Gastric stimulation systems and methods utilizing a transgastric probe

• US 8,214,049 B2
• Filed: 07/21/2008
• Issued: 07/03/2012
• Est. Priority Date: 07/25/2007
• Status: Expired due to Fees

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Brynelsen, Charles R., Wei, Michael F., Sparks, Kurt D., Wong, Kenneth L., Pool, George
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/176,950
• Publication Number:
  US 20090030475A1
• Time in Patent Office: 1,443 Days
• Field of Search: 607 1- 2, 607/40, 607115-116, 607/130, 607/133
• 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 stomach 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 stomach so that the probe extends into the internal cavity; and

at least one electrode disposed along the lead body proximally separated from the transgastric probe, wherein the at least one electrode is configured to be implanted in the patient on an outer surface of the stomach so as to be in electrical contact with the wall of the stomach at a location along the lead body proximally separated from the transgastric probe such that the lead has sufficient slack between the at least one electrode and transgastric probe to accommodate changes in the stomach when implanted.

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 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.

5. 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.

6. A lead as in claim 5, wherein the probe is configured to act as a return electrode.

7. 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 wall of the stomach while the transgastric probe is implanted.

8. A lead as in claim 7, wherein the suture disc positions the probe at an angle of less than approximately 90 degrees relative to the wall.

9. A lead as in claim 7, wherein the suture disc is removable.

10. 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.

11. A lead as in claim 10, wherein the buffer disc comprises a tissue adhering material.

12. 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.

13. A system for stimulating a stomach having an internal cavity, the system comprising:

a lead having a distal end and a proximal end;

a transgastric probe disposed near the distal end, the probe configured to be implanted across a wall of the stomach so that the distal end extends into the internal cavity during implantation;

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

at least one electrode disposed along the proximal end of the lead, wherein the at least one electrode is proximally separated from the transgastric probe and wherein the proximal end engages an outer surface of the stomach so as to be in electrical contact with an outer wall of the stomach at a location along the lead separated from the transgastric probe such that the lead has sufficient slack between the at least one electrode and transgastric probe to accommodate changes to the stomach when the probe is implanted.

14. A system as in claim 13, wherein the at least one electrode is disposed along the gastric probe.

15. A system as in claim 13, wherein the at least one electrode is disposed proximal to the gastric probe.

16. A system as in claim 13, wherein the transgastric probe includes a sensor configured to sense an aspect of the internal cavity.

17. A system as in claim 16, wherein the sensor comprises a temperature sensor.

18. A system as in claim 13, wherein the suture disc is foldable for delivery through a delivery device.

19. A system as in claim 13, wherein the suture disc positions the probe at an angle of less than approximately 90 degrees relative to the wall.

20. A system as in claim 13, wherein the suture disc obstructs a passageway through at least a portion of the lead when locked in coupled arrangement with the lead.

21. A method of stimulating a stomach having an internal cavity comprising:

advancing a lead toward an outer surface of the stomach, the lead having a transgastric probe and at least one electrode, wherein the at least one electrode is proximally separated from the transgastric probe along the lead;

implanting the transgastric probe across a wall of the stomach so that a distal tip of the transgastric probe extends into the internal cavity and a proximal portion of the transgastric probe engages the outer surface of the stomach;

affixing the at least one electrode to the outer surface of the stomach so as to be in electrical contact with the wall of the stomach at a location separated from the implanted transgastric probe, wherein the lead has sufficient slack between the at least one electrode and probe to accommodate changes to the stomach; and

cinching the wall of the stomach against the transgastric probe.

22. The method of claim 21, 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.

23. The method of claim 21, wherein cinching comprises placing a purse string suture around the transgastric probe.

24. The method of claim 21, wherein implanting the transgastric probe comprises implanting the probe across the wall near a greater curvature of the stomach.

25. The method of claim 24, wherein engaging the at least one electrode with the wall comprises engaging the wall in a zone near a lesser curvature of the stomach.

26. The method of claim 21, further comprising joining the lead with an implantable pulse generator.

27. The method of claim 21, wherein advancing the lead comprises approaching the outer surface of the organ with a laparoscopic approach.

28. The method of claim 21, 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.

29. The method of claim 21, wherein the at least one electrode is configured to be implanted in the wall so as to be in electrical contact with the wall at a location along the lead separated from the transgastric probe such that the at least one electrode engages the wall.