Method and apparatus for intentional impairment of gastric motility and/or efficiency by triggered electrical stimulation of the gastrointestinal tract with respect to the intrinsic gastric electrical activity

• US 7,941,221 B2
• Filed: 02/19/2004
• Issued: 05/10/2011
• Est. Priority Date: 09/26/2000
• Status: Active Grant

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Foley, Stephen T.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): HOLMES, REX R
• Application Number:
  US10/782,087
• Publication Number:
  US 20040162595A1
• Time in Patent Office: 2,637 Days
• Field of Search: 607/40, 607/41, 607/133, 607/138
• US Class Current: 607/40
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A sensor based gastric stimulator system and method for gastric stimulation of a patient employing an implantable gastric stimulator, which includes an information processor, an electrical stimulator circuit, and telemetry circuitry. The implantable stimulator senses intrinsic, gastric electrical activity (slow waves and/or peristaltic waves) and delivers electrical stimulation to intentionally disrupt or disorganize that activity. The stimulation is triggered by (tracks) normal gastric electrical activity and can be delivered with a spatial offset to anticipate the propagating gastric electrical activity or may be delayed temporally to anticipate the next propagating slow or peristaltic wave. The stimulator may be programmed to disrupt/disorganize all or a percentage of the intrinsic, normal gastric electrical activity. The programmer (via radio frequency data link) may non-invasively program stimulation parameters and intervals. The stimulator may provide stimulation to one or a plurality of stimulation sites and may incorporate one or a plurality of independently programmable sensing and/or stimulation channels. The information processor of the implantable gastric stimulator uses the gastric stimulation information from the non-electrode sensor for determining periods or windows of susceptibility for application of the electrical signals conveyed with the stimulation electrode for conveying electrical signals from the electrical stimulator circuit to the stomach wall of the patient.

Claims

1. A system for gastric stimulation of a patient comprising:

a plurality of sensing electrodes for sensing intrinsic gastric activity from a stomach wall of a patient;

an implantable gastric stimulator coupled to the plurality of sensing electrodes, the implantable gastric stimulator configured to receive the sensed intrinsic gastric activity and perform an analysis of the sensed intrinsic gastric activity to classify the activity as normal or abnormal, and determine whether to create an electrical stimulation based at least in part upon the classification of the sensed intrinsic gastric activity as normal or abnormal, wherein the implantable gastric stimulator delivers the electrical stimulation when the sensed intrinsic gastric activity is classified as normal;

a plurality of stimulation electrodes configured to convey the electrical stimulation from the implantable gastric stimulator to the stomach wall of the patient, wherein the plurality of stimulation electrodes defines a plurality of stimulation vectors, wherein;

the electrical stimulation is configured to disrupt normal gastric activity of the stomach, and

the implantable gastric stimulator is configured to switch between any of the plurality of stimulation vectors depending upon the sensed intrinsic gastric activity.

2. A system as recited in claim 1, further comprising one or a plurality of elongated lead body sheaths having proximal end connectors for coupling said stimulation and sensing electrodes with said implantable gastric stimulator, portions of said stimulation and sensing electrodes extending through the elongated lead body sheaths to their distal end, the distal end of the elongated lead body sheaths for electrical communication with the stomach wall of the patient and for positioning said stimulation and sensing electrodes on or in the stomach wall.

3. A system as recited in claim 1, wherein said plurality of the stimulation and sensing electrodes are positionable at different locations of the stomach wall.

4. A system as recited in claim 1, wherein the implantable gastric stimulator further comprises a radio frequency telemetry transceiver provided for communication with a remote programmer.

5. A system as recited in claim 1, wherein said implantable gastric stimulator comprises a programmable microprocessor or microcontroller.

6. A system as recited in claim 1, wherein the stimulator temporarily reverts to a power conserve condition at programmable times of the day.

7. A system as recited in claim 1, wherein said sensing electrodes communicate the sensed intrinsic gastric activity to the implantable gastric stimulator for identifying at the implantable gastric stimulator an interval, an amplitude, and a duration of the sensed intrinsic gastric activity.

8. A system as recited in claim 7, wherein said sensing electrodes communicate the sensed intrinsic gastric activity to the implantable gastric stimulator for identifying at the implantable gastric stimulator a frequency spectrum of the sensed intrinsic gastric activity.

9. A system as recited in claim 8, wherein the stimulator analyzes the sensed intrinsic gastric activity and classifies the sensed intrinsic gastric activity as a slow wave or a peristaltic wave.

10. A system as recited in claim 1, wherein the stimulator temporarily reverts to a power conserve condition in the absence of a programmable threshold of normal electrical activity.

11. A system as recited in claim 10, wherein the stimulator delivery of electrical stimulation is triggered by electrical activity classified as a plurality of normal events.

12. A system as recited in claim 11, wherein the stimulator is programmed to deliver electrical stimulation on all or a percentage of the plurality of normal events.

13. A system as recited in claim 12, wherein the electrical stimulation is delivered across the sensed intrinsic gastric activity.

14. A system as recited in claim 12, wherein the electrical stimulation is delivered with a spatial offset to the sensed intrinsic gastric activity.

15. A system as recited in claim 12, wherein the electrical stimulation is delivered with a temporal offset to the sensed intrinsic gastric activity.

16. A system as recited in claim 12, wherein the electrical stimulation is delivered in anticipation of a next normal electrical activity.

17. A system as recited in claim 15, wherein the temporal offset is programmable by a user.

18. A system as recited in claim 1, wherein the stimulator incorporates at least one stimulation channel coupled to the plurality of stimulation electrodes and at least one independently programmable sensing channel coupled to the plurality of sensing electrodes.

