OPTIMIZED COMPOSITION FOR INTERFACE DRESSING

20190142991 ยท 2019-05-16

    Inventors

    Cpc classification

    International classification

    Abstract

    The present invention relates to a composition which has a low affinity with respect to latex gloves, comprising a hydrophobic matrix, characterized in that said hydrophobic matrix comprises: for 100 parts by weight of a mixture P of 2 styrene-saturated olefin-styrene triblock copolymers, a first which has a viscosity of between 0.01 and 1 Pa.Math.s as measured in a 5% (weight/weight) solution in toluene and a second which has a viscosity of between 0.01 and 0.5 Pa.Math.s measured in a 15% (weight/weight) solution in toluene; from 300 to 1000 parts by weight of a plasticizer H, preferably a plasticizing oil; and from 90 to 600 parts by weight of petroleum jelly V;
    it also being specified that: the total amount, represented by P+H+V, of the mixture of elastomers, of plasticizer and of petroleum jelly is between 490 and 1700 parts by weight; the ratio between the total amount of the mixture of elastomers, of plasticizer and of petroleum jelly and the amount of petroleum jelly, represented by P+H+V/V, is less than 11;
    and said mixture of 2 copolymers comprises at least 20% by weight of the first copolymer.

    The present invention also relates to an interface dressing with reinforcement, with a support or which is self-supported, which dressing comprises such a composition.

    Claims

    1-11. (canceled)

    12. A composition which has a low affinity with respect to latex gloves, comprising a hydrophobic matrix, wherein said hydrophobic matrix comprises: for 100 parts by weight of a mixture P of a first styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s as measured in a 5% (weight/weight) solution in toluene and a second styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s as measured in a 15% (weight/weight) solution in toluene; from 300 to 1000 parts by weight of a plasticizer H; and from 90 to 600 parts by weight of petroleum jelly V; it further being specified that: the total amount, represented by P+H+V, of the mixture of copolymers, of plasticizer and of petroleum jelly is between 490 and 1700 parts by weight; the ratio between the total amount of the mixture of copolymers, of plasticizer and of petroleum jelly and the amount of petroleum jelly, represented by P+H+V/V, is less than 11; and said mixture P of 2 copolymers comprises at least 20% by weight of the first copolymer.

    13. The composition as claimed in claim 12, wherein the hydrophobic matrix comprises: for 100 parts by weight of a mixture P of a first styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s as measured in a 5% (weight/weight) solution in toluene and a second styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s as measured in a 15% (weight/weight) solution in toluene; from 500 to 1000 parts by weight of a plasticizer H; and from 100 to 400 parts by weight of petroleum jelly V; it further being specified that: the total amount, represented by P+H+V, of the mixture of copolymers, of plasticizer and of petroleum jelly is between 700 and 1200 parts by weight; the ratio between the total amount of the mixture of copolymers, of plasticizer and of petroleum jelly and the amount of petroleum jelly, represented by P+H+V/V, is less than 8; and said mixture P of 2 copolymers comprises at least 20% by weight of the first copolymer.

    14. The composition as claimed in claim 12, wherein the plasticizer H is a plasticizing oil.

    15. The composition as claimed in claim 12, wherein the mixture of 2 copolymers comprises at least 50% of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s.

    16. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s.

    17. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of less than or equal to 25% by weight, relative to the total weight of said hydrophobic matrix.

    18. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of between 2% and 20% by weight, relative to the total weight of said hydrophobic matrix.

    19. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of between 10% and 15% by weight, relative to the total weight of said hydrophobic matrix.

    20. The composition as claimed in claim 12, which further comprises one or more substances selected from the group consisting of substances which have a favorable role in wound treatment, bactericidal agents, bacteriostatic agents, painkillers, local anesthetics and anti-inflammatory agents, in an amount of between 0.01% and 20% by weight, relative to the total weight of the composition.

    21. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of between 2% and 20% by weight, relative to the total weight of said hydrophobic matrix; wherein said composition further comprises one or more substances selected from the group consisting of substances which have a favorable role in wound treatment, bactericidal agents, bacteriostatic agents, painkillers, local anesthetics and anti-inflammatory agents, in an amount of between 0.01% and 20% by weight, relative to the total weight of the composition.

