Method and apparatus for stimulating the sphenopalatine ganglion to modify properties of the BBB and cerebral blood flow

• US 7,120,489 B2
• Filed: 05/07/2001
• Issued: 10/10/2006
• Est. Priority Date: 05/08/2000
• Status: Active Grant

• Current Assignee: BrainsGate Ltd.
• Original Assignee: BrainsGate Ltd.
• Inventors: Gross, Yossi, Shalev, Alon
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/258,714
• Publication Number:
  US 20040015068A1
• Time in Patent Office: 1,982 Days
• Field of Search: 607/2, 607/45
• US Class Current: 607/2
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Apparatus for modifying a property of a brain of a patient is provided, including one or more electrodes (7), adapted to be applied to a site selected from a group of sites consisting of: a sphenopalatine ganglion (SPG) (6) of the patient and a neural tract originating in or leading to the SPG. A control unit (8) is adapted to drive the one or more electrodes to apply a current to the site capable of inducing (a) an increase in permeability of a blood-brain barrier (BBB) of the patient, (b) a change in cerebral blood flow of the patient, and/or (c) an inhibition of parasympathetic activity of the SPG.

Claims

1. Apparatus for modifying a property of a brain of a patient, comprising:

one or more electrodes, adapted to be applied to a site selected from a group of sites consisting of;

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

a control unit, adapted to drive the one or more electrodes to apply a current to the site capable of inducing an increase in permeability of a blood-brain barrier (BBB) of the patient,

wherein the control unit is adapted to configure the current to induce parasympathetic activation of the site.

2. Apparatus according to claim 1, wherein the one or more electrodes are adapted for a period of implantation in the patient greater than about one month.

3. Apparatus according to claim 1, and comprising a wire, adapted to connect the control unit to the one or more electrodes, wherein the control unit is adapted to drive the one or more electrodes from a position external to the patient.

4. Apparatus according to claim 1, wherein the control unit is adapted to drive the one or more electrodes by wireless communication from a position external to the patient.

5. Apparatus according to claim 4, and comprising an electromagnetic coupling, adapted to couple the control unit and the one or more electrodes.

6. Apparatus according to claim 4, wherein the control unit is adapted to be in electro-optical communication with the one or more electrodes.

7. Apparatus according to claim 4, wherein the control unit is adapted to be in electro-acoustic communication with the one or more electrodes.

8. Apparatus according to claim 1, wherein the control unit is adapted to be implanted in a nasal cavity of the patient.

9. Apparatus according to claim 1, wherein the one or more electrodes are adapted to be implanted in a nasal cavity of the patient.

10. Apparatus according to claim 1, wherein at least one of the one or more electrodes comprises a flexible electrode, adapted for insertion through a nostril of the patient and to extend therefrom to the site.

11. Apparatus according to claim 1, and comprising at least one biosensor, adapted to measure a physiological parameter of the patient and to generate a signal responsive thereto, wherein the control unit is adapted to modify a parameter of the applied current responsive to the signal.

12. Apparatus according to claim 11, wherein the biosensor comprises a blood flow sensor.

13. Apparatus according to claim 11, wherein the biosensor comprises a temperature sensor.

14. Apparatus according to claim 11, wherein the biosensor comprises a chemical sensor.

15. Apparatus according to claim 11, wherein the biosensor comprises an ultrasound sensor.

16. Apparatus according to claim 11, wherein the biosensor comprises transcranial Doppler (TCD) apparatus.

17. Apparatus according to claim 11, wherein the biosensor comprises laser-Doppler apparatus.

18. Apparatus according to claim 11, wherein the biosensor comprises a systemic blood pressure sensor.

19. Apparatus according to claim 11, wherein the biosensor comprises an intracranial blood pressure sensor.

20. Apparatus according to claim 19, wherein the intracranial blood pressure sensor comprises a detecting element adapted to be fixed to a cerebral blood vessel, and wherein the control unit is adapted to analyze the signal to detect an indication of a change in blood pressure indicative of a clot.

21. Apparatus according to claim 11, wherein the biosensor comprises a kinetics sensor.

22. Apparatus according to claim 21, wherein the control unit is adapted to analyze the signal to detect an indication of a change in body disposition of the patient.

