Gastric stimulator apparatus and method for use

• US 6,895,278 B1
• Filed: 12/17/1999
• Issued: 05/17/2005
• Est. Priority Date: 04/14/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Transneuronix Inc. (Medtronic Plc)
• Inventors: Gordon, Pat L.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/466,387
• Time in Patent Office: 1,978 Days
• Field of Search: 607/40, 607/45, 607/133, 607/8, 607/62, 607/58, 600/547
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus and method for stimulating neuromuscular tissue in the stomach. The neuromuscular stimulator stimulates the neuromuscular tissue by applying current-controlled electrical pulses. A voltage sensor detects the voltage across the neuromuscular tissue to determine if the voltage meets a predetermined voltage threshold. A control circuit adjusts the current-controlled pulse if the voltage is found to meet the voltage threshold, such that the voltage does not exceed the voltage threshold. A voltage-controlled pulse may also be applied to the tissue. A current sensor would then detect whether the current on the neuromuscular tissue meets a predetermined current threshold, and a control circuit adjusts the voltage controlled pulse such that the current does not exceed the current threshold. A real time clock may be provided which supplies data corresponding to the time of day during the treatment period. A programmable calendar stores parameters of the stimulating pulse, wherein the parameters have a reference to the time of day.

Claims

1. A neuromuscular stimulator for stimulating tissue of the gastrointestinal tract by applying a current-controlled electrical pulse to the neuromuscular tissue, comprising:

a voltage sensor to detect a voltage across the neuromuscular tissue being stimulated; and

circuitry configured to (a) compare the voltage with a predetermined voltage threshold and to adjust the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold, such that the voltage does not exceed the predetermined voltage threshold, (b) calculate electrode resistance;

said electrode resistance being voltage limit value divided by current value and (c) determine an increment of adjustment of voltage based on the electrode resistance.

2. The neuromuscular stimulator defined in claim 1, wherein the voltage threshold is adjustable.

3. The neuromuscular stimulator defined in claim 1, wherein the circuitry is configured to set the voltage threshold based on a current level associated with the current-controlled pulse.

4. The neuromuscular stimulator defined in claim 3, wherein the circuitry is configured to prepare a set of voltage thresholds and associated respective current levels.

5. The neuromuscular stimulator defined in claim 1, wherein the circuitry is configured to associate the electrode resistance with the current level of the current-controlled pulse.

6. The neuromuscular stimulator defined in claim 5, further comprising:

a memory device to store the electrode resistance and the associated current level.

7. The neuromuscular stimulator defined in claim 1, further comprising:

a display device to display the electrode resistance and the associated current level.

8. The neuromuscular stimulator defined in claim 1, further comprising:

a memory device to store an event characterized by the voltage being found to meet the predetermined voltage threshold.

9. The neuromuscular stimulator defined in claim 1, wherein the voltage sensor is configured to detect the voltage across the neuromuscular tissue at a leading edge of the electrical pulse.

10. The neuromuscular stimulator defined in claim 1, wherein the voltage sensor is configured to detect the voltage across the neuromuscular tissue at a trailing edge of the electrical pulse.

11. A neuromuscular stimulator for stimulating tissue of the gastrointestinal tract by applying a current-controlled electrical pulse to the neuromuscular tissue comprising:

a voltage sensor to detect a voltage across the neuromuscular tissue being stimulated; and

circuitry configured to (a) compare the voltage with a predetermined voltage threshold and to adjust the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold such that the voltage does not exceed the predetermined voltage threshold and (b) calculate capacitance of said tissue, said capacitance being the ratio of the current and the time rate of change of the voltage during an individual electrical stimulating pulse.

12. The neuromuscular stimulator defined in claim 11, wherein the circuitry is configured to determine the increment of adjustment based on the capacitance.

13. The neuromuscular stimulator defined in claim 11, wherein the circuitry is configured to associate the capacitance with the current level of the current-controlled pulse.

14. The neuromuscular stimulator defined in claim 11, further comprising:

a memory device to store the capacitance and the associated current level.

15. The neuromuscular stimulator defined in claim 11, further comprising:

a display device to display the capacitance and the associated current level.

16. A neuromuscular stimulator for stimulating tissue of the gastrointestinal tract by applying a current-controlled electrical pulse to the neuromuscular tissue, comprising:

a voltage sensor to detect a voltage across the neuromuscular tissue being stimulated; and

circuitry configured to compare the voltage with a predetermined voltage threshold and to adjust the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold such that the voltage does not exceed the predetermined voltage threshold.

wherein the neuromuscular stimulator is configured to determine and store a time value during the electrical pulse when the voltage associated with the electrical pulse meets the predetermined voltage threshold.

