Noninvasively adjustable gastric band

• US 7,899,540 B2
• Filed: 04/29/2005
• Issued: 03/01/2011
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Scott A., Parnis, Steven M., Maschino, Steven E.
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/118,980
• Publication Number:
  US 20060247722A1
• Time in Patent Office: 2,132 Days
• Field of Search: 607/40, 604/909
• US Class Current: 607/40
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method and apparatus for treatment of an eating disorder includes electrically stimulating the vagus nerve of the lower esophagus, cardia, esophageal/cardia junction, cardia/fundus junction or upper stomach so as to induce afferent action potentials on the vagus nerve. A device comprising a gastric band including stimulation electrodes may be noninvasively adjusted after implantation to provide increased or decreased restriction on the patient'"'"'s gastrointestinal tract. Each stimulus may be administered as a series of programmed pulses of defined amplitude, duration and period, to evoke a responsive signal to the brain by the target nerve, effective for producing a temporary feeling of satiety in the person. A programmable implantable stimulus generator may be operatively coupled to a nerve electrode. Methods are also provided to identify electrodes nearest to a branch of the vagus nerve to apply an electrical stimulation signal with improved efficiency.

Claims

1. A method of noninvasively adjusting a gastric band used for treating an eating disorder, the method comprising:

providing an implantable gastric band unit comprising

a gastric band comprising an inner periphery for contacting at least a portion of a patient'"'"'s gastrointestinal tract that is innervated by at least one of the anterior branch and the posterior branch of the vagus nerve, an adjustment element, a receiver coupled to said adjustment element, a plurality of stimulation electrodes on said inner periphery and at least one pressure sensor on said inner periphery;

providing an external adjustment controller for transmitting an adjustment signal to said receiver;

surgically coupling said implantable gastric band unit to said portion of the gastrointestinal tract;

noninvasively transmitting an adjustment signal to said receiver;

adjusting the constriction provided by said gastric band to said at least a portion of the gastrointestinal tract using said adjustment element in response to said adjustment signal; and

regulating said adjustment signal based on a pressure signal sensed by the at least one pressure sensor to maintain a desired constant pressure on said portion of said patient'"'"'s gastrointestinal tract, when said gastric band unit is used to treat obesity, compulsive overeating, bulimia nervosa or anorexia nervosa.

2. The method of claim 1 further comprising, prior to said step of noninvasively transmitting an adjustment signal, testing said adjustment element by transmitting a signal from said external adjustment controller to said receiver in an open surgical field.

3. The method of claim 1 wherein said adjustment element comprises an adjustable clamp.

4. The method of claim 1 wherein said adjustment element comprises a worm gear.

5. The method of claim 1 wherein said adjustment element comprises a balloon element.

6. The method of claim 1 wherein said method further comprises

coupling an electrical signal generator to said plurality of stimulation electrodes;

and

generating an electrical signal using said electrical signal generator and applying said electrical signal to at least one of said plurality of stimulation electrodes,

wherein said step of applying said electrical signal to at least one of said plurality of stimulation electrodes further comprises inducing at least one of efferent action potentials on said vagus nerve with said electrical signal.

7. The method of claim 6, wherein said gastric band further comprises a plurality of sensing electrodes capable of sensing an action potential on said anterior and/or posterior branch of said vagus nerve, or portion thereof, said method further comprising sensing said induced action potentials on said nerve using at least one of said plurality of sensing electrodes.

8. The method of claim 6 wherein electrically coupling at least one of said plurality of stimulation electrodes to said anterior and/or posterior branch of said vagus nerve, or a portion thereof comprises electrically coupling at least a first stimulation electrode to the patient'"'"'s anterior vagus nerve and coupling at least a second stimulation electrode to the patient'"'"'s posterior vagus nerve.

9. The method of claim 8 further comprising the step of inducing afferent action potentials on both said anterior vagus nerve and said posterior vagus nerve.

10. The method of claim 6 further comprising the step of inducing both afferent action potentials and efferent action potentials on said vagus nerve.

11. The method of claim 6 wherein said electrical signal generator is an implantable signal generator coupled to said plurality of stimulation electrodes and to said gastric band.