23. Apparatus according to claim 11, wherein the biosensor comprises an electroencephalographic (EEG) sensor.

24. Apparatus according to claim 11, wherein the biosensor comprises a blood vessel clot detector.

25. Apparatus according to claim 1, wherein the control unit is adapted to configure the current so as to facilitate uptake of a drug through the BBB when the permeability of the BBB is increased.

26. Apparatus according to claim 25, wherein the drug includes a chemotherapeutic drug, and wherein the control unit is adapted to configure the current to facilitate the uptake of the chemotherapeutic drug through the BBB when the permeability of the BBB is increased.

27. Apparatus according to claim 25, wherein the drug includes a drug for treating a brain tumor, and wherein the control unit is adapted to configure the current to facilitate the uptake of the drug for treating the brain tumor.

28. Apparatus according to claim 25, wherein the drug includes a drug for treating epilepsy, and wherein the control unit is adapted to configure the current to facilitate the uptake of the drug for treating the epilepsy.

29. Apparatus according to claim 25, wherein the drug includes large pharmaceutical molecules selected from the list consisting of:

hydrophilic molecules having a molecular weight of greater than about 200 Da, and lipophilic molecules having a molecular weight of greater than about 500 Da, and wherein the control unit is adapted to configure the current to facilitate the uptake of the large pharmaceutical molecules through the BBB.

30. Apparatus according to claim 1, wherein the one or more electrodes are adapted for a period of implantation in the patient less than about one week.

31. Apparatus according to claim 1, wherein the control unit is adapted to configure the current to treat a condition of the patient.

32. Apparatus according to claim 1, wherein the control unit is adapted to set a parameter of the current, to induce the increase in permeability of the BBB.

33. Apparatus according to claim 32, wherein the parameter includes a frequency of the current, and wherein the control unit is adapted to set the frequency of the current, to induce the increase in permeability of the BBB.

34. Apparatus according to claim 33, wherein the control unit is adapted to set the frequency to be greater than about 10 Hz, to induce the increase in permeability of the BBB.

35. Apparatus according to claim 32, wherein the parameter includes an amplitude of the current, and wherein the control unit is adapted to set the amplitude of the current, to induce the increase in permeability of the BBB.

36. Apparatus according to claim 32, wherein the parameter includes a waveform of the current, and wherein the control unit is adapted to set the waveform of the current, to induce the increase in permeability of the BBB.

37. Apparatus according to claim 36, wherein a shape of the waveform is selected from the list consisting of:

an exponential decay, a ramp up or down, a square wave, a monophasic shape, a biphasic shape, a sinusoid, a saw tooth, and a DC component, and wherein the control unit is adapted to set the waveform of the current, to induce the increase in permeability of the BBB.

38. Apparatus according to claim 36, wherein the waveform includes one or more pulse bursts, and wherein the control unit is adapted to set the waveform of the current, to induce the increase in permeability of the BBB.

39. Apparatus according to claim 1, wherein the control unit is adapted to be implanted at a site at a top of a bony palate of the patient.

40. Apparatus according to claim 1, wherein the control unit is adapted to be implanted at a site at a lower side of a bony palate of the patient.

41. Apparatus according to claim 1, comprising a drug, adapted to be administered to a blood circulation of the patient, wherein the control unit is adapted to configure the current to facilitate uptake of the drug from the blood circulation through the BBB when the permeability of the BBB is increased.

42. Apparatus according to claim 41, wherein the drug is adapted to be intravenously administered to the patient.

43. Apparatus according to claim 41, wherein the drug is adapted to be administered to the patient by injection.

44. Apparatus according to claim 41, wherein the drug comprises a chemotherapeutic drug.

45. Apparatus according to claim 41, wherein the drug comprises a drug for treating epilepsy.

46. Apparatus according to claim 41, wherein the drug comprises large pharmaceutical molecules selected from the list consisting of:

hydrophilic molecules having a molecular weight of greater than about 200 Da, and lipophilic molecules having a molecular weight of greater than about 500 Da.

47. Apparatus according to claim 1, wherein the site includes the SPG, wherein the one or more electrodes are adapted to be applied to the SPG, and wherein the control unit is adapted to drive the one or more electrodes to apply the current to the SPG.

48. Apparatus according to claim 1, wherein the site includes the neural tract originating in or leading to the SPG, wherein the one or more electrodes are adapted to be applied to the neural tract originating in or leading to the SPG, and wherein the control unit is adapted to drive the one or more electrodes to apply the current to the neural tract originating in or leading to the SPG.