Electrode Assemblies, Tools, And Methods For Gastric Wall Implantation

• US 20100324644A1
• Filed: 01/14/2007
• Published: 12/23/2010
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Elovici, Yuval, Milman, Lena, Spehr, Paul, Rousso, Benny, Levi, Tamir, Sonnenschein, Minelu, Govrin, Amir, Sonnenschein, Elazar, Glasberg, Offer, Harel, Tami
• Granted Patent: US 8,463,404 B2
• Time in Patent Office: Days
• US Class Current: 607/133
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 (450) is provided including an electrode (460) and an implantation tool (458) configured to be passed into an abdominal cavity of a patient, and to insert the electrode into a gastric wall of the patient, generally in parallel to the gastric wall. Other embodiments are also described.

Claims

1. Apparatus, comprising:

an electrode; and

an implantation tool configured to be passed into an abdominal cavity of a patient, and to insert the electrode into a gastric wall of the patient, generally in parallel to the gastric wall.

2. The apparatus according to claim 1, wherein the implantation tool is configured to insert a length of the electrode that is at least 1 cm into the gastric wall, generally in parallel to the gastric wall.

4. The apparatus according to claim 1, wherein the implantation tool is configured to move the electrode in a proximal direction, with respect to the implantation tool, to place the electrode into the gastric wall.

5. The apparatus according to claim 4, wherein the implantation tool comprises:

a securing device, which is configured to secure the implantation tool to a portion of the gastric wall; and

an element which is configured to puncture and move through the portion of the gastric wall, and draw the electrode proximally through the portion of the gastric wall.

6. The apparatus according to claim 4, wherein the implantation tool comprises:

a securing device, which is configured to secure the implantation tool to a portion of the gastric wall; and

an element which is configured to puncture and move distally through the portion of the gastric wall, and subsequently draw the electrode proximally through the portion of the gastric wall.

7. The apparatus according to claim 6, wherein the securing device comprises a suction applicator.

8. The apparatus according to claim 6, wherein the securing device comprises first and second articulating pieces, the first piece configured to engage an inner surface of the gastric wall, and the second piece configured to engage an outer surface of the gastric wall.

9. The apparatus according to claim 1, wherein the implantation tool comprises a screw having a distal tip configured for penetrating the gastric wall generally parallel to the gastric wall, and wherein the electrode is wrapped around the screw.

10. The apparatus according to claim 9, wherein the electrode is wrapped around the screw in such a manner that it remains wrapped around the screw during screwing of the screw into the gastric wall, and remains in the gastric wall during unscrewing of the screw from the gastric wall.

11. The apparatus according to claim 9, wherein a distal portion of the electrode is looped around a distal portion of the screw, between the distal tip and threading of the screw, in a manner that maintains the wire wrapped around the screw during screwing of the screw into the gastric wall.

12. The apparatus according to claim 1, wherein the implantation tool comprises:

a longitudinal element shaped to define a sharp distal tip that is configured to puncture the gastric wall; and

a hooking assembly releasably coupled to the longitudinal element and coupled distally to the electrode, such that distal movement of the hooking assembly pulls the electrode in a distal direction.

13. The apparatus according to claim 12, wherein the hooking assembly is coupled to the longitudinal element in such a manner that proximal motion of the longitudinal element following insertion of the electrode into the gastric wall decouples the hooking assembly from the longitudinal element.

14. The apparatus according to claim 13, further comprising a stylet selected from the group consisting of:

(a) a stylet coupled to the longitudinal element, a distal tip of the stylet being proximal to the distal tip of the longitudinal element, and wherein the hooking assembly is wrapped around the distal tip of the stylet,

(b) a stylet coupled to the longitudinal element, a distal tip of the stylet being proximal to the distal tip of the longitudinal element, and wherein the hooking assembly is shaped to define a loop, through which the distal tip of the stylet passes, and

(c) a stylet coupled to the longitudinal element, a distal tip of the stylet being proximal to the distal tip of the longitudinal element, and wherein a cup-shaped portion of the hooking assembly engages the distal tip of the stylet.

17. The apparatus according to claim 13, wherein the longitudinal element comprises a needle shaped to define a lateral opening, and wherein the hooking assembly is configured to pass through the lateral opening following decoupling of the hooking assembly from the longitudinal element.

18. The apparatus according to claim 1, wherein the implantation tool comprises a longitudinal element shaped to define a sharp distal tip that is configured to puncture the gastric wall,

wherein a distal portion of the electrode is parallel to a distal portion of the longitudinal element,

wherein the electrode is coupled to the implantation tool such that distal advancement of the implantation tool in the gastric wall advances the electrode in the gastric wall, and

wherein the implantation tool is configured to permit decoupling of the electrode from the implantation tool following implantation of the electrode in the gastric wall.

