IP Library Granted Patent US 12,427,309
Granted Patent B2
US 12,427,309 · App. 18/787,817 · Granted Sep 30, 2025

Methods for positioning signal delivery devices to treat sleep apnea, and associated devices and treatments

Inventors: David Herron (Los Angeles, CA); Guillaume Raux (El Paso, TX); Timothy A. Fayram (Gilroy, CA); Richard W. O'Connor (Atherton, CA)
Assignee: Invicta Medical, Inc.
A61N1/36003A61N1/0551A61N1/36192A61N1/36139
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Quick Facts
Patent No.
US 12,427,309
App. No.
18/787,817
Granted
Sep 30, 2025
Kind
B2
Abstract

The present technology is generally directed to methods for addressing a patient's sleep apnea. At least some of the methods can include one or more of percutaneously inserting an implantable signal delivery device at an insertion point on the patient's neck, moving the signal delivery device in a medial-to-lateral direction toward an ansa cervicalis nerve of the patient, and implanting the signal delivery device at a target location at least proximate to the ansa cervicalis nerve. The signal delivery device can include at least one electrode positioned to deliver a modulation signal to tissue at least proximate to the target location, such as a portion of the ansa cervicalis nerve. In some embodiments, delivery of the modulation signal can induce caudal traction in the patient and thereby address the patient's sleep apnea.

Claims (48)

1. A system for addressing a breathing obstruction in a patient, the system comprising:

an implantable signal delivery device configured to be positioned to deliver a modulation signal to an ansa cervicalis nerve of the patient, and

a controller communicatively coupled to the implantable signal delivery device and configured to—

receive an input corresponding to a modulation threshold of the patient's ansa cervicalis nerve at which one or more muscles innervated by the ansa cervicalis nerve produce a full tetanic response,

determine a modulation parameter value different than the modulation threshold and at which the one or more muscles produce less than the full tetanic response, wherein the modulation parameter value is determined based at least in part on the input, and

instruct the implantable signal delivery device to generate the modulation signal based at least in part on the modulation parameter value.

2. The system of claim 1 wherein the modulation parameter value is less than the modulation threshold by a predetermined amount.

3. The system of claim 1 wherein the modulation threshold is a first value of a modulation parameter, and wherein the modulation parameter value is a second value of the modulation parameter less than the first value.

4. The system of claim 3 wherein the modulation parameter includes a modulation amplitude.

5. The system of claim 1 wherein:

the input is a first input,

the controller is further configured to receive a second input corresponding to an arousal threshold at which delivery of the modulation signal causes the patient to rouse from sleep, and

the modulation parameter value is determined based at least in part on the first input and the second input.

6. The system of claim 1 wherein:

the input is a first input,

the controller is further configured to receive a second input corresponding to a perception threshold at which the patient consciously perceives the delivery of the modulation signal, and

the modulation parameter value is determined based at least in part on the first input and the second input.

7. The system of claim 1 wherein the modulation parameter value includes a modulation pulse width, wherein the modulation threshold includes a first pulse width value, and wherein the modulation parameter value includes a second pulse width value greater than the first pulse width value.

8. The system of claim 1 wherein:

the modulation signal is a second modulation signal;

the controller is further configured to cause a first modulation signal to be delivered to the ansa cervicalis nerve of the patient to produce the full tetanic response in the one or more muscles;

the input includes an amplitude, a frequency, and/or a pulse width of the first modulation signal associated with the modulation threshold of the patient's ansa cervicalis nerve; and

the second modulation signal is configured to cause less than the full tetanic response in the one or more muscles.

9. The system of claim 1 wherein the one or more muscles include a sternothyroid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response of the sternothyroid muscle.

10. The system of claim 1 wherein the one or more muscles include a sternohyoid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response of the sternohyoid muscle.

11. The system of claim 1 wherein the one or more muscles include a sternohyoid muscle of the patient and a sternothyroid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response in both the sternohyoid muscle and the sternothyroid muscle.

