Skin-compatible silicone composition

Abstract

To provide a skin adaptable silicone material which can be adhered to a skin of a mammal, an ostomy coupling including the material, and a method for producing the silicone material.SOLUTION: There is provided a skin adaptable silicone material which can be adhered to a skin of a mammal, the skin adaptable silicone material comprises: a silicone polymer network which is obtained by additional hardening of a vinyl functional siloxane polymer and a silicon hydride-containing cross linking agent, in the presence of a metal catalyst; sodium polyacrylate fine particles which are dispersed in the polymer network, absorb a moisture from a skin and are swollen in the silicone polymer network; and a permeability modified polymer which includes a hydrophobic domain and hydrophilic domain, and is polyester being configured to contribute to moisture management characteristics of the silicone material.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Field of the Invention The present invention relates to an adhesive skin-compatible composition, and more particularly, but not exclusively, to a skin adhesive component suitable for coupling an ostomy appliance to the skin area around the stoma of an ostomate.

[0002] Background Art An ostomate who has had an ileostomy, colostomy, or urostomy needs to attach a collection container, such as a bag, around the stoma, which is an artificial opening that exits the person's abdomen. Typically, the collection bag is secured to the skin around the stoma by an adhesive disk that may need to be changed several times a day. Frequent removal of the adhesive disk causes skin irritation and damage, and thus ostomy couplings have been developed in an attempt to increase comfort and improve health. An ostomy coupling configuration, generally referred to as a "two-piece" system, comprises a first coupling part to which an ostomy bag for receiving stoma effluent is attached, and a second coupling part (removably connectable to the first coupling part) provided on a substrate (or wafer) that can be adhered to the skin around the stoma. Thus, the ostomy bag can be easily replaced without having to remove the substrate from the skin. Many different types of coupling configurations have been proposed to maximize seal strength and minimize unwanted leakage. Exemplary two-piece ostomy bags are described in EP 0687166, EP 1959881, US 4,846,798, WO 93 / 18725, and EP 0334489.

[0003] However, since a person needs to wear an ostomy coupling continuously, The coupling configurations for both the two-piece and one-piece components need to be completely replaced at regular intervals due to the uptake of moisture that causes erosion and destruction of the adhesive disk when in contact with the skin. As will be understood, deterioration of the coupling wafer is highly undesirable as it compromises the hermetic contact with the skin. Conventionally, the adhesive disks of ostomy appliances contain a hydrophilic colloid that has a high absorption capacity and is generally benign when in contact with the skin for extended periods. However, conventional disks are disadvantaged due to their erosion and destruction by the uptake of moisture. Further, such systems can easily remove the coupling without causing skin irritation, but cannot provide the exact balance of requirements for a secure seal that should be maintained around the stoma during attachment. Considering the regularity of replacement required even for two-piece configurations, the compromise between adhesion and detachment cannot be found in such conventional systems. Accordingly, what is needed is a coupling component or configuration that promotes patient safety and comfort and maximizes wear time and is capable of contacting the skin.

[0004] Summary of the Invention The object of the present invention is to provide an adhesive skin-contactable component, and in particular, an ostomy coupling component or configuration that is configured to exhibit improved moisture management when attached in place to the skin around the stoma, although not exclusively. A particular object is to provide a skin-adherable component that is an ostomy appliance adhesive disk that is resistant to erosion and destruction in response to moisture, particularly for extending the wear time of the patient.

[0005] This object is achieved by providing a biocompatible silicone-based layer, disk or pad that includes moisture management properties including water absorption and breathability and is arranged in contact with the skin, the skin around the stoma and / or the skin around the stoma. In particular, this object is achieved by a silicone adhesive layer that is a room temperature vulcanizing silicone (RTV silicone) formed from a two-component system that is catalytically addition-cured.

[0006] This object is further achieved by a synthetic silicone gel-based adhesive layer formed from a polyorganosiloxane-based silicone polymer network containing Si-O and Si-C bonds, where the moisture control microparticles and the permeability modifying polymer are dispersed within the Si network. This polyorganosiloxane-based material containing superabsorbent (moisture absorbent) microparticles and the modifying polymer achieves a desired water vapor transmission rate (WVTR) through the matrix from the skin, and also exhibits a desired flexibility and an appropriate expanded free internal volume to accommodate the superabsorbent microparticles and the water vapor transmission regulating polymer additive. Such moisture management, including breathability, absorbency, permeability, and capillary action, provides an ostomy wafer or gasket that allows the ostomate to wear comfortably for a much longer period than currently available with conventional systems. The moisture-vapor control additives in the form of microparticles and polymers are selected to achieve a desired substrate adhesion to the skin with a low or very low risk of maceration. The synergistic behavior of the silicone polymer, the absorbent microparticles, and the polymer additive provides a desired balance between moisture absorption and moisture-vapor transmission (within the silicone matrix) without compromising the adhesion and cohesion properties of the wafer. The present base layer is adapted to provide an optimized transmission of water vapor, particularly across the entire surface area of contact between the wafer and the skin through the body. Thus, the present hydrophilic silicone-based wafer maintains its shape profile in the presence of moisture, is not eroded, and is gas, vapor, and moisture permeable.

[0007] As used herein, the term "microparticles" includes polymer species having a micron or submicron size suitable for dispersion within a larger polymer network, gel phase, particularly a silicone polymer network (suitable or appropriate for containing superabsorbent microparticles (SAP)). The moisture control SAP can be a hydrophilic colloid including natural, semi-synthetic, or synthetic hydrophilic colloids.

[0008] Natural hydrophilic colloids suitable for use in the invention of the subject matter include polysaccharides and cellulosic materials. Examples of polysaccharide hydrophilic colloids can include, in particular, plant extracts containing gums including xanthan gum or pectin. Examples of cellulosic materials can include cellulose, carboxymethyl cellulose, carboxymethyl β-glucan, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, and hydroxypropyl cellulose.

[0009] Semi-synthetic hydrophilic colloids can include starch or cellulose, for example, starch acrylonitrile graft copolymers, starch polyacrylate salts and sulfuric acid, vinyl sulfonate, methacrylic acid, vinyl alcohol, vinyl chloride copolymers, guar gum, polymers containing esterified uronic acid, for example, hyaluronate and alginate, hyaluronic acid polyvinyl alcohol blends, chitosan formed by partial or complete deacetylation and / or depolymerization of chitin.

[0010] Synthetic hydrophilic colloids suitable for use in the invention of the subject matter can include polyvinylpyrrolidone, carboxyvinyl polymer, and polyethylene oxide polymers, polymers and derivatives of methyl vinyl ether and maleic acid, polyvinyl alcohol, high molecular weight polyethylene glycol, and polypropylene glycol or polyethylene oxide.

