RFID-based apparatus, system, and method for therapeutic treatment of obstructive sleep apnea

• US 7,725,195 B2
• Filed: 02/16/2007
• Issued: 05/25/2010
• Est. Priority Date: 02/16/2006
• Status: Active Grant

• Current Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Original Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Inventors: Lima, Marcelo G., Craig, Stanley R. Jr.
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Bertram; Eric D.
• Application Number:
  US11/707,053
• Publication Number:
  US 20080109046A1
• Time in Patent Office: 1,194 Days
• Field of Search: 607/60
• US Class Current: 607/60
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Provided is an implantable RFID-enabled micro-electronic neurostimulator system for treating obstructive sleep apnea, comprising an implant having a top and a bottom layer, the bottom layer serving as an attachment mechanism such that the bottom layer of the implant encompasses the hypoglossal nerve and attaches to the top layer of the implant; a printed circuit board (PCB) attached to the top layer of the implant, the PCB having a first and a second opposing sides; a neural interface attached to the second side of the PCB; a core subsystem (CSS) attached to the first side of the PCB and electrically connected to the neural interface; and a radio frequency (RF) interface attached to the first side of the PCB and electrically connected to the CSS, wherein the implant is powered and controlled by an external programmable controller.

Claims

1. An implantable RFID-enabled micro-electronic neurostimulator system for treating obstructive sleep apnea, comprising:

an implant having a top and a bottom layer, the bottom layer serving as an attachment mechanism such that the bottom layer of the implant is adapted to couple to and at least partially surround the Hypoglossal nerve (HGN) and attaches to the top layer of the implant;

a printed circuit board (PCB) attached to the top layer of the implant, the PCB having a first and a second opposing sides;

a neural interface attached to the second side of the PCB;

a core subsystem (CSS) attached to the first side of the PCB and electrically connected to the neural interface, the core subsystem being included in a silicon chip placed on the top of the PCB with the chip connected to the neural interface via traced wires printed on the PCB;

a radio frequency (RF) interface attached to the first side of the PCB and electrically connected to the CSS; and

an external programmable controller configured to power and control the implant.

2. The RFID-enabled micro-electronic neurostimulator of claim 1, wherein the supplied power includes RF energy emitted by the controller.

3. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant, PCB, RF interface, and core subsystem are encased in a casing, the casing being a material selected from the group consisting of one or more titanium alloys, ceramic, and polyetheretherketone (PEEK).

4. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller includes a port for interfacing with a computer.

5. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is configured to stimulate patient specific nerve physiology and stimulation parameters.

6. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is shaped for placement around a patient'"'"'s ear.

7. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is configured to:

identify an implant having a unique ID tag;

communicate with the implant having the unique ID tag; and

send a signal to a transponder located in the implant.

8. The RFID-enabled micro-electronic neurostimulator system of claim 7, wherein the transponder is a passive RFID transponder.

9. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is configured to:

provide an RF signal to the implant;

sense and record data; and

interface with a programming device.

10. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is configured to communicate with the implant at preprogrammed intervals.

11. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the controller is configured to initiate a stimulation cycle by making a request to the core subsystem, the request being in the form of an encoded RF waveform including control data.

12. The RFID-enabled micro-electronic neurostimulator system of claim 11, wherein the request is encrypted.

13. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant is hermetically sealed.

14. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant is configured to provide continuous open loop electrical stimulation to the HGN during sleep hours.

15. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant is configured to provide constant stimulation to the HGN during sleep hours.

16. The RFID-enabled micro-electronic neurostimulator system of claim 15, wherein the implant is configured to provide bi-phasic stimulation of the HGN.

17. The RFID-enabled micro-electronic neurostimulator system of claim 15, wherein the stimulation pulse width is about 200 microseconds at a stimulation frequency of about 10-40 hertz.

18. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant is configured to provide stimulation to the HGN at preprogrammed conditions.

19. The RFID-enabled micro-electronic neurostimulator system of claim 18, wherein the implant is configured to provide bi-phasic stimulation of the HGN.

20. The RFID-enabled micro-electronic neurostimulator system of claim 18, wherein the implant stimulation pulse width is about 200 microseconds at a stimulation frequency of about 10-40 hertz.

21. The RFID-enabled micro-electronic neurostimulator system claim 1, wherein the implant is configured to deliver multiple modes of stimulation.

22. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the implant is configured to provide stimulation in multiple dimensions.

23. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the neural interface is manufactured with a biocompatible material coating.

24. The RFID-enabled micro-electronic neurostimulator system of claim 1, further comprising a plurality of individual electrodes.

25. The RFID-enabled micro-electronic neurostimulator system of claim 24, further comprising an array of anodes and cathodes.

26. The RFID-enabled micro-electronic neurostimulator system of claim 24, wherein the electrodes are spot welded to the printed circuit board and are comprised of a material selected from the group consisting of platinum and iridium.

27. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the neural interface does not include external wires or leads.

28. The RFID-enabled micro-electronic neurostimulator system of claim 1, further comprising a plurality of exposed electrode pairs serving as anode and cathode complementary elements.

29. The RFID-enabled micro-electronic neurostimulator system of claim 28, further comprising a matrix of platinum electrodes adapted to couple to one or more fascicles of the HGN.

30. The RFID-enabled micro-electronic neurostimulator system of claim 28, further comprising a matrix of platinum electrodes adapted to couple to one or more regions or groups of the HGN.

