Systems, methods and apparatus for delivering nerve stimulation to a patient with physician oversight

• US 9,526,653 B2
• Filed: 12/16/2011
• Issued: 12/27/2016
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Scion Neurostim Incorporated
• Original Assignee: Scion Neurostim, LLC
• Inventors: Rogers, Lesco L., Smith, Lanty L., Black, Robert D.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): ZINK, AMANDA L
• Application Number:
  US13/994,276
• Publication Number:
  US 20130296987A1
• Time in Patent Office: 1,838 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2007/0005 Ears
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

The present invention provides devices, systems and methods for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient. In some embodiments, the present invention provides a vestibular stimulation device configured both to generate a prescription for delivering one or more thermal waveforms and to deliver the prescribed thermal waveforms.

Claims

1. A vestibular stimulation device comprising:

an earpiece;

a thermoelectric device (TED) thermally coupled to said earpiece; and

a controller operatively connected to said TED, said controller comprising;

a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient; and

a control module configured to activate said TED to deliver the prescribed thermal waveform(s), wherein the one or more thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

2. The vestibular stimulation device of claim 1, wherein said set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient is stored in a prescription database.

3. The vestibular stimulation device of claim 2, wherein said prescription database reside(s) in a device selected from the group consisting of a patient control device, a physician control device, a physician support device and a registry.

4. The vestibular stimulation device of claim 3, wherein said prescription database resides in a registry that comprises prescriptions from at least one of one or more physician control devices and one or more physician support devices.

5. The vestibular stimulation device of claim 2, wherein said waveform database reside(s) in a device selected from the group consisting of a patient control device, a physician control device, a physician support device and a registry.

6. The vestibular stimulation device of claim 5, wherein said waveform database resides in a registry that comprises thermal waveforms from at least one of one or more physician control devices and one or more physician support devices.

7. The vestibular stimulation device of claim 2, wherein at least one of said prescription database and said waveform database reside(s) in said controller.

8. The vestibular stimulation device of claim 1, wherein said vestibular stimulation device further comprises a sensor operatively connected to said controller, said sensor configured to transmit data associated with the temperature of the earpiece to said controller.

9. The vestibular stimulation device of claim 8, wherein said control module is configured to use said data associated with the temperature of the earpiece to ensure that the appropriate one or more thermal waveforms are delivered to the vestibular system and the nervous system of said patient.

10. The vestibular stimulation device of claim 9, wherein using said data associated with the temperature of the earpiece to ensure that the appropriate one or more thermal waveforms are delivered to at least one of the vestibular system and the nervous system of said patient comprises adjusting an activation signal used to drive said TED responsive to said data associated with the temperature of the earpiece.

11. The vestibular stimulation device of claim 10, wherein said sensor repeatedly transmits data associated with the temperature of the earpiece to said controller and wherein said controller repeatedly adjusts the activation signal used to drive said TED.

12. The vestibular stimulation device of claim 8, wherein said controller is configured to shut down if the temperature of the earpiece drops below a low temperature threshold or exceeds a high temperature threshold.

13. The vestibular stimulation device of claim 12, wherein said low temperature threshold is 10 degrees Centigrade.

14. The vestibular stimulation device of claim 12, wherein said high temperature threshold is 50 degrees Centigrade.

15. The vestibular stimulation device of claim 1, wherein said controller further comprises a treatment module configured to generate one or more prescriptions.

16. The vestibular stimulation device of claim 15, wherein said treatment module is configured to generate a prescription responsive to receiving user input, wherein said user input comprises selection of a thermal waveform from a waveform database.

17. The vestibular stimulation device of claim 15, wherein said treatment module is configured to generate a prescription responsive to receiving user input, wherein said user input comprises modification of a thermal waveform selected from a waveform database.

18. The vestibular stimulation device of claim 1, wherein said controller further comprises a feedback database configured to store data associated with the delivery of one or more thermal waveforms to the vestibular system and for the nervous system of said patient.

19. The vestibular stimulation device of claim 18, wherein said controller comprises a portable memory device interface and said prescription database, and at least one of said waveform database and said feedback database reside(s) on a portable memory device inserted into the portable memory device interface.

20. The vestibular stimulation device of claim 19, wherein said portable memory device interface comprises an SD memory card interface and said portable memory device comprises an SD memory card.