[0011] Preferably, the moisture control SAP comprises sodium polyacrylate. Such particles are compatible with the addition-cured silicone matrix in the formed state and have been found to absorb moisture released from the skin so as to optimize the matrix's cohesive strength and thus swell appropriately without breaking the skin layer coating. Further, the sodium polyacrylate SAP contributes to providing the desired WVTR across the adhesive layer and promotes the desired wicking action. Particularly preferred sodium polyacrylate particles have excellent water absorption properties on the order of 350 g / g H2O and 55 g / g 0.9% NaCl. Further, such particles can be composed of a "fine" particle size selected such that the surface area / volume ratio is optimized to maximize the water absorption rate. As an example, spherical sodium polyacrylate SAP having a nominal radius of 20 μm has a surface area / volume ratio five times that of alternative non-sodium polyacrylate particles with a nominal radius of 100 μm. Further, the sodium polyacrylate has a pH including 6 - 7 and thus does not require specific / additional neutralization.

[0012] As used herein, the term "permeability-modifying polymer" encompasses polymers that affect the hydrophilicity and / or hydrophobicity of the silicone-based skin-compatible component and, in particular, achieve the desired moisture and vapor permeability / transmission rate through the silicone polymer matrix. The permeability-modifying polymer has a desired and predetermined molecular weight and size and can then be a single polymer or a combination of two or more polymers that affect the moisture-vapor permeability through the silicone matrix. The polymer additive acts synergistically with the superabsorbent particles to control the moisture and vapor flow through the silicone matrix, such that the matrix does not swell or absorb water to an undesirable extent typically associated with conventional hydrophilic colloids.

[0013] The permeability-modifying polymer preferably includes a hydrophilic domain and a hydrophobic domain that provides an entropy resistance to complete dissolution so as to promote water permeability without becoming absorbent.

[0014] According to a first aspect of the present invention, there is provided a skin-compatible component attachable to mammalian skin, comprising a silicone polymer network obtained by addition curing of a first part containing a vinyl-functionalized siloxane polymer and a second part containing a hydrosilicon (Si-H) -containing crosslinking agent in the presence of a metal catalyst, superabsorbent fine particles dispersed in the polymer network and configured to absorb moisture from the skin, and a permeability-modifying polymer dispersed in the polymer network.

[0015] Preferably, the superabsorbent fine particles have an average particle size of less than 150 μm.

[0016] Preferably, the peel adhesion of the present component under standard test conditions according to standard ISO 29862 (Standard LTM-01: Self-adhesive tapes - Determination of peel adhesion properties - 180-degree peel from a stainless steel plate at a constant speed of 300 mm / min) is in the range of 0.2 to 3.0 N / 25 mm, 0.5 to 3.0 N / 25, 0.8 to 3.0 N / 25 mm, 1.5 to 3.0 N / 25 mm, 1.8 to 3.0 N / 25 mm, 2.0 to 3.0 N / 25 mm or 2.0 to 4.0 N / 25 mm.

[0017] In particular, when the present silicone adhesive component is incorporated as part of a multi-component laminated assembly of the subject invention, it preferably has a peel adhesion of 0.2 to 0.8 N or 0.4 to 0.6 N according to ISO 29862 (25 mm strip stainless steel substrate). This is in contrast to conventional hydrophilic colloid skin-contact components which typically have a higher peel adhesion (ISO 29862) on the order of 6 to 9 N.

[0018] Preferably, the component of the subject invention comprises an adhesive tackiness in the range of 2 - 12 N, 2 - 10 N, 3 - 10 N, 4 - 10 N, 5 - 10 N, 6 - 10 N, or 6 - 8 N according to (Standard LTM-013: Adhesive Tackiness Test - Force required to pull a 12 mm diameter stainless steel compression plate at 90 degrees from the adhesive surface at a constant speed of 50 mm / min).

[0019] The present skin-compatible component with a polyorganosiloxane-based silicone polymer exhibits high elasticity and low shear strength. The elastic properties of the present silicone adhesive layer provide a coupling assembly configured to retain its shape when stretched below its breaking point when relaxed. The present silicone-based component is formed as a silicone gel adhesive composition that also provides a balance of elastic and viscoelastic properties to achieve good adhesion of the medical device to the skin, while being easily peelable or removable from the skin if desired. Due to the water absorption and water vapor transmission rate across the silicone layer, the subject invention provides a device, coupling, or instrument attachable to the skin that maintains and promotes the health of the skin. The selection of the microparticles and silicone polymer described herein both function to achieve the desired chemical, physical, and mechanical properties, resulting in a skin-compatible component that is not decomposed, eroded, or destroyed by water uptake. Thus, a coupling capable of contacting the skin provides a significantly longer skin wearing time compared to conventional devices.

[0020] The vulcanized silicone polymer is obtained by reacting an alkenyl-substituted polydiorganosiloxane, preferably a polydimethylsiloxane having a silicon-bonded vinyl group, allyl group or hexenyl group, and an organosiloxane containing silicon-bonded hydrogen atoms, and a catalyst for the reaction of the SiH group and the Si-alkenyl (SiVi) group, such as a platinum metal or its compound or its complex. The ratio of SiVi:SiH can be from 10:1 to 1:10. The preferred ratio of SiVi:SiH is 1:1. Changing the ratio of the reactive silicone from a 1:1 ratio can change the adhesion properties of the layer. When a harder and less tacky gel is required, the SiH component can be higher than SiVi, and when a softer layer with higher tackiness is required, the SiVi component can be higher than SiH. The silicone composition can be cured at ambient temperature, but the curing time can be shortened by exposing it to a high temperature of about 40 °C to about 150 °C. Non-limiting examples of such silicone polymer precursors include Soft Skin Adhesives SSA MG-7-1010, SSA 7-9900, 7-9950, Silpuran® 2114, 2117, 2122, 2130, 2140, 2142 and combinations thereof manufactured by Dow Corning Corporation, and SilGel® 612 manufactured by Wacker Chemicals. According to the present disclosure, the hydrophilic group-containing silicone can contain a polar group, such as an acid, amide, amino, sulfonyl, carboxyl, phosphate, phosphonate, etc. in the polydimethylsiloxane main chain. These groups can exist in an ionic form.

[0021] Moisture control microparticles having an average particle size of less than 150 μm provide a "fine" particle distribution within the polymer network. This is advantageous for providing the moisture management properties of the subject invention, and in particular for achieving capillary action moisture transport through the silicone polymer layer such that moisture (water) is readily transported across the silicone polymer layer. Thus, the present silicone polymer with the desired particle size of the moisture control particles is configured to absorb and release moisture when in contact with the skin when the skin-compatible component is worn by a patient, for example, on the skin around a stoma. As will be appreciated, the surface area / volume ratio is an important factor in determining the active surface area for absorption of moisture from the skin, for particles of any given shape, where the surface area / volume ratio is inversely proportional to the particle size. This particle size has been found to act synergistically to achieve the desired performance of the skin-compatible component with respect to adhesion, detachment, absorption, and water vapor transmission rate when incorporated within a polyorganosiloxane-based silicone matrix. This is achieved in part by the network formed by crosslinking of the two-component system containing the desired crosslink density and a continuous microstructure that captures the microparticles, while allowing the microparticles to swell during use without disrupting the cohesiveness of the silicone layer coating.

