Adhesion Materials and Methods of Manufacture

Abstract

The present invention consists in a new type of adhesion material and the method of production. This material is used in the medical area, or in areas where is necessary to connect a device to the skin. This connection occurred due to the polarity that exists in the two materials, more concrete through the electric bounds, in more specific the bound obtained is a hydrogen bound that is produced when the two materials are connected. The adhesion material comprises polyethylene glycol, citric acid, ascorbic acid, one or more sugars or sugar alcohol, glycerol as well as a lauric acid and/or oleic acid mixture with polypropylene grafted with maleic anhydride or Polyethylene grafted with maleic anhydride or poly (ethylene-alt-maleic anhydride) or polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride or polyisoprene-graft-maleic anhydride or poly(methyl vinyl ether-alt-maleic anhydride) or poly(isobutylene-alt-maleic anhydride) or poly(maleic anhydride-alt-1-octadecene) or poly(ethylene glycol)methyl ether methacrylate solution.

Claims

1. An adhesion material for binding an object to a skin of a human or an animal, the adhesion material comprising a mixture of polyethylene glycol, citric acid, ascorbic acid, glycerol, at least one of a sugar or a sugar alcohol, as well as one of lauric acid or oleic acid.

2. An adhesion material according to the claim 1, further comprising lignin.

3. An adhesion material according to claim 1, further comprising polypropylene grafted with maleic anhydride or polyethylene grafted with maleic anhydride or poly (ethylene-alt-maleic anhydride) or polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride or polyisoprene-graft-maleic anhydride or poly(methyl vinyl ether-alt-maleic anhydride) or poly(isobutylene-alt-maleic anhydride) or poly(maleic anhydride-alt-1-octadecene) or poly(ethylene glycol)methyl ether methacrylate solution.

4. An adhesion material according to claim 1, wherein 44% to 56% in weight is the mixture of polyethylene glycol, citric acid, ascorbic acid, glycerol xylitol and lauric acid/oleic acid or the material resulted from the reaction between them and 44% to 56% of weight is polypropylene grafted with maleic anhydride or polyethylene grafted with maleic anhydride or poly (ethylene-alt-maleic anhydride) or polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride or polyisoprene-graft-maleic anhydride or poly(methyl vinyl ether-alt-maleic anhydride) or poly(isobutylene-alt-maleic anhydride) or poly(maleic anhydride-alt-1-octadecene) or poly(ethylene glycol)methyl ether methacrylate solution.

5. The adhesion material according to claim 1, further comprising: 14% to 16% by weight of polyethylene glycol 400; 18% to 21% by weight of citric acid; 2% to 4% by weight of ascorbic acid; 4% to 6% in weight of glycerol; 5% to 7% In weight of xylitol 1% to 2% in weight of oleic acid.

6. The adhesion material according to claim 1, comprising 14% to 16% in weight of polyethylene glycol.

7. The adhesion material according to claim 1, wherein the molecular chain of polyethylene glycol is between 200 to 8000 g/mol,

8. The adhesion material according to claim 1, further comprising 18% to 21% in weight of citric acid.

9. The adhesion material according to claim 1, wherein the molecular weight of citric acid is 190 g/mol.

10. The adhesion material according to claim 1, wherein preferably comprises 2% to 4% in weight of ascorbic acid.

11. The adhesion material according to claim 1, wherein the molecular weight of ascorbic acid is 176 g/mol.

12. The adhesion material according to claim 1, wherein preferably comprises 4% to 6% in weight of glycerol.

13. The adhesion material according to claim 1, wherein the concentration of glycerol is 98 g/mol.

14. The adhesion material according to claim 1, wherein the sugar alcohol is selected from the group of alcohols consisting of xylitol or sorbitol and the sugar is from the group of carbohydrates consisting of sucrose, lactose, maltose or fructose.

15. The adhesion material according to claim 1, wherein the adhesion material further comprises 5% to 7% in weight of xylitol.

16. The adhesion material according to claim 1, where in the molecular weight of lauric acid or oleic acid is between 200 and 300 g/mol.

17. The adhesion material according to claim 3, further comprises 8% to 12% in weight of, polypropylene grafted with maleic anhydride or polyethylene grafted with maleic anhydride or poly (ethylene-alt-maleic anhydride) or polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride or polyisoprene-graft-maleic anhydride or poly(methyl vinyl ether-alt-maleic anhydride) or poly(isobutylene-alt-maleic anhydride) or poly(maleic anhydride-alt-1-octadecene) or poly(ethylene glycol)methyl ether methacrylate solution.

