Cervical vagal stimulation induced weight loss

• US 8,064,994 B2
• Filed: 01/14/2004
• Issued: 11/22/2011
• Est. Priority Date: 01/14/2003
• Status: Expired due to Fees

• Current Assignee: US Department of Veterans Affairs (Government of the United States of America)
• Original Assignee: US Department of Veterans Affairs (Government of the United States of America)
• Inventors: Sheikh, Sohail A., Pardo, Jose V.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Porter, Jr.; Allen
• Application Number:
  US10/541,853
• Publication Number:
  US 20060259077A1
• Time in Patent Office: 2,869 Days
• Field of Search: 607/2, 607/45, 607/115, 607/116, 607/118
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence

Abstract

Apparatus and methods for treating obesity using chronic cervical vagal nerve stimulation (cVNS) of the left vagus trunk are disclosed. Four men and ten women, average age 46 years (SD±10) were treated with output current typically 0.75 mA, pulse frequency 30 Hz and width 250 or 500 μs, and duty cycle of 30 s power per five minutes. Mean intake weight was 91 kg (SD±27, range 46 to 137 kg) with body mass index (BMI) 43 kg/m² (SD±5, range 18 to 49 kg/mn²). After 6-12 months, obese patients had marked weight loss while normal weights were maintained. Decrease in BMI was consistently proportional to initial BMI. Average weight loss at one year was 7 kg (SD±3, range −6 to +24) with mean drop in BMI of 2 kg/m² (SD±3, range −2 to +8)k. All patients denied any major dieting or exercise.

Claims

1. A method of treating morbid obesity in a patient, said method comprising:

implanting subcutaneously in a morbidly obese patient

a device comprising an electrical signal generator and a predetermined program for controlling at least one parameter of the electrical signal, and

at least one electrical lead having at least one proximal electrical connector and one distal nerve electrode;

operably connecting a proximal electrical connector of the electrical lead to the signal generator;

operably coupling a distal nerve electrode of the electrical lead to the trunk of only the left vagus nerve in the neck of the patient, and

activating the signal generator to chronically stimulate the vagus nerve with an electrical signal for a period of at least six months in accordance with the program;

whereby the method induces weight loss and maintains normal weight in the patient without changing lifestyle or diet.

2. The method of claim 1, wherein:

said electrical signal comprises at least one variable parameter selected from the group consisting of current amplitude, pulse width, pulse frequency, and a duty cycle of alternating intervals with power on and power off,

said device comprises at least two predetermined programs for controlling at least one parameter of said electrical signal according to a programmed regimen that cannot be altered while said device is implanted in the patient;

said signal generator is activated by an externally activated control system that selectively activates each of said at least two predetermined programs; and

said apparatus provides vagus nerve stimulation which is controllable by said externally activated control system.

3. The method of claim 2, wherein said externally activated control system is selected from the group consisting of a magnetically activated control system, a mechanically activated control system that responds to tapping on the skin near said device, and an acoustically activated control system that responds to an audio or supersonic signal.

4. The method of claim 2, wherein each of said at least two predetermined programs to control parameters of said electrical signal produces an electrical signal that has an output current amplitude between about 0.5 mA to about 1.5 mA, a stimulation frequency between about 10 Hz and 100 Hz, a pulse width in the range of 100 microseconds to 1000 microseconds (μ

s), and a duty cycle of intervals with power on for about 10 s to about 100 s and power off for the remainder of a 3 minute to 10 minute period of treatment.

5. The method of claim 2, wherein at least one of said at least two predetermined programs to control parameters of said electrical signal produces an electrical signal that comprises an output current amplitude of about 0.7 mA, a stimulation frequency of about 30 Hz, a pulse width of either about 250 microseconds or about 500 microseconds (μ

s), and a duty cycle of intervals with power on for about 30 s and power off for the remainder of a 5 minute period of treatment.

6. Apparatus for treating morbid obesity in a patient, said apparatus comprising:

a device suitable for implanting subcutaneously in a morbidly obese patient and at least one implantable electrical lead,

said device comprising an electrical signal generator,

said electrical lead having at least one proximal connector for operably connecting said electrical lead to said signal generator and at least one distal nerve electrode for operably coupling said electrical lead only to left trunk of the vagus nerve in the neck of the patient;

said signal generator comprising a power source suitable to chronically stimulate said trunk of the vagus nerve with an electrical signal while implanted for a period of at least one year,

said electrical signal having at least one variable parameter selected from the group consisting of current amplitude, pulse width, pulse frequency, and a duty cycle of alternating intervals with power on and power off,

said device further comprising at least two predetermined programs to reduce weight in a morbidly obese patient wherein at least one parameter of said electrical signal is controlled according to a programmed regimen that cannot be altered while said device is implanted in the patient;

said signal generator being activated by an externally activated control system that selectively activates each of said at least two predetermined programs;

whereby said apparatus provides chronic cervical vagus nerve stimulation which is controllable by said externally activated control system.

7. The apparatus of claim 6, wherein said external control system is selected for the group consisting of a magnetically activated control system, a mechanically activated control system that is adapted to be activated in response to tapping on the skin near said device, and an activation system responsive to an audio or supersonic signal generated by an external control component.

8. The apparatus of claim 6, wherein each of said at least two predetermined programs to control parameters of said electrical signal produces an electrical signal that has an output current amplitude between 0.5 mA to about 1.5 mA, a stimulation frequency between about 10 Hz and 100 Hz, a pulse width in the range of 100 microseconds to 1000 microseconds (μ

s), and a duty cycle of intervals with power on for about 10 s to about 100 s and power off for the remainder of each 3 minute to 10 minute period of treatment.

9. The apparatus of claim 6, wherein at least one of said at least two predetermined programs to control parameters of said electrical signal produces an electrical signal that has an output current amplitude of about 0.75 mA, a stimulation frequency of about 30 Hz, a pulse width of either about 250 microseconds or about 500 microseconds (μ

s), and a duty cycle of intervals with power on for about 30 s and power off for the remained of each 5 minute period of treatment.