# US 10,441,457 B2 · Devices, systems and methods for the treatment of sleep apnea

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- Number: US 10,441,457 B2
- Document ID: US10441457B2
- Status: Granted
- Kind: B2
- Application number: 14/818,914
- Filed: 2015-08-05
- Published: 2015-12-03
- Granted: 2019-10-15
- Earliest claimed: 2008-11-25
- Assignees: Lumen Devices, LLC
- Applicants: Lumen Devices LLC
- Inventors: Michael Friedman; John N. Irwin, III; William J. Gorman; John T. Garibotto; J. Christopher Flaherty
- Web page: https://patentgrep.com/patent/US10441457B2

## CPC

- A61F 5/566: {Intra-oral devices}
- A61B 1/00: Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes (examination of body cavities or body tracts using ultrasonic, sonic or infrasonic waves A61B8/12; endoscopic instruments for taking cell samples or for biopsy A61B10/04); Illuminating arrangements therefor (for the eyes A61B3/00)
- A61B 1/233: for the nose, i.e. nasoscopes {, e.g. testing of patency of Eustachian tubes}
- A61B 1/267: for the respiratory tract, e.g. laryngoscopes or bronchoscopes
- A61F 5/00: Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices (bandages, dressings or absorbent pads A61F13/00) {; Anti-rape devices}
- A61F 5/56: Devices for preventing snoring
- A61M 16/021: {operated by electrical means (A61M16/202 – A61M16/205 take precedence)}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61M 16/0461: {Nasoendotracheal tubes}
- A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections}
- A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters}
- A61M 16/0468: {with valves at the proximal end limiting exhalation, e.g. during speaking or coughing (air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203)}
- A61M 16/0488: {Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02)}
- A61M 16/0497: {Tube stabilizer}
- A61M 16/08: Bellows; Connecting tubes {(having means for taking samples G01N1/22); Water traps; Patient circuits}
- A61M 16/20: Valves specially adapted to medical respiratory devices
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A medical appliance for the treatment of one or more sleep disorders such as obstructive sleep apnea in a patient, the appliance comprising: a biasing member for inserting behind and exerting a force upon the patient's soft palate or tongue, wherein the biasing member is inserted in a reduced or minimized form and then expanded or firms once in place to exert the force. The appliance may be nasally inserted or be placed through the mouth. In a particular configuration, both the soft palate and tongue are biased to prevent obstruction of the flow of air in the nasopharyngeal airway.

## Claims

### Claim 1

A medical appliance for a patient comprising:
a nasal tube configured for insertion into a nasal passage of the patient;
a biasing member disposed about a distal portion of said nasal tube, wherein said biasing member is configured to receive a volume of fluid to expand said biasing member to exert a force upon a soft palate and/or base of a tongue of said patient, wherein the biasing member includes a multi-lobed balloon;
a membrane about the lobes of the multi-lobed balloon, wherein lumens between the lobes of the multi-lobed balloon and the membrane provide a passageway for a flow of air, and wherein the membrane is resiliently biased in a collapsed state, and wherein the membrane transitions to an expanded state when the biasing member receives the volume of fluid;
a valve positioned proximal to said biasing member; and
a tube lumen disposed between said valve and said biasing member,
wherein said valve being in fluid communication with said biasing member,
wherein said valve is positioned to receive the volume of fluid prior to said biasing member receiving the volume of fluid,
wherein said valve is capable of maintaining said biasing member in an expanded state,
wherein the membrane applies a compression force against the multi-lobed balloon,
wherein a flow of the volume of fluid expands the multi-lobed balloon by overcoming the compression force applied by the membrane, and
wherein the multi-lobed balloon is compressed by the applied compression force of the membrane when the valve is opened, removed, or deactivated.

### Claim 2 (depends on 1)

The appliance according to claim 1, further comprising a fill assembly connected to and in fluid communication with said valve.

### Claim 3 (depends on 2)

The appliance according to claim 2, wherein the fill assembly is removably attached to the valve.

### Claim 4 (depends on 2)

The appliance according to claim 2, wherein said fill assembly comprises a fluid selected from the group consisting of: a liquid and a gas.

### Claim 5 (depends on 1)

The appliance according to claim 1, wherein flow of fluid through said valve at least one of expands, contracts, or maintains a size of said biasing member.

### Claim 6 (depends on 1)

The appliance according to claim 1, wherein said valve is selected from the group consisting of: a duck-bill valve; a spring-activated valve; and a one-way fluid valve.

### Claim 7 (depends on 1)

The appliance according to claim 1, wherein said valve is configured to be opened to cause said biasing member to deflate.

### Claim 8 (depends on 1)

The appliance according to claim 1, further comprising a nose cone at a proximal end of said nasal tube.