[0022] The skin-compatible component of the subject invention provides a component configured to balance the transepidermal water loss (TEWL) from the skin and the water vapor transmission rate of the skin-compatible component (covering the skin), including an optimized water vapor transmission rate. This is partially achieved by the sodium polyacrylate SAP having a preferred particle size and at a preferred concentration within the mixture, as detailed herein. According to one aspect, the water vapor transmission rate (WVTR) of the present component, using the upright cup method at a layer thickness of 635 μm to 750 μm, is 100 - 500 g / m 2 .24 h, 150 - 400 g / m 2 .24 h, 200 - 300 g / m 2 .24 h or 220 - 280 g / m 2.It can be in the range of 24 h. Such water vapor transmission rates may correlate with the layer thickness of the silicone adhesive component having a thickness of 250 μm to 1,000 μm, 500 μm to 1,000 μm, or 635 μm to 1,000 μm.

[0023] The silicone portion of the network formed by the addition cure of the first part and the second part is advantageous for providing the desired physical and mechanical properties of the resulting cured component. In particular, by the selection of the components of the first part and the components of the second part, the degree of crosslinking can be controlled to provide the desired network microstructure for properly capturing the superabsorbent moisture control SAP as immobilized particles within the network. Furthermore, the two-component addition cure composition provides the desired viscoelastic properties, adhesive tack, adhesive peel, moisture absorption, cohesive strength, and WVTR. As will be understood, at least some of these properties can be considered to be opposite with respect to adhesion to mammalian skin, and the present component and manufacturing method provide a balance of these considerations to optimize the components for moisture management in the skin.

[0024] Accordingly, the present component exhibits improved wear time compared to conventional hydrophilic colloid-based components, while providing the desired adhesion (adhesive tack) and adhesive peel to avoid the problem of "lifting" during skin maceration and peeling. Furthermore, the cohesive strength of the component is optimized by the two-component addition cure adhesive to maintain the integrity of the adhesive skin covering in response to moisture absorption / swelling of the skin covering during a continuous wear time extended beyond 70 h and up to 400 h. In particular, the two-component addition cure component provides the desired WVTR that is specifically configured to complement the skin TEWL. In particular, the present two-component addition cure system can be considered to be advantageous over conventional one-component pressure-sensitive adhesives (PSAs) that do not include the same crosslink density and cohesive strength.

[0025] Preferably, the superabsorbent microparticles have an average particle size in the range of 10 to 40 μm, 15 to 35 μm, or 20 to 30 μm. Preferably, the superabsorbent microparticles are dispersed in the polymer network at a concentration in the range of 5 to 45 wt%, 10 to 40 wt%, 15 to 35 wt%, or 20 to 30 wt%. The particle size of the subject invention is advantageous for achieving the desired rate and speed of moisture absorption from the skin. Further, such a configuration provides the required rate of moisture permeation across the adhesive layer by wicking. In particular, a certain volume of moisture absorbed from the skin is appropriately transported across the silicone adhesive layer (and away from the skin) to avoid maceration of the skin, unwanted wetting of moisture, and thus lifting / peeling of the silicone layer during use. Also, this particle size provides the homogeneity and uniform distribution of superabsorbent microparticles (SAP) within the silicone matrix that improves the agglomeration strength. In one aspect, the superabsorbent SAP and preferably, sodium polyacrylate (SAP) has an absorption capacity of 350 g.g -1 (deionized water) or 55 g.g -1 (0.9 vol% saline).

[0026] Preferably, the organosilicon resin is included in the first or second part before addition curing. Preferably, the organosilicon resin is an MQ resin. The organosilicon resin, particularly, the MQ resin is advantageous for providing the desired balance between the adhesiveness and peel / peel-off characteristics of the adhesive. Optionally, the MQ resin has at least one reactive group, for example, a hydroxyl, alkoxy, hydride, or vinyl functional group. The silicone resin has the general formula R n SiX m O y(In the formula, R is a non-reactive substituent, usually Me or Ph, and X is a functional group H, OH, vinyl or OR). A cage-like oligosiloxane having these groups can be included. These groups can further condense to enhance or contribute to the resulting crosslinked polysiloxane network. Non-limiting examples of commercially available MQ resins are MQ-RESIN POWDER 803 TF manufactured by Wacker Chemical Corporation, VQM-135, VQM-146, HQM-105, HQM-107, SQO-299 and SQD-255 manufactured by Gelest Inc., Prosil 9932, MQOH-7 manufactured by SiVance, LLC.

[0027] Preferably, the aggregation enhancer is included in the first or second part before addition curing. Optionally, the aggregation enhancer includes any one or a combination of this set of fumed silica, fumed alumina, colloidal silica, nanoclay, silicate, silane-treated organic polymer, polymeric metal oxide, and non-polymeric metal oxide. Preferably, the aggregation enhancer includes fumed silica. The enhancer contributes to the aggregation strength characteristics of this component, helps maintain the integrity of the silicone adhesive layer in response to moisture absorption by the SAP, and helps manage the moisture-vapor transfer of the permeation-modifying polymer additive. In particular, the aggregation enhancer is further advantageous in minimizing and eliminating layer residues once peeled from the skin. The enhancer is further advantageous in facilitating the dispersion of the SAP and the permeation-modifying polymer additive within the matrix. Further, the aggregation enhancer further improves the integrity and aggregation strength at the peripheral edge of the silicone layer to reduce "edge bleed". Non-limiting examples of the aggregation enhancer of the present disclosure include silica. The silica can be fumed silica or precipitated silica, for example, AEROSIL® and SIPERNAT® grades manufactured by Evonik Industries, respectively. The silica powder can be hydrophilic or hydrophobic, for example, AEROSIL® 300, AEROSIL® 255, AEROSIL® R 812, AEROSIL® R 812 S, SIPERNAT® 120, SIPERNAT® 218, etc. Other non-limiting examples of the aggregation enhancer include fumed alumina, colloidal silica, nanoclay, silicate, silane-treated organic polymer, polymeric metal oxide, non-polymeric metal oxide, etc.

[0028] Preferably, the permeation-modifying polymer is adapted to change the moisture management properties of the silicone-based material by improving the water vapor permeability, which is alternatively characterized by the trans-epidermal water loss (TEWL) of the silicone material, when the material is placed in contact with the skin and worn for an extended period (typically, one hour or more), as may typically be encountered during use, when the material is wet, dry, or between these two extremes.

