Gastric stimulator apparatus and method for installing

• US 20030114895A1
• Filed: 02/05/2003
• Published: 06/19/2003
• Est. Priority Date: 04/14/1999
• Status: Abandoned Application

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Transneuronix Inc. (Medtronic Plc)
• Inventors: Jenkins, David A., Gordon, Pat L.
• Application Number:
  US10/359,105
• Publication Number:
  US 20030114895A1
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus for stimulating neuromuscular tissue of the gastrointestinal tract and methods for installing the apparatus to the neuromuscular tissue. Four electrodes are supported by an electrode assembly for attachment to the neuromuscular tissue. The electrodes are oriented substantially equidistantly with respect to the tissue and provide an electrical interface with the neuromuscular tissue. The pulse generator is provided with a switching matrix, and may stimulate the tissue in a time-varying manner by selecting pairs of electrodes and altering the polarities thereof while stimulating the tissue.

Claims

1. Method of installing a plurality of electrodes to tissue in the viscera for electrical stimulation of said tissue, comprising:

providing a first electrode-pair attachment member configured to pass through the tissue and supporting first and second electrodes thereon spaced a first distance apart, a second electrode-pair attachment member configured to pass through the tissue and supporting third and fourth electrodes thereon spaced a second distance apart, and a flexible bridging portion attached to the first and second electrode attachment members and configured to allow relative positioning of the first and second electrode attachment members in the tissue such that the first, second, third and fourth electrodes are substantially equidistantly spaced apart;

laparoscopically inserting the first and second electrode attachment members, the electrodes, and the bridging member through a surgical access opening in the patient; and

passing the first and second electrode attachment members through the neuromuscular tissue such that the first, second, third, and fourth electrodes are substantially equidistantly spaced apart, thereby forming an electrical interface between the electrodes and the neuromuscular tissue.

2. Method defined in claim 1, wherein the first electrode attachment member comprises a piercing member at end portion thereof, the passing the first and second electrode attachment members through the neuromuscular tissue comprising:

piercing the surface of the tissue with the piercing member at a first location, passing the electrode member through and along the tissue, and passing the piercing member out of the tissue at a second location, such that the first and second electrodes provide an electrical interface with the tissue.

3. Method defined in claim 2, wherein the first electrode attachment member comprises first and second retention members extending radially outward from the first electrode attachment member, the passing the first and second electrode attachment members through the neuromuscular tissue further comprising:

passing the first and second retention member along with the first electrode member, such that the first retention member passes through the tissue to a position outside the tissue and in engagement therewith at the second location to prevent the first electrode attachment member from moving axially from the second location to the first location, and the second retention member is positioned outside the tissue and in engagement therewith at the first location to prevent the first electrode attachment member from moving axially from the first location to the second location.

4. Method defined in claim 2, the passing the first and second electrode attachment members through the neuromuscular tissue further comprising:

sequentially advancing the first electrode attachment member and the bridging member along and through the tissue and out of the tissue at the second location; and

passing the second electrode attachment member through and along the tissue, such that the third and fourth electrodes provide an electrical interface with the tissue.

5. Method defined in claim 3, wherein the passing the first and second electrode attachment members through the neuromuscular tissue further comprising:

piercing the surface of the tissue with the piercing member at a third location, passing the first electrode member through and along the tissue, and passing the piercing member out of the tissue at a fourth location, such that the first and second electrodes provide an electrical interface with the tissue.

6. Method defined in claim 2, wherein the second electrode attachment member comprises a second piercing member at an end portion thereof, the passing the first and second electrode attachment members through the neuromuscular tissue further comprising:

piercing the surface of the tissue with the second piercing member at a third location, passing the second electrode attachment member through and along the tissue, and passing the second piercing member out of the tissue at a fourth location, such that the third and fourth electrodes provide an electrical interface with the tissue.

7. Method defined in claim 1, further comprising:

prior to laparoscopically inserting the first and second electrode attachment members, relatively positioning the first and second electrode attachment members in a compacted configuration.

8. Method defined in claim 1, wherein attaching the electrode attachment member to the surface of the neuromuscular tissue comprises attaching the electrode attachment member to the neuromuscular tissue in the viscera of the gastrointestinal tract.

