DE2808717A1 - MEDICAL AIDS AND MATERIALS SUITABLE FOR THEM - Google Patents

Description

Case 2/85 Dr.Ve/SF

JOHN RHODES, CARDIFF, WALES, GREAT BRITAIN

Medical aids and suitable ones

materials

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Medical aids and materials suitable for them

description

The invention relates to medical aids and materials suitable therefor. In particular, it relates to an adhesive Preparation that is suitable, among other things, for attaching medical aids to the body of animals and humans.

It is often necessary on the human or animal body to produce an adhesive connection for fastening a medical aid or a medical device. Although many adhesive formulations are known, few are suitable for use on human skin. The requirements for such an adhesive are strict; it must, but must, adhere firmly to human skin be removable without damaging the skin surface. Farther it must not cause inflammation even after a long period of time and it must have a minimal tendency to cause allergies to have. It must not contain any carcinogenic substances. The requirement not to cause allergic reactions is particularly difficult to meet and most of the adhesives available on the market cause allergies in a significant one Proportion of patients. If the patient has a tendency to allergies, a number may be necessary of adhesives before a compatible adhesive can be found. This is time consuming for the doctor and uncomfortable for the patient due to the allergic reactions.

An object of this invention is an adhesive preparation, containing a mixture of

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a) a poly (lower alkyl) methacrylate,

b) a physiologically compatible liquid plasticizer,

c) an inert particulate filler and

d) a chlorinated rubber.

The lower alkyl groups in the poly (lower alkyl) methacrylate contain 1 to 4 carbon atoms and the preferred polymer is polyethylene methacrylate. The poly (lower alkyl) methacrylate is a brittle solid, and preferably has a molecular weight in the range 50000-1000 00o _3, in particular in the range from 100,000 to 500 00o _3, for example about 200 000th

The plasticizer is a physiologically compatible liquid and is used to soften the poly (lower alkyl) methacrylate. A preferred group of plasticizers are ester plasticizers, in particular esters of dicarboxylic acids. Though Diester of aliphatic dicarboxylic acids with suitable properties can be found, diesters of aromatic dicarboxylic acids, especially phthalic diesters, are preferred. The alcohol components Such phthalic diesters can, for example, alkanols, alkoxycarbonyl-substituted alkanols and / or be aralkanols. The alkanols can for example have 1 to 8 carbon atoms and optionally with one Lower alkoxycarbonyl be substituted. A plasticizer which is particularly satisfactory from all points of view is butyl phthalyl butyl glycolate. This connection is available from Monsanto under the name "Santicizer B16". Other phthalic diesters that can be used are Butyl benzyl phthalate, which is also available from Monsanto under the name "Santicizer 160".

Another group of plasticizers which according to the invention

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ACT

can be used are N-substituted aryl sulfonamides. The aryl radical can, for example, optionally with Lower alkyl substituted phenyl such as tolyl. The substituent on the nitrogen atom is preferably lower alkyl. An example of such a plasticizer is N-ethyl-o, ptoluenesulfonamidj which is available under the name "Santicizer 8" from Monsanto.

The exact chemical character of the plasticizer is not critical to the invention. The plasticizer must, however, with the other components must be physically and physiologically compatible. As far as possible, it should not have any allergenic effects to have. Approval by the PDA (Pood and Drug Administration) for food and pharmaceutical preparations, is a good indication that the substance is physiologically tolerable.

The inert particulate filler is used to stabilize the preparation in the form of a cohesive gel. The filler also reduces the stickiness of the preparation and the amount and type of filler should be chosen so that the desired tack is obtained. Without filler, very strong stickiness is obtained and it is difficult to to interrupt the adhesion to the human skin without damaging the latter. Silica is used as a filler preferred. The filler preferably has a colloidal particle size. Other suitable fillers are fine distributed calcium carbonate, kieselguhr and silicates such as powder Glass, especially barium glass, lithium aluminum silicates or talc.

The chlorinated rubber improves the stickiness and the cohesion of the preparation. Preferred chlorinated rubbers are highly

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chlorinated hydrocarbons, such as highly chlorinated polyisoprene, which is sold under the name "Alloprene 20" from Imperial Chemical Industries is available.