    22. The composition as claimed in claim 12, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of between 2% and 20% by weight, relative to the total weight of said hydrophobic matrix; wherein said composition further comprises one or more substances selected from the group consisting of substances which have a favorable role in wound treatment, bactericidal agents, bacteriostatic agents, painkillers, local anesthetics and anti-inflammatory agents, in an amount of between 1% and 15% by weight, relative to the total weight of the composition.

    23. An interface dressing with reinforcement, with a support or which is self-supported, which comprises a composition as claimed in claim 12.

    24. An interface dressing with reinforcement, with a support or which is self-supported as claimed in claim 23, wherein the mixture of 2 copolymers consists of 70% by weight of the first copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s and of 30% by weight of the second copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s and wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of between 2% and 20% by weight, relative to the total weight of said hydrophobic matrix; wherein said composition further comprises one or more substances selected from the group consisting of substances which have a favorable role in wound treatment, bactericidal agents, bacteriostatic agents, painkillers, local anesthetics and anti-inflammatory agents, in an amount of between 1% and 15% by weight, relative to the total weight of the composition.

    25. A self-supported interface dressing formed from a thin layer of a composition comprising a hydrophobic matrix and comprising through-holes, wherein said hydrophobic matrix comprises: for 100 parts by weight of a mixture P of a first styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 1 Pa.Math.s as measured in a 5% (weight/weight) solution in toluene and a second styrene-saturated olefin-styrene triblock copolymer which has a viscosity of between 0.01 and 0.5 Pa.Math.s measured in a 15% (weight/weight) solution in toluene; from 500 to 1000 parts by weight of a plasticizer H; and from 100 to 400 parts by weight of petroleum jelly V; it further being specified that: the total amount, represented by P+H+V, of the mixture of copolymers, of plasticizer and of petroleum jelly is between 700 and 1200 parts by weight; the ratio between the total amount of the mixture of copolymers, of plasticizer and of petroleum jelly and the amount of petroleum jelly, represented by P+H+V/V, is less than 8; and said mixture P of 2 copolymers comprises at last 30% by weight of the first copolymer.

    26. A self-supported interface dressing as claimed in claim 25, wherein the plasticizer H is a plasticizing oil.

    27. The self-supported interface dressing as claimed in claim 25, wherein the hydrophobic matrix further comprises hydrocolloid particles in an amount of less than or equal to 25% by weight, relative to the total weight of said hydrophobic matrix.

    28. The self-supported interface dressing as claimed in claim 25, wherein the hydrophobic matrix comprises: for 100 parts by weight of a mixture P of 2 styrene-saturated olefin-styrene triblock copolymers, a first which has a viscosity of between 0.01 and 1 Pa.Math.s as measured in a 5% (weight/weight) solution in toluene and a second which has a viscosity of between 0.01 and 0.5 Pa.Math.s as measured in a 15% (weight/weight) solution in toluene; from 650 to 800 parts by weight of a plasticizer H; and from 150 to 200 parts by weight of petroleum jelly V; it further being specified that: the total amount, represented by P+H+V, of the mixture of copolymers, of plasticizer and of petroleum jelly is between 900 and 1100 parts by weight; the ratio between the total amount of the mixture of copolymers, of plasticizer and of petroleum jelly and the amount of petroleum jelly, represented by P+H+V/V, is less than 6; said mixture P of 2 copolymers comprises at least 50% by weight of the first polymer; and hydrocolloid particles in an amount of between 10% and 20% by weight relative to the total weight of the hydrophobic matrix.

    29. The self-supported interface dressing as claimed in claim 25, wherein it is in the form of a breathable net of which the mesh size is about 2 mm, the thickness is about 600 microns and the grammage is about 450 g/m.sup.2.

    Description

    [0151] Preparation of the Compositions

    [0152] The compositions of examples 1 to 7 were produced using the following constituents in the proportions, expressed in weight percent, mentioned in table 1. [0153] Elastomer: sequenced copolymer of poly(styrene-ethylene-butylene-styrene) (abbreviated to SEBS): [0154] KRATON G1651 viscosity at 5% (weight/weight) in toluene: 0.04 Pa.Math.s [0155] KRATON G1654 viscosity at 5% (weight/weight) in toluene: 0.02 Pa.Math.s [0156] KRATON G1652 viscosity at 15% (weight/weight) in toluene: 0.088 Pa.Math.s [0157] KRATON G1650 viscosity at 15% (weight/weight) in toluene: 0.2 Pa.Math.s [0158] plasticizer: Ondina919 mineral oil sold by the company SHELL [0159] antioxidant: IRGANOX 1010 sold by the company BASF [0160] petroleum jelly: Codex A petroleum jelly sold by the company AIGLON [0161] hydrocolloid: sodium carboxymethylcellulose CMC BLANOSE 7H4XF sold by the company ASHLAND.