31. The RFID-enabled micro-electronic neurostimulator system of claim 30, wherein the one or more regions or groups are comprised of one or more fascicles of the HGN.

32. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the neural interface is configured to stimulate the HGN.

33. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the neural interface is configured to sense neural activity of the nerve it interfaces with and transmit that sensed neural activity to the core subsystem.

34. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the silicon chip is configured to be powered by and receive a customized electrode stimulation program protocol from the controller.

35. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the core subsystem is configured to select a trained waveform from memory and start stimulation by providing an electrical signal to the neural interface upon receiving a request to enter into a stimulation state.

36. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the core subsystem is configured to report completion of a stimulation state to the controller via an RF communication and go to an idle state.

37. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the bottom layer does not include conductive parts.

38. The RFID-enabled micro-electronic neurostimulator system of claim 1, wherein the bottom layer does not include conductive parts.

39. An implantable RFID-enabled micro-electronic neurostimulator system for treating obstructive sleep apnea, comprising:

an implant having a top and a bottom layer, the bottom layer serving as an attachment mechanism such that the bottom layer of the implant is adapted to couple to and at least partially surround the Hypoglossal nerve (HGN) and attaches to the top layer of the implant;

a printed circuit board (PCB) attached to the top layer of the implant, the PCB having a first and a second opposing sides;

a neural interface attached to the second side of the PCB;

a core subsystem (CSS) attached to the first side of the PCB and electrically connected to the neural interface, the core subsystem configured to select a trained waveform from memory and start stimulation by providing an electrical signal to the neural interface upon receiving a request to enter into a stimulation state;

a radio frequency (RF) interface attached to the first side of the PCB and electrically connected to the CSS; and

an external programmable controller configured to power and control the implant.

40. The RFID-enabled micro-electronic neurostimulator of claim 39, wherein the supplied power includes RF energy emitted by the controller.

41. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant, PCB, RF interface, and core subsystem are encased in a casing, the casing being a material selected from the group consisting of one or more titanium alloys, ceramic, and polyetheretherketone (PEEK).

42. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller includes a port for interfacing with a computer.

43. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is configured to stimulate patient specific nerve physiology and stimulation parameters.

44. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is shaped for placement around a patient'"'"'s ear.

45. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is configured to:

identify an implant having a unique ID tag;

communicate with the implant having the unique ID tag; and

send a signal to a transponder located in the implant.

46. The RFID-enabled micro-electronic neurostimulator system of claim 45, wherein the transponder is a passive RFID transponder.

47. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is configured to:

provide an RF signal to the implant;

sense and record data; and

interface with a programming device.

48. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is configured to communicate with the implant at preprogrammed intervals.

49. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the controller is configured to initiate a stimulation cycle by making a request to the core subsystem, the request being in the form of an encoded RF waveform including control data.

50. The RFID-enabled micro-electronic neurostimulator system of claim 49, wherein the request is encrypted.

51. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant is hermetically sealed.

52. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant is configured to provide continuous open loop electrical stimulation to the HGN during sleep hours.

53. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant is configured to provide constant stimulation to the HGN during sleep hours.

54. The RFID-enabled micro-electronic neurostimulator system of claim 53, wherein the implant is configured to provide bi-phasic stimulation of the HGN.

55. The RFID-enabled micro-electronic neurostimulator system of claim 53, wherein the stimulation pulse width is about 200 microseconds at a stimulation frequency of about 10-40 hertz.

56. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant is configured to provide stimulation to the HGN at preprogrammed conditions.

57. The RFID-enabled micro-electronic neurostimulator system of claim 56, wherein the implant is configured to provide bi-phasic stimulation of the HGN.

58. The RFID-enabled micro-electronic neurostimulator system of claim 56, wherein the implant stimulation pulse width is about 200 microseconds at a stimulation frequency of about 10-40 hertz.

59. The RFID-enabled micro-electronic neurostimulator system claim 39, wherein the implant is configured to deliver multiple modes of stimulation.

60. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the implant is configured to provide stimulation in multiple dimensions.

61. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the neural interface is manufactured with a biocompatible material coating.

62. The RFID-enabled micro-electronic neurostimulator system of claim 39, further comprising a plurality of individual electrodes.

63. The RFID-enabled micro-electronic neurostimulator system of claim 62, further comprising an array of anodes and cathodes.

64. The RFID-enabled micro-electronic neurostimulator system of claim 62, wherein the electrodes are spot welded to the printed circuit board and are comprised of a material selected from the group consisting of platinum and iridium.

65. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the neural interface does not include external wires or leads.

66. The RFID-enabled micro-electronic neurostimulator system of claim 39, further comprising a plurality of exposed electrode pairs serving as anode and cathode complementary elements.

67. The RFID-enabled micro-electronic neurostimulator system of claim 66, further comprising a matrix of platinum electrodes adapted to couple to one or more fascicles of the HGN.

68. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the neural interface is configured to stimulate the HGN.

69. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the neural interface is configured to sense neural activity of the nerve it interfaces with and transmit that sensed neural activity to the core subsystem.

70. The RFID-enabled micro-electronic neurostimulator system of claim 39, wherein the core subsystem is configured to report completion of a stimulation state to the controller via an RF communication and go to an idle state.

71. The RFID-enabled micro-electronic neurostimulator system of claim 66, further comprising a matrix of platinum electrodes adapted to couple coupled to one or more regions or groups of the HGN.

72. The RFID-enabled micro-electronic neurostimulator system of claim 71, wherein the one or more regions or groups are comprised of one or more fascicles of the HGN.