Method and apparatus for treating oropharyngeal disorders with electrical stimulation

• US 20040034396A1
• Filed: 02/27/2003
• Published: 02/19/2004
• Est. Priority Date: 10/27/1995
• Status: Active Grant

• Current Assignee: ESD LLC
• Original Assignee: ESD LLC
• Inventors: Tucker, Howard, Freed, Marcy L., Kretschmer, Tim, Asmar, Marie, Kotton, Bernard, Freed, Leonard A., Christian, Michael O., Beytas, Erol M., Dunlay, Ed
• Granted Patent: US 7,039,468 B2
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61B 7/006 Detecting skeletal, cartilage or muscle noise A61B7/003 and A61B7/008 take precedence
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A simple, non-invasive method and apparatus for treating oropharyngeal disorders provides electrical stimulation to the oropharyngeal region of a patient. The apparatus includes an electrical neuromuscular stimulator that includes a pulse generator for generating a series of electrical pulses and a processor coupled to the pulse generator for controlling its operation. The apparatus also includes a first electrode and a second electrode, each of which includes a snap eyelet having a connector to which a lead wire may be attached, a conductive film and an adhesive and conductive gel layer that is adapted to be attached to the skin of the patient. The apparatus also includes at least one lead wire for attachment of the electrodes to the pulse generator and at least one adhesively backed tape overlay for securing the first and second electrodes to the skin of the patient. According to the method, the electrodes are placed on the skin of the patient'"'"'s throat, and the electrodes are secured to the skin of the patient'"'"'s throat by applying at least one adhesively backed tape overlay to the patient'"'"'s skin over at least a portion of each of the electrodes. The lead wires are attached to the connectors of the snap eyelets of the electrodes and to the output jack of the pulse generator, and a series of electrical pulses is generated using the pulse generator so as to apply the series of electrical pulses to the patient'"'"'s throat using the electrodes.

Claims

1. A method for treating oropharyngeal disorders in a patient by electrical neuromuscular stimulation, said method comprising the steps of:

(a) providing a first electrode and a second electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(b) providing at least one adhesively backed tape overlay for securing the first and second electrodes to the skin of the patient;

(c) providing a pulse generator for generating a series of electrical pulses, said pulse generator further comprising;

(i) a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses;

(ii) a duration control circuit for controlling the duration of time for which said pulse generator generates the series of electrical pulses; and

(iii) an intensity control circuit for regulating the series of electrical pulses such that the electrical current does not exceed a predetermined current or voltage value;

(iv) an output jack for connection of a lead wire;

(d) providing at least one lead wire having an electrode connection end and an output jack end, wherein said electrode connection end is adapted to be attached to a connector of a snap eyelet, and wherein said output jack end is adapted to be attached to the output jack of the pulse generator;

(e) placing the first electrode on the skin of the patient'"'"'s throat with the adhesive gel layer in contact with the skin;

(f) placing the second electrode on the skin of the patient'"'"'s throat with the adhesive gel layer in contact with the skin;

(g) securing the electrodes to the skin of the patient'"'"'s throat by application of at least one adhesively backed tape overlay to the skin of the patient'"'"'s throat over at least a portion of each of the electrodes;

(h) attaching a lead wire to the snap eyelet of each electrode and to the output jack of the pulse generator so as to electrically connect the snap eyelet of each electrode to the output jack;

(i) generating a series of electrical pulses using the pulse generator so as to apply the series of electrical pulses to the patient'"'"'s throat using the electrodes.

2. The method of claim 1 which includes the following steps:

(j) providing a clip that is adapted to secure a lead wire to an item of clothing of the patient;

(k) securing the lead wire to the item of clothing of the patient using the clip.

3. The method of claim 1 which includes the following steps instead of the corresponding steps of claim 1:

(b) providing an adhesively backed tape overlay having a centrally located slot therethrough;

(g) applying the adhesively backed tape overlay to the patient'"'"'s skin over the first and second electrodes with the slot aligned with the connectors of the snap eyelets.

4. The method of claim 1 which includes the following step instead of step (d) of claim 1:

(d) providing a lead wire having a first electrode connection end, a second electrode connection end and an output jack end, wherein each of said electrode connection ends is adapted to be attached to a connector of a snap eyelet, and wherein said output jack end is adapted to be attached to the output jack of the pulse generator;

and which includes the following steps instead of step (h) of claim 1;

(h1) attaching the first electrode connection end of the lead wire to the snap eyelet of the first electrode;

(h2) attaching the second electrode connection end of the lead wire to the snap eyelet of the second electrode;

(h3) attaching the output jack end of the lead wire to the output jack of the pulse generator.

