DK149734B - CLAIMS FOR DETERMINING AN OSTOMIPOSE TO THE SKIN AROUND A STOMA BY A PATIENT - Google Patents

Description

in 149734

The invention relates to an adhesive element for attaching an ostomy bag to the skin around the stoma of a patient, which bag is of the type comprising a flexible plate having an opening through which the stoma can pass, and wherein the surface of the plate which facing the patient, carrying a hydrophilic material.

After an ostomy operation, e.g. ileostomy, colo-stoma or ureterostomy, the patient has an opening through which a discharge occurs. The depleted is collected in a 10 bag which is replaced periodically. There have been considerable difficulties in securing the bag's attachment to the patient in a comfortable but dense manner, and in particular it has proved difficult to find suitable adhesives for use on adhesive elements of said type.

15 Although many adhesives are known, very few of these are suitable for use on human skin. The requirements for such an adhesive are strict; it must bind strongly to human skin, but could be pulled off without damaging the skin surface. Furthermore, it must not cause inflammation, even with prolonged contact, and must have a minimal tendency to cause allergy. It must be free of any substance which may be. carcinogenic. The requirement that it should not cause allergies is particularly difficult to meet, and most of the available adhesives tend to cause allergies in a significant proportion of patients. When the patient is prone to allergies, it may be necessary to try a number of adhesives before there is one that is compatible with the patient's skin. This is time-consuming 30 for the physician and meanwhile the patient is subject to discomfort due to allergic reactions.

It is known from Danish publication no. 132,645 to use a disc of hydrophilic material, e.g. karaya gum, which is both adhesive and water-absorbent, as an adhesive surface in such adhesive elements.

However, such adhesive elements have been found to be unreliable as the adhesive surface, when the hydrophilic material has absorbed a certain amount of fluid, becomes soft and can no longer adhere to the skin, thereby releasing the entire adhesive element, which can be of great detriment. for the patient.

It is from GB patent no. 554,186 and no.

585,184 are commonly known to use blends of synthetic rubber, filler, plasticizer and resin as medical adhesives, and additionally it is well known to use polyalkyl acrylate resins in medical drugs.

However, as mentioned, adhesive elements with such adhesives have been found to tend to cause allergies in a substantial proportion of patients.

Faced with the known adhesive elements, the adhesive element of the invention provides an adhesive element that adheres well and reliably to the skin and is easily peelable. In addition, with the embodiment of claim 4, an adhesive element is obtained which does not cause allergy.

The invention provides an adhesive element for attaching an ostomy bag to the skin around the stoma of a patient, which element comprises a flexible plastic sheet having an opening through which the stoma can pass and the surface of the plate facing the pouch. the tient carries a hydrophilic material, which adhesive is characterized in that this surface is divided into two zones, so that the plate on the part of the surface which is closest to the orifice carries a layer of hydrophilic rubber or mucus which swells at contact 30 with water, while the portion distant from the aperture is provided with an adhesive which does not swell upon contact with water.

The second surface may be integral with one of the walls of the bag, or the bag may be attached thereto in an appropriate mechanical manner, e.g. using an adhesive.

14973 * 3

According to the present adhesive element, the opening in the plate of the surface to be adhered to the patient is thus surrounded by a layer of hydrophilic rubber which swells upon contact with water. The hydrophilic rubber is preferably contained in a gutter between two upright webs formed in the plate. The preferred hydrophilic rubber is carcinoma rubber. In the presence of fluid leaking from the stoma, the karaya gum will absorb water and swell. The swelling rubber provides a good seal to the abdominal wall and will effectively prevent further fluid from flowing further out. This mechanism protects the adhesive at a greater distance from the opening from moisture.

This adhesive is preferably of the type containing synthetic rubber, filler and plasticizer, and, most preferably, an adhesive disclosed in Danish Patent Application No. 969/78, which consists of a gelled mixture of: a) polyethyl methacrylate; B) butyl-phthalyl-butyl-glycollate or butyl benzyl-phthalate, o) colloidal silica, and d) chlorinated polyisoprene, where 100 ml of component b) contains 16 - 84 g of component a), 6 - 16 g of component c) and 16 - 67 g of component d).

Instead of karaya gum, other natural or synthetic swellable hydrophilic gums or mucus, e.g. agar, alginates or suitable polyvinyl alcohol.

The plate, which will usually take the form of a disc with a central aperture, is preferably plastic.

Suitable resins include plasticized acrylic polymers and plasticized vinyl polymers such as plasticized PVC. Since parts 35 of the plate may come into contact with the patient, it is advisable that it be made of a material which does not tend to cause any adverse reaction upon contact with the human body. In particular, the material must be non-allergic. Suitable resin materials 5 may be selected from those used in the dental field. Any accelerator (eg, tertiary amine, peroxide or quinone) used to cure the material forming the plate must be selected with particular regard to this point of view. It may be advantageous to cure the material by actinic radiation (ultraviolet or visible light).

