Surgical tools and techniques for stimulation

• US 7,636,597 B2
• Filed: 11/13/2003
• Issued: 12/22/2009
• Est. Priority Date: 11/14/2002
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Benary, Raphael, Gross, Yossi, Shalev, Alon, Lorian, Adi
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/535,024
• Publication Number:
  US 20060195169A1
• Time in Patent Office: 2,231 Days
• Field of Search: 607/1, 607/2, 607/45, 607/46
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Apparatus for treating a subject is provided, the apparatus comprising (a) a stimulation device (352), adapted to be implanted in a vicinity of a site selected from the list consisting of: a sphenopalatine ganglion (SPG) (52) of the subject and a neural tract originating in or leading to the SPG; and (b) a connecting element (356), coupled to the stimulation device (352), and adapted to be passed through at least a portion of a greater palatine canal (282) of the subject. Also provided is a method for implanting a treatment stimulation device (352) in a vicinity of a site of a subject, the method comprising passing the device (352) through a greater palatine foramen (22) of the subject, and bringing the device (352) into contact with the vicinity of the site, the site selected from the list consisting of: a sphenopalatine ganglion (SPG) (52) of the subject and a neural tract originating in or leading to the SPG.

Claims

1. A method comprising:

widening at least a portion of a greater palatine canal of a subject;

passing a treatment stimulation device through a greater palatine foramen of the subject;

bringing the device into contact with a vicinity of a site of the subject, the site selected from the group consisting of;

a sphenopalatine ganglion (SPG) of the subject and a neural tract originating in or leading to the SPG;

applying stimulation with the device; and

configuring the stimulation to be sufficient to induce a change in cerebral blood flow of the subject.

2. The method according to claim 1, wherein the site includes the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the SPG.

3. The method according to claim 1, wherein the site includes a vidian nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the vidian nerve.

4. The method according to claim 1, wherein the site includes an ethmoidal nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the ethmoidal nerve.

5. The method according to claim 1, wherein the site includes a retro-orbital branch of the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the retro-orbital branch.

6. The method according to claim 1, wherein bringing the device into contact comprises:

observing one or more physiological responses of the subject to the stimulation; and

verifying desired placement of the device responsive to the observation.

7. The method according to claim 1, wherein the stimulation device includes at least one electrode, and wherein bringing the device into contact comprises bringing the electrode into contact with the vicinity of the site.

8. The method according to claim 7, wherein bringing the electrode into contact comprises wrapping the electrode around a nerve of the subject in the vicinity of the site.

9. The method according to claim 1, wherein the stimulation device includes a stimulator, the method comprising fixing the stimulator to a hard palate of the subject.

10. The method according to claim 9, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a supraperiosteal region of the hard palate.

11. The method according to claim 9, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to an upper surface of the hard palate in a nasal cavity of the subject.

12. The method according to claim 9, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a lower surface of the hard palate.

13. The method according to claim 1, wherein passing the device through the greater palatine foramen comprises determining a depth of insertion of the device in a greater palatine canal of the subject by observing at least one mark on the device indicative of the depth of the insertion.

14. The method according to claim 1, wherein widening the greater palatine canal of the subject comprises using a series of tools having successively greater diameters.

15. The method according to claim 1, wherein passing the device through the greater palatine foramen comprises mounting the device on an introducer, and passing the introducer through the greater palatine foramen.

16. The method according to claim 1, wherein bringing the device into contact comprises implanting the device in the vicinity of the site.

17. The method according to claim 1, wherein widening the greater palatine canal comprises using a series of periosteal elevators having successively greater diameters.

18. The method according to claim 1, wherein widening the greater palatine canal comprises abrading.

19. The method according to claim 1, wherein widening the greater palatine canal comprises removing osseous debris.

20. A method comprising:

widening at least a portion of a greater palatine canal of a subject;

passing a treatment stimulation device through the at least a portion of the greater palatine canal;

bringing the device into contact with a vicinity of a site of the subject, the site selected from the group consisting of;

a sphenopalatine ganglion (SPG) of the subject and a neural tract originating in or leading to the SPG; and

applying stimulation with the device; and

configuring the stimulation to be sufficient to induce a change in cerebral blood flow of the subject.

21. The method according to claim 20, wherein passing the device through the portion of the greater palatine canal comprises determining a depth of insertion of the device in the greater palatine canal by observing at least one mark on the device indicative of the depth of the insertion.

22. The method according to claim 20, wherein passing the device through the at least a portion of the greater palatine canal comprises passing the device through at least about 2 cm of the greater palatine canal.

23. The method according to claim 20, wherein widening the portion comprises using a series of tools having successively greater diameters.

24. The method according to claim 20, wherein passing the device through the at least a portion of the greater palatine canal comprises mounting the device on an introducer, and passing the introducer through the portion.

25. The method according to claim 20, wherein bringing the device into contact comprises implanting the device in the vicinity of the site.

26. The method according to claim 20, wherein the site includes the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the SPG.

