Treatment of eating disorders by nerve stimulation

• US 5,263,480 A
• Filed: 08/07/1992
• Issued: 11/23/1993
• Est. Priority Date: 02/01/1991
• 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., Wernicke, Joachim F.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Casler, Brian L.
• Application Number:
  US07/926,915
• Time in Patent Office: 473 Days
• Field of Search: 128/789-795, 128/642, 128/421, 128/419 R, 128/422-423, 128/419 C, 128/420.5, 128/731, 128/2
• US Class Current: 607/118
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method of treating patients with compulsive eating disorders includes the steps of detecting a preselected event indicative of an imminent need for treatment of the specific eating disorder of interest, and responding to the detected occurrence of the preselected event by applying a predetermined stimulating signal to the patient'"'"'s vagus nerve appropriate to alleviate the effect of the eating disorder of interest. For example, the preselected event may be a specified level of food consumption by the patient within a set interval of time, or the commencement of a customary mealtime according to the patient'"'"'s circadian cycle, or the passage of each of a sequence of preset intervals of time, or the patient'"'"'s own recognition of the need for treatment by voluntarily initiating the application of the stimulating signal to the vagus nerve. In cases in which the disorder is compulsive eating to excess, the stimulating signal is predetermined to produce a sensation of satiety in the patient. The occurrence of the preselected event is detected by summing the number of swallows of food by the patient within the set interval of time. In cases where the disorder is compulsive refusal to eat (anorexia nervosa), the stimulating signal is predetermined to produce a sensation of hunger or to suppress satiety in the patient.

Claims

1. A method of treating patients with eating disorders, which comprises the steps of:

detecting the commencement of a customary mealtime according to the patient'"'"'s circadian cycle, as being indicative of an imminent need for treatment of the patient'"'"'s eating disorder, and

responding to the detected commencement of the customary mealtime by applying a predetermined stimulating signal to the patient'"'"'s vagus nerve appropriate to alleviate the patient'"'"'s eating disorder.

2. A method of treating patients with an eating disorder associated with compulsive refusal to eat, which comprises the steps of:

detecting the commencement of a preselected event indicative of an imminent need for treatment of the patient'"'"'s eating disorder, and

responding to the detected occurrence of the preselected event by applying a predetermined stimulating signal to the patient'"'"'s vagus nerve appropriate to alleviate the patient'"'"'s eating disorder, said stimulating signal being predetermined to suppress a sensation of satiety in the patient.

3. The method of claim 2, wherein

the preselected event is the passage of each of a sequence of preset intervals of time.

4. The method of claim 2, wherein

the preselected event is the patient'"'"'s own recognition of the need for treatment by voluntarily initiating the application of said predetermined stimulating signal to the vagus nerve.

5. The method of claim 2, wherein

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

6. Apparatus for the treatment of patients suffering from eating disorders, in which the apparatus has an implantable neurostimulator device adapted to generate a preprogrammed electrical output signal upon activation of the device, and an implantable electrical lead assembly connectable to the neurostimulator device and with an electrode adapted to be secured to the patient'"'"'s vagus nerve for electrical excitation of the nerve to modulate its electrical activity, characterized in that:

the apparatus further includes sensor means electrically coupled to the neurostimulator device for detecting the occurrence of a predetermined event associated with the eating disorder of interest, and

activator means electrically coupled to the neurostimulator device and responsive to detection of the predetermined event to activate the neurostimulator device to apply its preprogrammed electrical output signal to the electrical lead assembly for electrical excitation of the vagus nerve to modulate the electrical activity of the nerve so as to stimulate or inhibit neural impulses and produce excitatory or inhibitory neurotransmitter release by the vagus nerve according to the specific nature of the eating disorder.

7. The apparatus of claim 6, in which:

the electrical parameters of the output signal of the neurostimulator device are programmable over a predetermined range of values to enable the apparatus to effectively treat the eating disorder of interest.

8. The apparatus of claim 6, in which:

the neurostimulator device is arranged and adapted to be calibrated to the specific patient and the specific eating disorder being treated.

9. The apparatus of claim 6, in which:

the sensor means comprises a timer which may be set to activate the neurostimulator device at normal mealtimes of the patient to modulate the electrical activity of the vagus nerve in a manner to suppress the patient'"'"'s appetite where the disorder is bulimia or compulsive eating to excess.

10. The apparatus of claim 6, in which:

the sensor means comprises a timer for detecting the passage of each of a sequence of time intervals as the event to be detected.

11. The apparatus of claim 6, in which:

the sensor means comprises means for detecting the gross amount of food consumed by the patient within a predetermined interval of time and responsive to consumption exceeding a preselected level to cause the neurostimulator device to modulate the electrical activity of the patient'"'"'s vagus nerve to suppress the patient'"'"'s appetite.

12. The apparatus of claim 6, in which:

the sensor means comprises means for totaling the number of swallows by the patient of the food being consumed, over a predetermined interval of time, and means for comparing the sensed total with a number indicative of a preprogrammed threshold level of food consumption for a normal healthy person of the patient'"'"'s sex, age and skeletal characteristics.

13. The apparatus of claim 6, in which:

the neurostimulator device includes mean for programming its output signal to modulate the electrical activity of the patient'"'"'s vagus nerve to suppress a sensation of satiety in the patient.

14. The apparatus of claim 6, in which:

the neurostimulator device is arranged and adapted for alternative activation manually by the patient to produce the electrical output signal for modulating the electrical activity of the vagus nerve.

15. The apparatus of claim 6, in which:

the electrical lead is adapted to be implanted with the electrode secured in electrically excitable relation to the patient'"'"'s vagus nerve in the vicinity of the stomach.

16. A new use for a neurostimulator device adapted to be implanted in a human patient, in which the device comprises an electrical signal generator which is programmable to generate an electrical output signal having selected signal parameters, and an electrical lead adapted to be connected to the signal generator including an electrode adapted to be implanted on the patient'"'"'s vagus nerve to modulate the electrical activity of the nerve in response to application of the programmed electrical output signal from the signal generator to the lead, the new use of the neurostimulator device characterized by therapeutic treatment and control of an eating disorder of the patient, including the steps of:

detecting the occurrence of a predetermined event associated with the eating disorder of interest, and

upon detection of the predetermined event, activating the neurostimulator device to apply the programmed electrical output signal of the signal generator to the lead for electrical excitation of the vagus nerve to modulate the electrical activity of the nerve so as to stimulate or inhibit neural impulses and produce excitatory or inhibitory neurotransmitter release by the vagus nerve according to the specific nature of the eating disorder.

17. The new use of the neurostimulator device of claim 16, in which:

the step of detecting comprises detecting a symptom of the eating disorder under treatment, and

further including the step of programming the electrical output signal of the signal generator for modulating the electrical activity of the vagus nerve so as to evoke or suppress a sensation of satiety in the patient according to the nature of the eating disorder under treatment.

18. A method of controlling the function of a neurostimulator device adapted to be implanted in a human patient, including the following steps:

selecting parameters including pulse amplitude, pulse width and on and off times of an electrical output signal of a pulse generator to develop an electrical signal for treating an eating disorder of the patient for application to a lead/electrode assembly implanted on the vagus nerve of the patient to appropriately modulate the electrical activity of the nerve, and

programming the pulse generator after implantation to set the selected parameters of its electrical output signal for treatment of said eating disorder.