12. A method of addressing a breathing obstruction in a patient, the method comprising:

receiving, at a controller communicatively coupled to a signal delivery device positioned to deliver a modulation signal to an ansa cervicalis nerve of the patient, an input corresponding to a modulation threshold of the patient's ansa cervicalis nerve at which one or more muscles innervated by the ansa cervicalis nerve to produce a full tetanic response;

determining a modulation parameter value different than the modulation threshold and at which the one or more muscles produce less than the full tetanic response, wherein the modulation parameter value is determined based at least in part on the input; and

instructing, via the controller, the signal delivery device to generate the modulation signal based at least in part on the modulation parameter value.

13. The method of claim 12 wherein the modulation parameter value is less than the modulation threshold by a predetermined amount.

14. The method of claim 12 wherein the modulation threshold is a first value of a modulation parameter, and wherein the modulation parameter value is a second value of the modulation parameter less than the first value.

15. The method of claim 13 wherein the modulation parameter includes a modulation amplitude.

16. The method of claim 12 wherein:

the input is a first input, the method further comprises receiving a second input corresponding to an arousal threshold at which delivery of the modulation signal causes the patient to rouse from sleep, and determining the modulation parameter value includes determining the modulation parameter value based at least in part on the first input and the second input.

17. The method of claim 11 wherein:

the input is a first input,

the method further comprises receiving a second input corresponding to a perception threshold at which the patient consciously perceives the delivery of the modulation signal, and

determining the modulation parameter value includes determining the modulation parameter value based at least in part on the first input and the second input.

18. The method of claim 12 wherein the modulation parameter value includes a modulation pulse width, wherein the modulation threshold includes a first pulse width value, and wherein the modulation parameter value includes a second pulse width value greater than the first pulse width value.

19. The method of claim 12 wherein:

the modulation signal is a second modulation signal;

the controller is further configured to cause a first modulation signal to be delivered to the ansa cervicalis nerve of the patient to produce the full tetanic response in the one or more muscles;

the input includes an amplitude, a frequency, and/or a pulse width of the first modulation signal associated with the modulation threshold of the patient's ansa cervicalis nerve; and

the second modulation signal is configured to cause less than the full tetanic response in the one or more muscles.

20. The method of claim 12 wherein the one or more muscles include a sternothyroid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response of the sternothyroid muscle.

21. The method of claim 12 wherein the one or more muscles include a sternohyoid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response of the sternohyoid muscle.

22. The method of claim 12 wherein the one or more muscles include a sternohyoid muscle of the patient and a sternothyroid muscle of the patient, and wherein the modulation threshold is associated with a full tetanic response in both the sternohyoid muscle and the sternothyroid muscle.

Assignments (4)
CHANGE OF NAME Recorded May 4, 2026
From: INVICTA MEDICAL, INC.
To: RESTERA, INC.
Reel/Frame 075501/0405 →
RELEASE OF SECURITY INTEREST Recorded Aug 13, 2025
From: APHELION CAPITAL, LLC, AS COLLATERAL AGENT
To: INVICTA MEDICAL, INC.
Reel/Frame 072014/0302 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2025
From: HERRON, DAVID; RAUX, GUILLAUME; FAYRAM, TIMOTHY A.; O’CONNOR, RICHARD
To: INVICTA MEDICAL, INC.
Reel/Frame 070898/0408 →
SECURITY INTEREST Recorded Feb 11, 2025
From: INVICTA MEDICAL, INC.
To: APHELION CAPITAL, LLC, AS COLLATERAL AGENT
Reel/Frame 070176/0383 →
Continuity (4)
Division 18607289 · Mar 15, 2024
Provisional Application 63622867 · Jan 19, 2024
Provisional Application 63452918 · Mar 17, 2023
Related Publication 20250001171A1 · Jan 2, 2025
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