Apparatus and method for mitigating sleep and other disorders through electromuscular stimulation

• US 5,792,067 A
• Filed: 03/13/1996
• Issued: 08/11/1998
• Est. Priority Date: 11/21/1995
• Status: Expired due to Fees

• Current Assignee: Manuel L. Karell
• Original Assignee: Manuel L. Karell
• Inventors: Karell, Manuel L.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/615,094
• Time in Patent Office: 881 Days
• Field of Search: 128/639, 128/642, 128/721, 128/724, 128/733, 128/777, 128/905, 128/848, 128/207.15, 607/42, 607/44-48, 607/60-61, 607/72-74, 607/134-135, 600/23-24, 600/26-27, 600/534, 600/545, 602/902
• US Class Current: 600/534
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

An electromuscular stimulator that effects a beneficial medical purpose selected from the group consisting of mitigating snoring, mitigating obstructive sleep apnea, mitigating hypertension, dental analgesia, general analgesia, monitoring physiological conditions and facilitating the intraoral delivery of medication is disclosed. The electromuscular stimulator includes a first electrode for making electrical contact with a first anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second anatomical structure; a control unit operably connected to the first and second electrodes; and a means for positioning the first and second electrodes relative to the first and second anatomical structures, respectively.

Claims

1. An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising:

a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx;

a second electrode for making electrical contact with a second intraoral anatomical structure;

a control unit operably connected to the first and second electrodes, the control unit comprising an electrical signal generator and further comprising a sensor for detecting the presence of a physiological condition; and

an intraoral member for positioning the first and second electrodes intraorally relative to the first and second anatomical structures, respectively.

2. The stimulator of claim 1, wherein the first electrode is adapted to be permanently attached to the first anatomical structure.

3. The stimulator of claim 1, wherein the first electrode comprises a pliable electroconductive material.

4. The stimulator of claim 1, wherein the first electrode comprises a carbon-impregnated metal.

5. The stimulator of claim 1, wherein the first electrode comprises an electroconductive carbon-impregnated plastic.

6. The stimulator of claim 1, wherein the first electrode comprises an electroconductive rubber.

7. The stimulator of claim 1, wherein the first electrode comprises an electroconductive gel.

8. The stimulator of claim 1, wherein the first and second anatomical structures comprise the same anatomical structure.

9. The stimulator of claim 1, wherein the control unit is sized to fit within the mouth of the user during operation.

10. The stimulator of claim 9, wherein the control unit is hermetically sealed.

11. The stimulator of claim 1, wherein the control unit is microminiaturized.

12. The stimulator of claim 1, wherein the control unit is capable of residing outside of the mouth of the user during operation.

13. The stimulator of claim 1, wherein the electrical signal generator comprises a pulse generator.

14. The stimulator of claim 1, wherein the electrical signal generator comprises a transcutaneous electrical nerve stimulator.

15. A method of determining a preferred characteristic of the electrical signal of the stimulator of claim 1, comprising the following steps:

a. positioning the stimulator in the mouth of the user;

b. applying an electrical signal having a characteristic to the first electrode;

c. measuring a physiological response of the user to the application of the electrical signal;

d. recording the characteristic and corresponding physiological response in a storage device;

e. varying the characteristic based on information recorded in the storage device, if the response is not minimally satisfactory; and

f. repeating steps (b) through (e), inclusive, until a minimally satisfactory response is measured.

16. The stimulator of claim 1, wherein the electrical signal generator generates an electrical signal having a characteristic selected from the group consisting of shape, amplitude, length, frequency, intermittent mode and constant mode.

17. The stimulator of claim 16, wherein the characteristic is controlled by the user.

18. The stimulator of claim 1, wherein the electrical signal generator comprises a digital integrated circuit.

19. The stimulator of claim 1, wherein the positioning means comprises a denture-like plate.

20. The stimulator of claim 1, wherein the positioning means is capable of being molded by the user.

21. The stimulator of claim 1, wherein the positioning means is fixedly attached to the control unit.

22. The stimulator of claim 1, further comprising a connecting means for removably attaching the positioning means to a third anatomical structure.

23. The stimulator of claim 22, wherein the connecting means utilizes an adhesive.

24. The stimulator of claim 22, wherein the connecting means utilizes a clamping device.

25. The stimulator of claim 22, wherein the connecting means utilizes a suction device.

26. The stimulator of claim 22, wherein the third anatomical structure comprises a palate.

27. The stimulator of claim 22, wherein the third anatomical structure comprises a tooth.

28. The stimulator of claim 1, wherein the positioning means is disposable.

29. The stimulator of claim 1, wherein the sensor comprises electrodes that monitor electrical activity in a brain.

30. The stimulator of claim 1, wherein the sensor comprises electrodes that monitor electrical activity in an intraoral muscle.

