SKIN CONTACT MATERIAL

Abstract

A substrate based skin contact material formed from a hydrocolloid having a silicone based component extending over regions of the substrate surface. The adhesive is formed non-continuously over the substrate to provide areas devoid of adhesive to allow appreciable moisture transfer between the skin and substrate and improve the skin friendliness of the material during use and allow convenient removal with avoidance of skin irritation.

Claims

1. A skin contact material comprising: a substrate having a first surface to be positioned against the skin and a second surface to be positioned away from the skin; and an adhesive layer coated on the first surface as a rectangular grid pattern formed by a plurality of protrusions extending over the first surface, wherein: the plurality of protrusions are coated on a flat face of the first surface that is devoid of projections; the plurality of protrusions include a first set of protrusions aligned in protrusion rows that are spaced apart from one another in a first direction and a second set of protrusions aligned in protrusion columns that are spaced apart from one another in a second direction perpendicular to the first direction; the first set of protrusions are aligned in each protrusion row with discontinuities located between adjacent protrusions and the second set of protrusions are aligned in each protrusion column with discontinuities located between adjacent protrusions; the first surface of the substrate includes a first side and a second side arranged opposite the first side; and the plurality of protrusions are coated only on the first side of the first surface without being coated on the second side of the first surface.

2. The skin contact material of claim 1, wherein the first set of protrusions include a first set of bumps.

3. The skin contact material of claim 2, wherein the second set of protrusions include a second set of bumps.

4. The skin contact material of claim 1, wherein the second side of the first surface is devoid of any projections or protrusions.

5. The skin contact material of claim 1, wherein the plurality of protrusions are uniformly distributed over the first side of the first surface.

6. The skin contact material of claim 1, wherein the adhesive layer is a two-part catalysed, low temperature curing silicon adhesive layer.

7. The skin contact material of claim 1, wherein the adhesive layer is a composite silicon layer that includes a plurality of different silicon-based materials.

8. The skin contact material of claim 7, wherein: the first set of protrusions include a first silicon-based material; and the second set of protrusions include a second silicon-based material.

9. The skin contact material of claim 1, wherein each of the first side and the second side accounts for half of a total surface area of the first surface.

10. The skin contact material of claim 1, wherein: the first set of protrusions are uniformly separated from one another in each protrusion row by a first separation distance; and the second set of protrusions are uniformly separated from one another in each protrusion column by a second separation distance.

11. The skin contact material of claim 10, wherein the first separation distance and the second separation distance are the same.

12. A skin contact material comprising: a substrate having a first surface to be positioned against the skin and a second surface to be positioned away from the skin; and an adhesive layer coated on the first surface by a plurality of protrusions extending over the first surface, wherein: the plurality of protrusions are coated on a flat face of the first surface that is devoid of projections; the plurality of protrusions include a first set of protrusions aligned in protrusion rows and a second set of protrusions aligned in protrusion columns; the first set of protrusions are aligned in each protrusion row with discontinuities located between adjacent protrusions and the second set of protrusions are aligned in each protrusion column with discontinuities located between adjacent protrusions; the first surface of the substrate includes a first side and a second side arranged opposite the first side; the plurality of protrusions are coated only on the first side of the first surface without being coated on the second side of the first surface; and the plurality of protrusions are uniformly distributed over the first side of the first surface.

13. The skin contact material of claim 12, wherein the protrusion rows are spaced apart from one another in a first direction and the protrusion columns are spaced apart from one another in a second direction different from the first direction.

14. The skin contact material of claim 12, wherein the second side of the first surface is devoid of any projections or protrusions.

15. The skin contact material of claim 12, wherein the adhesive layer is a composite silicon layer that includes a plurality of different silicon-based materials.

16. The skin contact material of claim 12, wherein each of the first side and the second side accounts for half of a total surface area of the first surface.

17. The skin contact material of claim 12, wherein: the first set of protrusions are uniformly separated from one another in each protrusion row by a first separation distance; and the second set of protrusions are uniformly separated from one another in each protrusion column by a second separation distance.