21. The vestibular stimulation device of claim 1, wherein said controller is configured such that the patient is prevented from at least one of modifying and deleting said prescription.

22. The vestibular stimulation device of claim 1, wherein said vestibular stimulation device further comprises a heat sink and wherein said TED is thermally coupled between said earpiece and said heat sink.

23. The vestibular stimulation device of claim 1, wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes instructions for providing a plurality of spaced-apart treatment sessions over a defined period of time.

24. The vestibular stimulation device of claim 1, wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes an expiration time after which the controller prohibits delivery of the one or more thermal waveforms.

26. The method of claim 25, wherein said vestibular stimulation device is a vestibular stimulation device according to claim 1.

25. A method of delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient, comprising:

generating a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of said subject; and

delivering the prescribed thermal waveform(s) to at least one of the vestibular system and the nervous system of the patient using a vestibular stimulation device, wherein the prescribed thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

27. The method of claim 25, wherein said prescription is generated using said vestibular stimulation device.

28. The method of claim 25, wherein said prescription is generated using a physician control device.

29. The method of claim 25, wherein generating a prescription comprises selecting a thermal waveform from a waveform database.

30. The method of claim 29, wherein said waveform database resides in said vestibular stimulation device.

31. The method of claim 30, wherein said vestibular stimulation device comprises a portable memory device interface and said waveform database resides on a portable memory device inserted into the portable memory device interface.

32. The method of claim 31, wherein said portable memory device interface comprises an SD memory card interface and said portable memory device comprises an SD memory card.

33. The method of claim 29, wherein said waveform database resides in a device selected from the group consisting of a physician control device, a physician support device and a registry.

34. The method of claim 33, wherein said waveform database resides in a registry that comprises thermal waveforms from at least one of one or more physician control devices and one or more physician support devices.

35. The method of claim 29, wherein said waveform database is periodically updated.

36. The method of claim 25, wherein generating a prescription comprises modifying a thermal waveform selected from a waveform database.

37. The method of claim 25, further comprising:

monitoring the patient'"'"'s response to the prescribed thermal waveform(s);

modifying the prescription based upon the patient'"'"'s response to the prescribed thermal waveform(s); and

delivering one or more thermal waveform(s) to at least one of the vestibular system and the nervous system of the patient using the vestibular stimulation device in accordance with the modified prescription.

38. The method of claim 25, wherein generating a prescription comprising the set of instructions for delivering one or more thermal waveforms includes generating instructions for providing a plurality of spaced-apart treatment sessions over a defined period of time.

39. The method of claim 25, wherein generating a prescription comprising the set of instructions for delivering one or more thermal waveforms includes generating an expiration time, and prohibiting a delivery of the one or more thermal waveforms after the expiration time.

40. A vestibular stimulation system comprising:

a physician control device configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient; and

a vestibular stimulation device configured to deliver the prescribed thermal waveform(s) to at least one of the vestibular system and the nervous system of said patient, wherein the prescribed thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

41. The vestibular stimulation system of claim 40, wherein said physician control device is configured to store said prescription in a prescription database residing therein.

42. The vestibular stimulation system claim 41, wherein said vestibular stimulation device is configured to access the prescription database residing in said physician control device and to retrieve said prescription therefrom.

43. The vestibular stimulation system of claim 40, wherein said physician control device is configured to transmit said prescription to said vestibular stimulation device over a wired or wireless communications channel.

44. The vestibular stimulation system of claim 40, wherein said physician control device is further configured to generate one or more thermal waveforms and wherein said prescription comprises a set of instructions for delivering one or more of the thermal waveforms generated by the physician control device to at least one of the vestibular system and the nervous system of said patient.

45. The vestibular stimulation system of claim 40, wherein said vestibular stimulation system further comprises a physician support device configured to generate one or more thermal waveforms, wherein said prescription comprises a set of instructions for delivering one or more of the thermal waveforms generated by the physician support device to at least one of the vestibular system and the nervous system of said patient.

46. The vestibular stimulation system of claim 45, wherein said physician support device is configured to store said one or more thermal waveforms in a waveform database residing therein.

47. The vestibular stimulation system claim 46, wherein said physician control device is configured to access the waveform database residing in said physician support device and to retrieve said one or more thermal waveforms therefrom.

