EP1011780A1

EP1011780A1 - A bandage for fixating a cannula of a venous catheter to a skin surface part of a person

Info

Publication number: EP1011780A1
Application number: EP97939972A
Authority: EP
Inventors: Philip Fleischer
Original assignee: Maersk Medical AS
Current assignee: Unomedical AS
Priority date: 1996-09-10
Filing date: 1997-09-08
Publication date: 2000-06-28
Also published as: WO1998010823A1; AU4199197A

Abstract

A bandage (10) for fixating a cannula (40) of a venous catheter relative to a skin surface part of a person comprises: a supporting element (18) to be arranged adjacent to the perforation aperture and below the cannula (40) for supporting the cannula, a connecting foil (25) defining a cover foil area, a cover sheet (12) of foil material having opposite first and second surfaces, the first surface of the cover sheet defining an area substantially exceeding the cover foil area, and an adhesive material applied to the first surface of the cover sheet. The supporting element (18) is connected to and suported by the connecting foil (25) which defines a transition area (28) between the supporting element and the cover sheet, as a folding line is defined within the transition area. The cover sheet (12) is foldable onto the supporting element (18) along the folding line for covering the cannula, for covering the perforation aperture, and for arranging the first surface of the cover sheet facing towards the supporting element, covering the supporting element and the connecting foil, adhering to the skin surface part and fixating the cannula onto the supporting element.

Description

A bandage for fixating a cannula of a venous catheter to a skin surface part of a person.

The present invention relates to a bandage for fixating a cannula of a venous catheter to a skin surface part of a person.

A bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person is known from US Patent No. 4,275,721, to which reference is made and which is herewith incorporated in the present specification by reference.

The known bandage comprises a cover sheet of a foil material and of an oblong configuration. One surface of the cover sheet is provided with an adhesive layer, on top of which a supporting element is arranged. The supporting element is located in its entirety within one half of the cover sheet, and a rectilinear slit extends from the end or short side of the oblong or rectangularly shaped bandage which end or short side is farthest from the supporting element. Basically, this known bandage constitutes a conventional, rectangularly shaped plaster having an offset supporting element which is circu ferentially enclosed or encircled by the adhesive layer, which rectangularly shaped plaster is further provided with a slit which extends from the short side of the rectangularly shaped plaster farthest from the supporting element. A conventional plaster may thus easily be converted into this known bandage by simply cutting the conventional plaster into the correct shape so as to locate the supporting element in an offset position relative to the centre of the rectangularly shaped bandage and by cutting the slit from the short side of the plaster farthest from the supporting element.

As will be readily understood, the bandage known from the above- mentioned US Patent for fixating a cannula of a venous catheter relative to a person is by no means of a structure which has been optimized for its intentional application, i.e. for fixating a cannula of a venous catheter of an arbitrary form relative to a skin surface part of a patient or person. Thus, this known bandage has to be used in connection with a supporting pad which has to be inserted between the skin surface part of the patient or person and the cannula of the venous catheter, which cannula is to be fixated by means of the bandage. The supporting pad clearly makes it complicated to fixate the cannula relative to the skin surface part by means of the bandage as not only the cannula has to be kept in a specific position while applying the bandage, but also the supporting pad has to be kept in a desired position supporting the cannula. It has further been realized that this rectangularly shaped, plaster-like bandage known from the above-mentioned US Patent suffers from inherent drawbacks originating from the fact that the overall structure is merely a conventional plaster. Thus, the structure has not been adapted to on the one hand handling the bandage while applying the bandage to the skin surface part of the patient or person for fixating the cannula of a venous catheter and also the supporting pad, if any, and on the other hand, fixating and maintaining the cannula of the venous catheter in a fixed position in order to eliminate any risk of moving the cannula of the venous catheter relative to the supporting skin surface part of the patient or person, which movement may cause damage to the vein of the patient or person, which vein has received the cannula of the venous catheter, or cause other severe damage due to perforation of tissue of the patient or person. The vein catheter bandage described in the above-mentioned US Patent suffers also from the serious drawback that its particular shape allows only a winged cannula to be supported and fixated thereupon, the fixation of a simple cannula of a tubular construction being extremely insecure due to the small zone of adhesion between the bandage and the cannula which is limited to the front area of the cannula.

