SPG stimulation via the greater palatine canal

• US 7,561,919 B2
• Filed: 02/07/2006
• Issued: 07/14/2009
• Est. Priority Date: 11/14/2002
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Altman, Hernan, Lorian, Adi, Degtyar, Leonid, Dayan, Avinoam, Natan, Amir, Gross, Yossi, Shalev, Alon
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/349,020
• Publication Number:
  US 20060287677A1
• Time in Patent Office: 1,253 Days
• Field of Search: 607 35- 60
• US Class Current: 607/46
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling

Abstract

Apparatus for application to a subject is provided, including an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends; and one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject. The apparatus further includes a receiver, fixed to the support element, and electrically coupled to the electrodes; and a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver. Other embodiments are also described.

Claims

1. Apparatus for application to a subject, comprising:

an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject;

a receiver, fixed to the support element, and electrically coupled to the electrodes;

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver; and

an oral appliance, adapted to be fixed to the transmitter, and shaped so as to define a surface that fits closely to a roof of the oral cavity.

2. The apparatus according to claim 1, wherein the wireless transmitter is adapted to be electromagnetically coupled to the receiver.

3. The apparatus according to claim 1, wherein the receiver is adapted to be wirelessly coupled to the wireless transmitter by induction.

4. The apparatus according to claim 1, wherein the electrodes are adapted to apply the current using only power received by the receiver from the wireless transmitter.

5. The apparatus according to claim 1, wherein at least a portion of the receiver is adapted to be positioned between mucosa and a hard palate of the subject.

6. The apparatus according to claim 1, wherein at least a portion of the receiver is adapted to be positioned between mucosa and an alveolar process of a maxilla of the subject.

7. The apparatus according to claim 1, comprising one or more electrode leads, which electrically couple the receiver to the electrodes, and which serve as the support element.

8. The apparatus according to claim 1, wherein the electrodes comprise exactly one cathode and exactly one anode, and wherein a closest distance between the cathode and the anode is greater than a closest distance between any portion of the cathode and any portion of the SPG when the electrodes are positioned in a vicinity of the SPG.

9. The apparatus according to claim 1, wherein the support element is sufficiently rigid to enable insertion of the support element into a body of the subject by pushing from a vicinity of the proximal end of the support element.

10. The apparatus according to claim 1, comprising a circuit module, which is fixed to the proximal end of the support element, and which comprises a printed circuit board and the receiver.

11. The apparatus according to claim 1, comprising:

an oral element, which comprises the wireless transmitter;

an external driver, which comprises a power source and circuitry, and which is adapted to be placed outside a body of the subject; and

one or more wires which electrically couple the external driver to the oral element.

12. The apparatus according to claim 1, comprising:

an oral element, which comprises the wireless transmitter and oral element circuitry coupled to the wireless transmitter; and

a power source, adapted to provide power to the wireless transmitter and circuitry.

13. The apparatus according to claim 12, comprising receiver circuitry, which is coupled to the support element and the receiver, wherein the oral element circuitry is adapted to drive the wireless transmitter to transmit energy that includes a stimulation waveform for application by the electrodes, wherein the receiver is adapted to receive the energy, and wherein the receiver circuitry is adapted to drive the electrodes to apply the stimulation waveform to the SPG.

14. The apparatus according to claim 12, wherein the oral element is adapted to temporarily placed against the roof of the oral cavity, without being fixed thereto.

15. The apparatus according to claim 1, wherein the support element has a length of between 1.8 and 3 cm.

16. The apparatus according to claim 15, wherein the support element has a length of between 2.6 and 3 cm.

17. The apparatus according to claim 1, comprising circuitry adapted to measure, using at least one of the electrodes, a level of stimulation induced by the applied current.

18. Apparatus for application to a subject, comprising:

an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject;

a receiver, fixed to the support element, and electrically coupled to the electrodes;

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver; and

an oral appliance, which comprises;

a capsule, which is configured to be placed and held between an alveolar process and an inner surface of a cheek of the subject;

the transmitter; and

an elongated coupling element, which couples the transmitter to the capsule.

19. Apparatus for application to a subject, comprising:

an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject;

a receiver, fixed to the support element, and electrically coupled to the electrodes;

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver; and

an oral appliance, adapted to be fixed to the transmitter, and adapted to be coupled to a structure selected from the group consisting of;

a tooth of the subject, and gingival covering an alveolar process of the subject.

