composition i

专利摘要:
COMPOSITION I - II AND PRODUCTS AND USES OF THE SAME.The present invention relates to a curable composition divided between at least one Part A and at least one Part B, the parts sealed within barrier means that prevent contamination, wherein the at least one Part A comprises: (i) one or more alkenyl groups containing prepolymers that have at least one alkenyl group or fraction per molecule, and wherein at least one Part B comprises: (ii) one or more SiH containing Prepolymers that have at least one Sih unit per molecule ; wherein the fraction further comprises: (iii) a curing catalyst by adding the alkenyl-containing prepolymer (i) to the SiH-containing prepolymer (ii), where the prepolymer (ii) is substantially absent from Part A and the prepolymer (i) is substantially absent from Part B, methods for preparing the composition, methods for sterilizing them, medical and non-medical use thereof, a device incorporating the composition, and a precursor to it including its composition sterilizable precursor, in particular a terminally sterilizable or terminally sterile composition for medical use, particularly in wound therapy, more particularly as a wound filler that can be shaped and shaped into the shape of a wound, more particularly for application in wound therapy. negative pressure injury (NPWT).
公开号:BR112013012785A2
申请号:R112013012785-6
申请日:2011-11-25
公开日:2020-10-20
发明作者:Marcus Damian Phillips；Delphine Blanc
申请人:Bluestar Silicones France Sas；Smith & Nephew Plc；
IPC主号:

专利说明:

