# US 12,214,136 B2 · Adjustable headgear tubing for a patient interface

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- Number: US 12,214,136 B2
- Document ID: US12214136B2
- Status: Granted
- Kind: B2
- Application number: 18/166,017
- Filed: 2023-02-08
- Published: 2023-08-03
- Granted: 2025-02-04
- Earliest claimed: 2019-11-29
- Assignees: ResMed Pty Ltd
- Applicants: Resmed Pty Ltd
- Inventors: Stewart Joseph Wagner; Aaron Samuel Davidson; Gerard Michael Rummery; Adam Francis Barlow; Hugh Francis Stewart Thomas; Justin John Formica; Mira Aswani
- Web page: https://patentgrep.com/patent/US12214136B2

## CPC

- A61M 16/0666: {Nasal cannulas or tubing (devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02)}
- A61M 16/0683: {Holding devices therefor}
- A61M 16/024: {including calculation means, e.g. using a processor}
- A61M 16/0605: {Means for improving the adaptation of the mask to the patient}
- A61M 16/0622: {having an underlying cushion}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0875: {Connecting tubes}
- A61M 16/0066: {Blowers or centrifugal pumps}
- A61M 16/0833: {T- or Y-type connectors, e.g. Y-piece}
- A61M 16/107: {in the inspiratory path}
- A61M 16/109: {the humidifying liquid or the beneficial agent}
- A61M 16/1095: {in the connecting tubes}
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 16/202: {electrically actuated}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/3653: by Joule effect, i.e. electric resistance
- A61M 2205/42: Reducing noise
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- A61M 2205/584: having a color code
- 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

Aspects of the present technology comprise a positioning and stabilising structure to hold a seal-forming structure in a therapeutically effective position on a head of a patient. The seal-forming structure may be constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use. The positioning and stabilising structure may comprise a front hoop arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head and a rear strap. The positioning and stabilising structure may comprise an adjustment mechanism for adjustment of the front hoop and the rear strap relative to the patient's head, the adjustment mechanism being arranged in a single operation to adjust both the front hoop and rear strap to enable the positioning and stabilising structure to fit different size heads.

## Claims

### Claim 1

A positioning and stabilising structure to hold a seal-forming structure in a therapeutically effective position on a head of a patient, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising:
a front hoop extending, in use, across the patient's cheek regions and arranged to contact, in use, regions of the patient's head superior to an otobasion superior of the patient's head, the front hoop comprising:
lower portions of two gas delivery tubes fluidly connected to the seal-forming structure, each lower portion of the gas delivery tube extending, in use, across one of the patient's cheek regions, the two gas delivery tubes being on different sides of the patient's head, and
a link connecting the two gas delivery tubes between the lower portions and upper portions of the two gas delivery tubes; and
a rear strap configured, in use, to pass around the back of the patient's head;
a de-coupling mechanism configured to decouple positional adjustment of the upper portions of the gas delivery tubes from movement of the seal-forming structure away from the patient's face in use to enable positional adjustment of the upper portions of the gas delivery tubes on the patient's head; and
an adjustment mechanism configured to adjust the front hoop and the rear strap relative to the patient's head, the adjustment mechanism being arranged in a single operation to adjust both the front hoop and the rear strap to enable the positioning and stabilising structure to fit different size heads.

### Claim 2 (depends on 1)

The positioning and stabilising structure as claimed in claim 1, wherein the de-coupling mechanism comprises:
the upper portions being bendable and including corrugations and/or concertinas on the upper portions to enable positional adjustment of the upper portions of the two gas delivery tubes on the patient's head in use; and
at least one swivel including a connection port configured to connect to an air circuit, the at least one swivel configured to allow relative rotation between the upper portions and the air circuit.

### Claim 3 (depends on 2)

The positioning and stabilising structure as claimed in claim 2, wherein the upper portions are positioned superior to an otobasion superior of the patient's head, in use.

### Claim 4 (depends on 3)

The positioning and stabilising structure as claimed in claim 3, wherein the at least one swivel rotates about a swivel axis, the swivel axis oriented substantially parallel to an axis along the upper portions.

### Claim 5 (depends on 2)

The positioning and stabilising structure as claimed in claim 2, wherein the at least one swivel includes a first swivel and a second swivel configured to rotate relative to the first swivel.

### Claim 6 (depends on 5)

The positioning and stabilising structure as claimed in claim 5, wherein the first swivel rotates about a first axis, and the second swivel rotates about a second axis perpendicular to the first axis.

