# US 10,500,300 B2 · Multi-layer wound care product with perforated release layer

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- Number: US 10,500,300 B2
- Document ID: US10500300B2
- Status: Granted
- Kind: B2
- Application number: 16/471,066
- Filed: 2017-12-19
- Published: 2019-10-31
- Granted: 2019-12-10
- Earliest claimed: 2016-12-20
- Assignees: BSN Medical, Inc.
- Applicants: BSN Medical GmbH
- Inventors: Verena Dybe; Sascha Casu
- Web page: https://patentgrep.com/patent/US10500300B2

## CPC

- A61L 15/44: Medicaments
- A61L 15/42: Use of materials characterised by their function or physical properties (liquid bandages A61L26/00)
- A61L 15/425: {Porous materials, e.g. foams or sponges}
- A61K 9/7092: {Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs}
- A61L 15/60: Liquid-swellable gel-forming materials, e.g. super-absorbents
- A61L 2300/114: Nitric oxide, i.e. NO
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A multi-layered wound care product includes an upper liquid-absorbing layer, an intermediate occlusive layer; and an active agent-releasing bottom layer. The latter two layers have common pores or perforations that enable the passage of wound exudate through the two layers to reach the liquid-absorbing layer. A use of the multi-layered wound care product for treatment of acute and chronic wounds and a method of producing the multi-layered wound care product are also provided.

## Claims

### Claim 1

A multilayered wound care product comprising:
an upper liquid-absorbing layer;
an intermediate occlusive layer; and
a bottom active agent-releasing layer;
wherein the occlusive layer and the active agent-releasing layer are sheet-like layers with pores or perforations, wherein each pore or perforation is a common pore or perforation that extends through a whole thickness of both the intermediate occlusive layer and the active agent-releasing layer that enable a passage of wound exudate through the common pores or perforations of such two layers to reach the liquid-absorbing layer and simultaneously enable a release of an active agent from an area between the pores or perforations to enter a wound site, and
wherein the occlusive layer is impermeable for fluids and prevents the active agent from spreading to the upper liquid-absorbing layer.

### Claim 2 (depends on 1)

The multilayered wound care product of claim 1, wherein the layers are connected by use of an adhesive or by welding, sealing or laminating using at least one of temperature and pressure.

### Claim 3 (depends on 1)

The multilayered wound care product of claim 1, wherein the upper liquid-absorbing layer contains at least one absorbent material selected from a group consisting of polymer foams, sponges, hydrocolloids, hydrogels and hydrophilic polymers such as superabsorbing polymers.

### Claim 4 (depends on 1)

The multilayered wound care product of claim 1, wherein the intermediate occlusive layer is a metal layer or a polymer layer of one of the following polymers: polyvinylidene chloride, polyethylene terephthalate (PET), oriented polypropylene (OPP), biaxially oriented polypropylene (BOPP), oriented polyamide (OPA), biaxially oriented polyamide (BOPA), or a multi-layer high barrier film, selected from a group consisting of polyethylene/ethyl vinyl alcohol copolymer/polyethylene (PE/EVOH/PE), PP/EVOH/PP, PP/EVOH/PE, polyamide/polyethylene (PA/PE), PE/PA/PE, PP/PA/PE, PA/EVOH/PA/PE and PP/PA/EVOH/PA/PE, EVOH/OPP, EVOH/BOPP, EVOH/OPA, EVOH/BOPA and PVDC/PET, or a metal-coated form of polymeric films.

### Claim 5 (depends on 1)

The multilayered wound care product of to claim 1, wherein the active agent-releasing layer comprises an active agent being a therapeutic gas selected from a group consisting of oxygen, ozone, carbon dioxide, nitric oxide or combinations thereof, wherein the wound care product further comprises a gas-permeable layer oriented towards a treatment site having common pores or perforations with the active agent-releasing layer and the occlusive layer.

### Claim 6 (depends on 1)

The multilayered wound care product of claim 1, wherein the active agent-releasing layer comprises different reactants that are separated from each other by a barrier, whereby breaking or removing the barrier allows a mixing of the reactants in order to generate the active agent.

### Claim 7 (depends on 6)

The multilayered wound care product of claim 6, wherein a first reactant is an NO donor and a second reactant is a reducing agent or a proton donor.