Jd Invention Patent Descriptive Report for "COMPOSITE-
TION | —- IL AND PRODUCTS AND USE OF THE SAME ". The present invention relates to a curable two-part composition, methods for preparing the composition, manufacturing it and methods for sterilizing it, medical and non-medical use thereof, methods for use or therapy therewith, a device incorporating the composition, and a precursor to it including its sterilizable precursor composition.
In particular, certain embodiments refer to a sterilizable or sterile composition for medical use, particularly in wound therapy, more particularly as a wound dressing or dressing material which can be shaped and shaped into the shape of a wound, or a wound. adhesive or sealant for a wound dressing, + more particularly for application in neural pressure wound therapy
(NPWT). "15 BACKGROUND OF THE INVENTION
NPWT is a relatively new treatment for open wounds. In short, negative pressure therapy can help in closing and healing many forms of "difficult to heal" wounds by reducing tissue edema; stimulating blood flow and granular tissue formation; removing excess exudate and can reduce bacterial load (and therefore risk of infection). In addition, therapy allows less injury to a wound leading to more rapid healing.
NPT therapy systems can also aid in the healing of surgically closed wounds by removing fluid and helping to stabilize tissue in the closed position.
An additional benefit of using TNP therapy can be found in grafts and flaps where removal of excess fluid is important and close proximity of the graft to the tissue is required to ensure tissue viability, typically in NPTW to the wound cavity or surface is filled or covered with a material that allows a partial vacuum to be transmitted (ie, not completely retract) to the wound bed when negative pressure is applied to the wound area, and also allows fluids to pass from the bed
- injury towards the source of negative pressure.
There are two primary approaches to NPTW, that is, gauze or foam types.
The gauze type involves the use of a drain wrapped in gauze covered by a sealed dressing.
The foam type involves the use of foam placed on or in the wound, also covered by a sealed dressing.
One mode is directed primarily to the NPTW foam type, Additional modes are directed to either the foam type or the NPTW gauze type, or to an additional NPTW type that uses a sealed dressing as a combination or pre-formed with layers of additional or similar absorption or distribution, a good foam-based NPTW material that offers good resistance to compression under load, is cross-linked polyurethane foam + internal high volume hydrophobic foam.
However, articles with a high internal free volume tend to be little draped due to the requirement for their structure to mechanically support their high internal free volume, and this is the case in NPTW applied foams.
Therefore the compress material for use in NPTW has | be molded to fit the wound to be protected.
This is typically achieved by the medical professional (doctor or nurse) by cutting a pre-formed foam block to approximately fit the wound using a scalpel, knife or scissors.
This operation can be complex and has the potential to introduce contamination, in addition, it is time-consuming and difficult for the medical professional, and therefore can be dangerous with the possibility of foam particles contaminating the site of injury or an accident during the cutting process.
Consequently the process of molding the wound dressing is currently an unaddressed problem in the field of NPTW.
Moldable compositions are known for use in treating wounds.
WOZ2009 / 156709 discloses an element or cloth to cover a wound in topical negative pressure injury therapy or a vacuum constructed of materials based on silicone or polyurethane, which
7 provide a substantially air-tight seal over a wound, which has a vacuum connecting pipe or line for connection to a negative pressure source molded or glued to the nozzle to reduce the likelihood of negative pressure leakage.
The cloth can be manufactured by melting a curable two-part silicone elastomer over the vacuum line, located in a mold.
The resulting cloth can be sterilized by irradiation and packaged in a sterile manner until required for use by being placed over a foam wound dressing or gauze An RTV-2 foam silicone wound dressing (curing at room temperature for curing by adding two-part), Cavi- Care, is sold non-sterile.
The North American document5.153.231 discloses the composition that is capable of providing a medical foam dressing. low density releasing two components into a mixing container by breaking their individual packaging, mixing and dispensing: 15 or melting on a surface such as an open wound and allowing the mixture to cure at room temperature. . It should be helpful to provide a moldable wound filler in place in the form of an RTV-2 silicone foam. It should also be useful to provide a moldable adhesive or sealant on the spot for an NPTW cloth or dressing. The problem is that for a filler, adhesive, wound sealant or similar RTV-2, the two parts must be available sterile.
Where a product for medical use is required to be sterile at the point of use, it is a well accepted principle that it should be manufactured using aseptic procedure only when terminal sterilization is not possible.
To guarantee the highest levels of sterility guarantee for a medical product, it must therefore be terminally sterile in its final packaging. - Although sterile foam wound dressing materials are available such as Allevyn '", a polyurethane foam wound dressing element, and black foam (“ Granufoam ”), a polyurethane wound dressing, provided packed in a sterile bag
no RTV-2 two-part silicone composition or, therefore, any foam-forming RTV-2 composition or otherwise, appears to be available sterile, like the two-part system before curing, or terminally sterile or sterile in primary packaging and therefore aseptically packed. In addition, a process for sterilizing these systems does not appear to be available.
An object of the invention is to provide an improved terminally sterile RTV-2 foam-forming silicone composition. It is an additional objective to provide an improved terminally sterile wound pad that can be shaped into a wound cavity. It is an additional objective to provide a terminally sterile foam-forming or non-foaming silicone composition RTV-2.
. It is an additional objective to provide a terminally sterile adhesive or seal that can be molded around a wound cavity.
A15 In an attempt to find a way to sterilize a curable, two-part foam-forming silicone composition that can be shaped into a desired shape and cured in place to form a three-dimensional shaped body, it has been found that most the sterilization techniques that typically must be employed to sterilize a material are inadequate or are unable to sterilize the composition without degradation. The same was true in trying to find a way to sterilize a two-part adhesive or seal.
Established terminal sterilization procedures provide a 10º confidence in sterility. An attractive path to sterilization appeared to be irradiation. This presents a cost-effective path for which the packaging requirement is readily available.
25kGy is a typical dose to achieve the required level of microbial extermination for terminal sterility. Meanwhile in gamma radiation irradiation 725kGy, Rhodorsil RTFoam 3240, a polydiorganosyloxane composition RTV-2 that has a mixture of prepolymer liquid Part A and Part B, experienced a considerable increase in viscosity in Part A while Part
7 B formed a solid elastomer. the resulting sterile composition was clearly unable to mix and shape. This increase in viscosity can be influenced by reducing the dosage levels of gamma ray irradiation to 15kGy and even —10kGy, however through a wide range of dosages the gamma irradiation alters the physical properties of the Part of the composition, with an increase in viscosity being observed at all dosage levels.
BRIEF DESCRIPTION OF THE INVENTION Surprisingly, a path has been found for the sterilization of packaged RTV-2 compositions, for which the composition is capable of withstanding sufficient radiation doses for sterilization without degradation.
Accordingly, according to a first embodiment of the present invention, a curable composition is provided which comprises or '15 is divided between at least one Part A and at least one Part B, wherein at least one Part A comprises: * (1 ) one or more alkenyl-containing prepolymers that have at least one alkenyl group or fraction per molecule, and wherein at least one Part B comprises: (li) one or more SiH-containing prepolymers that have at least one SiH units or fraction per molecule; wherein the fraction further comprises: (iii) a catalyst for curing by adding prepolymer containing alkenyl (1) to a prepolymer containing SiH (ii), where prepolymer (ii) is substantially absent from Part A and the prepolymer ()) is substantially absent from Part B. Preferably the Parts are sealed within barrier means in order to prevent contamination thereof. In a further preferred embodiment of the invention, a curable composition is provided for use as a negative pressure wound therapy wound filler material in which the composition comprises or is partitioned between at least Part A and
7 at least one Part B, wherein the at least one Part A comprises: (1) one or more alkenyl-containing prepolymers having at least one alkenyl group or fraction per molecule, and wherein at least one Part B comprises : (ii) one or more SiH containing prepolymers that have at least one SiH units or fraction per molecule; wherein the fraction further comprises: (iii) a catalyst for curing by adding prepolymer containing alkenyl (1) to a prepolymer containing SiH (ii), where the prepolymer (ii) is substantially absent from the Part A and the prepolymer (i) is substantially absent from Part B in which at least one Part A and at least one Part B. are adapted to be dispensed in a cooperative way facilitating their intimate contact and healing and forming a porous foam at Ú 15 which is capable of transmitting negative pressure. Alternatively, the composition can be useful as an adhesive or sealant for pressure injury therapy. º are negative, which is capable of adhering a negative pressure wound therapy cloth or that is air tight. Preferably the U Parts sealed within barrier means in order to prevent their contamination. In the above embodiments, the catalyst may be present in an inert Part, or preferably in at least one Part A, Adequately at least at least one Part The and / or at least one Part B is sterilizable by irradiation or sterilized by irradiation, or one of the same is sterilizable by irradiation or sterilized by irradiation and the other of the same is sterilizable or sterilized by other means.
In the above modalities, the phrase “prepolymer ... is substantially absent from" denotes that no detectable amount of the defined prepolymer is present in the defined Part, or if present, the amount of it is insufficient to cause an increase in the viscosity of the Party that should render the respective Parties unable to intimate contact, for example to flow for the purpose of dispensing and mixing,
so as to form a cured product.
Preferably the prepolymer (i) substantially comprises the totality of reactive prepolymer present in Part A, which is capable of undergoing a hydrosilylation reaction and the prepolymer (ii) substantially comprises the totality of prepolymer reactive substance present in Part B, which is capable of being subjected to the hydrosilylation reaction.
More preferably, the prepolymer (i) and / or (ii) substantially comprises the entire reactive prepolymer present in Part A and / or Part B respectively.
While it is clear that prepolymers incorporate a number of different molecules that differ in chain length and unit composition, and that a reactive prepolymer other than (i) or (ii) may be present in trace, certain modalities cover composi. tions for which this trace is insufficient to react with the prepolymer (i) or (ii) included in the same Part, in the course of sterilization by irradiation, for example, in a range where the viscosity of the Part is increased by more than 0% to 5% by weight and / or the * properties of the foam are affected by a volume reduction greater than 0% to 5%. For example, therefore, the Party that does not incorporate catalyst, like Part B, may incorporate a trace of prepolymer (i) greater than 0% to 5% by weight.
Part A, if it does not incorporate catalyst, may incorporate a trace of prepolymer (ii) greater than 0% to 5% by weight, however this is not preferred.
Preferably the prepolymer (ii) is completely absent from Part A.
Prepolymers include a discrete polymer chain distribution with different amounts of reactive groups.
Consequently, a more accurate measurement of trace from one Party to another is provided for the reason of reactive groups.
Consequently it was discovered that Part B can incorporate a trace of prepolymer (i) represented as a molar fraction (SiH units or fraction) / (alkenyl unit or fraction) greater than or equal to 2000, preferably greater than or equal to 5,000 more preferably greater than or equal to 10,000. Surprisingly, it was discovered that at least one
"o A 8/60 Íte A, and preferably both at least one Part A and at least one Part B are suitable to be subjected to a sufficient irradiation dose for their terminal sterilization. In this document reference to barrier means for the prevention of contamination of the respective Parts A and B is for any chemical or mechanical barrier that prevents contamination by infectious agents that are capable of proliferation, or by contaminants that are able to react with the prepolymers (i) and / or (ii), in a way that prevents the passage of substances that deleteriously affect the reaction of Parts A and B, for example, loss of components of the composition through leakage. barrier is able to prevent contamination by microorganisms or viruses, more preferably by pathogenic microbes or viruses, and leakage of components of the composition.
DETAILED DESCRIPTION OF THE INVENTION '15 It has surprisingly been found that although a standard irradiation cycle does not sterilize commercially available compositions without. degrade their abilities to form a cured polymer that has desired properties, modified compositions will withstand this cycle and are uniquely suited to provide a terminally sterile RTV-2 Composition, hitherto unknown and unavailable.
Modalities of the invention can be applied to any RTV, LTV or HTV compositions, which can comprise 2 or more components or parts. Preferably the composition of the invention is an RTV-2, LTV-2 or HTV-2 composition, foam-forming or otherwise, for any intended use that requires sterility. The curing chemistry by adding 2-part RTV, LTV and HTV compositions is based on the hydrosilylation of functional vinyl prepolymers by functional Si-hydride prepolymers. Vulcanization at room temperature is typically taken with the meaning of system cures below 50ºC. Low temperature vulcanization is taken with the meaning of system cures in the range of 50ºC to 130ºC. High temperature vulcanization is taken to mean system cures at a temperature above 130ºC.
Most preferably the composition is an RTV-2 composition.
- Modalities of the invention may also have application for any curable composition of two or more Parties for which the Parties are adapted to be dispensed or released cooperatively facilitating their intimate contact and healing. Therefore, these Parties are suitably fluid phase or capable of fluid behavior under acceptable dispensing or release conditions or capable of wetting a surface or material on which they are dispensed or released, for example, Part A and Part B are capable of wetting each other when cooperatively dispensed or released cooperatively.
Suitably at least one Part A and at least one Part B are sealed within or over at least two receptacles or holders. respective sizes and are adapted to be dispensed or released from them in a cooperative way facilitating intimate contact and healing of the '15 same. The receptacles or supports are suitably sealed anti-microbial. - Part A and Part B can be supplied sealed inside receptacles or on supports in a substantial absence of air inside the receptacles or on the supports.
In this reference document, Parts A and B, being present in receptacles in a substantial absence of air or humidity, are suitable for air or humidity that present less than 10% of the receptacle volume, preferably less than 5% of the receptacle volume. - ass. Air or moisture is adequately absent from any space above or around the composition, that is, empty or similar space, or this space is substantially absent. Air or moisture can additionally be absent from the composition itself, that is, the composition can be degassed or sprayed or something similar to remove air. It will be assessed that the purpose of providing an absence of air is to provide an absence of oxygen and moist steam.