    [0162] Production of the Composition

    [0163] The plasticizer, the hydrocolloid and the petroleum jelly were successively introduced, with stirring at a setpoint temperature of 90 C., into an IKA mixer and the mixture was blended until a homogeneous mixture was obtained.

    [0164] After having brought the setpoint temperature to 140 C., the 2 copolymers and the antioxidant were introduced, with stirring, then the mixture was blended until a homogeneous mixture was obtained.

    [0165] The mixture was then left to cool, then the mixer was emptied.

    TABLE-US-00001 TABLE 1 Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Plasticizer 74.95 75 75 61.5 68.48 68.48 68.48 Petroleum jelly 5 4.95 15 8.02 8.02 8.02 Antioxidant 0.12 0.2 0.12 0.2 0.2 0.2 0.2 Hydrocolloid 15 10 15 15 15 15 15 Kraton G1651 4.93 2.96 Kraton G1654 7.8 5.7 4.15 5.7 2.6 Kraton G1650 7 2.6 4.15 2.6 5.7 Kraton G1652 1.97

    [0166] Demonstration of the Adhesion of the Compositions to Latex Gloves:

    [0167] The conditions for carrying out the test and for producing the mock-ups used were the following.

    [0168] Production of the Mock-Ups

    [0169] The mock-ups were generally in the form of reinforced compositions in which a reinforcement is embedded in order to stiffen them.

    [0170] The reinforcement used was a thermoset knit, made of polyester yarns, produced by the company MDB TEXINOV under the reference 555. The grammage thereof was 40 g/m.sup.2. It had an extensibility, measured according to standard EN 13726-4, of 2.7 N/cm in the cross direction and 24 N/cm in the longitudinal direction.

    [0171] 2 sheets were thus produced using the compositions to be tested and this reinforcement was incorporated between the 2 sheets of composition, by applying a strong pressure using a hydraulic press on the assembly according to the following protocol.

    [0172] The 2 plates of the press were preheated. A non-stick plastic film, for example a white silicone-treated/fluorinated polyester film, referenced 50 MD 07, sold by the company Siliconature, was deposited on the lower plate of the press; the silicone-treated/fluorinated face being placed opposite to the lower plate. 10 g of one of the compositions described in table 1 were spread over this face and the latter was covered with a silicone-treated polyester film 75 micrometers thick, the silicone-treated side being placed in contact with the composition. 2 blocks of 0.70 mm were placed between the 2 polyester films at the ends of the lower plate of the press and the assembly was subjected to a pressure of 200 bar and a temperature of about from 90 to 100 C.

    [0173] A second sheet was produced in the same way.

    [0174] A sample of the reinforcement previously defined on the apparent composition was applied on one of these sheets, after having removed the silicone-treated/fluorinated polyester.

    [0175] Starting from the other of these sheets, after having removed the silicone-treated/fluorinated polyester, the face of this sheet, comprising the composition to be tested, was applied on the reinforcement surface-linked, to the other sheet, so as to thus obtain a silicone-treated polyestercompositionreinforcementcompositionsilicone-treated polyester complex.

    [0176] 2 blocks of 1 mm and 0.2 mm, respectively, were placed between the 2 silicone-treated polyester films at the ends of the lower plate of the press and a pressure of 200 bar and a temperature of about from 90 to 100 C. were applied.

    [0177] The mock-up was left to cool and its thickness was controlled with a micrometer so as to obtain a mock-up of which the thickness is about from 1 to 1.1 mm. It is in fact necessary to use such mock-ups of small thickness to carry out the test making it possible to measure the adhesion to latex gloves.

    [0178] Measurement of the Adhesion to Latex Gloves

    [0179] The adhesive power of the mock-ups produced according to the protocol previously described was measured using a conventional right-angle peel test. This peel test was carried out with an MTS dynamometer equipped with a 2-Newton sensor. This dynamometer makes it possible to measure the force required to detach the mock-up to be tested from a steel plate, covered with a sample of latex glove. This force is expressed in cN/cm.

