# US 11,896,515 B2 · Convex ostomy barrier

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- Number: US 11,896,515 B2
- Document ID: US11896515B2
- Status: Granted
- Kind: B2
- Application number: 16/341,227
- Filed: 2017-11-15
- Published: 2019-08-22
- Granted: 2024-02-13
- Earliest claimed: 2016-11-15
- Assignees: Hollister Incorporated
- Applicants: Hollister Incorporated
- Inventors: Gregory J. Czaplewski; Anthony Scalise; Tuan Tran; Peter L Visconti; Kenneth Nielsen; Jon Z. Lugenbill; Daniel A. March
- Web page: https://patentgrep.com/patent/US11896515B2

## CPC

- A61F 5/443: having {adhesive seals for securing to the body, e.g. of} hydrocolloid type seals, e.g. gels, starches or karaya gums
- A61F 5/4404: {Details or parts}
- A61F 5/445: Colostomy, {ileostomy or urethrostomy} devices (A61F5/441, A61F5/442, A61F5/443 take precedence)
- A61F 5/451: Genital {or anal} receptacles (A61F5/441, A61F5/442, A61F5/443 take precedence {; other body securing means A61F5/4408; devices for taking faeces samples A61B10/0038; devices for taking urine samples A61B10/007})
- 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)

## Abstract

A convex ostomy barrier includes a skin barrier, an inlet opening for receiving a stoma, and a convex insert. The convex insert includes an inner flange, an outer flange, and a middle portion arranged therebetween. The middle portion includes a pouch side surface for attaching a flange, a core-out portion configured to improve the flexibility of the convex insert, and a skin barrier support structure for supporting the skin barrier.

## Claims

### Claim 1

A convex ostomy barrier assembly for attaching an ostomy appliance to a peristomal skin surrounding a stoma, the convex ostomy barrier assembly comprising:
a skin barrier comprising an adhesive;
an inlet opening for receiving a stoma;
a convex insert arranged adjacent the skin barrier, the convex insert having a convex ring-shaped body and comprising:
an inner flange;
a middle portion including a pouch-side surface, a core-out portion, and a skin barrier support structure for supporting the skin barrier; and
an outer flange, wherein the inner flange and the outer flange are connected by the middle portion and arranged in different axial planes to define the convex ring-shaped body,
wherein the middle portion comprises a radial wall having the pouch-side surface radially and directly extending from the outer flange toward the inlet opening, and an axial wall extending axially from the radial wall in a body-side direction, wherein the inner flange extends from the axial wall toward the inlet opening, wherein the outer flange, the middle portion, and the inner flange provide a protrusion in the body-side direction, and wherein the pouch-side surface is defined on a pouch-side of the radial wall and located axially between the inner flange and an outer periphery of the outer flange; and
a flange including a body-side coupling ring attached to the pouch-side surface of the convex insert.

### Claim 2 (depends on 1)

The convex ostomy barrier assembly of claim 1, wherein the skin barrier support structure includes a plurality of support structures extending axially from a body-side of the radial wall; wherein the plurality of support structures form a split ring shape, wherein each of the plurality of support structures is surrounded by the core-out portion and includes a sloped body-side surface configured to support the skin barrier having a convex body-side surface.

### Claim 3 (depends on 1)

The convex ostomy barrier assembly of claim 1, wherein the core-out portion is defined by a plurality of core-out windows, and the skin barrier support structure includes a plurality of ribs, wherein the plurality of core-out windows and the plurality of ribs are arranged such that adjacent ribs are spaced apart from each other by a core-out window therebetween, and each of the core-out windows is defined by the radial wall, the axial wall, and the adjacent ribs.

### Claim 4 (depends on 3)

The convex ostomy barrier assembly of claim 3, wherein the convex insert includes about 8 ribs to about 30 ribs.

### Claim 5 (depends on 1)

The convex ostomy barrier assembly of claim 1, wherein the convex ostomy barrier assembly includes a tape, wherein the convex insert is attached to a pouch-side of the tape, and the skin barrier is attached to a body-side of the tape, wherein the outer flange has a concave body-side surface configured to conform to a curved contour of a lower base section of a convex portion of the convex ostomy barrier assembly.

### Claim 6 (depends on 5)

The convex ostomy barrier assembly of claim 5, wherein at least some portion of a body-side surface of the outer flange, the skin barrier support structure, or a body-side surface of the inner flange is attached to the tape.

### Claim 7 (depends on 6)

The convex ostomy barrier assembly of claim 6, wherein at least the body-side surface of the outer flange is heat sealed to the tape.

### Claim 8 (depends on 1)

The convex ostomy barrier assembly of claim 1, wherein the pouch-side surface of the middle portion is a flat surface defined on the pouch-side of the radial wall, wherein the flange is attached to the convex insert via a flange film, and wherein the flange film is attached to the pouch side surface.

### Claim 9 (depends on 8)

The convex ostomy barrier assembly of claim 8, wherein the flange film is heat sealed to the pouch side surface.

### Claim 10

A convex insert for an ostomy barrier having a convex ring-shaped body and comprising:
an inlet opening;
an inner flange;
a middle portion including a pouch-side surface, a core-out portion, and a skin barrier support structure, wherein the core-out portion is configured to improve flexibility of the convex insert; and
an outer flange, wherein the inner flange and the outer flange are connected by the middle portion and arranged in different axial planes to define the convex ring-shaped body,
wherein the middle portion comprises a radial wall having the pouch-side surface radially and directly extending from the outer flange toward the inlet opening, and an axial wall extending axially from the radial wall in a body-side direction, wherein the inner flange extends from the axial wall toward the inlet opening, wherein the outer flange, the middle portion, and the inner flange provide a protrusion in the body-side direction, and wherein the pouch-side surface is defined on a pouch-side of the radial wall and located axially between the inner flange and an outer periphery of the outer flange.

### Claim 11 (depends on 10)

The convex insert of claim 10, wherein the skin barrier support structure includes a plurality of support structures extending axially from a body-side of the radial wall; wherein the plurality of support structures form a split ring shape, wherein each of the plurality of support structures is surrounded by the core-out portion and includes a sloped body-side surface.

### Claim 12 (depends on 10)

The convex insert of claim 10, wherein the core-out portion is defined by a plurality of core-out windows, and the skin barrier support structure includes a plurality of ribs, wherein the plurality of core-out windows and the plurality of ribs are arranged such that adjacent ribs are spaced apart from each other by a core-out window therebetween, and each of the core-out windows is defined by a radial wall, an axial wall, and the adjacent ribs.

### Claim 13 (depends on 10)

The convex insert of claim 10, wherein the skin barrier support structure includes a ring-shaped structure extending axially from a body-side of the radial wall, wherein the core-out portion is defined by two ring-shaped core-out portions, and wherein the skin barrier support structure is arranged between the two ring-shaped core-out portions and has a sloped body-side surface.

### Claim 14 (depends on 10)

The convex insert of claim 10, wherein the skin barrier support structure includes a plurality of rod-like structures extending axially from a body-side of the radial wall.

### Claim 15 (depends on 10)

The convex insert of claim 10, wherein the skin barrier support structure includes a plurality of tube-like structures extending axially from a body-side surface of the radial wall.

### Claim 16 (depends on 10)

The convex insert of claim 10, wherein the core-out portion is defined by a plurality of openings in the middle section, and the skin barrier support structure is defined by a body-side surface of the middle section between the plurality of openings.