Consequently, a substantial absence of air can be provided in a manner known as displacement and / or removal of air. Des-
"air leasing is suitably by purging the space around the composition, such as the void present above the composition within the barrier medium, with a suitable inert gas; and / or by spraying the composition with an inert gas Air removal is suitably provided by supplying the Party in a receptacle substantially equal to the volume of the Party so as to substantially eliminate any void space. A suitable inert gas is argon or nitrogen or the like. air above the Part with inert gas The spraying displaces air within the Part with inert gas Corresponding volumes removes air above the Pardt Receptacles or supports preferably comprise any suitable material that endows a barrier medium as defined up to - here, preferably for microbial or viral infection and for ingress or egress of chemically reactive or contaminating material Ade- '15 materials - receptacle or support materials are selectable from any irradiation-tolerant material, preferably any gamma-ray, X-ray or electron-beam-tolerant material, which is sufficiently dense to be impermeable to contaminants, being suitably non-porous for these contaminants. The receptacle or support material can comprise any commonly available packaging materials and is preferably selected from polymeric materials such as polyolefins, for example, polyethylene (PE), polyethylene terephthalate (PET) and polypropylene (PP ), polystyrene (PS), polyamides, and the like, metals such as metal sheets, glass, silicone and composite materials, laminates and combinations thereof; more preferably being selected from PE, PET and PP.
The composition suitably includes receptacles or supports and any integrated cooperative medium is packaged in an additional external (secondary) packaging that is resistant to EO or is permeable to steam, which is suitable for sterilization in the usual way. In this way both the interior and exterior of the composition are kept sterile, and can be transported into a sterile field and opened.
7 A receptacle or support can be flexible or rigid. A receptacle or rigid support is suitably any vial or cartridge as known in the art. A flexible receptacle or support, for example, can be formed of a sheet of laminated metal that has a polymer film on each face as defined so far which can be heat sealed or laminated.
A receptacle may comprise a part that is intended for opening, rupture or mechanical penetration in order to release the Part of the sealed composition within it. A receptacle can therefore comprise a combination of different materials or a combination of different material thicknesses, which are either breakable or penetrable and not breakable or non-penetrable.
- The receptacles can be manually broken in weakened parts of them, or broken or mechanically penetrated by: 15 physical medium, for example, provided in a device for cooperative penetration and dispensing of the Parts of the composition. Suitable physical medium 7 includes needles, scapulas, punctures such as bayonet caps, plug-in means and the like, | Reference to cooperative dispensation as defined so far is for any method by which one or more Parties are dispensed simultaneously and in direct contact with the other one or more Parties, preferably with simultaneous mixing. Preferably, the receptacles are adapted to be received within a medium that provides a device for cooperatively releasing the respective Parts within one of the best precision for administering the composition.
Preferably the composition is suitable for dispensing in or around a wound. Preferably, the composition is suitable for dispensing or releasing in a sterile field or environment. This is particularly advantageous in the case of medical applications, for example, within the sterile field of an operating room allowing the possibility of dispensing directly or indirectly, for example, through a mold, within a wound in a sterile field or environment . This avoids the need
7 contact with the composition once dispensed, for example, to position or shape, and minimizes the risk of introducing infection.
One embodiment of the RTV-2 composition of the invention can comprise any prepolymers that follow a hydrosilylation reaction.
One prepolymer contains alkenyl groups, the other contains Si-H fractions. The group of siloxane polymers is based on a structure that comprises silicon and oxygen atoms alternated with various organic fractions linked to silicon. Healing can be defined as a treatment that decreases the flow of an elastomer. This change is usually caused by bonding reactions between polymer molecules. Where the fraction of silicon hydride (Si-H) is part of a polysiloxane, it is possible for alkenyl groups to either be part of a siloxane prepolymer or otherwise part of a pre-. non-siloxane polymer. The position of the alkenyl functional group is not critical and it can be either at the molecular chain terminals or in non-terminal positions along the molecular chain. Prepolymers (1) and (ii) are commercially available or 7 can be obtained by known techniques. Prepolymers (1) and / or (1) are appropriately selected independently of known and original homopolymeric and copolymeric fluid phase and copolymeric prepolymers, and their entangled systems and mixtures thereof. The compositions, in turn, cure to form copolymers, and may also include their entangled systems and mixtures with other non-reactive prepolymers if present in the composition. By fluid phase it is understood that the pre-polymers are capable of mixing to form the respective Part, Preferably the respective Parts are of a suitable viscosity to mix manually in a period of up to 1 minute.
The term fluid phase is intended to include prepolymers that can exist in the fluid phase or behave like fluids, that is, the sterile prepolymers are capable of mixing to form the respective Part.
Copolymeric prepolymers include all hybrids derived from two or more monomeric species, including alternating, periodic, statistical, random, block, linear, branched, star,
7 graft and pendants.
Entangled systems include interpenetrating networks (IPNs) and semi interpenetrating networks (SIPNs). It is also the case that these prepolymers can incorporate both organic and inorganic fractions.
Preferably, pre-polymers (i) and (ii) are selected from silicones, including modified siloxanes and siloxanes, polyurethanes (PU) including polyester and urethane polyethers, elastomeric polyether polyesters, polyglycolic acid, polyacetates such as ethyl vinyl acetate, polyacrylate, polyacids derived from polysaccharides, such as carboxyalkyl cellulose, carboxyalkyl chitosan and copolymers thereof, and their hybrids including copolymers, entangled systems and mixtures thereof, More preferably the curable composition makes use of a curing reaction by addition between organo-units hydrogensiloxane and organoalkenylsiloxane units.
These units can be incorporated into a wide range of polymeric, copolymeric, entangled prepolymers] 15 and mixed as defined so far. Therefore preferably the siloxane prepolymers (i) and (ii) include these respective units and are more 7 preferably polyorganosiloxanes.
Examples of hybrid organic-inorganic i polymer systems that have used both siloxane and organic units include: functionalized acrylate siloxane copolymers, which have found use in contact lenses (US 3,808,178); hybrid grafts where organic polymers are grafted onto a polysiloxane chain or where siloxanes are grafted onto organic polymers, for example, on silane grafting technology for crosslinked HDPE (US 3,646,155) where hybrid grafts have been used to allow crosslinking of organic polymers through siloxane bond formation; hybrid block copolymers for example silicone-polycarbonate block copolymers (US 3,274,155); and hybrid copolymers of cross-linked silicone and ethylene copolymers with vinyl-containing silicone copolymers which have found use in coating fabrics (US 2005/0100692); IPNs represent a special class of hybrid polymeric systems, these systems use a combination of mechanical entanglement
7 and crosslinking in which one polymer is cured around another; these include thermoplastics entangled with cured silicone by adding catalyzed platinum such as semi-IPNs silicone-urethane and including silicone-urethane and silicone-polyamide systems which are of general use or have found specific use in fabrics of coating (US 4,714,739, US
7,543,843); hydrophilic components immobilized in a silicone polymer (US 5,397,848) which have found use as a contact lens material; and silicone polymer cured around a non-reactive polymer of comparable adhesion, which has found use in covering fabrics (US7,132,170).
Prepolymers can also be selected from modified silicon (MS) which are used as adhesives in catheter tubing and the like.
Preferred compositions comprise a polydi-, organosiloxane (i) and / or (ii) prepolymer and / or their respective combinations with the aforementioned prepolymers. A composition in which the prepolymers' comprise or consist essentially of polydiorganosiloxane prepolymers (1) and (ii) has particular advantages, for example in applications where low toxicity is an advantage, preferably in medical applications. dental or non-medical or non-dental applications that require low toxicity or favorable biocompatibility.
The prepolymer (i) and (ii) can comprise respective alkenyl containing units and organohydrogensiloxane units located along the length of the polymer pre-chain, and / or as a pre-chain of end group units of polymer or a combination thereof. Prepolymer (i) chain and alkenyl end group units preferably comprise alkenyl group or R ° fraction * selected from C> .29 alkenyl optionally substituted or including one or more aryl groups or fractions. R ** can comprise terminal or non-terminal unsaturation, and can be of the formula i-l: () RAI, QRAI - Ra in which the groups Rº "* and Rº * º are selected regardless of group
- pos H, C1.29 alkyl and C5-20 aryl and combinations thereof and a fraction Rº "is selected from, single bonded Cy.20 alkyl and Cs.29 aryl groups and combinations thereof.
One of the R * it can be a fraction | bypassing the polymer chain.
More preferably each Rº * is independently selected from terminally and non-terminally unsaturated groups of vinyl, ally, propenyl, and butenyl, pentenyl, hexenyl, heptenyl, octenyl, nonenyl and decenyl, more preferably selected from vinyl and hexenyl groups .
Preferably the prepolymer (i) comprises a polydiorganosiloxane polymer or copolymer comprising alkenyl containing units of the formula (i-11): (HI) = Si-R * more particularly of the formula (i-II!) And / or - ( FIV): (HM) cOoO-SiRR * -o- A5 (EV) -O-SiRzR * where R ** is as defined so far and one or more groups R 'are organo groups suitably selected independently from groups alkyl and aryl, more preferably C1-25 alkyl and Cs.20 aryl groups and combinations thereof, for example from groups and fractions of methyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl and / or deciles.
More particularly the prepolymer (i) is selected from the formula iV and i-VI: EV: PiICO-SIR R $ -oO-P iVl Pi-O-SiR '> Rº * where P' denotes the remainder of polymer chain which can incorporate the same or different units, and R 'is as defined so far.
The prepolymer (1) can also comprise a polyorganosiloxane which exhibits, per molecule, at least two C2-Cs alkenyl groups attached to silicon and which has, for example, a viscosity of between 10 and 300 000 mbPars, which can in particular be formed of at least two siloxyl units of formula:
7 YRSIQUe.
(11) where: -Y is a C7-C alkenyl; s such as vinyl, allyl or hexenyl groups, preferably vinyl, -R is a monovalent hydrocarbon group with no unfavorable effect on catalyst activity which is generally chosen from of alkyl groups having 1 to 8 carbon atoms inclusive, such as methyl, ethyl, propyl and 3,3,3-trifluoropropyl, cycloalkyl groups, such as cyclohexyl, cycloheptyl and cyclooctyl groups , and aryl groups, such as xylil, tolyl and phenyl, -de 1or2,0é0,1o0u2ed + te = 1,20uU3,] optionally all other units being units of average formula: R SO,: (IV) in that Rtem the same meaning that above f = 0, 1,20u3.
- Examples of prepolymer (i) are, for example, dimethylpolysyloxanes which comprise dimethylvinylsilla endings, copolymers (methylvinyl) (dimethyl) polysiloxane which comprise trimethylsilyl endings or copolymers (methylvinyl) (dimethyl) polysiloxane which comprise dimethylvinyl endings. An accepted convention in the art to denote units of silicones according to the amount of oxygen atoms attached to the silicon is used here. This convention uses the letters M, D, T and Q (abbreviations for "mono", "di", "tri" and "four") to denote this amount of oxygen atoms. This nomenclature of silicones is described, for example, in the work by Walter Noll, "Chemistry and Technology of Silicones" ”, Academic Press, 1968, 2nd edition, on pages 1 to 9.
The prepolymer (1) can also be a silicone resin containing at least two alkenyl groups, preferably vinyl. This silicone resin comprising at least two different units of siloxane chosen from those of unit siloxane M of formula
Í R3SiO112, siloxane unit D of formula R2SiO2, 'siloxane unit T of formula RSiO3, and siloxane unit Q of formula SiO4 / 2, where R denotes a monovalent hydrocarbon group, under the conditions that at least one of these siloxane units is a siloxane unit T or Q and that at least two of the M, siloxane units D and T comprise an alkenyl group.
The silicone resin can be selected from the group consisting of: - an organopolysiloxane resin of formula MTYQ which essentially consists of: - (a) trivalent T siloxane units "of the formula R'SiO" ; - (b) monovalent siloxane units M of the formula RºSiO " , - and - (c) tetravalent siloxane units Q of the formula Sio * Ú 15 - an organopolysiloxane resin of formula MDY'Q consisting essentially of: '- ( a) divalent siloxane units DY 'of the formula RR'SiO ; - (b) monovalent siloxane units M of the formula RºSiO " , and - (c) tetravalent siloxane units Q of the formula Sio * - an organopolysiloxane resin of the MDDY'Q formula which essentially consists of: - (a) divalent DVi siloxane units of the RR'Si0 formula; - (b) D divalent siloxane units of the formula Rº8i0 - (b) monovalent siloxane units M of the formula RºSiO " , and - (c) tetravalent siloxane units Q of the formula Sio * - an organopolysiloxane resin of formula MYQ consisting essentially of: - (a) monovalent units of siloxane M "of the formula R'RºSIO ' ; and - (b) siloxane Q tetravalent units of the formula SiO * , and
7 - an organopolysiloxane resin of formula MYTY'Q consisting essentially of: - (a) monovalent units of siloxane MVi of formula R'RºSiO " ; - (b) trivalent units of siloxane TVi of formula R'SiO” , and - (c) tetravalent siloxane units Q of the formula Sio * where R denotes a monovalent hydrocarbon group such as methyl and R 'denotes a vinyl group: These resins are well-known branched organopolysiloxane oligomers or polymers which are commercially available They are supplied in the form of solutions, preferably siloxane solutions.
- The prepolymer units (ii) in chain and terminal group of polyorganganhydrogensiloxane are preferably selected from the “15 formulas; il -O-SiRH-O- 'ill —-O - Si Rº »H, more preferably the prepolymer (ii) is selected from the formula ii-lll and ji-IV: i iM Pi-O-SiRH- OP "ii-lV Pi O - Si R $ oH where Pi denotes the remainder of the polymer chain which can incorporate the same or different units and one or more R º groups are suitably selected organo groups independently of Cr1.20 alkyl, aryl Cs.29 and combinations thereof, for example, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl and / or decyl groups.
The prepolymer (ii) preferably comprises a polyorganganhydrogensiloxane - polydiorganosiloxane copolymer, incorporating one or more units i | and / or ii-I | ; il -O-SiRH-O- íi-Il —O - Si Rº2 H and one or more units ii-V and / or ii-VI: ii VO-SiR3-O0- i-VI - O - Si R3 where R is as defined so far, more
- 19/60 - preferably copolymer incorporating polygano-hydrogensiloxane end group units, that is, polymer pre-chain terminated with the group or fraction ii-VIl: ia = Si - H, more particularly with the unit of formula id ll —O - Si R2 H as defined so far.
More preferably, the prepolymer (ii) comprises methyl hydrogensiloxane-dimethylsiloxane copolymers.
