METHOD AND DEVICES FOR STIMULATION OF AN ORGAN WITH THE USE OF A TRANSECTIONALLY PLACED GUIDE WIRE

• US 20080051850A1
• Filed: 07/30/2007
• Published: 02/28/2008
• Est. Priority Date: 08/03/2006
• Status: Active Grant

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Brynelsen, Charles, Imran, Mir, Sparks, Kurt
• Granted Patent: US 7,509,175 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• 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

Devices, systems and methods are provided for electrical stimulation of a body organ, particularly within the gastrointestinal tract. In preferred embodiments, the stomach is the organ within the gastrointestinal tract which is targeted for such stimulation. A guide wire or other delivery device is positioned within the body so as to transect the stomach wall. Devices and systems are then advanced over the guide wire for attachment to the stomach wall. The guide wire may be placed by endoscopic, open, laparoscopic or a modified percutaneous approach. In a modified percutaneous approach, the stomach is accessed without the use of general anesthesia by advancing a needle through the abdomen, transecting the stomach wall with the needle and advancing the guide wire through the needle. In some embodiments, particularly for use in obese patients, the modified percutaneous approach includes advancing a trocar through the tissue of the patient toward the outer surface of the organ and advancing the needle through the trocar prior to transecting the wall with the needle.

Claims

1. A method of attaching a device to a wall of a hollow organ within a patient, the wall having an inner surface facing within the organ and an outer surface facing away from the organ, the method comprising:

positioning a guide wire wherein the guide wire transects the wall of the organ and extends through tissue to an exterior of the patient;

advancing the device over the guide wire from the exterior of the patient toward the organ, wherein the device comprises at least one lead having at least one electrode; and

attaching the device to the wall of the organ so that the at least one electrode is positioned so as to stimulate the wall.

2. A method as in claim 1, wherein positioning the guide wire comprises accessing the organ by a modified percutaneous approach without the use of general anesthesia, wherein the modified percutaneous approach comprises advancing a needle through the tissue of the patient toward the outer surface of the organ, transecting the wall with the needle and advancing the guide wire through the needle.

3. The method of claim 2, wherein the modified percutaneous approach includes advancing a trocar through the tissue of the patient toward the outer surface of the organ and advancing the needle through the trocar prior to transecting the wall with the needle.

4. The method of claim 2, wherein attaching the device to the wall comprises positioning the at least one electrode within the wall.

5. The method of claim 4, wherein positioning the at least one electrode within the wall comprises positioning the at least one electrode within or against a muscle layer within the wall.

6. The method of claim 4, further comprising implanting a stimulator externally of the hollow organ within the patient, wherein the stimulator is in electrical communication with the at least one lead.

7. The method of claim 1, wherein attaching the device comprises attaching a stimulator to the wall of the organ so that the stimulator is implanted within the hollow organ.

8. The method of claim 7, wherein positioning the guide wire comprises extending the guide wire through a mouth of the patient, the method further comprising advancing the stimulator through the mouth and over the guide wire toward the inner surface of the wall of the hollow organ.

9. The method of claim 1, wherein attaching the device comprises implanting a stimulator within the tissue external to the hollow organ.

10. The method of claim 1, wherein the device includes a retention feature and wherein attaching the device to the wall of the organ comprises positioning the retention feature within the wall of the organ.

11. The method of claim 10, wherein the organ comprises a stomach and the wall includes at least a muscle layer and a submucosal layer, and wherein positioning the retention feature within the wall of the organ comprises positioning the retention feature between the muscle layer and the submucosal layer.

12. The method of claim 1, wherein the device includes a fixation feature and a conical segment near the fixation feature, and wherein attaching the device to the wall of the organ comprises positioning the fixation feature against the outer surface of the organ while the conical segment transects the wall.

13. A method of attaching a device having a first portion and a second portion to a wall of a hollow organ within a patient, the wall having an inner surface facing within the organ and an outer surface facing away from the organ, the method comprising:

positioning a guide wire wherein the guide wire transects the wall of the organ;

advancing the first portion of the device over the guide wire in a direction toward the inner surface of the wall of the hollow organ;

advancing the second portion of the device over the guide wire in an opposite direction toward the outer surface of the wall of the hollow organ; and

joining the first and section portions together so as to attach the device to the wall of the hollow organ.

