Method and apparatus for treating irregular gastric rhythms

• US 6,216,039 B1
• Filed: 05/02/1997
• Issued: 04/10/2001
• Est. Priority Date: 05/02/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bourgeois, Ivan
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/850,724
• Time in Patent Office: 1,439 Days
• Field of Search: 607/40, 607/41, 607/73, 607/137, 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 treating gastric arrhythmia. The apparatus features an implantabler 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 muscle layer of the stomach. The apparatus further features a sensor to sense slow waves and determines whether the slow waves are occurring in an irregular or unstable manner. The apparatus further permits such slow waves to be diagnosed as either occurring in a bradygastria or a tachygastria and provides the appropriate electrical stimulation in response. Thus the present invention diagnoses and treats irregular gastric rhythm such as bradygastria and tachygastria.

Claims

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

a sensor for sensing a first interval of intrinsic gastrointestinal electrical activity between the frequency of 1 to 15 cycles/min. (0.017-0.25 Hz) and a second interval of intrinsic gastrointestinal electrical activity between the frequency of 1 to 15 cycles/min. (0.017-0.25 Hz);

a signal processor to process the sensed intrinsic gastrointestinal electrical activity and generate an abnormal gastrointestinal electrical activity trigger signal when the first interval differs from the second interval by an abnormal amount;

a pulse generator, the pulse generator coupled to the signal processor so as to receive the abnormal gastrointestinal electrical activity trigger signal, the pulse generator coupled to at least one medical electrical lead, the pulse generator emitting stimulation pulse trains at a first rate, wherein the first rate is a multiple of an average of a sensed intrinsic gastrointestinal electrical activity rate, and the multiple is about three times the average of a sensed intrinsic gastrointestinal electrical activity rate.

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 1, wherein the first frequency is greater than the second frequency.

5. The apparatus of claim 1, wherein the first frequency is less than the second frequency.

6. The apparatus of claim 1, wherein the first section has a first amplitude, the second section has a second amplitude.

7. The apparatus of claim 1, wherein the first amplitude is less than the second amplitude.

8. A method of regularizing slow waves in the GI tract comprising the steps of:

sensing slow wave within the GI tract and determining the a slow wave rate;

detecting whether the slow wave rate is outside a predetermined normal slow wave band;

detecting whether the slow wave rate has changed its rate outside a predetermined slow wave rate change band; and

delivering normalizing gastric rhythm electrical stimulation if the slow wave rate has changed outside a predetermined slow wave rate change band;

wherein the normalizing gastric rhythm electrical stimulation comprises delivering a series of electrical stimulation pulse trains and the electrical stimulation pulse trains are 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.

9. A method of regularizing slow waves in the GI tract according to claim 8, further comprising the steps of determining whether tachygastria is present and delivering tachygastria electrical stimulation, and

determining whether bradygastria is present and delivering bradygastria electrical stimulation.

10. A method of regularizing slow waves in the GI tract according to claim 9, wherein the step of delivering bradygastria electrical stimulation comprises delivering a series of one or more electrical pulses, each pulse having an amplitude between approximately 1-50 milliamps and pulse width between approximately 3-1000 microsecs.

11. A method of regularizing slow waves in the GI tract according to claim 10, wherein the bradygastria electrical stimulation is delivered at a rate of between approximately 7-27 bpm.