The prepolymer (ii) can also comprise a polyorganosiloxane, which exhibits, per molecule, at least two hydrogen atoms bound to silicon and preferably at least three units = SiH and which has, for example, a viscosity of between 1 and 5000 mPar * s, which can be. formed in particular by siloxyl units of the formula: H, x, Sio agi. PDM) where:. -X is a monovalent hydrocarbon group with no unfavorable effect on the activity of the catalyst which is generally chosen from alkyl groups having 1 to 8 carbon atoms including, such as methyl, ethyl, propyl and groups 3, 3,3-trifluoropropyl, cycloalkyl, such as the cyclohexyl, cycloheptyl and cyclooctyl groups, and aryl groups, such as xylyl, tolyl and phenyl, -g = 1or2, preferably = 1, i = 0 , 1 or 2eg + i = 1.20uU3, optionally all other units being units of average formula: XSiO aj 2 (V)) in which X has the same meaning as above and j = 0, 1.2 0u3. Examples of prepolymer (ii) are copolymers of polymethylhydrosiloxanes or methylhydrodimethylsiloxane.
Alternatively or in addition, prepolymers (1) and (ii) are as defined in US 5,153,231 for RTV-2Cavi- Care type compositions, also as defined in US 2006/0217016, US
7 3,928,629 and US 4,529,553, US 4,714,739 and US 2002/0010299 whose contents are incorporated by reference in this document, or as commercially available (Rhodorsil RTFoam 3240, Mepiseal, Silpuran 2111 A / B, Silpuran 2400/18 A / B ), and the like.
In the case where the prepolymer includes other units additional to ill, ilV, iil and jill for example, these are suitably non-reactive with the respective prepolymer at room temperature or under sterilization conditions.
Suitably the ratio of hydrogen atoms linked to silicon provided by (ii) to alkenyl fractions linked to silicon provided by (1) is at least 0.5: 1, preferably 1: 1, Preferably the curable composition modalities if - - follow the cure reaction catalyzed by addition according to the following scheme: 5 Pi RAIA ERATTZÇRAI, + pi - SiHR 2R2º [catalyst] Pi RAI CHRAIA CRATR - SiR2R2Ppi 'more preferably:: RE q nº Pi É + We So ”NR PA Nur catalyst
RR RUP 2 | Né 8 o ”o / N RA CoRAlt RAMO, Á
Is oP where integers are as defined so far and RP is selected from
7 P 'and Rº as defined so far and Rº º is selected from P * and Rº as defined so far.
Suitably the prepolymers (1) and (ii) and the catalyst (iii) are divided into at least one Part A and at least one Part B in order to provide the respective Parts A and B which alone are not reactive at temperature environment, or under sterilization conditions. The division can also be determined according to volume and viscosity. At least one Part A and at least one Part B can be substantially of equal volume and viscosity or of different volume and / or viscosity. Part A or Part B may incorporate a suitable viscosity moderator or diluent, in an amount to increase or reduce the volume and / or viscosity. Hereby Part A and Part B which have different volume and viscosity can be matched in volume and viscosity for improved ease and intimacy to mix and dispense. A suitable diluent is, for example, a silicone oil which is available in any desired viscosity for the purpose of thickening or thinning. Advantageously: it has been found that Part A comprising a silicone oil is sterilizable by radiation with no deleterious effect on the properties of the resulting cured composition.
In the case where Part A is of greater volume and greater viscosity than Part B, Part A can be divided between two or more Parts A1, A2 etc., of equal volume, providing approximately 3 or more Parts A and B in volume equal. Alternatively or in addition, Part B may incorporate silicone oil as a substantially inert diluent and / or thickener.
A catalyst as defined thus far can be any catalyst that is effective in catalyzing the addition cure reaction as defined so far, more preferably as illustrated so far. Suitable catalysts are selected from any known form of platinum, rhodium, palladium, nickel and similarly cured hydrosilylation catalysts, for example, as disclosed in US 5,153,231, US 2006/0217016, US 3,928. 629 and US 4,529,553 whose contents are included
7 incorporated in this document by reference.
A platinum catalyst can be selected from black platinum, platinum as deposited in carriers including silica such as silica gel or carbon such as charcoal powder, platinum chloride or acid chloroplatin and alcohol solutions thereof, acid salts platinum and chloroplatin and platinum complexes such as platinum / olefin, platinum / alkenylsiloxane, platinum / beta-diketone, platinum / phosphine and the like. Chloroplatinic acid can be hexahydrate or anhydrous form. A complex platinum can be prepared from chloroplatinic acid and its hexahydrate, or platinum chloride, platinum dichloride, platinum tetrachloride and its neutralized complexes with divinyletramethyldisiloxane , optionally diluted with polydimethylsiloxane terminal group dimethylvinylsiloxane. - A palladium catalyst can be selected from palladium on carbon, palladium chloride and the like. '15 A rhodium catalyst can be selected from rhodium chloride and one or more rhodium complexes that have the general formula iii-l. or ii: (ii) - RhX3 (SR2); (ill) Rh (CO) .Xz where each X represents a halogen atom and each R represents a radical alkyl or aryl or combination thereof having 1 to 8 including carbon atoms or the R'SiQ group in which Q represents a divalent aliphatic hydrocarbon radical having from 1 to 6 including carbon atoms and R 'represents an alkyl or aryl radical or combination thereof having from 1 to 8 including carbon atoms or a group (CH3a); Si -, not more than one R 'per molecule being (CH3) 3Si. For example, rhodium chloride / complex di (n-butyl) sulfide and the like.
A nickel catalyst is preferably a zero zero nickel selected from MºNico, such as bis (1,5-cyclooctadienyl) nickel - (NI (COD) 2) and MNIºG where M is a hydrocarbon ring cyclic bidentate elk of Cs.12 and G is selected from modulated and bidentate phosphorous groups that have hydrogen atoms, hydroxyl radicals
7 substituted or unsubstituted carbide or mixtures thereof attached to phosphorous atoms of the phosphorous groups. The composition can include a catalyst inhibitor.
Suitable inhibitors are known in the art.
For example, a catalyst inhibitor can be selected from a cyclic polymethylvinylsiloxane and an acetylenic alcohol, such as methyl butinol, for example, as in Cavi-Care, Preferably the composition comprises a reaction retardant by addition or a cross-linking inhibitor chosen, for example, from the following compounds: polyorganosiloxanes substituted with at least one alkenyl which can optionally be in cyclic form, tetramethylvinyl tetrasiloxane being particularly preferred, - organic phosphines and phosphites, Ú 15 - unsaturated starches, - alkyl maleates, and * - acetylenic alcohols.
These acetylenic alcohols (see FR-A-1 528 464 and FR-A-2 372 i 874), which are among the preferred thermal blockers of the hydrosilylation reaction, have the formula: (RNAR ") C (OH) -C = CH in which R 'is a linear or branched alkyl radical, or a phenyl radical; R "is H or a linear or branched alkyl radical, or a phenyl radical; where the radicals R', R" and the carbon atom alpha for the triple bond possibly form a ring; and in which the total amount of carbon atoms contained in R 'and R "is at least 5 and preferably 9 to 20, Examples that can be mentioned include: 1-ethynyl- 1-cyclohexanol; 3-methyl-1-dodecin-3-ol; 3,7,11-trimethyl-1-dodecin-3-ol;
7 1,1-diphenyl-2-propin-1-01; 3-ethyl-6-ethyl-1-nonin-3-ol; 2-methyl-3-butin-2-ol; 3-methyl-1-pentadecin-3-ol.
These a-acetylenic alcohols are commercial products. This retardant is present in a maximum proportion of 3000 ppm relative to the total weight of the polyorganosiloxanes in the silicone composition. Methyl butinol can be chosen as in Cavi-Care.
The composition can be non-foaming or it can be foaming, comprising (iv) a blowing agent, selected from any agent that involves gas or vapor as part of or during the curing reaction, for example , selected from donors - H, OH-containing agents, H-binding agents such as: - alcohols including methanol, ethanol, n-propanol, isopropanol, n-butanol, 2-butanol, tert-butanol, n-hexanol, n-octanol and benzyl alcohol. n- Propanol, n-butanol, n-hexanol and n-octanol being particularly preferred, '- polyols such as diols including, 4-butanediol, 1,5-pentanedio! and 1.7 heptanediol |, - silane or polysilane having at least one silanol group, or - water.
The foaming composition can produce a foam that has any desired porosity or pore architecture. In a particular advantage, a foaming composition provides an open pore foam. A preferred foaming composition is adapted to produce a very high internal free volume foam, for example, in the order of 70% to 90%. Preferred porous foams are mechanically resistant to prevent the foam structure from collapsing in use, most preferably they are adapted to form a cured three-dimensional body which is resiliently deformable.
Preferably, a foaming composition is adapted to provide a foam that cures to form open interfaces with damp or wet surfaces. These open interface foams are suitable for communicating with wound surfaces through the foam body, for example. In a particular advantage, it has been discovered that these open interface foams are supplied by silicone compositions. In an additional advantage the composition is suitable to provide a desired cured porous three-dimensional body.
When the composition is not foam-forming, it can take, after hydrosilylation, a silicone elastomer or a silicone gel. Within the meaning of the present invention, the term “silica gel” denotes a cross-linked silicone product characterized by a penetration rate of, for example, between 20 and 500 tenths of a mm (measured by ASTM D 2137 penetrometer, weight stem and cone: 62.59) When the composition is prepared for a silicone gel it may have at least one non-functionalized polyorganosiloxane comprising: '15 a) terminal siloxyl units of type M = (RÓ); SiO ,, in which the radicals Rº which are identical or different, correspond to an optionally substituted linear or branched C-group; -Cs and / or a substituted or unsubstituted aryl group, and] b) siloxyl-type units Identical or different D = (RÚ) SiO2s in those radicals R 'correspond to the same definition as Rº.
The physical properties of these gels are adjusted according to use by varying the levels of siloxyl units carrying functional groups Si-alkenyl and SiH and when it is present varying the percentage by weight of non-functionalized polyorganosiloxane, which is well known prior art.
To improve the adhesive properties of the silicone gel, the composition may additionally comprise a monofunctional polyorganosiloxane carrying a single Si-alkenyl group per molecule as taught by European Patent application EP-1633830-A2.
In addition, the composition can also comprise inorganic fillers such as reinforcement or bulk fillers. These charges can be supplied in the form of very finely divided products, whose diameter
7 particle average is less than 0.1 µm. These charges include in particular smoky silicas and precipitated silicas; their specific surfaces are generally greater than 10 m / g and generally fall within the range of 20 to 300 m / g.
These fillers can also be supplied in the form of products divided more coarsely, with an average particle diameter greater than 0.1 µm. In particular, mention may be made, as examples of these fillers, of raw quartz, calcium carbonate, diatom silica, calcined clay, rutile titanium oxide, iron, zinc, chromium, zirconia or magnesium oxides. alumina (hydrated or non-hydrated), boron nitride, lithoponium or barium metaborate; their specific surfaces are generally less than 30 m / g.
- The load can have a hydrophobic surface, which can be obtained by treating the load, for example. With suitable silanes, short chain siloxanes, Ú 15 fatty acids or resinous silicone materials. Suitable materials and processes for producing the surface of hydrophobic charges have been described in the literature, and are known to those skilled in the art. The charges can also be made up of a mixture of different types of charges with different particle sizes.
The composition can comprise active agents, which can have any desired activity for the purpose for which it is intended, for example, medically active and similar agents. Suitable active agents or APIs are stable in radiation as defined so far, preferably they are stable under the radiation levels required to obtain sterilization determined from the compositions disclosed in this document. These are commonly selected from antimicrobials and disinfectants such as silver and derivatives including silver oxide, silver nitrate, silver acetate and silver chloride, biguanides including polyhexamethylene and chlorhexidine glucanate and their active agents without acetates , such as pharmaceuticals, biocides, growth factors, hemostats and the like, nutrients, pain relievers and agents to minimize discomfort and similar and combination materials,
7 Antimicrobial agents, biocides and disinfectants can be selected from silver, in particular nano crystalline silver, and derivatives including complexes and silver salts such as ionic silver, silver zeolite, silver oxide, silver nitrate, silver acetate, silver chloride, silver sulfadiazine), biguanides including polyhexamethylene biguanide and chlorhexidine digluconate and its chlorhexidine acetate and diacetate salt acetate, manuka honey, peroxides (eg hydrogen peroxide), iodine (eg. iodine povidone), sodium hypochlorite, copper, copper complexes; zinc (for example, zinc oxide, zinc pyrithione), gold, gold complexes; phosphates, amines, amides and sulfonamides (eg hexatidine, proflavin, mafenide, nitrofurazone, norfloxacin; antibiotics (eg gentamiciine, bacitracin, rifamycin; alcohols and acids (eg. ethanol, phenoxy ethanol, “mupirocin ); known irradiation-stable antimicrobials include chlorhexidine, silver sulfadiazine (SSD) and nano crystalline silver, these are active components of commercially available sterile products "Y, Allevin Ag" and Acticoat ”” respectively; "nutrients, analgesics and other pain management techniques adequately include analgesics and anesthetics and can be selected from ametocaine, lidocaine, non-steroidal anti-inflammatory drugs;
Hemostatics can be selected from chitin, chitosan, kaolin; Antifibrinolytics such as amino acids, aminocaproic acid, tranexamic acid, aminomethylbenzoic acid; Proteinase inhibitors including aprotinin, antitrypsin alfa1, C1 inhibitor, camostat; Vitamin K and other hemostatics including vitamin K, phytomenadione, menadione; Fibrinogens including human fibrinogen; Local hemostatics including absorbable gelatin sponge, oxidized cellulose, tetra-galacturonic hydroxymethylester, adrenaline, thrombin, collagen, calcium alginate, epinephrine; Blood clotting factors including clotting factors
çcãolX, ll, VileX in combination, coagulation factor VIII, contour factor inhibitor VIII, coagulation factor IX, coagulation factor VII, Von Willebreand factor and coagulation factor VIII in combination,
7 coagulation XIII, eptacog alfa (activated), nonacog alfa, thrombin. Systemic hemostats: etamsylate, carbazochrome, batroxobin, romiplostim, eltrombopag; combination materials including superabsorbents, odor management, woven and non-woven Gellable fibers; Growth factors, wound debridement - mechanical, autolytic and enzymatic; Resorbable dressings and microstructure to influence incorporated cells; Cells, tissue (eg autologous treatments); Indicators; Dyes and dyes.
The composition may include additional components selected in addition to adjuvants, preservatives, extenders and the like. Adjuvants are preferably selected from fillers, dyes, colored indicators. Preservatives include propyl gallate.
. Preferably, a composition comprises, by weight percentage: “15 Padeà one or more prepolymers (i) (80 to 99%) Í blowing agent (0 to 10%) a catalyst (> 0 to 5%) Ú preservative ( 0 to 0.1%) ParleB: one or more prepolymers (ii) (94 to 100%) a foam stabilizer (0 to 11%) a catalyst inhibitor (0 to 0.1%) preservative (0 to 0.1%) * diluent or viscosity modifier (0 to 75%) The% volume ratio of Part A: B can be present in a 1:99: 99: 1, for example, 30:70 to 99: 1, respectively with or without added diluent or viscosity modifier. Preferably the% volume ratio of Part A: Part B is present at 30:70 to 70:30, more preferably 45:55 to 55:45, as substantially 50:50. Preferably, Parts A and B are of compatible viscosity which makes it possible to mix and substantially complete their reaction.
7 Suitably the viscosity of Part A: Part B is in the range of 6: 1 to 1: 8, preferably 5: 1 to 1: 5, more preferably substantially
