Intraoral electromuscular stimulation device and method

• US 6,212,435 B1
• Filed: 11/09/1999
• Issued: 04/03/2001
• Est. Priority Date: 11/13/1998
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Scarberry, Eugene N., Mechlenburg, Douglas M., Starr, Eric W., Lattner, Stefanie
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/436,857
• Time in Patent Office: 511 Days
• Field of Search: 607/42, 607/134, 600/529, 128/848
• US Class Current: 607/134
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

An intraoral electromuscular stimulation device and method to treat a breathing disorder. The stimulation device includes a first electrode, a first support member that maintains the first electrode in a sublingual location posterior to a frenulum and proximate to one of a first molar, a second molar and a third molar of a patient. A second electrode is maintained in a sublingual position posterior relative to the first electrode by a second support member. A further embodiment of the stimulation device includes a sensor that detects a respiratory parameter of a patient and outputs a signal indicative thereof. A control unit receives the signal from the sensor, distinguishes between inspiration and expiration, and initiates an electrical stimulation at a stimulation time prior to onset of inspiration and continues stimulation through a portion of inspiration at a level sufficient to induce muscle contraction without pain.

Claims

1. An intraoral electromuscular stimulation device adapted to provide intraoral electrical stimulation to a patient, said device comprising:

a dental appliance;

a first electrode disposed on a first portion of said dental appliance such that said first electrode is disposed in a sublingual location posterior to a frenulum and generally proximate to one of a first molar, a second molar, and a third molar of said patient; and

a second electrode disposed on a second portion of said dental appliance such that;

said second electrode is disposed in a sublingual position posterior relative to said first electrode, and wherein said first and said second electrodes are adapted to be located within an oral cavity of said patient by said dental appliance, such that a first area of said patient proximate to said first and said second electrodes is stimulated responsive to a stimulation energy being provided to said first and said second electrodes.

2. The intraoral electromuscular stimulation device according to claim 1, further comprising at least one attachment member operatively connected to said dental appliance, said attachment member being adapted and arranged to secure said dental appliance to an anatomical structure within said patient'"'"'s oral cavity.

3. The intraoral electromuscular stimulation device according to claim 1, wherein said dental appliance includes a passageway adapted to communicate an airway of said patient with a pressure support system for providing a breathing gas to said patient at an elevated pressure.

4. The intraoral electromuscular stimulation device according to claim 1, further comprising:

a third electrode disposed on a third portion of said dental appliance;

a third support member adapted to support said third electrode in a sublingual position posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar located on a side of a patient'"'"'s oral cavity opposite said first electrode; and

a fourth electrode disposed on a fourth portion of said dental appliance;

in a sublingual position posterior relative to said third electrode, and wherein said third and said fourth electrodes are adapted to be located within an oral cavity of said patient by said dental appliance such that a second area of said patient proximate to said third and said fourth electrodes is stimulated responsive to a stimulation energy being provided to said third and said fourth electrodes, with said first and said second areas being located at a common muscle group of said patient.

5. The intraoral electromuscular stimulation device according to claim 1, further comprising a third electrode disposed on a third portion of said dental appliance in a sublingual position posterior relative to said second electrode, and wherein said first, said second, and said third electrodes are adapted to be located within an oral cavity of said patient by said dental appliance such that a stimulation area of said patient proximate to said first, said second, and third fourth electrodes is selectively stimulated responsive to a stimulation energy being provided between at least two of said first, said second, and said third electrodes.

6. An intraoral electromuscular stimulation device adapted to provide intraoral electrical stimulation to a patient, said device comprising:

a first electrode;

a second electrode; and

supporting means for supporting said first electrode and said second electrode, wherein said first electrode is sublingually supported at a position posterior to a frenulum and, generally proximate to one of a first molar, a second molar and a third molar of said patient and said second electrode is sublingually supported in a position posterior relative to said first electrode.

7. The intraoral electromuscular stimulation device according to claim 6, wherein said supporting means is a unitary dental appliance on which said first electrode and said second electrode are disposed.

