Treatment of motility disorders by nerve stimulation

• US 5,540,730 A
• Filed: 06/06/1995
• Issued: 07/30/1996
• Est. Priority Date: 06/06/1995
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Baker, Ross G. Jr., Terry, Reese S. Jr., Marquette, Andre
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/469,174
• Time in Patent Office: 420 Days
• Field of Search: 607/2, 607/40, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus for treating patients with motility disorders applies a modulating signal to the patient'"'"'s vagus nerve to stimulate or inhibit neural impulses and produce excitatory or inhibitory neurotransmitter release by the vagus nerve according to the specific nature of the motility disorder. The apparatus includes a neurostimulator which can be activated to generate an electrical output signal. The neurostimulator is responsive to the sensing of a selected event having occurred which is indicative of the need for treatment of the motility disorder, and includes an activation element which responds to sensing of that event to activate the neurostimulator, and a lead with an electrode array to apply the electrical output signal as the modulating signal to the patient'"'"'s vagus nerve. Certain parameters of the output signal are programmable, and the neurostimulator can be calibrated according to the specific patient and the specific motility disorder being treated. One form of sensor detects the impedance of a selected part of the gastrointestinal system to detect the presence of excessive contractions in that part as an indication of hypermotility whether or not food has been consumed by the patient within a preset interval of time, and inadequate contractions in that part as an indication of hypomotility if food was consumed by the patient within a preset interval of time.

Claims

1. A method of treating patients suffering from motility disorders, comprising the steps of:

sensing a prescribed event indicative of an imminent need for treatment of a specific motility disorder of interest, and

responding to the sensed occurrence of the prescribed event by applying a stimulating electrical signal having predetermined electrical parameters to the patient'"'"'s vagus nerve to modulate the electrical activity of the vagus nerve in a manner to produce a reaction in the patient'"'"'s gastrointestinal tract by which to alleviate the motility disorder of interest.

2. The method of claim 1, wherein:

the prescribed event is inadequate contractions of at least a predesignated portion of the patient'"'"'s gastrointestinal tract compared with a range of contractions observed in human digestive systems deemed to be normal, within a predetermined interval of time following consumption of food by the patient.

3. The method of claim 2, wherein:

the predesignated portion of the patient'"'"'s gastrointestinal tract is the stomach.

4. The method of claim 1, wherein:

the prescribed event is onset of excessively rapid contractions of at least a predesignated portion of the patient'"'"'s gastrointestinal tract compared with speed of contractions observed in human digestive systems deemed to be normal, within one of (i) a predetermined interval of time following consumption of food by the patient, and (ii) a predetermined interval of time without consumption of food by the patient.

5. The method of claim 4, wherein:

the predesignated portion of the patient'"'"'s gastrointestinal tract is the stomach.

6. The method of claim 1, wherein:

the prescribed event is sensing by the patient of symptoms of the motility disorder of interest, and the response is the patient'"'"'s own recognition of the need for treatment by voluntarily initiating the application of said stimulating electrical signal to the vagus nerve.

7. The method of claim 1, wherein:

said stimulating signal is applied to the patient'"'"'s vagus nerve by application to a nerve electrode implanted on the vagus nerve in the vicinity of the patient'"'"'s stomach.

8. Apparatus for treating patients with motility disorders by application of a modulating signal to the patient'"'"'s vagus nerve to stimulate or inhibit neural impulses and produce excitatory or inhibitory neurotransmitter release by the nerve according to the specific nature of the motility disorder, comprising:

neurostimulator means for generating an electrical output signal in response to activation thereof, said neurostimulator means including

sensing means for detecting the occurrence of a selected event indicative of the need for imminent treatment of the motility disorder, and including activating means responsive to the detection for activating said neurostimulator means, and

lead/electrode means responsive to generation of the electrical output signal by said neurostimulator means for application thereof as said modulating signal to the patient'"'"'s vagus nerve.

9. The apparatus of claim 8, wherein:

said neurostimulator means further includes;

programming means for selectively programming the parameters of the electrical output signal of said neurostimulator means according to the nature of the motility disorder being treated, within respective predetermined ranges.

10. The apparatus of claim 8, wherein:

said neurostimulator memos further includes;

means for calibrating the neurostimulator means according to the specific patient and the specific motility disorder being treated.

11. The apparatus of claim 8, wherein:

the motility disorder being treated is hypomotility, and

said sensing means comprises impedance detecting means responsive to an absence of contractions of specified magnitude in the gastrointestinal system of the patient within a predetermined interval of time after consumption of food by the patient as the event to be detected.

12. The apparatus of claim 8, wherein:

the motility disorder being treated is hypermotility, and

said sensing means comprises impedance detecting means responsive to contractions in the gastrointestinal system of the patient despite an absence of consumption of food by the patient within a predetermined interval of time prior to the onset of said contractions as the event to be detected.

13. The apparatus of claim 8, wherein:

said sensing means comprises means for detecting voluntary triggering of said activating means by the patient as the event to be detected.

14. The apparatus of claim 8, wherein:

said lead/electrode means includes nerve electrode means and means for securing said nerve electrode means to the patient'"'"'s vagus nerve in the vicinity of the stomach.

15. The apparatus of claim 8, wherein:

said neurostimulator means is arranged and adapted to be implanted in the patient'"'"'s body.

16. A method of treating a patient suffering from a motility disorder in which a medical therapeutic device is implanted in the patient'"'"'s body, comprising the device-implemented steps of:

detecting a response of the patient'"'"'s gastrointestinal (GI) tract to consumption of food by the patient which is abnormal relative to predetermined normal human digestive processes and is indicative of a need for treatment to alleviate a motility disorder of interest, and

after detecting the abnormal response, applying to the patient'"'"'s vagus nerve an electrical stimulus configured to modulate the electrical activity of the nerve such that the motility disorder of interest is alleviated.

17. The method of claim 16, further including the step of

delaying the detecting step until the expiration of a predetermined interval of time from initial consumption of the food.

18. The method of claim 16, wherein:

the abnormal response to be detected is preselected to consist of abnormally slow contractions of the patient'"'"'s GI tract where the patient is suffering from hypomotility, and abnormally rapid contractions of the patient'"'"'s GI tract where the patient is suffering from hypermotility.

19. The method of claim 18, wherein:

the detecting step is performed by sensing electrical phenomena indicative of presence or absence of contractions of the patient'"'"'s stomach.

20. The method of claim 18, wherein:

the detecting step is performed by sensing electrical phenomena indicative of presence or absence of contractions of the patient'"'"'s large intestine.

21. The method of claim 16, wherein:

the electrical stimulus is configured as a pulsed signal by programming parameters of the signal including on-time, off-time, frequency, pulse width, and current.