Implantable stimulator that prevents DC current flow without the use of discrete output coupling capacitors

• US 6,035,237 A
• Filed: 05/23/1995
• Issued: 03/07/2000
• Est. Priority Date: 05/23/1995
• Status: Expired due to Term

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Mann, Alfred E., Schulman, Joseph H., Lebel, Ronald J., Gord, John C.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/447,455
• Time in Patent Office: 1,750 Days
• Field of Search: 607/2, 607/5, 607/37, 607/57, 607/63
• US Class Current: 607/63
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36142 for improving safety

Abstract

An implantable living tissue stimulator avoids the use of conventional coupling capacitors in its output stage, yet still prevents an average dc current flow from flowing through living tissue in electrical contact with the stimulator. The output stage generates and applies a biphasic stimulating current pulse to selected paired output terminals. The terminals, in turn, are electrically connected to respective electrodes which are positioned so as to contact the living tissue to be stimulated. In one embodiment, special circuitry is employed within the output stage to block dc current flow through the living tissue and to balance the electrical charge that is delivered to the living tissue. In another embodiment, the electrodes themselves are made from a material that allows them to function as a capacitor. In yet an additional embodiment, the coupling capacitors are integrated into the leads that connect the output terminals of the output stage with the electrodes.

Claims

1. An implantable living tissue stimulator comprising:

a case having a plurality of feed-through terminals;

first circuit means inside of the case for generating a stimulating current pulse; and

second circuit means within the case for providing an electrical current path between the first circuit means and a selected pair of the plurality of feed-through terminals through which the stimulating current pulse must pass, and for blocking dc current flow through the electrical current path;

said second circuit means comprising a plurality of circuit elements that do not include a coupling capacitor and do not include a coupling transformer in the electrical current path.

2. The implantable living tissue stimulator of claim 1 wherein said case comprises a hermetically sealed enclosure.

3. The implantable stimulator of claim 1 wherein said second circuit means comprises electronic circuit simulating means for simulating a coupling capacitor placed in the electrical current path.

4. The implantable stimulator of claim 3 wherein said electronic circuit simulating means comprises:

current monitoring means for measuring the amount of current flowing through the electrical current path as a function of time;

voltage means for applying a controlled voltage potential to said electrical current path;

switch means for selectively opening and closing said electrical current path; and

control means responsive to the current measured by the current monitoring means for selectively controlling the voltage means so that the controlled potential applied to said electrical current path varies as a function of how much voltage would build up on a coupling capacitor of a prescribed capacitance placed in said electrical current path, and for selectively controlling said switch means to open said electrical current path whenever the measured electrical current flowing in the electrical current path has not changed over a prescribed time period.

5. The implantable stimulator of claim 4 wherein said control means further includes means for controlling said switch means to open said electrical current path whenever the measured electrical current flowing in the electrical current path remains less than a prescribed current value.

6. The implantable stimulator of claim 4 further comprising a charge measuring means for measuring a coulomb value and wherein said control means further includes means for controlling said switch means to open said electrical current path whenever the measured electrical current flowing in the electrical current path remains less than a prescribed coulomb value.

7. The implantable stimulator of claim 4 wherein said first circuit means includes means for generating a biphasic current pulse comprising a first pulse of one polarity followed by a second pulse of the opposite polarity and wherein said control means further controls said switch means to open said electrical current path whenever one of the pulses of the biphasic current pulse is missing.

8. The implantable stimulator of claim 3 wherein said electronic circuit simulating means comprises:

current monitoring means for measuring the amount of current flowing through the electrical current path as a function of time;

voltage means for applying a controlled voltage potential to said electrical current path;

an equivalent load circuit;

switch means for selectively connecting said electrical current path to either the selected pair of the plurality of feed-through terminals or to said equivalent load circuit; and

control means responsive to the current measured by the current monitoring means for selectively controlling the voltage means so that the controlled potential applied to said electrical current path varies as a function of how much voltage would build up on a coupling capacitor of a prescribed capacitance placed in said electrical current path, and for selectively controlling said switch means to connect said electrical current path to said equivalent load circuit whenever the measured electrical current flowing in the electrical current path has not changed over a prescribed time period.

9. The implantable stimulator of claim 8 wherein said control means further includes means for controlling said switch means to open said electrical current path whenever the measured electrical current flowing in the electrical current path remains less than a prescribed current value.

10. The implantable stimulator of claim 8 further comprising a charge measuring means for measuring a coulomb value and wherein said control means further includes means for controlling said switch means to open said electrical current path whenever the measured electrical current flowing in the electrical current path remains less than a prescribed coulomb value.

