# US 10,369,250 B2 · Composition I-II and products and uses thereof

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- Number: US 10,369,250 B2
- Document ID: US10369250B2
- Status: Granted
- Kind: B2
- Application number: 13/989,569
- Filed: 2011-11-25
- Published: 2013-11-21
- Granted: 2019-08-06
- Earliest claimed: 2010-11-25
- Assignees: Smith & Nephew, Inc.; Bluestar Silicones France SAS
- Applicants: Marcus Damian Phillips; Delphine Blanc
- Inventors: Marcus Damian Phillips; Delphine Blanc
- Web page: https://patentgrep.com/patent/US10369250B2

## CPC

- A61L 26/0095: {Composite materials, i.e. containing one material dispersed in a matrix of the same or different material}
- A61F 13/0216
- A61L 15/26: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof {(A61L15/225 takes precedence)}
- A61L 15/425: {Porous materials, e.g. foams or sponges}
- A61L 15/585: {Mixtures of macromolecular compounds}
- A61L 24/0073: {with a macromolecular matrix}
- A61M 1/0088
- C08L 83/04: Polysiloxanes
- C08G 77/12: containing silicon bound to hydrogen
- C08G 77/20: containing silicon bound to unsaturated aliphatic groups
- C08L 83/00: Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
- 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)
- 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)}
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)
- C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS

## Abstract

A curable composition apportioned between at least one Part A and at least one Part B, the Parts sealed within barrier means preventing contamination, the at least one Part A comprising: (i) one or more alkenyl-group containing prepolymers having at least one alkenyl group or moiety per molecule, and the at least one Part B comprising: (ii) one or more SiH-containing prepolymers having at least one Si—H unit per molecule; the composition additionally comprising: (iii) a catalyst for curing by addition of alkenyl-containing prepolymer (i) to SiH-containing prepolymer (ii), wherein prepolymer (ii) is substantially absent from Part A and prepolymer (i) is substantially absent from Part B, methods for preparing the composition, methods for sterilisation thereof, medical and non-medical use thereof, a device incorporating the composition, and a precursor therefor including its sterilisable precursor composition, in particular a terminally sterilisable or terminally sterile composition for medical use, particularly in wound therapy, more particularly as a wound packing material which can be shaped and configured to the shape of a wound, most particularly for application in negative pressure wound therapy (NPWT).

## Claims

### Claim 1

A curable composition apportioned between at least one Part A and at least one Part B, the composition comprising:
the at least one Part A comprising one or more alkenyl-group containing polymers including at least one, or at least two, alkenyl group or moiety per molecule,
the at least one Part B comprising one or more SiH-containing polymers including at least one, or at least two, Si—H unit or moiety per molecule,
a catalyst for curing by addition of an alkenyl-containing polymer to a SiH-containing polymer, and
a blowing agent configured to evolve gas as part of or during a curing reaction,
wherein the SiH-containing polymer is absent from the at least one Part A and the alkenyl-group containing polymer is absent from the at least one Part B or the at least one Part B incorporates a trace amount of the alkenyl-group containing polymer represented as a molar ratio (Si—H unit or moiety)/(alkenyl unit or moiety) of greater than or equal to 2000,
wherein the at least one Part A and the at least one Part B are configured to be sterilized by irradiation without degradation thereof, and
wherein the curable composition is configured to form during the curing reaction as a resiliently deformable porous foam configured to transmit negative pressure.

### Claim 2 (depends on 1)

A curable composition as claimed in claim 1, wherein the at least one Part A comprises the catalyst.

### Claim 3 (depends on 1)

A curable composition as claimed in claim 1, wherein at least one of the at least one Part A or the at least one Part B is sterilized by irradiation.

### Claim 4 (depends on 1)

A curable composition as claimed in claim 1, wherein the one or more alkenyl-group containing polymers and the one or more SiH-containing polymers are selected from the group consisting of silicones, including siloxanes and modified siloxanes, polyurethanes (PU) including polyester and polyether urethanes, elastomeric polyether polyesters, polyglycolic acid, polyacetates such as ethyl vinyl acetate, polyacrylate, polyacid derivatives of polysaccharides, such as carboxyalkylcellulose, carboxyalkylchitosan and copolymers thereof, and their hybrids including copolymers, entangled systems and mixtures thereof.

### Claim 5 (depends on 1)

A curable composition as claimed in claim 1, wherein:
the curing reaction by addition of the alkenyl-containing polymer to the SiH-containing polymer further comprises curing between organohydrogensiloxane units and organoalkenylsiloxane units incorporated into polymeric, copolymeric, entangled, and mixed polymer systems, and
the alkenyl-containing polymer and the SiH-containing polymer are organosiloxanes.