Published international patent application, publication No. WO 93/00788 and published European patent application, application No. EP 0569 565 describe a bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person, which bandage comprises a cover sheet of a foil material having opposite first and second surfaces and defining an outer rim. An adhesive layer is applied to and covers the first surface, and a supporting element is arranged at and adheres to the first surface. The supporting element is located at a distance from the outer rim and is circumferential ly encircled by the adhesive layer, and the supporting element is further divided into first and second parts, the first part being contiguous to the adhesive layer. To the first surface and covering the first part of the supporting element a glue layer is applied, and the second part of the supporting element is uncovered by the glue layer. Through the supporting sheet and extending from the outer rim through the adhesive layer and into the first part of the supporting element, a slit is cut.

However reliable the above-mentioned bandage may be, it can only fixate in an adequate manner winged cannula, i.e. cannula of a structure having outwardly extending wings. In case a tubular cannula is introduced through the above-mentioned slit in a direction parallel to the length of the slit, the cannulae may not be covered by any adhesive layer and a reliable fixation may not be provided.

From US-patent No. 5,282,781 a device for securing a surgical instrument is known which device comprises two foil sheets which are adjoined one another and are adapted to be applied on top on one another sandwiching an instrument such as a cannula therebetween. Reference is made to the above US-patent which is further hereby incorporated in the present specification by reference.

From published international patent application, publication No.

W092/12757, a windowed vein catheter dressing is known which dressing constitutes an improvement including a window of the bandage known from US-patent No. 4,275,721.

Consequently, none of the existing types of bandages have been found to meet the requirement of being able to ensure a reliable fixation of any type of cannula and in particular a cannula of the type having no wings and being of a general cylindrical configuration. Therefore, an object of the present invention is to provide a bandage for fixating a cannula of a venous catheter of an arbitrary shape relative to a skin surface part of a person, which bandage is optimized as to, on the one hand, the handling of the bandage and the cannula while applying the bandage to the cannula and the skin surface part of the person, to which skin surface part the cannula is to be fixated, and, on the other hand, the fixation of the cannula relative to the person's skin surface part for providing a reliable fixation of the cannula relative to the skin surface part in order to eliminate any risk of causing injuries or harm to the person as a result of unintentional shifting or movement of the cannula relative to the skin surface part.

A particular advantage of the bandage according to the present invention resides in the fact that the bandage according to the present invention may be adopted for application onto the cannula of the venous catheter laterally or alternatively longitudinally relative to the longitudinal direction of the cannula and consequently in different embodiments be configurated in accordance with specific requirements and in particular allowing the bandage to be used for easily fixating the cannula relative to the skin surface part by a person applying the cannula and also fixating the cannula by means of the bandage.

A particular feature of the bandage according to the present invention relates to the fact that the bandage may be of an overall symmetrical configuration allowing the bandage to be applied from either side and/or by a left hand or a right hand individual applying the cannula and also fixating the cannula by means of the bandage.

A particular feature of the present invention relates to the provision of an inspection window by a hole of the cover sheet of the bandage which hole is covered by a transparent foil allowing visual inspection of the aperture of insertion of the needle of the cannula which bandage due to its structure provides a perfect fixation of the cannula without any risk of the cannula being shifted or moved relative to the skin surface part in spite of the provision of the inspection window.

