IP Library Granted Patent US 9,656,083
Granted Patent B2
US 9,656,083 · App. 14/898,956 · Granted May 23, 2017

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.
A61N1/36139A61B5/4836A61N1/0556A61N1/36A61N1/3611A61B5/021A61B5/026A61B5/02405A61B5/04A61B5/087A61B5/14542A61B5/4047A61B5/4818
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Quick Facts
Patent No.
US 9,656,083
App. No.
14/898,956
Granted
May 23, 2017
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 (37)

1. A method for titrating a stimulation parameter for one or more electrode contacts in a system for stimulating a hypoglossal nerve of a patient, the method comprising:

activating one of the one or more electrode contacts to stimulate the hypoglossal nerve of the patient;

obtaining a first physiological measurement from the patient;

comparing the first physiological measurement to a first predetermined target value;

adjusting a stimulation parameter for the one of the one or more electrode contacts if the first physiological measurement differs from the first predetermined target value, constituting an adjustment step;

wirelessly transmitting information to a display and/or recording device regarding which of the one or more electrode contacts is activated,

wherein the information includes an identity of the activated electrode contact and an amplitude of the activated electrode contact;

generating a number of pulses corresponding to the identity of the activated electrode contact;

generating a number of pulses corresponding to an amplitude scale of the amplitude; and

generating a voltage level corresponding to the amplitude within the amplitude scale.

2. The method of claim 1 further comprising:

repeating the method until the first physiological measurement reaches the first predetermined target value or until the stimulation parameter reaches a pre-set limit.

3. The method of claim 2 , wherein the stimulation parameter is changed incrementally during the adjustment step.

4. The method of claim 3 , wherein the stimulation parameter is changed by a percentage of an existing value of the stimulation parameter during the adjustment step.

5. The method of claim 1 further comprising:

obtaining a second physiological measurement from the patient, comparing the second physiological measurement to a second predetermined target value, and adjusting a second stimulation parameter for the one of the one or more electrode contacts if the second physiological measurement differs from the second predetermined target value.

6. The method of claim 5 , wherein the first and second physiological measurements are selected from the group consisting of nasal airflow, oral airflow, tidal volume, blood oxygen saturation level, blood pressure, peripheral arterial tone, pulse transit time, electroencephalography, electromyography, electrooculography, and combinations and/or derivatives thereof.

7. The method of claim 1 , wherein the method is performed while the patient is asleep.

8. The method of claim 7 , wherein adjustment of the stimulation parameter is paused while an arousal of the patient is detected, a worsening or altered condition of the first physiological measurement is detected, or a predetermined condition of the patient is detected.

9. The method of claim 1 , wherein the system is configured for preventing obstructive sleep apnea in the patient.

10. The method of claim 9 , wherein the first predetermined target value is a value of a person who does not have obstructive sleep apnea.

11. The method of claim 1 , wherein the stimulation parameter is selected from the group consisting of stimulation amplitude, stimulation phase duration, stimulation frequency, contact group assignment, group or contact enablement, group ramp up time, group on time, group ramp down time, group gap time, group population percentage, inter- and intra-therapeutic periodicity, and combinations thereof.

12. The method of claim 1 , wherein the first physiological measurement is selected from the group consisting of nasal airflow, oral airflow, tidal volume, blood oxygen saturation level, blood pressure, peripheral arterial tone, pulse transit time, electroencephalography, electromyography, electrooculography, and combinations and/or derivatives thereof.

13. The method of claim 1 further comprising:

repeating the method for each of the one or more electrode contacts or groups in the system.

14. The method of claim 1 , wherein the one or more electrode contacts includes a plurality of electrode contacts, each electrode contact being connected to an independent current source.

15. The method of claim 1 , wherein the system for stimulating a hypoglossal nerve of a patient includes six electrode contacts arranged on a cuff electrode and is configured for controlling a position of the patient's tongue.

16. The method of claim 1 further comprising:

obtaining a second physiological measurement from the patient;

comparing the second physiological measurement to a second predetermined target value;

adjusting a stimulation parameter for the one of the one or more electrode contacts if the second physiological measurement differs from the second predetermined target value; and

repeating the method until the first physiological measurement reaches the first predetermined target value and/or the second physiological measurement reaches the second predetermined target value, or until the stimulation parameter reaches a pre-set limit.

17. The method of claim 16 , wherein the first and second physiological measurements are selected from the group consisting of nasal airflow, oral airflow, tidal volume, blood oxygen saturation level, blood pressure, peripheral arterial tone, pulse transit time, electroencephalography, electromyography, electrooculography, and combinations and/or derivatives thereof.

18. The method of claim 17 , wherein the stimulation parameter is selected from the group consisting of stimulation amplitude, stimulation phase duration, stimulation frequency, contact group assignment, group or contact enablement, group ramp up time, group on time, group ramp down time, group gap time, group population percentage, inter- and intra-therapeutic periodicity, and combinations thereof.

19. The method of claim 16 further comprising:

repeating the method for each of the one or more electrode contacts or groups in the system.

20. The method of claim 16 , wherein the system for stimulating a hypoglossal nerve of a patient includes six electrode contacts arranged on a cuff electrode and is configured for controlling a position of the patient's tongue.

Assignments (6)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2015
From: MEADOWS, PAUL M.; LIMA, MARCELO G; ZAIDI, FAISAL N.; BENKE, JASPER
To: IMTHERA MEDICAL, INC.
Reel/Frame 037308/0719 →
Continuity (2)
Provisional Application 62027363 · Jul 22, 2014
Related Publication 20160199651A1 · Jul 14, 2016