# US 10,307,556 B2 · Patient interface devices with adhesive attachnment

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- Number: US 10,307,556 B2
- Document ID: US10307556B2
- Status: Granted
- Kind: B2
- Application number: 14/897,062
- Filed: 2014-06-10
- Published: 2016-04-28
- Granted: 2019-06-04
- Earliest claimed: 2013-06-13
- Assignees: Koninklijke Philips N.V.
- Applicants: Koninklijke Philips N.V.
- Inventors: Antonio Bugamelli; Jerome Matula, Jr.; Lutz Christian Gerhardt; Steven Ernest Franklin; Harmina Christina Zeijlstra; Lance Ranard Busch
- Web page: https://patentgrep.com/patent/US10307556B2

## CPC

- A61M 16/0688: {by means of an adhesive}
- A61M 16/0622: {having an underlying cushion}
- 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 16/0633: {with forehead support}
- 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

Patient interface devices (8) structured to deliver a flow of breathing gas to an airway of a patient include a member (16) structured to contact and adhere to a face of the patient responsive to the patient interface being donned by the patient, the member having a contact surface and an adhesive layer (34) provided on the contact surface.

## Claims

### Claim 1

A patient interface device structured to deliver a flow of breathing gas to an airway of a patient, comprising:
a member structured to contact and adhere to a face of the patient responsive to the patient interface device being donned by the patient, the member having a contact surface including a base region, an apex region located opposite the base region, a first side region, and a second side region located opposite the first side region, the member having an adhesive layer provided on the contact surface, wherein the adhesive layer has a pull-off strength limit value throughout the adhesive layer that is ≤40 kPa and an adhesive shear strength limit value throughout the adhesive layer that is ≤27 kPa, wherein a first thickness of the adhesive layer in the base region is ≥0.1 mm and ≤0.5 mm and wherein a second thickness of the adhesive layer in each of the apex region, the first side region and the second side region is ≥0.5 mm and ≤1.0 mm.

### Claim 2 (depends on 1)

The patient interface device according to claim 1, wherein the adhesive layer has an area (mm2) to adhesive shear strength (kPa) ratio of about 140 mm2/kPa to about 270 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 60 mm2/kPa to about 105 mm2/kPa.

### Claim 3 (depends on 1)

The patient interface device according to claim 1, wherein the member is a nasal mask portion structured to sealingly cover a nose of the patient, the patient interface device further comprising a hollow delivery tube portion fluidly connected to and extending from a top of the nasal mask portion, and a forehead support portion coupled to a distal end of the delivery tube portion, wherein a second adhesive layer is provided on a rear surface of the forehead support portion, wherein the second adhesive layer has a pull-off strength limit value throughout the second adhesive layer that is ≤40 kPa and an adhesive shear strength limit value throughout the second adhesive layer that is that is ≤27 kPa.

### Claim 4 (depends on 3)

The patient interface device according to claim 3, wherein the adhesive layer has an area (mm2) to adhesive shear strength (kPa) ratio of about 110 mm2/kPa to about 200 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 45 mm2/kPa to about 80 mm2/kPa, and wherein the second adhesive layer has an area (mm2) to adhesive shear strength (kPa) ratio of about 100 mm2/kPa to about 185 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 40 mm2/kPa to about 75 mm2/kPa.

### Claim 5 (depends on 1)

The patient interface device according to claim 1, wherein the member is a nasal cushion structured to contact a nose of the patient and deliver the flow of breathing gas to the nose, wherein the patient interface device further comprises a nasal sealing cover coupled to the nasal cushion, the nasal sealing cover surrounding and enveloping a portion of the nasal cushion contacting the nose.

### Claim 6 (depends on 5)

The patient interface device according to claim 5, wherein the adhesive layer has an area (mm2) to adhesive shear strength (kPa) ratio of about 140 mm2/kPa to about 270 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 60 mm2/kPa to about 105 mm2/kPa.

### Claim 7 (depends on 5)

The patient interface device according to claim 5, wherein the nasal cushion is a pillows style nasal cushion having a plurality of nasal prongs, wherein the nasal sealing cover surrounds and envelops the nasal prongs.

### Claim 8 (depends on 5)

The patient interface device according to claim 5, further comprising a nasal shell member structured to match a shape of and overlay and receive therein the nasal sealing cover, the nasal shell member having one or more attachment members structured to receive a strap member of a headgear component.

### Claim 9 (depends on 5)

The patient interface device according to claim 5, further comprising a delivery conduit member fluidly coupled to the nasal cushion, the delivery conduit member having a U-shaped bend portion structured to fit over and behind an ear of the patient responsive to the patient interface device being donned by the patient.