5. The method of claim 1 which includes the following steps instead of the corresponding steps of claim 1:

(e) placing the first electrode on the skin of the patient'"'"'s throat above the thyroid notch and generally on the centerline of the throat with the adhesive gel layer in contact with the skin;

(f) placing the second electrode on the skin of the patient'"'"'s throat below the first electrode and above the thyroid notch and generally on the centerline of the throat with the adhesive gel layer in contact with the skin.

6. The method of claim 1 which includes the following step instead of the corresponding step of claim 1:

(a) providing a first electrode and a second electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film having a first side and a second side, said first side being attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(iv) an electrically-insulating layer that is attached to the second side of the conductive film.

7. The method of claim 1 which includes the following step instead of the corresponding step of claim 1:

(a) providing a first electrode and a second electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said first side being generally circular and having a diameter of approximately 7 mm and said second side having a stud connector to which a lead wire may be attached;

(ii) a generally circular conductive carbon film having a diameter within the range of 16 mm-22 mm that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient.

8. The method of claim 1 which includes the following steps instead of the corresponding steps of claim 1:

(a) providing a first electrode, a second electrode, a third electrode and a fourth electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(c) providing a pulse generator for generating a series of electrical pulses, said pulse generator further comprising;

(i) a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses;

(ii) a duration control circuit for controlling the duration of time for which said pulse generator generates the series of electrical pulses; and

(iii) an intensity control circuit for regulating the series of electrical pulses such that the electrical current does not exceed a predetermined current or voltage value;

(iv) a first output jack and a second output jack, each of which is adapted for connection of a lead wire;

and which includes the following steps instead of step (d) of claim 1;

(d1) providing a first lead wire having a first electrode connection end that is adapted to be connected to the connector of the snap eyelet of the first electrode, a second electrode connection end that is adapted to be connected to the connector of the snap eyelet of the second electrode, and an output jack end that is adapted to be attached to an output jack of the pulse generator;

(d2) providing a second lead wire having a third electrode connection end that is adapted to be connected to the connector of the snap eyelet of the third electrode, a fourth electrode connection end that is adapted to be connected to the connector of the snap eyelet of the fourth electrode, and an output jack end that is adapted to be attached to an output jack of the pulse generator;

and which includes the following steps instead of step (e) of claim 1;

(e1) placing the first electrode on the skin of the patient'"'"'s throat above the thyroid notch and generally on the centerline of the throat with the adhesive gel layer in contact with the skin;

(e2) placing the second electrode on the skin of the patient'"'"'s throat above the thyroid notch, below the first electrode, and generally on the centerline of the throat with the adhesive gel layer in contact with the skin;

and which includes the following steps instead of step (f) of claim 1;

(f1) placing the third electrode on the skin of the patient'"'"'s throat below the thyroid notch and generally on the centerline of the throat with the adhesive gel layer in contact with the skin;

(f2) placing the fourth electrode on the skin of the patient'"'"'s throat below the thyroid notch, below the third electrode, and generally on the centerline of the throat with the adhesive gel layer in contact with the skin;

and which includes the following steps after step (g) instead of steps (h) and (i) of claim 1;

(h) attaching the first electrode connection end of the first lead wire to the connector of the snap eyelet of the first electrode;

(i) attaching the second electrode connection end of the first lead wire to the connector of the snap eyelet of the second electrode;

(j) attaching the third electrode connection end of the second lead wire to the connector of the snap eyelet of the third electrode;

(k) attaching the fourth electrode connection end of the second lead wire to the connector of the snap eyelet of the fourth electrode;

(l) attaching the output jack end of first lead wire to first output jack of the pulse generator;

(m) attaching the output jack end of second lead wire to second output jack of the pulse generator;

(n) generating a series of electrical pulses using the pulse generator so as to apply the series of electrical pulses to the patient'"'"'s throat using the electrodes.

9. The method of claim 8 which includes the following step instead of the corresponding step of claim 8:

(a) providing a first electrode, a second electrode, a third electrode and a fourth electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

wherein each electrode has a maximum electrical impedance of about 150 ohms.

