Methods for treating gastrointestinal disorders

• US 20060036293A1
• Filed: 07/29/2005
• Published: 02/16/2006
• Est. Priority Date: 08/16/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carbunaru, Rafael, Whitehurst, Todd K., McGivern, James P.
• Granted Patent: US 8,452,407 B2
• Time in Patent Office: Days
• 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 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37514 Brain implants

Abstract

A small implantable stimulator(s) having at least two electrodes is implanted adjacent to a gastrointestinal nerve and/or muscle for the stimulation treatment of gastrointestinal disorders, including gastrointestinal motility, sphincteric disorders, and/or eating disorders. The stimulator provides a means of stimulating tissue at a stimulation site when desired, and may be implanted via a minimal surgical procedure.

Claims

1. A method for treating a patient with a GI disorder, comprising:

providing at least one stimulator having at least two electrodes;

implanting the at least one stimulator adjacent to at least one stimulation site at least in part responsible for the GI disorder;

providing operating power to the at least one stimulator;

using at least one external appliance to transmit stimulation parameters to the at least one stimulator;

receiving and storing the stimulation parameters;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to the at least one stimulation site adjacent to the at least one stimulator;

wherein the stimulator has a size and shape suitable for placement of the electrodes adjacent to the at least one stimulation site.

2. The method of claim 1 wherein the GI disorder is a gastrointestinal motility disorder, a sphincteric disorder, or an eating disorder.

3. The method of claim 2 wherein the at least one stimulation site comprises a portion of an enteric nervous system.

4. The method of claim 3 wherein the portion of the enteric nervous system is an upper esophageal sphincter, a lower esophageal sphincter, a pyloric sphincter, an ileocecal sphincter, an internal anal sphincter, or an external anal sphincter.

5. The method of claim 3 wherein the portion of the enteric nervous system comprises at least one or more of a vagus nerve, a myenteric plexus, a submucosal plexus, a sympathetic pelvic plexus, a celiac plexuses, a superior, mesenteric ganglion, an inferior mesenteric ganglion, a hypogastric plexuses, an outer longitudinal layer of the muscularis externa, an inner circular layer of the muscularis externa, an aorticorenal ganglion, a renal plexus, an intermesenteric plexus, a testicular plexus, a superior hypogastric plexus, a sacral splanchnic nerves, a sacral plexus, an inferior hypogastric plexus, a rectal plexus, a vesical plexus, and a prostatic plexus.

6. The method of claim 1 further comprising:

providing at least one sensor;

using the at least one sensor to sense a medical condition; and

determining the stimulation parameters based upon the sensed medical condition.

7. The method of claim 6 wherein the at least one sensor is a part of the stimulator.

8. The method of claim 1 further comprising:

providing a pump wherein said pump has at least one infusion outlet;

using the at least one infusion outlet to deliver a drug; and

wherein the pump is part of the stimulator.

9. The method of claim 8 further comprising providing at least one infusion port at the end of at least one flexible catheter wherein said catheter is part of the stimulator.

10. The method of claim 1 further comprising:

providing a pump wherein said pump is coupled to at least one replenishing port;

using the at least one replenishing port to refill the pump with a drug; and

wherein the pump is part of the stimulator.

11. The method of claim 10 further comprising providing at least one replenishing port at the end of at least one flexible catheter wherein the catheter is part of the stimulator.

12. The method of claim 1 further comprising providing at least one electrode located on a surface of at least one flexible lead wherein said lead is attached at one end to the stimulator.

13. A method for treating a patient with a GI disorder, comprising:

providing at least one stimulator having at least two electrodes;

providing at least one sensor;

implanting the at least one stimulator adjacent to at least one stimulation site at least in part responsible for the GI disorder;

providing operating power to the at least one stimulator;

using the sensor to sense a medical condition;

determining stimulation parameters based upon the sensed medical condition;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to the at least one stimulation site adjacent to the at least two electrodes;

wherein the stimulator has a size and shape suitable for placement of the electrodes adjacent to the at least one stimulation site.