20. The apparatus according to claim 19, wherein the oral appliance is adapted to be coupled to the tooth of the subject.

21. The apparatus according to claim 19, wherein the oral appliance is adapted to be coupled to the gingival covering the alveolar process of the subject.

22. The apparatus according to claim 19, wherein at least a portion of the support element is adapted to be placed in a greater palatine canal of the subject.

23. Apparatus for application to a subject, comprising:

an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject;

a receiver, fixed to the support element, and electrically coupled to the electrodes; and

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver,

wherein the distal end of the support element comprises a surgical punch.

24. Apparatus for application to a subject, comprising:

an elongated support element having a length of between 1.8 cm and 4 cm, and having proximal and distal ends;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject;

a receiver, fixed to the support element, and electrically coupled to the electrodes; and

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver,

wherein at least a portion of the support element is adapted to be placed in a greater palatine canal of the subject, and

wherein the support element comprises a lock, adapted to hold the support element in place after insertion thereof into the greater palatine canal.

25. Apparatus for application to a subject, comprising:

one or more electrodes adapted to apply an electrical current to tissue of the subject selected from the group consisting of;

a sphenopalatine ganglion (SPG), a greater palatine nerve, a lesser palatine nerve, a sphenopalatine nerve, a communicating branch between a maxillary nerve and an SPG, an otic ganglion, an afferent fiber going into the otic ganglion, an efferent fiber going out of the otic ganglion, an infraorbital nerve, a vidian nerve, a greater superficial petrosal nerve, and a lesser deep petrosal nerve;

a receiver, electrically coupled to the one or more electrodes;

a wireless transmitter, adapted to be placed in an oral cavity of the subject, and to be wirelessly coupled to the receiver; and

an oral appliance, adapted to be fixed to the transmitter, and shaped so as to define a surface that fits closely to a roof of the oral cavity.

26. The apparatus according to claim 25, wherein the tissue includes the SPG, and wherein the one or more electrodes are adapted to apply the current to the SPG.

27. The apparatus according to claim 25, wherein the wireless transmitter is adapted to be electromagnetically coupled to the receiver.

28. The apparatus according to claim 25, wherein the receiver is adapted to be wirelessly coupled to the wireless transmitter by induction.

29. Apparatus comprising an implantable neural stimulator, which comprises:

an elongated support element having a length of between 2.6 cm and 3 cm, having a distal end, and adapted to be placed in a greater palatine canal of a subject;

one or more electrodes fixed to the support element in a vicinity of the distal end thereof, and adapted to apply an electrical current to a sphenopalatine ganglion (SPG) of the subject; and

a needle shaped so as to define a sharp distal end and a bore, which bore is adapted to hold the support element and the electrodes during insertion of the support element and the electrodes into the greater palatine canal, and to be withdrawn from the greater palatine canal thereafter, leaving the support element and electrodes in the greater palatine canal,

wherein the support element comprises a lock, adapted to hold the support element in place after insertion thereof into the greater palatine canal.

30. A method comprising:

placing an elongated support element, having a length of between 2.6 cm and 3 cm and having a distal end, into a bore of a needle shaped so as to define a sharp distal end;

inserting, into a greater palatine canal of a subject, the needle holding the support element;

withdrawing the needle from the greater palatine canal thereafter, leaving the support element in the greater palatine canal; and

applying, from a vicinity of the distal end of the support element, an electrical current to a sphenopalatine ganglion (SPG) of the subject,

wherein inserting the support element comprises locking the support element in place after insertion thereof into the greater palatine canal.

31. A method comprising:

wirelessly transmitting energy from within an oral cavity of a subject;

receiving the energy; and

using the received energy, applying an electrical current to tissue of the subject selected from the group consisting of;

a sphenopalatine ganglion (SPG), a greater palatine nerve, a lesser palatine nerve, a sphenopalatine nerve, a communicating branch between a maxillary nerve and an SPG, an otic ganglion, an afferent fiber going into the otic ganglion, an efferent fiber going out of the otic ganglion, an infraorbital nerve, a vidian nerve, a greater superficial petrosal nerve, and a lesser deep petrosal nerve.

32. The method according to claim 31, wherein the tissue includes the SPG, and wherein applying the current comprises applying the current to the SPG.

33. The method according to claim 31, wherein wirelessly transmitting the energy comprises electromagnetically transmitting the energy.