### Claim 6 (depends on 1)

A curable composition as claimed in claim 1, wherein a viscosity ratio of the at least one Part A: the at least one Part B is in the range of 6:1 - 1:8.

### Claim 7 (depends on 1)

A curable composition as claimed in claim 1 for medical or non-medical, dental or non-dental use including use as dyes; preservatives; gels; foams; aerosols; pharmaceuticals; adhesives; encapsulants; hair/skin care; cosmetic use; dental use; release coatings; coatings; adhesives and sealants; wound care including wound dressings; skin care including scar reduction; cavity care; medical device encapsulation such as electronic device encapsulation for biomedical applications; mould making; orthopaedics; drug delivery systems including antimicrobial systems; haemostatic and pharmaceutical systems; nutrition including manufacture of foodstuffs; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated medium or atmosphere such as those having low immunity; sterile, clean or aseptic applications; germination or propagation of living matter such as plants or organisms; including manufacture and repair of equipment, apparatus or components for any of the above and in particular aerospace, submarine, sterile, clean or aseptic, germination or propagation, including use as foams, aerosols, adhesives, release coatings, coatings, adhesives and sealants, wound care in relation to NPWT in a sterile field or environment; and, use as a negative pressure wound therapy wound filling material, adhesive or sealant, wherein the at least one Part A and at least one Part B are adapted to be dispensed in cooperative manner facilitating intimate contact and curing thereof and formation of a porous foam which is capable of transmitting negative pressure, adhering a negative pressure wound therapy drape or which is air-tight.

### Claim 8 (depends on 1)

The medical or non-medical use of a composition as claimed in claim 1 selected from the group consisting of use as dyes; preservatives; gels; foams; aerosols; pharmaceuticals; adhesives; encapsulants; hair/skin care; cosmetic use; dental use; release coatings; coatings; adhesives and sealants; wound care; skin care including scar reduction; cavity care; medical device encapsulation such as electronic device encapsulation for biomedical applications; mould making; orthopaedics; drug delivery systems including antimicrobial systems; haemostatic and pharmaceutical systems; nutrition including manufacture of foodstuffs; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated medium or atmosphere such as those having low immunity; sterile, clean or aseptic applications; germination or propagation of living matter such as plants or organisms; including manufacture and repair of equipment, apparatus or components for any of the above and in particular aerospace, submarine sterile, clean or aseptic, germination or propagation; in wound therapy, including use as foams, aerosols, adhesives, release coatings, coatings, adhesives and sealants, wound care in relation to NPWT in a sterile field or environment, including use as a wound filler or wound packing material or cavity foam dressing, adhesive or sealant; for use as a negative pressure wound therapy wound filling material, wherein the at least one Part A and the at least one Part B are adapted to be dispensed in cooperative manner facilitating intimate contact and curing thereof and formation of a porous foam which is configured to transmit negative pressure, adhering a negative pressure wound therapy drape which is substantially air-tight.

### Claim 9 (depends on 1)

A curable composition as claimed in claim 1, wherein the composition is terminally sterile, wherein a sterility level of the composition corresponds to a sterility assurance level (SAL) of equal to or less than 10−6 such that the theoretical probability of there being a viable microorganism present is equal to or less than 1×10−6.

### Claim 10 (depends on 5)

A curable composition as claimed in claim 5, wherein the alkenyl-containing polymer and the SiH-containing polymer are polyorganosiloxanes.

### Claim 11 (depends on 1)

A curable composition as claimed in claim 1, wherein a viscosity ratio of the at least one Part A: the at least one Part B is in the range of 5:1 -1:5.

### Claim 12 (depends on 1)

A curable composition as claimed in claim 1, wherein a viscosity ratio of the at least one Part A: the at least one Part B is 1:1.

### Claim 13 (depends on 1)

A curable composition as claimed in claim 1, wherein the at least one Part A and the at least one Part B are sterilized and a viscosity ratio of the at least Part A: the at least Part B is the same before and after sterilization.

### Claim 14 (depends on 1)

A curable composition as claimed in claim 1, wherein the blowing agent is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, 2-butanol, tert-butanol, n-hexanol, n-octanol, benzyl alcohol, 4-butanediol, 1,5-pentanediol, 1,7-heptanediol, silane including at least one silanol group, polysilane including at least one silanol group, water, and combination thereof.

### Claim 15 (depends on 1)

A curable composition as claimed in claim 1, wherein the composition further comprises a diluent which is radiation sterilizable.

### Claim 16 (depends on 1)

A curable composition as claimed in claim 1, wherein the porous material comprises 70% to 90% free internal volume.