11. Compositions of differing viscosity can be mixed in devices with an increased length mixing head, for example. Sterilization of a composition can induce some increase in viscosity, and therefore the viscosity ratio is preferably that of the post-sterilization parts. Preferably the composition comprises prepolymers that are relatively short in length compared to those of the designed sterile prepolymer. Prepolymers undergo chain elongation during irradiation to a desired final viscosity or density. Preferably the Part A prepolymer (s) that have at least -; one alkenyl unit or fraction per molecule is relatively short in length compared to that of the sterile prepolymer (s) with part A respondents in part A.
Preferably, the respective sterile parts have a viscosity suitable for mixing manually within a period of up to 1 minute. In a particular advantage, Part A and / or Part B may comprise shortened prepolymers that will increase in molecular weight during sterilization to provide species with the desired properties after sterilization. More particularly Part A and optionally Part B comprise prepolymers of determined chain length so that an increase in molecular weight after irradiation sterilization gives the prepolymers a desired molecular weight, viscosity, rheology or similar after sterilization. More preferably, Part A comprises these shortened prepolymers. The shortening is preferably in a percentage that corresponds to the percentage of increase in the molecular weight and viscosity of the Part during sterilization. This percentage will vary according to the chemical nature of any composition provided. For example, for a polydiorganosiloxane composition, the shortening of Part A prepolymers is typically tailored to provide a 9 to 11% reduction in viscosity.
7 and the shortening of the Part B prepolymers is typically in measure to provide a 17 to 23% reduction in viscosity. A predicted problem with dispensing low viscosity compositions at the bottom of the 5 to 300 Pa “s range is to retain the composition in position at a desired location until curing is complete. Low viscosity compositions tend to flow into or away from a desired location during the initial curing period, if not contained. WOZ2004 / 108175 (Molnlicke Health Care AB) discloses the compound problem encountered if the composition is affected by body movements, pressure or friction. Preferably, the composition may have, in the initial mixture, a viscosity within the range of 10 to 120Pa * s, more preferably within the range of 20 to 80 Pa * s. The composition can comprise one or more fillers to impart thixotropic properties to it. A suitable filler can be smoked silica, for example, such as Wacker Chemie,: 15 Wacker HDKTM. VVO2004 / 108175 discloses Wacker HDKTM as especially effective for this purpose. "The prepolymers (1) and (ii) have a crosslinking function, the prepolymer (ii) can also cooperate with the blowing agent to cause foaming.
Most preferably, a composition comprises, by weight of part, a Cavi-Care composition modification listed in document US 5.153.231 example col 7 whose content is incorporated in this document by reference, for example, in which everything from the pre- polymer 1) is moved to Part A: EEA | PDMS with blocked dimethylvinylsilyl, viscosity 64mm 450mmº / s, 0.01mol% vinyl groups | PDMS with dimethylvinylsilyl blocked end, viscous [Gnome Dogemane game Feres Ed
Butyl methyl! | eos | Trimethylsilila “With blocked end polymethyl- 16 Lmcrogersinaro vcosdado Sâmrit, 1, anane mange | hexamethyldisiloxane hydrogen treated with alcohol F (CF2) .CH.CH; OH In a further aspect of the invention there is provided a method for preparing a composition as defined so far from its precursor composition comprising the steps of: combining the prepolymers (1), (ii) and the catalyst (iji) as defined. 5 defined here to form at least Part A and at least Part B as defined so far; and sealing Part (s) A and Part (s) B in receptacles with barrier means as defined so far. : Preferably the combination is with additional components,. 10 by weight percent as defined so far.
In a further aspect of the invention there is provided a method for sterilizing the composition which comprises irradiating at least one of Part A and Part B, more preferably irradiating with X-rays, gamma rays and / or electron beam, more preferably irradiating gamma rays . Preferably the irradiation is in a sterilizing dose, Preferably Part B or both Parts A and B are irradiated. In the event that only one of Parts A and B is irradiated, the other Party is properly sterilized by another known or original means. Sterilization is considered a special process due to the difficulty in checking through retrospective tests that products that have passed through a sterilization cycle they are in fact sterile. Sterilization controls for medical devices are achieved by a combination of validated sterilization processes, selection of appropriate packaging for the sterilization process and the application of quality assurance principles.
7 de for the control of microbial biocharge in raw materials, intermediates, finished products and in the production environment.
Terminal sterilization of medical devices and medical products is performed using gamma-ray irradiation among other processes, as defined in the document BS EN 556 - 1: 2001 Sterilization of medical devices - Requirements for terminally sterilized devices to be labeled sterile.
Using gamma radiation, short wavelength electromagnetic radiation (photons) are emitted from radioactive substances in the nuclear transition process.
Any radiation source can be used for product sterilization, and is preferably the isotope of cobalt 60 (60Co). Radiation sterilization is concerned with the exposure of an item to lonizing radiation under defined validated conditions. - Using electron beam radiation, continuous or pulsed fluxes of high energy electrons are emitted. i 15 The Cobalt 60 radioisotope is the source of energy for use in gamma irradiation facilities and is manufactured specifically for this purpose.
The irradiation process takes place in a specially designed cell, constructed of reinforced concrete often up to two | meters thick, This design ensures that radiation is attenuated so that there is no increase in external background levels.
The Cobalt 60 pellets are sealed inside stainless steel cylinders, referred to as source pencils.
These pencils are placed inside a metal shelf of the fountain located inside the concrete cell.
The fountain shelf can only be in one of two positions: the storage position, which most commonly is inside a deep pool of water, or in the elevated operating position.
During operation, the source shelf is surrounded by product circulating in a conveyor system.
The energies emitted by the decay of Cobalt 60 are insufficient to induce radioactivity in any material, regardless of the extent of exposure to the source. (httpo: /Wwww.synergihealthplc,com/PDF/ Gamma-Processing.pdf) Electron beam processing is well established as a technology to initiate chemical change at a molecular level in
“Polymers presented as thin sections, for example, heat sink tubing and wire and cable insulation. As a result of increased available energy from new generation equipment, this technology has established itself as a valuable addition to the range of sterilization processes available to sterilize medical, dressing and pharmaceutical devices. The generation of electron beams is typically done by means of electron accelerators. Electron accelerators can best be described by analogy with a television tube. A heated tungsten filament forms the electron gun, a high voltage placed through the filament pulls the electrons away from the filament and accelerates them downwards in a vacuum tube. The beam then passes through an oscillating magnetic field that “ sweeps 'the same back and forth (analogous to the horizontal scan: of a TV tube), so that it emerges from the scanning cone through a thin metallic window, usually made of titanium, in a' 15 configuration in fan shape. The products then pass through this electron curtain to receive the required radiation dose, “(http: /www.sinergihealthplc,com/PDF/ Electron-Beam.pdf) X-ray irradiation is appropriate for products that are very dense for electron beam. Much more penetrating than the electron beam, X-rays are very similar to gamma rays generated from cobalt with the key difference that X-rays are powered by electricity. High-energy X-rays are electromagnetic photons of short high frequency wave. They are emitted when high energy electrons are stopped by a material that has a high atomic number.
X-rays are generated using beams of highly energized electron accelerators. Electron accelerators work in a similar way to large cathode ray tubes on old TVs. They accelerate electrons from a plasma around a filament using electric fields for the desired energy (or speed). Consequently, its radiation can be turned on and off. To generate X-rays, the electron accelerator needs to be equipped with an X-ray converter. The X-ray converter is designed to stop electron acceleration and is
7 typically a water-cooled tungsten or tantalum plate in an appropriate mechanical assembly.
Efficiency for X-ray emission increases with electron energy and with the atomic number of the target material. The energy spectrum of X-rays is wide; the maximum photon energy is the same as the kinetic energy of incident electrons. With X-ray energies of 5 MeV and 7 MeV, the penetration into the product is greater than that provided by gamma rays from a non-collimated source of cobalt 60. Both X-rays and gamma rays are photons. They lose their energy in matter in the same way and have a good penetration energy. However, its different production processes lead to different emission characteristics:. The emission of X-rays is concentrated over a dimension, which means that a large fraction of X-rays are emitted in the forward direction. The emission of gamma rays is isotropic. 60Co pencils are usually 'placed on a fountain shelf with 2D extension. : Therefore, the sources of X-rays and gamma rays are different and the dosages in the product will also be different. The dosage is the amount of radiation delivered per unit time such as kGy / min, Simulations based on modeling of sterilization installation with devices | X-ray and gamma-ray doctors show a twice as high dose for X-rays compared to gamma-rays. (http: /Avww.emdt.co.uk/article/x- ray-sterilization-technology-future and http: /Mwww.emdt.co.uk/article/x-ray- sterilization).
The results are determined as the “biocharge”, this being the population of viable microorganisms in a product and / or a package. A product is determined to be “sterile” if it is free of viable microorganisms.
A level of sterility assurance (SAL) is given as the likelihood that a viable microorganism will be present in a product unit after sterilization. SAL is normally expressed as 10th.
e Requirements for terminally sterile devices to be labeled “sterile” are defined as a 10º SAL, or in other words that the theoretical probability of a viable microorganism present in a device is equal to or less than 1 x 10º ( BS EN 556 - 1: 2001 Sterilization of medical devices - Requirements for terminally sterile devices to be labeled as sterile).
An appropriate gamma-irradiation dose for a composition is in the range of 15 to 42 kGy (Isotron). Different irradiation processes (continuous and passing) are adequate. A reduced dose that obtains terminal sterility of the most sensitive parts of the composition is in the range of 15 to 25kGi. Preferably a dose is in the range of kGy +/- 10% or 15 to 20 kGy. "Electron beam irradiation is suitable for sterilizing low-density, low-volume receptacle wall compositions. An appropriate '15 dose is provided by a 10 MeV electron beam (Isotron). The composition can be terminally sterile, or that is, sterilized in its (primary) packaging, or otherwise, for example, aseptically filled in. In a further aspect of the invention there is provided a method for preparing an elastomer comprising combining at least one Part (s) ) A and at least one Part (s) B of a composition as defined so far with curing or crosslinking thereof. The method may be a method for preparing a foam, adhesive or porous seal which comprises combining the hair at least one Part (s) A and at least one Part (s) B of a foaming and / or adhesive or sealant composition as defined so far with curing or crosslinking thereof.
Preferably the method is performed in a sterile field.
In a further aspect of the invention an elastomer is provided which comprises a cured or crosslinked composition as defined herein.
The elastomer is obtained properly by combining at least one Part (s) A and at least one Part (s) B of a composition as
7 defined so far with curing or crosslinking.
The elastomer may be a foam, adhesive or porous seal which comprises a cured or crosslinked foam and / or adhesive or sealant composition as defined herein.
The foam, adhesive or porous elastomeric sealant can be obtained by combining at least one Part (s) A and at least one Part (s) B of a foaming composition and / or adhesive or sealant as defined so far with curing or reticulation of them.
Preferably the elastomer is terminally sterile. By "e-lastomer" is meant the resulting final product obtained after combining or mixing at least one Part A and at least one Part B to form a mixture, with curing or cross-linking thereof. Curing or cross-linking is initiated properly subjecting the low temperature (less than room temperature (around 20 ° C), room temperature (room temperature)] 15 or high (higher than room temperature up to 190 ° C) In a further aspect of the invention medical or non-medical use is provided , dental or non-dental of a composition or elastomer as defined so far.This use includes use as dyes; preservatives; gels; foams; aerosols; pharmaceuticals; adhesives; encapsulants; hair / skin treatment; cosmetic use; dental use ; removable coatings; coatings; adhesives and sealants; wound treatment; skin treatment including scar reduction; caries treatment; medical device encapsulation such as device encapsulation electronic item for biomedical applications; making molds; orthopedic; drug delivery systems including antimicrobial systems; hemostatic and pharmaceutical systems; nutrition including making edibles; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated environment or atmosphere such as those with 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
2 of the above and in particular aerospace, submarine sterile, clean or aseptic, germination or propagation.
A particularly advantageous medical use is as a foaming composition as defined so far. A foam forming composition is particularly suitable for use in wound therapy, more particularly for use as a wound filler or wound dressing material or foam cavity dressing, more particularly in NPTW. The foam-forming composition is particularly advantageous in that it can be used in a sterile field or environment. It is in this field, working in very severe wounds, that the advantages of a disposable moldable foam are most relevant, and even a non-sterile composition cannot be used. gives. Consequently, modalities disclosed in this document make it possible for the first time to use a curable foam composition in a '15 sterile field.
The foaming composition for use in treating wounds or wound therapies is suitable for providing a porous cured resilient three-dimensional deformable body. It is particularly advantageous in providing support for the wound while being compressible as the wound heals and closes.
Preferably the foaming composition provides a cured three-dimensional body with an open pore. In the case of a composition suitable for NPTW, the open pore system allows the development of a negative pressure in the wound, transmitted through the open pore foam body. The fluids from the wound can be evacuated through the foam body.
In foam-based NPTW the wound cavity is filled or covered with a porous foam compress material and covered and sealed with a flexible sheet (a cloth) that is reasonably impermeable to fluids. In NPTW based gauze a corresponding procedure is followed but using gauze pad material in place of porous foam compress material. NPTW based em combined
7 preformed dressing or dressing any procedure can be followed if gauze or foam is used. A vacuum line is inserted under or through the cloth into the wound site and its distal end is connected to a vacuum source (commonly a pump). The wound cavity, closed by the cloth and fabric, contracts under atmospheric pressure and visibly compresses the compress material. The flagrant movement of the tissue ceases after a few tens of seconds and fluid flows from the wound (out of the tissue). The fluid is transmitted through the compress material and through the vacuum line to a collection vessel positioned between the distal end of the vacuum line and the vacuum source. The wound dressing material mechanically supports the tissue to which it is applied, and also allows flow. fluid free away from the site when a vacuum is applied, even when compressed.