48. The vestibular stimulation system of claim 45, wherein said physician support device is configured to transmit said one or more thermal waveforms to said physician control device over a wired or wireless communications channel.

49. The vestibular stimulation system of claim 48, wherein said physician control device is configured to generate said prescription responsive to receiving/retrieving said one or more thermal waveforms from said physician support device.

50. The vestibular stimulation system of claim 40, wherein said physician control device is configured to access a waveform database residing in a device selected from the group consisting of a physician support device and a registry and to receive and retrieve one or more thermal waveforms therefrom.

51. The vestibular stimulation system of claim 50, wherein said physician control device is configured to generate said prescription responsive to receiving/retrieving said one or more thermal waveforms from said device.

52. The vestibular stimulation system of claim 50, wherein said waveform database resides in a registry that comprises thermal waveforms from at least one of one or more physician control devices and one or more physician support devices.

53. The vestibular stimulation system of claim 40, wherein said vestibular stimulation device is further configured to generate feedback data.

54. The vestibular stimulation system of claim 53, wherein said vestibular stimulation device is configured to store said feedback data in a feedback database residing therein.

55. The vestibular stimulation system of claim 54, wherein said physician support device is configured to access the feedback database residing in said vestibular stimulation device and to retrieve said feedback data therefrom.

56. The vestibular stimulation system of claim 54, wherein said physician control device is configured to access the feedback database residing in said vestibular stimulation device and to retrieve said feedback data therefrom.

57. The vestibular stimulation system of claim 53, wherein said vestibular stimulation device is configured to transmit said feedback data to said physician support device over a wired or wireless communications channel.

58. The vestibular stimulation system of claim 57, wherein said physician support device is configured to analyze said feedback data and to modify one or more of said one or more thermal waveforms responsive to said analysis.

59. The vestibular stimulation system of claim 58, wherein said physician support device is configured to store said modified thermal waveform(s) in the waveform database residing therein.

60. The vestibular stimulation system of claim 59, wherein said physician control device is configured to access the waveform database residing in said physician support device and to retrieve said modified thermal waveform(s) therefrom.

61. The vestibular stimulation system of claim 58, wherein said physician support device is configured to transmit the modified thermal waveform(s) to said physician control device over a wired or wireless communications channel.

62. The vestibular stimulation system of claim 61, wherein said physician control device is configured to modify said prescription responsive to receiving/retrieving said modified thermal waveform(s) from said physician support device.

63. The vestibular stimulation system of claim 62, wherein said physician control device is configured to store said modified prescription in said prescription database.

64. The vestibular stimulation system of claim 53, wherein said vestibular stimulation device is configured to transmit said feedback data to said physician control device over a wired or wireless communications channel.

65. The vestibular stimulation system of claim 64, wherein said physician control device is configured to analyze said feedback data and to modify said prescription responsive to said analysis.

66. The vestibular stimulation system of claim 65, wherein said physician control device is configured to store said modified prescription in said prescription database residing therein.

67. The vestibular stimulation system of claim 66, wherein said vestibular stimulation device is configured to access the prescription database residing in said physician control device and to retrieve said modified prescription therefrom.

68. The vestibular stimulation system of claim 65, wherein said physician control device is configured to transmit said modified prescription to said vestibular stimulation device over a wired or wireless communications channel.

69. The vestibular stimulation system of claim 68, wherein said vestibular stimulation device is configured to deliver one or more thermal waveforms to at least one of the vestibular system and the nervous system of said patient in accordance with said modified prescription.

70. The vestibular stimulation system of claim 40, wherein the physician control device is configured to generate the prescription by generating instructions for providing a plurality of spaced-apart treatment sessions over a defined period of time.

71. The vestibular stimulation system of claim 40, wherein the physician control device is configured to generate the prescription by generating an expiration time, and prohibiting a delivery of the one or more thermal waveforms after the expiration time.

72. A vestibular stimulation device comprising:

an earpiece;

a thermoelectric device (TED) thermally coupled to said earpiece; and

a controller operatively connected to said TED, said controller comprising;

a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient; and

a control module configured to activate said TED to deliver the prescribed thermal waveform(s), wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes instructions for providing a plurality of spaced-apart treatment sessions over a defined period of time.

73. The vestibular stimulation device of claim 72, wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes an expiration time after which the controller prohibits delivery of the one or more thermal waveforms.