14. The method of claim 13, wherein positioning the guide wire comprises extending the guide wire through a mouth of the patient, and wherein advancing the first portion comprises advancing the first portion through the mouth and over the guide wire toward the inner surface of the wall of the hollow organ.

15. The method of claim 13, wherein positioning the guide wire comprises extending the guide wire through an abdomen of the patient, and wherein advancing the second portion comprises advancing the second portion through the abdomen and over the guide wire toward the outer surface of the wall of the hollow organ.

16. The method of claim 13, wherein positioning the guide wire comprises accessing the organ by a modified percutaneous approach without the use of general anesthesia, wherein the modified percutaneous approach comprises advancing a needle through an abdomen of the patient toward the outer surface of the organ, transecting the wall with the needle and advancing the guide wire through the needle.

17. The method of claim 16, wherein the modified percutaneous approach includes advancing a trocar through the abdomen of the patient toward the outer surface of the organ and advancing the needle through the trocar prior to transecting the wall with the needle.

18. A lead for stimulating a wall of a hollow organ within a patient, the wall having an inner surface facing within the organ, an outer surface facing away from the organ and a plurality of layers therebetween, the lead comprising:

a lead body having a proximal end, a distal end and a guide wire lumen extending through at least a portion of the lead body, the proximal end configured for attachment to a source of electrical energy;

a retention feature disposed near the distal end, the retention feature extending radially outwardly from the lead body and configured for positioning between layers of the wall; and

at least one electrode disposed along the lead so that electrical energy supplied to the at least one electrode stimulates the wall while the retention feature is positioned between layers of the wall.

19. The lead of claim 18, wherein the layers of the wall include a muscle layer and a submucosal layer, and wherein the retention feature is configured for positioning between the muscle layer and the submucosal layer.

20. The lead of claim 18, wherein the at least one electrode is disposed along the retention feature.

21. The lead of claim 18, further comprising a fixation feature disposed proximally of the retention feature, the fixation feature extending radially outwardly from the lead body and configured to contact a surface of the wall.

22. The lead of claim 21, wherein the at least one electrode is disposed along the fixation feature.

23. The lead of claim 21, wherein the at least one electrode is disposed along a segment of the lead body between the retention feature and the fixation feature.

24. The lead of claim 23, wherein the at least one electrode has the shape of a coil, ring, longitudinal strip, or combination of these.

25. The lead of claim 21, wherein the layers of the wall include a muscle layer and a submucosal layer, and wherein the retention feature and fixation feature are spaced apart so that the retention feature is positionable between the muscle layer and the submucosal layer while the fixation feature is positionable against a surface of the organ.

26. A method of attaching a device to a wall of a hollow organ within a patient, the device comprising a stimulator coupled to at least one lead having at least one electrode, the method comprising:

positioning a first guide wire so that the guide wire transects the wall of the organ at a first location;

advancing the stimulator over the first guide wire;

attaching the stimulator to the wall of the organ at the first location;

positioning a second guide wire so that the guide wire transects the wall of the organ at a second location;

advancing the at least one lead over the second guide wire;

attaching the at least one lead to the wall of the organ at the second location so that the at least one electrode is positioned so as to stimulate the wall.

27. The method of claim 26, wherein the hollow organ has an outer surface facing tissue extending between the organ and the exterior of the patient, and wherein positioning the first guide wire comprises accessing the organ by a modified percutaneous approach without the use of general anesthesia, wherein the modified percutaneous approach comprises advancing a needle through the tissue of the patient toward the outer surface of the organ, transecting the wall with the needle and advancing the first guide wire through the needle.

28. The method of claim 26, wherein the hollow organ has an outer surface facing tissue extending between the organ and the exterior of the patient, and wherein positioning the second guide wire comprises accessing the organ by a modified percutaneous approach without the use of general anesthesia, wherein the modified percutaneous approach comprises advancing a needle through the tissue of the patient toward the outer surface of the organ, transecting the wall with the needle and advancing the second guide wire through the needle.