9. Method of applying electrical stimulation to the neuromuscular tissue in the viscera, comprising:

providing an electrode attachment assembly supporting first, second, third and fourth electrodes thereon for attachment to the tissue such that the first, second, third and fourth electrodes are substantially equidistantly spaced apart;

laparoscopically inserting the electrode attachment assembly through a surgical access opening in the patient;

attaching the electrode attachment assembly to the neuromuscular tissue such that the first, second, third, and fourth electrodes are substantially equidistantly spaced apart, thereby forming an electrical interface between each of the first, second, third, and fourth electrodes and the neuromuscular tissue; and

electrically stimulating the tissue in a time-varying manner with selectable pairs of the first, second, third and fourth electrodes with a pulse generator.

10. Method defined in claim 9, wherein the providing an electrode attachment assembly comprises providing a first electrode attachment member configured to pass through the tissue and supporting first and second electrodes thereon spaced a first distance apart, a second electrode attachment member configured to pass through the tissue and supporting third and fourth electrodes thereon spaced a second distance apart, and a flexible bridging portion attached to the first and second electrode attachment members and configured to allow relative positioning of the first and second electrode attachment members in the tissue such that the first, second, third and fourth electrodes are substantially equidistantly spaced apart, and

wherein the attaching the electrode attachment member to the neuromuscular tissue comprises passing the first and second electrode attachment members through the neuromuscular tissue such that the first, second, third, and fourth electrodes are substantially equidistantly spaced apart, thereby forming an electrical interface between the electrodes and the neuromuscular tissue.

11. Method defined in claim 9, wherein the providing an electrode attachment assembly comprises providing an electrode attachment member supporting the first, second, third and fourth electrodes on a distal surface thereon spaced substantially equidistantly apart, and

wherein the attaching the electrode attachment member to the neuromuscular tissue comprises attaching the distal surface of the electrode attachment member to the surface of the viscera, thereby forming an electrical interface between each of the first, second, third, and fourth electrodes and the neuromuscular tissue.

12. Method defined in claim 11, wherein the providing an electrode attachment assembly further comprises providing a helical attachment member extending from the distal surface of the electrode attachment member, and

wherein the attaching the electrode attachment member to the neuromuscular tissue further comprises attaching the distal surface of the electrode attachment member to the surface of the viscera with the helical attachment member.

13. Method defined in claim 11, wherein the attaching the electrode attachment member to the neuromuscular tissue further comprises attaching the distal surface of the electrode attachment member to the surface of the viscera with sutures.

14. Method defined in claim 11, wherein the attaching the electrode attachment member to the neuromuscular tissue further comprises attaching the distal surface of the electrode attachment member to the surface of the viscera with staples.

15. Method defined in claim 10, wherein the first, second, third, and fourth electrode comprise a first and a second diagonally-oriented electrode pair, and wherein electrically stimulating the tissue comprises:

applying electrical stimulation between the electrodes of the first diagonally-oriented electrode pair and the electrodes of the second diagonally-oriented electrode pair, wherein each electrode in the first diagonally-oriented electrode pair has a first polarity and each electrode in the second diagonally-oriented electrode pair has a second polarity.

16. Method defined in claim 10, wherein the first, second, third, and fourth electrode comprise a first and a second diagonally-oriented electrode pair, and wherein electrically stimulating the tissue comprises:

applying electrical stimulation across the first diagonally-oriented electrode pair during a first time period; and

applying electrical stimulation across the second diagonally-oriented electrode pair during a second time period.

17. Method defined in claim 16, further comprising:

applying electrical stimulation across the first diagonally-oriented electrode pair during a third time period such that the polarity of each of the electrodes comprising the first diagonally-oriented electrode pair is reversed from the polarity of the respective electrodes during the first time period; and

applying electrical stimulation across the second diagonally-oriented electrode pair during a fourth time period such that the polarity of each of the electrodes comprising the second diagonally-oriented electrode pair is reversed from the polarity of the respective electrodes during the second time period.

18. Method defined in claim 10, wherein the first, second, third, and fourth electrodes comprise a first, second, third and fourth adjacent electrode pairs, and wherein electrically stimulating the tissue comprises:

applying electrical stimulation across the first adjacent electrode pair during a first time period;

applying electrical stimulation across the second adjacent electrode pair during a second time period;

applying electrical stimulation across the third adjacent electrode pair during a third time period; and

applying electrical stimulation across the fourth adjacent electrode pair during a fourth time period.

19. Apparatus for electrically stimulating neuromuscular tissue of the viscera by applying electrical pulses to the neuromuscular tissue, the electrical pulses supplied by a pulse generator, comprising:

first and second electrodes electrically connected with the pulse generator;

first electrode-pair attachment member having a body portion configured to penetrate through the tissue and supporting the first and second electrodes thereon spaced a first distance apart;

third and fourth electrodes electrically connected with the pulse generator;

second electrode-pair attachment member having a body portion configured to penetrate through the tissue and supporting the third and fourth electrodes thereon spaced a second distance apart; and

bridging portion attached to the first and second electrode-pair attachment members and configured to allow relative positioning of the first and second electrode-pair attachment members in the tissue such that the first, second, third and fourth electrodes may be substantially equidistantly spaced apart.