34. The method according to claim 31, wherein wirelessly transmitting the energy comprises transmitting the energy using induction.

35. A method comprising:

inserting an elongated support element into a body of a subject, the element having a length of between about 1.8 cm and about 4 cm, and having proximal and distal ends;

wirelessly transmitting energy from within an oral cavity of the subject;

receiving the energy at the support element; and

using the received energy, applying, from a vicinity of the distal end of the support element, an electrical current to a sphenopalatine ganglion (SPG) of the subject.

36. The method according to claim 35, wherein wirelessly transmitting the energy comprises electromagnetically transmitting the energy.

37. The method according to claim 35, wherein wirelessly transmitting the energy comprises transmitting the energy using induction.

38. The method according to claim 35, wherein applying the current comprises applying the current using only the energy transmitted from within the oral cavity.

39. The method according to claim 35, wherein transmitting the energy comprises transmitting the energy from an oral appliance shaped so as to define a surface that fits closely to a roof of the oral cavity.

40. The method according to claim 35, wherein transmitting the energy comprises coupling an oral appliance to a tooth of the subject, and transmitting the energy from the oral appliance.

41. The method according to claim 35, wherein transmitting the energy comprises coupling an oral appliance to gingival covering an alveolar process of the subject, and transmitting the energy from the oral appliance.

42. The method according to claim 35, wherein transmitting the energy comprises placing a capsule between an alveolar process and an inner surface of a cheek of the subject, placing, in the oral cavity, a wireless transmitter coupled to the capsule by an elongated coupling element, and transmitting the energy from the wireless transmitter.

43. The method according to claim 35, wherein receiving the energy comprises receiving the energy at a site between mucosa and a hard palate of the subject.

44. The method according to claim 35, wherein receiving the energy comprises receiving the energy at a site between mucosa and an alveolar process of a maxilla of the subject.

45. The method according to claim 35, wherein inserting the support element comprises using the distal end of the support element to punch an incision in mucosa of a roof of the oral cavity.

46. The method according to claim 35, wherein applying the current comprises driving the current between exactly one cathodic site and exactly one anodal site, and wherein a closest distance between the cathodic and anodal sites is greater than a closest distance between the cathodic site and any portion of the SPG.

47. The method according to claim 35, wherein inserting the support element into the body comprises pushing the support element into the body from a vicinity of the proximal end of the support element.

48. The method according to claim 35, wherein inserting the support element comprises:

preparing a submucosal surface on a hard palate of the subject;

inserting the support element into a greater palatine canal of the subject; and

placing a circuit module, which is fixed to the proximal end of the support element, against the prepared submucosal surface, and

wherein receiving the energy at the support element comprises receiving the energy at the circuit module.

49. The method according to claim 35, wherein inserting the support element comprises:

preparing a submucosal surface on an alveolar process of a maxilla of the subject;

inserting the support element into a greater palatine canal of the subject; and

placing a circuit module, which is fixed to the proximal end of the support element, against the prepared submucosal surface, and

wherein receiving the energy at the support element comprises receiving the energy at the circuit module.

50. The method according to claim 35, wherein wirelessly transmitting the energy from within the oral cavity comprises receiving the energy within the oral cavity from a site outside the subject via one or more wires, and wirelessly transmitting the received energy from within the oral cavity.

51. The method according to claim 35, wherein wirelessly transmitting the energy comprises wirelessly transmitting energy that includes a stimulation waveform, and wherein applying the current comprises applying the stimulation waveform to the SPG.

52. The method according to claim 35, wherein wirelessly transmitting the energy comprises wirelessly transmitting the energy from a site within the oral cavity in a vicinity of a roof of the oral cavity.

53. The method according to claim 35, wherein the support element has a length of between 1.8 and 3 cm, and wherein inserting the support element comprises inserting the support element having the length of between 1.8 and 3 cm.

54. The method according to claim 53, wherein the support element has a length of between 2.6 and 3 cm, and wherein inserting the support element comprises inserting the support element having the length of between 2.6 and 3 cm.

55. The method according to claim 35, wherein inserting the support element comprises inserting at least a portion of the support element into a greater palatine canal of the subject.

56. The method according to claim 55, wherein inserting the support element comprises locking the support element in place after insertion thereof into the greater palatine canal.

57. The method according to claim 35, comprising measuring, from the vicinity of the distal end, a level of stimulation induced by the applied current.