The proportion of the various components in the preparation can be, for example, as follows per 100 ml of plasticizer: poly (lower alkyl) methacrylate 16 to 84 g, preferably 20 to 45 g; Filler 6 to 16 g, preferably 8 to 12 g and chlorinated rubber 16 to 67 g _3, preferably 20 to 40 g. The relative proportion of the components should be adjusted within the limits given above in order to obtain products with the desired properties. Optimal relative proportions for a certain, desired combination of properties can be determined by simple experiments.

The preparation can be prepared by dispersing powdered poly (lower alkyl) methacrylate in the plasticizer and dissolving it or allowing the powder to dissolve in the plasticizer until gel formation. The filler and the chlorinated rubber can be used at any point, preferably when the viscosity is still low enough to allow thorough mixing to allow to be admitted. According to a preferred method, the filler is mixed with the plasticizer, then the poly (lower alkyl) methacrylate and finally the chlorinated rubber are added.

The mixture is initially a stiff paste which, after the plasticizer has dissolved the poly (lower alkyl) methacrylate, turns into a homogeneous gel. The transition temperature is carried out slowly at-RaunL and by heating, for example at 40 ° to 80 ^D C, speeds. If desired, higher or lower temperatures can be used. At 60 ^° C., the transition can generally be about 4 to 5

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Hours to be finished. The transition time is very different from that Fine distribution of the poly (lower alkyl) methacrylate dependent. Preferably this material is in powder form with the Particle size in the range from 50 to 400 mesh (British Standard Sieve), preferably below 200 mesh, accordingly 0.076 mm clear mesh size, in front.

After the transition, the preparation is in the form of a translucent, flexible gel with a rubbery consistency and a sticky handle. It shows good adhesion to the human skin. The material is stable, ie it remains cohesive, does not flow at higher filler concentrations and retains its tack and adhesive properties during long storage times and during long periods of use. It is often advantageous to let the preparation gel in situ on the surface to be made adhesive. The preparation can also be applied to a surface with a release coating before the transition to the gel and gelled in the form of a layer which is then laminated onto the object to be made tacky. According to another method, a dispersion of the preparation in an organic solvent, which dissolves all components of the preparation, with the exception of the filler, can be prepared and applied to the object to be tackified, whereupon the solvent is evaporated. Suitable organic solvents are, for example, chlorinated hydrocarbons, such as chloroform or methylene dichloride. Further suitable solvents are lower aliphatic ketones, for example acetone, aliphatic ethers, for example diethyl ether and lower alkanols, for example ethanol. Often it is preferred not to use a solvent, as some patients are allergic to common organic solvents. It can therefore be more advantageous to roll the preparation in paste form as a thin layer between two surfaces provided with release coatings and then to apply it to the counterpart to be made tacky.

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stood either before or after the transition of the mixture into the gel form.

The preparation can be used as an adhesive for various purposes, especially, but not exclusively, for attachment to human skin, e.g. as an adhesive coating used for surgical tapes and other medical and surgical dressings, drapes, and appliances will. Such a surgical tape or such a bandage has a flexible substrate, one surface of which has the preparation according to the invention is provided on. At the The substrate can be a flat textile structure or a plastic film, in particular a microporous plastic trade fabric foil. If a bandage with a healing effect is desired the drug can be added to the adhesive preparation will. Examples of such drugs are antibiotics, antiseptics, coal tar derivatives (which are used for certain dermatological Conditions are valuable) and anti-inflammatory compounds, such as steroids. Such associations can to cover wounds or other damaged areas of skin, such as lower leg ulcers such as varicose veins, be used. For such uses, the adhesive preparation has the advantage that it is present is not sticky from water. Therefore, when the bandage is used to cover damaged and weeping areas of the skin, it will not apply to the damaged areas, but rather only adhere to the undamaged skin at the edge.

A particularly advantageous use of the adhesive preparation according to the invention is the fastening of the pocket an ostomy device on the patient's skin around the stoma. After an ostomy operation, e.g. ileum ",

Uretheric or external intestinal fistula, if the patient has a stoma, through

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that the material to be removed leaves the body. The secretion is collected in a bag that is periodically replaced. So far it has been very difficult to put the bag in one comfortable but tight shape to attach to the patient.

