IP Library Granted Patent US 12,440,677
Granted Patent B2
US 12,440,677 · App. 17/858,668 · Granted Oct 14, 2025

Multiple-lead implantable systems for stimulation of cranial nerves

Inventors: Lynn Elliott (Maple Grove, MN); Stephen C. Masson, Jr. (Raleigh, NC)
Assignee: NUXCEL2, L.L.C.
A61N1/3611A61B5/08A61N1/0551A61N1/0556A61N1/36125A61N1/37518A61B5/11A61B5/4836A61N1/36078A61N1/375
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Quick Facts
Patent No.
US 12,440,677
App. No.
17/858,668
Granted
Oct 14, 2025
Kind
B2
Abstract

Neuromodulation of cranial nerves can be used to treat sleep or breathing disorders, among other diseases and disorders. A neuromodulation system can include a housing configured for implantation in an anterior cervical region of a patient, such as at or under a mandible of the patient, such as at least partially in one or more of a submental triangle, a submandibular triangle, and a carotid triangle. The system can include an electrode lead coupled to the housing, and the electrode lead can include an electrode configured to be disposed at or near a cranial nerve target in the patient. The system can be configured to generate electrical neuromodulation signals for delivery to the cranial nerve target using the electrode.

Claims (28)

1. An implantable system for neuromodulation of cranial nerves, the system comprising:

a first housing configured for implantation in an anterior cervical region of a patient, adjacent to or under a mandible of the patient and between a mylohyoid muscle and a digastric muscle that bound respective portions of the anterior cervical region of the patient, wherein the first housing includes a first housing wall configured for implantation adjacent to the mylohyoid muscle and the first housing includes at least one other housing wall that is tapered and extends away from the first housing wall toward the digastric muscle;

a battery provided in the first housing;

a first electrode lead coupled to the first housing, the first electrode lead comprising at least one electrode configured to be disposed at or near a first cranial nerve target in the patient;

a second electrode lead coupled to the first housing, the second electrode lead comprising at least one electrode configured to be disposed at or near a second cranial nerve target in the patient, wherein the first and second cranial nerve targets are on opposite sides of a sagittal midline of the patient; and

a signal generator circuit provided in the first housing and configured to use power from the battery to generate electrical neuromodulation signals for delivery to the cranial nerve target using the at least one electrode of the first electrode lead or the second electrode lead, wherein the neuromodulation signals are configured to treat a breathing disorder or a sleep disorder of the patient.

2. The system of claim 1 , wherein the first and second electrode leads are coupled to respective opposing sides of the first housing.

3. The system of claim 1 , wherein the neuromodulation signals generated by the signal generator circuit are configured to treat obstructive sleep apnea.

4. The system of claim 3 , wherein the first cranial nerve target comprises a main body of a hypoglossal nerve of the patient or a branch of the hypoglossal nerve of the patient.

5. The system of claim 1 , wherein the second cranial nerve target comprises a branch of a trigeminal nerve of the patient.

6. The system of claim 1 , wherein the second cranial nerve target comprises a branch of a facial nerve of the patient.

7. The system of claim 1 , wherein the second cranial nerve target comprises a ganglion or a branch of a glossopharyngeal nerve of the patient.

8. The system of claim 1 , wherein the signal generator circuit is configured to provide the neuromodulation signals concurrently to the electrodes of the first and second electrode leads, and wherein an electrostimulation vector that is produced in response to a first one of the neuromodulation signals is configured to modify a different electrostimulation vector that is produced in response to a second one of the neuromodulation signals.

9. The system of claim 1 , wherein the first housing is configured to be implanted in a submental triangle region of the patient.

10. The system of claim 1 , comprising an anchor configured to couple a portion of the first housing to a digastric tendon.

11. An implantable neuromodulation system comprising:

a first housing disposed in a first cervical triangle region of a patient bounded at least in part by a mylohyoid muscle and a digastric muscle of the patient, wherein the first housing includes a first wall configured to be disposed adjacent to the mylohyoid muscle and the first housing includes a second wall that extends away from the first wall and tapers toward the digastric muscle;

first and second electrode leads coupled to the first housing, the first and second electrode leads comprising respective electrodes configured to be disposed at or near cranial nerve targets in the patient;

a communication circuit implanted outside of the first cervical triangle region of the patient; and

an interface coupling first circuitry in the first housing and the communication circuit;

wherein the first circuitry comprises a battery and comprises signal generator circuitry coupled to the electrodes of the first and second electrode leads, the signal generator circuitry configured to use power from the battery to generate neuromodulation signals to treat a breathing disorder or a sleep disorder of the patient; and

wherein the communication circuit comprises a wireless power communication coil.

12. The implantable neuromodulation system of claim 11 , wherein the first housing and the communication circuit are configured to be separated by a distance that is sufficient to accommodate an anterior portion of the digastric muscle of the patient.

13. The implantable neuromodulation system of claim 11 , wherein the communication coil is configured to wirelessly receive a power signal from a source external to a body of the patient, and wherein the first circuitry is configured to provide at least a portion of the received power signal to the battery for storage.

14. The implantable neuromodulation system of claim 11 , wherein the first housing is configured to be implanted in a submental triangle of the patient.

15. The implantable neuromodulation system of claim 11 , further comprising a physiologic status sensor disposed in or coupled to the first housing, wherein the physiologic status sensor is configured to measure information about a respiration, heart rate, blood pressure, sympathetic tone, parasympathetic tone, posture, activity level, body impedance, or electric activity of the patient, and wherein the signal generator circuitry is configured to generate the neuromodulation signals to treat obstructive sleep apnea based on the information from the physiologic status sensor.

16. The implantable neuromodulation system of claim 11 , further comprising an accelerometer disposed in or coupled to the first housing, wherein the accelerometer is configured to measure information about a respiration, heart rate, or posture of the patient, and wherein the signal generator circuitry is configured to generate the neuromodulation signals to treat obstructive sleep apnea based on the information from the accelerometer.

17. The implantable neuromodulation system of claim 11 , comprising an anchor configured to couple a portion of the first housing to a digastric tendon.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 6, 2022
From: ELLIOTT, LYNN; MASSON, STEPHEN C., JR.
To: NUXCEL2, L.L.C.
Reel/Frame 060414/0100 →
Continuity (3)
Continuation PCTUS2021012723 · Jan 8, 2021
Provisional Application 62959617 · Jan 10, 2020
Related Publication 20220339441A1 · Oct 27, 2022
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