AU612111B2 - Fixing system for securing catheters, cannulas or similar to the surface of the skin, and process for the sterile securing thereof - Google Patents

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

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AO-A-743 7 7/ 8 7 P AWELTORGA 4ISATION FOR GEISTIGES EIGENTUM S 0 PCT ~Internaonales Ibiro SINTERNATIONALE ANMELDUNG VEROFFENTLIGHT NACH DEM VERTRAG OJBER DIE INTERNATIONALE ZUSA214MENARBEIT AUF DEM GEBIET DES PATENTWFSENS (PCT) (51) Internat~onale Patentklassifikation 4: Internationale Vcrofentlichungsnummer: WO 87/ 07164 A61M 1,5,02Al (3 neatols (21) Ilaternationales Aktenzeichen: PCT/DE87/00240 4 wa' El' -ST PLE Cornelia; Willibaldstr.

36/38, 0-800 Man en 2 DE).

(22) 1Internation ales Anmeldedatum: 26. Mai 1987 (26.05.87) (81) Bestimmungsstaaten: AU, DK, FI, HU, JP, KR, NO, (31) Prioritaitsnktenzeichen: P 36 17 8,82.9 US.

P 36 43 985.1 P 37 13 114.1 (32) Priorittitsdaten: 28. Mai 1986 (28.05.86) bfit internationalern Recherchenbericht, 22. Dezember 1986 (2 2.12.86) Vor A blauf derflir Aderungen der Ansprdche zugelas- 16, April 1987 (16.04.87) senen Frist. Verdffentlichzing Wrd iviederholt falls Anderungen eintreffen, (33) PrioriUtslaiid: DE (71) Anraelder (fir alle Bestimrnungsstaaten ausser US): A"*1P i. FE- 'LOH.MtANN-GM vB14' [D E/D El; Irlicher 7r Strasse 55, D-5450 Neuwied 12 lu (72)Erfider;undAUSTRALIAN Erfinder/Anmelder (nurfilr US): BECHER, Frank [DE/ DE]; Hohenfelder St.5 -40 oln D) 2 2 DAECT OFICE (54) itl F XIN SY TEM FOR SEC RING CAT ETE S, ANN LAS OR IIA R 4 TOH UR A E O (54) Biteen: FIXIR SYSTEM ZEUR BFIUG OATHETERNO SINILEN TODTE DG.SUFC DEF HAUTOBERFLACHE SOWIE VERFARREN ZUR STERILEN BEFESTIGUNG DERSELBEN (57) stract Fixing system for securing catheters, cannulas or simoilar with a skin foil coated with a skin-adhesive layer with a covering foil and a top plaster with 4 aOThe!;ve layer which adheres to the skin foil with a ,op-plaster covering layer as well as a 'process for the sterile securing of a cannula to the skin, involving the fol- lowing 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 tile skin; and sticking the top plaster over the cannula, (57) Zusammenfassung Fixiersystem zur Befestigung von Kathetern, Kanillen od, dgl, mit einer Hautadhflsionsschicht beschichteten [-autfolie mit Abc~ckfolie und einemn mit einer auf' der H-autfolie klebenden Ilaicleberschicht ausgerUsteten Oberpflaster mit einer Oberpflasterabdeckschicht sowie ein Verfahren zivr sterilen lBefestigung elner Kanfille an der Haut, mit folgenden Schritten: Aufbringen einer bakteriendichten Hautfolie mit H-autadhilsionsschicht aur die H-aut im Ei'nstichbereich der KanOlel; Setzen der Kanille durch die Hautfolle; Aufbringen eines elnen elastischen, bakteriendichten, auf dem Unterpflaster haftenden Film bildenden KlebstoffeF auf den die Einistichsteli umrgebendeni Bereich des Unterpflasters und den aUs der Haut herausra1genden Kantllenabschnitt, und Aufkleben des Oberoflasters iOber der Kanilie, Il i i Fixing system for fastening catheters, cannulas or the like to the skin surface and process for the sterile fastening thereof.

The invention relates to a fixing system for fastening cannulas, catheters, etc. to the skin, as well as to a process for the sterile fastening of a cannula to the skin.

Cannulas and catheters are here understood to mean "probes" of the type used e.g. fo. introducing into and removing from vessels body fluids and can be in the form of needles, cannulas, catheters, measurement probes for measuring certain body perameters, such as the oxygen partial pressure, etc.), as well as infusion means. Cannulas must be secured to the body, e.g. during the dialysis of patients or during longer infusions. Means for fixing cannulas and catheters are known.