### Claim 10 (depends on 1)

The patient interface device according to claim 1, wherein the member is a mask having a cushion, the contact surface being part of the cushion, wherein the adhesive layer comprises a first adhesive portion provided in the base region, a second adhesive portion provided in the first side region, a third adhesive portion provided in the second side region, and a fourth adhesive portion (164A, 164B) provided in the apex region, wherein the first adhesive portion has an area (mm2) to adhesive shear strength (kPa) ratio of about 10 mm2/kPa to about 25 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 4 mm2/kPa to about 12 mm2/kPa, wherein the second and third adhesive portions each have an area (mm2) to adhesive shear strength (kPa) ratio of about 5 mm2/kPa to about 15 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 2 mm2/kPa to about 7 mm2/kPa, and wherein the fourth adhesive portion has an area (mm2) to adhesive shear strength (kPa) ratio of about 5 mm2/kPa to about 13 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 2 mm2/kPa to about 6 mm2/kPa.

### Claim 11 (depends on 1)

The patient interface device according to claim 1, wherein the member is a mask having a cushion, the contact surface being part of the cushion, wherein the adhesive layer comprises a first and second adhesive portions provided on opposite sides of the base region at points that are immediately adjacent to the first side region and the second side region, respectively, and a third adhesive portion provided on the apex region spanning from one side to the other of the apex region through a middle of the apex region.

### Claim 12 (depends on 1)

The patient interface device according to claim 1, wherein the member is a mask having a cushion, the contact surface being part of the cushion, wherein the adhesive layer comprises a first and second adhesive portions provided on opposite sides of the base region at points that are immediately adjacent to the first side region and the second side region, respectively, and third and fourth adhesive portions are provided on the first side region and the second side region, respectively, immediately adjacent to the apex region.

### Claim 13 (depends on 1)

The patient interface device according to claim 1, wherein the adhesive layer is provided in a regular pattern selected from a group consisting of a plurality of rounded and spaced dots, a checkerboard pattern of generally parallel strips, and a plurality of strips provided in an overlapping mesh/grid pattern.

### Claim 14 (depends on 1)

The patient interface device according to claim 1, wherein the member comprises a stacked structure having a silicone base with a hydrophilic silicone layer provided on the silicone base, wherein the adhesive layer is provided on the hydrophilic silicone layer.

### Claim 15 (depends on 1)

The patient interface device according to claim 1, wherein the adhesive layer has a peel adhesion value throughout the adhesive layer of 0.15-0.2 N mm−1.

### Claim 16

A patient interface device structured to deliver a flow of breathing gas to an airway of a patient, comprising:
a nasal cushion structured to contact a nose of the patient and deliver the flow of breathing gas to the nose;
an attachment member coupled to and surrounding at least a portion of the nasal cushion, the attachment member being structured to contact and adhere to a face of the patient responsive to the patient interface device being donned by the patient, the attachment member having a contact surface and an adhesive layer provided on the contact surface, wherein the adhesive layer has a pull-off strength limit value throughout the adhesive layer that is ≤40 kPa and an adhesive shear strength limit value throughout the adhesive layer that is ≤27 kPa, wherein a first thickness of the adhesive layer in a first region thereof is ≥0.1 mm and ≤0.5 mm and wherein a second thickness of the adhesive layer in a second region thereof is ≥0.5 mm and ≤1.0 mm.

### Claim 17 (depends on 16)

The patient interface device according to claim 16, wherein the nasal cushion is a pillows style nasal cushion having a plurality of nasal prongs, wherein the attachment member is a nasal sealing cover that surrounds and envelops the nasal prongs.

### Claim 18 (depends on 16)

The patient interface device according to claim 16, wherein the attachment member has a central body, a first arm member extending from a first side of the central body and a second arm member extending from a second side of the central body, the first arm member having a first cheek attachment portion at a distal end thereof, the second arm member having a second cheek attachment portion at a distal end thereof, wherein the adhesive layer comprises a first adhesive portion provided on a rear of the first cheek attachment portion, and a second adhesive portion provided on a rear of the second cheek attachment portion, wherein the attachment member further includes a nasal attachment member that extends from a top portion of the central body that together with the central body defines a nasal orifice, wherein the adhesive layer comprises a third adhesive portion provided on a rear of the nasal attachment member.

### Claim 19 (depends on 18)

The patient interface device according to claim 18, wherein the first region includes the third adhesive portion and the second region includes the first and second adhesive portions.

### Claim 20 (depends on 19)

The patient interface device according to claim 19, wherein the first and second adhesive portions each have an area (mm2) to adhesive shear strength (kPa) ratio of about 100 mm2/kPa to about 180 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 40 mm2/kPa to about 72 mm2/kPa, and wherein the third adhesive portion has an area (mm2) to adhesive shear strength (kPa) ratio of about 32 mm2/kPa to about 68 mm2/kPa and an area (mm2) to pull-off strength (kPa) ratio of about 10 mm2/kPa to about 30 mm2/kPa.