14. The method of claim 13 wherein the GI disorder is a gastrointestinal motility disorder, a sphincteric disorder, or an eating disorder.

15. The method of claim 14 wherein the at least one stimulation site comprises a portion of an enteric nervous system.

16. The method of claim 15 wherein the portion of the enteric nervous system is an upper esophageal sphincter, a lower esophageal sphincter, a pyloric sphincter, an ileocecal sphincter, an internal anal sphincter, or an external anal sphincter.

17. The method of claim 15 wherein the portion of the enteric nervous system comprises at least one or more of a vagus nerve, a myenteric plexus, a submucosal plexus, a sympathetic pelvic plexus, a celiac plexuses, a superior, mesenteric ganglion, an inferior mesenteric ganglion, a hypogastric plexuses, an outer longitudinal layer of the muscularis externa, an inner circular layer of the muscularis externa, an aorticorenal ganglion, a renal plexus, an intermesenteric plexus, a testicular plexus, a superior hypogastric plexus, a sacral splanchnic nerves, a sacral plexus, an inferior hypogastric plexus, a rectal plexus, a vesical plexus, and a prostatic plexus.

18. The method of claim 13 wherein the at least one sensor is a part of the stimulator.

19. The method of claim 13 further comprising providing at least one electrode located on a surface of at least one flexible lead wherein the lead is attached at one end to the stimulator.

20. The method of claim 13 further comprising:

providing a pump wherein said pump is coupled to at least one infusion outlet;

using the at least one infusion outlet to deliver a drug; and

wherein the pump is part of the stimulator.

21. The method of claim 20 further comprising providing at least one infusion port at the end of at least one flexible catheter wherein the catheter is part of the stimulator.

22. The method of claim 13 further comprising:

providing a pump wherein said pump is coupled to at least one replenishing port;

using the at least one replenishing port to refill the pump with a drug; and

wherein the pump is part of the stimulator.

23. The method of claim 22 further comprising providing at least one replenishing port at the end of at least one flexible catheter wherein the catheter is part of the stimulator.

24. A method for treating a patient with a GI disorder, comprising:

providing at least one implantable microstimulator having at least two electrodes;

providing at least one sensor wherein the at least one sensor is a part of the at least one implantable microstimulator;

implanting the at least one implantable microstimulator adjacent to at least one stimulation site at least in part responsible for the GI disorder;

providing operating power to the at least one implantable microstimulator;

using the sensor to sense a medical condition;

determining stimulation parameters based upon the sensed medical condition;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerve structures adjacent to the at least two electrodes;

wherein the at least two electrodes of the implantable microstimulator have a size and shape suitable for placement adjacent to the at least one stimulation site.

25. The method of claim 24 wherein the GI disorder is a gastrointestinal motility disorder, a sphincteric disorder, or an eating disorder.

26. The method of claim 25 wherein the at least one stimulation site comprises a portion of an enteric nervous system.

27. The method of claim 26 wherein the portion of the enteric nervous system is an upper esophageal sphincter, a lower esophageal sphincter, a pyloric sphincter, an ileocecal sphincter, an internal anal sphincter, or an external anal sphincter.

28. The method of claim 26 wherein the portion of the enteric nervous system comprises at least one or more of a vagus nerve, a myenteric plexus, a submucosal plexus, a sympathetic pelvic plexus, a celiac plexuses, a superior, mesenteric ganglion, an inferior mesenteric ganglion, a hypogastric plexuses, an outer longitudinal layer of the muscularis externa, an inner circular layer of the muscularis externa, an aorticorenal ganglion, a renal plexus, an intermesenteric plexus, a testicular plexus, a superior hypogastric plexus, a sacral splanchnic nerves, a sacral plexus, an inferior hypogastric plexus, a rectal plexus, a vesical plexus, and a prostatic plexus.