8. The intraoral electromuscular stimulation device according to claim 7, wherein said dental appliance includes a passageway adapted to communicate an airway of said patient with a pressure support system for providing a breathing gas to said patient at an elevated pressure.

9. The intraoral electromuscular stimulation device according to claim 6, further comprising attaching means for securing said supporting means to an anatomical structure within said patient'"'"'s oral cavity.

10. The intraoral electromuscular stimulation device according to claim 6, further comprising:

a third electrode, wherein said supporting means supports said third electrode in a sublingual position posterior to said frenulum and generally proximate to one of a first molar, a second molar and a third molar on a side of an oral cavity opposite said first electrode; and

a fourth electrode, wherein said supporting means supports said fourth electrode in a sublingual position posterior relative to said third electrode.

11. The intraoral electromuscular stimulation device according to claim 6, further comprising a third electrode, wherein said supporting means also supports said third electrode such that said third electrode is sublingually supported at a position posterior to said second electrode.

12. An electromuscular stimulating system comprising;

(1) an intraoral electrode dental appliance, comprising;

a first electrode,

a first support member adapted to support said first electrode in a sublingual position posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar of a patient,

a second electrode, and

a second support member adapted to support said second electrode in a sublingual position posterior relative to said first electrode; and

(2) a stimulation unit operatively coupled to said first electrode and said second electrode, said stimulation unit providing stimulating energy to a portion of said patient via said first and said second electrodes, wherein stimulation of said portion of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

13. The electromuscular stimulating system according to claim 12, wherein said stimulation unit includes:

a power supply; and

a control unit operatively coupled to said power supply to provide stimulating energy to said first and said second electrodes as a series of pulses and to control at least one characteristic of said series of pulses.

14. The electromuscular stimulating system according to claim 12, wherein said stimulation unit further includes a sensor adapted to detect a physiological characteristic of said patient and to provide a signal to said stimulation unit indicative of said physiological characteristic, and wherein said stimulation unit controls said series of pulses based on said signal from said sensor.

15. The electromuscular stimulating system according to claim 12, further comprising:

a third electrode;

a third support member adapted to support said third electrode in a sublingual position posterior to said frenulum and generally proximate to one of a first molar, a second molar and a third molar located on a side of said patient'"'"'s oral cavity opposite said first electrode;

a fourth electrode; and

a fourth support member adapted to support said fourth electrode in a sublingual position posterior relative to said third electrode, wherein said stimulation unit is operatively coupled to said third electrode and said fourth electrode and provides stimulating energy to a patient via said third and said fourth electrodes, wherein stimulation of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

16. The intraoral electromuscular stimulation device according to claim 15, wherein said first support member, said second support member, said third support member and said fourth support member are fixed to one another to define a dental appliance.

17. The electromuscular stimulating system according to claim 12, further comprising:

a third electrode; and

a third support member adapted to support said third electrode in a sublingual position posterior relative to said second electrode, wherein said stimulation unit is operatively coupled to said third electrode and provides stimulating energy to a patient via said third electrode, wherein stimulation of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

18. The intraoral electromuscular stimulation device according to claim 17, wherein said first support member, said second support member, and said third support member are fixed to one another to define a dental appliance.

19. The electromuscular stimulating system according to claim 12, wherein said first support member and said second support are fixed to one another to define a dental appliance and wherein said dental appliance includes a passageway adapted to communicate an airway of said patient with a pressure support system for providing a breathing gas to said patient at an elevated pressure.

20. The electromuscular stimulating system according to claim 12, further comprising:

(3) a pressure support system providing a gas flow to said patient, said pressure support system in combination with providing said stimulation energy, said pressure support system comprising;

a pressure generator,

a conduit operatively coupled to said pressure generator, and

a patient interface device operatively coupled to said conduit for communicating said conduit with an airway of said patient.