### Claim 7 (depends on 5)

The positioning and stabilising structure as claimed in claim 5, wherein the first swivel is rotatable independently of the second swivel.

### Claim 8 (depends on 5)

The positioning and stabilising structure as claimed in claim 5, wherein the decoupling mechanism further comprises a tube connector coupled to the two gas delivery tubes, which diverge from the tube connector.

### Claim 9 (depends on 8)

The positioning and stabilising structure as claimed in claim 8, wherein the first swivel is connected directly to the tube connector.

### Claim 10 (depends on 8)

The positioning and stabilising structure as claimed in claim 8, wherein the tube connector is non-rotatable relative to the two gas delivery tubes, and wherein the first swivel is rotatable relative to the tube connector.

### Claim 11 (depends on 1)

The positioning and stabilising structure as claimed in claim 1, wherein the de-coupling mechanism is Y-shaped or V-shaped.

### Claim 12 (depends on 1)

The positioning and stabilising structure as claimed in claim 1, wherein the adjustment mechanism is operable to adjust a length of a link member between the lower portions, wherein adjustment of the length adjusts both the front hoop and the rear straps simultaneously.

### Claim 13

A positioning and stabilising structure to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 4 cmH2O with respect to ambient air pressure throughout the patient's respiratory cycle in use, the positioning and stabilising structure comprising:
at least one hoop extending, in use, across the patient's cheek regions and arranged to contact, in use, regions of the patient's head superior to an otobasion superior of the patient's head, wherein the at least one hoop comprises:
at least one gas delivery tube to deliver the flow of air to the entrance of a patient's airways via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to overlie, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head; and
an adjustment mechanism configured to adjust the at least one hoop to enable the positioning and stabilising structure to fit different size heads, the adjustment mechanism comprises one or more inflatable portions; and
a controller and at least one sensor in communication with the controller, the at least one sensor being configured to generate a signal based on whether the patient is experiencing sleep apnea, the controller configured to regulate a volume of air within the one or more inflatable portions based on the signal from the one or more sensors indicating the patient is experiencing apnea.

### Claim 14 (depends on 13)

The positioning and stabilising structure according to claim 13, wherein at least one inflatable portion of the one or more inflatable portions forms a patient contacting portion of the hoop and is configured to adjust the position of the at least one gas delivery tube on the patient's head.

### Claim 15 (depends on 13)

The positioning and stabilising structure according to claim 13, wherein the one or more inflatable portions adjusts an effective length of the hoop.

### Claim 16 (depends on 15)

The positioning and stabilising structure according to claim 15, wherein the at least one inflatable portion is movable between a deflated state and an inflated state, and wherein the deflated state forms a larger effective length than the inflated state.

### Claim 17 (depends on 13)

The positioning and stabilising structure according to claim 13, further comprising a retainer disposed in a side of the at least one gas delivery tube for retaining the one or more inflatable portions relative to the at least one gas delivery tube.

### Claim 18 (depends on 17)

The positioning and stabilising structure according to claim 17, wherein the retainer is in the form of one or more fasteners fixed to the at least one gas delivery tube.

### Claim 19 (depends on 18)

The positioning and stabilising structure according to claim 18, wherein the retainer is in the form of a loop that surrounds the at least one gas delivery tube.

### Claim 20 (depends on 17)

The positioning and stabilising structure according to claim 17, wherein the retainer is disposed on an inferior side of the at least one gas delivery tube and a complimentary retainer is disposed on a superior surface of the one or more inflatable portions.

### Claim 21 (depends on 13)

The positioning and stabilising structure according to claim 13, wherein the one or more inflatable portions are fixed to the at least one gas delivery tube.

### Claim 22 (depends on 14)

The positioning and stabilising structure according to claim 14, wherein the one or more sensors comprises a pressure sensor, a light sensor, and/or a position sensor, and the one or more sensors is configured to determine an inflation state of the one or more inflatable portions.

### Claim 23 (depends on 14)

The positioning and stabilising structure according to claim 14, further comprising a valve configured to selectively provide airflow into the one or more inflatable portions.

### Claim 24 (depends on 23)

The positioning and stabilising structure according to claim 23, wherein the controller is configured to control a position of the valve.

### Claim 25 (depends on 23)

The positioning and stabilising structure according to claim 23, wherein a position of the valve is manually controllable.