18. The adhesion material of claim 1, wherein the adhesion material is attached to a medical device adapted to be in contact with the skin.

19. Method for production of an adhesive material comprising a mixture of polyethylene glycol, citric acid, ascorbic acid, glycerol, at least one of a sugar or a sugar alcohol, as well as one of lauric acid or oleic acid, wherein the polyethylene glycol, citric acid, ascorbic acid, sugar alcohol or sugar, glycerol and lauric acid/oleic acid are mixed at temperatures between 80° C. to 200° C., during 2 h to 24 h, using pressures between zero and 2 atmospheres and with a mixing velocity between 1 to 2000 rpm.

20. Method according to claim 19 wherein the velocity of the mixing between polyethylene glycol, citric acid, ascorbic acid, glycerol and lauric acid/oleic acid with polypropylene grafted with maleic anhydride or Polyethylene grafted with maleic anhydride or poly (ethylene-alt-maleic anhydride) or polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride or polyisoprene-graft-maleic anhydride or poly(methyl vinyl ether-alt-maleic anhydride) or poly(isobutylene-alt-maleic anhydride) or poly(maleic anhydride-alt-1-octadecene) or poly(ethylene glycol)methyl ether methacrylate solution ranges between 1 rpm to 1000 rpm, with a temperature of mixture between 23° C. and 100° C., during 1 minute to 24 hours.

21. An adhesive patch comprising an external layer made of a waterproof and breathable material, an intermediate layer made of a fabric, and an inner layer made of the adhesion material, the adhesion material comprising a mixture of polyethylene glycol, citric acid, ascorbic acid, glycerol, at least one of a sugar or a sugar alcohol, as well as one of lauric acid or oleic acid.

22. The adhesive patch of claim 21, wherein the external layer is at least one of ePTFE, silicone, TPU, PEBA or EVA.

23. The adhesive patch of claim 21, wherein the intermediate layer is made of one of non-woven or woven fabric.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] For easier understanding, the figures and tables representing preferential embodiments not intend to limit the object of the present description.

[0051] FIG. 1 shows the molecular structure of polypropylene grafted with maleic anhydride;

[0052] FIG. 2 shows the molecular structure of polyethylene grafted with maleic anhydride.

[0053] FIG. 3 shows the molecular structure of poly (ethylene-alt-maleic anhydride).

[0054] FIG. 4 shows the molecular structure of polystyrene-block-poly(ethylene-ran-butylene)-block-polystyrene-graft-maleic anhydride.

[0055] FIG. 5 shows the molecular structure of polyisoprene-graft-maleic anhydride.

[0056] FIG. 6 shows the molecular structure of poly(methyl vinyl ether-alt-maleic anhydride).

[0057] FIG. 7 shows the molecular structure of poly(isobutylene-alt-maleic anhydride).

[0058] FIG. 8 shows the molecular structure of poly(maleic anhydride-alt-1-octadecene).

[0059] In FIG. 9 is an example of how the materials can be placed.

[0060] FIG. 10 shows the molecular structure resulted by the reaction between the different polyols.

[0061] FIG. 11 show the results of adhesion strength of the adhesive comparing with products already in the market.

[0062] FIG. 12 show the material attached to the skin

DETAILED DESCRIPTION OF THE INVENTION

EXAMPLE 1

[0063] In this example the application of the composition will be illustrated. The composition used in the adhesion material on the adhesive patch as shown in the FIG. 12, is a mixture of

[0064] 14% to 16% by weight of polyethylene glycol 400;

[0065] 18% to 21% by weight of citric acid;

[0066] 2% to 4% by weight of ascorbic acid;

[0067] 4% to 6% in weight of glycerol;

[0068] 5% to 7% In weight of xylitol

[0069] 1% to 2% in weight of oleic acid.

[0070] The biopolymer resulted from the reaction of the different polyols is mixed, in this case is used between 44% and 56% in weight with the maleic anhydride polymer. The adhesion material comprises 44% to 56% in weight of poly(methyl vinyl ether-alt-maleic anhydride). The materials to be use in the adhesion material are mixed by hand or with the help of a mixing machine at temperatures between 23° C. and 90° C., and with a velocity of mixing between 1 rpm and 1000 rpm. Poly(methyl vinyl ether-alt-maleic anhydride) was selected because this material presents the molecular length necessary to interact with the deep zone of the skin.