    [0180] The test was carried out at 23 C. and 50% relative humidity.

    [0181] The procedure of the test was the following.

    [0182] a. Preparation of the Steel Plate Covered with a Sample of Latex Glove

    [0183] This preparation is illustrated by FIGS. 1 to 13 which describe the successive implementation steps.

    [0184] A latex glove (size 8-9) referenced 112-1567 sold by the company VWR is used (FIG. 1).

    [0185] The powdered latex glove is turned inside out (FIG. 2) with the user face on the inside. The glove thus turned inside out is shaken so as to remove the powder (FIG. 3) and the fingers and the thumb of the glove are cut off (FIG. 4). The glove, still turned inside out, is pulled onto a 1-liter cylinder 68 mm in diameter (FIGS. 5 and 6), the user face of the glove thus coming into contact with the cylinder. A strip of masking tape (sold by the company Plasto under the reference P 3650) 5 cm wide and 10 cm long is stuck to the glove without creating folds. The glove is cut along the edges of the masking tape so as to obtain a sample covered with masking tape on one of its faces (FIGS. 8 and 8A).

    [0186] A double-sided adhesive sold by the company Plasto under the reference P753 is stuck on the steel plate used to carry out the peel test, while avoiding creating folds or bubbles (FIGS. 9 and 10). The protector is then detached from the double-sided adhesive (FIG. 11) and the masking-tape face of the sample of glove previously obtained is stuck onto the adhesive while avoiding folds and bubbles (FIG. 12). A test piece 1.5 cm wide and 10 cm long is cut from the mock-up to be tested and is deposited by centering it on the glove fixed to the steel plate as previously obtained and a 3 kg roller is passed back and forward across it twice at the speed of 200 mm/min (FIG. 13).

    [0187] The 90 degree peel test was then carried out at the speed of 300 mm/min. The test was reproduced 5 times for each composition to be tested. The results obtained are the mean of these 5 measurements. The adhesive powers obtained, expressed with their standard deviation (i), are collated in table 2.

    TABLE-US-00002 TABLE 2 Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Adhesive 9.76 17.36 47.12 2.08 3.72 4.7 3.96 power i = 1.89 i = 3.62 i = 7.96 i = 0.55 i = 0.74 i = 1.59 i = 3.62

    [0188] Examples 4 to 7 correspond to compositions according to the invention.

    [0189] In addition, with the latex glove selected, it was noted that all the mock-ups corresponding to examples 4 to 7 according to the invention could be easily handled.

    [0190] The compositions of examples 1 and 3 correspondent respectively to the formulations of examples 1 and 5 of patent application WO 00/16725. When the mock-ups which correspond to these 2 examples and that which corresponds to example 2 were handled with the latex glove selected, it was noted that all these mock-ups adhered to this latex glove, which made them very difficult to handle.

    [0191] This clearly gave confirmation that the test carried out is representative of the affinity phenomenon. When the adhesive power, measured according to this test, is less than 7 cN/cm, the mock-ups do not adhere to latex gloves.

    [0192] None of the compositions of comparative examples 1 to 3 meet this criterion of non-adhesion.

    [0193] Moreover, a self-supported interface dressing was produced using the composition of example 4 which has the lowest adhesive power found, according to the following procedure.

    [0194] The plasticizer and the hydrocolloid were successively introduced, with stirring at a setpoint temperature of 90 C., into a vertical mixer and the mixture was blended until a homogeneous mixture was obtained.

    [0195] After having brought the setpoint temperature to 140 C., the 2 copolymers and the antioxidant were introduced, with stirring, and the mixture was blended until a homogeneous mixture was obtained.

    [0196] The petroleum jelly was then introduced with stirring at 140 C., in two steps, until a homogeneous mixture was obtained.

    [0197] The mixture thus obtained was hot-cast at a temperature of about 120-130 C. onto an engraved flat plate forming the imprint of a square-mesh net or grid.

    [0198] After cooling and demolding, the expected dressing was obtained in the form of a square-mesh net having a thickness of approximately 600 m, a mesh size of about 2 mm and a grammage of about 450 g/m.sup.2.

    [0199] The dressings thus produced were placed between two temporary protective films made of silicone-treated polyester, 50 m thick.

    [0200] A self-supported interface dressing which has excellent cohesion and extensibility properties, but especially which does not pose any problem when it is handled with latex gloves since it does not adhere, was thus obtained.