Device and method for treating dysphagia with electrical stimulation

• US 8,583,240 B2
• Filed: 04/10/2012
• Issued: 11/12/2013
• Est. Priority Date: 07/18/2011
• Status: Active Grant

• Current Assignee: Marcy L. Freed
• Original Assignee: Marcy L. Freed
• Inventors: Freed, Marcy L.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/443,372
• Publication Number:
  US 20130023952A1
• Time in Patent Office: 581 Days
• Field of Search: 607/48, 607/72
• US Class Current: 607/48
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

An electrical stimulation device and non-invasive method for treating dysphagia and artificially promoting swallowing by simultaneous electrical stimulation of the pharyngeal and facial muscles. The device includes a plurality of electrodes selectively placed in electrical contact with pharyngeal and oral-facial regions of a patient and a series of electrical pulses in electrical contact with each of the plurality of electrodes with a generator. The generator includes a pulse rate modulator for generating electrical pulses having a frequency generally fixed at 80 hertz, a pulse width modulator for generating a series of electrical pulses each at a duration fixed at 300 microseconds, and a governor for regulating the electrical pulses such that at least one of current does not to exceed 4.4 milliamps RMS or power does not to exceed 9.6 MW RMS. The electrical pulses selectively stimulate muscles located proximate to the electrodes to close the mouth and initiate swallowing.

Claims

1. A device for treating dysphagia using electrical stimulation that simultaneously closes the mouth and activates a swallowing reflex in the pharyngeal region of the throat, comprising:

a. a power source;

b. eight electrode output plug connectors;

c. a signal generator configured to provide four facial muscle output signals to four said electrode output plug connectors and configured to provide four pharyngeal region output signals to four said electrode output plug connectors simultaneously with said four facial muscle output signals, each said output signal having an intensity, a frequency, and a pulse duration;

d. an output protector circuit for limiting said intensity of each said output signals;

e. a treatment duration circuit for controlling the duration of operation of said signal generator;

f. a ramp control circuit for controlling said intensity of each said output signal;

g. a monitor for displaying operating parameters of said device;

h. one electrode attached to each said electrode output plug connector;

i. wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for closing the mouth prior to swallowing by applying said output signal to said output plug connectors connected to said electrodes attached to the facial region of a patient;

j. wherein said signal generator regulates said intensity, said frequency, and said pulse duration of said output signal in accordance with a procedure for treating dysphagia by applying said output signal to said output plug connectors connected to said electrodes attached to the pharyngeal region of a patient;

k. wherein said treatment duration circuit and said ramp control circuit regulate said output signal in accordance with a procedure for treating dysphagia by applying said output signal to the pharyngeal region of the patient; and

,

i. wherein said output protector circuit is programmed to limit said intensity of said output signal in accordance with a treatment tolerance level of the patient.

2. A device according to claim 1, wherein said intensity of said of said output signal ranges from 0 to 4.4 milliamps.

3. A device according to claim 1, wherein said frequency of said output signal is approximately 80 Hertz.

4. A device according to claim 1, wherein said pulse duration is approximately 300 microseconds.

5. A device according to claim 1, wherein said output protector circuit limits said intensity of said output signal so as not to exceed approximately 4.4 milliamps.

6. A method for treating dysphagia by simultaneously stimulating muscles in the facial region that control closure of the mouth and by stimulating the pharyngeal region, comprising the following steps:

a. selecting an electrical stimulator with at least two pharyngeal stimulating electrodes and four facial stimulating electrodes, said electrical stimulator configured to simultaneously stimulate said pharyngeal and facial stimulating electrodes when properly positioned on a patient to cause swallowing;

b. attaching at least two said pharyngeal stimulating electrodes longitudinally over the anterior pharyngeal region of the throat that when stimulated initiate the swallowing reflex in the pharyngeal region;

c. attaching at least two pairs of facial stimulating electrodes to the facial regions on the face and around the mouth that when stimulated close the mouth, and,

d. activating said electrical stimulator to simultaneously stimulate said pharyngeal and facial stimulating electrodes.