19. The apparatus according to claim 18, wherein the longitudinal element comprises a rod.

20. The apparatus according to claim 18, wherein a proximal portion of the longitudinal element is shaped to define a bore, and wherein a distal portion of the longitudinal element, proximal to the sharp distal tip, is not shaped to define a bore.

21. The apparatus according to claim 18, wherein a distal portion of the longitudinal element, proximal to the sharp distal tip, is shaped to define an arc when viewed in axial cross-section.

25. The apparatus according to claim 21, wherein the distal portion of the electrode is disposed within the arc defined by the distal portion of the longitudinal element.

26. The apparatus according to claim 25, wherein the implantation tool comprises a pushing element, configured to decouple the electrode from the longitudinal element by applying a pushing force to the electrode during proximal motion of the longitudinal element.

27. The apparatus according to claim 25, wherein the implantation tool comprises one or more coupling rings, coupled to the distal portion of the longitudinal element, and wherein the distal portion of the electrode is slidably coupled within the one or more coupling rings.

28. The apparatus according to claim 27, wherein the one or more coupling rings inhibit decoupling of the distal portion of the longitudinal element from the distal portion of the electrode due to relative lateral motion of the longitudinal element with respect to the electrode, but permit decoupling of the distal portion of the longitudinal element from the distal portion of the electrode due to relative axial motion of the longitudinal element with respect to the electrode.

29. The apparatus according to claim 1, wherein the implantation tool is configured to be secured to the gastric wall to facilitate the insertion of the electrode.

30. The apparatus according to claim 29, wherein the implantation tool comprises a securing device, the securing device comprising first and second articulating pieces, the first piece configured to engage an inner surface of the gastric wall, and the second piece configured to engage an outer surface of the gastric wall.

31. The apparatus according to claim 30, wherein the first piece is configured to be inserted through the gastric wall from the abdominal cavity.

32. The apparatus according to claim 30, wherein the securing device is shaped to define a channel for passage of the electrode therethrough and thereby guide the electrode into the gastric wall.

33. The apparatus according to claim 29, comprising a suction source, configured to hold the implantation tool in a desired orientation with respect to the gastric wall.

34. The apparatus according to claim 33, wherein the suction source is configured to maintain an alignment of the implantation tool with the gastric wall prior to and during insertion of the electrode into the gastric wall.

35. The apparatus according to claim 1, wherein the electrode comprises two electrodes, and wherein the implantation tool is configured to implant the electrodes in the gastric wall, without removing the implantation tool from a body of the patient between successive electrode implantations.

36. The apparatus according to claim 35, comprising a cartridge, within which are disposed the two electrodes.

37. The apparatus according to claim 36, wherein the cartridge is generally cylindrical in shape, and wherein the two electrodes are separated by 150-180 degrees with respect to an axis of the cartridge.

38. The apparatus according to claim 37, wherein the cartridge is configured to be rotated, following implantation of a first one of the electrodes, to facilitate implantation of a second one of the electrodes.

39. The apparatus according to claim 38, wherein the cartridge is configured to be secured to a site of implantation of the first electrode to facilitate the implantation of the first electrode and during rotation of the cartridge, and to subsequently be secured to a site of implantation of the second electrode to facilitate the implantation of the second electrode.

40. The apparatus according to claim 39, comprising a source of suction, to secure the cartridge to the site of implantation of the first electrode.

41. The apparatus according to claim 39, comprising a securing device, configured to secure the cartridge to the gastric wall by squeezing an inner surface and an outer surface of the gastric wall at the site of implantation of the first electrode.

136. The apparatus according to claim 38, wherein the cartridge, by being rotated following the implantation of the first electrode, is configured to facilitate implantation of the second electrode at a distance from the first electrode that is equal to the circumferential distances between the first and second electrodes while the first and second electrodes are disposed within the cartridge.

3. (canceled)

15-16. -16. (canceled)

22-24. -24. (canceled)

42-125. -125. (canceled)

126. A method, comprising:

orienting an electrode to be generally parallel with a gastric wall of a stomach; and

implanting in the gastric wall a length of the electrode that is at least three times a local thickness of the gastric wall such that following implantation, the length of electrode is generally parallel with the gastric wall.

127. The method according to claim 126, wherein implanting comprises inserting into the gastric wall a length of the electrode that is at least five times a local thickness of the gastric wall.

128. The method according to claim 126, wherein implanting comprises inserting into the gastric wall a length of the electrode that is at least ten times a local thickness of the gastric wall.

129. The method according to claim 126, wherein implanting comprises placing the length of the electrode substantially entirely within a single layer of the stomach.

130. A method, comprising:

orienting an axis of a helical electrode to be generally parallel with a gastric wall of a stomach; and

screwing the helical electrode into the gastric wall, such that the axis of the helical electrode is generally parallel with the gastric wall.

131. The method according to claim 130, wherein screwing the helical electrode comprises screwing a screw around which the electrode is wrapped.

132. The method according to claim 131, comprising unscrewing the screw to leave the electrode in the gastric wall.

133-135. -135. (canceled)