IE60248B1

IE60248B1 - "Fixing system for fastening catheters, cannulas or the like to the skin surface and process for the sterile fastening thereof"

Info

Publication number: IE60248B1
Application number: IE137887A
Authority: IE
Original assignee: Lohmann Therapie Syst Lts
Priority date: 1986-05-28
Filing date: 1987-05-27
Publication date: 1994-06-15
Also published as: PL160666B1; FI880349A0; DK32888D0; PT84957A; EP0247571A1; DK32888A; SK278943B6; HU206051B; PL265938A1; AU7437787A; AU612111B2; HUT47040A; PH25195A; ATE66623T1; NO880300D0; JPH01500326A; SK382287A3; DE3772453D1; NZ220465A; IL82692A0

Abstract

Fixing system for securing catheters, cannulas or similar with a skin foil (3) coated with a skin-adhesive layer (2), with a covering foil (1), and a top plaster (6) with an adhesive layer (5) which adheres to the skin foil (3), with a top-plaster covering layer (4), as well as a process for the sterile securing of a cannula to the skin, involving the following steps: application of a bacteria-tight skin foil with a skin adhesion layer to the skin in the region of cannula penetration; passing of the cannula through the skin foil; application of an adhesive, which forms an elastic, bacteria-tight film which adheres to the lower plaster, to the region of the latter surrounding the point of penetration and to the cannula section which projects from the skin; and sticking the top plaster over the cannula.

Description

The invention relates to a fixing system for attaching catheters, cannulas or the like, having a film, coated with a skin adhesion layer, with a covering film and having an upper plaster, adhering layer. fitted to the with a pressure-sensitive adhesive layer skin film, with an upper plaster covering Cannulas and catheters are to be understood in this case to mean all probes, such as are used, for example, for introducing/draining body fluids into/out ox vessels, such as needles, cannulas, catheters, measuring probes (or for measuring particular physical parameters, such as partial pressure of oxygen or the like), infusion devices and the like. Cannulas must be secured on the body, for example, during dialysis in patients in the case of relatively long infusions to avoid mechanical stress of the latter.

Devices for fixing cannulas and catheters are known,, For example, EP-B1-76 896 and ΕΡ-Ά1-121 679 disclose a medical dressing for fixing a probe, which dressing has a dressing portion which can be attached by a plaster on the skin and, at the same time, on the part of the probe projecting from the skin. Said dressing portion is fitted with an extension of tubular construction which serves as a support or receptacle for the part of ths probe projecting from the skin.

German Utility Model 82 04 827.4 describes a retaining device, DE-A-3,212,458 relates to a bandage system for catheters to be applied externally to male patients and refers, in particular, to the geometric design of strips of plaster. $ y j DE-C-2,947,427 relates to a vein catheter bandage which sticks a cannula with a shutoff valve to the skin by means ox a plaster having a watertight and air-permeable film, fitted with a pressure-sensitive adhesive, which film can, if appropriate, have a moisture-absorbent layer on the side facing away from the skin - preferred dimensions for the plaster are stated as 95 x 60 mm.

DE-A-3,105,187 describes a cannula fixing plaster having a punched-out segment of the plaster, which plaster is stuck to the cannula when the cannula has been inserted and in this way prevents the cannula from being pulled out while the rest of the plaster is stuck to the skin.

EP-A1-I1S 526 relates to a different principle of attaching cannulas to the skin, in which a catheter retaining device is attached by means of a needle which is inserted through the skin of the patient to be treated.

In special cases, the catheter is occasionally even sewn to the skin to secure its position.

US-A-3,918,445 (Buttaravoli) discloses a fixing system for attaching catheters or the like, having a skin plaster with a covering film and having an upper plaster, which can be stuck to the skin film, with an upper plaster covering layer.

In this case, the lower plaster consists of a polyurethane ' foam, is non-transparent and not air-permeable.

Holes in the upper plaster are proposed for the inspection of the infusion needle.

