Adhesive composition and element for attaching to human skin

Abstract

An adhesive composition is intended to provide the attaching to human skin, comprising a continuous phase and a discontinuous phase of hydrocolloids, with the continuous phase comprising by weight, based on the total weight of the adhesive composition: (i) 1 to 12% by weight of a sequenced polymer of the styrene-isoprene-styrene or styrene-butadiene-styrene type, (ii) (a) 1 to 15% of a polymer of the elastomer butyl type, possibly as a mixture with up to 25% by weight of a polymer of the polyisobutylene type, or (b) more than 10% to 30% of a polymer of the polyisobutylene type, free of polymer of the elastomer butyl type, (iii) 1 to less than 10% of a polymer of the ethylene vinyl acetate type, with the sum of these three types of polymers representing from 10 to 40%.

Claims

1. An adhesive composition intended to provide the attaching on human skin, comprising a continuous phase and a discontinuous phase of hydrocolloids, the continuous phase comprising by weight, based on the total weight of the adhesive composition: (i) 1 to 12% by weight of a sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (a) 1 to 15% by weight of a butyl elastomer polymer, optionally in a mixture with up to 25% by weight of a polyisobutylene polymer, or (b) from 15% to 30% by weight of a polyisobutylene polymer, free of butyl elastomer polymer, (iii) 1 to less than 10% by weight of an ethylene vinyl acetate polymer, with the sum of these three types of polymers representing from 10 to 40% by weight, and wherein the composition comprises 40 to 60% by weight of discontinuous phase of hydrocolloids.

2. The composition according to claim 1, wherein the composition is free of polar oil and/or wherein polar phase represents less than 10% by weight.

3. The composition according to claim 1, wherein the continuous phase comprises: (i) 2 to 8% by weight of the sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, optionally in a mixture with up to 25% by weight of the polyisobutylene polymer, (iii) 2 to less than 10% by weight of the ethylene vinyl acetate polymer.

4. The composition according to claim 1, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, free of polyisobutylene polymer.

5. The composition according to claim 1, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, in a mixture with from 10 to 25% by weight of the polyisobutylene polymer.

6. The composition according to claim 1, wherein the continuous phase comprises: (i) 2 to 8% by weight of the sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (b) from 15% to 30% by weight of the polyisobutylene polymer, free of butyl elastomer polymer, (iii) 2 to less than 10% by weight of the ethylene vinyl acetate polymer.

7. The composition according to claim 1, wherein the ethylene vinyl acetate polymer comprises from 30 to 70% by weight of vinyl acetate monomer.

8. The composition according to claim 1, wherein the composition further comprises 10 to 30% by weight of tackifier resin.

9. The composition according to claim 1, wherein the discontinuous phase comprises a majority of at least one compound chosen from cellulose fibers, crosslinked or non-crosslinked carboxymethylcellulose, sodium, hydroxyethylcellulose, guar or karaya gum or gum arabic, xanthans, starches, alginates, pectin, gelatine, psyllium, carob extract, agarose, carrageenans, polyacrylamides, or mixtures thereof.

10. The composition according to claim 1, wherein the discontinuous phase is free from products of animal origin.

11. An element for attaching a bag for collecting body fluids, comprising the adhesive composition as claimed in claim 1 and, on the face opposite that which is intended to be in contact with the skin, a film.

12. The element according to claim 11, wherein the film is a polyethylene film or ethylene-vinyl acetate copolymer or the mixture thereof.

13. The composition according to claim 2, wherein the continuous phase comprises: (i) 2 to 8% by weight of the sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, optionally in a mixture with up to 25% by weight of the polyisobutylene polymer, (iii) 2 to less than 10% by weight of the ethylene vinyl acetate polymer.

14. The composition according to claim 2, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, free of polyisobutylene polymer.

15. The composition according to claim 3, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, free of polyisobutylene polymer.

16. The composition according to claim 2, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, in a mixture with from 10 to 25% by weight of the polyisobutylene polymer.

17. The composition according to claim 3, wherein: (ii) (a) 2 to 10% by weight of the butyl elastomer polymer, in a mixture with from 10 to 25% by weight of the polyisobutylene polymer.

