Noninvasively adjustable gastric band

• US 20060247722A1
• Filed: 04/29/2005
• Published: 11/02/2006
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Armstrong, Scott A., Parnis, Steven M.
• Granted Patent: US 7,899,540 B2
• Time in Patent Office: Days
• 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, mechanically and/or pharmaceutically/chemically stimulating a of 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. The device 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. An implantable stimulus generator may be operatively coupled to a nerve electrode, pressure device or chemical outlet to apply a defined signal to a selected nerve branch. The implantable stimulus generator is programmable to allow clinician programming of defined signal parameters effective to treat the eating disorder of the patient. 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, providing an implantable gastric band unit comprising a gastric band, an adjustment element, and a receiver coupled to said adjustment element;

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

surgically coupling said implantable gastric band unit to at least a portion of the patient'"'"'s gastrointestinal tract;

noninvasively transmitting an adjustment signal to said receiver; and

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.

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 step of providing an implantable gastric band unit comprises providing a gastric band having a plurality of electrodes, and wherein said step of surgically coupling said implantable gastric band unit comprises electrically coupling at least one of said plurality of electrodes to a vagus nerve on said at least a portion of the gastrointestinal tract, said method further comprising the steps of:

providing an electrical pulse generator coupled to said plurality of electrodes,

generating an electrical signal using said electrical pulse generator;

applying said electrical signal to at least one of said plurality of electrodes coupled to a vagus nerve.

7. The method of claim 6 further comprising the step of inducing afferent action potentials on said vagus nerve with said electrical signal.

8. The method of claim 7 wherein providing a gastric band having a plurality of electrodes coupled thereto comprises providing a band having a plurality of stimulation electrodes and a plurality of sensing electrodes, said method further comprising the step of sensing said induced action potentials on said nerve using said sensing electrodes.

9. The method of claim 6 wherein electrically coupling at least one of said plurality of electrodes to a vagus nerve comprises electrically coupling at least a first electrode to the patient'"'"'s anterior vagus nerve and coupling at least a second electrode to the patient'"'"'s posterior vagus nerve.

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

11. The method of claim 7 further comprising the step of inducing efferent action potentials on said vagus nerve.

12. The method of claim 6 wherein said step of providing an electrical pulse generator comprises providing an implantable pulse generator coupled to said plurality of electrodes by a lead.

13. The method of claim 6 wherein said step of providing an electrical pulse generator comprises providing an external pulse generator that is inductively coupled to said plurality of electrodes.

14. The method of claim 6 wherein said step of providing an electrical pulse generator comprises providing a pulse generator having a controller capable of independently addressing each of said plurality of electrodes to deliver said electrical signal to any combination of said plurality of electrodes.

15. 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.

16. The method of claim 1, wherein said eating disorder is selected from the group consisting of obesity, bulimia nervosa, and anorexia nervosa.

17. 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.

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

an implantable gastric band having an inner periphery for contacting at least a portion of the patient'"'"'s gastrointestinal tract;

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

an implantable receiver capable of receiving said adjustment signal and providing said adjustment signal to said adjustment element;

an external adjustment controller for generating and noninvasively transmitting said adjustment signal to said implantable receiver.

19. The gastric band system of claim 18 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.

20. The gastric band system of claim 18 wherein said adjustment element comprises an adjustable clamp.

21. The gastric band system of claim 18 wherein said adjustment element comprises a worm gear.

22. The gastric band system of claim 18 wherein said adjustment element comprises at least one balloon element.

23. The gastric band system of claim 18 wherein said implantable gastric band comprises a plurality of electrodes, and wherein at least one of said plurality of electrodes is electrically coupled to a vagus nerve on said at least a portion of the gastrointestinal tract.

24. The gastric band system of claim 23 wherein said at least one of said plurality of electrodes is capable of inducing afferent action potentials on said vagus nerve.

25. The gastric band system of claim 23 further comprising an electrical pulse generator electrically coupled to said plurality of electrodes and capable of generating an electrical signal for application to said vagus nerve.

26. The gastric band system of claim 25 wherein said electrical pulse generator comprises an implantable pulse generator, said system further comprising at least one lead electrically coupling said implantable pulse generator to said plurality of electrodes.

27. The gastric band system of claim 18 wherein said implantable gastric band comprises a plurality of stimulation electrodes and a plurality of sensing electrodes.

28. The gastric band system of claim 18 wherein said implantable gastric band comprises a plurality of electrodes, and wherein at least a first electrode of said plurality of electrodes is electrically coupled to the patient'"'"'s anterior vagus nerve and at least a second electrode of said plurality of electrodes is electrically coupled to the patient'"'"'s posterior vagus nerve.

29. The gastric band system of claim 25 wherein said electrical pulse generator comprises an external pulse generator that is inductively coupled to said plurality of electrodes.

30. The gastric band system of claim 25 wherein said electrical pulse generator comprises a controller capable of independently addressing each of said plurality of electrodes to apply said electrical signal to any combination of said plurality of electrodes.

31. The gastric band system of claim 25 wherein said electrical signal comprises a pulsed electrical signal and said pulse generator comprises a controller for defining said pulsed electrical signal by a plurality of stimulation parameters including at least a current magnitude, a frequency, and a pulse width.

32. The gastric band system of claim 18, wherein said eating disorder is selected from the group consisting of obesity, bulimia nervosa, and anorexia nervosa.

33. The gastric band system of claim 18, wherein said adjustment controller comprises a computer algorithm for adjusting said constriction of said gastric band on said gastrointestinal tract.

34. The gastric band system of claim 33, wherein said algorithm adjusts said constriction according to the circadian rhythms of the patient.

35. The gastric band system of claim 34, wherein said algorithm adjusts said constriction according to the time of day.

36. The gastric band system of claim 18, wherein said implantable gastric band comprises at least one pressure sensor for sensing a pressure between said band and said gastrointestinal tract, and said external adjustment controller comprises a computer algorithm for adjusting said constriction of said gastric band to maintain a desired pressure on said pressure senor.

37. The gastric band system of claim 36, wherein said desired pressure is a constant pressure.

38. The gastric band system of claim 36, wherein said desired pressure comprises a pressure profile that varies according to the time of day.