[0071] A non-woven or a woven fabric, such as but not limited to polyamide, polyester, cotton, fibers of polypropylene or polyethylene, is used as the substrate for the adhesive patch. This substrate is a layer of a material with the capability to protect the adhesion material and the skin from atmosphere.

[0072] The adhesive patch was obtained as follows. Firstly, a protective layer with a thickness between 50 μm and 500 μm of silicone was applied at room temperature to one of the faces of the non-woven or woven fabric. This silicone layer is applied at room temperature using the technique of knife-coating and/or spraying and/or printing. The protective layer was cured up to a maximum of three hours at temperatures between 23° C. to 100° C.

[0073] After this cure period the adhesion material was added to the other one of the faces of the non-woven or woven fabric by knife-coating, nano-printing or nano-spray.

EXAMPLE 2

[0074] This example illustrates a way of producing an adhesion material to be used in a hot and cold therapy adhesive patch. An adhesion material of a butyl ester of methyl vinyl ether grafted with maleic anhydride was selected because this composition presents the molecular length necessary to interact with the deep zone of the skin and has in its structure the maleic anhydride necessary to adhere to the skin.

[0075] The adhesion material can be made through the following process: The composition to be used in the adhesion material is a mixture of:

[0076] 14% to 16% by weight of polyethylene glycol 400;

[0077] 18% to 21% by weight of citric acid;

[0078] 2% to 4% by weight of ascorbic acid;

[0079] 4% to 6% in weight of glycerol;

[0080] 5% to 7% In weight of xylitol

1% to 2% in weight of oleic acid. The polyol resulted from the reaction of the different polyols can also be used, in this case is used between 44% and 56% in weight. The adhesion material must have 44% to 56% in weight of a butyl ester of methyl vinyl ether grafted with maleic anhydride.

[0081] The materials were mixed for between 1 min to 24 hours at a temperature between 23° C. and 110° C., more preferably between 30-90° C. The materials were mixed between 1 min to 24 hours.

[0082] The adhesion material is added to the face of the adhesive patch that will be in contact with the skin through knife-coating, nano-printing or nano-spray.

[0083] A protective layer of polyether block amide (PEBA) with a thickness of between 50 μm and 500 μm is added to the external face of the medical device. The protective layer will be used to protect the adhesion material from the atmosphere. The protective layer will be added to the adhesive patch by painting or thermoforming.

EXAMPLE 3

[0084] This example is a way of applying the adhesive to a wound dressing that uses a non-woven or woven fabric. A protective material is also used to protect the adhesion material from the atmosphere, and the adhesion material will enable adhesion to the skin. Poly (ethylene-alt-maleic anhydride) was used as the adhesion material because this adhesion material has the capability to interact with the water in the skin, as described above.

[0085] This adhesion material was made through the following process: The adhesion material to be used in the adhesive is a mixture of

[0086] 14% to 16% by weight of polyethylene glycol 400;

[0087] 18% to 21% by weight of citric acid;

[0088] 2% to 4% by weight of ascorbic acid;

[0089] 4% to 6% in weight of glycerol;

[0090] 5% to 7% In weight of xylitol

[0091] 1% to 2% in weight of oleic acid.

[0092] The polyol resulted from the reaction of the different polyols can also be used, in this case is used between 44% and 56% in weight. The adhesion material must have 44% to 56% in weight of poly(ethylene glycol)methyl ether methacrylate solution.

[0093] To mix the different components of the adhesion material, temperatures between 23° C. and 110° C., and more preferably between 30-90° C., were used. The materials were mixed between 1 min to 24 hours. These components were mixed by hand or with a help of a mixer with a mixing velocity between 1 rpm and 1000 rpm for between 1 min to 2 hours.

[0094] The adhesion material was applied to one face of the non-woven fabric made of a polyamide or a layer of thermoplastic polyurethane (TPU) with thickness of between 50 μm and 500 μm.

Testing

[0095] Tests regarding the adhesion capability of the adhesives were made, and these are shown in FIG. 12. These tests were made according with the standard ASTM D 3359-97 “tape test”. They compared the adhesion strength of the examples of this document invention with prior art materials, namely Combihesive IIS from Convatec and Askina “Thinsite” from BBraun. These tests evaluated the maximum and the minimum force needed to remove the adhesive. The figure shows that to remove the adhesive was necessary less force (10N) compared with the ones in the state-of-the-art (13N for Askina and 12 for Combihesive). Relatively to the minimum force the adhesive developed needed more force (2N) comparatively to the Convatec (1N) but need less force when compared to the product of BBraun (8N).