US-A-4,122,,857 (Haerr) refers to a device for fixing tubes and the like to the skin of a patient, with which device a lower plaster and an upper plaster are proposed which can be connected to each other, if appropriate, on one side and are essentially of equal sise, In this case, the tube to be attached is placed on the lower plaster, which has been stuck to the skin, and is stuck to the lower plaster by means of an upper plaster. It is proposed that materials fitted with a bactericide are used.

US-A-4,333,468 (Geist) discloses a cannula support body which is equipped to receive a cannula or the like, said body having a baseplate and a receiving apparatus which opens at the top. This is a mechanically lockable arrangement which, apart from the joint in the cannula support body, is inflexible.

Strips of plaster for fixing cannulas are sold under the name of POROFIX cannula plasters; these consist of adhesive plasters with a slot which are of assistance, in particular, in the fixing of StrauB cannulas in the case of infusions.

The known cannula fixing plasters are thus subject to improvement, in that, in the previously known fixing plasters, skin films or skin plasters were used which were not water vapour-permeable, with the result that maceration of the surface of the skin could occur.

Furthermore, the skin films according to the prior art were not previously transparent, with the result that the locally determined insertion of an infusion cannula through the plaster was not possible, since th© puncture point could not be viewed through the plaster.

It was also disadvantageous in the known cannula fixing devices that the puncture point and the areas of skin located below it were poorly protected in the puncture channel from infections caused by bacteria which migrate from the surface of the skin. Attempts were indeed made to avoid this problem be disinfecting the skin prior to the puncture? however, the disinfection covered only the upper layers of the skin and cannot prevent bacteria from being able to enter the puncture channel from outside.

Good fixing of the cannula is essential in order to prevent the cannula from slipping for a relatively long period.

The arrangements according to the prior art use either very complicated apparatuses for fixing cannulas, which apparatuses are stuck to the skin with adhesive plaster, or very simple plasters with incisions or the like are used which do not allow satisfactory longer-term fixing of the cannulas.

The object of the invention is consequently to provide an improved cannula fixing system which protects the puncture point from infections, even in the case of cannulas, such as, for example, shunts in the ease of dialysis patients, remaining for relatively long periods, and, whilst being wellfixed, simultaneously avoids damage to the layers of skin, in which case a good inspection of the puncture point is to be possible.

According to the invention, the object is achieved by a fixing system for attaching catheters, cannulas or the like, having a skin film, coated with a skin adhesion layer, with a covering film and having an upper plaster, fitted with a pressure-sensitive adhesive layer adhering to the skin film, with an upper plaster covering layer, the skin film being a flexible, water vapour-permeable and bacteria-tight transparent incision film material consisting of synthetic or natural polymer, and that [sic], if appropriate, the upper plaster and its pressure-sensitive adhesive layer are also transparent.

Incision films are, as described, for example, in: Wilson, Kohn Verbandstoffe und Krankenpflegeartikel [Dressing materials and patient care articles], Deutscher Apotheker Verlag Stuttgart, 1983, self-adhesive operation films which are bacteria-tight and transparent.

Due to the use of this material, it is possible to Insert infusion needles, for example, through the incision film, since it is possible to view the puncture point through said incision film and, due to the thin film, the skin covered adhesively by the incision film behaves essentially in the same way as skin without incision film, that is to say can be compressed or raised in the same manner.

A preferred design of the invention is characterised in that the layers are placed one above the other in the manner of a sandwich and are connected to one another on one side in a partial region without intermediate film or by an intermediate separating film, the upper plaster covering film becoming an intermediate separating film between the skin film and the pressure-sensitive adhesive layer of the upper plaster.

Furthermore, it is advantageous if, in the case of a fixing system according to the invention, the incision film is, for example, a natural or synthetic polymer, such as cross-linked collagen, polyurethane or the like.

If both the upper plaster and the skin film are of transparent construction, it is possible, even in the case of longer-term fixing of a cannula/catheter, etc., to check the position thereof constantly by inspecting the outside of the cannula fixing system without removal or opening of the fixing system being necessary, which entails risks of infection or injury for the patient. In many cases, cannula exchanges can be avoided by this advantageous design.

