SK278943B6 - The system for fixing the catheters, cannulas and the like on the skin surface - Google Patents

Abstract

The system for fixing of catheters consists of the leather foil, in its bottom part being covered by the adhesive layer (2), on which the covering foil (1) is located and of the upper adhesive plaster (6), while this plaster is equipped with the adhesive layer (5) able to be glued on the leather foil (3) and with the covering film (4) covering the upper plaster (6). The upper foil (3) is created based on the flexible water steam transmitting and bacteria non transmitting transparent foil material created based on natural or synthetic polymer.

Description

Technical field

The invention relates to a system for attaching catheters, cannulas or the like, comprising, in its lower part, a skin film coated with an adhesive layer on which a covering film is provided and an upper adhesive-coated adhesive layer adhering to the skin film and the covering film, covering the top patch.

BACKGROUND OF THE INVENTION

Cannulas and catheters are devices that are used, for example, to deliver and remove liquids into and out of the body and may take the form of needles, cannulas, catheters, probes, for example, to measure some body parameters such as oxygen partial pressure and the like. infusion aids. These cannulas need to be fixed to the body, for example, during dialysis or during long-term infusion. Means for fixing cannulae and catheters are generally known.

EP-B1-76 896 and EP-A1-121 679 disclose a bandage for the fixation of medical devices, which consists of a bandage for attaching to the skin and a part which is the device itself. This part has a tubular protrusion which fits or supports its own cannula or catheter.

Industrial design DE no. 82 04 827.4 discloses a device consisting of two platelets between which a cannula is mounted, the platelets being held on the skin by a patch.

DE-OS 32 12 458 describes catheter bandages used in men. This is particularly the geometric configuration of the strips of the various patches.

In DE patent no. 29 47 427 is a bandage that can be used on catheters inserted into veins. Essentially, the patches are provided with a waterproof, air-permeable, adhesive film and optionally a liquid-absorbing layer on the side facing away from the skin. The bandage fixes the cannula to the skin. The preferred size of the patch is 95 x 60 mm.

DE-OS 31 05 187 describes a patch for fixing the cannula with a protruding segment which, after insertion of the cannula, is fixed and prevents its movement as the remaining part of the dressing adheres to the skin.

EP-AI-116 526 describes another principle of attaching a cannula to the skin, in particular a device for holding a catheter in the form of a needle passing through the skin. In some cases it is also envisaged that the catheter be sewn to the skin to fix it in the desired position.

From US-A-3 916 446 (Buttaravoli), a fixation system for attaching catheters or the like is known with a skin patch with a cover film and a skin patch adhering to the skin film, the top patch having a cover layer.

The bottom patch is made of polyurethane foam, it is opaque and is not air permeable.

To observe the infusion needle, it is proposed to create openings in the upper region.

US-A-4 122 857 (Haerr) relates to a fixation device for hoses and the like fastened to the skin of a patient in which a lower patch and an upper patch are provided which may optionally be joined together and are substantially the same size. The hose to be fastened is placed on the lower patch applied to the skin and is applied to the lower patch by means of the upper patch. It is proposed to use materials that are modified to be bactericidal.

From US-A-4,333,468 (Geist), a cannula support body is known which is adapted to mount a cannula or the like, and this has a base plate and a clamping device opening upwards. This is a mechanically lockable device which, regardless of the joint of the cannula support body, is stationary.

Under the trade name POROFIX, patches are commonly available, in particular in the form of strips, for fixing cannulae. These are, in particular, adhesive patches provided with a slot, particularly suitable for fixing Strauss cannulas during infusions.

These known cannula fixation patches have the common disadvantage that overlapped skin parts cannot breathe. The film is impermeable to water vapor and oxygen, so macerations of the skin surface may occur.

Furthermore, the prior art skin films were not yet transparent, therefore it was not possible to locally locate the infusion cannula locally with the patch and the injection site with the patch could not be observed.

However, these known compositions also have disadvantages, in particular the substantial disadvantage that the injection site or the onset of the duct into which the cannula is inserted and the adjacent skin part are not protected against infection by bacteria on the skin surface. Attempts have been made to overcome this problem at least in part by disinfecting the skin prior to insertion of the cannula. However, disinfection only affects the superficial part of the skin and cannot prevent the passage of infection from the lower layers of the skin to the canal.

It is important to ensure a good fixation of the cannula to prevent the cannula from slipping over a long period of time, which has not been possible until now.