11. The implantable stimulator of claim 8 wherein said first circuit means includes means for generating a biphasic current pulse comprising a first pulse of one polarity followed by a second pulse of the opposite polarity and wherein said control means further controls said switch means to open said electrical current path whenever one of the pulses of the biphasic current pulse is missing.

12. The implantable stimulator of claim 8 wherein said current monitoring means comprises an integrating coulomb counter that generates a coulomb-indicating voltage v_i that varies as a function of the integrated coulomb count flowing in any one direction through the electrical current path.

13. The implantable stimulator of claim 8 wherein said current monitoring means comprises a current-to-voltage converter means for generating a current-indicating voltage v_i that varies as a function of the measured average current flowing through the electrical current path.

14. The implantable stimulator of claim 13 wherein said current-to-voltage converter means comprises two current mirror circuits, a first of which generates a voltage v₁ that varies as a function of the measured average current flowing in one direction through the electrical current path, and a second of which generates a voltage v₂ that varies as a function of the measured average current flowing in the other direction through the electrical current path.

15. The implantable stimulator of claim 14 wherein said current-to-voltage converter means includes means for generating a signal Wn which specifies a particular current polarity for the current-indicating voltage v_i.

16. The implantable stimulator of claim 3 wherein said first and second circuit means are realized using CMOS transistors configured to function as prescribed circuit elements on the same semiconductor chip.

17. The implantable stimulator of claim 1 wherein said second circuit means comprises electronic circuit control means, further comprising a plurality of circuit elements that do not include a coupling capacitor or a coupling transformer in the electrical current path, for preventing a stimulation current pulse from being applied through said electrical current path unless said stimulation current pulse comprises a biphasic current pulse.

18. The implantable stimulator of claim 17 wherein said electronic circuit control means comprises:

current monitoring means for monitoring the amplitude and polarity of a stimulation current pulse flowing through said electrical current path as a function of time; and

comparison means for comparing the current monitored by the current monitoring means with a reference value, and for preventing further current flow in the electrical current path in the event the current monitored by the current monitoring means is not a biphasic current pulse.

19. The implantable stimulator of claim 18 wherein said current monitoring means comprises

a current-to-voltage converter means for generating a current-indicating voltage v_i (t) that varies as a function of the measured current flowing through the electrical current path over time, and

means for generating a reference voltage v_REF (t);

and

wherein said comparison means comprises

voltage comparator means for comparing the voltage v_i (t) with the reference voltage v_REF (t), and

switch means for disrupting the electrical current path whenever v_i (t) differs from V_REF (t) by more than a prescribed amount.

20. The implantable stimulator of claim 1 wherein said first circuit means generates a biphasic current stimulation pulse, and wherein said second circuit means comprises electronic circuit control means for cancelling dc current flow in the electrical current path.

21. The implantable stimulator of claim 20 wherein said means for cancelling dc current flow comprises:

means for sensing current flow in the electrical current path and generating a first signal representative of the sensed current flow;

means for integrating the first signal and generating a second signal that comprises the integrated first signal, and wherein said means for integrating uses a time constant that is much longer than the biphasic current stimulation current pulse so that the integrator only responds to average dc current; and

transconductance amplifier means for converting the second signal to a second current and for injecting the second current back into the electrical current path.

22. The implantable stimulator of claim 1 wherein said first circuit means generates a biphasic current stimulation pulse, and wherein said second circuit means comprises means for measuring an average dc current and electronic circuit control means for blocking dc current flow through the electrical current path whenever the average dc current exceeds a prescribed threshold.

23. The implantable stimulator of claim 22 wherein said means for blocking dc current flow comprises:

means for sensing current flow in the electrical current path and generating a first signal representative of the sensed current flow;

means for integrating the first signal and generating a second signal that comprises the integrated first signal, and wherein said means for integrating uses a time constant that is much longer than the biphasic current stimulation current pulse so that the integrator only responds to average dc current;

means for comparing the second signal to the prescribed threshold and generating a first latch signal in the event the second signal exceeds the prescribed threshold; and

switch means for disrupting the electrical current path in response to the first latch signal.

24. The implantable stimulator of claim 23 wherein said means for comparing comprises means for comparing the second signal to a positive threshold and a negative threshold, and for generating the first latch signal in the event that the second signal exceeds either the positive threshold or the negative threshold.

25. An implantable living tissue stimulator comprising:

a biphasic current pulse generator; and

output circuit means for receiving a biphasic current pulse generated by the biphasic current pulse generator and directing such biphasic current pulse along an electrical current path to a selected pair of a plurality of output terminals;

said output circuit means comprising

prevention means for preventing an average dc current flow through the electrical current path, said prevention means comprising a plurality of circuit elements that do not include a coupling capacitor in the electrical current path.

26. The implantable stimulator of claim 25 wherein said prevention means comprises means for cancelling dc current flow in the electrical current path.

