US 11,839,767 C1 (255th)
Systems and methods for stimulation of cranial nerves
Lynn Elliott, Maple Grove, MN (US); and Stephen C. Masson, Jr., Raleigh, NC (US)
Filed by NuXcel2, L.L.C., Reno, NV (US)
Assigned to NUXCEL2, L.L.C., Brooklyn Park, MN (US)
Supplemental Examination Request No. 96/050,069, Nov. 14, 2024.
Reexamination Certificate for Patent 11,839,767, issued Dec. 12, 2023, Appl. No. 17/790,573, Jul. 1, 2022.
PCT Filed Jan. 8, 2021, PCT No. PCT/US2021/012723
§ 371(c)(1), (2) Date Jul. 1, 2022,
PCT Pub. No. WO2021/142278, PCT Pub. Date Jul. 15, 2021.
Claims priority of provisional application 62/959,617, filed on Jan. 10, 2020.
Ex Parte Reexamination Certificate from Reexamination Ordered under 35 U.S.C. 257 issued on Jun. 9, 2025.
Int. Cl. A61N 1/36 (2006.01); A61B 5/00 (2006.01); A61B 5/08 (2006.01); A61B 5/11 (2006.01); A61N 1/05 (2006.01); A61N 1/375 (2006.01)
CPC A61N 1/3611 (2013.01) [A61B 5/08 (2013.01); A61N 1/0551 (2013.01); A61N 1/0556 (2013.01); A61N 1/36125 (2013.01); A61N 1/37518 (2017.08); A61B 5/11 (2013.01); A61B 5/4836 (2013.01); A61N 1/36078 (2013.01); A61N 1/375 (2013.01)]
OG exemplary drawing
AS A RESULT OF REEXAMINATION, IT HAS BEEN DETERMINED THAT:
Claims 1, 21, 23, 28 and 37 are determined to be patentable as amended.
Claims 2-20, 22, 24-27, 29-36 and 38, dependent on an amended claim, are determined to be patentable.
New claims 39-49 are added and determined to be patentable.
1. An implantable system for neuromodulation of cranial nerves, the system comprising:
a first housing configured for implantation [ sized for being implanted ] in a submental triangular region of a patient , wherein the first housing is configured for implantation [ and for being positioned at least partially under an anterior digastric muscle of the patient and ] between a mylohyoid muscle that bounds a first portion of the submental triangular region and a [ the anterior ] digastric muscle that bounds a second portion of the submental triangular region;
a first electrode lead coupled to the first housing, the first electrode lead comprising at least one electrode configured to be coupled to a first cranial nerve target in the patient and distal to the first housing;
a power storage circuit provided in the first housing; and
a signal generator circuit provided in the first housing and coupled to the power storage circuit, wherein the signal generator circuit is configured to use power from [ only ] the power storage circuit to generate electrical neuromodulation signals for delivery to the cranial nerve target using the at least one electrode of the first electrode lead, wherein the neuromodulation signals are configured to treat a breathing disorder or a sleep disorder of the patient; wherein the first housing is a hermetic enclosure for the power storage circuit and the signal generator circuit.
21. The implantable system of claim 1, 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 [ anterior ] digastric muscle.
23. An implantable neuromodulation system comprising:
an elongate first housing configured for implantation [ sized for being implanted ] in a submental triangular region of a patient , wherein the first housing is configured for implantation [ and for being positioned ] between a mylohyoid muscle that bounds a superior portion of the submental triangular region and a [ an anterior ] digastric muscle that bounds an inferior portion of the submental triangular region;
a battery and a power management circuit provided in the first housing;
a first electrode lead coupled to the first housing and configured to be disposed in a submandibular region, wherein at least one cuff electrode on the first electrode lead is configured to be disposed distal to the first housing and around a portion of a first branch of a hypoglossal nerve of the patient; and
electrostimulation generation and control circuitry disposed in the first housing and configured to use power from [ only ] the battery to provide electrostimulation signals to the patient using the first electrode lead, wherein the electrostimulation signals are configured to treat a sleep disorder or breathing disorder of the patient.
28. The implantable neuromodulation system of claim 23, wherein the first housing comprises a rectangular frustum structure with a base surface configured to be oriented posteriorly in the submandibular [ submental triangular ] region, and a top surface configured to be oriented anteriorly in the submandibular [ submental triangular ] region, wherein an area of the base surface exceeds an area of the top surface.
37. The implantable system of claim 23, wherein the elongate first housing includes a first portion configured for implantation adjacent to the mylohyoid muscle and the first housing includes a second portion that extends toward an interior surface of the [ anterior ] digastric muscle.
