STIMULATION FOR TREATING BRAIN EVENTS AND OTHER CONDITIONS

• US 20070083245A1
• Filed: 08/17/2006
• Published: 04/12/2007
• Est. Priority Date: 08/19/2005
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Lamensdorf, Itschak, Altman, Hernan, Dayan, Avinoam
• Granted Patent: US 8,055,347 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Apparatus for treatment is provided, including one or more electrodes, configured to be applied to a site of a subject, and adverse cerebrovascular condition treatment functionality. The functionality comprises a control unit configured to drive the one or more electrodes to apply electrical stimulation to the site during a plurality of stimulation periods which includes at least first and last stimulation periods, set an inter-period interval between initiation of the first stimulation period and initiation of the last stimulation period to be at least 24 hours, and configure the stimulation during the first and last stimulation periods to induce at least one neuroprotective occurrence selected from the group consisting of: an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances. The site is 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. Additional embodiments are also described.

Claims

1. Apparatus for treatment, comprising:

one or more electrodes, configured to be applied to a site of a 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; and

adverse cerebrovascular condition treatment functionality, which comprises a control unit configured to;

drive the one or more electrodes to apply electrical stimulation to the site during a plurality of stimulation periods which includes at least first and last stimulation periods,

set an inter-period interval between initiation of the first stimulation period and initiation of the last stimulation period to be at least 24 hours, and

configure the stimulation during the first and last stimulation periods to induce at least one neuroprotective occurrence selected from the group consisting of;

an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances.

2. The apparatus according to claim 1, wherein the control unit is configured to set the inter-period interval to be no more than a maximum value.

3. The apparatus according to claim 1, wherein the control unit is configured to set the inter-period interval to be no more than nine months.

4. The apparatus according to claim 1, wherein the control unit is configured to store a maximum total time of stimulation per each time period having a given duration, and to drive the one or more electrodes to apply the stimulation no more than the maximum total time per each time period having the given duration.

5. The apparatus according to claim 1, wherein the plurality of stimulation periods includes at least one second stimulation period between the first and last stimulation periods, and wherein the control unit is configured to drive the one or more electrodes to apply the stimulation during the first, second, and last stimulation periods, and to configure the stimulation during the first, second, and last stimulation periods to induce the at least one neuroprotective occurrence.

6. The apparatus according to claim 1, wherein the initiation of the last stimulation period occurs simultaneously with a conclusion of the first stimulation period, and wherein the control unit is configured to drive the one or more electrodes to apply the stimulation continuously from the initiation of the first stimulation period to a conclusion of the last stimulation period.

7. The apparatus according to claim 1, wherein the initiation of the last stimulation period occurs after a conclusion of the first stimulation period, and wherein the control unit is configured to withhold driving the one or more electrodes to apply the stimulation during at least one non-stimulation period between the conclusion of the first stimulation period and the initiation of the last stimulation period.

8. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply the stimulation for between one and six hours during each of the first and last stimulation periods.

9. The apparatus according to claim 1, wherein the control unit is configured to set a strength of the stimulation during at least one of the plurality of stimulation periods to be insufficient to induce a significant increase in permeability of a blood-brain barrier (BBB) of the subject.

10. The apparatus according to claim 1, wherein the control unit is configured to set the inter-period interval to be at least four weeks.

11. The apparatus according to claim 1, comprising a user interface, which is configured to receive as input a treatment duration value, wherein the control unit is configured to set the inter-period interval to be equal to the inputted treatment duration value.

12. The apparatus according to claim 11, wherein the control unit is configured to store a predetermined maximum treatment duration value, and to compare the inputted treatment duration value with the maximum treatment duration value.

13. The apparatus according to claim 1, wherein the site includes the SPG, and wherein the one or more electrodes are configured to be applied to the SPG.

14. The apparatus according to claim 13, comprising an elongated support element configured to be placed within a greater palatine canal of the subject, sized to extend from a palate of the subject to the SPG, and having a distal end, wherein the electrodes are fixed to the support element in a vicinity of the distal end thereof

15. The apparatus according to claim 1, wherein the control unit is configured to drive the one or more electrodes to apply the stimulation during the first period at a first stimulation strength and during the last period at a second stimulation strength, and to set the second stimulation strength to be different from the first stimulation strength.

16. The apparatus according to claim 15, wherein the control unit is configured to set the second stimulation strength to be less than the first stimulation strength.

17. A method for treatment, comprising:

identifying that a subject suffers from an adverse cerebrovascular condition;

responsively to the identifying, applying electrical stimulation to a site of the subject during a plurality of stimulation periods which includes at least first and last stimulation periods, the site 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;

setting an inter-period interval between initiation of the first stimulation period and initiation of the last stimulation period to be at least 24 hours; and

configuring the stimulation during the first and last stimulation periods to induce at least one neuroprotective occurrence selected from the group consisting of;

an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances.

18. The method according to claim 17, wherein setting the inter-period interval comprises setting the inter-period interval to be no more than a maximum value.