'15 Porosity is a function of the amount of pores and their sizes. It can be conveniently measured as a function of "swelling. The foaming composition adequately supplies a foam which has a swelling compared to the composition in the range of 3 to 10. The swelling can be regulated by the choice and quantity of the foaming agent, but it is also a function of the polymer.In a particular advantage the compositions, and in particular the polydiorganosiloxane compositions, provide porosity which is eminently suitable for wound treatment applications. , the body has a very high free internal volume, for example.
70% to 9S90% as defined so far.
Generally, pore sizes affect negative pressure transmission. Therefore, the smaller the pores, the lower the negative pressure that can be established and the shorter its duration when the foam is progressively compressed involving the growth of the tissue. However, the larger the pore size, the lower the tension force, and the smaller the support that the foam is able to provide.
The composition suitably provides a cured foam material that has resilience and stress resistance capable of withstanding negative pressure widely from -40 to -200 mm Hg such as 80 to 120 mm Hg below ambient atmospheric pressure without causing the foam to collapse. In a preferred embodiment the pores are resilient to tissue contraction, and do not collapse under contraction, so that negative pressure can be maintained.
Preferably a foam-forming composition is adapted to provide a foam that is open at its interfaces with damp or wet surfaces, more preferably it is a polydiorganosiloxane composition. This creates the ideal material for generating negative pressure on a wound surface while keeping communication with the wound open.
: The polydiorganosiloxane composition is adapted to selectively provide negative pressure to wet wound surfaces, for example, through an opening or valve that can be readily inserted directly into its remote sealed face to the wound surface or "indirectly" through a vacuum connection tube connected to this: sealed face.
In a preferred embodiment, the pores are resilient to tissue contraction, and do not collapse under contraction, so that negative pressure can be maintained. The composition adequately provides a cured foam material that has resilience and resistance to tension capable of withstanding negative pressure of more than -150mm Hg, preferably 60 to 120mm Hg such as 60 to 100mm Hg below ambient atmospheric pressure, or 80 at 120 mm Hg below ambient atmospheric pressure without causing the foam to collapse.
Preferably a foam-forming composition is adapted to provide a foam that is open at its interfaces with damp or wet surfaces, more preferably it is a silicone composition. This creates the ideal material to generate negative pressure on a wound surface while keeping communication with the wound open. In an additional advantage the composition
7 tion is suitable to provide a desired cured three-dimensional porous body.
The polydiorganosiloxane composition is adapted to selectively provide negative pressure to wet wound surfaces, for example, through an opening or valve that can be readily inserted directly into yours. fassa. vedadasemeila = dsonoedicio = dos hollow gnio.s
7 “stent”, supporting the wound and keeping it open.
Additional medical or non-medical uses for which the composition is particularly advantageous include use as an adhesive or sealant composition as defined so far. An adhesive or sealant composition is particularly suitable for use in clean, aseptic or sterile applications, more particularly as an adhesive or sealant for clean storage or aseptic packaging of items such as medicines, particularly packaging of medicines within a medical device. , or nutritional and similar items, or in the repair and / or maintenance and / or manufacture of sterile, aseptic or clean devices or machinery. Preferably the composition for use as an adhesive or sealant in sterile, clean or aseptic conditions is packaged within "additional barrier means as defined herein. Additional barrier means provide a barrier to infection. Therefore, the composition is a double-wrapped item, this allows the removal of the first sealed sterile packaging layer to reveal receptacles or supports such as cartons for or incorporated into a syringe, strips of adhesive and the like, which are completely sterile inside and outside, making it easier to enter a sterile environment. The composition that omits an additional barrier means must comprise an external non-sterile surface of receptacles or supports and associated barrier means. use the composition using standard medical device conditions as described so far, it should not be possible to take a composition like this within a sterile field.The adhesive or sealant composition is suitable for introducing into a clean or aseptic area and dispensing or releasing on contact with an item to be adhered or sealed. Optionally a closing means is applied to it. For example, a sealant bed can be dispensed in around the mouth of a sterile bottle prior to the application of a closure medium, or to any surface that is desired to seal, A closure medium or other opposite or adjacent surface is applied properly with light pressure to thereby ensure that it is
a seal is produced between the mouth and the cover or other opposite or adjacent surfaces. In this way, a sterile universal seal is made available to the surgeon or clinician, laboratory technician, food manufacturer or mechanic. The seal can be supplied in a double bagged seal applicator and dispensed through a static mixer at the point of use. In this way, a sterile dispenser and sealant can be conveniently supplied to the user. A certain sealant composition can be useful, for example, in the dressing of medical dressings, it is useful, for example, to restrict the exudation of an exudated wound or ingress of infection, or to provide a vacuum seal for application of NPTW; or as a sterile on-site sealing cap for laboratory flasks and other containers (for example, Petri dish lids, sample storage jars, culture flasks, flasks and dewar vessels) under clean or aseptic techniques; or in the aseptic manufacture of packaged nutritional items such as, for example, foodstuffs including milk, fruit juice, egg; or in the repair and / or maintenance 7 or manufacture of sterile, aseptic or clean and similar devices or machinery.
A sealant for medical dressings can be applied in any known or original way. WO 00/74738 (Guiuron) discloses the use of silicone-based RTV-2 compositions to seal wounds to minimize potential infections. Therefore, the sealant of the invention can be used properly by casting over the wound and surrounding the skin allowing healing.
WO2004 / 108175 (Molnlicke Health Care AB) discloses the use of silicone-based RTV-2 compositions for disintegrated skin or skin around wounds to minimize potential infections and protect against the damaging effects of exudated injury. The sealant is used applied to the skin around a wound, or the skin disintegrated, applying an adhesive or non-adhesive dressing on the wound and in contact with the sealant and allowing healing, or applied to an adhesive dressing or not. - sive, applying the dressing to a wound and allowing healing. In any
7 if the dressing is sealed to the skin around the wound, the composition shows an admirable improvement in these methods by providing the surgeon, clinician or patient with sterile sealant for use in these known ways or modifications thereof.
Edibles can be sealed in a container, for example, Tetra Pak as described so far. In this way the sealant can be supplied in bulk for mixing and dispensing on an automated industrial scale (for example, using robotic dispensing systems as provided by Rampíf Dosiertechnik GMBH) under aseptic conditions. Sterile bagged cartridges of the 2 components can be manufactured for insertion in the dispensing machine. In this way, sterile cartridges of the 2 components can be supplied for distribution within the manufacturing area - aseptic and insertion into the dispensing machine. When repairing and / or maintaining machinery, the replacement of gaskets is particularly intended. Here the sealant can be applied to a flange area or sealing surface as a bed prior to joining the "components to form a seal. This reduces the need to sterilize individual gaskets prior to introduction into the aseptic environment and can reduce the need for purchase or manufacture of multiple gaskets In the manufacture of aseptic devices or machinery, the manufacture of spaceships, marine or submarines, or components thereof, is particularly aimed at in order to meet the protection requirements of the planet. sealant can be dispensed to create a gasket in place as defined so far. Alternatively, the foam-forming composition can be dispensed as anti-vibration or insulation material for heat or electrical purposes. The sealant can be supplied in a syringe applicator double bagged and dispensed through a static mixer at the point of use. This way a sterile dispenser and sealant can be provided conveniently for the user. Alternatively, sterile bagged receptacles such as cartridges from the Composition Parts can be supplied for distribution within an aseptic manufacturing area and insertion into a dispensing machine.
In an additional aspect, a wound dressing is provided which comprises the foam or foamed, adhesive or sealant composition or composition as defined herein. In a further aspect, a method is provided to dispense or release, and cure a composition as defined so far, which comprises dispensing within a desired location or opening at curing temperature for the curing time.
The composition can be mixed and dispensed manually. Alternatively, any form of dispensing device can be employed.
Therefore, in a further aspect of the invention, a composition dispensing device is provided which comprises a terminally sterile composition As defined so far. Preferably the device is an NPTW device. Suitably, a device comprises: a mixing head that has a means for receiving 2 or more cartridges comprising Parts A and B. The cartridges are adapted to 'fix and lock in place on the device. A suitable device for NPTW is a two-tube syringe suitable for loading 40g of prepolymer and equipped with a mixing head.
In a further aspect, a method of therapy is provided which comprises dispensing a sterile composition as defined so far, preferably a terminally sterile composition, at the site of an injury.
In a further aspect a therapy method as defined herein is provided which is a negative pressure wound therapy method which comprises dispensing a terminally sterile composition as defined so far directly or indirectly within a wound and allowing foam and heal, sealing the wound including the cured foamed composition and optionally including a negative pressure connection means, and applying negative pressure to the wound.
The composition can be dispensed directly into an open and covered wound cavity or dispensed into a cavity.
7 covered by an opening in the cover or dispensed into a mold and inserted into a wound cavity.
An open pore surface or surface recess is generated which can be connected directly or indirectly to a source of negative pressure.
The currently available wound fillers require removal and cleaning or replacement on a regular basis, typically every 8, 12 or 24 hours, with the maximum recommended period for a dressing to remain in place being 48 hours in the case, for example, foam, up to 72 hours for black foam, and 72 hours for gauze.
After longer periods, tissue incorporation may occur.
In the case of foam, the washed dressing can be reused for up to a week, but when the wound healing progresses, filling can be produced. successively smaller costs.
In a particular advantage, the composition can be dispensed: 15 from within a wound prepared in a sterile field and can remain in place without the need for cleaning and replacement due to the molding process being simplified and highly accurate, in instead, the used filling is discarded and a new filling is simply dispensed.
The degree of contraction that has occurred in the tissue can be determined by monitoring a reduction in the negative pressure that is provided or by a reduction in the resilient deformation of the cured composition, and if sufficient contraction is observed, the cured composition can be removed and new composition dispensed within the wound to continue therapy.
The curable foaming composition preferably has a pore structure that is capable of being compressed under moderate pressures, when the tissue contracts, without pore collapse.
The composition can be mixed and dispensed manually.
Alternatively, any form of dispensing device can be used.
Therefore, in a further aspect of the invention, a dispensing device for the composition is provided which comprises a terminally sterile composition as defined so far. Preferably the device is an NPTW device.
Suitably a device that compares
'comprises a mixing head which has the means to receive 2 or more cartridges comprising Parts A and B.
The cartridges are adapted to install and lock in place on the device.
A suitable device for NPTW is a 40g mixing head. In an additional aspect a method is provided to treat an injury site, which comprises: dispensing a terminally sterile composition around at least a part of the injury site, wherein the composition comprises a seal capable of making a substantially liquid-tight seal; cover the wound site with a substantially fluid-tight cloth, where the cloth contacts at least part of the composition terminally sterile dispensing and forms an airtight seal flowing over the wound; and applying negative pressure to the injury site using a negative pressure source connected to the injury site. Preferably the composition comprises a first part and a second part.
Preferably, the method further comprises curing the composition during or after covering the wound site.
Preferably the method further comprises placing a padding such as foam, gauze or the like within the wound site.
The cloth adequately comprises an opening to thereby connect the source of negative pressure.
The opening can be positioned centrally, to one side or at the perimeter of the cloth.
The method may additionally comprise creating at least one opening within or under the cloth to thereby connect the source of negative pressure.
Preferably, the terminally sterile composition is sterilized before dispensing, exposing the composition to radiation in a thermally sterilizing dose.
Preferably the thermally sterile foaming composition is a composition as defined so far.
In a further aspect of the invention, a method is provided
7 to treat an injury site, which comprises: applying a dressing to an injury site releasing a first part A of a terminally sterile composition from a support around at least a part of the injury site and exposing a second part, exposing a second part B of a terminally sterile composition supported on a fluid airtight cloth, cover the wound site with the cloth, in order to thereby contact and adhere the first and second exposed parts and adhere the cloth around the wound site; and applying negative pressure to the injury site using a negative pressure source connected to the injury site. . It is predicted that the range of negative pressure for certain modalities of the present invention can be between approximately -20 mm It is 15 Hge-200mm Hg (note that these pressures are relative to the normal ambient atmospheric pressure, therefore -200 mm Hg should be approximately 560 mm Hg in practical terms). Appropriately, the pressure range can be between approximately -40 mm Hg and -150 mm Hg.
Alternatively, a pressure range of up to -75 mm Hg, up to -80 mmHg or above -80mm Hg can be used. A pressure range of below -75 mm Hg could also be used appropriately.
Alternatively, a pressure range above -100 mm Hg or above - 150 mm Hg could be used. | It will be appreciated that according to certain embodiments of the present invention the pressure supplied can be modulated over a period of time according to one or more desired and predefined pressure profiles.
For example, this profile may include modulating the negative pressure between two predetermined negative pressures P1 and P2 so that the pressure is kept substantially constant at P1 for a predetermined period of time T1 and then adjusted accordingly by varying the work pump or restricting the flow of fluid or the like, to a new preset pressure P2 where the pressure can be maintained substantially
