Treating refractory hypertension by nerve stimulation

• US 5,707,400 A
• Filed: 09/19/1995
• Issued: 01/13/1998
• Est. Priority Date: 09/19/1995
• Status: Expired due to Term

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Marquette, Andre, Baker, Ross G. Jr., Terry, Reese S. Jr.
• Primary Examiner(s): Getzow, Scott
• Application Number:
  US08/531,175
• Time in Patent Office: 847 Days
• Field of Search: 607/44, 607/45
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

A method of treating patients suffering from refractory hypertension includes identifying a patient suffering from the disorder and applying a stimulating electrical signal to the patient'"'"'s vagus nerve predetermined to modulate the electrical activity of the nerve and to alleviate the hypertension. The step of applying the stimulation may be performed manually by the patient, or automatically following detection of the hypertension by sensing the patient'"'"'s blood pressure, or, preferably by continuous or periodic application without use of a sensor. The stimulating signal is a pulse waveform with programmable signal parameter values including pulse width, output current, frequency, on time and off time.

Claims

1. A method of treating patients suffering from refractory hypertension, comprising the steps of:

implanting a neurostimulating device constructed and arranged to generate a stimulating electrical signal as an output thereof in the body of the patient operative to sense a prescribed event indicative of an imminent need for treatment of the refractory hypertension, said prescribed event being the patient'"'"'s blood pressure exceeding a programmed threshold level, the step of implanting including connecting said output directly to the vagus nerve of the patient for application of said stimulating electrical signal thereto, and

programming the device to automatically respond to the sensed occurrence of the prescribed event with application of a stimulating electrical signal having programmed electrical parameters to the patient'"'"'s vagus nerve to modulate the electrical activity of the vagus nerve in a manner to alleviate the refractory hypertension.

2. The method of claim 1, further including:

providing a capability for manual activation of the device by the patient upon sensing symptoms of refractory hypertension.

3. The method of claim 1, further including:

programming the device to produce a periodic stimulating electrical signal to modulate electrical activity of the vagus nerve according to the patient'"'"'s circadian rhythm.

4. The method of claim 1, wherein:

the predetermined stimulating electrical signal is a pulse waveform with signal parameters programmed to modulate electrical activity of the vagus nerve.

5. The method of claim 4, including:

programming parameter values of the pulse waveform, including pulse width, output current, frequency, on time and off time before application of the stimulating electrical signal to the vagus nerve.

6. The method of claim 1, including:

applying said stimulating signal to the patient'"'"'s vagus nerve by connecting said output of the device to a nerve electrode implanted on the vagus nerve at a site in the patient'"'"'s neck.

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

detecting elevated blood pressure of the patient as indicating a need to initiate treatment to alleviate the hypertension, and

after detecting the elevated blood pressure, applying an electrical stimulus directly to the patient'"'"'s vagus nerve, said stimulus being configured to modulate the electrical activity of the nerve such that the hypertension is alleviated.

8. The method of claim 7, wherein

the detecting step is performed by sensing blood pressure by means of a pressure detector wrapped on the upper arm of the patient.

9. The method of claim 7, wherein

the detecting step is performed by sensing electrical impedance changes with undulations of blood pressure at a site adjacent an artery of the patient.

10. The method of claim 7, 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.