[0029] Preferably, the permeability-modifying polymer is a water-soluble polymer. Preferably, such a polymer can include a hydrophobic domain and can include a hydrophilic domain. Such domains contribute to the moisture management properties of the polymer.

[0030] Preferably, the permeability-modifying polymer is not chemically bonded to the silicone polymer network. The polymer additive can be configured to be located between the strands of the silicone matrix forming the semi-interpenetrating polymer network in order to modulate the permeability of the bulk material. Thus, the moisture management polymer additive and the superabsorbent microparticles can be considered as distinguishable and separate species with respect to the interconnected silicone network obtained by the catalytic crosslinking of the vinyl-functionalized silane polymer and the hydrogenated silicon-containing crosslinking agent.

[0031] Optionally, the permeability-modifying polymer is any one of the following set of combinations: polyvinyl alcohol (PVA), polyvinyl chloride (PVC), poloxamer, polyester, polyvinyl pyrrolidone (PVP). Optionally, the permeability-modifying polymer can include poly(2-vinylpyridine), polyacrylonitrile, polymethyl methacrylate (PMMA) or polybutadiene.

[0032] Preferably, the permeability-modifying polymer is a poloxamer and optionally, poloxamer 407 (alternatively, called poloxamer F127 (EO 100 PO 65 EO 100 ) or poloxamer P123 (EO 19 PO 69 EO 19) and includes. Such a poloxamer within the silicone matrix can form a micelle structure. Such a structure can include a core of the PPO block and a corona of the PEO block. Optionally, the permeability-modifying polymer includes polycaprolactone (PCL), and optionally polycaprolactone diol, polyhydroxyalkanoate (PHA), polyglycolide or polyglycolic acid (PGA), polylactic acid (PLA), polyhydroxybutyrate (PHB), polyadipate (PEA), polybutylene succinate (PBS), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), polyethylene terephthalate (PBT), polytrimethylene terephthalate (PTT), polyethylene naphthalate (PEN), polybutylene succinate adipate (PBSA), polybutylene adipate (PBA) or a polyester including polybutylene adipate terephthalate (PBAT).

[0033] Optionally, the permeability-modifying polymer is PVA and includes a molecular weight in the range of 50,000 to 150,000, 60,000 to 120,000, 70,000 to 100,000 or 80,000 to 90,000.

[0034] Optionally, the permeability-modifying polymer is PVP and includes a molecular weight in the range of 5,000 to 50,000, 10,000 to 40,000, 15,000 to 35,000 or 20,000 to 30,000.

[0035] Optionally, the permeability-modifying polymer is PVC and includes a molecular weight in the range of 50,000 to 100,000 or 70,000 to 90,000.

[0036] Optionally, the permeability-modifying polymer is PCL and includes a molecular weight in the range of 200 to 1,000, 200 to 800, 300 to 700, 400 to 700, 500 to 600 or 500 to 580.

[0037] The molecular weight of the polymers referred to in this specification can be the number average molar mass (mn), the mass average molar mass (mw) or the Z average molar mass (mz).

[0038] Optionally, the permeability modifying polymer is included in the skin-compatible component at 0.1 to 5.0 wt%, 0.1 to 4.0 wt%, 0.1 to 3.0 wt%, 0.1 to 2.0 wt%, 0.2 to 1.8 wt%, 0.2 to 1.6 wt%, 0.2 to 1.2 wt%, 0.2 to 1.0 wt%, 0.2 to 0.8 wt%, 0.2 to 0.4 wt% or 0.6 to 1.0 wt%. Optionally, the permeability modifying polymer may be included at 5.0 to 10.0 wt%. However, the permeability modifying polymer is preferably included as a small amount of additive (less than 5 wt%) to adjust the moisture management properties. Such a relatively low concentration of the permeability modifying polymer is not detrimental to other desired physical and mechanical properties of the material, including in particular viscoelastic properties, adhesive tack, adhesive peel, cohesive strength, etc. In particular, it is important that the polymer additive does not increase the adhesive tack to such an extent that it will provide skin maceration and "lifting" upon removal in any way.

[0039] According to a second aspect of the present invention, there is provided an ostomy coupling comprising a moisture and gas permeable support layer, an ostomy appliance or an ostomy appliance connection provided on a first surface of the support layer, and a skin-compatible component as claimed herein attached to a second surface of the support layer.

[0040] Optionally, the polyurethane layer includes a thickness in the range of 0.02 to 0.08 mm. The polyurethane layer has a water vapor transmission rate of more than 10,000 or 15,000 or an MVTR in the range of 15,000 to 20,000 or 1,700 to 18,000 or 17,500 g.m -2 .24h -1It can include the MVTR. The polyurethane layer can include a tensile strength of 40 to 50 MPa and an elongation at break of 500%. Preferably, the support layer can be considered porous so as to allow the permeation of moisture, water vapor and gas through the support layer, and thus provide a completely "breathable" skin-adhesive covering pad or disk.

[0041] Preferably, the silicone matrix layer is protected by a release liner configured to be quickly and conveniently removed before attaching the silicone layer in direct contact with the skin. Optionally, the release liner can include a thermoformable material, a fluoropolymer-treated film, LDPE, polyethylene terephthalate (PET) or a polycarbonate-based material.

[0042] Optionally, the support layer can include any one or a combination of this set of a breathable silicone layer, a polyethylene block amide polymer, a polytetrafluoroethylene polymer, an acrylic latex polymer or a polyolefin-based layer. Preferably, the support layer includes polyurethane.

[0043] Optionally, the ostomy appliance can include a bag or pouch attached directly to the support layer or via an intermediate layer. Optionally, the intermediate layer can include polyethylene or can include any one or a combination of this set of a polyester disk, non-woven polyester, non-woven polyethylene, a polypropylene disk, non-woven polypropylene. Optionally, the intermediate layer can be a single-sided or double-sided adhesive annular ring that can be adhered to one or more components forming part of the assembly. Such a configuration would avoid the need to weld the intermediate layer to other components, for example, by RF welding or sonic welding.

[0044] Preferably, the stoma appliance connection part comprises a first part of a two-component bag or pouch connection assembly (known in the art). In the connection assembly, the second part of the connection assembly is attached to the bag or pouch, and the first part and the second part are removably and fittingly engageable to removably fix the bag or pouch to the coupling.

[0045] Optionally, the coupling comprises an opening extending through the support layer and the skin-compatible component. Optionally, the stoma appliance includes a bag or pouch attached directly to the support layer or via an intermediate layer. Optionally, the intermediate layer comprises polyethylene. Optionally, the intermediate layer comprises any one or a combination of this set of polyester discs, polyester gauzes, polyethylene gauzes, polypropylene discs, and polypropylene gauzes. Such materials can be configured as single-sided or double-sided adhesive rings or pads that are adhesive to other components within the assembly.

