Method and system for dynamic vocal fold closure with neuro-electrical stimulation

• US 6,978,787 B1
• Filed: 04/03/2002
• Issued: 12/27/2005
• Est. Priority Date: 04/03/2002
• Status: Expired due to Fees

• Current Assignee: Michael Broniatowski
• Original Assignee: Michael Broniatowski
• Inventors: Broniatowski, Michael
• Primary Examiner(s): Manuel, George C.
• Assistant Examiner(s): Faulcon, Jr., Lenwood
• Application Number:
  US10/115,803
• Time in Patent Office: 1,364 Days
• Field of Search: 128/898, 607/72, 607/42, 607/40
• US Class Current: 128/898
• CPC Class Codes: A61B 2017/00743 Type of operation; Specification of treatment sites A61B2017/00238 takes precedence
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601

Abstract

A method and system for treating dysphagia using electrical stimulation of a human'"'"'s or animals'"'"'s vagus nerve, or recurrent laryngeal nerve, or both to cause glottic or vocal fold motion in humans or animals. Stimulation is caused by utilizing a power source; an external controller for generating and providing an output signal having a given intensity, frequency, and pulse duration; an output protector circuit for limiting the intensity of the output signal; a treatment duration circuit for controlling the duration of operation of the external controller, a ramp control circuit for controlling the intensity of the output signal; and a monitor portion for displaying operating parameters of the device. The external controller regulates the intensity, the frequency, and the pulse duration of the output signal in accordance with a procedure for treating dysphagia.

Claims

1. A method of treating dysphagia after administering general anesthesia to a human or animal utilizing electrical stimulation of a vagus nerve, a recurrent laryngeal nerve or both which comprises:

a. performing a tracheotomy;

b. identifying a vagus nerve or a recurrent laryngeal nerve or both by electrically stimulating said vagus nerve or said recurrent laryngeal nerve or both with a hand held electrical stimulator;

c. dissecting the soft tissue overlying said vagus nerve, or said recurrent laryngeal nerve, or both;

d. verifying glottic fold adduction by inserting a transnasal flexible fiberoptic laryngoscope;

e. wrapping a perineural electrode around said vagus nerve or recurrent laryngeal nerve or both;

f. inducing said glottic fold adduction by electrically stimulating said vagus nerve or said recurrent laryngeal nerve or both with a hand held electrical stimulator;

g. verifying glottic fold adduction by means of said transnasal flexible fiberoptic laryngoscope;

h. attaching said perineural electrode to neighboring soft tissue of the neck;

i. making an incision on the side of said perineural electrode placement over said human'"'"'s chest approximately 5 centimeters below human'"'"'s clavicle;

j. dissecting a subcutaneous pocket over said human'"'"'s facia of the pectoralis major muscle;

k. creating surgically a path between the upper aspect of said subcutaneous pocket over said clavicle into said cervical field for electric wires of said perineural electrode;

l. implanting a receiver stimulator in said subcutaneous pocket;

m. passing said electric wires from said perineural electrode through said path to said receiver stimulator;

n. creating a looped section of said electrical wire to avoid any tension;

o. wrapping said perineural electrode around said vagus nerve, or said recurrent laryngeal nerve, or both;

p. inducing motion of said glottic folds by means of an external transmitter applied transcutaneously over the implanted receiver stimulator for verification of glottic fold motion prior to closing said incisions;

q. closing said incisions at the subcutaneous pocket with absorbable sutures and adhesive strips; and

r. confirming glottic fold motion by applying said electrical stimulation to said vagus nerve, said recurrent laryngeal nerve or both.

2. The method as defined in claim 1, step f wherein intensity of said electrical stimulation ranges from 0.1 to 2.0 milliamperes.

3. The method as defined in claim 2, wherein an output protector circuit limits said intensity of said electrical stimulation so as not to exceed 1 milliampere.

4. The method as defined in claim 1, step f wherein frequency of said electrical stimulation ranges from 20 to 60 Hertz.

5. The method as defined in claim 4, wherein frequency of said electrical stimulation is preferably 42 Hertz.

6. The method as defined in claim 1, step f wherein pulse duration ranges from 30 to 300 microseconds.

7. The method as defined in claim 6, wherein pulse duration is preferably 48 microseconds.