The prior art arrangements either use very expensive materials to fix the cannulas or, on the contrary, very simple patches with notches or the like, which cannot satisfactorily fix the cannula over a long period of time. It is therefore apparent that the known devices have only partially addressed the above problems. When formulations with apertures or slits were used, they did not provide satisfactory fixation of the cannula in long-term use.

SUMMARY OF THE INVENTION

SUMMARY OF THE INVENTION It is an object of the present invention to provide an improved cannula fastening system that protects the insertion site from infection even in the case of cannulas that remain in place for prolonged periods, such as short-circuiting in patients undergoing dialysis. damage.

According to the invention, this problem is solved by a system for attaching catheters, cannulae and the like with a skin sheet coated with an adhesive layer and a cover sheet and with an upper patch provided with an adhesive layer adhering to the skin sheet and a cover film covering the top patch characterized by that The skin sheet is formed of a compliant, water vapor permeable, bacteria-impermeable, transparent incision film material of synthetic or natural material. The material may be collagen, a natural or synthetic polymer, for example polyurethane and the like, as is commonly known as commercially available.

SK 278943 Β6

The emission films are, for example as described in Wilson, Kohn Verbandstoffe und Krankenpflegeartikel, Deutscher Apotheker Verlag Stuttgart, 1983, self-adhesive operational films which are impermeable to bacteria and are transparent.

The use of this material makes it possible to insert, for example, infusion needles with an incision foil, since it is possible to observe the injection site and the skin on which the incision foil is adhered is essentially thin-film based on the thin foil. possibly raised.

The top plaster and / or cover film and the adhesive layers may be transparent, therefore, the site of insertion of the cannula or catheter may be observed.

If both the upper patch and the topsheet are transparent, the position of these devices can still be checked for long-term fixation of the cannula, catheter or the like without the need to remove the entire system, which usually carries the risk of infection or injury to the patient. As a result of this preferred arrangement, it is often possible to avoid unnecessary replacement of the cannula.

The skin sheet and the top patch are stacked on top of each other and may be joined on one side, the cover film being placed as a separating interlayer between the skin sheet and the topsheet adhesive layer.

If the area of the skin film is larger than the area of the patch, due to the large adhesive surface, the skin covering layer is very well maintained and a top patch with a very thick adhesive layer can be used, which could lead if placed directly on the skin. damage to the upper skin layer. The top patch usually has a much smaller area than the bottom of the system, so there is no skin damage by eliminating the large area of the top patch, which has less water vapor and air permeability due to its tack capability.

In this case, it is advantageous to use a very thick adhesive layer to be deposited on the skin. The topsheet topsheet preferably has a means of removing a portion of the topsheet.

In a preferred embodiment, the skin layer may be coated on one or both sides with an effective, preferably bactericidal, substance. In order to prevent the topsheet from detaching from the skin, a more sticky edge strip may be provided on the edge of the adhesive layer to be deposited on the skin.

The top patch may be perforated to ensure that, if solvent application is necessary, the adhesive may be easily removed by neutralizing the adhesive layer with a solvent. After use of the solvent, the top patch and then the cannula can be removed. The skin covering layer can then be removed. The perforation also prevents damage to the overlapped skin layer.

The system according to the invention may comprise as an adhesive an elastic polymer or a precursor thereof that adheres to the skin surface and the cannula surface and, upon application to the skin cover and upon insertion of the cannula, forms an impermeable seal to the skin insertion site.

The system of the invention may also include a cannula receiving means with an aperture adapted to the outer shape of the cannula; the device is placed on the skin layer and fixed at a predetermined position on the cannula opening. The cannula receiving device may also comprise an adhesive backing layer which is connected to the skin layer and fixed during insertion of the cannula. This embodiment is particularly suitable when the topsheet is not to be firmly attached to the cannula, which in some cases could be painful in removing the cannula. In this case, the cannula is secured by friction in the opening of the device to accommodate it.

The cannula receiving device is preferably cast from an elastic material, preferably a polymer, which is optionally transparent. A suitable polymer for a sagittarius such use is, for example, silicone rubber.

The invention also relates to a method of sterile attachment of the cannula to the skin, such that a skin-impermeable skin layer, which is impermeable to bacteria, is applied to the injection site and to the surrounding area together with the skin-adhesive adhesive layer. The cannula is passed through the skin layer and a sealant is applied to the skin to form an elastic, bacteria-impermeable film that adheres to the lower patch in the area of the cannula insertion. The cannula is inserted through the skin layer and an elastic, bacteria-impermeable film is adhered to the lower portion of the patch adjacent the lower portion of the patch and at least to the portion of the cannula that protrudes from the skin while connecting the upper patch to the cannula.