19. The method according to claim 17, wherein setting the inter-period interval comprises setting the inter-period interval to be no more than nine months.

20. The method according to claim 17, wherein applying the stimulation comprises storing a maximum total time of stimulation per each time period having a given duration, and applying the stimulation no more than the maximum total time per each time period having the given duration.

21. The method according to claim 17, wherein the plurality of stimulation periods includes at least one second stimulation period between the first and last stimulation periods, wherein applying the stimulation comprises applying the stimulation during the first, second, and last stimulation periods, and wherein configuring the stimulation comprises configuring the stimulation during the first, second, and last stimulation periods to induce the at least one neuroprotective occurrence.

22. The method according to claim 17, wherein the initiation of the last stimulation period occurs simultaneously with a conclusion of the first stimulation period, and wherein applying the stimulation during the first and last stimulation periods comprises applying the stimulation continuously from the initiation of the first stimulation period to a conclusion of the last stimulation period.

23. The method according to claim 17, wherein the initiation of the last stimulation period occurs after a conclusion of the first stimulation period, and wherein applying the stimulation during the first and last stimulation periods comprises withholding applying the stimulation during at least one non-stimulation period between the conclusion of the first stimulation period and the initiation of the last stimulation period.

24. The method according to claim 17, wherein the adverse cerebrovascular condition includes an ischemic stroke, and wherein identifying that the subject suffers from the condition comprises identifying that the subject has experienced the ischemic stroke.

25. The method according to claim 17, wherein configuring the stimulation comprises setting a strength of the stimulation during at least one of the plurality of stimulation periods to be less than 40% of a strength that induces a maximum increase in CBF in the subject that is achievable by applying the stimulation.

26. The method according to claim 17, wherein configuring the stimulation comprises setting a strength of the stimulation during at least one of the plurality of stimulation periods to a level that induces less than 40% of a maximum increase in CBF in the subject that is achievable by applying the stimulation.

27. The method according to claim 17, wherein applying the stimulation during the first and last stimulation periods comprises applying the stimulation for less than six hours during each of the first and last stimulation periods.

28. The method according to claim 17, wherein applying the stimulation during the first and last stimulation periods comprises applying the stimulation for between one and six hours during each of the first and last stimulation periods.

29. The method according to claim 17, wherein applying the stimulation comprises placing an electrical stimulator in a vicinity of the site, and activating the stimulator to apply the stimulation.

30. The method according to claim 17, wherein setting the inter-period interval comprises setting the inter-period interval to be at least 48 hours.

31. The method according to claim 30, wherein setting the inter-period interval comprises setting the inter-period interval to be at least one week.

32. The method according to claim 31, wherein the plurality of stimulation periods includes a plurality of daily stimulation periods, wherein applying the stimulation comprises applying the stimulation during at least one of the daily stimulation periods on every day between the initiation of the first stimulation period and the initiation of the last stimulation period, and wherein configuring the stimulation comprises configuring the stimulation during the plurality of daily stimulation periods to induce the at least one neuroprotective occurrence.

33. The method according to claim 32, wherein applying the stimulation comprises applying the stimulation for at least 30 minutes every day between the initiation of the first stimulation period and the initiation of the last stimulation period.

34. The method according to claim 33, wherein applying the stimulation comprises applying the stimulation for at least 60 minutes every day between the initiation of the first stimulation period and the initiation of the last stimulation period.

35. The method according to claim 31, wherein setting the inter-period interval comprises setting the inter-period interval to be at least two weeks.

36. The method according to claim 35, wherein setting the inter-period interval comprises setting the inter-period interval to be at least four weeks.

37. The method according to claim 17, wherein the condition includes an adverse cerebrovascular event, wherein identifying that the subject suffers from the condition comprises identifying that the subject has experienced the event, and wherein applying the stimulation comprises applying the stimulation beginning at least three hours after the event.

38. The method according to claim 37, wherein applying the stimulation comprises applying the stimulation beginning at least six hours after the event.

39. The method according to claim 38, wherein applying the stimulation comprises applying the stimulation beginning at least nine hours after the event.

40. The method according to claim 39, wherein applying the stimulation comprises applying the stimulation beginning at least 12 hours after the event.

41. The method according to claim 40, wherein applying the stimulation comprises applying the stimulation beginning at least 24 hours after the event.

42. The method according to claim 17, wherein configuring the stimulation comprises setting a strength of the stimulation during at least one of the plurality of stimulation periods to be insufficient to induce a significant increase in permeability of a blood-brain barrier (BBB) of the subject.

43. The method according to claim 42, wherein setting the strength comprises setting the strength of the stimulation during the at least one of the plurality of stimulation periods to be less than 40% of a strength that is sufficient to induce the significant increase in permeability of the BBB.

44. The method according to claim 17, wherein the site includes the SPG, and wherein applying the stimulation comprises applying the stimulation to the SPG.

45. The method according to claim 44, wherein applying the stimulation comprises:

placing an elongated support element within a greater palatine canal of the subject, sized to extend from a palate of the subject to the SPG, and having a distal end; and

applying the stimulation from a vicinity of the distal end of the support element.

