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

• US 9,339,651 B2
• Filed: 10/07/2014
• Issued: 05/17/2016
• 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:
  US14/507,989
• Publication Number:
  US 20150119955A1
• Time in Patent Office: 588 Days
• Field of Search: 607/42, 607/17, 607/66
• US Class Current: 1/1
• 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 system used for controlling a position of a patient'"'"'s tongue, the system comprising:

an electrode having a plurality of contacts, the plurality of contacts configured to be implanted proximate a Hypoglossal nerve, the electrode configured to apply one of at least one electric signal to one of at least one targeted motor efferent groups located within a Hypoglossal nerve to stimulate at least one muscle of the tongue;

an implantable pulse generator (IPG) coupled to the electrode, the IPG being programmable, independent of respiration cycle, to;

assign each of the plurality of contacts to one of a plurality of functional groups,

deliver at least two electric signals to the plurality of contacts in a pattern of electric frequencies;

apply the at least two electric signals at a starting frequency,

ramp the starting frequency downwards to a target frequency,

maintain an amplitude of at least one electric signal of a first functional group of the plurality of functional groups 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,

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

ramp 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 system of claim 1, wherein the IPG is programmable to assign the plurality of contacts to one of the plurality of functional groups.

3. The system of claim 2, wherein the IPG is programmable to sequence or interleave the plurality of functional groups.

4. The system of claim 2, wherein each functional group of the plurality of functional groups maintains an open airway in the patient and the first functional group includes at least one or more different muscles than the second functional group.

5. The system of claim 1, wherein the electrode includes six contacts.

6. The system of claim 1, wherein the contacts are each driven by their own independent current source.

7. The system of claim 1, wherein the electrode includes a cuff housing configured to wrap around a portion of the Hypoglossal nerve.

8. The system of claim 1, wherein the at least one electric signal is applied to the Hypoglossal nerve via an open loop system.

9. The system of claim 1, wherein the electrode is driven by multiple current sources.

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

an electrode having a plurality of contacts, the plurality of contacts being configured to be implanted proximate a Hypoglossal nerve;

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

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

the IPG being programmed to apply 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 then ramp the starting frequency downwards to a target frequency,

wherein the IPG is further programmed to;

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

keep 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,

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

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

11. The system of claim 10, wherein the IPG is programmable to assign the plurality of contacts to one of the plurality of functional groups.

12. The system of claim 11, wherein each functional group of the plurality of functional groups maintains an open airway in the patient and the first functional group includes at least one or more different muscles than the second functional group.

13. The system of claim 10, wherein the electrode includes six contacts.

14. The system of claim 10, wherein the electrode is driven by multiple current sources.

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

programming an implantable pulse generator (IPG), the IPG being electronically coupled to an electrode having a plurality of contacts, the plurality of contacts being implanted proximate a Hypoglossal nerve, to;

assign each of the plurality of contacts to one of a plurality of functional groups,

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

apply 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,

ramp the starting frequency downwards to a target frequency,

keep an amplitude of at least one electric signal of a first functional group of the plurality of functional groups 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,

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

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

16. The method of claim 15, wherein the IPG is programmable to assign the plurality of contacts to one of the plurality of functional groups.

17. The method of claim 16, wherein each functional group of the plurality of functional groups maintains an open airway in the patient and the first functional group includes at least one or more different muscles than the second functional group.