WO2005048891A1

WO2005048891A1 - Face plate of an ostomy appliance and method of collecting stomal material

Info

Publication number: WO2005048891A1
Application number: PCT/DK2003/000785
Authority: WO
Inventors: Ole SKJØDT; Jan Wohlgemuth; Jørgen FORBJERG-LARSEN; Ole Pedersen
Original assignee: Dansac AS
Current assignee: Dansac AS
Priority date: 2003-11-18
Filing date: 2003-11-18
Publication date: 2005-06-02
Anticipated expiration: 2006-05-18
Also published as: AU2003281965A1; WO2005048892A3; WO2005048892A2

Abstract

A face plate 1 for use in an ostomy appliance and comprising a layer 2 of skin friendly adhesive having a surface for being attached to the peristomal skin surface of a user of the appliance, a first aperture 10 formed through the layer and a membrane 11 of an elastically and/or plastically deformable material attached to the face plate and extending across and covering said aperture, a portion of said membrane covering the aperture being deformed in a direction transverse to the plane of the aperture 10 by means of pressure applied in that direction by a mandrel 13 or a finger so as to form a deformed portion of the membrane for use as a sheath for receiving the stoma after the free end of the sheath has been cut off along a cutting line 15.

Description

FACE PLATE OF AN OSTOMY APPLIANCE AND METHOD OF COLLECTING STOMAL MATERIAL

The present invention relates to a face plate for use in an ostomy appliance and comprising a layer of skin friendly adhesive having a proximal surface for being attached to the peristomal skin surface of a user of said appliance and a first aperture formed through said layer.

In connection with face plates of this type it is a problem that stomal fluids and solids can come into contact with the adhesive layer and the peristomal skin surface because of the detrimental effects hereof.

Several attempts have been made to solve this problem by providing a sheath or collar around the stoma so as to create a barrier between the stoma outlet and the base of the stoma where the skin surface and the adhesive layer can be attacked by the stomal material.

Such sheaths or collars have been disclosed in US 2,684,676, 3,021 ,843, 3,878,847 and 6,071 ,268, GB 2 041 753, WO 02/15827 and EP 1 348 412, the disclosures of which are incorporated herein by reference.

The solutions disclosed are in many cases rather complicated both to use and to manufacture, and they do not lend themselves to adaptation of the sheath to the individual quite differing shapes of the stomas of different persons.

It is a main object of the present invention to provide means to allow such sheaths or collars to be easy to use, manufacture and lend themselves to individual adaptation.

According to the invention, such means are obtained by providing a membrane of an elastically and/or plastically deformable material attached to said face plate and extending across and covering said aperture. Hereby, a portion of said membrane covering said aperture may be deformed in a direction transverse to the plane of said aperture by means of pressure applied in said direction so as to form a deformed portion of the membrane for use as a sheath for receiving a stoma of a user of said ostomy appliance.

Hereby it is obtained in a simple manner that the sheath may be formed according to the size and shape of the individual stoma.

Although the face plate according to the invention may be used for other ostomy appliances, in the currently preferred embodiment the ostomy appliance comprises a pouch for receiving stomal material and having a second aperture arranged substantially in register with said first aperture.

In the currently preferred embodiment a carrier sheet is attached to a distal surface of said adhesive layer opposed said proximal surface and the carrier sheet constitutes said membrane.

Hereby a particularly simple and inexpensive face plate with individualised sheath may be obtained

Alternatively, said membrane is constituted by a film of plastic material attached directly or indirectly to said layer of adhesive at a region surrounding said first aperture.

Although the face plate according to the invention may be used for so-called one piece appliances where the ostomy pouch is permanently attached to the face plate or for so-called two piece appliances where the ostomy pouch is removably attached to the face plate by means of releasable adhesive, in the currently preferred embodiment a first coupling ring for engaging a corresponding second coupling ring on an ostomy pouch surrounding said second aperture is attached directly or indirectly to said adhesive layer such that said first coupling ring surrounds said first aperture. Advantageously, said first coupling ring surrounds said film of plastic material. In an alternative embodiment, said film of plastic material is attached to said first coupling ring.

So as to allow stomal material to exit the stoma a third aperture is provided in said film of plastic material or in said carrier sheet in the portion thereof covering said first aperture and in the currently preferred embodiment said third aperture has been provided after said deformation of said film of plastic material or said carrier sheet has taken place.

