US 11,857,792 C1 (254th)
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. 96/050,068, Nov. 14, 2024.
Reexamination Certificate for Patent 11,857,792, issued Jan. 2, 2024, Appl. No. 17/860,346, Jul. 8, 2022.
Application 96/050,068 is a continuation of application No. PCT/US2021/012723, filed on Jan. 8, 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. 6, 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 and 13-15 are determined to be patentable as amended.
Claims 2-12 and 16-22, dependent on an amended claim, are determined to be patentable.
New claims 23-30 are added and determined to be patentable.
1. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
providing [ implanting ] an implantable neuromodulation device housing in an anterior cervical region [ a submental triangle ] of a patient [ at least partially under an anterior digastric muscle of the patient ] between a mylohyoid muscle of the patient and a [ the anterior ] digastric muscle of the patient [ , the implantable neuromodulation device housing containing power storage circuitry and signal generator circuitry within the housing and being sized for being implanted in the submental triangle of the patient] ;
coupling the implantable neuromodulation device housing to first tissue in the anterior cervical region [ submental triangle ] of the patient;
providing [ implanting ] a first electrode lead, coupled to a portion of the device housing and to [ the ] signal generator circuitry inside the device housing, at or near a first cranial nerve target in the patient, wherein the signal generator circuitry is coupled to [ the ] power storage circuitry that is inside the device housing;
coupling the first electrode lead to second tissue in the [ an ] anterior cervical region of the patient; and
applying [ using power from the power storage circuitry provided to the signal generator circuitry to apply ] a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuitry and using electrodes of the first electrode lead, wherein the first electrical signals are configured to treat the sleep disorder or breathing disorder of the patient.
13. The method of claim 1, wherein providing the implantable neuromodulation device housing in the region [ submental triangle ] includes providing the implantable neuromodulation device housing inferior to the mylohyoid muscle of the patient and superior to at least a portion of the [ anterior ] digastric muscle of the patient.
14. The method of claim 13, wherein the implantable neuromodulation device housing includes a first portion configured to be disposed adjacent to the mylohyoid muscle of the patient and the housing includes a second portion that extends toward a superior surface of the [ anterior ] digastric muscle of the patient.
15. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
providing [ implanting ] an implantable neuromodulation device housing between a mylohyoid muscle and a digastric muscle [ and ] in a submental triangular region of the patient;
coupling the implantable neuromodulation device housing to first tissue in the submental triangular region of the patient, wherein the device housing encloses a signal generator circuit and a power storage circuit;
electrically coupling an electrode of a first electrode lead to the signal generator circuit inside the device housing;
coupling the electrode to a first cranial nerve target in or adjacent to the submental triangular region of the patient; and
applying [ using power from the power storage circuit provided to the signal generator circuit to apply ] a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuit and the electrode of the first electrode lead, wherein the first neuromodulation signal is configured to treat the sleep disorder or breathing disorder of the patient.
[ 23. The method of claim 1, wherein the device housing has an overall volume no greater than three cubic centimeters.]
[ 24. The system of claim 1, wherein the device housing has vertical and horizontal sides no greater than 30 millimeters.]
[ 25. The system of claim 1, wherein the device housing has a thickness of no greater than six millimeters.]
[ 26. The system of claim 1, wherein the device 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.]
[ 27. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
implanting an implantable neuromodulation device housing in a submental triangle of a patient at least partially under an anterior digastric muscle of the patient between a mylohyoid muscle of the patient and the anterior digastric muscle of the patient, the implantable neuromodulation device housing containing a battery and signal generator circuitry within the housing and being sized for being implanted in the submental triangle of the patient;
coupling the implantable neuromodulation device housing to first tissue in the submental triangle of the patient;
implanting a first electrode lead, coupled to a portion of the device housing and to the signal generator circuitry inside the device housing, at or near a first cranial nerve target in the patient, wherein the signal generator circuitry is coupled to the battery inside the device housing;
coupling the first electrode lead to second tissue in an anterior cervical region of the patient; and
using only power from the battery provided to the signal generator circuitry to apply a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuitry and using electrodes of the first electrode lead, wherein the first electrical signals are configured to treat the sleep disorder or breathing disorder of the patient.]
[ 28. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
implanting an implantable neuromodulation device housing between a mylohyoid muscle and a digastric muscle and in a submental triangle of the patient;
coupling the implantable neuromodulation device housing to first tissue in the submental triangle of the patient, wherein the device housing encloses a signal generator circuit and a battery;
electrically coupling an electrode of a first electrode lead to the signal generator circuit inside the device housing;
coupling the electrode to a first cranial nerve target in or adjacent to the submental triangle of the patient; and
using only power from the battery provided to the signal generator circuit to apply a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuit and the electrode of the first electrode lead, wherein the first neuromodulation signal is configured to treat the sleep disorder or breathing disorder of the patient.]
[ 29. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
implanting an implantable neuromodulation device housing in a submental triangle of a patient at least partially under an anterior digastric muscle of the patient between a mylohyoid muscle of the patient and the anterior digastric muscle of the patient, the implantable neuromodulation device housing containing a battery and signal generator circuitry within the housing and being sized for being implanted in the submental triangle of the patient;
coupling the implantable neuromodulation device housing to first tissue in the submental triangle of the patient;
implanting a first electrode lead, coupled to a portion of the device housing and to the signal generator circuitry inside the device housing, at or near a first cranial nerve target in the patient, wherein the signal generator circuitry is coupled to the battery inside the device housing;
coupling the first electrode lead to second tissue in an anterior cervical region of the patient; and
without any externally provided power, applying a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuitry and using electrodes of the first electrode lead, wherein the first electrical signals are configured to treat the sleep disorder or breathing disorder of the patient.]
[ 30. A method for treating a sleep disorder or a breathing disorder of a patient, the method comprising:
implanting an implantable neuromodulation device housing between a mylohyoid muscle and a digastric muscle and in a submental triangle of the patient;
coupling the implantable neuromodulation device housing to first tissue in the submental triangle of the patient, wherein the device housing encloses a signal generator circuit and a battery:
electrically coupling an electrode of a first electrode lead to the signal generator circuit inside the device housing;
coupling the electrode to a first cranial nerve target in or adjacent to the submental triangle of the patient; and
without any externally provided power, applying a first neuromodulation signal to the first cranial nerve target using first electrical signals from the signal generator circuit and the electrode of the first electrode lead, wherein the first neuromodulation signal is configured to treat the sleep disorder or breathing disorder of the patient.]