Another object of the invention relates to an adhesive element for fastening the pocket of an ostomy aid to the The patient's skin around the stoma, which is a flexible pad with an opening for the implementation of the stoma, wherein one surface of the cushion is provided with an adhesive preparation according to the invention. The other surface can form a unit with the wall of the bag or the bag can be fitted with suitable mechanical devices, for example with a Glue, attached to it.

The pad is generally in the form of a disc with a central opening and is preferably made of one Plastic. Plastics suitable for this purpose are plasticized acrylic polymers and plasticized vinyl polymers, such as soft PVC. Since parts of the cushion can come into contact with the patient, it is preferably made of one material that does not cause adverse reactions when it comes into contact with the human body. In particular, should the material preferably does not have any allergenic effects. Suitable plastics can be made from those used in dentistry can be selected. Accelerators (e.g. tertiary amine, peroxide or quinone), which are used for curing of the preparation used to form the cushion should be selected with particular care in this regard will. It can be advantageous to cure the preparation with actinic radiation (UV or visible light).

The part surrounding the opening is preferably the cushion

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relatively stiff, while the edge area is more flexible. These Condition can be achieved by increasing the padding thickness in the middle area and / or adding one or more stiffeners Tissue around the opening are met. As a whole, however, the cushion should be flexible enough to accommodate the patient not to cause any discomfort and to be able to follow the course of the abdominal wall closely.

According to a particularly preferred embodiment of the invention, the opening in the cushion is on the one to be attached to the patient The surface is surrounded by a layer of a hydrophilic resin that swells when it comes into contact with water. This resin is preferably contained in a recess between two fabrics arranged on the cushion. as hydrophilic resin, karaya gum is preferably used. If fluid seeps from the stoma, the karaya gum becomes Absorb water and swell. The swollen resin provides a good seal for the abdominal wall and prevents it effective the seeping out of further liquid at the edge. This facility protects the adhesive from the effects of moisture. '

Instead of karaya gum, other natural or synthetic ones can be used swellable hydrophilic resins, for example agar-agar, Alginates or an appropriate grade of polyvinyl alcohol can be used.

The other surface of the pad can be integral with the ostomy pouch or the pouch can be used with suitable mechanical means such as clips or, preferably, glue. This surface of the pad comes in not in contact with the skin and therefore any suitable adhesive can be used. This glue doesn't have to

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be physiologically acceptable, although the invention Adhesive formulation can often be suitable for this purpose.

The adhesive preparation present in the form of a cohesive sheet-like structure, according to the invention, can extend over the edge of the pad and the free surface of the adhesive sheet can be used in the attachment of the bag help with the upholstery. If the free surface is not used for this purpose, it and the edges "des adhesive sheet preferably made non-adhesive, to prevent adhesion to clothes or the like.

According to a preferred embodiment, the pocket or the bag used to collect secretion from the stoma without removing the pad from the patient will. This avoids having to remove the entire device from the patient every day. This embodiment is particularly useful for patients with an external colon fistula. According to the embodiment mentioned, the pocket is preferably attached with a contact adhesive Upholstery attached.

The device described above is particularly useful for ostomy patients, but it can also be used to collect the discharge from a fistula. If necessary the pad can have means for fastening to a belt, for example in the form of openings or loops, at opposite ends of the pad or at opposite ends of the diameter if the pad is disc-shaped is, wherein the loops are provided for attachment to a corresponding fastener at the ends of the belt are. Through the following examples and the figure, which shows an adhesive element according to the invention in cross section, the invention is to be further illustrated.

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In the figure, the abdominal wall 1 of the patient has been surgically provided with a stoma 2. The adhesive element according to the invention is a disk 3 made of plastic, which has a central opening 4. The opening H is surrounded by two concentric fabrics 5 and 6 which form a recess, a ring of karaya rubber 7 being located in the recess. The outer part of the disc adheres to the abdominal wall by means of a layer 8 of the adhesive of the composition given below. A suitable bag or sack for collecting the secretion can be attached to the other surface 9 of the disc.

