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

• US 10,195,436 B2
• Filed: 04/17/2017
• Issued: 02/05/2019
• 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): Hulbert, Amanda
• Assistant Examiner(s): Edwards, Philip C
• Application Number:
  US15/489,004
• Publication Number:
  US 20170216590A1
• Time in Patent Office: 659 Days
• Field of Search: 607 42, 607 17, 607 66
• 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 configured to control 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, each of the plurality of contacts being configured to apply at least one electric signal to the Hypoglossal nerve; and

an implantable pulse generator (IPG) coupled to the electrode, the IPG being programmed, without taking into account a timing of respiration, to;

deliver at least two electric signal groups to at least two muscles of the patient'"'"'s tongue via the plurality of contacts in a pattern of electric frequencies, each of the at least two electric signal groups including at least one electric signal, the at least two electric signal groups including a first electric signal group and a second electric signal group;

apply the first electric signal group at a first starting amplitude;

ramp the first starting amplitude of the first electric signal group upwards to a first target amplitude;

maintain the first target amplitude of the first electric signal group for a first pre-determined amount of time;

ramp the first target amplitude of the first electric signal group down to a first rest amplitude;

apply the second electric signal group at a second starting amplitude while the first electric signal group is being maintained at the first target amplitude or while the first electric signal group is being ramped from the first target amplitude down to the first rest amplitude; and

ramp the second starting amplitude of the second electric signal group upwards to a second target amplitude; and

maintain the second target amplitude of the second electric signal group for a second pre-determined amount of time.

2. The system of claim 1, wherein the IPG is programmed to sequence or interleave the application of the at least two electric signal groups.

3. The system of claim 1, wherein the IPG is further programmed to:

apply the first and second electric signal groups at a starting frequency; and

ramp the starting frequency of the first and second electric signal groups down to a target frequency.

4. The system of claim 1, wherein the IPG is programmed such that a period of one of the at least two electric signals does not overlap with a period of another of the at least two electric signals.

5. The system of claim 1, wherein the IPG is programmed such that an amount of stimulation is generally equally shared between the plurality of contacts.

6. The system of claim 1, wherein the at least two electric signals are each driven by their own independent current source.

7. The system of claim 1, wherein the IPG is programmed to pulse each contact at different or overlapping intervals.

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

9. The system of claim 1, wherein the IPG is programmed to apply the at least two electric signals to the Hypoglossal nerve via an open loop system.

10. The system of claim 1, wherein the IPG is programmed to initiate a therapy session, wherein the application of the at least two electric signals is delayed for a predetermined amount of time after the therapy session is initiated.

11. The method of claim 1, wherein IPG is programmed to apply the at least two electric signals simultaneously.