Method and apparatus for sensing a stimulating gastrointestinal tract on-demand

• US 5,861,014 A
• Filed: 04/30/1997
• Issued: 01/19/1999
• Est. Priority Date: 04/30/1997
• Status: Expired due to Term

• Current Assignee: Michael J. Jaro
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Familoni, Babajide O.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/846,783
• Time in Patent Office: 629 Days
• Field of Search: 607/40
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Method and apparatus for providing on-demand 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 sensor for sensing abnormalities in gastric electrical activity. The pulse generator further features means for recognizing the type of gastric abnormality sensed. That is means for detecting whether gastric arrhythmia, bradygastria, dysrhythmia, tachygastria or retrograde propagation or uncoupling are present. If any of these gastric rhythm abnormalities are detected, then the pulse generator features means for emitting stimulation pulse trains to the gastric system to treat the detected gastric rhythm abnormalities. The stimulation pulse trains may take many forms and may be emitted for various periods of time.

Claims

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

a housing,

means for sensing electrical activity of the gastrointestinal tract between the frequency of approximately 1 to 15 cycles/min. positioned within the housing,

a controller positioned within the housing, the controller coupled to the means for sensing,

means for generating electrical stimulation pulse trains, the means for generating electrical stimulation pulse trains controlled by the controller and positioned within the housing; and

means for electrically coupling the means for generating to a gastrointestinal tract of a patient.

2. The apparatus of claim 1 wherein the signal processor comprises a bandpass amplifier responsively coupled to the means for sensing the bandpass amplifier producing a bandpass filtered signal from the sensed signal, and

a zero-level detector coupled to the bandpass amplifier to thereby produce a pulse train of a frequency component proportional to a highest amplitude spectral component of the bandpass signal.

3. The apparatus of claim 1 further comprising means for recording the intrinsic gastrointestinal electrical activity for a preset period of time in response to the sensing of an abnormal electrical activity signal.

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

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

a sensor for sensing intrinsic gastrointestinal electrical activity between the frequency of approximately 1 to 15 cycles/min.;

a signal processor to process the sensed intrinsic gastrointestinal electrical activity between the frequency of approximately 1 to 15 cycles/min. (0.017-0.25 Hz) and generate an abnormal gastrointestinal electrical activity trigger signal when abnormal gastrointestinal electrical activity is sensed;

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 the medical electrical lead, the pulse generator emitting stimulation pulse trains for a pre-set period of time in response to the abnormal gastrointestinal electrical activity trigger signal from the signal processor.

5. The apparatus of claim 4 wherein the signal processor comprises a bandpass amplifier responsively coupled to the means for sensing the bandpass amplifier producing a bandpass filtered signal from the sensed signal;

and

a zero-level detector coupled to the bandpass amplifier to thereby produce a pulse train of a frequency component proportional to a highest amplitude spectral component of the bandpass signal.

6. The apparatus of claim 4 further comprising means for recording the intrinsic gastrointestinal electrical activity for a preset period of time in response to the generation of an abnormal;

electrical activity signal.

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

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

a sensor for sensing intrinsic gastrointestinal electrical activity between the frequency of approximately 1 to 15 cycles/min.;

a signal processor to process the sensed intrinsic gastrointestinal electrical activity between the frequency of approximately 1 to 15 cycles/min. and generate an abnormal gastrointestinal electrical activity trigger signal when abnormal gastrointestinal electrical activity is sensed;

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 the medical electrical lead, the pulse generator emitting stimulation pulse trains only during the time the abnormal gastrointestinal electrical activity trigger signal is received.

8. The apparatus of claim 7 wherein the signal processor comprises a bandpass amplifier responsively coupled to the means for sensing the bandpass amplifier producing a bandpass filtered signal from the sensed signal;

a zero-level detector coupled to the bandpass amplifier to thereby produce a pulse train of a frequency component proportional to a highest amplitude spectral component of the bandpass signal.

9. The apparatus of claim 8 further comprising means for recording the intrinsic gastrointestinal electrical activity for a preset period of time in response to the generation of an abnormal electrical activity signal.

10. An apparatus for providing on-demand stimulation of the gastrointestinal tract comprising:

a housing, the housing having means for detecting cyclic activity of smooth muscle;

means for processing the detected cyclic activity of smooth muscle greater than approximately 5 cycles per minute or less than approximately 2 cycle per minute, the means for processing emitting an abnormal gastrointestinal activity signal when the cyclic activity of smooth muscle is greater than approximately 5 cycles per minute or less than approximately 2 cycle per minute is processed;

means for detecting the emission of the abnormal gastrointestinal activity signal by the processing means and generating electrical stimulation in response to the abnormal gastrointestinal activity signal;

means for electrically coupling the means for generating to a gastrointestinal tract of a patient.

11. The apparatus of claim 10 wherein the means for processing emitting an abnormal gastrointestinal activity signal when the cyclic activity of smooth muscle greater than approximately 5 cycles per minute or less than approximately 2 cycle per minute is processed;

and means for emitting electrical stimulation in response to the abnormal gastrointestinal activity signal.

12. The apparatus of claim 10 wherein the means for processing the detected cyclic activity of smooth muscle processes the detected cyclic activity of smooth muscle which is greater than approximately 10 cycles per minute or less than approximately 1 cycle per minute.