System for stimulating a hypoglossal nerve for controlling the position of a patient's tongue

• US 8,886,322 B2
• Filed: 02/28/2013
• Issued: 11/11/2014
• Est. Priority Date: 11/10/2009
• Status: Active Grant

• Current Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Original Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Inventors: Meadows, Paul M., Lima, Marcelo G., Craig, Stanley R., Zaidi, Faisal N., Elias, Monir M.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US13/779,938
• Publication Number:
  US 20130253627A1
• Time in Patent Office: 621 Days
• Field of Search: 607/42, 607/17, 607/66
• US Class Current: 607/42
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• 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 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A system for controlling a position of a patient'"'"'s tongue includes attaching at least one electrode to the patient'"'"'s Hypoglossal nerve and applying an electric signal through the electrode to at least one targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue. The system may also include the use of more than one contact to target more than one motor efferent and stimulating more than one muscle. The stimulation load to maintain the position of the tongue may be shared by each muscle. The position of the patient'"'"'s tongue may be controlled in order to prevent obstructive sleep apnea.

Claims

1. A method for controlling a position of a patient'"'"'s tongue, the method comprising:

implanting an electrode having a plurality of contacts, the plurality of contacts being proximate a Hypoglossal nerve;

implanting an implantable pulse generator (IPG), the IPG being electronically coupled to the electrode;

programming the IPG, independent of respiration cycle, to deliver at least two electric signals to the plurality of contacts;

applying the at least two electric signals at a starting frequency via the plurality of contacts to at least two targeted motor efferent groups located within the Hypoglossal nerve to stimulate at least two muscles of the tongue; and

ramping the starting frequency downwards to a target frequency,

wherein programming the IPG includes;

assigning each contact to one of a plurality of functional groups,

keeping an amplitude of at least one electric signal of a first functional group at a target amplitude for a pre-determined amount of time and then replacing the at least one electric signal of the first functional group with at least one electric signal of a second functional group of the plurality of functional groups,

ramping an amplitude of the at least one electric signal of the second functional group from an initial level up to the target amplitude, and

ramping the amplitude of the at least one electric signal of the second functional group from the target amplitude down to a rest amplitude.

2. The method of claim 1, wherein programming the IPG includes sequencing or interleaving the plurality of functional groups.

3. The method of claim 1, wherein programming the IPG includes ramping the amplitude of the at least one electric signal of the first functional group of the plurality of functional groups from an initial level up to the target amplitude.

4. The method of claim 1, wherein a period of the at least one electric signal of the first functional group partially overlaps with a period of the at least one electric signal of the second functional group.

5. The method of claim 1, wherein a period of the at least one electric signal of the first functional group does not overlap with a period of the at least one electric signal of the second functional group.

6. The method of claim 1, wherein programming the IPG includes sharing a generally level amount of stimulation between the plurality of contacts.

7. The method of claim 1, wherein applying the at least two electric signals includes driving each contact by their own independent current source.

8. The method of claim 1, wherein programming the IPG includes pulsing each contact at different or overlapping intervals.

9. The method of claim 1, wherein the electrode includes a cuff housing and wherein implanting the electrode includes wrapping the cuff housing around a portion of the Hypoglossal nerve.

10. The method of claim 1, wherein the at least two electric signals are applied to the Hypoglossal nerve via an open loop system.

11. The method of claim 1 further comprising:

initiating a therapy session, wherein the applying the at least two electric signals is delayed for a predetermined amount of time after initiating the therapy session.

12. The method of claim 1, wherein the at least two electric signals are applied at least once during both inhalation and exhalation of a respiration cycle.

13. The method of claim 1, wherein the at least two electric signals are applied simultaneously.