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EP-4735061-A1 - SILICONE POLYMER SKIN ADHESIVE

EP4735061A1EP 4735061 A1EP4735061 A1EP 4735061A1EP-4735061-A1

Abstract

The present invention relates to a silicone polymer skin adhesive comprising fibres of a polyhydroxylated polysaccharide distributed throughout, as well as to wearable products comprising the silicone polymer skin adhesive, pre-cure compositions capable of forming the silicone polymer skin adhesive, methods of using the silicone polymer skin adhesive, 5 and methods of manufacturing the silicone polymer skin adhesive.

Inventors

  • BONNEFIN, Wayne
  • BUGEDO ALBIZURI, Ander
  • Hamerslagh, Brian John
  • MINTER, Daniel

Assignees

  • Advanced Medical Solutions Limited

Dates

Publication Date
20260506
Application Date
20240628

Claims (19)

  1. 1. A silicone polymer skin adhesive comprising fibres of a polyhydroxylated polysaccharide distributed throughout.
  2. 2. The silicone polymer skin adhesive according to claim 1 , wherein the fibres are cellulose fibres, optionally wherein the fibres are cotton and I or regenerated cellulose, such as viscose rayon fibres.
  3. 3. The silicone polymer skin adhesive according to any previous claim, wherein the fibres have a number average fibre length in the range of from 20 pm - 1500 pm as determined by microscopy, optionally from 200 pm to 1000 pm, such as from 200 pm to 900 pm.
  4. 4. The silicone polymer skin adhesive according to any previous claim, wherein the fibres are present in an amount of at least 0.25 %wt relative to the total weight of the silicone polymer skin adhesive, optionally from 0.25 to 5.0 %wt, optionally from 1 .0 %wt to 3.0 %wt.
  5. 5. The silicone polymer skin adhesive according to any previous claim, wherein the silicone polymer skin adhesive has a peel strength of from 0.1 to 10 N/2.5 cm, optionally from 0.5 to 5.0 N/2.5cm, such as 1.0 to 2.0 N/2.5cm, e.g. around 1.6 N/2.5cm.
  6. 6. The silicone polymer skin adhesive according to any previous claim, wherein the silicone polymer skin adhesive has a moisture vapour transmission rate (MVTR) of from 700 g/m 2 /24hrs to 2000 g/m 2 /24hrs, optionally from 900 g/m 2 /24hrs to 1100 g/m 2 /24hrs.
  7. 7. The silicone polymer skin adhesive according to any previous claim, wherein the silicone polymer skin adhesive has a wear time of at least 10 days.
  8. 8. The silicone polymer skin adhesive according to any previous claim, wherein the silicone polymer skin adhesive is disposed on a substrate, optionally wherein the substrate is a wearable product or a component part of a wearable product.
  9. 9. The silicone polymer skin adhesive according to claim 8, wherein the combined thickness of the silicone polymer skin adhesive and substrate is from 25 pm to 1000 pm or from 50 pm to 250 pm optionally from 75 pm to 150 pm, such as around 100 pm.
  10. 10. The silicone polymer skin adhesive according to claim 8 or 9, wherein the substrate is a medical device or a component part of a medical device.
  11. 11 . The silicone polymer skin adhesive according to any previous claim, wherein the silicone polymer skin adhesive is provided in the form of a film, optionally wherein a release liner is disposed on the film.
  12. 12. A wearable product comprising a silicone polymer skin adhesive according to any one of claims 1-11 , the silicone polymer skin adhesive disposed on the product so as to be capable of adhering the product to the skin of a user.
  13. 13. The wearable product according to claim 12, further comprising a release liner disposed on the silicone polymer skin adhesive.
  14. 14. The wearable product according to any of claims 12-13, wherein the product is a medical device or component part of a medical device.
  15. 15. A pre-cure composition capable of forming the silicone polymer skin adhesive according to any of claims 1-11 upon curing, the pre-cure composition comprising a silicone polymer precursor mixture and fibres of the polyhydroxylated polysaccharide distributed throughout the mixture.
  16. 16. A method of manufacturing a silicone polymer skin adhesive according to any of claims 1-11 , the method comprising curing the pre-cure composition according to claim 15.
  17. 17. Use of the silicone polymer skin adhesive according to any of claims 1-11 for adhering a wearable product to skin, optionally mammalian skin, e.g. human skin.
  18. 18. A method of adhering a skin adhesive according to any of claims 1-11 to the skin, the method comprising contacting the skin adhesive to the skin.
  19. 19. A method of treating a wound using a wound dressing, wherein the wound dressing comprises the skin adhesive of any of claims 1-11 as a contact layer.

