IP Library Granted Patent US 11,647,947
Granted Patent B2
US 11,647,947 · App. 16/856,862 · Granted May 16, 2023

Method for adjusting a system for stimulating a hypoglossal nerve

Inventors: Paul M. Meadows (Glendale, CA); Marcelo G. Lima (San Diego, CA); Faisal N. Zaidi (San Diego, CA); Jasper Benke (San Diego, CA)
Assignee: ImThera Medical, Inc.
A61B5/4836A61B5/02108A61B5/087A61B5/14542A61B5/369A61B5/389A61B5/398A61B5/4818A61N1/0556A61N1/3601A61N1/3611A61N1/36139A61N1/36185A61B5/021A61B5/026A61B5/02405A61B5/24A61B5/4047
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Quick Facts
Patent No.
US 11,647,947
App. No.
16/856,862
Granted
May 16, 2023
Kind
B2
Abstract

A method for titrating a stimulation parameter for one or more electrode contacts in a system for stimulating a hypoglossal nerve of a patient includes activating one of the one or more electrode contacts to stimulate the hypoglossal nerve of the patient, obtaining a first and/or second physiological measurement from the patient, comparing the first and/or second physiological measurement to a first and/or second predetermined target value, adjusting a stimulation parameter for the one of the one or more electrode contacts if the first and/or second physiological measurement differs from the first and/or second predetermined target value.

Claims (36)

1. A method of treating sleep apnea using nerve stimulation, the method comprising:

implanting an electrode having a plurality of electrode contacts into a patient;

electrically coupling the plurality of electrode contacts to a hypoglossal nerve of the patient;

assigning each electrode contact of the plurality of electrode contacts to at least one functional group of a plurality of functional groups, each functional group of the plurality of functional groups being associated with a different movement of a tongue of the patient and including one or more electrode contacts of the plurality of electrode contacts; and

providing stimulation sequentially by each functional group of the plurality of functional groups to cause movement of the tongue of the patient corresponding to the functional group providing the stimulation, the stimulation of each functional group including a ramp up time.

2. The method of claim 1 , wherein each functional group stimulates at least one different nerve fiber in the hypoglossal nerve, and the at least one different nerve fiber stimulated by each functional group is associated with at least one different muscle configured to produce the different movement of the tongue.

3. The method of claim 1 , wherein providing the stimulation sequentially by each functional group allows for the tongue of the patient to be continuously maintained in a desired position while reducing an occurrence of fatigue in muscles associated with each of the different movements of the tongue associated with each functional group.

4. The method of claim 1 , wherein the stimulation provided by each functional group includes a duty cycle having a group on time and a group gap time, the group on time being a time period in which the stimulation is applied by a corresponding functional group and the group gap time being a time period in which the stimulation is not applied by the corresponding functional group.

5. The method of claim 4 , wherein the ramp up time of a first functional group of the plurality functional groups overlaps with the group on time of a second functional group of the plurality of functional groups, such that at least two functional groups simultaneously provide the stimulation.

6. The method of claim 4 , wherein the group gap time of the stimulation provided by each functional group is configured to prevent or reduce fatigue in at least one muscle associated with the different movement associated with the corresponding functional group by allowing for the at least one muscle to rest and recover from the stimulation.

7. The method of claim 4 , wherein the group on times of the stimulations provided by the plurality of functional groups are configured to reduce fatigue.

8. The method of claim 1 , wherein the stimulation provided by each functional group further includes a ramp down time.

9. A method of treating sleep apnea using nerve stimulation, the method comprising:

electrically coupling a plurality of electrode contacts of an electrode to a hypoglossal nerve of a patient;

assigning each electrode contract of the plurality of electrode contacts to at least one functional group of a plurality of functional groups, each functional group of the plurality of functional groups being associated with a different movement of a tongue of the patient and including one or more electrode contacts of the plurality of electrode contacts; and

providing stimulation sequentially by each functional group of the plurality of functional groups to cause movement of the tongue of the patient corresponding to the functional group providing the stimulation, the stimulation of each functional group including a ramp up time.

10. The method of claim 9 , wherein each functional group stimulates at least one different nerve fiber in the hypoglossal nerve, and the at least one different nerve fiber stimulated by each functional group is associated with at least one different muscle configured to produce the different movement of the tongue.

11. The method of claim 9 , wherein providing the stimulation sequentially by each functional group allows for the tongue of the patient to be continuously maintained in a desired position while reducing an occurrence of fatigue in muscles associated with each of the different movements of the tongue associated with each functional group.