EP-Bl-76 896 and EP-Al-121 679 discloses a "medical dressing for fixing a probe", having a dressing portion which can be fastened to the skin and to the part of the probe projecting from the skin by means of plasters. This dressing portion is provided with a tubular extension, which serves as a support or reception means for the probe part projecting from the skin.

German utility model 82 04 827.4 describes a holding or retaining device having two clamping plates, which receive the cannula and is then secured by plaster to the skin.

DE-OS 32 12 '458 discloses a bandage system for catheters to be externally applied to males and more particularly relates to the geometrical configuration of plaster strips.

German patent DE PS 29 47 427 relates to a vein catheter bandaga which, by means of a plaster with a watertiSht, air-permeable, contact adhesively finished film, which can optionally have a moisture-absorbent layer on the skin"remote side, fixes a cannula with a stop valve to the skin; 95 x 6Oran being given as the preferred A q NO ATTESTATION OR SEAL REQUIRED (Ro (Rode) (Steinberg S;gnature(s) of declarart(s).

SANDERCOCK, SMITH BEADLE P.O. Box 410, Hawthorn 3122, Australia Telephone (+613) 819 2099 To: Commissioner of Patents, Telex: 34491 Sandpat Australia Telefax No. +61 3 819 1334 Group 3 -2 dimensions for the plaster.

DE-OS 31 05 187 describes a cannula fixing plaster with a punched out plaster segment which, after the insertion of the cannula, is fixed to the latter and in this way prevents the removal of the cannula, whilst the remaining plaster adheres to the skin.

EP-Al-116 526 relates to another principle for fastening cannulas to the skin, in which a catheter retaining device is fixed by means of a needle passed through the skin of the patient to be treated.

In special cases the catheter is even sewn to the skin fo4 fixing it into position.

regys-ered +Ccrad 4 mark For example, under the-trade naa-POROFIX cannula plasters, plaster strips are commercially availabe for fixing such cannulas.. They are adhesive plasters with a slit, which is in particular used for fixing Strauss cannulas during infusions.

These known cannula fixing plasters have the advantage that the underlying skin portions can breath, the film being water vapour and oxygen-permeable, so that there can be no maceration of the skin surface.

However, it is a disadvantage of the known cannula fixing means, that the insertion or puncture point and the underlying skin portions in the puncture or insertion channel are not adequately protected against infections',through bacteria which enter from the skin surface.

Attempts have been made to at least partly obviate this problem by disinfecting the skin prior to puncturing. However, disinfection only covers the upper skin layers and is unable to prevent the penetration into the insertion channel of bacteria from lower lying skin layers or from the outside.

It is important to ensure a good fixing of the cannulaj so as to prevent slipping thereof over a long period.

'4, I I V 3 *o o* 9 The prior art arrangements only partly solve this problem. It is either necessary to use very complicated means for fixing the cannula, which are stuck to the skin with the adhesive plaster, or simple plasters with incisions or slits are used, which do not lead to a satisfactory, long-term cannula fixing.

The problem of the present invention is consequently to provide an improved cannula fixing system, which prevents the insertion or puncture point against infection, even in the case of cannulas which are left in longer, such ae e.g. shunts in the case of dialysis patients and accompanied by good fixing, simultaneously prevents damage to the skin layers.

According to the invention this problem is solved by a fixing system for fastening catheters or cannulas or the like, having a skin film coated with a skin adhesion layer and having a cover film and an overplaster finished with a contact adhesive layer adhering to the skin film and having an overplaster cover characteriz)d therein, that the skin film is a flexible, water vapour-permeable and bacteria-tight transparent incision film material of synthetic or natural polymer, and that optionally also the overplaster and its contact adhesive layer is transparent.

A preferred development of the invention is characterised in that the layers are superimposed in sandwich-like manner and on one side are interconnected in a partial region without an inturmediate film or by an intermediate separating film, the overplaster cover film becoming an intermediate separating film between the skin mwspe08/lts 91 3 21 I

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3A f ilm and the contact adhesive coating of the overplaster.

The f ixing system may incorporate a skin f ilm being a natural or synthetic polymer, such as cross-linked collagen, polyurethLne, etc. commercially available in incision film form.

mwspeOl8/lts.2 9 91 4 3 4 If both Lhe cverplaster and skin film are to be made transparent, it is possible even in the case of the longer-term fixing of a cannula, catheter, etc., to constantly check the position thereof by inspecting the outside of the cannula fixing system, without it being necessary to remove or open the latter, which would have infection or injury risks for the patient. As a result of this advantageous construction, it is possible in many cases to obviate cannula changes.

