System and method for treating obstructive sleep apnea

Patent metadata

Field	Value
Publication number	US-10029098-B2
Application number	US-201615341039-A
Country	US
Kind code	B2
Filing date	Nov 2, 2016
Priority date	Nov 19, 2013
Publication date	Jul 24, 2018
Grant date	Jul 24, 2018

Abstract

One aspect of the present disclosure relates to a system for treating obstructive sleep apnea in a subject. The system can include a power source and a neuromuscular stimulator in electrical communications with the power source. The neuromuscular stimulator can include a controller and at least one electrode. The controller can be configured to receive certain power and stimulation parameters associated with a therapy signal from the power source. The at least one electrode can be configured to deliver the therapy signal to a target tissue associated with control of a posterior base of the tongue of the subject.

First claim

The following is claimed:

1. A method for treating obstructive sleep apnea (OSA) in a subject, the method comprising the steps of:
obtaining a closed-loop system that includes a power source, a neuromuscular stimulator, and a sensing component, the neuromuscular stimulator being in electrical communication with the power source and including a controller and at least one electrode, the controller contained within a housing and being configured to receive certain power and stimulation parameters associated with a therapy signal from the power source, the sensing component being configured to detect at least one physiological parameter or a related symptom associated with OSA;
implanting the neuromuscular stimulator in the subject so that the at least one electrode is in electrical communication with tissue associated with one or more muscles of an anterior lingual musculature of the subject;
placing the sensing component on or in the subject;
securing implanting the housing in a mandible of the subject;
obtaining a sensor signal, by the sensing component, based on the detected at least one physiological parameter or the related symptom associated with OSA; and
activating, by the controller, the neuromuscular stimulator to adjust application of the therapy signal to the tissue in response to the sensor signal to treat the OSA.

2. The method of claim 1 , wherein the activating step causes a posterior base of a tongue of the subject to be displaced in an anterior direction or change a surface morphology of the posterior base of the tongue to allow and increase oropharyngeal airway volume.

3. The method of claim 1 , wherein the neuromuscular stimulator comprises a lead, which has the at least one electrode and the sensing component disposed thereon.

4. The method of claim 1 , wherein the neurostimulator comprises
a first lead having at least one first electrode disposed thereon; and
a second lead having at least one second electrode disposed thereon.

5. The method of claim 1 , wherein the at least one physiological parameter is muscle activity of the one or more muscles of the anterior lingual musculature, nerve electrical activity of the one or more muscles of the anterior lingual musculature, tongue position, or oropharyngeal airflow.

6. The method of claim 1 , wherein the related symptom associated with OSA is apnea, hypopnea, a continuous reduction in ventilation, a sustained reduction in ventilation, excessive daytime sleepiness, a neurocognitive defect, or depression.

7. The method of claim 1 , wherein the neuromuscular stimulator comprises a first electrical lead connected to the housing and the at least one electrode is connected to the first electrical lead.

8. The method of claim 7 , wherein, prior to securing implanting the housing:
a first hole is drilled through the mandible; and
the first electrical lead is inserted through the first hole so that the at least one electrode extends through the first hole and is in electrical communication with the tissue associated with the one or more muscles of the anterior lingual musculature.

9. The method of claim 1 , wherein the neuromuscular stimulator comprises first and second electrical leads and the at least one electrode comprises a first electrode connected to the first electrical lead and a second electrode connected to the second electrical lead.

10. The method of claim 9 , wherein:
first and second holes are drilled through the mandible, the first and second holes being located on either side of a midline of the subject; and
the first electrical lead and the second electrical lead are inserted through the first and the second holes, respectively, so that the first electrode of the first lead is in electrical communication with a first portion of the tissue and the second electrode of the second electrical lead is in electrical communication with a second portion of the tissue.

11. The method of claim 1 , wherein the sensing component is an EMG sensor and the at least one physiological parameter is a muscle activity of the tongue, whereby a decrease in sensed muscle activity of the tongue generates the sensor signal.

12. A method for treating disordered breathing that occurs during sleep in a subject comprising:
obtaining a closed-loop system comprising a sensing component and a neurostimulator having at least one electrode disposed thereon;
implanting at least a portion of the neurostimulator in the subject's mandible;
placing the sensing component on or in the subject;
positioning the neurostimulator so that the electrode is in electrical communication with tissue associated with one or more muscles of an anterior lingual musculature or a nerve that innervates the anterior lingual musculature;
obtaining a sensor signal, by the sensing component, based on a detected at least one physiological parameter or a related symptom associated with the disordered breathing; and
activating the neurostimulator to deliver an electrical signal to the tissue in response to the sensor signal to open an oropharyngeal airway.

13. The method of claim 12 , wherein the neurostimulator comprises at least one lead, wherein the at least one electrode and the sensing component are both located on the at least one lead.

Assignees

• Cleveland Clinic Found

Inventors

• Papay Frank A

Classifications

• A61N1/36135

  using physiological parameters · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/3611 Primary

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title

• A61F2002/2807

  Chin implants · CPC title

• A61F2/2803

  for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071) · CPC title