[0046] Optionally, the stoma appliance connection part includes a first part of a bag or pouch connection assembly. In the connection assembly, the second part of the connection assembly is attached to the bag or pouch, and the first part and the second part are removably and fittingly engageable to removably fix the bag or pouch to the coupling.

[0047] To further enhance the moisture management and vapor permeation of the present coupling (and then to avoid skin maceration, etc.), the coupling can further include an additional skin contact layer disposed on the skin side of the skin-compatible component. Preferably, the additional skin contact layer is a silicone-based adhesive component extending over a selected area of the skin side or surface of the skin-compatible component.

[0048] Preferably, the additional skin contact layer is formed discontinuously on the skin-compatible component so as to provide an exposed area of the skin-compatible component lacking the additional skin contact layer. Thus, for the material in contact with the skin, adhesion is provided first via the additional skin contact layer and then by the exposed surface area of the skin-compatible component (not covered by the additional skin contact layer). Such a configuration improves the consideration of the present material for the skin during use by enhancing the breathability of the silicone layer and enabling easy removal of moisture from the skin without causing irritation.

[0049] Preferably, the additional skin contact layer is a silicone adhesive layer provided on the skin side of the skin-compatible component and intended to be arranged in contact with the skin and adhere to the skin. The additional skin contact layer is discontinuous on the skin side of the skin-compatible component, such that the area of the surface is not hidden by the additional skin contact layer and the area can be arranged directly adjacent to and / or in contact with the skin.

[0050] Optionally, the additional skin contact layer contains a two-part catalytic silicone elastomer. Optionally, the additional skin contact layer can contain a composite of a plurality of different silicones and / or silicone-based materials.

[0051] Optionally, the additional skin contact layer contains the same material as the skin-compatible component. Optionally, the additional skin contact layer contains the same material as the skin-compatible component but does not contain superabsorbent microparticles. That is, the additional skin contact layer can contain a silicone polymer network obtained by addition curing of a first part containing a vinyl-functionalized siloxane polymer and a second part containing a hydrogenated silicon-containing crosslinking agent in the presence of a metal catalyst.

[0052] Optionally, the additional skin contact layer can be formed as lines or dots on the skin side of the skin-compatible component. In such a configuration, the skin-compatible component can be regarded as the base material. When the additional skin contact layer is formed as individual dots, flicks or marks, the pattern formed by these dots can be uniform across the skin side of the base material. Alternatively, this pattern can vary on the surface of the base material, and the material can include different patterns in different regions on the base material. When the additional skin contact layer includes lines or ridges extending on the base material, these lines can extend in different directions. In this case, the spacing between the lines or ridges can be the same or variable across the surface of the base material. Optionally, the lines can form a square, rectangular or circular grid pattern. Optionally, the lines or ridges are distributed on the skin side to form a geometric shape. Preferably, the additional skin contact layer is bonded to the base material and takes the form of concentric circles spreading around a central opening extending through the base material and / or the multilayer coupling.

[0053] According to a third aspect of the present invention, there is provided a method for manufacturing a skin-compatible component attachable to the skin of a mammal, comprising mixing a first part containing a vinyl-functionalized siloxane polymer with a second part containing a hydrogenated silicon (Si-H) -containing crosslinking agent to form a mixture, incorporating superabsorbent fine particles into the mixture, incorporating a permeability-modifying polymer into the mixture, and curing the mixture with a metal catalyst, wherein the superabsorbent fine particles and the permeability-modifying polymer are dispersed in the resulting addition-cured silicone polymer network.

[0054] Preferably, the first part or the second part further includes an organosilicon resin. Preferably, the organosilicon resin includes an MQ resin. Preferably, the organosilicon resin is trimethylsilyl silicate having silanol functionality. Preferably, the organosilicon resin is contained in the mixture in an amount of 0.2 to 10 wt%, 1 to 9 wt%, 2 to 8 wt%, 3 to 7 wt% or 4 to 6 wt%.

[0055] Preferably, the first part or the second part further comprises a flocculation enhancer. Preferably, the flocculation enhancer comprises fumed silica. Preferably, the fumed silica has a bulk density of 0.4 to 0.8 g / mL and a Brunauer-Emmett-Teller (BET) specific surface area of 200 to 320 mm 2 / g, 210 to 310 mm 2 / g, 230 to 300 mm 2 / g or 230 to 290 mm 2 / g. Preferably, the fumed silica is included in the mixture at 0.2 to 2.0 wt%, 0.3 to 2.0 wt%, 0.5 to 1.5 wt% or 0.8 to 1.2 wt%.

[0056] Preferably, the superabsorbent microparticles and preferably the sodium polyacrylate microparticles have a particle size in the range of 10 to 40 μm, 15 to 35 μm or 20 to 30 μm. Preferably, the superabsorbent microparticles and preferably the sodium polyacrylate microparticles are included in the mixture at 5 to 45 wt%, 15 to 35 wt%, 20 to 30 wt% or 22 to 28 wt%.

[0057] Preferably, the vinyl-functionalized siloxane polymer comprises vinyl-terminated polydimethylsiloxane (PDMS). Preferably, the hydrosilylation (Si-H) containing crosslinker comprises hydride-terminated polydimethylsiloxane (PDMS).

[0058] Preferably, the vinyl-terminated polydimethylsiloxane (PDMS) comprises a first vinyl-terminated PDMS having a mass average of 10,000 to 20,000 and a second vinyl-terminated PDMS having a mass average of 70,000 to 100,000. These mass average polymer distributions provide the resulting cured silicone matrix with the desired crosslink density, porosity and flocculation strength so as to withstand the swelling of the layer during use and not undergo degradation that would cause damage to the coating in some way.

[0059] Preferably, the vinyl-functionalized siloxane polymer contains vinyl-terminated polydimethylsiloxane (PDMS), and the hydrosilylation (Si-H) containing crosslinking agent contains hydride-terminated polydimethylsiloxane (PDMS).

[0060] Preferably, the first part is contained in the mixture at 30-40 wt% or 31-35 wt%, and the second part is contained in the mixture at 30-40 wt% or 33-37 wt%.

[0061] Preferably, the superabsorbent microparticles are contained in the mixture at 20-30 wt% or 22-28 wt%. Preferably, the MQ resin is contained in the mixture at 2-8 wt% or 3-7 wt%. Preferably, the fumed silica is contained in the mixture at 0.2-2.0 wt%, 0.5-1.5 wt% or 0.8-1.2 wt%.

[0062] Preferably, the first part further contains an organoplatinum catalyst and a silicone-vinyl containing inhibitor, the second part further contains vinyl-terminated polydimethylsiloxane (PDMS), and preferably, the superabsorbent microparticles are sodium polyacrylate.

[0063] According to a fourth aspect of the present invention, there is provided a skin-compatible component attachable to mammalian skin, produced by the method claimed herein.