18. The skin contact material of claim 17, wherein the first separation distance and the second separation distance are the same.

19. The skin contact material of claim 12, wherein the first set of protrusions include a first set of bumps.

20. The skin contact material of claim 19, wherein the second set of protrusions include a second set of bumps.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A specific implementation of the present invention will now be described, by way of example only, and with reference to the accompanying drawings in which:

[0018] FIG. 1 is perspective view of a skin contact material having a substrate and an adhesive component bonded to one face of the substrate according to the specific implementation;

[0019] FIG. 2 is a cross section to A-A of FIG. 1;

[0020] FIG. 3 is a perspective view of a further specific implementation of the skin contact material of FIG. 1;

[0021] FIG. 4 is a cross section through B-B to FIG. 3;

[0022] FIG. 5 is a perspective view of a stoma gasket formed from the skin contact material according to a specific implementation;

[0023] FIG. 6 contains a cross sectional side view of the stoma gasket at an adhesive ring of FIG. 5 secured in position against a patient's skin and in contact with a flange of an ostomy bag;

[0024] FIG. 7 is a cross sectional side view of the skin contact material used as a wound dressing adhesive to maintain a dressing in position over a wound at the skin; and

[0025] FIG. 8 is a side view of an ostomy bag having a flange comprising the skin contact material according a specific implementation.

DETAILED DESCRIPTION OF THE INVENTION

[0026] Referring to FIGS. 1 and 2, the skin contact material 100 comprises a substrate 101 having a first surface 102 intended to be facing the skin and an opposed second surface 103 intended to be facing away from the skin. An adhesive layer 104 is provided on the surface 102 and according to the specific implementation, layer 104 comprises a rectangular grid pattern formed by perpendicular aligned ridges 105, 106.

[0027] Adhesive layer 104, formed from the narrow ridges 105, 106 is regarded as ‘discontinuous’ over surface 102 such that the adhesive 104 does not coat completely surface 102 and there is provided regions 107 that are devoid of adhesive 104 with regions 107 being exposed substrate 102. The rectangular grid pattern formed by ridges 105, 106 is uniform across surface 102 such that the space between ridges 105, 106 is equal in the respective directions across substrate surface 102. According to the specific implementation, the thickness of substrate 101 is in range 0.5 to 5.0 mm. The distance by which ridges 105, 106 extend from surface 102 is a small percentage of this thickness and may be of the order of 0.01 mm.

[0028] FIGS. 3 and 4 illustrate a further embodiment of the skin contact material of FIGS. 1 and 2. According to the further embodiment, the adhesive layer is formed as a regular repeating array of nodes or bumps 300. The bumps 300 are separated from one another by a regular or uniform discreet separation distance such that the skin contact surface 102 of substrate 101 is exposed at spacings 301 between the bumps 300.

[0029] The material of the embodiment of FIGS. 1 to 4 is suitable for use as a medical grade skin contact material and in particular a material for adherence to the skin of colostomy, ileostomy and urostomy appliances. The material is also suitable for adherence to the skin of patient monitoring appliances, prosthetics and wound dressings.

[0030] Specifically with regard to ostomy applications, FIG. 5 illustrates a specific embodiment of the skin contact material 500 formed as an annular disc suitable for use as a skin contact stoma gasket. The skin contact material 500 comprises a central aperture or bore 504 extending through skin contact material 500. Skin contact material 500 comprises a substrate 506 having a skin contact surface 501 and opposed surface 502 intended to be facing away from the skin. An adhesive layer 503 is provided on the surface 501 and is formed as a series of concentric circles extending between central bore 504 and parameter edge 507. The concentric circles of the adhesive layer 503 are spaced apart from one another and therefore formed as discreet ridges separated by regions 505 of exposed substrate surface 501.

