Electrode assemblies, tools, and methods for gastric wall implantation

• US 8,463,404 B2
• Filed: 01/14/2007
• Issued: 06/11/2013
• Est. Priority Date: 03/24/2005
• Status: Expired due to Fees

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Levi, Tamir, Spehr, Paul, Glasberg, Offer, Harel, Tami, Milman, Lena, Rousso, Benny, Sonnenschein, Elazar, Elovici, Yuval, Sonnenschein, Minelu, Govrin, Amir
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US12/160,616
• Publication Number:
  US 20100324644A1
• Time in Patent Office: 2,340 Days
• Field of Search: 607/133, 607/40, 607/116, 128/898
• 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;

a lead, coupled to the electrode; and

an implantation tool, which comprises;

a securing device, which is configured to secure the implantation tool to a portion of a gastric wall of a patient; 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 to insert the electrode into the gastric wall generally in parallel to the gastric wall,

wherein the implantation tool is configured to be removed from a body of the patient after implanting the electrode, such that only the electrode and the lead remain in the body.

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.

3. The apparatus according to claim 1, wherein the securing device comprises a suction applicator.

4. The apparatus according to claim 1, 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.

5. Apparatus, comprising:

an electrode;

a lead, coupled to the electrode; and

,

an implantation tool, which comprises a longitudinal element shaped to define a sharp distal tip that is configured to puncture a gastric wall of a patient,

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 generally in parallel to the gastric wall,

wherein the implantation tool is configured to permit decoupling of the electrode from the longitudinal element defining the sharp tip following implantation of the electrode in the gastric wall, and

wherein the implantation tool is configured to be removed from a body of the patient after implanting the electrode, such that only the electrode and the lead remain in the body.

6. The apparatus according to claim 5, wherein the longitudinal element comprises a rod.

7. The apparatus according to claim 5, 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.

8. The apparatus according to claim 5, 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.

9. The apparatus according to claim 8, wherein the distal portion of the electrode is disposed within the are defined by the distal portion of the longitudinal element.

10. The apparatus according to claim 9, 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.

11. The apparatus according to claim 9, 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.

12. The apparatus according to claim 11, 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.

13. The apparatus according to claim 5, wherein the implantation tool is configured to decouple the electrode from the longitudinal element defining the sharp tip by proximal withdrawal of the implantation tool.

14. Apparatus, comprising:

two electrodes; and

an implantation tool, which (a) is configured to implant the electrodes in a gastric wall of a patient, without removing the implantation tool from a body of the patient between successive electrode implantations, and (b) comprises a cartridge, within which are removably disposed the two electrodes,

wherein the cartridge is generally cylindrical in shape, and is configured (a) to implant a first one of the electrodes, (b) subsequently to be rotated, and (c) subsequently to implant a second one of the electrodes.

15. The apparatus according to claim 14, wherein the two electrodes are separated by 150-180 degrees with respect to an axis of the cartridge.

16. The apparatus according to claim 14, 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.

17. The apparatus according to claim 16, comprising a source of suction, to secure the cartridge to the site of implantation of the first electrode.

18. The apparatus according to claim 16, 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.

19. The apparatus according to claim 14, 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 a circumferential distance between the first and second electrodes while the first and second electrodes are disposed within the cartridge.

20. The apparatus according to claim 14, wherein the cartridge is configured to implant the electrodes in the gastric wall generally in parallel to the gastric wall.

21. The apparatus according to claim 14, further comprising two leads, which are coupled to the two electrodes, respectively, wherein the implantation tool is configured to be removed from a body of the patient after implanting the two electrodes, such that only the two electrodes and the two feuds remain in the body.

22. The apparatus according to claim 14, wherein the cartridge is shaped so as to define two lateral chambers, within which are removably disposed the two electrodes, respectively.

23. A method comprising:

providing an electrode and a lead coupled to the electrode;

using a securing device of an implantation tool, securing the implantation tool to a portion of a gastric wall of a patient;

puncturing and moving distally an element of the implantation tool through the portion of the gastric wall, and subsequently using the element to draw the electrode proximally through the portion of the gastric wall, thereby inserting the electrode into the gastric wall generally in parallel to the gastric wall; and

removing the implantation tool from a body of the patient after implanting the electrode, such that only the electrode and the lead remain in the body.

24. A method comprising:

providing an electrode and a lead coupled to the electrode;

providing an implantation tool, which includes a longitudinal element shaped to define a, sharp distal tip that is configured to puncture a gastric wall of a patient, wherein a distal portion of the electrode is parallel to a distal portion of the longitudinal element;

distally advancing the implantation tool in the gastric wall so as to advance the electrode in the gastric wall generally in parallel to the gastric wall;

decoupling the electrode from the longitudinal element defining the sharp tip following implantation of the electrode in the gastric wall; and

removing the implantation tool from a body of the patient after implanting the electrode, such that only the electrode and the lead remain in the body.

25. The method according to claim 24, wherein decoupling comprises decoupling the electrode from the longitudinal element defining the sharp tip by proximally withdrawing the implantation tool.

26. A method comprising:

providing two electrodes;

providing an implantation tool, which (a) Is configured to implant the electrodes in a gastric wall of a patient, without removing the implantation tool from a body of the patient between successive electrode implantations, and (b) includes a generally cylindrically-shaped cartridge;

within which are removably disposed the two electrodes;

implanting a first one of the electrodes using the cartridge;

thereafter, rotating the cartridge; and

thereafter, implant a second one of the electrodes using the cartridge.

27. The method according, to claim 26, wherein implanting the first and the second electrodes comprises implanting the first and the second electrodes in the gastric wall generally in parallel, to the gastric wall, using the cartridge.

28. The method according to claim 26, further comprising:

providing two leads, which are coupled to the two electrodes, respectively; and

removing the implantation tool from a body of the patient after implanting the two electrodes, such that only the two electrodes and the two leads remain in the body.