Methods and devices for gastrointestinal stimulation

• US 7,881,797 B2
• Filed: 04/25/2007
• Issued: 02/01/2011
• Est. Priority Date: 04/25/2006
• Status: Active Grant

• Current Assignee: ValenTx, Inc.
• Original Assignee: ValenTx, Inc.
• Inventors: Fluet, Greg, Griffin, Bobby, Dann, Mitchell
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/789,561
• Publication Number:
  US 20080058887A1
• Time in Patent Office: 1,378 Days
• Field of Search: 607/40, 604/264, 604/270, 604/500
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Methods and devices for gastrointestinal stimulation are disclosed. In one embodiment, disclosed is an electrical stimulator device that includes a circuit board and a battery contained within a base housing; a conduction element; and at least one electrode. In some embodiments, the stimulator base housing can be directly attached to a wall of a body lumen. In other embodiments, the stimulator base housing can be attached to a cuff or a sleeve device. In still other embodiments, one or more elements of the system are free-floating within the GI tract. The devices can be delivered endoscopically, and in some embodiments toposcopically.

Claims

1. A gastrointestinal stimulation system, comprising:

a gastrointestinal bypass sleeve configured to be implanted in a patient and having a length to extend distally from the gastroesophageal junction, through the stomach, and into the intestine; and

an electrical stimulator component comprising at least one electrode, the electrode configured to stimulate the intestine, wherein the electrode is operably attached to the gastrointestinal bypass sleeve at a location spaced apart from the pylorus when the gastrointestinal bypass sleeve is implanted in the patient.

2. The gastrointestinal stimulation system of claim 1, further comprising a gastrointestinal attachment cuff having a tubular body, a proximal end and a distal end.

3. The gastrointestinal stimulation system of claim 1, wherein the electrical stimulator component further comprises a circuit board, a battery, and a conductive element.

4. The gastrointestinal stimulation system of claim 3, wherein the battery is configured to be recharged using RF energy.

5. The gastrointestinal stimulation system of claim 3, wherein the conductive element is a ribbon.

6. The gastrointestinal stimulation system of claim 5, wherein the ribbon has one of a U-shaped or S-shaped cross-section.

7. The gastrointestinal stimulation system of claim 1, wherein the electrical stimulator is triggered by a sensor configured to detect one of the group selected from:

pressure, temperature, pH, motion, and strain.

8. The gastrointestinal stimulation system of claim 3, wherein the conductive element is a lead wire.

9. The gastrointestinal stimulation system of claim 3, further comprising at least one biasing element operably connected to the electrode.

10. The gastrointestinal stimulation system of claim 9, wherein the biasing element is configured to increase one of the contact surface area or the contact surface time between the electrode and a lumen of the gastrointestinal tract.

11. The gastrointestinal stimulation system of claim 1, wherein the gastrointestinal bypass sleeve is at least partially inverted within itself, and adapted for eversion within the gastrointestinal tract.

12. The gastrointestinal stimulation system of claim 1, wherein at least part of the electrical stimulation component is configured to be attached to a serosal surface of a wall of the gastrointestinal tract.

13. A method of treating a patient, comprising the steps of:

providing a gastrointestinal sleeve device having an elongate tubular body, with a proximal end and a distal end;

providing an electrical stimulation component comprising;

a circuit board and a battery contained within a base housing;

a conduction element; and

at least one electrode, the electrode being operably attached to the gastrointestinal bypass sleeve;

positioning the gastrointestinal sleeve device in the patient'"'"'s digestive tract such that the proximal end is at the gastroesophageal junction, the distal end is in the intestine, and the at least one electrode is in the intestine, spaced apart from the pylorus; and

stimulating the intestine via the at least one electrode.

14. The method of treating a patient as in claim 13, wherein the base housing is operably attached to the sleeve.

15. The method of treating a patient as in claim 13, wherein positioning of the electrical stimulation device and the gastrointestinal sleeve device does not occur during the same procedure.

16. The method of treating a patient as in claim 13, further comprising the steps of:

providing a gastric space-filling device operably attached to the base housing of the electrical stimulation component; and

deploying the space-filling device within the stomach.

17. The method of treating a patient as in claim 16, wherein the space-filling device is a balloon.

18. The method of treating a patient as in claim 13, wherein the at least one electrode is attached along an outer surface of the gastrointestinal bypass sleeve.

19. The method of treating a patient as in claim 13, further comprising the step of attaching the proximal end of the sleeve at the gastroesophageal junction.

20. The method of treating a patient as in claim 13, wherein the proximal end of the sleeve is attached to the gastroesophageal junction via an attachment cuff.