If the surface of the skin film is larger than the overplaster, as a result of the larger adhesive surface a very good adhesion of the skin film to the skin is ensured and it is now possible to adhere to the skin film an overplaster with a very strong adhesive in the contact adhesive coating, which might even lead to skin layer injuries if it was used on the skin. It is appropriate for the overplaster to have a much smaller area than the underplaster, so as to prevent any maceration of the skin by air and moisture exclusion on using an overplaster with poor air and moisture conduction.

It is advantageous in this case if the contact adhesive layer of the overplaster more strongly adheres to the skin film than the skin adhesion layer to the skin. Preferably the overplaster cover film has a separating line and optionally two removal aids for each intermediate separating film portion.

According to a pieferred development of the invention, the skin film can be coated with an active substance on one or both sides and preferably with a bactericidal substance or the like. To prevent the detachment of the edges of the skin film from the skin, in addition to the skin adhesion layer, the skin film can have an all-round, more strongly contact adhering adhesive rim or border.

The overplaster can be perforated, so as to ensure that in the case of any necessary application of a solvent to the overplaster it is -Y i 1 5 possible to ensure an easy removal thereof by neutralising the adhesive layer by the solvent. Following said solvent treatment, it is possible to remove the upper plaster and then the cannula.

The skin film can then be removed. The perforations also prevent maceration of underlying skin surfaces.

The inventive fixing system, according to a specially preferred embodiment, also includes an adhesive-forming elastic polymer or its starting material, which adheres to the skin surface and the cannula surface and following application to the skin film and insertion point forms a bacteria-tight sealing of the insertion point together with the skin film.

According to another embodiment of the invention, the inventive fixing system can also have a cannula support body and also a reception opening adapted to the outside shape of a cannula, in such a way that when the cannula support body is applied to the skin film, the cannula is fixed in a pre-determined angular position in the reception opening. The cannula support body can also have an optionally contact adhesively finished support surface, with which it is engaged on the skin film and can e.g.

be fixed during the insertion of the cannula. This embodiment is particularly advantageous if it is intended to avoid firm adhesion of the overplaster to the cannula, which could in certain circumstances be painful for the patient on removing the cannula. In this case the cannula is fastened by frictional engagement in the reception opening:.of the cannula support body.

Advantageously the cannula support body is a moulded article from elastic material, preferably a polymer, which is optionally transparent. Silicone rubber or other polymers are e.g. suitable for this purpose.

The invention also relates to a process for the sterile fastening of a cannula to the skin, characterised by the application of a bacteria-Light skin film with skin adhesion layer to the skin in A43z 6 the puncture or insertion region of the cannula, passing the cannula through the skin film, applying to the skin an adhesive forming an elastic, bacteria-tight film adhering to the underplaster in the cannula insertion region, passing the cannula through the skin film, applying to the area of the underplaster surrounding the insertion point an adhesive forming an elastic, bacteria-tight film adhering to the underplaster and to at least part of the cannula portion projecting from the skin and sticking the overplaster over the cannula.

A preferred variant of the inventive process is characterised in that a cannula support body is engaged and fixed on the skin film or skin, with subsequent or prior embedding of the cannula in the reception opening of the cannula support body.

The cannula support body can be fixed in position both by means of a contact adhesive layer, by means of an adhesive or by sticking over with the overp'iaster.

In a prefecred embodimett of an inventive fixing system with two separate plasters comprising covcr fil: skin adhesion layer and skin film, together with an overplaster cover film, contact adhesive layer and overplaster, the skin film, which is preferably an incision film, is detached from its surface cover layer and adhered to the skin surface to be provided with a cannula. The incision film is then perforated by the cannula. The punching out of an incision film portion by the hypodermic needle and the feeding of the same into the insertion or puncture channel can be obviated in that either a suitable semi-blunt cannula form is chosen, so that only a horseshoe-shaped tab is punched out and continues to be connected to the film cn one side, or an incision film can be used crosslinked collagen), Another advantageous alternative involves the use of a cannula, with a retractable central pin, Easy cleaning is made possible in that prior to the introduction of liquids into the body, the inside of the cannula A4VS LI 1 I

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-7 is cleaned e.g. by producing a vacuum on the body-remote side, sucking up of residues of punched out portions and also tissue parts.

