Weight loss method and device

• US 7,835,796 B2
• Filed: 04/29/2005
• Issued: 11/16/2010
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Armstrong, Scott A., Parnis, Steven M.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US11/118,452
• Publication Number:
  US 20060247719A1
• Time in Patent Office: 2,027 Days
• Field of Search: 607/40, 607/116, 607/118, 607/133, 607/62
• US Class Current: 607/40
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• 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 system for treating an eating disorder by electrical stimulation of a vagus nerve of the patient in a manner to induce an afferent action potential on the nerve, comprising:

an implantable gastric band having an inner periphery for contacting at least a portion of the patient'"'"'s gastrointestinal tract innervated by said vagus nerve, said gastric band comprising a plurality of electrodes for electrical communication with said at least a portion of the gastrointestinal tract and said vagus nerve, wherein said plurality of electrodes is used for both sensing and inducing afferent action potentials; and

a pulse generator coupled to said plurality of electrodes and configured to generate a test electrical signal to be applied to said plurality of electrodes, and also configured to select which of said electrode(s) are to be used to induce said action potentials based on detection of an afferent action potential in said nerve induced by said test electrical signal and sensed by at least one said electrode, and further configured to provide an electrical stimulation signal to at least said selected electrode sufficient to induce an exogenous afferent action potential on said vagus nerve of the patient while permitting transmission of native action potentials on said nerve.

2. The system of claim 1, wherein said electrical stimulation 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 selected from the group consisting of a voltage magnitude, a current magnitude, a frequency, a pulse width, an on-time and an off-time.

3. The system of claim 2 wherein said controller is capable of independently addressing each of said plurality of electrodes to deliver said electrical signal to any combination of said plurality of electrodes.

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

5. The system of claim 1 wherein said electrical stimulation signal is configured to generate both exogenous afferent and exogenous efferent action potentials on the vagus nerve of the patient while permitting said transmission of native action potentials on said nerve.

6. The system of claim 1 wherein said implantable gastric band further comprises an adjustment element that allows said band to be non-invasively and post-operatively adjusted in size to vary a constriction applied to said at least a portion of the gastrointestinal tract.

7. The system of claim 6 wherein said adjustment element comprises at least one inflatable balloon member.

8. A method of treating an eating disorder by electrical stimulation of a vagus nerve of the patient to induce afferent action potentials on said nerve, comprising:

surgically coupling an implantable gastric band to at least a portion of the patient'"'"'s gastrointestinal tract innervated by said vagus nerve, wherein said implantable gastric band comprises a plurality of electrodes;

generating an electrical test signal and applying said electrical test signal to at least two of said plurality of electrodes;

identifying at least a first electrode of said plurality of electrodes that senses a test action potential or is nearest to an electrode that senses said test action potential on said vagus nerve induced by said electrical test signal;

generating an electrical stimulation signal configured to induce an exogenous afferent action potential on said vagus nerve of the patient without blocking native action potentials on said nerve;

applying said electrical stimulation signal to said identified first electrode to induce said exogenous afferent action potential on said nerve while permitting transmission of native action potentials on said nerve, to treat said eating disorder comprising obesity, bulimia or anorexia nervosa.

9. The method of claim 8 further comprising the step of providing a pulse generator, said step of generating an electrical stimulation signal comprising generating an electrical stimulation signal using said pulse generator.

10. The method of claim 9 wherein said step of providing a pulse generator comprises providing an implantable pulse generator and a lead, said method further comprising the step of coupling said pulse generator to said plurality of electrodes with said lead.

11. The method of claim 9 wherein said step of providing a pulse generator comprises providing an external pulse generator that is inductively coupled to said plurality of electrodes.

12. The method of claim 9 wherein said step of providing a 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.

13. The method of claim 8 wherein said implantable gastric band comprises a plurality of stimulation electrodes and a plurality of sensing electrodes, said method further comprising sensing said induced action potentials on said nerve using said sensing electrodes.

14. The method of claim 13, wherein said plurality of sensing electrodes are located above said plurality of stimulating electrodes on said band.

15. The method of claim 8 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 8, wherein said eating disorder is selected from the group consisting of obesity, bulimia nervosa, and anorexia nervosa.

17. The method of claim 8 comprising inducing said exogenous afferent action potentials and inducing exogenous efferent action potentials on said vagus nerve while permitting transmission of native action potentials on said nerve.

18. The method of claim 8 wherein said identifying comprises identifying said first electrode and a second electrode, wherein said first electrode senses a first test action potential or is nearest to an electrode that senses said first test action potential on the patient'"'"'s anterior vagus nerve, and said second electrode senses a second test action potential or is nearest to an electrode that senses said second test action potential on the patient'"'"'s posterior vagus nerve.

19. The method of claim 18 wherein inducing exogenous afferent action potentials on said vagus nerve comprises inducing exogenous afferent action potentials on both said anterior vagus nerve and said posterior vagus nerve while permitting transmission of native action potentials on said nerves.

20. The method of claim 8 wherein said step of providing an implantable gastric band comprises providing a band having an adjustment element.

21. The method of claim 20 wherein said adjustment element is configured for non-invasive actuation, said method further comprising the step of post-operatively and non-invasively adjusting the size of the gastric band to vary a constriction of said at least a portion of the gastrointestinal tract.

22. The method of claim 20, wherein said at least a portion of the patient'"'"'s gastrointestinal tract comprises at least a portion of the lower esophagus, cardia, esophageal/cardia junction, and cardia/fundus junction.

23. The method of claim 8, wherein said step of generating an electrical stimulation signal comprises generating an electrical stimulation signal in response to a patient command.

24. The method of claim 23, wherein said patient command is provided by a magnetic signal from said patient.

25. The method of claim 8 wherein said plurality of electrodes are capable of both sensing and inducing action potentials on said nerve.