The above object, the above advantage, and the above feature together with numerous other objects, advantages, and features which will be evident from the description below are obtained by means of a bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person, the cannula being positioned obliquely relative to the skin surface part and perforating the skin surface part in a perforation aperture, comprising: a supporting element to be arranged adjacent to the perforation aperture and below the cannula for supporting the cannula in a position resting on the supporting element, a connecting foil defining a cover foil area, a cover sheet of a foil material having opposite first and second surfaces and defining a first end, the first surface of the cover sheet defining an area substantially exceeding the cover foil area, and an adhesive material applied to the first surface of the cover sheet, the connecting foil being connected to the cover sheet at the first end thereof and constituting an extension thereof, the supporting element being connected to and supported by the connecting foil, the connecting foil defining a transition area between the supporting element and the cover sheet, a folding line being defined within the transition area, the cover sheet being foldable onto the supporting element along the folding line for covering the cannula supported by and resting on the supporting element, for covering the perforation aperture, and for arranging the first surface of the cover sheet facing towards the supporting element, covering the supporting element and the connecting foil, adhering to the skin surface part and fixating the cannula onto the supporting element.

According to the basic realization of the present invention, the bandage according to the present invention is distinct from conventional bandages for fixating cannulae of venous catheters relative to skin surface parts of persons or individuals in which conventional bandages the supporting element is provided as a pad on the adhesive side of the cover sheet. For arranging the bandage and fixating the cannula of the venous catheter relative to the skin surface part of the person in the intentional orientation, the spaced apart relationship relative to the supporting element is readily arranged below the cannula and the cover sheet is folded onto the cannula and onto the supporting element providing an integral covering of the cannula and supporting element fixating the cannula and at the same time the supporting supporting element relative to the skin surface part of the person. As the supporting element and the cover sheet are kept in spaced apart relationship through the provision of the connecting foil, the cover sheet also provides a covering of the perforation aperture.

The double adhesive concept described in the above mentioned PCT and EP patent applications may also be applied in connection with the bandage according to the present invention. The bandage according to the present invention may in accordance with well-known techniques within the technical field of bandages be produced from individual components which may be configurated and/or adopted by the application of one or more adhesive layers on one surface or on opposite surfaces as well. According to a first embodiment of the bandage according to the present invention, the bandage is produced from basically three individual components constituted by the supporting element, the cover sheet and the connecting foil as the connecting foil is constituted by a separate foil component constituting an interconnecting element or bridging element interconnecting the supporting element and the cover sheet. According to a second or alternative embodiment of the bandage according to the present invention, the connecting foil is constituted by a part or segment of the cover sheet and is consequently integral with the cover sheet.

It is to be understood that the term supporting element is, in the present context, to be construed a generic term covering elements which may constitute a supporting element such as a supporting cushion or supporting pad and serving the main purpose of supporting the lower surface i.e. the surface of the cannula facing towards the skin surface part of the person without causing damages and in particular injuries to the skin surface part of the person. The supporting element may constitute an element serving the purpose of absorbing liquids such as blood and water from the skin surface of the person and be constituted by a first absorbing pad.

The adhesion of the cover sheet to the skin surface part of the person in question may readily be established through the difference in area of the connecting foil and the cover sheet as the connecting foil defines a cover foil area which is substantially smaller than the area defined and covered by the cover sheet. Consequently, as the cover sheet is applied covering the connecting foil, the cover sheet readily contacts the skin surface and adheres thereto. Alternatively and/or additionally, the connecting foil may be provided with apertures or perforations allowing the cover sheet to adhere to the skin surface through the apertures or perforations of the connecting foil for fixating the overall bandage to the skin surface. It is to be understood that the cover sheet preferably includes a complete adhesive covering at its first surface allowing the cover sheet to adhere in facial contact to the cannula and also adhere to the upper side of the connecting foil and at the same time adhere to the skin surface as the cover sheet extends beyond the connecting foil and adheres to the skin surface along at least a part and preferably a substantially part of the perimeter of the connecting foil.

