Apparatus and process for stimulation of a state of complete continence in the neospincter in the preparation of continent neostomies

• US 6,606,518 B1
• Filed: 08/04/2000
• Issued: 08/12/2003
• Est. Priority Date: 08/06/1999
• Status: Expired due to Fees

• Current Assignee: Transneuronix Inc. (Medtronic Plc)
• Original Assignee: Transneuronix Inc. (Medtronic Plc)
• Inventors: Cigaina, Valerio
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): Droesch, Kristen
• Application Number:
  US09/632,834
• Time in Patent Office: 1,103 Days
• Field of Search: 128/885, 128/897, 128/898, 600/29-31, 600/36, 600/372-373, 607/1-3, 607/40-41, 607/115-116, 607/133, 623/24-25, 623/66.1, 623/14.13, 623/23.64, 623/23.66, 623/902
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

The present invention provides an apparatus and process which can stimulate a state of complete continence of the neosphincter in the preparation of continent neostomies. More specifically, the present invention provides an apparatus and process for the stimulation of a state of complete continence of the neosphincter in the preparation of continent neostomies, comprising an electrocatheter with an electrode inserted above the neostomy near, and in electrical contact with, transplanted muscle tissue (i.e., a strip of antral gastric musculature) which has been transplanted to the distal segment of the intestine or other organ where an ostomy has been created. The apparatus and process can restore the organic continence in a subject who has undergone therapeutic alteration of an indispensable segment of the visceral anatomy (i.e., the anus or the urinary bladder), thereby significantly improving quality of life.

Claims

1. A process to provide a state of complete continence in a patient in need of a neostomy for attachment of an endoabdominal organ via an endoabdominal lumen to a neostomy site, said process comprising transplanting a strip of antral gastric musculature to the distal segment of the endoabdominal lumen adjacent to the neostomy site and implanting an electrocatheter with at least one electrode in electrical contact with the strip of antral gastric musculature, whereby stimulation of the strip of antral gastric musculature through the electrode allows generation of a reverse pressure gradient inside the endoabdominal lumen and provides the state of complete continence.

2. The process as defined in claim 1, wherein the endoabdominal lumen is a portion of intestines and the strip of antral gastric musculature is obtained from the patient.

3. The process as defined in claim 1, wherein the endoabdominal lumen is a portion of urethra and the strip of antral gastric musculature is obtained from the patient.

4. The process as defined in claim 1, wherein the stimulation of the strip of antral gastric musculature is electrical.

5. The process as defined in claim 1,wherein the electrocatheter includes an electrostimulator.

6. The process as defined in claim 5, wherein the electrostimulator provides a series of electrical pulses or bursts to the strip of antral gastric musculature with a predetermined dosage time.

7. The process as defined in claim 6, wherein the series of electrical pulses or bursts has a frequency of about 1 to about 170 Hz, a pulse time of about 80 to about 720 μ

sec, and a pulse amplitude of about 0.5 to about 18 mA.

8. The process as defined in claim 7, wherein the predetermined dosage time is about 1 second to about 24 hours.

9. The process as defined in claim 7, wherein the electrostimulator can be adjusted to periodically interrupt delivery of the series of electrical pulses or bursts.

10. The process as defined in claim 8, wherein the electrostimulator can be adjusted to periodically interrupt delivery of the series of electrical pulses or bursts.

11. The process as defined in claim 6, wherein the electrostimulator operates using an automatic cycling procedure wherein automatic simulation is provided depending on the dosage time.

12. The process as defined in claim 6, wherein the electrostimulator operates using a single cycling procedure wherein simulation is activated using an external device.

13. The process as defined in claim 6, wherein the electrostimulator operates using an on demand cycling procedure wherein stimulation is activated and stopped using an external device.