10. The method of claim 8 which includes providing a pulse generator having an intensity control circuit for independently regulating:

(a) the current of the series of electrical pulses that are passed through the first output jack; and

(b) the current of the series of electrical pulses that are passed through the second output jack.

11. The method of claim 10 which includes providing a pulse generator having an intensity control circuit for independently regulating:

(a) the current of the series of electrical pulses that are passed through the first output jack; and

(b) the current of the series of electrical pulses that are passed through the second output jack;

so that the current of each pulse is within the range of 0.5 to 25 milliamps.

12. An apparatus for applying electrical neuromuscular stimulation to a patient for treatment of oropharyngeal disorders, said apparatus comprising:

(a) a first electrode and a second electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(b) at least one adhesively backed tape overlay for securing the first and second electrodes to the skin of the patient;

(c) a pulse generator for generating a series of electrical pulses, said pulse generator comprising;

(i) a frequency controller for modulating an electrical signal generated by the pulse generator at a predetermined frequency to produce the series of electrical pulses;

(ii) a duration control circuit for controlling the duration of time for which said pulse generator generates the series of electrical pulses; and

(iii) an intensity control circuit for regulating the series of electrical pulses such that the electrical current does not exceed a predetermined current or voltage value;

(iv) an output jack for connection of a lead wire;

(d) a lead wire having a first electrode connection end, a second electrode connection end and an output jack end, wherein each of said electrode connection ends is adapted to be attached to a connector of a snap eyelet, and wherein said output jack end is adapted to be attached to the output jack of the pulse generator.

13. The apparatus of claim 12 wherein the adhesively backed tape overlay has a centrally located slot therethrough, so that it may be applied to the patient'"'"'s skin over the first and second electrodes with the slot aligned with the connectors of the snap eyelets.

14. The apparatus of claim 12 wherein each of the electrodes comprises:

(a) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(b) a conductive film having a first side and a second side, said first side being attached to the first side of the snap eyelet;

(c) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(d) an electrically-insulating layer that is attached to the second side of the conductive film.

15. The apparatus of claim 12 which includes:

(a) a first electrode, a second electrode, a third electrode and a fourth electrode, each of which comprises;

(i) a snap eyelet having a first side and a second side, said second side having a connector to which a lead wire may be attached;

(ii) a conductive film that is attached to the first side of the snap eyelet;

(iii) an adhesive and conductive gel layer that is attached to the conductive film and adapted to be attached to the skin of the patient;

(b) a pulse generator having a first output jack and a second output jack, each of which is adapted for connection of a lead wire;

(c) a first lead wire having a first electrode connection end, a second electrode connection end and an output jack end, wherein said first electrode connection end is adapted to be connected to the connector of the first electrode, said second electrode connection end is adapted to be connected to the connector of the second electrode and said output jack end is adapted to be connected to the first output jack of the pulse generator.

(d) a second lead wire having a third electrode connection end, a fourth electrode connection end and an output jack end, wherein said third electrode connection end is adapted to be connected to the connector of the third electrode, said fourth electrode connection end is adapted to be connected to the connector of the fourth electrode and said output jack end is adapted to be connected to the second output jack of the pulse generator.

16. The apparatus of claim 15 wherein the pulse generator has an intensity control circuit for independently regulating:

(a) the current of the series of electrical pulses that are passed through the first output jack; and

(b) the current of the series of electrical pulses that are passed through the second output jack.

17. The apparatus of claim 16 wherein the intensity control circuit independently regulates:

(a) the current of the series of electrical pulses that are passed through the first output jack; and

(b) the current of the series of electrical pulses that are passed through the second output jack;

each within the range of 0.5 to 25 milliamps.

18. An electrode for use in applying electrical neuromuscular stimulation to a patient for treatment of oropharyngeal disorders, said electrode comprising:

(a) a snap eyelet having a first side and a second side, said first side being generally circular and having a diameter of about 7 mm and said second side having a stud connector to which a lead wire may be attached;

(b) a generally circular conductive film having a diameter within the range of 16 mm-22 mm that is attached to the first side of the snap eyelet;

(c) an adhesive and conductive layer of cross-linked hydrogel that is attached to the conductive film and adapted to be attached to the skin of the patient.

19. The electrode of claim 18 which includes an electrically-insulating layer that is attached to the second side of the conductive film.

20. The electrode of claim 18 which has a maximum electrical impedance of about 150 ohms.