurality of anodal energy pulses commencing with an initial pulse having an initial pulse energy and terminating with a terminating pulse having a terminating pulse energy, and wherein the intervening pulses are increased from said initial pulse energy to a maximum pulse energy and decreased from the maximum pulse energy to said terminating pulse energy sufficiently to avoid depolarization of the myocardial cells.

15. The apparatus of claim 12 wherein said delivery means further comprises:

electrode means for delivering said anodal stimulation therapy simultaneously between multiple site electrodes spaced about the heart and a common return electrode.

16. The apparatus of claim 12 wherein said delivery means further comprises:

electrode means for delivering said anodal stimulation therapy between at least one large surface area electrode positioned about the heart and a return electrode.

17. The apparatus of claim 12 wherein said delivery means further comprises:

electrode means for delivering said anodal stimulation therapy simultaneously between multiple site intracardiac electrodes and a common return electrode.

18. The apparatus of claim 12 wherein said delivery means further comprises:

electrode means for delivering said anodal stimulation therapy between a large surface area intracardiac electrode positioned within the heart or a heart vessel and a return electrode.

19. The apparatus of claim 12 wherein said delivering means further comprises:

electrode means for delivering said anodal stimulation pulse simultaneously between a plurality of closely spaced electrode pairs adjacent the heart chamber.

20. Apparatus as set forth in claim 12 and further comprising

means for measuring a physiologic function of the body and generating a value measurement signal responsive thereto;

and

means for responding to the value of said measurement signal so as to modify the anodal stimulation pulse characteristics to optimize the measured function.