Method and apparatus for electrical stimulation of the gastrointestinal tract

• US 5,836,994 A
• Filed: 04/30/1997
• Issued: 11/17/1998
• Est. Priority Date: 04/30/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc), Michael J. Jaro
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bourgeois, Ivan
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/846,786
• Time in Patent Office: 566 Days
• Field of Search: 607/40, 607/41, 607/73, 607/133, 607/138, 607/143, 600/29, 600/30
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method and apparatus for providing electrical stimulation of the gastrointestinal tract. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular layer of the stomach. The pulse generator preferably features sensors for sensing gastric electrical activity, and in particular, whether peristaltic contractions are occurring. In particular two sensors are featured. The first sensor senses low frequency gastrointestinal electrical activity between the frequency of 0.017-0.25 Hz and the second sensor senses intrinsic gastrointestinal electrical activity between the frequency of 100-300 Hz, which occurs upon normal peristaltic contractions. The second sensor only senses for a preset period after low frequency gastrointestinal electrical activity has been sensed by the first sensor. The pulse generator further delivers stimulation pulse trains to the gastrointestinal tract at a period of time after low frequency gastrointestinal electrical activity has been sensed by the first sensor. If, however, the second sensor senses intrinsic gastrointestinal electrical activity between the frequency of 100-300 Hz, then the delivery of stimulation pulse trains to the gastrointestinal tract is inhibited. In such a manner the present invention detects the occurrence of normal peristaltic contractions and further provides electrical stimulation to the gastrointestinal tract if such normal peristaltic contractions are not detected.

Claims

1. An apparatus for providing electrical stimulation to the gastrointestinal tract comprising:

a medical electrical lead having means for electrically coupling to the gastrointestinal tract;

a first sensor for sensing intrinsic gastrointestinal electrical activity between the frequency of 100-5000 Hz, the sensor coupled to the means for electrically coupling to the gastrointestinal tract, the sensor emitting an intrinsic gastrointestinal electrical activity signal upon the sensing of intrinsic gastrointestinal electrical activity;

a pulse generator coupled to the medical electrical lead having means for electrically coupling to the gastrointestinal tract and the first sensor, the pulse generator emitting asynchronous stimulation pulse trains at a first rate, the pulse generator inhibiting the emission of asynchronous stimulation pulse trains at a first rate upon the emission of the intrinsic gastrointestinal electrical activity signal by the first sensor.

2. The apparatus according to claim 1 wherein the stimulation pulse trains comprise a series of pulse trains emitted at a frequency of 30 Hz and a duration of approximately 4 seconds, each pulse lasting 330 microseconds with an amplitude of between approximately 0.5 to 10 Volts or a current of between approximately 0.1 milliamps to 30 milliamps.

3. The apparatus according to claim 1 wherein the pulse train having a first section and a second section, the first section having a first frequency, the second section having a second frequency.

4. The apparatus of claim 3 wherein the first frequency is greater than the second frequency.

5. The apparatus of claim 3 wherein the first frequency is less than the second frequency.

6. The apparatus of claim 3 wherein the first section has a first amplitude, the second section has a second amplitude.

7. The apparatus of claim 3 wherein the first amplitude is less than the second amplitude.

8. An apparatus for providing electrical stimulation to the gastrointestinal tract comprising:

a medical electrical lead having means for electrically coupling to the gastrointestinal tract;

a first sensor for sensing low frequency gastrointestinal electrical activity between the frequency of 0.017-0.25 Hz, the sensor coupled to the means for electrically coupling to the gastrointestinal tract, the sensor emitting a low frequency gastrointestinal electrical activity signal upon the sensing of low frequency gastrointestinal electrical activity;

a second sensor for sensing intrinsic gastrointestinal electrical activity between the frequency of 100-5000 Hz, the sensor coupled to the means for electrically coupling to the gastrointestinal tract and the first sensor, the second sensor emitting an intrinsic gastrointestinal electrical activity signal upon the sensing of intrinsic gastrointestinal electrical activity between the frequency of 100-5000 Hz within a pre-set period after the emission of a low frequency gastrointestinal electrical activity signal by the first sensor;

a pulse generator coupled to the means for electrically coupling to the gastrointestinal tract, the first sensor and the second sensor, the pulse generator emitting asynchronous stimulation pulse trains at a first rate, the pulse generator inhibiting the emission of asynchronous stimulation pulse trains at a first rate upon the emission of the intrinsic gastrointestinal electrical activity signal by the second sensor.