In another aspect, the present invention relates to a coupling ring for use with a face plate according to any of the preceding claims, a film of elastically and/or plastically deformable plastic material being attached to said coupling ring such that said film extends across and covers the area defined by said coupling ring.

In a further aspect the present invention relates to an ostomy appliance comprising a face plate according to the invention and a coupling ring according to the invention.

In a yet further aspect, the present invention relates to a method of collecting stomal material from a stoma, said method comprising the steps of

- providing a face plate for use in an ostomy appliance and comprising a layer of skin friendly adhesive having a proximal surface for being attached to the peristomal skin surface of a use of said appliance, a first aperture formed through said layer and a membrane of an elastically and/or plastically deformable material attached to said face plate and extending across and covering said aperture,

- deforming the portion of said membrane covering said aperture in a direction transverse to the plane of said first aperture by means of pressure applied in said direction so as to form a deformed portion of the membrane for use as a sheath for receiving a stoma of a user of said ostomy appliance,

- providing a second aperture in said portion of said membrane for receiving said stoma, and - attaching said adhesive layer to the peristomal skin surface of said user such that said stoma is received in said first and second apertures.

In the currently preferred embodiment of the method according to the invention, said deformation is carried out by inserting a finger or a mandrel in said first aperture from the proximal or bodyside surface of said adhesive layer, and said second aperture is provided after said deformation of said portion of said membrane has taken place.

According to the invention the mandrel used in the method according to the invention is cylindrical with a cross section shape that is selected from the group of cross section shapes comprising circular, elliptical, oval and irregular such that the cross section is individually adapted to a particular stoma or group of stomas or the mandrel is tapered with a cross section shape that is selected from the group of cross section shapes comprising circular, elliptical, oval and irregular such that the cross section is individually adapted to a particular stoma or group of stomas.

In a final aspect, the present invention relates to a mandrel for use in the method according to the invention.

In the following the different aspects of the invention will be described more in detail with reference to various embodiments of the face plate according to the invention shown solely by way of example in the accompanying drawings where:

Fig. 1 is a schematic cross sectional view of a first embodiment of a face plate according to the invention,

Fig. 2 is a schematic, partly sectional view of the face plate of Fig. 1 deformed by means of a mandrel, Fig. 3 is a schematic, partly sectional view of the face plate of Fig. 1 deformed by means of a finger,

Fig. 4 is a schematic, sectional view of the face plate of Fig. 1 in deformed condition with the end of the deformation cut off, the face plate being adhered to the peristomal skin surface of a user of the face plate with the stoma thereof inserted in the cut off deformation,

Fig. 5 is a schematic cross sectional view of a second embodiment of a face plate according to the invention, and

Fig. 6 is a schematic, partly sectional view of the face plate of Fig. 5 deformed by means of a mandrel.

Referring now to Fig. 1 , a face plate for a so-called two piece ostomy appliance referred to generally by the numeral 1 comprises a layer 2 of skin friendly adhesive of any of the numerous types known in the art. The distal or bodyside surface of the layer 2 is covered by a release sheet 3 for protecting the adhesive layer 2 before use and for being removed before applying the proximal surface of the adhesive layer to the peristomal skin of a user of the ostomy appliance which the face plate 1 forms part of.

A carrier sheet 4 is securely attached to the distal surface of the adhesive layer 2. A coupling ring 5 for engaging a not shown coupling ring of an ostomy pouch is attached to the carrier sheet 4 by means of a ring 6 of plastic film material welded or adhered to the coupling ring 5 at an annular attachment region 7 and to the carrier sheet 4 at a second annular attachment region 8 spaced from attachment region 7 by an annular non-attached zone 9 such that the coupling ring 5 may be displaced away from the carrier sheet 4 by flexing of the non- attached region 9 of the ring 6, a so-called floating flange solution.

An aperture 10 is formed in the layer 2 and the sheets 3 and 4 for receiving the stoma of the user of the appliance. A circular disc of film 11 of an elastically and/or plastically deformable material is attached to the ring 6 by means of an annular weld or adhesive seam 12 such that the film disc 11 overlies and covers the aperture 10.

