Nerve stimulation and blocking for treatment of gastrointestinal disorders

• US 8,538,542 B2
• Filed: 07/21/2011
• Issued: 09/17/2013
• Est. Priority Date: 02/03/2003
• Status: Expired due to Fees

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Knudson, Mark B., Wilson, Richard R., Tweden, Katherine S., Conrad, Timothy R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/188,293
• Publication Number:
  US 20110282411A1
• Time in Patent Office: 789 Days
• Field of Search: 607 40- 41, 607 45- 46, 607 59- 61, 607/72
• US Class Current: 607/59
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Systems and methods of using a system for treating a gastrointestinal disorder characterized by dysmotility of a gastrointestinal organ. A system comprises a first electrode adapted for placement on the vagus nerve at a stimulation site proximal to at least one site of vagal innervation of a gastrointestinal organ, a second electrode adapted for placement on the vagus nerve at a site proximal to the stimulation site, a third electrode adapted for placement on the vagus nerve at a distal blocking site distal to the stimulation site, an implantable controller comprising at least one circuit for generating a neural conduction blocking signal connected to the second and third electrode, at least one circuit for generating a neural conduction stimulating signal connected to the first electrode; and an external programmer configured to communicate at least one parameter for the neural conduction blocking signal to the implantable controller; and an external coil adapted to be worn by the patient, wherein the external coil is connected to the external programmer, and is adapted to inductively couple to the implantable controller.

Claims

1. A system for treating a gastrointestinal disorder characterized by dysmotility of a gastrointestinal organ comprising:

a first electrode adapted for placement on a vagus nerve at a stimulation site proximal to at least one site of vagal innervation of a gastrointestinal organ and below a diaphragm of patient, and

a second electrode adapted for placement on said vagus nerve at a site proximal to said stimulation site,

a third electrode adapted for placement on said vagus nerve at a distal blocking site distal to said stimulation site,

an implantable controller comprising an induction coil, at least one circuit for generating a neural conduction blocking signal connected to the second and third electrode, at least one circuit for generating a neural conduction stimulating signal connected to the first electrode, a battery, and a central processing unit comprising program storage and memory; and

an external programmer configured to;

communicate at least one parameter for the neural conduction blocking signal to the implantable controller, wherein the parameter is selected for the neuroconduction blocking signal to i) at least partially downregulate the vagus nerve, ii) allow at least partial recovery of the nerve activity following discontinuation of the neural conduction blocking signal, and iii) reduce pancreatic and biliary output via inhibition of pancreo-biliary output, and

communicate at least one parameter for the neural conduction stimulating signal to the implantable controller, wherein the parameter is selected for the neuroconduction stimulating signal to enhance pancreatic and biliary output; and

an external coil adapted to be worn by the patient, wherein the external coil is connected to the external programmer, and is adapted to inductively couple to the induction coil of the implantable controller.

2. The system of claim 1, wherein the at least one parameter for the neural conduction blocking signal is selected from the group consisting of frequency, amplitude, pulse width, timing and duty cycle.

3. The system of claim 2, wherein the selected parameter is frequency.

4. The system of claim 3, wherein the frequency is at least 500 Hz.

5. The system of claim 2, wherein the selected parameter is the timing of the neural conduction blocking signal.

6. The system of claim 5, wherein the timing of the neural conduction blocking signal is intermittent.

7. The system of claim 2, wherein each blocking signal is applied concurrently with the stimulation signal.

8. The system of claim 1, wherein the first electrode is adapted to be placed on a vagal trunk.

9. The system of claim 8, wherein the vagal trunk innervates an organ selected from the group consisting of an esophagus, stomach, pancreas, duodenum, jejunum, and ileum.

10. The system of claim 1, wherein the at least one parameter for the neural conduction stimulating signal is selected from the group consisting of frequency, amplitude, pulse width, timing and duty cycle.

11. The system of claim 10, wherein the selected parameter is timing of the electrical signal.

12. The system of claim 11, wherein the stimulation signal is applied once every ten minutes.

13. The system of claim 10, wherein the stimulation signal has a frequency of 12 Hz.

14. The system of claim 1, wherein the vagus nerve comprises an anterior, a posterior, or anterior and posterior vagus nerves.