7 tially constant for an additional predetermined period of time T2. Two, three or four or more predetermined depression values and the respective time periods can be used optionally. Appropriately, pressure flow profiles can also be provided in more complex wave amplitude / frequency forms, for example, sinusoidal, toothache, systolic-diastolic or similar.
In a further aspect of the invention, a wound dressing is provided which comprises the foaming composition as defined so far. Preferably the wound dressing is an NPTW wound dressing. In a further aspect of the invention, a NPTW kit is provided which comprises a fluid-tight wound dressing, a terminally sterile dispensable or releasable curable composition and a fixing means for a vacuum pump to provide negative pressure. for dressing, preferably the terminally sterile curable composition is a composition of the invention as defined so far. 'Modalities of the invention will now be illustrated in a non-limiting manner with reference to the Figures in which Figures 1 and 2 illustrate an NPTW foam-filled wound dressing; Figures 3 and 7, 8, 9 and 10 illustrate the use and application of a wound dressing with a sterile foam filling dispensable on a patient; Figures 4, 5 and 6 illustrate a set including a sealing and wound dressing composition; Figures 11 to 15 illustrate the use and application of a modality of a set of cover, device and wound seal in a patient. l Now referring to Figure 1, in conventional foam-based NPTW the wound cavity (1) is filled or covered with a porous foam compress material (2), which may need to be cut to the shape (2x shown as a) and covered and sealed with a lamina
7 that of flexible adhesive (a cloth, 3) that is reasonably impervious to fluids.
With reference to Figure 2, a vacuum line (4) is inserted (5) under or through the cloth (3) into the wound site (1), in various ways it is received in an opening or crack in the foam ( 6), or wrapped in gauze.
The distal end (not shown) of the vacuum line (4) is connected to a vacuum source (commonly a pump, not shown). The wound cavity, closed by the cloth and tissue, contracts under the force of atmospheric pressure and visibly compresses the filler or dressing material.
However, the system tends to leak vacuum.
In Figure 3A, a sterile foam-forming composition (10) is shown being dispensed from a syringe (11) inside the site of: injury (1). In Figure 3B, the composition cures once dispensed to form a foam (12) that contacts the wound bed (1). In Figure i 15 3C, a cloth (3) is placed over and sealed in place in a conventional manner. The vacuum line (4) is inserted (5) through the cloth (3) in a conventional manner that the vacuum can be initiated through the vacuum line (4) .The wound cavity behaves correspondingly as described in Figure 2. This system improves the fit of the foam filling, and reduces the stresses placed on the cloth. adhesive seal.
Figure 4A illustrates a composition for use as an NPTW seal.
Sealant (20) is used by applying skin close to or around an injury site (1), or disintegrated skin.
Adhesive or non-adhesive cloth (3) is applied, with optional dressing (not shown) on the wound (1) and in contact with the seal (20) and the seal is allowed to heal in contact with the cloth.
The vacuum line (4) is inserted through an opening (5) in the cloth (3) in a conventional manner so that the vacuum can be started via the vacuum line (4). The seal improves the quality of the negative pressure transmitted to the wound bed.
Figure 5 shows a variant of Figure 4, in which pump (8) is removably connected (5a) through the opening (5b) in the cloth (3). Figure 6 shows an additional variant in which pre-cloth
7 formed (33) incorporating the integral vacuum line liner (34) and opening (5) is positioned over seal (30) applied through syringe (11). In this case the cloth (33) incorporates an adhesive layer (39), and therefore the seal is either dispensed around the wound in a conventional manner as shown in step 3, or the seal (33) is dispensed at the edges of the adhered cloth (33 ) as shown in step 4, Figures 7 to 10 show an additional variant to Figures 3A to 3C, in which the cloth (3) is placed over the wound site (1) before the composition (10) is dispensed from the syringe (11) through the opening (5). The composition forms the foam and cures to form a foam block (12) including the button (13) that protrudes through the opening (5). The button (13) is broken to provide an opening within the foam body.
Figure: 10 shows the vacuum line (4) coupled to the opening (5) and connected to the vacuum pump (8) in a conventional manner. '15 Figures 11 to 15 show variants to Figures 4a, 5 and 6, related to the dispensing of seal 20 to seal the combination of dressings / cloths (2a, 3) including the integrated door (5) for the vacuum line (4). For these dressing combinations (2a, 3) it is necessary to dispense the veil (20) in the skin region (1a) that will be under the part of the perimeter of the dressing (3) involving the dressing part (2a) , as shown in Figure 15. In the case where it is difficult to predict where this part of the perimeter will make contact with the skin (1a), it is advantageous to dispense around the edge of the dressing combination (2a, 3), as in Figures 11 and 12. An alternative seal (20) can be dispensed at the edge of the cloth in positions where they can be observed or if there is a suspicion that there may be leaks.
Alternative sealant (20) can be dispensed directly from the dressing combination, also shown in Figure 15, as a seal (2), and the dressing can then be applied over the wound.
In all cases, strips of adhesive tape (3a) can be overlaid to ensure both satisfactory adhesion and sealing.
In all cases, curing, sealing and vacuum operation are as previously described.
The invention can be carried out in practice in several ways, and the modalities of which will be described by way of example only,
7 COMPARATIVE EXAMPLE Example CE 1 Composition preparation Polydimethylsiloxane composition RTV-2 Cavi-Care is a commercially available Pt RTV-2 catalyzed foam forming silicone (Smith & Nephew) that has a growth time of 30 to 105 seconds, packaged as Parts A and B in bags of foil formed from laminated aluminum foil on either side with PE. Rhodorsil RT 3240 A / B foam (Bluestar Silicones) is a Pt RTV-2 catalyzed foam forming silicone elastomer that has a growth time of 7.5 minutes. Sterilization »The compositions were subjected to gamma irradiation using a source of Co irradiation and electron beam irradiation in 10MeV,“ 15 in 10.15, 20 and 25KkGi, After sterilization the following was determined and compared "with non-sterile polymer : Viscosity In each case, Part B of the composition formed a solid elastomer (gamma) and suffered an increase in viscosity (electron beam).
Part A of the composition experienced an increase in viscosity with any radiation medium, with gamma rays in 25 to 42 kGy, the increase in viscosity was 230% (Cavi-Care) or 850% (Rhodorsil).
Curing Cavi-Care and Rhodorsil Part B irradiated with gamma rays cannot be subsequently reacted to provide an acceptable cured foam product. Cured Rhodorsila Part A irradiated with non-irradiated Part B provided an unacceptably long cure time in the case of gamma rays and electron beam. Density and compressibility of the foam not tested. Sterility test í This was not tested since the sterile composition was not curable.
It is expected that the gamma irradiation dose has achieved sterilization.
EXAMPLE 1-A two-part composition and a method for its preparation will be described hereinafter 'The viscosities of the examples below correspond to an amount of dynamic viscosity that was measured, in a manner known to you, at 25ºC . The viscosities were measured using a Brookfield viscometer according to the instructions of the standard AFNOR NFT 76 106 of May 1982. These viscosities correspond to a quantity of "Newtonian" dynamic viscosity at 25ºC, that is, the dynamic viscosity is. measured, in a manner known to you, in a shear rate gradient that is low enough for the measured viscosity to be independent of the rate gradient. Some two-component "compositions were prepared comprising Parts P1 and P2, whose compositions are described in Table 1:. 1) Components in Part A of the tested compositions: -M = (CH3); SiO12, MY = (CH3) J VISIO, or (CH = CH -) (CH3) -SiO 1/2, DY = (CH3) (ViSiO22 or (CHi = CH- (CHa) SiO22 and Q = SIO42 -a: vinyl polyorganosiloxane resin comprising siloxyl groups M, DY and Q (also named as “MDYQ” resin) with: -b1: polydimethylsiloxane blocked at each end of the chain by a MY unit and having a viscosity of 3500 mPasa25C.
-b2: polydimethylsiloxane blocked at each end of the chain by a MY unit and having a viscosity of 100,000 mPa.s at 25ºC, -b3: polydimethylsiloxane blocked at each end of the chain by a MY unit and having a viscosity of 1 500 mPa.s at 25ºC, -b4: blocked polydimethylsiloxane at each end
c 53/60 * of the chain by a MY unit and having a viscosity of 230 mPa.s at 25ºC. -c1: diatomaceous earth, sold under the trade name CE-LITE-SFO. - c2: Smoked treated silica with a low specific surface area of 30m2 / g (BET), sold under the trade name AEROSILO RISO - d: Hexanol. - e: Karstedt platinum catalyst. -f1: polydimethylsiloxane blocked at each end of the chain by an M unit and having a viscosity of 1000 mPa.s at 25ºC. -g: poly (vinylmethyl) (dimethyl) siloxane oil having a content of. DY 'unit of 2% by weight and a MY unit content of 0.4% per | Weight. | 15 2) Components in Part B of the tested compositions: -a: Vinyl polyorganosiloxane resin comprising groups' siloxyl M, DU and Q (also named as «MDVIQ» resin). - b1: polydimethylsiloxane blocked at each end- | chain lengths by one (CH3) 2VISION, »and having a viscosity of
3,500mPasa25C. | - b2: polydimethylsiloxane blocked at each end of the chain by a (CH3) 2ViSiO unit, and having a viscosity of
100,000 mPa.s at 25ºC. | -f1: polydimethylsiloxane blocked at each end of the chain by a (CH3) 3SiO ,, unit, and having a viscosity of
1,000 mPa.s at 25ºC. -f2: polydimethylsiloxane blocked at each end of the chain by a (CH; 3) 3SiO ,, unit, and having a viscosity of
100,000 mPa.s at 25ºC. - | i: polydimethylsiloxane oil blocked at each end of the chain by a (CH3) 2HSiOyg unit 5. - h: polymethylhydrogensiloxane oil blocked at each | O
7 ends of the chain per one HSiOnp (CH3) unit, 5. -j: solutions comprising 1% ethynylcyclohexanol in a polydimethylsiloxane oil blocked at each end of the unit chain (CH3), VISIO, having a viscosity of 600 mPa.sa 25 € The tested compositions are described in Table 1 below: Table 1: COMPOSITIONS: Parts by weight at 15.09 12.51 12.49. E | a | : Fe [Ml 1488) 208) 4a: ld | 36 | an | 36 | 36 and | on | om | on | on | . RR A RC O O Ex.1 Ex.2 Ex.3 Ex.4: Po = [a [ag
MR ND O A O ii cc cc / 1768] namo ra | 1768 lh 45.45 45.45 a Ho Weight ratio Part A /
- [these | 66 [65 [E7TComparison | Es | 4676 ie sa Ts Bee =] - Fo
ER ART 05 | Rs as TO to Fes TO
DR RA AA RREO [ar rm | o as as o RE ass [as and PO rs es | 6: me - | 455 l FPA AE. Weight ratio Part A / 100 / 24.9 | In Example 6, the composition was made by mixing the three Parts A, B and C (Part C components are indicated by “*"). Examples 1 to 7 are foam formations. Example 8 is not foaming. 3) Sterilization and cross-linking Parts A and B were irradiated by gamma rays, electron beam or X-rays in various doses including between 10kGi to 35kGi. After sterilization, each Part was then mixed with the corresponding part, sterilized (or not) sterilized as in Example 6 or B8), according to the reason mentioned in Table 1. After curing, the resulting solid elastomers or foams are evaluated and compared with non-sterile elastomers (results recorded in Tables 2a 5).
7 4) Tests As shown by the results of Examples 1, 2, 3,4 and 6, it is possible to irradiate Parts A and B by gamma rays, electron beam or X-rays even at high doses (10kGi to 35kGi) with none or slight acceptable increase in viscosity.
In addition, the properties of elastomeric foams are similar to those of non-sterile foams.
The addition of inert silicone oil as a diluent for Part B allowed the viscosity and volume of Parts A and B to be balanced. Comparative Example 7 demonstrates that the presence in Part B of polysiloxanes having SiH units and of polysiloxanes having units SiVinil leads to prepolymer gel or cured after Part B sterilization.
Therefore, it is not possible to mix Parts A and B in order to produce the foam.
Do not . However, Example 5 demonstrates that the presence of 0.5% by weight of a polydimethylsiloxane blocked at each end of the chain by a (CH3) 2ViSiO, (M ”') unit is acceptable.
Table 2: Lcetataçen irradiation technique | the [toe ass | the wing] sound | ERSaENDOEINEO:
7 Table 2 (cont.) Lo] een - | Irradiation dose in Part A (kG | | wing | Irradiation dose in Part B (kG Do 254 | Viscosity of Part A (mPa.s. 1600 5200 Viscosity of Part B (mPa.s 1700 2700 Density of cured foam (g / = 0.24 0.26 in Hardness after 15 "at 23ºC (Sh00 25 Hardness after 1 day at 23ºC (Sho0 41 Manual kinetics at 23ºC 2'55" Table 3 'Read it Jeenmes Beam of irradiation technique None | X-rays | None | Range 7 electrons Irradiation dose na: 26.3 25.1 18.1 to 31.3 Part A (kG 'Irradiation dose na 24.4 251 | 181a31.3 Part B (kG: Viscosity of Part À 5300 17300 1700 3800 3000 mPa.s) Viscosity of Part B 1600 2700 50 150 mPa.s: Foam density 0.19 0.23 0.19 0.26 0.24 cured (g / cm Hardness after 15 "at 13 18 22 25 25 23ºC (Sh00 Hardness after | day at 31 33 40 39 42 23ºC (Sh0o0 Manual kinetics at 23ºC 230 "240"
Í Table 3 (cont.) Example 6 (part 3 has not been irradiated Beam of irradiation technique None | Electron range Dose of immaciation in Pane ne - fo oa Dose of irradiation in Part B (kG: EE 25.2 to 30.4 Viscosity of Part A (mPa.s 5120 5120 5120 Viscosity of Part B (mPa.s <5000 <5000 <5000 Density of cured foam (g / em 0.18 Hardness after 15 "at 23ºC (Sh00 lo oo - Hardness after 1 day at 23ºC (Sh00 37 Manual kinetics at 23º 5 dass Jaco Table 4 Electron beam- Irradiation technique None | Gamma Gamma 7 trons Irradiation dose in Part A. 10.1 23.7 to 23.8 kG: Dose of irradiation in Part B ”10.1 25.0 226 to 23.1 Viscosity of Part A (mPa.s; 5120 6960 45200 | 11000 Viscosity of Part BimPas) 5600 - Íes [eira je => Density of cured foam 0.17 1/1 g / cm ”Hardness after 15º to 23ºc (snoo jo df Hardness after 1 day at 23ºC 38/1 1 Shoo 23% manual kinetics As shown by the results in Table 5, it is possible to irradiate Parts A and B by rays gamma or electron beam even at high doses s (25kGi) with no or slight acceptable increase in viscosity.
Besides that,
'the properties of elastomers are similar to those of non-sterile polymers. Table 5: Example 8 (non-foaming; Beam - Beam of Irradiation Technique None | Range Electron electron Range of radiation at 25.1 18.1 to 31.3 o Part A (KG Dose of radiation at 181 a 25.1 18.1a31.3 | 25, Part B (kG 31.3 Viscosity of Part A 2400 5100 3800 2400 | 2400 mPa.s. Viscosity of Part B 1800 2500 2400 | 2500. MPa.s Density of foam 2h05 / / 2ho05 | 2h10: cured (g / cm Hardness after 1h at 35 1/34 30 '150ºC (ShA
TIS Mechanical properties 1.8 1/17 12 MPa E / B (%) | 144 1 1 136 after 1h a
THS 150ºC 2,2 / / 2,3 2,3 Nimm Example 3 - Determination of contaminant tolerated in the prepolymer (i) in PartB The compositions were prepared incorporating different amounts of vinyl in Part B and irradiated by gamma rays or a beam of electrons in 25 kGy. The tested compositions are described in Table 6 below:
7 Table 6: COMPOSITIONS: Parts by weight Components Part A Example 9 to 15.01 b1 45.02. TT .b3 35.00 IT'S
E: e Components Part B [sm] o; 2775. s i 27.75 h 71.26 'Weight ratio Part A / Part (s) B 86.3 / 13.7 The results are as follows: - Effect of irradiation% weight (1) on Part B | H / Vi ratio Example - 7 | unacceptable <1000 - Comparison Example 9 acceptable, slight effect on | (1% short chain | 10000 density (0.18 to 0.28) | Vinyl) 15000 Example 5 acceptable 0.5% long chain | 80000 a ga = Example 5 120000 These results show that a low level of prepolymer (1) is acceptable in PartB, which is insufficient to influence the properties of the composition. A limit level was determined at which the prepolymer (1) is unacceptable in Part B. In the ratio H / Vi = 2,000 the properties of Part B are changed but the composition remains functional. Within this limit level, at the ratio H / Vi = 5,000 the properties of Part B are minimally changed and the function is good. Within this preferred level, at H / Vi = 10,000 the properties of Part B are substantially unchanged and the function is excellent.