31. The stimulator of claim 1, wherein the sensor comprises a chemical sensor that monitors an intraoral level of a gas selected from the group consisting of CO₂, O₂ and any hydrocarbon emitted from tissue.

32. The stimulator of claim 1, wherein the sensor comprises a force gauge that monitors the tone of an intraoral muscle.

33. The stimulator of claim 1, wherein the sensor comprises an air flow sensor that monitors intraoral air flow.

34. The stimulator of claim 1, wherein the sensor comprises a microphone that monitors intraoral sounds.

35. The stimulator of claim 1, wherein the control unit further comprises a controller operably connected to the electrical signal generator for activating the electrical signal generator.

36. The stimulator of claim 35, wherein the controller comprises a digital integrated circuit.

37. The stimulator of claim 1, wherein the control unit further comprises a controller operably connected to the sensor and operably connected to the electrical signal generator for activating the electrical signal generator in response to detection of the physiological condition.

38. The stimulator of claim 27, wherein the controller determines the type of electrical signal to be generated in response to the physiological condition.

39. The stimulator of claim 1, wherein the control unit further comprises a power supply.

40. The stimulator of claim 39, wherein the power supply is chemical-based.

41. The stimulator of claim 39, wherein the power supply comprises a battery.

42. The stimulator of claim 39, wherein the power supply comprises an external energy source.

43. The stimulator of claim 1, wherein the control unit comprises:

an intraoral control unit;

an extraoral control unit; and

a communication element operably connecting the intraoral control unit to the extraoral control unit.

44. The stimulator of claim 43, wherein the communication element is an electromagnetic signal.

45. The stimulator of claim 44, wherein the electromagnetic signal is a radio frequency signal.

46. The stimulator of claim 43, wherein each of the intraoral control unit and the extraoral control unit further comprises an electromagnetic signal communication device selected from the group consisting of a transmitter, a receiver and a transceiver for communicating the electromagnetic signal between the intraoral control unit and the extraoral control unit.

47. The stimulator of claim 1, further comprising an air channel operatively connected to the positioning member and having an intraoral end and an extraoral end for providing free flow of air between the mouth of the user and ambient atmosphere.

48. The stimulator of claim 47, wherein said extraoral end of said air channel comprises a tube, and said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube.

49. A method of determining a preferred intraoral position for the first electrode of the stimulator of claim 1, comprising the following steps:

a. positioning the first electrode in a position on the first anatomical structure;

b. applying an electrical signal to the first electrode;

c. measuring a physiological response of the user to the application of the electrical signal;

d. recording the position and corresponding physiological response in a storage device;

e. varying the position based on information recorded in the storage device, if the response is not minimally satisfactory; and

f. repeating steps (a) through (e), inclusive, until a minimally satisfactory response is measured.

50. A method of modifying the positioning means of the stimulator of claim 1 to effect an anatomical fit with the mouth of the user, comprising the following steps:

softening the positioning means by placing it in a hot liquid bath;

molding the positioning means into a desired anatomical shape; and

cooling the device until it hardens.

51. An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising:

a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx;

a second electrode for making electrical contact with a second intraoral anatomical structure;

a control unit operably connected to the first and second electrodes;

an intraoral member adapted to position the first and second electrodes intraorally relative to the first and second anatomical structures, respectively; and

an air channel operably connected to said intraoral member and having an intraoral end and an extraoral end, said extraoral end comprising a tube adapted for location outside the user'"'"'s mouth when in use to provide a free flow of air between the user and ambient atmosphere.

52. The stimulator of claim 51, wherein said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube.

53. An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising:

a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx;

a second electrode for making electrical contact with a second intraoral anatomical structure;

an intraoral member adapted to position the first and second electrodes intraorally relative to the first and second anatomical structures, respectively;

an intraoral control unit operably connected to the first and second electrodes; and

an extraoral control unit in operable communication with the intraoral control unit through an electromagnetic signal;

wherein each of the intraoral control unit and the extraoral control unit further comprises an electromagnetic signal communication device selected from the group consisting of a transmitter, a receiver and a transceiver for communicating the electromagnetic signal between the intraoral control unit and the extraoral control unit.

54. The stimulator of claim 53, further comprising an air channel operably connected to said intraoral member and having an intraoral end and an extraoral end, said extraoral end comprising a tube adapted for location outside the user'"'"'s mouth when in use to provide a free flow of air between the user and ambient atmosphere.

55. The stimulator of claim 54, wherein said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube.

56. An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising:

a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx;

a second electrode for making electrical contact with a second intraoral anatomical structure;

a control unit operably connected to the first and second electrodes, the control unit comprising an electrical signal generator and further comprising a controller operatively connected to the electrical signal generator for activating the electrical signal generator; and

an intraoral member for positioning the first and second electrodes intraorally relative to the first and second anatomical structures, respectively.

57. The stimulator of claim 56, wherein the controller comprises a digital integrated circuit.