20. Apparatus defined in claim 19, wherein the first electrode-pair attachment member further comprises:

a sharpened piercing member extending from the body portion thereof for piercing the tissue.

21. Apparatus defined in claim 20, wherein the first electrode-pair attachment members further comprises:

a connecting member between the piercing member and the body portion fabricated from a material that may be severed to allow separation of the piercing member from the body portion.

22. Apparatus defined in claim 19, wherein the first electrode-pair attachment member has retention members extending radially outward from the body portion thereof to engage a surface of the tissue to prevent axial movement in one direction of the first electrode attachment member with respect to the tissue.

23. Apparatus defined in claim 19, wherein the body portion is flexible to allow the first electrode-pair attachment member to enter the tissue at a first location through a first surface thereof, to pass through the tissue, and to partially pass out of the tissue at the surface thereof at a second location spaced apart from the first location.

24. Apparatus defined in claim 19, wherein the bridging portion has a bifurcated configuration, having a pair of first end portions attached respectively to the end portions of the first and second electrode-pair attachment members, and a single second end portion providing electrical connection to the pulse generator via a lead positioned therebetween.

25. Apparatus defined in claim 19, wherein the first electrode-pair attachment member has a securing member having a first position to engage a surface of the tissue to inhibit axial movement of the first attachment member with respect to the tissue, and resiliently movable to a second position allowing relative axial movement between the electrode-pair attachment member and the tissue.

26. Apparatus defined in claim 25, wherein the securing member has a substantially frusto-conical configuration configured to move between the first configuration defining an acute angle with respect to the axis of the body portion and the second configuration defining an obtuse angle with respect to the axis of the body portion,

the securing member configured to move between the first and second configurations in response to the predetermined contact force of the first electrode-pair attachment member with the tissue.

27. Apparatus defined in claim 19, wherein the bridging portion has a first end portion connected to an end portion of the first electrode-pair attachment member and a second end portion connected to an end portion of the second electrode-pair attachment member.

28. Apparatus defined in claim 19, wherein the bridging portion is flexible to allow relative positioning of the first and second electrode-pair attachment members in a compacted configuration to pass through a laparoscopic surgical access opening.

29. Apparatus defined in claim 19, wherein the viscera includes the gastrointestinal tract.

30. Apparatus defined in claim 19, further comprising:

a pulse generator configured to supply electrical pulses to the first, second, third, and fourth electrodes in a time-varying manner with selectable pairs of the electrodes.

31. Apparatus defined in claim 30, wherein the pulse generator comprises a switching matrix responsive to a controller for applying the selectable pairs of electrodes with stimulating pulses of predetermined polarities.

32. Apparatus defined in claim 30, wherein the pulse generator is configured to apply electrical stimulation between the first diagonally-oriented electrode pair having a first polarity and the second diagonally-oriented electrode pair simultaneously having a second polarity.

33. Apparatus defined in claim 30, wherein the first, second, third, and fourth electrodes comprise a first and a second diagonally-oriented electrode pair, and wherein the pulse generator is configured to apply electrical stimulation across the first diagonally-oriented electrode pair during a first time period, and apply electrical stimulation across the second diagonally-oriented electrode pair during a second time period.

34. Apparatus defined in claim 33, wherein the pulse generator is further configured to apply electrical stimulation across the first diagonally-oriented electrode pair during a third time period such that the polarity of each of the electrodes comprising the first diagonally-oriented electrode pair is reversed from the polarity of the respective electrodes during the first time period, and apply electrical stimulation across the second diagonally-oriented electrode pair during a fourth time period such that the polarity of each of the electrodes comprising the second diagonally-oriented electrode pair is reversed from the polarity of the respective electrodes during the second time period.

35. Apparatus defined in claim 30, wherein the first, second, third, and fourth electrodes comprise a first, second, third and fourth adjacent electrode pair, and wherein the pulse generator is configured to apply electrical stimulation across the first adjacent electrode pair during a first time period, apply electrical stimulation across the second adjacent electrode pair during a second time period, apply electrical stimulation across the third adjacent electrode pair during a third time period, and apply electrical stimulation across the fourth adjacent electrode pair during a fourth time period.