The connecting foil may constitute a bridging element serving the sole purpose of keeping the supporting element and the cover sheet in the intentional spaced apart relationship and allowing the cover sheet to be folded onto the cannula and the supporting element for fixating the cannula and the supporting element relative to the skin surface part of the person. However, in the presently preferred embodiment of the bandage according to the present invention, the connecting foil also constitutes an adhering element as the connecting foil is preferably provided with an adhesive covering at a surface thereof coextensive with the first surface of the cover sheet allowing the connecting foil to be adhered to the first surface of the cover sheet through the adhesive covering of the connecting foil. Alternatively and/or additionally, the connecting foil may be provided with an adhesive covering at a surface thereof opposite to the first surface of the cover sheet allowing the connecting foil to be adhered to the skin surface part of the person providing a reliable fixation of the supporting element prior to the step of folding the cover sheet onto the cannula and also the supporting element for fixating the cannula relative to the skin surface part of the person.

The fixation of the cannula relative to the skin surface part and also the technique of applying the bandage onto the cannula and onto the supporting element for fixating the cannula relative to the skin surface part may be improved by the provision of an adhesive covering applied to the supporting element for causing the cannula to adhere to the supporting element which adhesive covering, on the one hand, allows the supporting element and the cannula to be positioned in a specific orientation during the process of applying the bandage and maintained in the intentional position and, on the other hand, improves the fixation of the cannula as the cannula is adhered at its lower surface to the upper surface of the supporting element and at its upper surface fixated by means of the cover sheet covering the cannula and also covering and adhering to the supporting element. The fixation of the cannula relative to the skin surface part of the person may according to the above described advantageous embodiment in which the supporting element is provided with an adhesive covering be further improved by the provision of an additional adhesive covering for causing the supporting element to adhere to the skin surface part of a person. Consequently, the supporting element may constitute a double adhesive element the lower surface of which adheres to the skin surface part and the upper surface of which adheres to the lower surface of the cannula.

The aperture of insertion or the perforation aperture may in accordance with a first embodiment of the bandage according to the present invention be covered by the cover sheet or alternatively in accordance with an alternative embodiment of the bandage according to the present invention be covered by a second absorbing pad constituting a component of the bandage according to the present invention and intended to be arranged covering the perforation aperture.

According to alternative embodiments of the above described second embodiment of the bandage according to the present invention comprising a second absorbing pad, the second absorbing pad may be constituted by a separate absorbing pad component or alternatively be made from the same absorbing pad material as the first absorbing pad to be arranged supporting the cannula. Provided the two absorbing pads of the above described second embodiment of the bandage according to the present invention are produced from the same absorbing pad material, the second absorbing pad may advantageously be separated from the first absorbing pad to be arranged below and supporting the cannula through a slit cut through the absorbing pad material.

According to a further or third embodiment of the bandage according to the present invention, the cover sheet is provided with a transparent area allowing visual inspection of the perforation aperture. The transparent area of the cover sheet is readily produced by providing a hole through the cover sheet at the location to be arranged on top of the perforation aperture and covering the hole by means of a transparent foil. According to a particular aspect of the present invention, the bandage according to the present invention may be applied transversly or alternatively longitudinally relative to the cannula. Thus, according to a first embodiment of the bandage according to the present invention, the folding line extends substantially parallel with the cannula when the bandage is applied to the skin surface part of the person and the cover sheet is foldable substantially transversly relative to the cannula when folded onto the supporting element. Alternatively, according to a second embodiment of the bandage according to the present invention, the folding line extends substantially transversly relative to the cannula when the bandage is applied to the skin surface part of the person and the cover sheet is foldable along the longitudinal orientation of the cannula when folded onto the supporting element.

According to further alternative embodiments of the above described second embodiment of the bandage according to the present invention, the cover sheet is foldable along the folding line from the perforation aperture towards the supporting element, or alternatively, the cover sheet is foldable along the folding line from the supporting element towards the perforation aperture.

In order to render it possible to handle the bandage before the bandage is applied to the cannula and to the skin surface part of the person, to which skin surface part the cannula is to be fixated, the bandage preferably further comprises release foils covering all the exposed adhesive areas. The release foils may be constituted by a sil iconized paper, siliconized or non-siliconized^" polyester, polypropylene, polyethylene or a similar plastic material.