27. The method according to claim 20, wherein the site includes a vidian nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the vidian nerve.

28. The method according to claim 20, wherein the site includes an ethmoidal nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the ethmoidal nerve.

29. The method according to claim 20, wherein the site includes a retro-orbital branch of the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the retro-orbital branch.

30. The method according to claim 20, wherein bringing the device into contact comprises:

observing one or more physiological responses of the subject to the stimulation; and

verifying desired placement of the device responsive to the observation.

31. The method according to claim 20, wherein the stimulation device includes at least one electrode, and wherein bringing the device into contact comprises bringing the electrode into contact with the vicinity of the site.

32. The method according to claim 31, wherein bringing the electrode into contact comprises wrapping the electrode around a nerve of the subject in the vicinity of the site.

33. The method according to claim 20, wherein the stimulation device includes a stimulator, the method comprising fixing the stimulator to a hard palate of the subject.

34. The method according to claim 33, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a supraperiosteal region of the hard palate.

35. The method according to claim 33, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to an upper surface of the hard palate in a nasal cavity of the subject.

36. The method according to claim 33, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a lower surface of the hard palate.

37. The method according to claim 20, wherein widening the portion comprises using a series of periosteal elevators having successively greater diameters.

38. The method according to claim 20, wherein widening the portion comprises abrading.

39. The method according to claim 20, wherein widening the portion comprises removing osseous debris.

40. A method comprising:

passing a treatment stimulation device through a greater palatine foramen of a subject;

bringing the device into contact with a vicinity of a site of the subject, the site selected from the group consisting of;

a sphenopalatine ganglion (SPG) of the subject and a neural tract originating in or leading to the SPG;

applying stimulation with the device; and

configuring the stimulation to be sufficient to modulate permeability of a blood-brain-barrier of the subject.

41. The method according to claim 40, wherein the site includes the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the SPG.

42. The method according to claim 40, wherein the site includes a vidian nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the vidian nerve.

43. The method according to claim 40, wherein the site includes an ethmoidal nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the ethmoidal nerve.

44. The method according to claim 40, wherein the site includes a retro-orbital branch of the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the retro-orbital branch.

45. The method according to claim 40, wherein bringing the device into contact comprises:

observing one or more physiological responses of the subject to the stimulation; and

verifying desired placement of the device responsive to the observation.

46. The method according to claim 40, wherein the stimulation device includes a stimulator, the method comprising fixing the stimulator to a hard palate of the subject.

47. The method according to claim 46, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a supraperiosteal region of the hard palate.

48. The method according to claim 46, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to an upper surface of the hard palate in a nasal cavity of the subject.

49. The method according to claim 46, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a lower surface of the hard palate.

50. The method according to claim 40, wherein bringing the device into contact comprises implanting the device in the vicinity of the site.

51. The method according to claim 40, wherein passing the device through the greater palatine foramen comprises widening a greater palatine canal of the subject.

52. The method according to claim 51, wherein widening the greater palatine canal comprises abrading.

53. The method according to claim 51, wherein widening the greater palatine canal comprises removing osseous debris.

54. A method comprising:

passing a treatment stimulation device through at least a portion of a greater palatine canal of a subject;

bringing the device into contact with a vicinity of a site of the subject, the site selected from the group consisting of;

a sphenopalatine ganglion (SPG) of the subject and a neural tract originating in or leading to the SPG;

applying stimulation with the device; and

configuring the stimulation to be sufficient to modulate permeability of a blood-brain-barrier of the subject.

55. The method according to claim 54, wherein bringing the device into contact comprises implanting the device in the vicinity of the site.

56. The method according to claim 54, wherein the site includes the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the SPG.

57. The method according to claim 54, wherein the site includes a vidian nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the vidian nerve.

58. The method according to claim 54, wherein the site includes an ethmoidal nerve of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the vicinity of the ethmoidal nerve.

59. The method according to claim 54, wherein the site includes a retro-orbital branch of the SPG of the subject, and wherein bringing the device into contact with the vicinity of the site comprises bringing the device into contact with the retro-orbital branch.

60. The method according to claim 54, wherein bringing the device into contact comprises:

observing one or more physiological responses of the subject to the stimulation; and

verifying desired placement of the device responsive to the observation.

61. The method according to claim 54, wherein the stimulation device includes a stimulator, the method comprising fixing the stimulator to a hard palate of the subject.

62. The method according to claim 61, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a supraperiosteal region of the hard palate.

63. The method according to claim 61, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to an upper surface of the hard palate in a nasal cavity of the subject.

64. The method according to claim 61, wherein fixing the stimulator to the hard palate comprises coupling the stimulator to a lower surface of the hard palate.

65. The method according to claim 54, wherein passing the device through the at least a portion of the greater palatine canal comprises widening the portion.

66. The method according to claim 65, wherein widening the portion palatine canal comprises abrading.

67. The method according to claim 65, wherein widening the portion comprises removing osseous debris.