12. The method of claim 9 , wherein the stimulation provided by each functional group includes a duty cycle having a group on time and a group gap time, the group on time being a time period in which the stimulation is applied by a corresponding functional group and the group gap time being a time period in which the stimulation is not applied by the corresponding functional group, the group gap time being configured to prevent or reduce fatigue in at least one muscle associated with the different movement associated with the corresponding functional group by allowing for the at least one muscle to rest and recover from the stimulation.

13. The method of claim 9 , further comprising:

activating one or more electrode contacts of the electrode to provide the stimulation to the hypoglossal nerve; and

upon activating the one or more electrode contacts of the electrode, initiating a delay of the stimulation configured to allow the patient to fall asleep before providing the stimulation.

14. The method of claim 9 , further comprising:

adjusting one or more parameters of the stimulation, the one or more parameters comprising at least one of the assignment of the plurality of electrode contacts to the plurality of functional groups, whether or not an electrode contact or functional group is enabled or disabled, a stimulation amplitude, a stimulation phase duration, a stimulation frequency, a group ramp up time, a group on time, a group ramp down time, a group gap time, group population percentages, or inter- and intra-therapeutic periodicity; and

measuring one or more physiological measurements,

wherein adjusting the one or more parameters of the stimulation is performed to improve the one or more physiological measurements, the improvement of the one or more physiological measurements being determined by a change in the one or more physiological measurements toward a normative value.

15. A system for treating sleep apnea using neurostimulation, the system comprising:

an electrode configured to be implanted into a patient, the electrode having a plurality of electrode contacts configured to be electrically coupled to a hypoglossal nerve of the patient;

an implantable pulse generator (IPG) configured to provide stimulation to the hypoglossal nerve via the plurality of electrode contacts according to instructions executed by a processor, wherein the instructions, when executed by the processor, cause the processor to:

assign each electrode contact of the plurality of electrode contacts to at least one functional group of a plurality of functional groups, each functional group of the plurality of functional groups being associated with a different movement of a tongue of the patient and including one or more electrode contacts of the plurality of electrode contacts; and

provide the stimulation sequentially by each functional group of the plurality of functional groups to cause movement of the tongue of the patient corresponding to the functional group providing the stimulation, the stimulation of each functional group including a ramp up time.

16. The system of claim 15 , wherein the plurality of electrode contacts are configured to be arranged on the hypoglossal nerve such that the stimulation provided by each functional group is configured to stimulate at least one different nerve fiber in the hypoglossal nerve, and the at least one different nerve fiber stimulated by each functional group is associated with at least one different muscle configured to produce the different movement of the tongue.

17. The system of claim 15 , wherein providing the stimulation sequentially by each functional group is configured to allow for the tongue of the patient to be continuously maintained in a desired position while reducing an occurrence of fatigue in muscles associated with each of the different movements of the tongue associated with each functional group.

18. The system of claim 15 , wherein the stimulation provided by each functional group includes a duty cycle having a group on time and a group gap time, the group on time being a time period in which the stimulation is applied by a corresponding functional group and the group gap time being a time period in which the stimulation is not applied by the corresponding functional group.

19. The system of claim 18 , wherein the group gap time of the stimulation provided by each functional group is configured to prevent or reduce fatigue in at least one muscle associated with the different movement associated with the corresponding functional group by allowing for the at least one muscle to rest and recover from the stimulation.

20. The system of claim 18 , wherein the ramp up time of a first functional group of the plurality functional groups overlaps with the group on time of a second functional group of the plurality of functional groups, such that the instructions, when executed by the processor, further allow the IPG to simultaneously provide the stimulation to at least two functional groups.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2021
From: ACF FINCO I LP
To: IMTHERA MEDICAL, INC.
Reel/Frame 057535/0850 →
SECURITY INTEREST Recorded Aug 16, 2021
From: IMTHERA MEDICAL, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 057188/0115 →
RELEASE OF SECURITY INTEREST Recorded Aug 16, 2021
From: ARES CAPITAL CORPORATION, AS AGENT FOR THE LENDERS
To: IMTHERA MEDICAL, INC.
Reel/Frame 057188/0573 →
PATENT SECURITY AGREEMENT Recorded Dec 30, 2020
From: IMTHERA MEDICAL, INC.
To: ACF FINCO I LP, AS COLLATERAL AGENT
Reel/Frame 054881/0683 →
PATENT SECURITY AGREEMENT Recorded Jun 17, 2020
From: IMTHERA MEDICAL, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 052963/0651 →
Continuity (4)
Continuation 15492079 · Apr 20, 2017
Continuation 14898956
Provisional Application 62027363 · Jul 22, 2014
Related Publication 20200330032A1 · Oct 22, 2020