A particularly preferred embodiment with active ingredient-filled incision film is particularly advantageous if the inventive cannula fixing plaster is left on the skin for a long time. The same also applies in the case of patients, where an infection would have a particularly negative effect, because a cannula is frequently introduced into their vessel, e.g. in the case of dialysis patients. In such cases a so-called shunt is produced, i.e. a connection between the artery and the vein and then a new cannula can be inserted there for each dialysis. An incision film coated with bactericidal active substances on the top of the skin film, in addition or alternatively thereto, would substantially prevent a migration of bacteria towards the body-remote puncture point, According to a particularly preferred embodiment of the inventive fixing plaster, the overplaster portion and skin film portion, separated by an intermediate separating film which is optionally adhesive on both sides, are superimposed. It is preferable for the intermediate separating film to have a separating line, which defines a larger and a smaller surface portion. It is appropriate if the removable intermediate separating film parts and cover films have removal aids.

Firstly the cover -film covering the skin film on the skin side is removed (optionally using a removal aid) and the remaining sandwichlike plaster system is adhered as an entity to the skin. Subsequently patt or all the overplaster is drawn off from the skin film together with the intermediate separating film. A portion of the intermediate separating film is detached from the separating intermediate film residue alcng a prepared separating line and detached from the overplaster. The now exposed contact adhesive layer is adhered totthe skin fUim. The remainder of the intermediate separating film is now I rI b il i iii rl"" 8 flapped away from the skin film, together with the overplaster part covered but not adhered by it, so that the skin film, preferably an incision film, is located freely over the puncture point and this is then followed by puncturing. The intermediate separating film is now completely removed, optionally with a second removal aid and the overplaster is placed over the cannula, so that it rests in roughly horseshoe-shaped manner on the lower plaster and the cannula projects from the open side of the horseshoe. (Obviously the sequence of steps can be modified, e.g. the cannula is engaged first and following this the 'verplaster is stuck down.) To avoid maceration phenomena and in order to facilitate removal of the overplaster by solvents, it may be appropriate to perforate the overplaster.

With the aid of the inventive cannula fixing plaster, the cannula is adhered in a pocket formed by the skin film and overplaster and consequently contact between cannula and skin is substantially avoided.

To avoid the punching out of a skin film portion on inserting the cannula, the latter can be engaged on one edge, even outside the fixing system, so that improved fixing of the cannula is made possible by the inventive fixing system. There is no complete covering of the insertion region by the skin film and use is solely made of the fixing action of the fixing plaster system.

The individual parts of the fixing system, such as the underplaster, overplaster, the adhesive matched thereto and the cannula support body are essential to the invention.

The invention is described in greater detail hereinafter relative to the drawings, wherein show: Fig. I an inventive system with separate overplaster and skin film.

9 Fig. 2 a longitudinal section through a sandwich-like overplaster skin film combination according to the invention.

Fig. 3 a plan view of the plaster according to fig. 2 in the fitted state.

Fig. 4 the plaster according to figs. 2 and 3 prior to the application of the overplaster and with adhesive applied.

Fig. 5 a plan view of the inventive overplaster cover layer combination with removal aid and separating line.

Fig. 6 a view of an inventive fixing system with cannula support body.

Fig. 7 the inventive fixing system of fig. 6 along line VII-VII'.

As shown in fig. 1, a preferred embodiment of the inventive "underplaster" comprises a cover film 1, a skin adhesion layer 2 and a skin film 3, which is preferably finished in air and watervapourpermeable and optionally also bactericidal manner. The "upper part" of the fixing system comprises an overplaster 6, a contact adhesive layer 5 and an overplaster cover film 4, optionally with removal aid.

The fixing system shown in fig. 1 is able to fix cannula 8 which, following the adhesion of the skin film to the skin, is optionally sealed wit'. a bacteria-tight adhesive 7 and is subsequently fastened by the overplaster 6 stuck to the skin film 3.

Fig. 2 shows a sandwich-like variant of the inve-tive fixing system, in which the same layers as described in fig. 1 are superimposed, but in this case the overplaster cover-la 4 has become an intetmediate separating film.

Fig. 3 shows the plaster shown in fig. 2 applied to the skin. A smaller overplaster 6 is stuck to a large surface skin film 2 and fixes cannula 8 in position.

it4v 0 10 In fig. 4 the cannula 8 has already perforated the stuck down skin film ind the overplaster with a portion freed from the intermediate separating film has been stuck to the skin film 3.

The bacteria-tight adhesive 7 has been applied around the insertion point on skin film 3 and the free cannula end, whilst forming a foil-like seal. The overplaster portion 6 still provided with the intermediate separating film 4 is flapped back and has on its end a removal aid, which facilitates the removal of the remaining intermediate film portion. The next operation is to remove by mcans of the removal aid the intermediate separating film 4 from the remainder of overplaster 6, to place the latter over cannula 8 and secure same by adhesion.