If the surface of the skin film is larger than that of the upper plaster, the larger adhesive area achieves a very good adherence of the skin film to the skin and an upper plaster having an adhesive with very strong properties in the pressure-sensitive adhesive layer, which could even lead to injuries to the layer of skin if it were used on the skin, can then be stuck to the skin film. In this case, it is expedient for the upper plaster to have a far smaller surface than the lower plaster in order to prevent maceration of the skin, if appropriate, due to the exclusion of air and moisture in the case of an upper plaster with poor air and moisture conduction being used. In this case, it is advantageous for the pressure-sensitive adhesive layer of the upper plaster to adhere more strongly to the skin film than the skin adhesion layer on the skin.

The upper plaster covering film preferably has a separating line and, if appropriate, two removal aids, one for each intermediate separating film portion.

In a preferred design of the invention, the skin film can be coated on one or both sides, preferably with a bactericidal substance or the like. To prevent the borders of the skin film becoming detached from the skin, the skin film can have an all-round, more strongly pressure-sensitive adhering adhesive border in addition to the skin adhesion layer.

The upper plaster can be perforated. It can. be ensured by this means that, in the case of application of a solvent to the upper plaster being necessary, easy removal of the upper plaster is ensured by neutralising of the adhesive layer by the solvent.

After this solvent treatment, the upper plaster could be pulled off and the cannula removed. Subsequently, the skin film can be removed. Furthermore, due to the perforation, maceration of the areas of skin located below it can be prevented.

In a particularly preferred embodiment, the fixing system according to the invention comprises an elastic polymer or its starting material, preferably forming an adhesive, which polymer adheres to the skin film and the cannula surface and, after application to the skin film and the puncture point, together with the skin film forms a bacteria-tight seal for the puncture point. Another consequence of this is that no body fluid emerges below the plaster, that is to say the puncture point is sealed towards the outside, which can be very expedient in patients suffering from diseases which can be transmitted by contact with blood, such as hepatitis or AIDS.

In a further embodiment of the invention, the fixing system according to the invention can furthermore have a cannula support body and, furthermore, a reception opening which is adapted to the external shape of a cannula in such a way that the cannula is fixed in a predetermined angular position in the reception opening in the case of the cannula support body being applied to the skin film. In this case, the cannula support body can also have a resting surface which is fitted, if appropriate, with a pressure-sensitive adhesive and with which it can be applied to the skin film and fixed, for example, while the cannula is being inserted: This embodiment is particularly advantageous if sticking the upper plaster to th® cannula, which could possibly lead to the patient suffering pain when the cannula is removed, is to be avoided. In this case, the cannula is attached by frictional engagement in the reception opening of the cannula support body.

The cannula support body is advantageously a moulded article made from an elastic material, preferably a polymer, which is, if appropriate, transparent. For this purpose, silicone rubber or other polymers are suitable, for example.

The cannula support body can be fixed in its position both via a pressure-sensitive adhesive layer, by means of an adhesive or by sticking the upper plaster over it.

In the fixing system according to the invention, having two separate plasters consisting of covering film, skin adhesion layer and skin film as well as upper plaster covering film, pressure-sensitive adhesive layer and upper plaster, the skin film, which is an incision film, is firstly detached from its surface covering layer and stuck to the surface of the skin to be provided with a cannula. Subsequently, the incision film is pierced by means of the cannula. The punching-out of a piece of incision film through the injection needle and infiltration thereof into the puncture channel can be avoided by selecting a suitable semi-blunt cannula shape, by means of which only a horseshoe shaped tab is punched out which remains connected to the film by one side? another advantageous alternative consists in using a cannula with a retractable central spike; a simple possibility of cleaning also consists in cleaning the inside of th© cannula, for example by generating a negative pressure on the side facing away from the body and. removing by suction remains of punchedout portions and parts of tissue, prior to introducing fluids into the body.