12. The method of claim 6 wherein said electrical signal generator is an external signal generator that is inductively coupled to said plurality of stimulation electrodes.

13. The method of claim 6 wherein said electrical signal generator comprises a controller capable of independently addressing each of said plurality of stimulation electrodes to deliver said electrical signal to any combination of said plurality of electrodes.

14. The method of claim 6 wherein said step of generating an electrical signal comprises generating a pulsed electrical signal defined by a plurality of stimulation parameters including at least a current magnitude, a frequency, and a pulse width.

15. The method of claim 1, wherein said at least a portion of the patient'"'"'s gastrointestinal tract comprises a portion of the gastrointestinal tract in the cardia region.

16. The method of claim 1 further comprising, sensing pressure with said at least one pressure sensor and sending to said external adjustment controller the pressure signal.

17. A noninvasively adjustable gastric band system for treating an eating disorder comprising,

an implantable gastric band comprising an inner periphery for contacting at least a portion of a patient'"'"'s gastrointestinal tract that is innervated by at least one of the anterior branch and the posterior branch of the vagus nerve, a plurality of stimulation electrodes positioned on said inner periphery configured for electrically coupling to said at least one of the anterior branch and the posterior branch of said vagus nerve on said at least a portion of the gastrointestinal tract, and at least one pressure sensor on said inner periphery configured to sense the pressure between said band and said portion of the gastrointestinal tract, and to send a pressure signal;

an implantable adjustment element coupled to said implantable gastric band and configured for adjusting the constriction of said implantable gastric band on said gastrointestinal tract in response to an adjustment signal;

an implantable receiver configured for receiving said adjustment signal and providing said adjustment signal to said adjustment element;

an external adjustment controller configured for generating and noninvasively transmitting said adjustment signal to said implantable receiver and configured to receive said pressure signal and programmed to regulate said adjustment signal based on said received pressure signal to maintain a desired constant pressure on said portion of said patient'"'"'s gastrointestinal tract; and

the gastric band system configured for treating obesity, compulsive overeating, bulimia nervosa or anorexia nervosa.

18. The gastric band system of claim 17 wherein said at least a portion of the patient'"'"'s gastrointestinal tract comprises a portion of the patient'"'"'s gastrointestinal tract in the cardia region.

19. The gastric band system of claim 17 wherein said adjustment element comprises an adjustable clamp.

20. The gastric band system of claim 17 wherein said adjustment element comprises a worm gear.

21. The gastric band system of claim 17 wherein said adjustment element comprises at least one balloon element.

22. The gastric band system of claim 17 wherein at least one of said plurality of stimulation electrodes is capable of inducing afferent action potentials on said vagus nerve.

23. The gastric band system of claim 17 comprising an implantable signal generator coupled to said electrodes.

24. The gastric band system of claim 17 wherein said implantable gastric band further comprises a plurality of sensing electrodes configured for sensing an action potential on said anterior and/or posterior branch of said vagus nerve, or portion thereof.

25. The gastric band system of claim 17 wherein at least a first stimulation electrode pair of said plurality of stimulation electrodes is positioned on said inner periphery for electrically coupling to the patient'"'"'s anterior vagus nerve and at least a second stimulation electrode pair of said plurality of stimulation electrodes is positioned on said inner periphery for electrically coupling to the patient'"'"'s posterior vagus nerve.

26. The gastric band system of claim 17 comprising an external signal generator that is inductively coupled to said plurality of stimulation electrodes.

27. The gastric band system of claim 17 comprising an electrical signal generator including a controller configured for independently addressing each of said plurality of stimulation electrodes to apply an electrical signal to any combination of said plurality of stimulation electrodes.

28. The gastric band system of claim 27 wherein said electrical signal comprises a pulsed electrical signal and said controller is configured to define said pulsed electrical signal by a plurality of stimulation parameters including at least a current magnitude, a frequency, and a pulse width.

29. The gastric band system of claim 17, wherein said adjustment element is programmed to contain a treatment algorithm for adjusting said constriction of said gastric band on said gastrointestinal tract to maintain said constant pressure.