Fig. 5 shows the surface portion of fig. 4 from the intermediate 4separating film 4 side It is possible to see two removal aids and a separating line, along which initially a part of the intermediate separating film is removed and then overplaster 6 is stuck to skin film 3.

Fig. 6 shows a further development of the inventi"e fixing system, in which camiula support body 9 formed from an elastic polymer is adhered to the skin film 3 with a support surface 10, which here has a contact adhesive finish. The cannula support body 9 has a receptlor. opening 11, in which the cannula 8 can be frictionally engaged. In the presently shown embodiment cannula 8 can be pressed through a slit in an elastic boundary wall, of reception opening 1i1 and is :secured by the cannula support body walls which elastically return to their inoperative position* Fig. 7 sectionally shows the fixing system of fig. 6 along line VII-VIIt', For the better fastening of cannula 8, in this case an overplaotcr 6 is adhered over the cannulU support body 9. In this embodiment there is no need for a contact adhesive coating of the skin aupp-rt surface

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Claims (9)

1. Fixing system for fastening catheters or cannulas or the like, having a skin film coated with a skin adhesion layer and having a cover film and an overplaster finished with a contact adhesive layer adhering to the skin film and having an overplaster cover characterized therein, that the skin film is a flexible, water vapour-permeable and bacteria-tight transparent incision film material of synthetic or natural polymer, and that optionally also the overplaster and its contact adhesive layer is transparent.

2. Fixing system according to claim 1, characterized therein that the film material is polyurethane or crosslinked collagen.

3. Fixing system according to any on. of claims 1 or 2 characterized thereitL that the surface of the skin film is 6u larger than that of overplaster.

4. Fixing system according to any one of claims 1 to 3 characterized therain that the contact adhesive layer of overplaster adheres more strongly to the skin film than the skin adhesion layer to the skin.

5. Fixing system according to any one of claims 1 to 4, characterized therein that the overplaster cover film has a separating line and optionally two removal aids, one for 013: each portion.

6. Fixing system according to any one of claims 1 to 4 characterized therein that the skin film additionally has an iall-round, strongly contact adhering adhesive border.

7. Fixing system according to any one claims 1 to 6 further characterized by an e.astic polymer or its mwspe018/lts 91 3 21 kJ)uuu 1111Ln t-xuuZU1U11etjj unu elneCIm mu einer aui cer riautioiie KieDenaen i-ialEKieoerscnIent pJ) ausgerusteten Oberpflaster mit einer Oberpflasterabdeckschicht sowie emn Verfahren zur sterilen Befestigung einer Kaniffle an der Haut, mit folgenden Schritten: Aufbringen einer bakteriendichten Hautfolie mit Hautadhqsionsschicht auf die Haut im Einstichbereich der Kantile; Setzen der Kanfle durch die Hautfolie; Aufbringen eines einen elastischen, bakteriendichten,' auf dem Unterpflaster haftenden Film bildenden Kiebstoffes auf den die EinstichstdW. umgebenden Bereich des Unter- pflasters und den aus der Haut herausragenden Kanfilenabschnitt, und Auf'kleben des Oberuflasters iUber der Kanfile. 121 starting material which adheres to the skin film and the cannula surface and in this way form_- a bacteria-tight sela'. for the insertion point.

8. Fixing system according to arx; one of claims 1 to 7 further characterized by a cannula support body optionally with a contact adhesively finished support surface and with a reception opening adapted to the external shape of a cannu~a in such a way that canrula in the case of the cannula support body being appl~,ed to the skin film or skin is fixed in a pre-determined angular posi.tion in reception opening.

9. Fixing system according to claim 9, further characterized in that the cannula support body is a molded got article made from an elastic polymer material that optionally may be transparent. Fixing system according to any one of claims 1 to 9 substantially as hereinbe~fore described witl, particular refe rence to the drawings. DATED this 21 March 1991 SMITH SHELSTON BEADLE Fellows Institute of Patent Attorneys of Australia Patent Attorneys for the Applicant: 0 o mwspe08/1ts 91 321 moisture-absorbent layer on the skin-remote side, fixes a cannula with a stop valve to the skin; 95 x 6 0nim being given as the preferred 1- o 4 Overplaster coverfilm/intermediate separating film Contact adhesive layer List of reference numerals 1 Cover film 2 Skin adhesion layer 3 Skin film 4 Overplaster coverfilm/intermediate separating film Contact adhesive layer 6 Overplaster 7 Adhesive 8 Cannula 9 Cannula support body Support surface of 9 11 Reception opening in 9 ,vtvs