46. The method according to claim 17, wherein applying the stimulation comprises applying the stimulation during the first period at a first stimulation strength and during the last period at a second stimulation strength, and setting the second stimulation strength to be different from the first stimulation strength.

47. The method according to claim 46, wherein setting the second stimulation strength comprises setting the second stimulation strength to be less than the first stimulation strength.

48. Apparatus for treating a subject, comprising:

one or more electrodes, configured to be applied to a site 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; and

a control unit, configured to;

drive the one or more electrodes to apply electrical stimulation to the site, and

configure the stimulation to excite nervous tissue of the site at a strength sufficient to induce at least one neuroprotective occurrence selected from the group consisting of;

an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances, and insufficient to induce a significant increase in permeability of a blood-brain barrier (BBB) of the subject.

49. The apparatus according to claim 48, wherein the control unit is configured to set the strength to less than 90% of a strength sufficient to induce the significant increase in the permeability of the BBB.

50. The apparatus according to claim 48, wherein the control unit is configured to set the strength to less than 40% of a strength sufficient to induce the significant increase in the permeability of the BBB.

51. The apparatus according to claim 48, wherein the control unit is configured to set the strength to more than 50% of a strength sufficient to induce the significant increase in the permeability of the BBB.

52. The apparatus according to claim 48, wherein the site includes the SPG, and wherein the electrodes are configured to be applied to the SPG.

53. The apparatus according to claim 52, comprising an elongated support element configured to be placed within a greater palatine canal of the subject, sized to extend from a palate of the subject to the SPG, and having a distal end, wherein the electrodes are fixed to the support element in a vicinity of the distal end thereof.

54. A method for treating a subject, comprising:

applying electrical stimulation to a site 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; and

configuring the stimulation to excite nervous tissue of the site at a strength sufficient to induce at least one neuroprotective occurrence selected from the group consisting of;

an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances, and insufficient to induce a significant increase in permeability of a blood-brain barrier (BBB) of the subject.

55. The method according to claim 54, wherein configuring the stimulation comprises setting the strength to less than 90% of a strength sufficient to induce the significant increase in the permeability of the BBB.

56. The method according to claim 54, wherein configuring the stimulation comprises setting the strength to less than 40% of a strength sufficient to induce the significant increase in the permeability of the BBB.

57. The method according to claim 54, wherein configuring the stimulation comprises setting the strength to more than 50% of a strength sufficient to induce the significant increase in the permeability of the BBB.

58. The method according to claim 54, wherein the site includes the SPG, and wherein applying the stimulation comprises applying the stimulation to the SPG.

59. The method according to claim 58, wherein applying the stimulation comprises:

placing an elongated support element within a greater palatine canal of the subject, sized to extend from a palate of the subject to the SPG, and having a distal end; and

applying the stimulation from a vicinity of the distal end of the support element.

60. A method for treatment, comprising:

identifying that a subject has suffered from an adverse cerebrovascular event;

responsively to the identifying, applying, beginning at least three hours after the event, electrical stimulation to a site 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; and

configuring the stimulation to excite nervous tissue of the site at a strength sufficient to induce at least one neuroprotective occurrence selected from the group consisting of;

an increase in cerebral blood flow (CBF) of the subject, and a release of one or more neuroprotective substances.

61. The method according to claim 60, wherein applying the stimulation comprises applying the stimulation beginning at least six hours after the event.

62. The method according to claim 61, wherein applying the stimulation comprises applying the stimulation beginning at least nine hours after the event.

63. The method according to claim 62, wherein applying the stimulation comprises applying the stimulation beginning at least 12 hours after the event.

64. The method according to claim 63, wherein applying the stimulation comprises applying the stimulation beginning at least 24 hours after the event.

65. The method according to claim 60, wherein configuring the stimulation comprises setting the strength to be insufficient to induce a substantial increase in permeability of a blood-brain barrier (BBB) of the subject.

66. The method according to claim 60, wherein the event includes a stroke, and wherein applying the stimulation comprises applying the stimulation beginning at least three hours after the stroke.

67. The method according to claim 60, wherein applying the stimulation comprises applying the stimulation intermittently.

68. The method according to claim 60, wherein applying the stimulation comprises:

applying the stimulation during a plurality of stimulation periods which includes at least first and last stimulation periods, wherein initiation of the first period is at least three hours after the event; and

setting an inter-period interval between the initiation of the first stimulation period and initiation of the last stimulation period to be at least 24 hours, and

wherein configuring the stimulation comprises configuring the stimulation during the first and last stimulation periods to induce the at least one neuroprotective occurrence.

69. The method according to claim 60, wherein the site includes the SPG, and wherein applying the stimulation comprises applying the stimulation to the SPG.

70. The method according to claim 69, wherein applying the stimulation comprises:

placing an elongated support element within a greater palatine canal of the subject, sized to extend from a palate of the subject to the SPG, and having a distal end; and

applying the stimulation from a vicinity of the distal end of the support element.