A particularly preferred embodiment, using an incision film, charged with a substance, is expedient particularly if the cannula fixing plaster according to the invention remains on the skin for a long period. This also applies to patients, in which an infection can have particularly negative effects because a cannula is inserted into their vessel frequently, e.g. in the case of dialysis patients; in these cases, a socalled shunt, a connection between artery and vein, is produced, where a new cannula is inserted for each dialysis.

Even an incision film, additionally or alternatively coated with bactericidal substances on the upper side of the skin film, would be able to prevent to a great extent a migration of bacteria to the puncture point at the latter facing away from the body.

In a further particularly preferred embodiment of the fixing plaster according to the invention, the upper plaster portion and the skin film portion are arranged one above the other, separated by an intermediate separating film which, is, if appropriate, adhesive on both sides. The intermediate separating film preferably has a separating line which defines a larger and a smaller surface portion. In this case, it is expedient for the removable intermediate separating film parts and covering films to have removal aids.

The covering film covering the skin film on the skin side is firstly removed (possibly using a removal aid) and the remaining sandwich-type plaster system is stuck as a whole to the skin. Subsequently, a part of or the entire upper plaster is removed from the skin film together with the intermediate separating film. One portion of the intermediate separating film is separated from the remains of the intermediate separating film along a preparing separating line and detached from the upper plaster. The now exposed pressure-sensitive adhesive layer is stuck to the skin film. Subsequently, tha remains of the intermediate separating film are folded back from the skin film, together with the portion of the upper plaster which is covered by said remains and is not stuck on, with the result that the skin film is exposed over the puncture point - The puncture then takes place. The intermediate separating film is now completely removed - if appropriate using a second removal aid - and the upper plaster is wrapped over the cannula so that it rests on the lower plaster approximately in a horseshoe shape and the cannula projects on the open side of the horseshoe. (Of course, the sequence of the steps can also be altered, for example the cannula inserted first and the upper plaster stuck on afterwards ).

To avoid the appearance of maceration and to facilitate the detachment of the upper plaster by a solvent, it can be expedient for the upper plaster to be perforated.

With the aid of the cannula fixing plaster according to the invention, the cannula is stuck in a pouch, formed by the skin film and the upper plaster, and thus contact of the cannula with the skin is largely avoided.

To avoid the punching-out of a portion of skin film when the cannula is inserted, the cannula can also be inserted outside the fixing system, at an edge thereof, thus allowing the improved fixing of the cannula by the fixing system according to the invention, in which case complete covering of the puncture region of the skin film does not take place, but the fixing effect of the fixing plaster system alone is used.

The individual constituents of the fixing system, such as the lower plaster, the upper plaster and the adhesive, adapted to said plasters, and the cannula support body are essential to the invention.

The invention is explained in greater detail below with reference to the attached drawing, in which: Figure 1 shows a system according to the invention with separate upper plaster and skin film? Figure 2 shows a longitudinal section through a sandwichtype upper plaster - skin film - combination according to the invention; Figure 3 shows the plaster of Figure 2 in the plan view in the state of use; Figure 4 shows the plaster of Figures 2 and 3 prior to the upper plaster being wrapped over, with the adhesive applied; and Figure 5 shows a plan view of an upper plaster - covering layer - combination according to the invention with removal aid and separating line.

Figure δ shows a view of a fixing system according to the invention with a cannula support body; and Figure 7 shows the fixing system, according to the invention, of Figure 6, cut along the line VII-VII'.

As shown in Figure 1, a preferred embodiment of the lower plaster according to the invention consists of a covering film 1, a skin adhesion layer 2 and a skin film 3 which can preferably be fitted so as to be air- and water vapourpermeable, if appropriate also bactericidal. The upper part of the fixing system consists of an upper plaster S, a pressure-sensitive adhesive layer 5 and an upper plaster covering film 4, if appropriate with removal aid. The fixing system illustrated in Figure 1 can fix the cannula 8, which is inserted after sticking on the skin film, is sealed, if appropriate, with a bacteria-tight adhesive 7 and is subsequently attached by the upper plaster a stuck to the skin film 3. - 13 Figure 2 illustrates a sandwich-type variation of the fixing system according to the invention, in which the same layers, as described for Figure 1, are present adhering one above the other, but the upper plaster covering layer 4 is, in this case, an intermediate separating film.