17. A method of stimulating neuromuscular tissue of the gastrointestinal tract comprising:

(a) preparing a set of voltage thresholds and associated respective current levels comprising;

setting a test value for the voltage threshold;

applying a first current pulse to the tissue to be stimulated;

iteratively varying the test value until the voltage level across the tissue is found to meet the test value; and

associating the voltage level with the respective current level in the set of voltage thresholds;

(b) applying a current-controlled electrical pulse to the neuromuscular tissue to stimulate the neuromuscular tissue;

(c) detecting a voltage across the neuromuscular tissue being stimulated;

setting the voltage threshold based on a current level associated with the current-controlled pulse;

(d) comparing the voltage with a predetermined voltage threshold; and

(e) adjusting the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold by the detecting, such that the voltage does not exceed the predetermined voltage threshold.

18. The method defined in claim 17, wherein preparing the set of voltage thresholds further comprises:

before the step of associating, multiplying the measured voltage level by a factor selected from a range between about 1.0 and 1.5.

19. The method defined in claim 17, wherein the detecting a voltage across the neuromuscular tissue being stimulated comprises detecting the voltage at a leading edge of the electrical pulse.

20. The method defined in claim 17, wherein the detecting the voltage across the neuromuscular tissue being stimulated comprises detecting the voltage at a trailing edge of the electrical pulse.

21. A method of stimulating neuromuscular tissue of the gastrointestinal tract comprising:

(a) applying a current-controlled electrical pulse to the neuromuscular tissue to stimulate the neuromuscular tissue;

(b) calculating electrode resistance, said electrode resistance being voltage limit value divided by current value;

(c) detecting a voltage across the neuromuscular tissue being stimulated;

(d) comparing the voltage with a predetermined voltage threshold; and

(e) adjusting the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold by the detecting such that the voltage does not exceed the predetermined voltage threshold wherein the step of adjusting the current-controlled pulse comprises determining an increment of adjustment of voltage based on the electrode resistance.

22. The method defined in claim 21, further comprising:

after calculating the electrode resistance, associating the electrode resistance with the current level of the current-controlled pulse.

23. The method defined in claim 22, further comprising:

after the step of associating the electrode resistance with the current level of the current-controlled pulse, storing the electrode resistance and the associated current level in a database.

24. The method defined in claim 21, further comprising:

after the step of associating the electrode resistance with the current level of the current-controlled pulse, displaying the electrode resistance and the associated current level.

25. A method of stimulating neuromuscular tissue of the gastrointestinal tract comprising:

(a) applying a current-controlled electrical pulse to the neuromuscular tissue to stimulate the neuromuscular tissue;

(b) calculating capacitance of said tissue, said capacitance being the ratio of the current and the time rate of change of the voltage;

(c) detecting a voltage across the neuromuscular tissue being stimulated;

(d) comparing the voltage with a predetermined voltage threshold; and

(e) adjusting the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold by the detecting, such that the voltage does not exceed the predetermined voltage threshold.

26. The method defined in claim 25, wherein the step of adjusting the current-controlled pulse further comprises:

determining the increment of adjustment based on the capacitance.

27. The method defined in claim 25, further comprising:

after the step of calculating the capacitance, associating the capacitance with the current level of the current-controlled pulse.

28. The method defined in claim 25, further comprising:

after the step of associating the capacitance with the current level of the current-controlled pulse, storing the capacitance and the associated current level in a database.

29. The method defined in claim 25, further comprising:

after the step of associating the capacitance with the current level of the current-controlled pulse, displaying the capacitance and the associated current level.

30. The method defined in claim 25, wherein the detecting a voltage across the neuromuscular tissue being stimulated comprises detecting the voltage at a leading edge of the electrical pulse.

31. The method defined in claim 25, wherein the detecting the voltage across the neuromuscular tissue being stimulated comprises detecting the voltage at a trailing edge of the electrical pulse.

32. A method of stimulating neuromuscular tissue of the gastrointestinal tract comprising:

(a) applying a current-controlled electrical pulse to the neuromuscular tissue to stimulate the neuromuscular tissue;

(b) detecting a voltage across the neuromuscular tissue being stimulated;

(c) comparing the voltage with a predetermined voltage threshold;

(d) storing an event in memory characterized by the voltage being found to exceed the predetermined voltage threshold; and

(e) adjusting the current-controlled pulse if the voltage is found to meet the predetermined voltage threshold by the detecting such that the voltage does not exceed the predetermined voltage threshold.