# US 2019/0167935 A1 · Deformable insert for low pressure patient interface

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- Number: US 2019/0167935 A1
- Document ID: US20190167935A1
- Status: Published application
- Kind: A1
- Application number: 16/267,286
- Filed: 2019-02-04
- Published: 2019-06-06
- Earliest claimed: 2012-08-03
- Assignees: Fisher & Paykel Healthcare Limited
- Applicants: Fisher & Paykel Healthcare Limited
- Inventors: Silas Sao Jin Siew; Andrew Paul Maxwell Salmon; Wen Dong Huang
- Web page: https://patentgrep.com/patent/US20190167935A1

## CPC

- A61M 16/0622: {having an underlying cushion}
- A61M 16/00: Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators (iron lungs A61H31/02); Tracheal tubes
- A61M 16/06: Respiratory or anaesthetic masks
- A61M 16/0616: {with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure}
- 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 16/0825: {with ball-sockets}
- A61M 16/0875: {Connecting tubes}
- A61M 16/0816: {Joints or connectors}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2209/088: on the body
- A61M 2210/0618: Nose
- 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 patient interface includes a frame, an inflatable seal, and a deformable insert. The frame includes an outer portion, an inner portion, and an opening extending therebetween. The inflatable seal is secured to the inner portion of the frame. The inflatable seal defines an internal volume and has at least one aperture. The deformable insert includes an outer surface, an inner surface and a passageway extending therebetween. The deformable insert is positioned within the internal volume of the seal and aligned with at least a portion of the frame inner portion. The passageway is aligned with the frame opening to define a gas flow path from the frame outer portion to the at least one aperture of the seal.

## Claims

### Claim at position 1

-28. (canceled)

### Claim 29

A patient interface comprising:
a frame comprising an outer portion, an inner portion, and an opening extending therebetween;
an inflatable seal secured to the inner portion of the frame, the inflatable seal defining an internal volume and having an aperture; and
a deformable insert comprising an outer surface, an inner surface and an insert opening providing a passageway through the deformable insert,
wherein the deformable insert is configured to be positioned within the internal volume of the inflatable seal such that the inner surface faces the frame, and the insert opening is aligned with the opening to provide a first gas flow path through the opening, the aperture and the insert opening, and
wherein a peripheral edge of the deformable insert is configured to fit within the internal volume of the seal to provide a second gas flow path from the opening around the peripheral edge of the deformable insert.

### Claim 30 (depends on 29)

The patient interface of claim 29, wherein the deformable insert is removably positioned within the internal volume of the inflatable seal.

### Claim 31 (depends on 29)

The patient interface of claim 29, wherein the deformable insert is positioned entirely within the internal volume of the inflatable seal.

### Claim 32 (depends on 29)

The patient interface of claim 29, wherein the entire deformable insert is deformable.

### Claim 33 (depends on 29)

The patient interface of claim 29, wherein the insert opening of the deformable insert is larger than the aperture of the inflatable seal.

### Claim 34 (depends on 29)

The patient interface of claim 29, wherein the deformable insert is sized to substantially extend from one lateral portion of the inflatable seal to an opposite lateral portion of the inflatable seal.

### Claim 35 (depends on 29)

The patient interface of claim 29, wherein the inflatable seal inflates under internal pressure from a pressurized gases supply and when pressed against the face of a user, creating a seal with the nose or face of the user.

### Claim 36 (depends on 29)

The patient interface of claim 29, wherein the deformable insert is configured to contact the frame and an inner surface of the inflatable seal to provide a cushion between a user's nose and the frame during use when the inflatable seal is inflated to a pressure below about 6 cm H2O.

### Claim 37 (depends on 36)

The patient interface of claim 36, wherein the cushion provided by the deformable insert is soft and comfortable.

### Claim 38 (depends on 29)

The patient interface of claim 29, wherein the deformable insert is made from a material selected from the group comprising: foam, gel, an inflatable cell, rubber, foamed rubber, plastic elastomer, silicone, and three-dimensional spacer fabric.

### Claim 39 (depends on 29)

The patient interface of claim 29, wherein the inflatable seal comprises a posterior face configured to contact the face of the patient and an anterior face opposite the posterior face, wherein the outer surface of the deformable insert is posterior to the anterior face of the inflatable seal.

### Claim 40 (depends on 29)

The patient interface of claim 29, wherein the inflatable seal has a patient-facing side and an outward-facing side opposite the patient-facing side, and wherein the aperture is positioned on the outward-facing side, and is configured to allow gas from a gases supply conduit to flow into the inflatable seal.

### Claim 41 (depends on 29)

The patient interface of claim 29, wherein the inflatable seal comprises a pair of protruding nostril locators protruding from the inflatable seal, each nasal locator including an outlet aperture.

### Claim 42 (depends on 29)

The patient interface of claim 29, wherein the frame comprises a protruding lip on the inner portion configured to engage with the inflatable seal.

### Claim 43 (depends on 29)

The patient interface of claim 29, wherein the deformable insert has a substantially rectangular or trapezoidal shape.

### Claim 44 (depends on 29)

The patient interface of claim 29, further comprising a strap secured to the frame, wherein the strap extends from one side portion of the frame to the other side portion of the frame.