In a preferred embodiment of the method of the invention, the cannula receiving device is joined to the skin layer, wherein the cannula is inserted into the opening of the device before or after it is inserted.

The cannula receiving device may be fixed in position by an adhesive layer, glue, or by engagement with the topsheet.

In a preferred embodiment of the device fixation system with two separate patches consisting of a cover film, a skin adhesive and a topsheet, a topsheet, an adhesive layer and a topsheet cover film, the kiycia skin layer is separated from its cover film and deposited to the surface. The skin covering layer is then punctured with a cannula. The cannula can be, for example, a hypodermic needle, the opening for insertion of the needle can be a horseshoe or a slit. In another preferred embodiment, mandrins can be provided with mandrins. In this case, the cannula can be easily cleaned before introducing liquids into the body; this cleaning can be accomplished, for example, by applying a vacuum to terminate the cannula extending outward from the body followed by aspiration of the cannula material.

One preferred embodiment of the system according to the invention when using an active skin cover layer is used when the system is to be deposited on the skin for a long time or where infection is particularly undesirable because the cannula is inserted frequently into the vessel, e.g. the need for dialysis. In such cases, so-called. short circuit, that is, the connection between the artery and the vein; a cannula is then introduced into this junction at each dialysis. In this case, a bactericidal substance is deposited on the surface of the skin layer, optionally in the form of an additional film, in order to substantially inhibit the penetration of the bacteria to the point where the cannula passes through the skin.

According to a particularly preferred embodiment, the upper patch and the skin covering layer are stacked on top of each other, which are separated from one another by a separating intermediate layer, optionally provided with an adhesive layer on both sides. It is advantageous to provide a separating intermediate with a separating line that defines a larger and a smaller part of the surface. It is also advantageous to provide the separating intermediate layer and the covering film with means for removing them.

This is done by first removing the cover film from the adhesive layer to be deposited on the skin, optionally using a suitable device, and the remaining part of the entire system is adhered to the skin as a whole. Then, part or all of the top patch and the skin covering layer together with the separating interlayer are removed. A portion of the separating layer is separated from the remainder of the layer in a preformed dividing line and separated from the top patch. The adhesive layer thus exposed is adhered to the skin covering layer. The remainder of the separating interlayer together with the upper patch is then peeled off, so the skin covering layer is loosely positioned above the injection site. A puncture is then performed. After the puncture, the separating interlayer is completely removed, optionally using the appropriate device, and the top patch is placed on the cannula so that it lies on it in the form of a horseshoe from which the open end protrudes the cannula. The procedure may be altered by first sticking the patch on the cannula and then sticking the cannula onto the skin cover.

In order to prevent damage to the skin and to facilitate the removal of the top patch by solvents, it is possible to provide holes in the patch.

By using the system of the invention, the cannula is mounted in a duct formed of a skin covering and an upper plaster. Contact between the cannula and the skin is essentially excluded.

In order to avoid rupture of the skin layer during insertion of the cannula, it is possible to introduce the cannula at the edge of the skin layer. This does not completely cover the insertion site with the skin covering, only the cannula is fixed by the entire system.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in more detail with reference to the accompanying drawings:

FIG. 1 shows a system according to the invention with a separate topsheet and a skin covering, FIG. 2 shows a longitudinal section through a layered system according to the invention; FIG. 3 is a cross-sectional view of the system of the invention; FIG. 4 shows the system of FIG. 2 and 3 prior to being deposited on the skin with the putty applied, FIG. Fig. 5 is a view of a system according to the invention using a device to remove the topsheet / liner combination and the dividing lines; 6 shows a system according to the invention with a cannula receiving device, FIG. 1 is a cross-sectional view of the system of the invention shown in FIG. 6, along line VII-VII.

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIG. 1, a preferred embodiment of the system according to the invention consists in its lower part of a cover sheet I, an adhesive layer 2 to be deposited on the skin and a cover skin layer 3, preferably the cover layers are permeable to air and water vapor and optionally bactericidal. The upper part of the system consists of an upper patch 6, an adhesive layer 5 and a topsheet covering film 4, optionally provided with a means to remove it. The system of FIG. 1 is intended to fix the cannula 8, which can be sealed with a bacterium-impermeable sealant 7 and fixed by an upper patch 6 adhered to the skin layer 3.

