Augmentation of muscle contractility by biphasic stimulation

• US 6,141,587 A
• Filed: 05/27/1998
• Issued: 10/31/2000
• Est. Priority Date: 08/19/1996
• Status: Expired due to Term

• Current Assignee: MR3 Medical, LLC
• Original Assignee: Mower Family Chf Treatment Irrevocable Trust
• Inventors: Mower, Morton M.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/085,360
• Time in Patent Office: 888 Days
• Field of Search: 607/9-11, 607/13-16, 607/46, 607/48, 607/49, 607/50, 607/39-41, 607/68, 607/70, 607/74, 128/898
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• 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 1/3708 for power depletion

Abstract

Augmentation of electrical conduction and contractility by biphasic stimulation of muscle tissue. A first stimulation phase has a first phase polarity, amplitude, and duration. The first stimulation phase, which acts as a conditioning mechanism, is administered at no more than a maximum subthreshold amplitude. A second stimulation phase has a second polarity, amplitude, and duration. The two phases are applied sequentially. Contrary to current thought, anodal stimulation is applied as the first stimulation phase, followed by cathodal stimulation as the second stimulation phase. In this fashion, pulse conduction through muscle is improved, together with an increase in contractility. Furthermore, this mode of biphasic stimulation reduces the electrical energy required to elicit contraction. In addition, the conditioning first stimulation phase decreases the stimulation threshold by reducing the amount of electrical current required for the second stimulation phase to elicit contraction. The muscle tissue encompassed by the present invention includes skeletal (striated) muscle, cardiac muscle, and smooth muscle.

Claims

1. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first phase amplitude is ramped from a baseline value to a second value.

2. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the first phase amplitude is equal to or less than a maximum subthreshold amplitude.

3. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the second value is at a maximum subthreshold amplitude.

4. The method for stimulating muscle tissue with biphasic waveforms according to claim 3, where the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

5. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the first phase duration is at least as long as the second phase duration.

6. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the first phase duration is about one to nine milliseconds.

7. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the second phase duration is about 0.2 to 0.9 millisecond.

8. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the second phase amplitude is about two volts to twenty volts.

9. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the second phase duration is less than 0.3 millisecond, and the second phase amplitude is greater than 20 volts.

10. The method for stimulating muscle tissue with biphasic waveforms according to claim 1, where the second phase duration is less than approximately 6 milliseconds and the second phase amplitude is at least 200 millivolts.

11. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first phase amplitude is ramped from a baseline value to a second value, and wherein the absolute value of the second value is equal to the absolute value of the second phase amplitude.

12. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first stimulation phase further comprises a series of stimulating pulses of a predetermined amplitude, polarity, and duration.

13. The method for stimulating muscle tissue with biphasic waveforms according to claim 12, where the first stimulation phase further comprises a series of rest periods.

14. The method for stimulating muscle tissue with biphasic waveforms according to claim 13, where applying the first stimulation phase further comprises applying a rest period of a baseline amplitude after at least one stimulating pulse.

15. The method for stimulating muscle tissue with biphasic waveforms according to claim 14, where the rest period is of equal duration to the duration of the stimulating pulse.

16. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first phase polarity is positive and the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

17. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first phase duration is at least as long as the second phase duration and the first phase duration is about one to nine milliseconds.

18. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the first phase duration is at least as long as the second phase duration and the second phase duration is about 0.2 to 0.9 millisecond.

19. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the second phase amplitude is about two volts to twenty volts.

20. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than twenty volts.

21. A method for stimulating muscle tissue with biphasic waveforms, comprising:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape, and a first phase duration for preconditioning the muscle tissue to accept subsequent stimulation;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape, and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle;

wherein the stimulation to the muscle is selected from the group consisting of direct stimulation to the muscle and indirect stimulation to the muscle; and

wherein the indirect stimulation is administered through skin.

22. A method for stimulating muscle tissue with biphasic waveforms, comprising the steps of:

defining a first stimulation phase with a positive polarity, a first phase amplitude, a first phase shape and a first phase duration, where the first phase amplitude is about 0.5 to 3.5 volts, and the first phase duration is about one to nine milliseconds;

defining a second stimulation phase with a negative polarity, a second phase amplitude that is larger in absolute value than the first phase amplitude, a second phase shape and a second phase duration, where the second phase amplitude is about two volts to twenty volts, and the second phase duration is about 0.2 to 0.9 millisecond; and

applying the first stimulation phase and the second stimulation phase in sequence to the muscle tissue, wherein the muscle tissue is selected from the group consisting of striated muscle, smooth muscle and mixed muscle, and wherein the stimulation to the muscle is selected from the group consisting of direct stimulation to the muscle and indirect stimulation to the muscle.