19. A system as recited in claim 18, wherein at least one stimulation channel is programmable to parameters associated with nerve stimulation.

20. A system as recited in claim 1, wherein the implantable gastric stimulator employs a neural network to classify the sensed intrinsic gastric activity.

21. A system for gastric stimulation of a patient comprising:

a plurality of sensing electrodes for sensing intrinsic gastric activity from a stomach wall of a patient;

an implantable gastric stimulator coupled to the plurality of sensing electrodes, the implantable gastric stimulator configured to receive the sensed intrinsic gastric activity and perform an analysis of the sensed intrinsic gastric activity to classify the activity as normal or abnormal, and determine whether to create an electrical stimulation based at least in part upon the classification of the sensed intrinsic gastric activity as normal or abnormal, wherein the implantable gastric stimulator delivers the electrical stimulation when the sensed intrinsic gastric activity is classified as normal; and

a plurality of stimulation electrodes configured to convey the electrical stimulation from the implantable gastric stimulator to the stomach wall of the patient, wherein the electrical stimulation is configured to disrupt normal gastric activity of the stomach, wherein;

the stimulator temporarily reverts to a power conserve condition in the absence of a programmable threshold of normal electrical activity, delivers the electrical stimulation when the stimulator classifies sensed electrical activity as a plurality of normal events, is programmed to deliver electrical stimulation on all or a percentage of the plurality of normal events, and is configured to adapt temporal delivery of electrical stimulation based upon an algorithm considering a running history of recent predecessor electrical activity events.

22. A system as recited in claim 21, wherein the polarity of the stimulation electrodes is programmable by a user at the stimulator allowing stimulation between a single pair or a plurality of electrodes.

23. A system as recited in claim 22, wherein the stimulator is programmed to switch the polarity of one or a plurality of the various stimulation electrodes to accommodate multiphase stimulation.

24. A system as recited in claim 23, wherein the electrical stimulation comprises one or a plurality of biphasic pulses programmable within the following parameters, comprising:

pulse amplitude between 0.0 to 15 V or 0.0 to 15 mA;

pulse width between 20 msec to 500 msec;

pulses per event between 1 and 5; and

first phase width between 25 to 100 percent of pulse width.

25. A system as recited in claim 24, wherein the stimulator comprises an array, the array comprising two or more capacitors, and the pulse width is accommodated by switching between the two or more capacitors in the array.

26. A system as recited in claim 25, wherein the electrical stimulation comprises an alternating polarity pulse train programmable within the following parameters, comprising:

pulse amplitude between 0.0 to 15 V or 0.0 to 15 mA;

pulse width between 100 μ

sec and 750 μ

sec;

pulses per second (frequency) between 10 to 120 Hz; and

duration of pulse train between 0.5 and 30 seconds.

27. A system as recited in claim 26, wherein the stimulator comprises a memory and the parameters comprising quantities, interval frequency, duration, and amplitude for the sensed events and quantities of paced events are stored in memory for subsequent recall.

28. A system as recited in claim 27, wherein the sensed intrinsic gastric activity can be telemetered from the implantable gastric stimulator to an external programmer to assist in establishing the appropriate stimulation parameters.

29. A method for gastric stimulation of a patient comprising:

sensing intrinsic gastric activity on the stomach wall of a patient;

classifying the sensed intrinsic gastric activity as normal or abnormal;

determining when to apply electrical stimulation to the stomach wall of the patient based upon the classification of the sensed intrinsic gastric activity as normal or abnormal;

selecting at least one of a plurality of stimulation vectors across the stomach wall for application of electrical stimulation based upon the sensed intrinsic gastric activity;

forming an electrical signal in response to the determining when the sensed intrinsic gastric activity is classified as normal; and

applying the electrical signal via the at least one selected stimulation vector to disrupt normal gastric activity of the stomach.

30. The method of claim 29 further comprising maintaining a history of predecessor electrical events.

31. The method of claim 29 further comprising analyzing the sensed intrinsic gastric activity and classifying the sensed intrinsic gastric activity as a slow wave or a peristaltic wave.

32. The method of claim 29 wherein the step of determining determines a percentage of normal events and the step of disrupting applies the electrical signal for the percentage of electrical events.

33. The method of claim 29, wherein the step of applying is triggered by electrical activity classified as normal.

34. A system comprising:

a plurality of sensing electrodes for sensing intrinsic electrical gastric activity from a stomach wall of a patient;

an implantable gastric stimulator coupled to the sensing electrodes, wherein the implantable gastric stimulator receives the sensed intrinsic electrical gastric activity and classifies the activity as normal or abnormal, and wherein the stimulator creates electrical stimulation when the sensed intrinsic electrical gastric activity is classified as normal; and

a plurality of stimulation electrodes for conveying the electrical stimulation from the implantable gastric stimulator to the stomach wall of the patient, wherein the plurality of stimulation electrodes defines a plurality of stimulation vectors, wherein;

the electrical stimulation is configured to disrupt normal gastric activity of the stomach; and

the implantable gastric stimulator is configured to switch between any of the plurality of stimulation vectors based on the sensed intrinsic electrical gastric activity.

35. A method comprising:

sensing intrinsic electrical gastric activity from a stomach wall of a patient;

classifying the intrinsic electrical gastric activity as normal or abnormal;

selecting at least one of a plurality of stimulation vectors across the stomach wall for application of electrical stimulation to the patient based upon the sensed intrinsic electrical gastric activity;

applying electrical stimulation to the patient via the at least one selected stimulation vector when the intrinsic electrical gastric activity is classified as normal, wherein the electrical stimulation is configured to disrupt normal gastric activity of the stomach; and

withholding application of electrical stimulation to the patient when the intrinsic electrical gastric activity is classified as abnormal.