### Claim 8 (depends on 7)

The multilayered wound care product of claim 7, wherein the NO donor is selected from a group consisting of inorganic nitrite salts, alkyl nitrites, diazeniumdiolated organic compounds, trans[RuCl([15]aneN4)NO]2+, Nitrosyl-ligands, 6-nitrobenzo[a]pyrol, S-nitroso-glutathione, S-nitroso-thiols, S-nitroso-N-acetyl-D-penicillamine (SNAP), L-arginine, L-citrulline, nitroglycerin (GTN), isosorbide 5-mononitrate (ISMN), isosorbide dinitrate (ISDN), pentaerythritol tetranitrate (PETN), erythrityl tetranitrate (ETN), amino acid derivatives, N6-(Iiminoethyl)lysine) (L-NIL), L-N5-(1-iminoethyi)ornithine (LN-NIO), Na-methyl-L-arginine (L-NMMA), S-nitroso glutathione (SNOG), S,S-dinitrosodithiol (SSDD), 2-[(pyridin-3-ylcarbonyl)amino]ethyl nitrate (nicorandil), sodium nitroprusside (SNP), S-nitroso-N-acetylpenicillamine (SNAP), [8-[2-hydroxy-3-(propan-2-ylamino)propoxy]-3,4-dihydro-2H-chromen-3-yl] nitrate (Nipradilol), 3-morpholino-sydnonimine (SIN-1), molsidomine, DEA-NONOate (2-(N,N-diethylamino)diazenolate-2-oxide), spermine NONOate (N-[4-[1-(3-aminopropyl)-2-hydroxy-2-nitrosohydrazino]butyl-1,3-propanediamine), 3-(5′-hydroxymethyl-2′ furyl)-1-benzyl indazole (YC-1), nitroaniline derivatives, 2-methyl-2-nitrosopropane, imidazoyl derivatives, nitrate ester, hydroxyl nitrosamine, hydroxylamine and hydroxyl urea, and combinations thereof.

### Claim 9 (depends on 8)

The multilayered wound care product of claim 8, wherein the inorganic nitrite salts are salt is selected from a group consisting of LiNO2, NaNO2, KNO2, RbNO2, CsNO2, FrNO2, Be(NO2)2, Mg(NO2)2, Ca(NO2)2, Sr(NO2)2, Ba(NO2)2, and Ra(NO2)2 and combinations thereof.

### Claim 10 (depends on 7)

The multilayered wound care product of claim 7, wherein the reducing agent is selected from a group consisting of ascorbic acid, cysteine, glutathione, penicillamine, N-acetylcysteine, iodine, hydroquinone, mercaptosuccinic acid, thiosalicylic acid, methylthiosalicylic acid, dithiothreitol, dithioerythritol, 2-mercaptoethanol, FeSO4, and FeCl2, and combinations thereof.

### Claim 11 (depends on 10)

The multilayered wound care product of claim 10, wherein the reducing agent is capable of forming a transient nitrosyl complex and is selected from a group consisting of Cu, Cu(I), V(III), Mo(VI), Fe(II), I−, Ti(III), Co(II), Mn(II), and Cr(III) and their salts.

### Claim 12 (depends on 7)

The multilayered wound care product of claim 7, wherein the proton donor is selected from a group consisting of H2SO4, HCl, HBr, HI, HNO3, acetic acid, lactic acid, tartaric acid, ascorbic acid, citric acid, salicylic acid, and combinations thereof.

### Claim 13 (depends on 1)

The multilayered wound care product of claim 1, wherein the active agent-releasing layer is coated on a wound-facing side with an pressure sensitive adhesive wound contact layer, a material of which is selected from a group consisting of polyacrylate adhesive, silicone, natural rubber-based adhesive, synthetic rubber-based adhesive or hotmelt.

### Claim 14 (depends on 1)

The multilayered wound care product of claim 1, wherein the pores or perforations have a triangular, rectangular, hexangular, ellipsoid or circular form.

### Claim 15 (depends on 1)

The multilayered wound care product of claim 1, wherein the pores or perforations account for between 1% to 50%, of an area of at least one of the active agent-releasing layer and the occlusive layer.

### Claim 16 (depends on 1)

The multilayered wound care product of claim 1, wherein the pores or perforations are evenly distributed on the area of the active agent releasing layer.

### Claim 17 (depends on 1)

The multilayered wound care product of claim 1, wherein the occlusive layer exhibits a circumferential rim at the pores or perforation by projecting over an area of the active agent-releasing layer.

### Claim 18 (depends on 1)

The multilayered wound care product of claim 1, wherein the upper liquid-absorbing layer, the intermediate occlusive layer, and the active agent-releasing bottom layer are bonded at a border portion or at edges of said layers.

### Claim 19 (depends on 1)

A method of treatment of chronic wounds, comprising:
providing the multilayered wound care product of claim 1; and
applying the multilayered wound care product to treat one selected from a group consisting of: burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, arterial ulcers, diabetic ulcers, chronic vascular ulcers, draining wounds, tunnelled or undermined wounds, surgical wounds, and trauma wounds.