[0064] According to a further aspect of the present invention, there is provided a method of manufacturing an ostomy coupling, comprising applying an organosiloxane-based silicone polymer mixture (described and claimed herein) to a moisture and gas permeable support layer, curing the organosiloxane-based silicone polymer with the support layer, and attaching an ostomy appliance or an ostomy appliance connection part to a part of the support layer.

Brief Description of the Drawings

[0065] Hereinafter, specific embodiments of the present invention will be described by way of example only with reference to the accompanying drawings.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

[0066] DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION The silicone polymer-based skin-compatible component of the subject invention is configured, in particular, to be placed on mammalian skin and adapted to have desired adhesion properties such that, when worn by a person, it has desired peel properties that allow the component to be removed from the skin while maintaining a firm adhesion to the skin (as the skin moves). Thus, the silicone-based component is a hydrophilic wetting agent configured to absorb moisture into the silicone matrix without compromising the adhesive, cohesive, and peel properties. The component of the subject invention allows for the permeation of water vapor through the body of the matrix such that the skin (in contact with this component) can breathe. Thus, this silicone wafer is advantageously balanced in terms of moisture absorption and moisture and water vapor permeation, at least in part, by the composition of the silicone matrix and additives (in the form of SAP and moisture management polymer species), to avoid maceration of the skin.

[0067] The invention of the subject matter is particularly suitable for fixing medical instruments or devices to the skin of mammals, particularly to the skin around a stoma and the skin around the stoma. Such devices can include, but are not limited to, catheters, intravenous supply lines, fixation devices, wound dressings, treatment devices, drug delivery devices, ostomy appliances, etc.

[0068] From here, the invention of the subject matter will be described with reference to a specific implementation in which the moisture-absorbing microparticle silicone-based matrix forms a component part of an ostomy appliance coupling called the "substrate" of the "two-component" system. However, the invention of the subject matter can be used for "one-component" ostomy appliances, as will be understood. Referring to FIGS. 1 and 2, the coupling assembly 100 comprises a moisture- and water-vapor-permeable "breathable" substrate layer 101 having a first surface 101a and a second surface 101b. According to a specific implementation, the layer 101 has a water vapor transmission rate (MVTR) of more than 700 g.m -2 .24h -1 -24h, preferably 700 - 950 g.m -2 .24h -1 and contains polyurethane. According to a specific implementation, the polyurethane layer has an MVTR of 875 g.m -2 .24h -1has an MVTR. The polyethylene disk 105 is fixed to the first layer 101a of the substrate by RF welding or ultrasonic welding or using an adhesive. The polyethylene disk 105 provides a mount for the first part 106 of an ostomy appliance coupling mechanism to removably engage with the second part of a coupling mechanism provided in an ostomy appliance, particularly a coupling in an ostomy bag. The first part 106 of the coupling preferably forms an annular flange that is frictionally integrated with the second part of the coupling mechanism and is removably lockable to provide a sealed coupling between an ostomy bag (not shown) and the coupling configuration 100 of FIGS. 1 and 2. According to a particular implementation, the first part 106 of the coupling mechanism (which, as will be understood and recognized by those skilled in the art, can be any form of connection) is fixed to the layer 105 by RF welding or ultrasonic welding. However, according to a further implementation, the layer 105 can be a double-sided adhesive tape (annular ring) suitable for bonding to the surface 101a and the component part 106.

[0069] The silicone polymer matrix layer 102 is applied to the second surface 101b of the substrate by coating the second surface 101b using a homogeneous liquid-phase uncured silicone polymer mixture and then cured (i.e., room temperature vulcanized) in place on the substrate 101. The silicone polymer layer 102 is covered and protected by a release liner 103. According to a particular implementation, the release liner 103 includes a fluoropolymer-treated film. The liner 103 is removably disposed on the silicone layer 102 and is removed prior to attaching the coupling assembly 100 to a person's skin by a mating contact with the silicone polymer layer surface 102b.

[0070] Layers 101 and 102 are annular with a generally circular or oval disk-shaped profile. The through-hole 104 extends through layers 101 and 102 and is dimensioned to have an inner diameter slightly larger than the outer diameter of the stoma, where layers 101 and 102 have a generally circular outer periphery 107. As a result, this coupling can be regarded as a generally annular disk. Thus, the coupling assembly 100 is configured to fit closely and make a sealed contact with the skin around the stoma and be attached in the conventional manner for both single-piece and two-piece stoma appliances.

[0071] According to a particular implementation, the polyurethane substrate 101 includes a layer thickness of 20 μm to 50 μm, and the silicone polymer layer 102 includes a thickness of about 400 to 900 μm. The polyethylene disk 105 includes a thickness of 80 to 150 μm, and the release liner 103 includes a thickness in the range of 40 to 150 μm.

[0072] Figures 2 to 4 illustrate an ostomy appliance coupling of a second embodiment, which is a variation of the embodiment described with reference to Figures 1 to 2. According to a further embodiment, the breathable polyurethane layer 101, the silicone polymer layer 102, and the release liner 103 are as described for the first embodiment. However, instead of the polyethylene disk 105, a weldable nonwoven layer 200 is fixed to the first surface 101a of the polyurethane. The nonwoven layer 200 is also annular and includes an inner diameter and an outer diameter corresponding to those of layers 101 and 102, and as a result, a welding extension of layers 101 and 102 is formed at plane B-B. According to a specific implementation, the thickness of the nonwoven layer 200 is 30 to 600 μm. Then, the first part 106 of the appliance coupling mechanism is welded to the nonwoven layer 200 by RF welding or ultrasonic welding.

[0073] Hereinafter, specific embodiments of the polymer layer 102 will be described with reference to the following examples. The polymer layer 102 is formed as a silicone polymer matrix obtained by addition curing of a first part and a second part. In addition to achieving a desired balance of viscoelastic properties, adhesive tack, adhesive peel, hygroscopicity, cohesive strength, and water vapor transmission rate (WVTR), auxiliary components are included in the first part and / or the second part to achieve the desired physical and mechanical properties of the resulting silicone network.

[0074] The two-component composition can be cured / vulcanized at ambient temperature (or elevated temperature including the range of 30° to 150°). The curing / vulcanization time can be varied depending on the relative concentrations and components within the first and second parts.

[0075] Examples [Table 1]

[0076] The following examples were prepared using various permeable modified polymers that form part of the starting materials identified in Table 1. The permeable modified polymers are preferably included in the Part B silicone composition, but can be included in Part A.