In FIG. 2 shows a layered system according to the invention, the individual layers of FIG. 1 are placed directly on top of each other, in which case the cover film 4 is an upper patch 6 by a separating intermediate layer.

In FIG. 3 shows the system of FIG. 2 after application to the skin. The smaller upper patch 6 is deposited on the skin layer 3 and fixes the cannula 8 in its position.

In FIG. 4, the cannula 8 has already penetrated the skin layer 3 and the upper patch 6 is adhered to the skin layer 3. The bacteria-impermeable sealant 7 has been applied at the injection site to the skin layer 3 and the free end of the cannula 8. Adhesive layer 5 still covered The film 4 is folded away with the cover film 4 provided with a removal means to facilitate removal of the remainder of the cover film 4. Thereafter, the cover film 4 is removed from the remainder of the top patch 6 and the top patch 6 is placed over the cannula 8 and retained.

In FIG. 5 shows the upper part of the system of FIG. 4, separated from the outer skin layer 3. Two devices can be observed to remove the outer skin film 4 of the upper patch 6 and the dividing line according to which it is possible to remove part of the outer skin film 4 and then adhere the upper skin patch 6 to the skin skin layer 3.

In FIG. 6 shows a further embodiment of the system according to the invention, supplemented by a device 9 for receiving the cannula 8 formed by an elastic polymer. This device 9 is adhered to the skin layer 3 by its backing layer 10 having an adhesive surface. The cannula receiving device 9 has an opening 11 into which the cannula 8 can be mounted by friction. In the embodiment shown in FIG. 6, it is possible to push the cannula 8 through the elastic opening 11a and to place it permanently in the device 9 for receiving the cannula 8, the walls of which return to their original position due to their elasticity.

In FIG. 7 shows the system of FIG. 6, taken along section VII-VII '. In order to better fix the cannula 8, in this case the upper patch 6 is placed over the cannula receiving device 9. In this case, there is no need to provide the adhesive layer 9 with an adhesive surface for its secure placement on the skin layer 3.

Claims (16)

PATENT CLAIMS A catheter mounting system, cannula or the like, comprising in its part a skin film which is coated with an adhesive layer on which a cover film is provided and an upper patch provided with an adhesive layer adhering to the skin film and a cover film covering the top patch characterized in that the skin film (3) is formed of a flexible, water vapor permeable, bacterially impermeable, transparent film material of synthetic or natural material. The system according to claim 1, characterized in that the top patch (6) and its adhesive layer (5) are transparent. The system according to claim 1, characterized in that the skin sheet (3) and the top patch (6) are stacked and connected on one side, the cover film (4) being arranged as a separating interlayer between the skin sheet (3) and an adhesive layer (5) of the upper patch (6). System according to claim 1, 2 or 3, characterized in that the skin layer (3) is made of a synthetic or natural material, for example collagen or polyurethane. System according to claims 1 to 4, characterized in that the surface of the skin film (3) is larger than the surface of the upper patch (6). The system according to claims 1 to 3, characterized in that the adhesive layer (5) of the upper patch (6) has a greater adhesion to the skin film (3) than the adhesive layer (2). System according to claim 3, characterized in that the cover film (4) is provided with a dividing line. System according to claim 7, characterized in that the cover film (4) is provided with a dividing line and two aids, for example notches, for removing the part thus formed. System according to claims 1 to 6, characterized in that the skin film (3) is coated on one side or on both sides with an active ingredient coating, for example a bactericidal substance. System according to claims 1 to 6, characterized in that the skin film (3) is formed of a cut foil material and is provided with an edge of adhesive material. System according to claims 1 to 10, characterized in that the upper patch (6) is perforated. System according to claims 1 to 6 and 9 and 10, characterized in that a sealant (7), for example an elastomer such as silicones, acrylates or rubbers, is deposited on the skin foil (3) and on the surface of the cannula (8). or a starting material thereof, for example based on materials for the manufacture of synthetic rubber. System according to claim 12, characterized in that a device (9) is provided for receiving the cannula (8). System according to claim 13, characterized in that the device (9) is provided with an adhesive backing layer (10) with an opening (11) corresponding to the solid shape of the cannula (8). System according to claim 14, characterized in that the cannula receiving device (9) is cast from an elastic material, for example a polymer, such as a silicone resin. System according to claim 15, characterized in that the material of which the device (9) for receiving the cannula (8) is formed is transparent.