权利要求:
Claims (19)
[1]
1. Curable composition divided between at least one Part A and at least one Part B, wherein at least one Part A comprises: (i) one or more polymers containing alkenyl group having at least one, or at least two, alkenyl groups or fraction per molecule, and in which at least one Part B comprises: (ii) one or more polymers containing Si-H that have at least one, or at least two, units or fraction of Si-H per molecule; wherein the COMPOSITION further comprises: (iii) a catalyst for curing by adding polymer containing alkenyl (i) to the polymer containing Si-H (ii), and optionally (iv) a blowing agent, selected from- from any agent that develops gas as part of or during the cured reaction, where polymer (ii) is absent from Part A and polymer (i) - is substantially from Part B or Part B incorporates a trace of polymer (i) represented as a molar fraction (unit or fraction of i SiH) / (unit or alkenyl fraction) greater than or equal to 2000.
[2]
A composition according to claim 1, wherein the at least one Part A comprises catalyst.
[3]
Composition according to any one of claims 1 and 2, which is terminally sterile, being characterized by a sterility safety level (SAL) equal to or less than 10º or in other words - words that the theoretical probability of a micro - viable organism present in a device is equal to or less than 1 x 10-º.
[4]
4. Curable composition, according to any one of claims 1 to 3, in which either each Part A and / or each Part B is sterilized by irradiation, preferably selected from gamma rays, x-rays and electron effect and their combinations .
[5]
5. Curable composition according to any one of claims 1 to 4, in which polymers (i) and (ii) are selected from a. two s' silicones, including modified siloxanes and siloxanes, polyurethanes (PU) including polyester and polyether urethanes, elastomeric polyether polyesters, polyglycolic acid, polyacetates such as ethyl vinyl acetate, polyacrylate, polysaccharide-derived polyacids, such as carboxyalkylcellulose, carboxyalkylcellulose, carboxyalkylcellulose, carboxyalkylcellulose. chitosan and copolymers thereof, and their hybrids including copolymers, entangled systems and mixtures thereof.
[6]
6. Curable composition, according to any one of claims 1 to 5, which makes use of a curing reaction by addition between organohydrogensiloxane units and organoalkenylsiloxane units optionally incorporated in polymeric, copolymeric, entangled polymers and mixed as defined in claim 5, wherein the polymers (i) and (yl) are organosiloxanes, preferably polyorganosiloxanes.
[7]
7. Curable composition, according to any one of claims: 1 to 6, in which Part A or Part B incorporates a viscosity moderator or diluent, in quantity to increase or reduce the volume and | or viscosity, for example, a silicone oil in any viscosity - desired for the purpose of thickening or thinning.
[8]
Composition according to any one of claims' 1a7, wherein the viscosity of Part A: Part B is in the range of 6: 1 to 1: 8, preferably 5: 1 to 1: 5, more preferably substantially 1: 1, and for which the sterilization of a polymer can induce some increase in viscosity, and therefore the viscosity ratio is preferably that of the post-sterilization parts
[9]
9. Curable composition, according to any one of claims 1 to 8, for medical or non-medical, dental or non-dental use including use as dyes; preservatives; gels; foams; aerosols; pharmacists; stickers; encapsulants; hair / skin treatment; cosmetic use; dental use; removable coverings; coatings; adhesives and sealants; wound treatment including dressing; skin treatment | 30 including scar reduction; caries treatment; encapsulation of medical device such as encapsulation of electronic device for biomedical applications; making molds; orthopedic; administration systems
Medication traction including antimicrobial systems; hemostatic and pharmaceutical systems; nutrition including making edibles; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated environment or atmosphere such as those that have 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, underwater, sterile, clean or aseptic, germination or propagation, including use as foams, aerosols, adhesives, removable coatings, coatings, adhesives and sealants, treatment of wounds in relation to NPWT, more particularly in a sterile field or environment, including use as a wound filler material or compress or dressing material, adhesive or foam sealant for cavity; and use as an adhesive material or sealant for filling negative pressure wound therapy, in which at least one Part A and at least one Part B are adapted to be dispensed cooperatively facilitating intimate contact and healing of the same and formation of a porous foam that is capable of transmitting negative pressure, adhering to a negative pressure wound therapy cloth or that is air tight.
[10]
10. Curable composition, according to any of the claims | to 9, which when dispensed in a location where the location takes the form of a device comprising a mixing head that has the means to receive 2 or more cartridges comprising the respective Parts A and B.
[11]
A method for preparing a composition as defined in any one of claims 1 to 10, comprising the steps of: combining polymers (i) and (1), catalyst (ii) and optional blowing agent (iv) as defined here to form at least Part A and at least Part B as defined so far.
[12]
A method for sterilizing a composition as defined in any of claims 1 to 10, which comprises irradiating the Parts of the composition, preferably with gamma, X-ray or electron beam irradiation in a sterilizing dose or irradiating at least one of Part A and Part B and sterilize the other Part (s) of them by alternative means.
[13]
13. Method for preparing an elastomer comprising combining at least one Part (s) A and at least one Part (s) B of one | composition as defined in any one of claims 1a10, with curing or cross-linking thereof.
[14]
14. Elastomer comprising the curable or crosslinkable composition as defined in any one of claims 1 to 10.
[15]
15. Medical or non-medical use of a terminally sterile composition or terminally sterile elastomer as defined in any “of the claims | 10 or 14 selected in particular from use as dyes; preservatives; gels; foams; aerosols; pharmacists; adhesives; encapsulants; hair / skin treatment; cosmetic use; dental use *; removable coverings; coatings; adhesives and sealants; wound treatment; skin treatment including scar reduction; ] caries treatment; encapsulation of medical device such as encapsulation of electronic device for biomedical applications; making molds; orthopedic; drug delivery systems including antimicrobial systems; hemostatic and pharmaceutical systems; nutrition including the manufacture of edibles; aerospace, marine and subsea applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated environment or atmosphere such as those with 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.
[16]
16. Composition dispensing device having a composition as defined in any one of claims 1 inside
Ú to 10.
[17]
A device according to claim 16, wherein the device comprises a device comprising a mixing head that has means for receiving 2 or more cartridges comprising Parts A and B, or comprises a syringe with two tubes suitable for loading with 40g of polymers and equipped with a mixing head.
[18]
18, Composition according to any one of claims 1 to 10, for use in a method for treating an injury site comprising dispensing a foaming composition as defined in any one of claims 1 to 10 within at least a part of the wound site, where the foaming composition forms a porous foam material that is capable of transmitting negative pressure; dispensing the composition as defined in any one of claims 1 to 10 around at least a part of the injury site, wherein the composition comprises a first part and a second part which when combined form a material capable of making a substantially liquid-tight seal and covering the wound site Ú with a substantially fluid-tight cloth, wherein the cloth covers at least a portion of the dispensed composition; or applying a dressing to an injury site to release a first part of a composition as defined in any one of claims 1 to 10 from a support around or around at least a part of the injury site and exposing said part , expose a second part of a composition supported on a fluid-tight cloth to cover the wound site with the cloth, in order to thus contact and adhere the first and second exposed parts and adhere the cloth around or around the injury; wherein the method further comprises forming a fluid tight seal over the wound; and apply negative pressure to the injury site using a source
Ú of negative pressure connected to the injury site. apply negative pressure to the injury site using a negative pressure source connected to the injury site. seal the injury site with a substantially liquid hermetic seal, and apply negative pressure to the injury site using a negative pressure source connected to the injury site.
[19]
19. NPTW kit comprising a fluid-tight wound dressing, a dispensable or releasable curable or curable foaming composition, curable adhesive or sealing composition or elastomer as defined in any of claims 1 to 10, 14 and 16 to 18 and fixing means for a vacuum pump to provide a negative pressure to the dressing. .
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US20130310781A1|2013-11-21|

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JP2014505118A|2014-02-27|

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CA2819032C|2020-06-23|

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EP2643412A1|2013-10-02|

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US20200254139A1|2020-08-13|

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AU2011333538B2|2015-04-16|

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法律状态:
2020-10-27| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: REFERENTE A 8A ANUIDADE. |

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2021-02-17| B08K| Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]|Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2599 DE 27-10-2020 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |

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2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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GB1019997.4|2010-11-25|

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GBGB1019997.4A|GB201019997D0|2010-11-25|2010-11-25|Comopition I-II|

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GB1104512.7|2011-03-17|

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GBGB1104512.7A|GB201104512D0|2011-03-17|2011-03-17|Composition I - lla|

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PCT/GB2011/001652|WO2012069794A1|2010-11-25|2011-11-25|Composition i-ii and products and uses thereof|

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