[0077] [Table 2]

[0078] Manufacturing Method The Silpuran®-based components A and B were weighed, and the other components of the examples were added at their respective concentrations. These components were thoroughly mixed to ensure complete dispersion of the components within this mixture, in particular, of the SAP (i.e., sodium polyacrylate) and the permeability-modifying polymer. This is advantageous for providing complete and homogeneous dispersion of the components within the silicone matrix, in particular, of the SAP and the permeability-modifying polymer. In particular, thorough mixing reduces the risk of SAP and / or permeability-modifying polymer agglomeration, which would be detrimental to the moisture-vapor management (absorption and permeation) properties across the total surface area of the skin-compatible components. The above components were mixed using a medium-shear to low-shear mixing technique, either by centrifugation or dispersion at 1000 - 3000 rpm. The surplus heat energy was removed by active cooling. Vacuum-phase mixing was used as the final step to provide a liquid-phase uncured silicone formulation. The laminated assemblies 100 of FIGS. 1 - 4 were manufactured by laminating the liquid-phase silicone formulation onto the polyurethane layer surface 101b and subsequently room-temperature vulcanizing (RTV) under controlled conditions. Then, the release liner 103, the polyethylene disk 105, and the first part 106 of the coupling were attached to form the multi-component assembly 100.

[0079] TEWL Performance and Results This silicone adhesive is advantageous for providing a "soft" non-invasive peel from the skin in order to reduce the potential for skin lifting / damage. Further, the adhesive includes the desired cohesive strength and adhesive tack such that it is maintained in place for an extended wear time on the order of over 400 hours without degradation and loss of moisture absorption and permeation in the adhesive layer. The present invention particularly provides a balance of wear performance characteristics for skin compatibility, including edge lift, adhesion during wear, adhesion during removal, moisture control, skin condition after wear, skin trauma during removal, and skin residue during removal. This silicone adhesive is advantageous such that it can be worn continuously during low, moderate, and high levels of physical activity and exercise when the wearer engages in such physical activities. This skin adhesive is further advantageous for meeting other ergonomic factors such as comfort during wear and conformity to skin / body topography.

[0080] Transepidermal water loss (TEWL) or equivalent moisture vapor transmission rate (MVTR) is a well-established technique for determining the water and vapor transmission rate across a material. These properties are particularly important for material compositions adhered to the skin. According to the subject invention, it is important that this silicone material does not leach SAP, monomer, or polymer, adheres well to the skin, but does not adhere to the extent that it will damage the skin (i.e., skin peeling or skin lifting) in any way upon removal. The silicone-based materials of the examples were evaluated to determine the relative TEWL ratings in both "dry" and "wet" environments and to understand how the permeability of this silicone material would function as a dressing applied to the skin, which can be in some cases between two extremes, i.e., dry and wet. It is important that this silicone-based material has some degree of permeability and water vapor permeability without being overly absorbent. Thus, the addition of a permeability-modifying polymer provides a means of improving / enhancing the permeability of the silicone layer without significantly contributing to or enhancing the absorption characteristics of the material (which can be controlled by changing the concentration and / or type and configuration of SAP).

[0081] Although not bound by theory, the present permeability-modifying polymer (added in relatively small amounts) is positioned between the silicone matrices forming the semi-interpenetrating polymer network, thereby presumably modulating the permeability of the bulk material. It is important that this additive not be too hydrophilic since it will promote swelling and water uptake of the bulk material. Thus, the permeability-modifying polymer was selected to include a hydrophobic domain that causes an entropic resistance to complete dissolution and promotes water permeability without absorbency.

[0082] The TEWL test was performed to measure the water vapor transmission rate across the silicone materials of Examples 1-8 in addition to Comparative Examples 9 and 10. Comparative Example 9 is a silicone material containing the components of Table A without a permeability-modifying polymer, and Comparative Example 10 is a silicone material containing the components of Table A with a hydrophilic colloid added.

[0083] Equipment The Heidolph Hei-Toeque 100 was used for high-speed stirring of the silicone resin. A drawdown bar (1000 micrometers thick) was used to spread the silica across the entire PU film. The TEWL values were recorded on a Delfin Technologies Vapometer (serial SWL5316) equipped with an indoor sensor S / N RHD1236.

[0084] Recording of the TEWL of the samples Silicone matrix samples were prepared from the materials in Tables 1 and 2. This mixture was spread over the entire PU film, then incubated for 10 minutes and incubated at 100 °C. The water permeability of the coating was measured by a portable device calibrated to measure the TEWL of the skin and surface with respect to ambient temperature and humidity. The measurement of the coating was not performed in a specially air-conditioned room, but in all cases, the ambient temperature was 22 - 24 °C, and the sample was heated to 32 °C to mimic the temperature on the skin surface. The indoor humidity varied from 40% to 49%, and from the analysis of variance comparison of the data, no obvious correlation was found between the indoor humidity and the observed TEWL.

[0085] To measure the TEWL of the adhesive material, it was not possible to connect the vapor meter directly to the adhesive. Instead, to mimic these applications in medical dressings, the TEWL was measured by a sandwich design with the adhesive contained between two barrier sheets. The upper PU film mimics the protective layer on the medical dressing, and the lower one separates the adhesive from the moisture source. The lower barrier layer was tested with both PU film and Wattman filter paper to compare different occlusive materials. Under the lower barrier layer, a standard tissue paper piece, either wet or dry, was used in an experimental design made to mimic the skin surface where a high moisture content is separated from the adhesive by a thin skin barrier. The samples were incubated with the wet / dry tissue at 32 °C for 1 hour to ensure complete adaptation to their environment and measured immediately after removing the samples from the incubation oven. In most cases, the TEWL was measured at four different points on each surface, and each material was repeated four times, giving n = 16 to determine the variation of the samples. Also, with this experimental design, since this type of occlusive behavior has been identified as harmful to the wearer, it would be important that the adhesive does not reduce its TEWL as the relative moisture level increases, so it became possible to compare the changing TEWL of the materials under both dry and wet conditions.

[0086] Sample A small amount of the permeability-modifying polymer (0.8%) was included in the mixtures of Table 1 for testing. Examples 7 and 8 were variations of Examples 1 to 6 in that 0.4 w / w% of the permeability-modifying polymer instead of 0.8 w / w% was added to the mixtures of Table 1.

[0087] Results The results of the TEWL test are shown in Table 3.

[0088]

Table 3

[0089] From the results, it is confirmed that by including the permeability-modifying polymer, the transepidermal water loss increases as a measure of the water vapor transmission rate across the silicone matrix, compared to the silicone material without the permeability-modifying polymer (Comparative Example 9). All of Examples 1 to 8 show an increase in the water vapor transmission rate under both dry and wet conditions. As shown, it is considered that the permeability of the silicone matrix changes by including a relatively small amount of the modifying polymer to change the bulk hydrophilicity of the material.