The cover sheet of the bandage according to the present invention may be configurated in any arbitrary shape provided the cover sheet fulfils the above requirements of fixating the cannula and also fixating the supporting element relative to the skin surface part. Thus, according to alternative geometrical embodiments of the bandage according to the present invention, the cover sheet may be of a rectangular configuration, a quadratic configuration, a circular configuration, an elliptic configuration or a combination of the above configurations. The foil material of the supporting sheet of the bandage according to the present invention may be made from any appropriate material which may be used as a supporting sheet material. Provided the adhesive layers are substantially water-impermeable, the foil material may be made from water- impermeable or water-permeable material. In order to hinder any penetration of water through the cover sheet from the environment into the area covered by the bandage, the foil material is, however, preferably a substantially water- impermeable material such as spun bond, spun lace, woven or non-woven foil materials of polyester, nylon, polypropylene, polyethylene, polyurethane, polyvinylchloride, clear tape or other transparent or non-transparent material, or combinations thereof.

The individual components of the bandage according to the present invention including the supporting element, the adhesive covering, the first surface of the cover sheet, the cover sheet itself and the connecting foil and also any additional adhesives and/or release foils etc. may readily be chosen by a person having ordinary skill in the art from materials which are well-known in the art for medical application including medical grade supporting element materials, cover sheets, release foils, adhesives etc.

The adhesive layer may be constituted by a medical grade acrylic adhesive, a medical, natural or synthetic rubber resin adhesive or other medical grade adhesive.

In the present context the terms sheets or foils are to be construed as generic terms which are further to be considered synonymous, as the terms sheet and foil describe the configuration of the component or element in question constituting a component or an element having two opposite parallel surfaces and a small thickness as compared to the dimensions of the sides of the element. In this context, the expression term is to be understood as expressing a factor 10 or more.

The invention will now be further described with reference to the drawings, in which:

Fig. la is a perspective and schematic view of a first embodiment of a bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person, viewed from one end of the bandage and illustrating a first or lower surface of the bandage covered by cover sheet parts,

fig. lb is a perspective and schematic view of the first embodiment of the bandage shown in Fig. la, but viewed from the opposite end of the bandage and illustrating a second or upper surface of the bandage and further illustrating the cannula and the bandage after the partial removal of the cover sheet parts of the bandage in an intermediate stage of a fixation operation,

fig. lc is a perspective and schematic view of the first embodiment of the bandage shown in figs, la and lb, illustrating its application in connection with a cannula,

fig. 2 is an exploded and schematic view of the first embodiment of the bandage shown in figs, la, lb and lc,

fig. 3a is a perspective and schematic view similar to the view of fig. la of a second embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person,

fig. 3b is a perspective and schematic view similar to the views of fig. lb of the second embodiment of the bandage shown i fig. 3a

fig. 3c is a perspective and schematic view similar to the view of fig. lc of the embodiment of the bandage shown in figs. 3a and 3b,

fig. 4 is an exploded and schematic view similar to the view of fig. 2 of the second embodiment of the bandage shown in figs. 3a, 3b and 3c,

fig. 5a is a perspective and schematic view of a third embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person,

fig. 5b is a perspective and schematic and partly cut-away view of the third embodiment of the bandage shown in fig. 5a, illustrating the bandage after the partial removal of cover sheet parts of the bandage in an intermediate stage of a fixation operation,

fig. 6a is a perspective and schematic view similar to the view of fig. 5a of a fourth embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person,

fig. 6b is a perspective and schematic view similar to the view of fig. 5b of the fourth embodiment of the bandage shown in Fig. 6a,

fig. 6c is a perspective and schematic view of the fourth embodiment of the bandage shown in figs. 6a and 6b, illustrating its application in connection with a cannula,

fig. 7a is a perspective and schematic view similar to the views of fig. 5a and 6a of a fifth embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person,

fig. 7b is a perspective and schematic view of the fifth embodiment of fig. 7a supporting a winged valve/cannula assembly in an intermediate stage of a fixation operation,