Before applying the face plate 1 to the peristomal skin of said user, the user or a care person deforms the film disc 11 as shown in Figs. 2-3 either by means of a circular cylindrical mandrel 13 (Fig. 2) or a finger 14 (Fig. 3) such that a sheath for the user's stoma may be formed by removing the mandrel 13 or the finger 14 and cutting the end of the deformed portion of the film disc 11 off along a line 15 such that an aperture is formed for receiving the free and of a stoma 16 of the user (see Fig. 4) when the face plate 1 , after removal of the release sheet 3, is applied to the peristomal skin surface 17 of the user.

The deformed portion of the film disc 11 thus forms a protective sheath 18 to prevent or hinder stomal fluids and solids from contacting the adhesive layer 2 and the peristomal skin surface 17.

The plastic material of the film disc 11 may be any elastically and/or plastically deformable material that is compatible with the stoma surface. It is preferable that the material have a certain amount of elasticity after being deformed such that the sheath 18 will exert a certain pressure on the stoma 16 and follow the stoma in the movements thereof that occur during the wear time of the face plate 1.

Materials that would be suitable are EMA, EVA, PE, PET, polyamide and PUR.

The disc 11 could be made of a membrane of open or closed cell foam made of one of the mentioned materials or of silicone.

Referring now to Figs. 5-6, an alternative embodiment of the face plate 1 is shown where the disc 11 has been left out and the carrier sheet 4 extends across and covers the aperture 10. The procedure for deforming the carrier sheet 4 to form the sheath of the stoma is the same as described in connection with the film disc 11 in the previous embodiment, the sheath 18 being more circular cylindrical because the attachment of the carrier sheet 4 to the adhesive layer 2 ends adjacent the aperture 10. The diameter of the mandrel 19 is shown smaller than the diameter of the mandrel 13 corresponding to a smaller diameter stoma.

The advantage of the second embodiment is that the production of the face plate 1 is simpler and thus less expensive because the step of applying the film disc 11 is avoided. On the other hand, the choices of materials is somewhat more limited because the carrier sheet material must be suited for attachment to the adhesive layer and to the coupling ring 5 or the floating flange ring 6. The currently preferred material for the carrier sheet 4 is EMA.

The mandrels 13 and 19 are shown as being circular cylindrical, but for certain stoma shapes and sizes frusto-conical mandrels may be better suited such that the deformation also becomes frusto-conical. Other shapes of the mandrels may be employed, for instance mandrels with an elliptical or oval cross section or an irregular cross section to reflect the irregular cross section of the particular stoma. Each user could be supplied with an individually adapted mandrel shaped to suit the shape of the particular stoma of the particular user.

The film disc 11 or carrier sheet of the face plate 1 may be deformed before being supplied to the user such that the user only needs to cut the aperture or perhaps perform a supplementary deformation before cutting.

The disc 11 may be attached to the face plate in other ways, for instance by being attached to the coupling ring 5 before the coupling ring is attached to the face plate.

The coupling ring 5 and the corresponding coupling ring on the detachable ostomy pouch (not shown) may be substituted by matching surfaces on the face plate and the ostomy pouch having a repeatedly releasable adhesive on one or both of the surfaces.

In the case of a so-called one-piece ostomy appliance where the ostomy pouch is permanently secured to the face plate, the deformed portion of the film disc 11 or the carrier sheet 4 is pulled backwards through the stoma receiving aperture in the face plate by the mandrel or finger such that the end of the deformed portion may be cut off before inserting the sheath back through the aperture so as to project into the ostomy pouch for receiving the stoma.

The disc 11 or the carrier sheet 4 may be provided with a pre-formed aperture in the portion thereof overlying the aperture 10 such that the cutting operation is entirely avoided as the pre-formed aperture corresponds to the cross section of the particular stoma corresponding to the pre-formed aperture. Alternatively, the cutting operation can serve to expand the pre-formed aperture.

Claims

1. A face plate for use in an ostomy appliance and comprising a layer of skin friendly adhesive having a proximal surface for being attached to the peristomal skin surface of a user of said appliance, a first aperture formed through said layer and a membrane of an elastically and/or plastically deformable material attached to said face plate and extending across and covering said aperture.