21. The intraoral electromuscular stimulating device according to claim 12, wherein said first support member and said second support are fixed to one another to define a dental appliance.

22. The intraoral electromuscular stimulation device according to claim 21, further comprising at least one attachment member operatively connected to said dental appliance, said attachment member being adapted and arranged to secure said dental appliance to an anatomical structure within said patient'"'"'s oral cavity.

23. An electromuscular stimulating system comprising:

(1) an intraoral electrode dental appliance, comprising;

a first electrode,

a second electrode, and

supporting means for supporting said first electrode and said second electrode such that said first electrode is sublingually supported in a position posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar in a patient and said second electrode is sublingually supported in a position posterior relative to said first electrode; and

(2) stimulating means for providing stimulating energy to a portion of said patient through said first and said second electrodes, wherein stimulation of said portion of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

24. The electromuscular stimulating system according to claim 23, further comprising:

a third electrode, wherein said supporting means supports said third electrode in a sublingual position posterior to said frenulum and generally proximate to one of a first molar, a second molar and a third molar on a side of said patient'"'"'s oral cavity opposite said first electrode; and

a fourth electrode, wherein said supporting means supports said fourth electrode in a sublingual position posterior relative to said third electrode.

25. The electromuscular stimulating system according to claim 23, further comprising sensing means for detecting a physiological characteristic of said patient and for providing a signal to said stimulating means indicative of said physiological condition, said stimulating means controlling impulses provided to said patient based on said signal from said sensing means.

26. The intraoral electromuscular stimulating system according to claim 23, wherein said first support member and said second support are fixed to one another to define a dental appliance.

29. The method according to claim 24, further comprising:

positioning a third electrode in said patient'"'"'s mouth, wherein said third electrode is sublingually supported in a position posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar on a side of said patient'"'"'s oral cavity opposite said first electrode;

positioning a fourth electrode in said patient'"'"'s oral cavity, wherein said fourth electrode is sublingually supported in a position posterior relative to said third electrode;

applying an electrical stimulation to a portion of said patient between said third electrode and said fourth electrode.

27. A method of providing intraoral eletromuscular simulation comprising:

positioning a first electrode in a patient'"'"'s oral cavity, wherein said first electrode is sublingually supported in a position posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar;

positioning a second electrode in said patient'"'"'s oral cavity, wherein said second electrode is sublingually supported in a position posterior relative to said first electrode;

applying an electrical stimulation to a portion of said patient between said first electrode and said second electrode.

28. The method according to claim 27, further comprising:

detecting a physiological characteristic of said patient; and

providing a signal indicative of said physiological characteristic, wherein said applying electrical stimulation step includes controlling electrical pulses provided to said patient based on said signal indicative of said physiological condition.

30. The method according to claim 27, wherein positioning said first electrode and said second electrode includes sublingually locating a dental appliance on which said first electrode and said second electrode are disposed and securing said dental appliance to an anatomical structure within said patient'"'"'s mouth.

31. The method according to claim 27, further comprising a step of providing a flow of gas to said patient via a patient interface device.

32. An intraoral electromuscular stimulation device adapted to provide intraoral electrical stimulation to a patient, said device comprising:

a first electrode;

a first support member adapted to support said first electrode in a sublingual location within said patient on a first side of said patient'"'"'s oral cavity;

relative to said patient'"'"'s midline

a second electrode;

a second support member adapted to support said second electrode in a sublingual location within said patient posterior relative to said first electrode and on a same side of said patient'"'"'s oral cavity as said first electrode;

a sensor adapted to detect a respiratory parameter of said patient and to output a signal indicative thereof; and

a control unit operatively coupled to said sensor, said first electrode and said second electrode, said control unit receiving said signal from said sensor and distinguishing between inspiration and expiration of said patient based thereon, said control unit initiating an electrical stimulation of said patient in one of an anterior-to-posterior and posterior-to-anterior direction via said first and said second electrodes at a stimulation start time prior to onset of inspiration, continuing stimulation through a portion of inspiration, and providing stimulation at an energy level sufficient to induce contraction of a targeted muscle without inducing pain.

