Apparatus, system and method for therapeutic treatment of obstructive sleep apnea

• US 7,937,159 B2
• Filed: 04/01/2010
• Issued: 05/03/2011
• 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): Bertram; Eric D.
• Application Number:
  US12/752,931
• Publication Number:
  US 20100198306A1
• Time in Patent Office: 397 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

An implantable neurostimulator for treating obstructive sleep apnea comprises an implant configured to at least partially surround a Hypoglossal nerve (HGN) and a plurality of electrodes each attached to the implant. Each electrode configured to contact the HGN and electrically stimulate one or more regions or groups of the HGN.

Claims

1. An implantable 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 be coupled to and at least partially surround a 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 PCB;

a core subsystem (CSS) attached to the first side of the PCB and electrically connected to the neural interface;

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

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

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, and

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.

2. The system of claim 1, further comprising a plurality of individual electrodes.

3. The system of claim 1, wherein the implant is configured to provide stimulation to the HGN at preprogrammed conditions.

4. The system of claim 1, wherein the core subsystem being included in a silicon chip attached to the PCB with the chip connected to the neural interface via traced wires printed on the PCB.

5. The 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.

6. The system of claim 1, further comprising a matrix of electrodes coupled to one or more fascicles or regions of the HGN.

7. The system of claim 1, wherein the supplied power includes RF energy emitted by the controller.

8. The system of claim 1, wherein the controller is configured to stimulate patient specific nerve physiology and stimulation parameters.

9. The system of claim 1, wherein the controller is shaped for placement around a patient'"'"'s ear.

10. The 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.

11. The 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.

12. The system of claim 1, wherein the controller is configured to communicate with the implant at preprogrammed intervals.

13. The system of claim 1, wherein the implant is configured to provide continuous open loop electrical stimulation to the HGN during sleep hours.

14. The system of claim 1, wherein the implant is configured to deliver multiple modes of stimulation.

15. The system of claim 1, wherein the implant is configured to provide stimulation in multiple dimensions.

16. Previously Presented) The system of claim 1, wherein the neural interface does not include external wires or leads.

17. The system of claim 1, wherein the neural interface is configured to stimulate the HGN.

18. The 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.

19. An implantable 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 be coupled to and at least partially surround a 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 PCB;

a core subsystem (CSS) attached to the first side of the PCB and electrically connected to the neural interface;

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

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

wherein the core subsystem being included in a silicon chip attached to the PCB with the chip connected to the neural interface via traced wires printed on the PCB.

20. The system of claim 19, further comprising a plurality of individual electrodes.

21. The system of claim 19, wherein the implant is configured to provide stimulation to the HGN at preprogrammed conditions.

22. The system of claim 19, wherein the silicon chip is configured to be powered by and receive a customized electrode stimulation program protocol from the controller.

23. The system of claim 19, further comprising a matrix of electrodes coupled to one or more fascicles or regions of the HGN.

24. The system of claim 19, 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.

25. The system of claim 19, wherein the supplied power includes RF energy emitted by the controller.

26. The system of claim 19, wherein the controller is configured to stimulate patient specific nerve physiology and stimulation parameters.

27. The system of claim 19, wherein the controller is shaped for placement around a patient'"'"'s ear.

28. The system of claim 19, 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.

29. The system of claim 19, wherein the controller is configured to:

provide an RF signal to the implant;

sense and record data; and

interface with a programming device.

30. The system of claim 19, wherein the controller is configured to communicate with the implant at preprogrammed intervals.

31. The system of claim 19, wherein the implant is configured to provide continuous open loop electrical stimulation to the HGN during sleep hours.

32. The system of claim 19, wherein the implant is configured to deliver multiple modes of stimulation.

33. The system of claim 19, wherein the implant is configured to provide stimulation in multiple dimensions.

34. The system of claim 19, wherein the neural interface does not include external wires or leads.

35. The system of claim 19, wherein the neural interface is configured to stimulate the HGN.

36. The system of claim 19, 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.