Gastric Stimulation Systems and Methods Utilizing a Transgastric Probe

• US 20090030475A1
• Filed: 07/21/2008
• Published: 01/29/2009
• Est. Priority Date: 07/25/2007
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Pool, George, Wong, Kenneth L., Brynelsen, Charles R., Wei, Michael F., Sparks, Kurt D.
• Granted Patent: US 8,214,049 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Gastric stimulation devices, systems and methods are provided, particularly for stimulating a gastric organ having an internal cavity. Such devices and systems are typically implanted outside of the gastric organ while the environment of the internal cavity is probed and monitored by one or more sensors. The sensor information may be used to affect the stimulation signals provided to the gastric organ by the devices and systems. Such feedback integration assists in providing treatments and stimulation programs that are tailored to the needs of the individual patient.

Claims

1. A lead for stimulating a gastric organ having an internal cavity, the lead comprising:

a lead body having a distal end;

a transgastric probe disposed near the distal end of the lead body, the probe configured to be implanted across a wall of the organ so that its distal tip extends into the internal cavity; and

at least one electrode disposed along the lead body proximal to the transgastric probe, wherein the at least one electrode is engageable with the wall so as to be in electrical contact with the wall.

2. A lead as in claim 1, wherein the transgastric probe includes a sensor configured to sense an aspect of the internal cavity.

3. A lead as in claim 2, wherein the sensor comprises a temperature sensor.

4. A lead as in claim 1, wherein the organ comprises a stomach and wherein one of the at least one electrodes is disposed at a location along the lead body which allows the one of the at least one electrodes to engage the wall in a zone near a lesser curvature of the stomach while the probe is implanted near a greater curvature of the stomach.

5. A lead as in claim 1, wherein the lead body includes an anchoring feature which is attachable to the stomach wall so as to anchor the at least one electrode in engagement with the wall.

6. A lead as in claim 1, wherein the probe has an outer surface exposed to the internal cavity during implantation wherein the outer surface primarily comprises a conductive material.

7. A lead as in claim 6, wherein the probe is configured to act as a return electrode.

8. A lead as in claim 1, further comprising a suture disc disposed along the lead body, wherein the suture disc is positioned so as to be attached to the organ wall while the transgastric probe is implanted.

9. A lead as in claim 8, wherein the suture disc positions the probe at an angle of less than approximately 90 degrees relative to the wall.

10. A lead as in claim 8, wherein the suture disc is removable.

11. A lead as in claim 1, further comprising a buffer disc positionable near the wall while the probe is implanted so as to assist in sealing a transgastric path made by the probe.

12. A lead as in claim 11, wherein the buffer disc comprises a tissue adhering material.

13. A lead as in claim 1, wherein the probe has an outer surface exposed to the internal cavity during implantation wherein the outer surface primarily comprises a polymer, a flexible polymer, a perfluoro elastomer or a combination of these.

14. A lead as in claim 1, further comprising at least one electrode disposed along the probe.

15. A system for stimulating a gastric organ having an internal cavity, the system comprising:

a lead having a transgastric probe disposed near its distal end, the probe configured to be implanted across a wall of the organ so that its distal tip extends into the internal cavity; and

a suture disc removably coupleable with the lead so that the suture disc is attachable to the organ wall while the transgastric probe is implanted; and

at least one electrode disposed along the lead, wherein the at least one electrode is engageable with the wall so as to be in electrical contact with the wall.

16. A system as in claim 15, wherein the at least one electrode is disposed along the gastric probe.

17. A system as in claim 15, wherein the at least one electrode is disposed proximal to the gastric probe.

18. A system as in claim 15, wherein the transgastric probe includes a sensor configured to sense an aspect of the internal cavity.

19. A system as in claim 18, wherein the sensor comprises a temperature sensor.

20. A system as in claim 15, wherein the suture disc is foldable for delivery through a delivery device.

21. A system as in claim 15, wherein the suture disc positions the probe at an angle of less than approximately 90 degrees relative to the wall

22. A system as in claim 15, wherein the suture disc obstructs a passageway through at least a portion of the lead when locked in coupled arrangement with the lead.

23. A method of stimulating a gastric organ having an internal cavity comprising:

advancing a lead toward an outer surface of the gastric organ, the lead having a transgastric probe and at least one electrode;

implanting the transgastric probe across a wall of the organ so that its distal tip extends into the internal cavity; and

engaging the at least one electrode with the wall so as to be in electrical contact with the wall.

24. The method of claim 23, wherein the at least one electrode is disposed along the lead proximal to the transgastric probe near an anchoring feature, and wherein engaging the at least one electrode comprises attaching the anchoring feature to the outer surface of the organ.

25. The method of claim 23, further comprising cinching the wall of the organ against the transgastric probe.

26. The method of claim 25, wherein cinching comprises placing a purse string suture around the transgastric probe.

27. The method of claim 23, wherein the organ comprises a stomach and wherein implanting the transgastric probe comprises implanting the probe across the wall near a greater curvature of the stomach.

28. The method of claim 27, wherein engaging the at least one electrode with the wall comprises engaging the wall in a zone near a lesser curvature of the stomach.

29. The method of claim 23, further comprising joining the lead with an implantable pulse generator.

30. The method of claim 23, wherein advancing the lead comprises approaching the outer surface of the organ with a laparoscopic approach.

31. The method of claim 23, wherein advancing the lead comprises approaching the outer surface of the organ with a percutaneous endoscopic gastrostomy approach or a modified percutaneous endoscopic gastrostomy approach.