The adhesive preparation used has the following " given composition, where parts for pesticides are calculated in grams and for liquids in ml:

Butyl phthalyl butyl glycolate 6 parts

Polyethyl methacrylate 2 parts

"Alloprene 20" 2 parts

colloidal silica 0.65 parts.

The butyl phthalyl butyl glycolate is currently available from Monsanto under the name "Santicizer B16". Otherwise it can can be obtained by known esterification processes.

Polyethyl methacrylate was in powder form, particle size 240 mesh (British Standard Sieve), corresponding to Ο, Οββ mm clearers Mesh size and used with an average molecular weight of about 200,000. It was made by ADI Plastics Limited, Marton, Blackpool, Great Britain.

"Alloprene 20" is chlorinated polyisoprene and is available from Imperial Chemical Industries (Alloprene Section), Runcorn, Cheshire, Great Britain available.

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The silicon dioxide was pharmaceutical grade with a low iron content.

The silica was first mixed with the butylphthalyl butyl glycolate mixed, after which successively polyethyl methacrylate and "Alloprene" were added. A highly viscous paste was obtained which was mixed mechanically. The paste was then rolled out between two sheets of silicone coated paper to a thickness of about 1.5 mm and during Left in gel form in an oven at 60 ° C for 6 hours.

After cooling, the adhesive preparation was in the form of a cohesive extremely sticky sheet-like structure, which is cut to the desired size and shape could. This adhesive preparation is good for the human body tolerate. In fact, no adverse reactions to this adhesive formulation have been observed to date, not even at Patients who are allergic to various known medical adhesives. Although of course not it can be said that the material according to the invention will never cause allergic reactions, it seems, in this regard to be superior to most known adhesives. To keep the device in good contact with the abdominal wall, the adhesive expands slightly beyond the pane 3.

Another adhesive preparation has the following composition:

Butyl benzyl phthalate 6 ml

Polyethyl methacrylate 2 g

"Alloprene 20" 2 g

colloidal silicon dioxide 0.5 g.

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The same polyethylene methacrylate was used as in the first-mentioned adhesive preparation. The mixing and transition process was carried out ₃ as already described.

The disk consisted of an acrylic copolymer and was produced as follows: 16 parts of polyethylene methacrylate of the type described above were mixed with 10 parts of a liquid mixture of 2 % Ν, Ν-dimethyl-p-toluidine, 30 % ethylene glycol dimethacrylate (from Röhm & Haas) and 68 % Butyl phthalyl butyl glycolate mixed.

The resulting liquid slurry was immediately poured into a mold and cured for 15 minutes at 60 ° C. to form a flexible, rubber-like disk. The accelerator N, N-dimethyl-p-toluidine can be replaced by other suitable tertiary amines _3, however, the compound mentioned is preferred in order to avoid allergy problems.

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Claims (1)