33. The intraoral electromuscular stimulation device according to claim 32, wherein said stimulation start time is between 100-200 ms prior to onset of inspiration.

34. The intraoral electromuscular stimulation device according to claim 32, wherein said control unit determines said stimulation start time for initiating stimulation by comparing said signal to a threshold value.

35. The intraoral electromuscular stimulation device according to claim 32, wherein said sensor is one of a respiratory effort detector and a device adapted to measure a flow of fluid.

36. The intraoral electromuscular stimulation device according to claim 32, wherein said first support member is adapted to support said first electrode in a sublingual location posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar of said patient, and wherein said second support member is adapted to support said second electrode in a sublingual position posterior relative to said first electrode.

37. The intraoral electrode stimulation device according to claim 36, wherein said first support member and said second support are fixed to one another to define a dental appliance.

38. The intraoral electrode stimulation device according to claim 36, further comprising:

a third electrode; and

a third support member adapted to support said third electrode in a sublingual position posterior relative to said second electrode, wherein said control unit is operatively coupled to said third electrode and provides stimulating energy to a patient via said third electrode.

39. The intraoral electrode stimulation device according to claim 32, further comprising:

a third electrode;

a third support member adapted to support said third electrode in a sublingual position on a side of a patient'"'"'s oral cavity opposite a side associated with said first electrode;

a fourth electrode; and

a fourth support member adapted to support said fourth electrode in a sublingual position on said side of a patient'"'"'s oral cavity opposite said side associated with said first electrode and posterior to said third electrode, wherein said control unit is operatively coupled to said third electrode and said fourth electrode and provides stimulating energy to a patient via said third and said fourth electrodes, wherein stimulation of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

40. The intraoral electrode stimulation device according to claim 39, wherein said first support member is adapted to support said first electrode in a sublingual location posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar of said patient, wherein said second support member is adapted to support said second electrode in a sublingual position posterior relative to said first electrode, wherein said third support member is adapted to support said third electrode in a sublingual location posterior to a frenulum and generally proximate to one of a first molar, a second molar and a third molar on a side of an oral cavity opposite said first electrode, wherein said fourth support member is adapted to support said fourth electrode in a sublingual position posterior relative to said third electrode, and wherein said control unit provides stimulating energy to a portion of said patient via said third and said fourth electrodes such that stimulation of said portion of said patient takes place in one of an anterior-to-posterior direction and a posterior-to-anterior direction.

41. A method of providing intraoral electromuscular simulation comprising:

positioning a first electrode and a second electrode in sublingual positions within a patient'"'"'s oral cavity on a same side of said patient'"'"'s oral cavity relative to said patient'"'"'s midline, wherein said second electrode is located in a position posterior relative to said first electrode;

detecting a respiratory parameter of said patient and providing a signal indicative thereof, said parameter being sufficient to differentiate between inspiration and expiration of said patient; and

applying an electrical stimulation to a portion of said patient between said first electrode and said second electrode in one of a posterior-to-anterior direction and an anterior-to-posterior direction, wherein initiating application of said electrical stimulation occurs at a stimulation start time prior to onset of inspiration and continues through a portion of inspiration, and wherein stimulation is provided at an energy level sufficient to induce contraction of a targeted muscle without inducing pain.

42. The method according to claim 41, wherein said stimulation start time is between 100-200 ms prior to onset of inspiration.

43. The method according to claim 41, wherein said step of applying electrical stimulation includes determining said stimulation start time for initiating stimulation by comparing said signal to a threshold value.

44. The method according to claim 41, wherein said respiratory parameter is one of a respiratory effort and a flow of fluid.

45. The method according to claim 41, wherein positioning said first electrode and said second electrode includes locating a dental appliance on which said first electrode and said second electrode are disposed within an oral cavity of said patient and securing said dental appliance to an anatomical structure within said patient'"'"'s mouth.