Advantageously, the portion of the plate surrounding the aperture is relatively rigid while the peripheral portion is more flexible. These conditions can be achieved by increasing the thickness of the plate in the central region and / or by using one or more stiffening webs around the aperture. However, the plate as a whole must be sufficiently flexible to prevent it from causing discomfort to the patient and to achieve a close proximity to the abdomen.

The second surface of the plate may be integrally formed with the ostomy bag, or the bag may be secured in an appropriate mechanical manner, e.g. with hooks or more preferably with adhesive. This side of the bag does not come into contact with the skin and any suitable adhesive may be used. It is not necessary that this adhesive can be tolerated physiologically, but often the same adhesive will be suitable for the purpose.

The adhesive carried in accordance with the invention on the one portion of the plate spaced apart from the orifice may extend in the form of a continuous layer beyond the periphery of the plate and the free surface of the adhesive layer may help to retain the bag. on the plate.

If not used for this purpose, it is advisable to render this exposed surface and the edges of the adhesive layer non-adhesive to avoid adhesion to clothing and the like.

In a preferred embodiment, the stoma discharge collection bag can be replaced without removal of the plate from the patient. This eliminates tearing of the entire device from the patient every day. This embodiment is particularly useful in connection with colo-ostomy bags. In this embodiment, the bag is preferably attached to the plate by means of a contact adhesive.

The present adhesive element is particularly suitable for ostomy patients, but may also be of value in collecting fistula discharge. If desired, the plate may comprise means for attaching a belt, e.g. in the form of openings or projections on opposite edges of the plate (or at opposite ends of a diameter when the plate is circular) for attaching corresponding fasteners to the end of a belt.

An embodiment of the invention is described below with reference to the drawing, which illustrates an adhesive element according to the invention shown in cross section.

In the drawing, 1 denotes the abdominal wall of a patient who is surgically provided with a stoma 2. An adhesive member comprises a disc 3 of mold 25 with a central opening 4. The opening 4 is surrounded by 2 concentric webs 5 and 6 forming a gutter containing a ring of karaya rubber 7. The outer portion of the disc is attached to the abdominal wall with a layer of adhesive 8 having the composition set forth below. The second second surface 9 of the disc is provided for attaching a bag suitable for the discharge to be collected.

The adhesive extends slightly beyond the disc 3 to thereby keep the unit in good contact with the abdominal wall.

6 t49734

The composition of the adhesive is as follows, with parts referring to ml as regards liquids and to g as regards solids:

Butyl phthalyl butyl glycolate 6 parts 5 Polyethyl methacrylate 2 parts

Alloprene ® 20 2 parts

Colloidal silica 0.65 parts

The butyl phthalyl butyl glycolate is available from Monsanto as. "Santicizer ® B16". leafy it can be prepared by standard esterification methods ·

The polyethyl methacrylate was in the form of a powder having a particle size of less than 240 mesh (British standard sieve) and had an average molecular weight of approx.

200 '000th It was purchased from ADI Plastics Limited, Mar-15 ton, Blackpool, England.

"Alloprene® 20" is a chlorinated polyisoprene available from Imperial Chemical Industries (Alloprene Section), Runcorn, Cheshire, England.

The silica was of a low-quality pharmaceutical grade 20 µm.

First, the silica was mixed with butyl-phthalyl-butyl glycolate, and the polyethyl-metal acrylate and "Alloprene® 11 were then added sequentially. A very viscous paste was obtained which was mixed mechanically. The paste 25 was then rolled between two layers of silicone coated -5 pie sheets to a thickness of about 1.5 mm and allowed to convert for 6 hours in an oven at 60 ° C.

After cooling, the adhesive was available as a coherent, highly adhesive layer that could be cut to the desired size and shape. This adhesive · is very well tolerated by the human body. In fact, so far, no adverse reaction to it has been observed even in patients who are allergic to many common medical adhesives.

Another adhesive composition is as follows: 7

Butyl benzyl phthalate 6 ml

Polyethyl methacrylate 2 g

Alloprene ® 20 2 g

Colloid silica 0.5 g 5 The polyethyl methacrylate was the same as used in the first adhesive. The mixing and conversion procedure was as described.

The disc was formed from an acrylic polymer prepared as follows. 16 parts of the 10 polyethyl methacrylate described above were mixed with 10 parts of a liquid mixture of the composition 2% N, N-dimethyl-p-toluidine, 30% ethylene glycol dimethacrylate (from Rohm '

Haas) and 68% butyl-phthalylbutyl glycollate.

The resulting fluid slurry was immediately poured into a mold and cured for 15 minutes at 60 ° C to form a flexible rubbery disc. The accelerator (N, N-dimethyl-p-toluidine) may be replaced by other suitable tertiary amines, but this material should preferably be selected taking into account that allergy problems should be avoided.