Description

Silicone Polymer Skin Adhesive Field of the Invention The present invention relates to improvements in silicone polymer skin adhesives useful in adhering wearable articles, such as medical devices, to skin. Silicone polymer skin adhesives, and wearable products comprising the silicone polymer skin adhesive are described. The present disclosure also describes a pre-cure composition capable of forming the silicone polymer skin adhesive, as well as uses of the silicone polymer skin adhesive and a method of manufacturing the silicone polymer skin adhesive. Background of the Invention Wearable technology is becoming more prevalent in modern society. In certain instances, it is desirable to be able to adhere the respective technology to the skin of a subject so it remains in position close to, or in contact with, the body surface. This is especially relevant for medical applications where a medical device may need to be held in place on the skin for prolonged periods, particularly in moist or exuding environments such as in wound care applications or where high levels of perspiration may occur. Various skin adhesives have been developed in the field to allow products to be safely adhered to the skin, and which can later be removed following use. A number of commercially available skin adhesives are known, such as silicone polymer adhesives and those based on styrene block copolymers, polyisobutylene, polyethylene, poly(ethylene-vinyl acetate) (EVA) acrylics and polyurethane chemistries. Hydrocolloids are often used for medical applications because they are compatible with skin for prolonged periods. However, hydrocolloids are prone to erosion I disintegration upon moisture uptake and are therefore not ideal for certain medical applications where moist or exuding environments are encountered, such as in wound care applications. Furthermore, hydrocolloids tend to exhibit high peel profiles which can lead to patient discomfort upon removal. Silicone polymer skin adhesives (typically available in the form of silicone gels) are a suitable alternative because they are able to safely bond to the skin even in moist environments, and are readily removable after use without damaging healthy skin, e.g. by peeling (i.e. , they provide peel adhesion profiles that are less likely to cause trauma upon removal). However, conventional silicone polymer skin adhesives can also come with some drawbacks, such as poor moisture management due to their typical hydrophobicity and short wear times. It is desirable in wearable product applications for the adhesive to remain intact and securely bonded to the subject for a suitable duration. This is to allow the product to be adhered for prolonged periods and so avoid repeated removal and reapplication of adhesive, which can be time consuming and uncomfortable for the subject. Conventional skin adhesives can be prone to loss of adhesion and I or integrity over prolonged time frames, so there is a desire to provide skin adhesives for wearable product applications that have increased wear time. It is also desirable to be able to manage moisture at the skin surface as build-up of moisture at the adhesive location can lead to irritation/maceration, growth of harmful microorganisms, and ultimately diminished adhesion between the adhesive and skin surface. In this regard, it has been proposed in the art to include superabsorbent particulates in skin adhesives to modify their moisture absorption profile (e.g. W02009127207A1 , WO2012022352A1). However, it has been observed that uptake of water by superabsorbent particulates can lead to swelling of the polymer matrix. Such swelling is undesirable as it can lead to complications, especially when the polymer adhesive is part of a multi-layer structure, e.g. a laminate structure, because of the resulting change in size I shape of the polymer layer relative to the other layered components. Significant swelling can also in turn diminish the integrity of the adhesive and can lead to substrate breakdown which can result in residue being left on the skin. Attempts to mitigate this detrimental swelling effect in the context of silicone adhesives have included adding yet further additive components to the adhesive compositions to further modify the moisture handling properties (e.g. EP3801656A1), but this necessarily increases the complexity of the adhesive composition and may detrimentally effect other physical properties of the adhesive, such as peel strength, elasticity, and gel cohesiveness etc. The present invention seeks to obviate or mitigate one or more of the above mentioned disadvantages. Summary of the Invention According to a first aspect is a silicone polymer skin adhesive comprising fibres of a polyhydroxylated polysaccharide distributed throughout. It has been advantageously found by the inventors that the inclusion of polyhydroxylated polysaccharide fibres (especially cellulose fibres) in silicone adhesive leads to a surprising increase in