18. The composition according to claim 2, wherein the continuous phase comprises: (i) 2 to 8% by weight of the sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (b) from 15% to 30% by weight of the polyisobutylene polymer, free of butyl elastomer polymer, (iii) 2 to less than 10% by weight of the ethylene vinyl acetate polymer.

19. The composition according to claim 2, wherein the ethylene vinyl acetate polymer comprises from 30 to 70% by weight of vinyl acetate monomer.

20. An adhesive composition intended to provide the attaching on human skin, comprising a continuous phase and a discontinuous phase of hydrocolloids, the continuous phase comprising by weight, based on the total weight of the adhesive composition: (i) 1 to 12% by weight of a sequenced polymer of styrene-isoprene-styrene or styrene-butadiene-styrene, (ii) (a) 1 to 15% by weight of a butyl elastomer polymer, optionally in a mixture with up to 25% by weight of a polyisobutylene polymer, or (iii) 1 to less than 10% by weight of an ethylene vinyl acetate polymer, with the sum of these three types of polymers representing from 10 to 40% by weight, and wherein the composition comprises 40 to 60% by weight of discontinuous phase of hydrocolloids.

21. The element according to claim 12, wherein the film is with a thickness of 25 to 100 m.

Description

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

(1) Polymers of the SIS or SBS type

(2) These polymers are conventional and known in the art. These are block copolymers based on styrene and isoprene or butadiene (or a mixture of the two).

(3) The texture copolymer of the continuous phase of the styrene-isoprene-styrene or styrene-butadiene-styrene type, is constituted preferably of a styrene-isoprene-styrene sequenced copolymer. These polymers can contain variable quantities of diblocks or triblocks, with double or triple sequences.

(4) Reference can be made for a description of these polymers to document WO2011/157278, page 8, lines 6-18, passage to which it is expressly referred to. Reference can also be made to document U.S. Pat. No. 4,855,335, col. 3, lines 16-23 passage to which it is expressly referred to.

(5) Examples of copolymers of the styrene-isoprene-styrene or styrene-butadiene-styrene texture type that are suitable according to the invention are for example certain copolymers Kraton from

(6) Shell Chemical Company, for example of the D11 type (D1161, D1117 and D1112), or these copolymers such as Vector 4113 from Dexco or Cariflex S-1707 from Shell.

(7) Polymers of the Butyl or PIB Type

(8) These polymers are also conventional.

(9) The polymer conventionally identified under the term butyl is a polybutyl elastomer comprising a minority portion of isoprene. Use can be made of those commercialised under the names Butyl 268 from Exxon, or Butyl BK from Togliatti/Nizhnekamsk.

(10) The molecular weight of the butyl elastomer is adapted to the application, for example a molecular weight Mn from 200,000 to 600,000.

(11) The polymer PIB is also well known to those skilled in the art. Those of the Oppanol range available from BASF can be used, with for example grades B10, B12 and B15. The molecular weight of the PIB is adapted to the application, for example a molecular weight Mn less than 100,000, preferably from 40,000 to 60,000.

(12) EVA

(13) This type of polymer is also known. Those comprising from 30 to 70% by weight of monomer vinyl acetate can for example be used.

(14) Those of the LEVAMELT range of grades 400 or 700 or of the Evatane range can be used.

(15) Tackifier Resins

(16) The tackifier resins used in the invention are conventional.

(17) More precisely, tackifier resins, the tackifier agent used can include a mixture of high-activity tackifier resins, for example based on terpene resins, and/or having medium activity, and/or having low activity but furthermore having reinforcing properties. Reference can be made to document EP1871845 for a description of the suitable tests.

(18) These tackifier resins are conventional. Resins of the terpene type can thus be used, for example terpene-styrene, that can have a softening temperature of about 105 C. (ring and ball method) and a molecular weight by mass of about 1000. Resins that also have a reinforcing action can also be used. For example a thermoplastic polymer derived substantially from -methylstyrene having for example a molecular weight by mass between 300 and 3000 can be used. The elasticity of the composition can thus be modulated. Totally hydrogenated resins can also be used.

(19) Examples of such resins are the resins commercially available under the names Regalite, Arkon, Dercolyte, Piccolyte S, Zonatac, Kristalex, Piccotex and Escorez.

(20) The respective quantities of the various types of resins can vary such as will be appreciated by those skilled in the art.

