Implantable tissue stimulator output stabilization system

• US 5,222,494 A
• Filed: 07/31/1991
• Issued: 06/29/1993
• Est. Priority Date: 07/31/1991
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Baker, Ross G. Jr.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/738,801
• Time in Patent Office: 699 Days
• Field of Search: 128/419 PT, 128/421, 128/419 R
• US Class Current: 607/118
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

Apparatus is disclosed for stabilizing the value of a parameter of the output pulses of a tissue stimulator, such as the magnitude of the current or the charge delivered in each output pulse to excite the cell membranes of the tissue to be stimulated. The apparatus measures the value of this parameter against target limits, and if either limit is exceeded, adjusts the value of a second parameter of the output pulses, such as voltage level or pulse width, to stabilize the value of the first parameter. The value of the first parameter may be measured by sampling thereof at a rate considerably less than the frequency of the output pulses, and the value of the second parameter then adjusted to bring the value of the first parameter within the target limits. Both current and charge stabilization modes of the pulse generating stimulator for efficient excitation of cell membranes of the selected tissue are described.

Claims

1. An implantable tissue stimulator for delivering stimulating pulses to selected tissue of a patient via one or more electrodes implanted on or near the tissue, comprising:

pulse generator means for sequentially generating output pulses in a programmable pattern for application to the tissue, and

control loop means connected to the pulse generator means for measuring the magnitude of a predetermined parameter of selected ones of the output pulses at a predetermined point of the selected pulses and for adjustment of said magnitude to stabilize the value thereof for subsequent ones of the output pulses, the control loop means including

adjustment means responsive to measurements of said magnitude differing from a predetermined value for controlling the pulse generator means to adjust said predetermined parameter of the output pulses to reduce the difference to within a preselected amount.

2. The invention of claim 1, wherein the control loop means includes measurement means for measuring said magnitude periodically.

3. The invention of claim 2, wherein the measurement means measures said magnitude over separated cycles of the output pulses.

4. The invention of claim 1, wherein

said predetermined parameter is current delivered in each output pulse, and

the control loop means includes measurement means for performing said measurements, the measurement means including

means for performing successive approximations of the magnitude of the current of said selected ones of the output pulses by measuring the current magnitude of at least one output pulse but not all output pulses per burst and completing the approximation after a sequence of bursts.

5. The invention of claim 1, wherein

said predetermined parameter is current, and

the control loop means includes measurement means for performing said periodic measurements, the measurement means . including:

limit means for establishing predetermined high and low control limits for the current magnitude of the output pulses, and

comparison means for alternately comparing the current magnitude of selected ones of the output pulses against the established high and low control limits, and

the adjustment means includes;

varying means responsive to the comparison means for varying the voltage of the output pulses to bring the current magnitude of the pulses within said limits when the comparison means determines that either limit is exceeded.

6. The invention of claim 5, wherein the varying means is responsive to the comparison means to vary said current magnitude to fall within said limits only when the comparison means determines that multiple ones of the output pulses in each sequence have exceeded at least one of said limits.

7. The invention of claim 1, wherein said predetermined parameter is current, and said predetermined point of the selected pulses at which the measurement is performed is the trailing edge of the respective selected pulses.

8. The invention of claim 1, wherein

said predetermined parameter is current, and

said predetermined point of the selected pulses at which the measurement is performed is the approximate midpoint of the respective selected pulses.

9. The invention of claim 1, wherein said measurements are performed by sampling the output pulses at a rate much less than the frequency at which the output pulses are generated.

10. The invention of claim 1, wherein

said predetermined parameter is charge delivered in the output pulse, and

said adjustment means is responsive to measurement of charge in an output pulse differing from said predetermined value for controlling the pulse generator means to adjust the duration of the output pulses to reduce the difference to within a preselected amount.

11. The invention of claim 1, wherein

said predetermined parameter is charge delivered in the output pulse, and

the control loop means including measurement means for performing said measurements, the measurement means including:

limit means for establishing predetermined high and low control limits for the charge magnitude of the output pulses, and

comparison means for comparing the charge magnitude of said selected ones of the output pulses against said high and low control limits, and

the adjustment means includes;

means responsive to the comparison means for varying the duration of the output pulses to bring the charge magnitude of the pulses within said limits when the comparison means determines that either of said limits is exceeded.

12. The invention of claim 1, wherein

said predetermined parameter is charge delivered in the output pulse, and

the control loop means includes measurement means for performing said measurements, the measurement means including:

means for integrating the output pulse current over a predetermined time interval to determine the magnitude of the charge delivered in each output pulse.

13. The invention of claim 1, wherein

said predetermined parameter is charge delivered in the output pulse, and

the control loop means further includes means for modelling the excitable cell membrane repolarization of the selected tissue to control the output pulse durations to induce a threshold charge across the membrane sufficient for excitation thereof.

14. The invention of claim 1, wherein

said predetermined parameter is charge delivered in the output pulse, and

the control loop means further includes means for modelling the charge delivered in each output pulse to induce a threshold charge across the excitable cell membranes of the tissue to be stimulated which accounts for charge loss attributable to leakage from the membranes.

23. The invention of claim 1, wherein the first parameter is the amount of electrical charge delivered in each output pulse.