Claims 1..Adhesive preparation containing a gel-like mixture the end a) a poly (lower alkyl) methacrylate, b) a physiologically compatible liquid plasticizer, c) an inert particulate filler and d) a chlorinated rubber. 2. Adhesive preparation according to claim I _3, characterized in that it contains poly (lower alkyl) methacrylate as polyethyl methacrylate. 3. Adhesive preparation according to claim 1 or 2, characterized characterized in that the poly (lower alkyl) methacrylate has a molecular weight in the range from 50,000 to 1,000,000 . 4. Adhesive preparation according to claim 3, characterized in that that the poly (lower alkyl) methacrylate has a molecular weight in the range from 100,000 to 500,000. 5. Adhesive preparation according to one or more of the preceding Claim characterized in that they contains a phthalic acid diester as a plasticizer. 6. Adhesive preparation according to claim 5, characterized in that that the alcohol component of the phthalic diester optionally substituted with an alkoxycarbonyl radical Are alkanols of 1 to 8 carbon atoms and / or aralkanols. 7. Adhesive preparation according to claim 5 j thereby marked JB 09837/0682 ....... draws attention to the fact that it contains butyl phthalyl butyl glycolate as a plasticizer. 8. Adhesive preparation according to claim 5, characterized that it contains butyl benzyl phthalate as a plasticizer. 9. Adhesive preparation according to one or more of the claims 1 to 4j characterized in that they are as V plasticizer contains an N- (lower alkyl) -arylsulfonamide. 10. Adhesive preparation according to claim 9, characterized in that that they use N ~ ethyl-o, p-toluenesulfonamide as a plasticizer contains. 11. Adhesive preparation according to one or more of the preceding Claims j characterized in that they are colloidal silicon dioxide as the inert particulate filler contains. 12. Adhesive preparation according to one or more of the preceding Claims, characterized in that it contains highly chlorinated polyisoprene as chlorinated rubber. 13 · Adhesive preparation according to one or more of the preceding Claims, characterized in that they contain 16 to 84 g of poly (lower alkyl) methacrylate per 100 ml of plasticizer, Contains 6 to 16 g of the filler and 16 to 67 g of chlorinated rubber. 14. Adhesive preparation according to claim 13, characterized in that that they contain 20 to 45 g of poly (lower alkyl) methacrylate, 8 to 12 g of filler and 20 809837/0682 Contains up to 40 g of chlorinated rubber. 15. Adhesive preparation according to one or more of the preceding Claims, characterized in that it contains a medicament. 16. Adhesive preparation according to claim I5, characterized in that that they use antibiotics, antiseptics, coal tar derivatives, and / or anti-inflammatory compounds contains. 17. Adhesive preparation according to claim 1, characterized in that that they are polyethylene methacrylate, butyl phthalyl butyl glycolate contains as a plasticizer, colloidal silicon dioxide as a filler and chlorinated polyisoprene. 18. Medical device, characterized in that it an adhesive preparation according to one or more of the Contains preceding claims. 19. Medical aid according to claim l8, characterized in that it is in the form of a surgical adhesive tape is present. 20. Medical aid according to claim 19, characterized in that it is in the form of an adhesive bandage is present. 21. Adhesive element for securing the pocket of an ostomy device on the skin around a patient's stoma, characterized in that it is a flexible pad with a Has an opening for the implementation of the stoma and a surface of the pad with an adhesive preparation 809837/0682 according to one or more of claims 1 to 17 is provided. 22. Adhesive element according to claim 21, characterized in that that the cushion is in the form of a disk and has a central opening. 23- adhesive element according to claim 21 or 22, characterized in that that the cushion is made of plastic; 24. Adhesive element according to one or more of claims 21 to 23, characterized in that the opening surrounding part of the cushion is relatively stiff and the edge part is more flexible. 25. Adhesive element according to one or more of claims 21 to 24, characterized in that the opening of the Cushion on the surface facing the patient with a layer of hydrophilic resin, which when in contact with Water swells, is surrounded. 26. Adhesive element according to claim 25, characterized in that the resin is in one between two on the pad arranged tissues formed recess is included. 27. Adhesive element according to claim 25 or 26, characterized in that that the resin is karaya gum. 28. Adhesive element according to one or more of claims 21 to 27, characterized in that the, the adhesive bearing opposite surface forms a unit with an ostomy pocket. 809837/0682 29. Kafteleroent according to one or more of the claims through 27, characterized in that this is the adhesive-bearing opposite surface on an ostomle pocket is attached " 30. Adhesive element according to claim 29, characterized in that the Qstomy-Tasehe by a contact adhesive Is attached to your cushion. 31. Adhesive element according to one or more of claims 21 to 30, characterized in that the cushion Has means for attachment to a belt. 32 '. Process for producing the adhesive preparation according to one or more of claims 1 to 17, characterized in that the components of the preparation are mixed and the paste obtained is allowed to pass into a homogeneous gel-like preparation ^{at an elevated temperature 1.} 33. The method according to claim 32, characterized in that
80 ° C ο net that the increased temperature is in the range of 40 bxs 3 ^. Process according to claim 32 or 33 _5, characterized in that the poly (lower alkyl) methacrylate has a particle size in the range from 50 to 400 mesh (British Standard Sieve). 35. The method according to one or more of claims 32 to 34, characterized in that the obtained Applying paste to the surface to be made adhesive and allowing it to pass into a homogeneous preparation there '. 809837/0682 36. Dispersion of the preparation nacii one or more of the Claims 1 to 17 in. An organic solvent, which all components of the preparation., with Except for the filler, it dissolves. 809837/0682