(21) Hydrocolloid

(22) The discontinuous phase constituted of hydrophilic polymers in the form of hydrocolloids is of the type well known in the art, containing a substantial quantity of compounds such as cellulose fibres, carboxymethylcellulose, sodium, cross-linked or other, and hydroxyethylcellulose, as well as compounds similar to guar gum, and substances such as xanthans, alginates, pectin, gelatine, psyllium, carob extract, gum arabic, agarose, carrageenans and polyacrylamides.

(23) The hydrocolloids used in the invention are conventional.

(24) Plasticizer

(25) A plasticizer will be used, which more preferably is an apolar oil. An example of such an oil or plasticizer is a polyalphaolefin, such as the one available under the name Durasyn. A mineral oil, a paraffin, a castor oil, a synthetic paraffin wax from Shell, the Sun 5512 resin from Sun or Primol from Hercules can also be used.

(26) The adhesive composition can comprise other agents or additives, such as an agent with medicinal action, for example chosen from chitosan and -L-fucose, or additives such as antioxidants.

(27) The invention also relates to an element for attaching a bag for collecting body fluids comprising the aforementioned adhesive composition and, on the face opposite the one that must be in contact with the skin, a conventional coating film known in the art.

(28) Such a film is a polyethylene or EVA film, of suitable thickness.

(29) Examples of Composition

(30) The compositions of the table are prepared by mixing constituents, according to the proportions by weight. The components are given in the table. The order of introduction is that which appears in the table.

(31) After each introduction, a mixing of about 10 min is implemented in order to obtain good homogeneity. The final mixing lasts about 50 min. The composition thus obtained is extruded, with an extrusion time of about 60 min, in the form of a sheet 1 mm thick and cut into elements used for tests for attaching bags for collecting body fluids.

(32) The elements are then tested.

(33) Fmax and Tack: The test consists in the pulling off of a punch executed using a traction machine and measuring the force required for the pulling off of the punch (Fmax), in determined conditions of contact time with the composition before pulling off and of the pulling off speed. The tack is measured with the same test but with very short contact times.

(34) Fcompression and % relaxation: the test consists of a compression test executed using a traction machine to measure the rigidity (Fcompression) as well as the capacity for relaxation (% relaxation), in determined conditions of contact time with the composition.

(35) The following table gives the compositions and the values of the measurements of the tests.

(36) TABLE-US-00001 Formulas 1 2 3 4 5 6 SIS Kraton D1161 3.04 6.50 4.56 Vector 4113 3.04 6.5 5.5 EVA Levamelt 686 3 3 2.6 2.6 6.5 3 Levamelt 400/EVATAN 2.1 2.1 3 2 40/55 Butyl Butyl 268 7.44 7.44 7.27 7.27 3 3 PIB Oppanol B15 13 12 Oppanol B12 11.00 11 6 Oppanol B10 9 9 Resins Rgalite 9.02 3.3 Dercolyte 15.43 Piccolyte S 5.3 13.33 7.3 7.7 Kristalex 3.46 6.5 Piccotex 3.46 6.5 5.5 5.19 Escorez 3.72 Plasticizer Durasyn 5.04 5.04 11.6 13.7 9.9 7.55 Hydrocolloids CMC7M 12.00 8 11 Guar 10.00 9 9 12 7 11 CMC12M 7 14 15 14 Gelatine 16.00 14 12 11 15 Pectin 11.00 11 11 11 12 9 Superabsorbant A500 5 8.5 Characteristics Tack 1.15 1.15 1.27 1.25 1.35 1.20 Fmax 4.60 4.80 3.20 3.40 3.80 3.00 F compression 3.10 3.00 2.50 2.40 2.60 2.50 % relaxation 67.00 65.00 60.00 60.00 72.00 65.00

(37) Consideration is now given to other properties of the compositions according to the invention.

(38) Tests in Patients

(39) Tests have been conducted in the conditions of a hospital environment, i.e. wherein the installation and the removing are carried out by hospital personnel. The hospital personnel or the patients determined several parameters among which the immediate adhesiveness, the presence of residue on the skin after the removal of the composition, the facility in applying the bag, the facility in removing the bag, the conformability and the adhesiveness of the bag when it is worn by the patient.

(40) The results obtained are excellent and the compromise is reached.

(41) As such, the invention relates to adhesive compositions and elements for attaching that have the compromise sought for ostomy bags.