Figure 3 shows the plaster illustrated in Figure 2 in the state as applied to the skins stuck to a skin film 2, covering a large area, is a smaller upper plaster 6 which fixes the cannula 8 in its position.

In Figure 4, the cannula 8 has already been inserted through the stuck-on skin film and the upper plaster stuck to the skin film 3 with a portion freed from the intermediate separating film. The bacteria-tight adhesive 7 is applied to the skin film 3 around the puncture point and to the free end of the cannula with formation of a film-type seal. The portion 3 of the upper plaster, still provided with the intermediate separating film 4, is folded back and has at its end a removal aid which facilitates the removal of the remaining piece of intermediate film.

As the next operation, the intermediate separating film 4 Is now to be removed from the remains of the upper plaster β by means of the removal aid, the upper plaster to be wrapped over the cannula 8 and stuck down.

Figure 5 shows the portion of the surface shown folded back in Figure 4, seen from the side 3 of the intermediate separating film. Two removal aids can be clearly seen as well as a separating line, along which a partial portion of the intermediate separating film can firstly be removed and the upper plaster 6 can then be stuck to the skin film 3.

Figure 6 shows a further development of the fixing system according to the invention, in which a cannula support body 9, made from an elastic polymer, with a resting surface 10, which, in this case, is fitted with a pressure-sensitive adhesive, is stuck to the skin film 3. Provided in the cannula support body 9 is a reception opening 11, into which the cannula 8 can be inserted with frictional engagement. In the embodiment illustrated here, the cannula 8 can be pressed through a slot in an elastic boundary wall of the reception opening 11 and is held by the cannula support body walls which return elastically to their position of rest.

Figure 7 illustrates the fixing system of Figure δ along the line vn-vil'. In this case, for better attachment of the cannula 8, an upper plaster β is stuck over the cannula support body 9; in this embodiment, a pressure-sensitive adhering coating of the surface 10 resting on the skin can be omitted.

Claims

1. Fixing system for attaching catheters, cannulas or the like, having a skin film, coated with a skin adhesion layer, with a covering film and having an upper plaster, fitted with a pressure-sensitive adhesive layer adhering to the skin film, with an upper plaster covering layer, wherein the skin film is a flexible, water vapourpermeable and baeteria-tight transparent incision filxn material consisting of synthetic or natural polymer and wherein, if appropriate, the upper plaster and its pressure-sensitive adhesive layer are also transparent.

2. Fixing system according to Claim 1, wherein the incision film material is polyurethane or a cross-linked collagen.

3. Fixing system according to one of the preceding claims, wherein the surface of the skin film is larger than that of the upper plaster.

4. Fixing system according to one of the preceding claims, wherein the pressure-sensitive adhesive layer of the upper plaster adheres more strongly to the skin film than the skin adhesion layer to the skin.

5. Fixing system according to one of Claims 1 to 4, wherein the upper plaster covering film has a separating line and. If appropriate, two removal aids, one for each portion.

6. . Fixing system according to Claim 1 to 4, wherein the skin film additionally has an all-round, strongly pressuresensitive adhering adhesive border.

7. Fixing system according to one of the preceding claims, wherein the system includes an elastic polymer or its starting material, preferably forming an adhesive, which polymer adheres to the skin film and the cannula surface in ths region of the puncture point and in this wav forms a bacteria-tight seal for the puncture point. 5

8. Fixing system according to one of the preceding claims, further characterised by a cannula support body, if appropriate with a resting surface, fitted with a pressure-sensitive adhesive, and with a reception opening which is adapted to the external shape of the cannula in 10 such a way that the cannula is fixed in a pre-determined angular position in the reception opening in the case of the cannula support body being applied to the skin film or the skin.

9. Fixing system according to Claim 8, wherein the cannula 15 support body is a moulded article made from an elastic material, preferably a polymer, which is, if appropriate, transparent.

10. A fixing system substantially as hereinbefore described with reference to the drawings.