# US 10,864,375 B2 · Devices and methods for sleep apnea treatment

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- Number: US 10,864,375 B2
- Document ID: US10864375B2
- Status: Granted
- Kind: B2
- Application number: 16/102,471
- Filed: 2018-08-13
- Published: 2018-12-06
- Granted: 2020-12-15
- Earliest claimed: 2011-10-03
- Assignees: LivaNova USA, Inc.
- Applicants: LivaNova USA, Inc.
- Inventors: Stephen Bolea; Wondimeneh Tesfayesus; John Beck; Thomas Hoegh; Robert Atkinson; Sidney Hauschild
- Web page: https://patentgrep.com/patent/US10864375B2

## CPC

- A61N 1/3611: {Respiration control (stimulating respiratory organs A61N1/3601)}
- A61F 5/566: {Intra-oral devices}
- A61N 1/3601: {of respiratory organs}
- A61B 2017/248: {Operations for treatment of snoring, e.g. uvulopalatoplasty}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices and methods for improving the coupling between the soft palate and the genioglossus. This may be accomplished, for example, but shortening or stiffening the palatoglossal arch. Improved coupling between the soft palate and the genioglossus may be beneficial to a patient suffering from obstructive sleep apnea (OSA) as a stand-alone procedure, or in combination procedures and devices that cause anterior displacement of the tongue such as hypoglossal nerve stimulation, genioglossus advancement surgery, mandibular advancement surgery, mandibular advancement (oral) appliances, etc.

## Claims

### Claim 1

A method of treating an upper airway tissue collapse condition of a patient, comprising:
implanting at least one tissue engagement member in the patient's upper airway to tighten the patient's upper airway tissue from a first condition of the patient's upper airway tissue to a second condition of the patient's upper airway tissue that has a greater stiffness than the first condition, the patient's upper airway tissue in the second condition conveying anterior movement of the patient's tongue to maintain a patency of the patient's upper airway, wherein the at least one tissue engagement member extends between the patient's genioglossus muscle and a portion of the patient's upper airway tissue; and
disposing a stimulation device configured for delivering an electrical stimulation to a nerve innervating a tongue protrusion muscle of the patient to cause anterior movement of the patient's tongue,
wherein the electrical stimulation improves an efficacy of the at least one tissue engagement member.

### Claim 2 (depends on 1)

The method of claim 1, wherein tightening the patient's upper airway tissue includes tightening the patient's pharyngeal tissue.

### Claim 3 (depends on 2)

The method of claim 2, wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatoglossus.

### Claim 4 (depends on 2)

The method of claim 2, wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatopharyngeus.

### Claim 5 (depends on 2)

The method of claim 2, wherein tightening the patient's pharyngeal tissue includes shortening the patient's pharyngoepiglottic fold.

### Claim 6 (depends on 1)

The method of claim 1, wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the delivering of the electrical stimulation mitigates the obstructive sleep apnea condition.

### Claim 7 (depends on 1)

The method of claim 1, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and
wherein the delivering of the electrical stimulation corresponds to a mitigation of the first tissue collapse at the first location, and wherein the tightening of the patient's upper airway tissue corresponds to a mitigation of the second tissue collapse at the second location.

### Claim 8 (depends on 1)

The method of claim 1, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and
wherein the delivering of the electrical stimulation corresponds to a mitigation of the first tissue collapse at the first location, and wherein an upper airway movement due to the electrical stimulation and the tightening of the patient's upper airway tissue corresponds to a mitigation of both the first tissue collapse and the second tissue collapse.

### Claim 9 (depends on 1)

The method of claim 1, wherein the stimulation device is further configured to modify the electrical stimulation signal in response to receiving a signal from an external therapy controller.

### Claim 10 (depends on 1)

The method of claim 1, further comprising implanting a sensing lead in the patient, wherein the stimulation device is further configured to sense inspirations of the patient via the sensing lead and deliver the electrical stimulation synchronized with the sensed inspirations of the patient.

### Claim 11

A system for treating an upper airway condition of a patient, the system comprising:
at least one tissue engagement member configured for implantation in the patient's upper airway to tighten the patient's upper airway tissue from a first condition of the patient's upper airway tissue to a second condition of the patient's upper airway tissue that has a greater stiffness than the first condition, the patient's upper airway tissue in the second condition conveying anterior movement of the patient's tongue to maintain a patency of the patient's upper airway, wherein the at least one tissue engagement member extends between the patient's genioglossus muscle and a portion of the patient's upper airway tissue; and
a stimulation device configured for delivering an electrical stimulation to a nerve innervating a tongue protrusion muscle of the patient to cause anterior movement of the patient's tongue;
wherein the electrical stimulation is configured to improve an efficacy of the at least one tissue engagement member.

### Claim 12 (depends on 11)

The system of claim 11, wherein tightening the patient's upper airway tissue includes tightening the patient's pharyngeal tissue.

### Claim 13 (depends on 12)

The system of claim 12, wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatoglossus.

### Claim 14 (depends on 12)

The system of claim 12, wherein tightening the patient's pharyngeal tissue includes shortening the patient's palatopharyngeus.

### Claim 15 (depends on 12)

The system of claim 12, wherein tightening the patient's pharyngeal tissue includes shortening the patient's pharyngoepiglottic fold.

### Claim 16 (depends on 11)

The system of claim 11, wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the electrical stimulation is configured to mitigate the obstructive sleep apnea condition.

### Claim 17 (depends on 11)

The system of claim 11, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and
wherein the electrical stimulation is configured to mitigate the first tissue collapse at the first location and the tightening of the patient's upper airway tissue corresponds to a mitigation of the second tissue collapse at the second location.

### Claim 18 (depends on 11)

The system of claim 11, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient's upper airway and a second tissue collapse at a second location within the patient's upper airway; and
wherein the electrical stimulation is configured to mitigate the first tissue collapse at the first location, and wherein an upper airway movement due to the electrical stimulation and the tightening of the patient's upper airway tissue corresponds to a mitigation of both the first tissue collapse and the second tissue collapse.

### Claim 19 (depends on 11)

The system of claim 11, further comprising an external therapy controller, wherein the stimulation device is further configured to modify the electrical stimulation signal in response to receiving a signal from the external therapy controller.

### Claim 20 (depends on 11)

The system of claim 11, further comprising a sensing lead configured for implantation in the patient, wherein the stimulation device is further configured to sense inspirations of the patient via the sensing lead and deliver the electrical stimulation synchronized with the sensed inspirations of the patient.