27. The implantable stimulator of claim 26 wherein said means for cancelling dc current flow in the electrical current path comprises:

means for sensing current flow in the electrical current path and generating a first signal representative of the sensed current flow;

means for integrating the first signal and generating a second signal that comprises the integrated first signal, and wherein said means for integrating uses a time constant that is much longer than the biphasic current stimulation current pulse, whereby the integrator only responds to average dc current; and

transconductance amplifier means for converting the second signal to a second current and for injecting the second current back into the electrical current path.

28. The implantable stimulator of claim 25 wherein said prevention means comprises means for cutting off the dc current flow through the electrical current path whenever the dc current exceeds a prescribed threshold.

29. The implantable stimulator of claim 28 wherein said means for cutting off the dc current flow comprises:

means for sensing current flow in the electrical current path and generating a first signal representative of the sensed current flow;

means for integrating the first signal and generating a second signal that comprises the integrated first signal, and wherein said means for integrating uses a time constant that is much longer than the biphasic current stimulation current pulse, whereby the integrator only responds to average dc current;

means for comparing the second signal to the prescribed threshold and generating a first latch signal in the event the second signal exceeds the prescribed threshold; and

switch means for disrupting the electrical current path in response to the first latch signal.

30. An implantable living tissue stimulator comprising:

biphasic current pulse generator means for generating a series of biphasic current pulses;

output circuit means for receiving a biphasic current pulse generated by the biphasic current pulse generator means and directing such biphasic current pulse along an electrical current path to a selected pair of a plurality of output terminals;

an electrode array comprising a plurality of electrodes, each electrode of said plurality of electrodes being connected to one of the plurality of output terminals, a selected pair of said plurality of electrodes thereby having the biphasic current pulse applied thereto; and

means for preventing dc current flow, without output coupling capacitors or output coupling transformers, through the selected pair of said plurality of electrodes of said electrode array.

31. The stimulator as set forth in claim 30 wherein the means for preventing dc current flow through the selected pair of said plurality of electrodes of said electrode array comprises electronic circuit means inserted into the electrical current path between the biphasic current pulse generator and the selected pair of the plurality of output terminals that simulates a coupling capacitor.

32. The stimulator as set forth in claim 30 wherein the means for preventing dc current flow through the selected pair of said plurality of electrodes of said electrode array comprises electronic circuit means inserted into the electrical current path between the biphasic current pulse generator and the selected pair of the plurality of output terminals that cancels average dc current flow in the electrical current path.

33. The stimulator as set forth in claim 30 wherein the means for preventing dc current flow through the selected pair of said plurality of electrodes of said electrode array comprises electronic circuit means inserted into the electrical current path between the biphasic current pulse generator and the selected pair of the plurality of output terminals for disrupting the dc current flow in the electrical current path whenever the amplitude of the dc current exceeds a prescribed threshold.

34. The stimulator as set forth in claim 30 wherein the means for preventing dc current flow through the selected pair of said plurality of electrodes comprises an electrode-tissue interface capacitance, and wherein each electrode of the selected pair of electrodes has an oxide layer thereon, and further wherein each electrode of the selected pair of electrodes comprises a plate of the electrode-tissue interface capacitance, with the oxide layer on each electrode functioning as a dielectric material for the electrode-tissue interface capacitance.

35. The stimulator as set forth in claim 34 wherein the electrode means comprises means for making said electrodes from a sintered anodizable material.

36. The stimulator as set forth in claim 35 wherein said sintered anodizable material comprises sintered anodizable tantalum.

37. A method of stimulating living tissue with a stream of biphasic stimulation current pulses while preventing an average dc current flow from flowing through the living tissue, said method comprising:

generating a series of biphasic stimulation current pulses;

applying the series of biphasic stimulation pulses to an electrical current path that includes an electrode pair in contact with the living tissue; and

cancelling dc current flow in the electrical current path by;

sensing any dc current flow in the electrical current path having a time constant associated therewith that is longer than the biphasic stimulation current pulse,

generating an offsetting current that is equal to but opposite in polarity from the sensed dc current flow, and

injecting the offsetting current into the electrical current path.

38. A method of stimulating living tissue with a stream of biphasic stimulation current pulses while preventing an average dc current flow from flowing through the living tissue, said method comprising:

generating a series of biphasic stimulation current pulses;

applying the series of biphasic stimulation pulses to an electrical current path that includes an electrode pair in contact with the living tissue; and

blocking dc current flow in the electrical current path by;

sensing any dc current flow in the electrical current path having a time constant associated therewith that is longer than the biphasic stimulation current pulse,

comparing the sensed dc current to a prescribed threshold level, and

disrupting the electrical current path to the tissue whenever the sensed dc current exceeds the prescribed threshold level.