APPARATUS AND METHOD FOR PROVIDING CONTINENCE TO A GASTROINTESTINAL OSTOMY

• US 20090157140A1
• Filed: 11/04/2008
• Published: 06/18/2009
• Est. Priority Date: 12/13/2007
• Status: Active Grant

• Current Assignee: Leto Medical, LLC
• Original Assignee: Leto Medical, LLC
• Inventors: Schneider, James G., Martino, Nicholas, Minasi, John
• Granted Patent: US 7,765,007 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61F 5/4407 Closure means other than valves
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An apparatus, and method, for providing continence to a gastrointestinal ostomy of a patient, the apparatus having a sealing device for retaining discharge of effluents or waste products from an ostomy, at least one pair of electrodes capable of delivering electrical stimulation to affect the smooth muscles of the patient'"'"'s intestine and a stimulation generator in electrical communication with at least one pair of electrodes and capable of generating said electrical stimulation, wherein the electrical stimulation is selected to induce muscle contraction, relaxation, a tonic state or a flaccid state in the smooth muscles of the patient'"'"'s intestine.

Claims

1. An apparatus for providing continence to a gastrointestinal ostomy of a patient, comprising:

a sealing device for retaining discharge of effluents or waste products from the ostomy;

at least one pair of electrodes capable of delivering electrical stimulation; and

at least one stimulation generator in selective communication with the at least one pair of electrodes;

wherein the at least one stimulation generator provides through any of the at least one pair of electrodes electrical stimulation to the patient'"'"'s intestine, to thereby inhibit the advancement of intestinal contents by controlling muscle activity in a segment of the intestine.

2. The apparatus of claim 1, wherein the sealing device is selected from the group consisting of a plug, a catheter with removable plug, a stoma sealing membrane, an absorbent tampon, and an absorbent pad.

3. The apparatus of claim 1, wherein the sealing device is an ostomy bag.

4. The apparatus of claim 1, wherein the sealing device further comprises a vent to permit release of flatus via the ostomy.

5. The apparatus of claim 1, and further comprising at least one electrical lead to provide electrical communication between the stimulus generator and the at least one pair of electrodes.

6. The apparatus of claim 1, wherein at least one of the at least one pair of electrodes can be attached during use directly to the smooth muscle of the patient'"'"'s intestine, to thereby deliver electrical stimulation directly to smooth muscles of the patient'"'"'s intestine.

7. The apparatus of claim 1, wherein at least one of the at least one pair of electrodes can be disposed during use to deliver electrical stimulation directly to portions of the patient'"'"'s enteric nervous system.

8. The apparatus of claim 1, wherein at least one of the at least one pair of electrodes can be disposed during use to deliver stimulation directly to larger branch nerves of the autonomic nervous system associated with the smooth muscles of the patient'"'"'s intestine.

9. The apparatus of claim 1, wherein the stimulus generator has circuitry for providing at least one electrical stimulation pulse.

10. The apparatus of claim 1, wherein the stimulus generator has circuitry for providing multiple electrical stimuli in a preselected order.

11. The apparatus of claim 1, wherein the stimulus generator has circuitry for controlling all electrical stimulation pulse parameters.

12. The apparatus of claim 1, wherein the stimulus generator has circuitry for sensing at least one of electrical, physical, and chemical activity in the patient'"'"'s intestine.

13. The apparatus of claim 1, wherein at least one of the at least one pairs of electrodes is incorporated into the material of the sealing device

14. The apparatus of claim 1, wherein at least one of the at least one pairs of electrodes is located at least one of distal and proximal to the sealing device.

15. The apparatus of claim 1, and further comprising a cover, mountable over a distal end of the patient'"'"'s ostomy and wherein the stimulation generator is mounted beneath the ostomy cover.

16. The apparatus of claim 1, wherein the at least one pair of electrodes and the at least one stimulation generator are combined together to provide a unitary sensing/stimulating package.

17. The apparatus of claim 16, and further comprising at least one separate sensing device not combined with a stimulation generator, so that the apparatus includes both a separate sensing device and a unitary sensing/stimulating package.

18. A method for providing continence to a gastrointestinal ostomy of a patient;

comprising the steps of;

providing a patient having a gastrointestinal ostomy with an apparatus for providing continence, the apparatus having a sealing device for retaining discharge of effluents or waste products from the ostomy, at least one pair of electrodes capable of delivering electrical stimulation, at least one stimulation generator providing electrical stimulation to the patient'"'"'s intestine through any of the at least one pair of electrodes;

preselecting any of the at least one pairs of electrodes and the site of the electrical stimulation; and

applying electrical stimulation via the stimulation generator to the preselected at least one pairs of electrodes;

thereby inhibiting advancement of intestinal contents by controlling muscle activity in a segment of the intestine.

19. The method of claim 18, and further comprising inducing at least one of contraction and relaxation of the smooth muscles of the patient'"'"'s intestine by electrical stimulation.

20. The method of claim 18, and further comprising inducing at least one of a tonic state and a flaccid state in the smooth muscles of the patient'"'"'s intestine by electrical stimulation.