[0031] FIG. 6 illustrates the skin contact material 500 of FIG. 5 secured in position at the peristomal skin 604. The adhesive ridges of the adhesive layer 503 are positioned in contact with the peristomal skin 604 such that regions 505 are in a position very close to or in direct contact with skin 604 so as to provide moisture transfer between skin contact material 500 and skin 604. That is, moisture is actively transferred from skin 604 and into material 500 via regions 505. This would otherwise not be possible if adhesive layer 503 extended continuously over skin contact surface 501.

[0032] An ostomy bag 600 comprises a flange 601 formed from a solid support 602 that supports an attachment flange 603. Bag 600 is secured to the skin 604 indirectly by mating attachment 603 with the external facing surface 502 of skin contact material 500. Central bore 504 of skin contact material 500 is appropriately sized to fit around stoma 605 and allow the free passage of excreted matter into bag 600. The ostomy bag 600 and the skin contact material 500 may be readily removed from the peristomal skin 604 by simply pilling-away the skin contact material 500.

[0033] FIG. 7 illustrates a further use of the present skin contact material as a wound dressing. The wound dressing 700 comprises a substrate 701 and an adhesive layer 702 incompletely formed across the skin contact surface of substrate 701. According to the further embodiment, adhesive layer 702 may be formed at an outer perimeter region of the substrate so as to provide a central region 705 that is devoid of adhesive 702.

[0034] Alternatively, adhesive layer 702 may extend across the entire skin facing surface of substrate 701 but importantly comprising regular repeating regions that are devoid of the adhesive layer. The adhesive patch 700 is configured to retain a second wound dressing material 704 in contact with the skin 706 surrounding the region of a wound 703. Due to the moisture transfer capability of substrate 701, the skin 706 at the region in contact with the pad 700, is allowed to breathe and does not become irritated by this contact.

[0035] According to further embodiments, the silicon adhesive layer 104, 300, 503, 702 may also be provided on the second surface of the substrate 103, 502 intended to be facing away from the skin. This second opposed adhesive layer may have the same or a different configuration to the skin contact adhesive layer on the first surface. Also, this second and opposed adhesive layer may have a uniform configuration across the second surface 103, 502 or the configuration may be different at different regions on surface 103, 502 as described with references to the first adhesive layer detailed in FIGS. 1 to 7.

[0036] FIG. 8 illustrates an ostomy bag 800 having an internal chamber 801 to receive excreted matter. An attachment flange 802 provides an interface between the chamber 801 and a stoma whilst providing a means of attachment of the bag 800 to the peristomal skin. The present skin contact material is formed as a permanent or releasable part of flange 802 and extends around a central aperture 805 for positioning around the stoma. Flange 800 comprises a substrate 803 with moisture transfer characteristics as described with reference to FIGS. 1 to 7. A silicone adhesive layer 804, as described herein, is formed as discrete concentric circles on the skin facing side of flange 802 and extends around the central aperture 805 as described with reference to FIG. 5.

[0037] According to further specific implementations the substrate may be non-hydrocolloid based and may comprise medical grade polymers such as polyalkylenes, polyesters and/or silicone based materials.

[0038] According to a first example the substrate may comprise a low density polyethylene. Suitable low density polyethylene materials include those available from Dow Corning, MI, USA under the product range Dow™ LDPE.

[0039] According to a second example the substrate may comprise a high density polyethylene. Suitable materials include those available from Dow Corning, MI, USA under the product range Dow™ HDPE or materials under the product range Eraclene™ HDPE available from Polimeri Europa, ENI Rome, Italy.

[0040] According to a third example the substrate may comprise a polypropylene material. Suitable materials include those available from Westlake Plastics Company, PA, USA under the product range Propylux™ HS.

[0041] According to a fourth example the substrate may comprise a polyester material. Suitable materials include polyesters available from Bayer MaterialScience LLC, PN, USA under the product range Texin™ RxHM125.

[0042] According to a fifth example, the substrate may comprise a silicone based material. Suitable materials include those available from Dow Corning, MI, USA under the product range Silastic™ and the Class VI Elastomers under the product range C-6.

[0043] As will be appreciated, the different types of substrate according to the further examples are bondable to the adhesive layer according to conventional bonding techniques and processes as described with reference to the previous embodiments.