24. The invention of claim 23 wherein the second parameter is the output pulse voltage.

25. The invention of claim 23, wherein the second parameter is the output pulse duration.

15. Apparatus for stabilizing the value of the amount of electrical charge delivered in each of the output pulses of a neurostimulator for stimulating the excitable cell membranes of a selected nerve, comprising:

measuring means for ascertaining the value of said electrical charge of the output pulses,

comparing means responsive to the ascertained value for comparison thereof with a target value reflecting a desired limit on the value of said electrical charge, and

adjusting means responsive to a discrepancy between the values under comparison for adjusting the duration of each output pulse to reduce the discrepancy and thereby stabilize the value of the electrical charge, whereby to control the output pulses of the neurostimulator to enhance the efficiency of stimulation of the nerve membranes, said adjusting means including means for immediately ending a pulse when the target value is reached.

16. Apparatus for stabilizing the value of a parameter of the output pulses of a neurostimulator for stimulating the excitable cell membranes of a selected nerve, comprising:

measuring means for sampling the value of said first parameter of the output pulses intermittently at separated cycles of the output pulses to ascertain the value of said parameter,

comparing means responsive to the ascertained value of said parameter for comparison thereof with a target value reflecting a desired limit on the value of said parameter, and

adjusting means responsive to a discrepancy between the values under comparison for adjusting the value of a second parameter of the output pulses related to the first-mentioned parameter to reduce the discrepancy and thereby stabilize the value of the first parameter, whereby to control the output pulses of the neurostimulator to enhance the efficiency of stimulation of the nerve membranes.

17. The invention of claim 16, wherein said comparing means compares the sampled value of the first parameter against a pair of upper and lower target values representing limits on the value of the first parameter.

18. The invention of claim 17, wherein the measuring means samples the value of the first parameter at a rate much slower than the rate at which the output pulses are generated.

19. The invention of claim 18, wherein said adjusting means adjusts the value of the second parameter to reduce the discrepancy only when the sampled value is outside desired upper and lower limits reflected by said pair of target values.

20. The invention of claim 18, wherein the adjusting means adjusts the value of the second parameter to reduce the discrepancy only when the sampled value is outside desired upper and lower limits reflected by said pair of target values over a multiplicity of pulse cycles.

21. The invention of claim 16, wherein the first parameter is the output pulse current.

22. The invention of claim 21, wherein the second parameter is the output pulse voltage.

26. Apparatus for stabilizing the value of a parameter of the output pulses of a neurostimulator for stimulating the excitable cell membranes of a selected nerve, comprising:

measuring means for ascertaining the value of said parameter of the output pulses by performing a series of successive approximations of said parameter over a sequence of said output pulses,

comparing means responsive to the ascertained value of said parameter for comparison thereof with a target value reflecting a desired limit on the value of said parameter, and

adjusting means responsive to a discrepancy between the values under comparison for adjusting the value of a second parameter of the output pulses related to the first-mentioned parameter to reduce the discrepancy and thereby stabilize the value of the first parameter, whereby to control the output pulses of the neurostimulator to enhance the efficiency of stimulation of the nerve membranes.

27. A method of stimulating body tissue, which comprises:

implanting a stimulating electrode adjacent the tissue to be stimulated;

applying electrical pulses to the electrode to stimulate the tissue; and

continually adjusting the level of current or charge delivered in the applied electrical pulses to maintain the value thereof within a predetermined range of values deemed most efficient for exciting the tissue to be stimulated, including adjusting the voltage level or the duration of the output pulses, and further including modelling the charge delivered in each output pulse to be constant for compensation thereof according to the time constant of the excitable cell membranes of the tissue to be stimulated.

28. The method according to claim 27, wherein the continual adjustment of the level of current or charge delivered in the output pulses further includes automatically terminating each output pulse upon delivery of an electrical charge therein which is sufficient to excite the cell membranes of the tissue, whether such charge is compensated or not.

29. A method of stimulating body tissue, which comprises:

implanting a stimulating electrode adjacent the tissue to be stimulated;

applying electrical pulses to the electrode to stimulate the tissue; and

continually adjusting the level of current or charge delivered in the applied electrical pulses to maintain the value thereof within a predetermined range of values deemed most efficient for exciting the tissue to be stimulated, including adjusting the voltage level or the duration of the output pulses, and further including modelling the charge delivered in each output pulse to induce a threshold charge across the excitable cell membranes of the tissue to be stimulated which accounts for charge loss attributable to leakage from the membranes.

30. Apparatus for stabilizing the magnitude of the current of the output pulses of a neurostimulator for stimulating the excitable cell membranes of a selected nerve, comprising:

measuring means for measuring the magnitude of the current of selected ones of the output pulses by sampling the current magnitude at a predetermined point of the selected pulses,

comparing means responsive to the measured value of the current magnitude for comparison thereof with a target value reflecting a desired limit on the current magnitude, and

adjusting means responsive to a discrepancy between the values under comparison for adjusting the value of a second parameter of the output pulses related to current magnitude thereof to reduce the discrepancy and thereby stabilize the value of the current magnitude, whereby to control the output pulses of the neurostimulator to enhance the efficiency of stimulation of the nerve membranes.

31. The invention of claim 30, wherein the measuring means performs the sampling at the trailing edge of the output pulses in separated cycles thereof.

32. The invention of claim 30, wherein the measuring means performs the sampling near the midpoint of the output pulses in separated cycles thereof.