2. A face plate according to claim 1 , wherein the portion of said membrane covering said aperture is deformed in a direction transverse to the plane of said aperture by means of pressure applied in said direction so as to form a deformed portion of the membrane for use as a sheath for receiving a stoma of a user of said ostomy appliance.

3. A face plate according to claim 1 or 2, wherein said ostomy appliance comprises a pouch for receiving stomal material and having a second aperture arranged substantially in register with said first aperture.

4. A face plate according to any of the preceding claims, wherein a carrier sheet is attached to a distal surface of said adhesive layer opposed said proximal surface.

5. A face plate according to claim 4, wherein said carrier sheet constitutes said membrane.

6. A face plate according to any of the claims 1-4, wherein said membrane is constituted by a film of plastic material attached directly or indirectly to said layer of adhesive at a region surrounding said first aperture.

7. A face plate according to any of the preceding claims, wherein a first coupling ring for engaging a corresponding second coupling ring on an ostomy pouch surrounding said second aperture is attached directly or indirectly to said adhesive layer such that said first coupling ring surrounds said first aperture.

8. A face plate according to claim 6 and 7, wherein said first coupling ring surrounds said film of plastic material.

9. A face plate according to claim 7 or 8, wherein said film of plastic material is attached to said first coupling ring.

10. A face plate according to any of the preceding claims, wherein a third aperture is provided in said film of plastic material or in said carrier sheet in the portion thereof covering said first aperture.

11. A face plate according claim 10, wherein said third aperture has been provided after said deformation of said film of plastic material or said carrier sheet has taken place.

12. A coupling ring for use with a face plate according to any of the preceding claims, a film of elastically and/or plastically deformable plastic material being attached to said coupling ring such that said film extends across and covers the area defined by said coupling ring.

13. An ostomy appliance comprising a face plate according to any of the claims 1-11.

14. An ostomy appliance comprising a coupling ring according to claim 12.

15. A method of collecting stomal material from a stoma, said method comprising the steps of

- providing a face plate for use in an ostomy appliance and comprising a layer of skin friendly adhesive having a proximal surface for being attached to the peristomal skin surface of a use of said appliance, a first aperture formed through said layer and a membrane of an elastically and/or plastically deformable material attached to said face plate and extending across and covering said aperture, - deforming the portion of said membrane covering said aperture in a direction transverse to the plane of said first aperture by means of pressure applied in said direction so as to form a deformed portion of the membrane for use as a sheath for receiving a stoma of a user of said ostomy appliance, - providing a second aperture in said portion of said membrane for receiving said stoma, and

- attaching said adhesive layer to the peristomal skin surface of said user such that said stoma is received in said first and second apertures.

16. A method according to claim 15, wherein said deformation is carried out by inserting a finger or a mandrel in said first aperture from the proximal or bodyside surface of said adhesive layer.

17. A method according to claim 15 or 16, wherein said second aperture is provided after said deformation of said portion of said membrane has taken place.

18. A method according to any of the claims 15-17, wherein a carrier sheet is attached to a distal surface of said adhesive layer opposed said proximal surface.

19. A method according to claim 18, wherein said carrier sheet constitutes said membrane.

20. A method according to any of the claims 15-18, wherein said membrane is constituted by a film of plastic material attached directly or indirectly to said layer of adhesive at a region surrounding said first aperture.

21. A method according to any of the claims 15-29, wherein a first coupling ring for engaging a corresponding second coupling ring on an ostomy pouch surrounding said second aperture is attached directly or indirectly to said adhesive layer such that said first coupling ring surrounds said first aperture.

22. A method according to claim 20 and 21 , wherein said first coupling ring surrounds said film of plastic material.

23. A method according to claim 21 or 22, wherein said film of plastic material is attached to said first coupling ring.

24. A method according to any of the claims 16-23, wherein the mandrel is cylindrical with a cross section shape that is selected from the group of cross section shapes comprising circular, elliptical, oval and irregular such that the cross section is individually adapted to a particular stoma or group of stomas.

25. A method according to any of the claims 16-23, wherein the mandrel is tapered with a cross section shape that is selected from the group of cross section shapes comprising circular, elliptical, oval and irregular such that the cross section is individually adapted to a particular stoma or group of stomas.

26. A mandrel for use in a method according to any of the claims 16- 25.