9. A method of electrically stimulating an organ of the gastrointestinal tract comprising the steps of:

sensing low frequency slow waves within an organ of the gastrointestinal tract;

determining whether the sensed low frequency slow waves a exceeds predetermined slow wave amount;

delivering slow wave electrical stimulation if the sensed low frequency slow waves do not exceed the predetermined slow wave amount and delivering burst electrical stimulation;

sensing high frequency spike activity within the organ of the gastrointestinal tract;

determining whether the sensed high frequency spike activity exceeds a predetermined fast wave amount; and

delivering burst electrical stimulation if the sensed high frequency spike activity is lower than the predetermined fast wave amount.

10. The method of electrically stimulating an organ of claim 9 wherein the step of sensing low frequency slow waves comprises sensing gastrointestinal electrical activity between the frequency of approximately 0.017-0.25 Hz.

11. The method of electrically stimulating an organ of claim 9 wherein the step of sensing high frequency spike activity comprises sensing gastrointestinal electrical activity between the frequency of approximately 100-5000 Hz.

12. The method of electrically stimulating an organ of claim 9 wherein the step of sensing high frequency spike activity comprises sensing gastrointestinal electrical activity between the frequency of approximately 100-5000 Hz for only a preset period of time after the step of sensing low frequency slow waves.

13. The method of electrically stimulating an organ of claim 9 wherein the step of delivering slow wave electrical stimulation comprises a series of pulse trains emitted at a frequency of 30 Hz and a duration of approximately 4 seconds, each pulse lasting 330 microseconds with an amplitude of between approximately 0.5 to 10 Volts or a current of between approximately 0.1 milliamps to 30 milliamps.

14. The method of electrically stimulating an organ of claim 9 wherein the step of delivering burst electrical stimulation comprises delivering a series of pulse trains emitted at a frequency of 30 Hz and a duration of approximately 4 seconds, each pulse lasting 330 microseconds with an amplitude of between approximately 0.5 to 10 Volts or a current of between approximately 0.1 milliamps to 30 milliamps.

15. A method of electrically stimulating an organ comprising the steps of:

sensing a parameter indicative of the fullness of an organ within the GI tract;

sensing the absence of muscular contractions in the organ; and

delivering an electrical muscular contraction stimulation to the organ to thereby cause a contraction to occur in the organ.

16. The method of electrically stimulating an organ of claim 15 wherein the step of sensing the absence of muscular contractions in the organ comprises:

sensing low frequency slow waves; and

sensing gastrointestinal electrical activity between the frequency of approximately 100-5000 Hz for only a preset period of time after the step of sensing low frequency slow waves.

17. An apparatus for providing electrical stimulation to the gastrointestinal tract comprising:

a pulse generator, the pulse generator generating electrical stimulation pulse trains at a pre set frequency,

a medical electrical lead having means for electrically coupling to the gastrointestinal tract;

means for sensing low frequency slow waves within an organ of the gastrointestinal tract; and

means for sensing high frequency spike activity within an organ of the gastrointestinal tract for a first pre set period of time after the sensing of low frequency slow waves, the means for sensing high frequency spike activity coupled to the pulse generator and inhibiting the generation of the electrical stimulation pulse trains for a second pre set period of time when the sensed high frequency spike activity exceeds a programmed high frequency spike activity value.

18. The apparatus of claim 17 wherein the means for sensing low frequency slow waves comprises means for sensing gastrointestinal electrical activity between the frequency of approximately 0.017-0.25 Hz.

19. The apparatus of claim 17 wherein the means for sensing high frequency spike activity for a first pre set period of time after the sensing of low frequency slow waves comprises means for sensing gastrointestinal electrical activity between the frequency of approximately 100-5000 Hz.