# US 11,432,966 B2 · Composite dressings for improved granulation and reduced maceration with negative-pressure treatment

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- Number: US 11,432,966 B2
- Document ID: US11432966B2
- Status: Granted
- Kind: B2
- Application number: 15/997,761
- Filed: 2018-06-05
- Published: 2018-12-13
- Granted: 2022-09-06
- Earliest claimed: 2017-06-07
- Assignees: KCI Licensing, Inc.
- Applicants: KCI Licensing, Inc.
- Inventors: Christopher Brian Locke; Timothy Mark Robinson; John R. Harper
- Web page: https://patentgrep.com/patent/US11432966B2

## CPC

- A61F 13/05: specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
- A61F 13/0223: {characterized by parametric properties of the fluid retention layer, e.g. absorbency, wicking capacity, liquid distribution}
- A61F 13/15203: {Properties of the article, e.g. stiffness or absorbency (chemical aspects A61L15/00)}
- A61F 13/537: characterised by a layer facilitating or inhibiting flow in one direction or plane, e.g. a wicking layer {(A61F13/538 takes precedence)}
- A61M 1/915: {Constructional details of the pressure distribution manifold}
- A61M 1/962: {having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction}
- A61F 13/0206: with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
- A61F 13/0213: {the fluid retention member being a layer of hydrocolloid, gel forming material}
- A61F 2013/00217: {not adhering to the wound}
- A61F 2013/53445: {from several sheets}
- A61F 2013/53782: {with holes}
- A61M 1/985: {the dressing itself forming the collection container}
- 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)
- 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

Dressings for tissue treatment with negative pressure and methods of using the dressings for tissue treatment with negative pressure, which may comprise a dressing having at least three layers assembled in a stacked relationship. The first layer may comprise or consist essentially of a polymer film having a plurality of fluid restrictions that are normally unstrained or closed. The second layer may comprise a manifold, and the third layer may comprise or consist essentially of a polymer drape. A fourth layer, which may be coupled to the first layer opposite the second layer, may comprise or consist essentially of a silicone gel having a plurality of apertures. In some examples, the plurality of apertures in the fourth layer may be registered with the fluid restrictions of the first layer.

## Claims

### Claim 1

A dressing for treating a tissue site with negative pressure, the dressing comprising:
a first layer comprising a polymer film having a plurality of fluid restrictions through the polymer film that are configured to expand in response to a pressure gradient across the polymer film;
a second layer coupled to the first layer, the second layer comprising a manifold, wherein the first layer is configured to be interposed between the manifold and the tissue site and at least partially exposed to the tissue site;
a third layer coupled to the second layer opposite the first layer, the third layer comprising a polymer drape; and
a fourth layer coupled to the first layer opposite the second layer and comprising a gel including a plurality of apertures, wherein a dimension of one or more of the fluid restrictions through the polymer film exceeds a dimension of at least one of the plurality of apertures.

### Claim 2 (depends on 1)

The dressing of claim 1, wherein the fourth layer comprises a hydrophobic gel.

### Claim 3 (depends on 2)

The dressing of claim 2, wherein the third layer and the fourth layer enclose the first layer and the second layer.

### Claim 4 (depends on 2)

The dressing of claim 2, wherein the third layer and the fourth layer enclose the first layer and the second layer, and the fourth layer is adapted to contact the tissue site.

### Claim 5 (depends on 2)

The dressing of claim 2, wherein the hydrophobic gel is a silicone gel.

### Claim 6 (depends on 1)

The dressing of claim 1, wherein the plurality of apertures in the fourth layer are in registration with at least some of the plurality of fluid restrictions in the first layer.

### Claim 7 (depends on 1)

The dressing of claim 1, wherein the plurality of apertures are in registration with the fluid restrictions.

### Claim 8 (depends on 1)

The dressing of claim 1, wherein the plurality of apertures each expose at least a portion of one of the fluid restrictions.

### Claim 9 (depends on 1)

The dressing of claim 1, wherein the plurality of apertures in the fourth layer are coextensive with the second layer, and wherein substantially all the plurality of apertures are in registration with the fluid restrictions in the first layer.

### Claim 10 (depends on 1)

The dressing of claim 1, wherein the fourth layer is configured to be interposed between the manifold and the tissue site.

### Claim 11 (depends on 1)

The dressing of claim 1, wherein one or more of the fluid restrictions comprises a slot including a length that exceeds the dimension of at least one of the plurality of apertures such that the slot overlaps an edge of the at least one of the plurality of apertures.

### Claim 12 (depends on 1)

The dressing of claim 1, wherein each of the apertures are sized to expose no more than two of the fluid restrictions.

### Claim 13 (depends on 1)

The dressing of claim 1, wherein the fourth layer comprises an area density less than 300 grams per square meter.

### Claim 14 (depends on 1)

The dressing of claim 1, wherein the polymer drape comprises a margin that extends beyond the first layer and the second layer, and an adhesive layer disposed in the margin.

### Claim 15 (depends on 1)

The dressing of claim 1, wherein the manifold comprises a foam.

### Claim 16 (depends on 15)

The dressing of claim 15, wherein the foam is reticulated and has a free volume of at least 90%.

### Claim 17 (depends on 15)

The dressing of claim 15, wherein the foam is porous and has an average pore size in a range of 400-600 microns.

### Claim 18 (depends on 1)

The dressing of claim 1, wherein the manifold has a thickness less than 7 millimeters.

### Claim 19 (depends on 1)

The dressing of claim 1, wherein the manifold is hydrophobic.

### Claim 20 (depends on 1)

The dressing of claim 1, wherein the polymer film is hydrophobic.

### Claim 21 (depends on 20)

The dressing of claim 20, wherein the polymer film has a contact angle with water greater than 90 degrees.

### Claim 22 (depends on 20)

The dressing of claim 20, wherein the polymer film is a polyethylene film.

### Claim 23 (depends on 1)

The dressing of claim 1, wherein the fluid restrictions comprise a plurality of slots, each of the slots having a length less than 4 millimeters.

### Claim 24 (depends on 1)

The dressing of claim 1, wherein the fluid restrictions comprise a plurality of slots, each of the slots having a width less than 2 millimeters.

### Claim 25 (depends on 1)

The dressing of claim 1, wherein the fluid restrictions comprise a plurality of slots, each of the slots having a length less than 4 millimeters and a width less than 2 millimeters.

### Claim 26 (depends on 1)

The dressing of claim 1, wherein the fluid restrictions are coextensive with the polymer film.

### Claim 27 (depends on 1)

The dressing of claim 1, wherein the fluid restrictions are coextensive with the manifold.

### Claim 28 (depends on 1)

The dressing of claim 1, wherein a tissue-facing surface of the dressing is smooth.