[ 39. The system of claim 1, wherein the first housing has an overall volume no greater than three cubic centimeters.]
[ 40. The system of claim 1, wherein the first housing has vertical and horizontal sides no greater than 30 millimeters.]
[ 41. The system of claim 1, wherein the first housing has a thickness of no greater than six millimeters.]
[ 42. The system of claim 1, wherein the first housing has (a) an overall volume no greater than three cubic centimeters, (b) vertical and horizontal sides no greater than 30 millimeters, and (c) a thickness of no greater than six millimeters.]
[ 43. An implantable system for neuromodulation of cranial nerves, the system comprising:
a first housing sized for being implanted in a submental triangle of a patient and for being positioned at least partially under an anterior digastric muscle of the patient and between a mylohyoid muscle that bounds a first portion of the submental triangle and the anterior digastric muscle that bounds a second portion of the submental triangle;
a first electrode lead coupled to the first housing, the first electrode lead comprising at least one electrode configured to be coupled to a first cranial nerve target in the patient and distal to the first housing;
a battery in the first housing; and
a signal generator circuit in the first housing and coupled to the battery, wherein the signal generator circuit is configured to use power from the battery, without any externally provided power, to generate electrical neuromodulation signals for delivery to the cranial nerve target using the at least one electrode of the first electrode lead, wherein the neuromodulation signals are configured to treat a breathing disorder or a sleep disorder of the patient; wherein
the first housing is a hermetic enclosure for the battery and the signal generator circuit.]
[ 44. An implantable neuromodulation system comprising:
an elongate first housing sized for being implanted in a submental triangle of a patient and for being positioned between a mylohyoid muscle that bounds a superior portion of the submental triangle and an anterior digastric muscle that bounds an inferior portion of the submental triangle;
a battery and a power management circuit provided in the first housing;
a first electrode lead coupled to the first housing and configured to be disposed in a submandibular region, wherein at least one cuff electrode on the first electrode lead is configured to be disposed distal to the first housing and around a portion of a first branch of a hypoglossal nerve of the patient; and
electrostimulation generation and control circuitry disposed in the first housing and configured to use power from the battery, without any externally provided power, to provide electrostimulation signals to the patient using the first electrode lead, wherein the electrostimulation signals are configured to treat a sleep disorder or breathing disorder of the patient.]
[ 45. An implantable system for neuromodulation of cranial nerves, the system comprising:
a first housing sized for being implanted in a submental triangle of a patient and for being positioned at least partially under an anterior digastric muscle of the patient and between a mylohyoid muscle that bounds a first portion of the submental triangle and the anterior digastric muscle that bounds a second portion of the submental triangle;
a first electrode lead coupled to the first housing, the first electrode lead comprising at least one electrode configured to be coupled to a first cranial nerve target in the patient and distal to the first housing;
a battery provided in the first housing;
a signal generator circuit provided in the first housing and coupled to the battery, wherein the signal generator circuit is 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, wherein the neuromodulation signals are configured to treat a breathing disorder or a sleep disorder of the patient; and
a wireless communication coil coupled to a power management circuit in the first housing, wherein the wireless communication coil is disposed on or inside the first housing; wherein
the first housing is a hermetic enclosure for the battery and the signal generator circuit.]
[ 46. The implantable system of claim 45, 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 anterior digastric muscle.]
[ 47. An implantable neuromodulation system comprising:
an elongate first housing sized for being implanted in a submental triangle of a patient and for being positioned between a mylohyoid muscle that bounds a superior portion of the submental triangle and an anterior digastric muscle that bounds an inferior portion of the submental triangle;
a battery and a power management circuit provided in the first housing;
a first electrode lead coupled to the first housing and configured to be disposed in a submandibular region, wherein at least one cuff electrode on the first electrode lead is configured to be disposed distal to the first housing and around a portion of a first branch of a hypoglossal nerve of the patient;
electrostimulation generation and control circuitry disposed in the first housing and configured to use power from the battery to provide electrostimulation signals to the patient using the first electrode lead, wherein the electrostimulation signals are configured to treat a sleep disorder or breathing disorder of the patient; and
a wireless communication coil coupled to the power management circuit in the first housing, wherein the wireless communication coil is disposed on or inside the first housing.]
[ 48. The implantable neuromodulation system of claim 47, wherein the first housing comprises a rectangular frustum structure with a base surface configured to be oriented posteriorly in the submental triangle and a top surface configured to be oriented anteriorly in the submental triangle, wherein an area of the base surface exceeds an area of the top surface.]
[ 49. The implantable neuromodulation system of claim 47, wherein the first housing comprises sidewalls that are contoured to correspond to contours of the submental triangle.]