[0090] Further Embodiments Further embodiments of the present invention are illustrated with reference to FIGS. 5A and 5B. FIG. 5A is a variation of the embodiments of FIGS. 1 and 2, and FIG. 5B is a variation of the embodiments of FIGS. 3 and 4. Both embodiments include a silicone matrix containing any of the SAPs and polymer additives of Examples 1 to 8 herein. According to both further embodiments, an additional skin contact layer 300 is adhered to and positioned on the surface 102b of the silicone polymer matrix layer 102. The additional skin contact layer 300 is preferably formed of the same material as layer 102. However, different materials, such as silicone or a hydrophilic colloid-based material, can be used. In a preferred embodiment, layer 300 includes a silicone polymer matrix formed from the components of Table 1 (excluding SAP and the permeability-modifying polymer).

[0091] The additional skin contact layer 300 can be regarded as an additional adhesive layer formed from narrow ridges that are discontinuous on the surface 102b such that the additional skin contact layer 300 does not completely cover the surface 102b, and a region 301 is provided that lacks the additional skin contact layer 300 where the region 301 is the exposed surface region of the silicone polymer matrix layer 102.

[0092] According to the embodiment of FIG. 5A, the pattern of the additional skin contact layer 300 on the surface 102b is a rectangular grid pattern or concentric circles formed by uniform ridges extending across the surface 102b. The spacing between the ridges can be equal in each direction across the surface 102b.

[0093] The embodiment of FIG. 5B includes an additional skin contact layer 300 formed as a regular repeating array of nodes or bumps. The bumps can be separated from each other by a regular or uniform individual separation distance such that the skin contact surface 102b of the silicone polymer matrix layer 102 is exposed in the spaces 301 between the bumps 300.

[0094] According to a specific embodiment, the additional skin contact layer 300 on the surface 102b is formed as a series of concentric circles extending radially between the central hole 104 and the outer periphery 107. The concentric circles (or other polygons (i.e., rectangles) or non-polygons (i.e., ellipses)) can be spaced apart from each other radially and formed as separate ridges separated by regions of the exposed surface 102b. Such an embodiment is further beneficial in improving the strength and integrity of the moisture seal of this coupling and reducing the risk of fluid leakage from under the coupling between the surface 102b and the skin.

Claims

1. A skin-compatible silicone-based material attachable to mammalian skin, a silicone polymer network obtained by addition curing of a vinyl-functionalized siloxane polymer and a hydrogenated silicon-containing crosslinking agent in the presence of a metal catalyst, sodium polyacrylate fine particles having an average particle size of less than 150 μm, which are dispersed in the polymer network and are configured to absorb moisture from the skin and swell within the silicone polymer network, and a permeation-modifying polymer that is a polyester and includes hydrophobic and hydrophilic domains and is configured to contribute to the moisture management characteristics of the silicone-based material. The silicone-based material.

2. The silicone-based material according to claim 1, wherein the sodium polyacrylate has an average particle size in the range of 10 to 40 μm, 15 to 35 μm, or 20 to 30 μm.

3. The silicone-based material according to claim 1 or 2, wherein the sodium polyacrylate is dispersed in the polymer network at a concentration in the range of 5 to 45 wt%, 10 to 40 wt%, 15 to 35 wt%, or 20 to 30 wt%.

4. The silicone-based material according to any one of claims 1 to 3, wherein the obtained silicone polymer network further includes an organosilicon resin and fumed silica as an aggregation strengthening agent.

5. The silicone-based material according to claim 4, wherein the organosilicon resin is an MQ resin, and the aggregation strengthening agent includes fumed silica and any one or combination of fumed alumina, colloidal silica, nanoclay, silicate, silane-treated organic polymer, polymer metal oxide, and non-polymer metal oxide.

6. The silicone-based material according to any one of claims 1 to 5, wherein the polyester is a water-soluble polymer having a hydrophobic domain.

7. The silicone-based material according to any one of claims 1 to 6, wherein the polyester is not chemically bonded to the silicone polymer network.

8. The silicone-based material according to claim 7, wherein the polyester is polycaprolactone diol.

9. The silicone-based material according to any one of claims 1 to 8, comprising polyester in an amount of 0.1 to 5.0% by weight, 0.1 to 4.0% by weight, 0.1 to 3.0% by weight, 0.1 to 2.0% by weight, 0.2 to 1.8% by weight, 0.2 to 1.6% by weight, 0.2 to 1.2% by weight, 0.2 to 1.0% by weight, 0.2 to 0.8% by weight, 0.2 to 0.4% by weight or 0.6 to 1.0% by weight.

10. A wetness and gas permeable support layer, An ostomy appliance or an ostomy appliance connection provided on a first surface of the support layer, And a skin-compatible silicone-based material according to any one of claims 1 to 9 attached to a second surface of the support layer. An ostomy coupling.

11. The support layer is as follows: ・A breathable silicone layer ・A polyethylene block amide polymer ・A polytetrafluoroethylene polymer ・An acrylic latex polymer ・A polyolefin-based layer ・Polyurethane The coupling according to claim 10, comprising any one of the above.

12. A method for producing a skin-compatible silicone-based material attachable to the skin of a mammal, comprising: Mixing a vinyl-functionalized siloxane polymer with a hydrogenated silicon-containing crosslinking agent to form a mixture; Including sodium polyacrylate fine particles having an average particle diameter of less than 150 μm in the mixture; Including a permeable modifying polymer which is a polyester, contains hydrophobic and hydrophilic domains and is configured to contribute to the moisture management characteristics of the silicone-based material, in the mixture; Curing the mixture with a metal catalyst, Wherein the sodium polyacrylate fine particles and the polyester are dispersed in the resulting addition-cured silicone polymer network. Method.

13. The method according to claim 12, wherein the mixture further comprises an organosilicon resin.

14. The method according to claim 13, wherein the organosilicon resin is a trimethylsilyl silicate having a silanol functional group which is an MQ resin, and is contained in the mixture in an amount of 0.2 to 10% by weight, 1 to 9% by weight, 2 to 8% by weight, 3 to 7% by weight or 4 to 6% by weight.

15. Further, the method according to any one of claims 12 to 14, wherein fumed silica is contained in the mixture in an amount of 0.2 to 2.0% by weight, 0.3 to 2.0% by weight, 0.5 to 1.5% by weight or 0.8 to 1.2% by weight.

16. The method according to any one of claims 12 to 15, wherein the sodium polyacrylate has an average particle size in the range of 10 to 40 μm, 15 to 35 μm or 20 to 30 μm and is contained in the mixture at 5 to 45% by weight, 15 to 35% by weight or 20 to 30% by weight.

17. The method according to claim 16, wherein the polyester is polycaprolactone diol.

18. The method according to any one of claims 12 to 17, wherein the polyester is contained in the mixture at 0.1 to 5.0% by weight, 0.1 to 4.0% by weight, 0.1 to 3.0% by weight, 0.1 to 2.0% by weight, 0.2 to 1.8% by weight, 0.2 to 1.6% by weight, 0.2 to 1.2% by weight, 0.2 to 1.0% by weight, 0.2 to 0.8% by weight, 0.2 to 0.4% by weight or 0.6 to 1.0% by weight.

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