IP Library Granted Patent US 12,636,497
Granted Patent B2
US 12,636,497 · App. 17/654,451 · Granted May 26, 2026

Systems and methods for improving sleep disordered breathing

Inventors: Anthony V. Caparso (North Ridgeville, OH); Josh Nickols (Louisville, KY); Francis A. Papay (Cleveland, OH); Kelly Emerton (Santa Rosa, CA)
Assignees: XII Medical, Inc.; The Cleveland Clinic Foundation
A61N1/36139A61N1/0548A61N1/3611A61N1/37229G06T7/70G06T11/60G06V10/42G06V10/60G06V20/13G06V20/176A61B5/1114A61B5/1116A61B5/394A61B5/4552A61B5/4812A61B5/4818A61N1/37211
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Quick Facts
Patent No.
US 12,636,497
App. No.
17/654,451
Granted
May 26, 2026
Kind
B2
Abstract

A neuromodulation system is provided herein. The system can include a neuromodulation device, an electronics package, which can be part of the neuromodulation device; an external controller; a sensor; and a computing device. The neuromodulation device can include a neuromodulation lead having a lead body configured to be bent to a desired shape and to maintain that shape in order to position the electrodes relative to neural and/or muscular structures when fully deployed. The neuromodulation device can also include an antenna including an upper and a lower coil electrically connected to each other in parallel. The computing device can execute a closed-loop algorithm based on physiological sensed data relating to sleep.

Claims (34)

1 . A neuromodulation system comprising:

a neuromodulation device comprising:

a lead comprising a lead body and a plurality of electrodes disposed on the lead body, wherein, when the lead is implanted and fully deployed, the electrodes are positioned proximate a hypoglossal nerve, and

a first antenna operatively coupled to the lead;

an external mat comprising:

a substrate comprising a substrate layer; and

a second antenna comprising a conductive trace forming a first loop and a second loop, wherein the first loop and the second loop are on a first face of the substrate layer, wherein the second loop is positioned outside of the first loop and the first loop is positioned outside of the second loop; and

a control unit configured to excite the second antenna such that the second antenna produces an electromagnetic field for inducing electrical current in the first antenna to power the neuromodulation device, wherein the electromagnetic field extends between the first loop and the second loop.

2 . The neuromodulation system of claim 1 , wherein the mat is configured to be positioned on a sleeping surface during use.

3 . The neuromodulation system of claim 1 , wherein the control unit is configured to be electrically coupled to the mat, and wherein the control unit comprises a data link configured for two-way communication with the neuromodulation device.

4 . The neuromodulation system of claim 1 , further comprising an electronics package, wherein the first antenna is a part of the electronics package, and wherein the electronics package further comprises a processor.

5 . The neuromodulation system of claim 1 , wherein the mat is thin and flexible.

6 . The neuromodulation system of claim 1 , wherein the neuromodulation device is configured to be implanted in a head of a patient.

7 . The neuromodulation system of claim 1 , wherein the trace forms a third loop.

8 . The neuromodulation system of claim 7 , wherein the third loop is positioned outside each of the first and second loops, and each of the first and second loops are positioned outside of the third loop.

9 . The neuromodulation system of claim 7 , wherein the trace forms a fourth loop.

10 . The neuromodulation system of claim 9 , wherein the fourth loop is positioned outside of each of the first, second, and third loops, and each of the first, second, and third loops are positioned outside of the fourth loop.

11 . The neuromodulation system of claim 1 , wherein the lead body comprises a left portion and a right portion, and wherein, when the lead body is implanted and fully deployed, the left and right portions are positioned proximate a left branch and a right branch of the hypoglossal nerve, respectively.

12 . A neuromodulation system comprising:

an implantable stimulator comprising:

a lead comprising a lead body and a plurality of electrodes disposed on the lead body, wherein, when the lead is implanted and fully deployed, the electrodes are positioned proximate a hypoglossal nerve, and

a first antenna operatively coupled to the lead;

a substrate configured to be positioned outside of a patient's body during use, wherein the substrate comprises a substrate layer and a second antenna, wherein the second antenna comprises a conductive metal trace forming a first loop enclosing a first area and a second loop enclosing a second area, wherein the first loop and the second loop are on a first face of the substrate layer, wherein the first and second areas do not overlap; and

a control unit configured to excite the second antenna such that the second antenna produces an electromagnetic field for inducing electrical current in the first antenna to power the lead, wherein the electromagnetic field extends between the first loop and the second loop.

13 . The neuromodulation system of claim 12 , wherein the second antenna is configured to be positioned on a sleeping surface during use.

14 . The neuromodulation system of claim 12 , wherein the control unit is configured to be electrically coupled to the second antenna, and wherein the control unit comprises a data link configured for two-way communication with the implantable stimulator.

15 . The neuromodulation system of claim 12 , further comprising an electronics package, wherein the first antenna is a part of the electronics package, and wherein the electronics package further comprises a processor.

16 . The neuromodulation system of claim 12 , wherein the substrate is thin and flexible.

17 . The neuromodulation system of claim 12 , wherein the implantable stimulator is configured to be positioned in a head of the patient.

18 . The neuromodulation system of claim 12 , wherein the trace forms a third loop.

19 . The neuromodulation system of claim 18 , wherein the third loop is positioned outside of each of the first and second loops, and each of the first and second loops are positioned outside of the third loop.

20 . The neuromodulation system of claim 18 , wherein the trace forms a fourth loop.

21 . The neuromodulation system of claim 20 , wherein the fourth loop is positioned outside of each of the first, second, and third loops, and each of the first, second, and third loops are positioned outside of the fourth loop.

22 . The neuromodulation system of claim 12 , wherein the lead body comprises a left portion and a right portion, and wherein, when the lead body is implanted and fully deployed, the left and right portions are positioned proximate a left branch and a right branch of the hypoglossal nerve, respectively.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2023
From: PAPAY, FRANCIS A.; EMERTON, KELLY
To: THE CLEVELAND CLINIC FOUNDATION
Reel/Frame 063886/0472 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 11, 2022
From: CAPARSO, ANTHONY; NICKOLS, JOSH
To: ENHALE MEDICAL, INC.
Reel/Frame 059242/0127 →
CHANGE OF NAME Recorded Mar 11, 2022
From: ENHALE MEDICAL, INC.
To: XII MEDICAL, INC.
Reel/Frame 059362/0618 →
Continuity (3)
Continuation 16866523 · May 4, 2020
Provisional Application 62841978 · May 2, 2019
Related Publication 20220266030A1 · Aug 25, 2022
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