fig. 7c is a perspective and schematic view of the fifth embodiment shown in the figs. 7a and 7b supporting a winged valve/cannula assembly in a final stage of the fixation operation where the gripping tab and the winged part of the valve/cannula assembly are visualised by phantom lines,

fig. 7d is a perspective/schematic and partly cut-away view of the fifth embodiment shown in fig. 7a and 7b, illustrating a cannula supported thereupon,

fig. 8a is a perspective and schematic view of a sixth embodiment of a bandage according to the present invention, fig. 8b is a perspective and schematic view of the sixth embodiment of the bandage shown in fig. 8a in an intermediate stage of a fixation operation,

fig. 9 is a perspective and schematic view of a fifth and presently preferred method of producing the first embodiment of the bandage according to the present invention shown in Figs, la, lb, lc and 2 and illustrating the multilayer structure of the bandage,

fig. 10a is a perspective and schematic view similar to the view of fig. 5a of a seventh embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person,

fig. 10b is a perspective and schematic view of the seventh embodiment shown in fig. 10a, illustrating its application in connection with a cannula,

fig. 11a is a perspective and schematic view of an eighth embodiment of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person, and

fig. lib is a perspective and schematic view of the eighth embodiment shown in fig. 11a, illustrating its application in connection with a cannula.

In the following examples, identical component parts of the various embodiments are designated identical reference numerals, while variants of different respective embodiments in their entirety are designated the same reference numerals as the original embodiment, but are further primed for each new variant, i.e. a variant of an embodiment 10 will be primed once (10'), a second variant, twice (10"), etc.

In Figs, la, lb and lc, a first embodiment of a bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person is shown designated the reference numeral 10 in its entirety. The skin surface part may e.g. constitute a skin surface part at the back of the person's hand or on the back, forearm, chest or one of the legs of the person in question. The bandage 10 basically comprises a longitudinally symmetrical cover sheet 12 of a sheet material, such as a plastic material, a woven or non-woven fibrous material or any other appropriate sheet material and of a substantially rectangular configuration. The cover sheet 12 defines a first and a second surface and is prolonged at one end with a longitudinally symmetric, lobe-shaped double adhesive sheet 25 comprising a broad sheet-contacting end 24, a narrowing central portion 28 and a cannula-gripping end made of two gripping tabs 22 formed by a wedge- or tongue-shaped slit 20 in the above-mentioned lobe. The first surface of the bandage 10 is disclosed in fig. la and constitutes a lower surface of the bandage to be arranged in facial contact with the above mentioned skin surface part of the person at which skin surface part a venous catheter is arranged and applied perforating the skin of a person providing a perforation aperture. The second surface of the bandage 10 disclosed in fig. lb constitutes a top surface opposite to the above mentioned first or lower surface. It is to be understood that terms such as "lower" and "upper" referring to the orientation of the bandage refers to the orientation in relation to the skin surface part rather than in relation to the gravitational field, as an upper surface facing outwardly from the skin surface part of the person may, provided the bandage is applied to the back of the person and the person is lying or resting on his or her back, constitute a downwardly orientated surface in relation to the gravitational field still in the present context be considered the outer or upper surface referring to the general technique of applying the venous catheter and the bandage to the upper side of the hand of a patient or person.

The adhesive sheet 25, being coated with an adhesive on both sides, is adhered to the first, non-adhesive side of the cover sheet 12, and a supporting element 18 is adhesively attached to the other adhesive side of the double adhesive sheet 25. The supporting element 18 is made from fibrous material which is an organic-compatible material.

At the first surface of the bandage 10 shown in fig. la which first surface constitutes a lower surface to be applied in facial contact with the above mentioned skin surface part of the person is on top of the adhesive sheet 25 provided with a first release sheet 16. The release sheet 16 covers the adhesive material at the first surface or lower surface of the double adhesive sheet 25 and provides a non-adhered part 15 overlapping the cover sheet 12 and serving to remove the first release sheet 16 from the double adhesive sheet 25.

At the second or opposite surface of the bandage illustrated in fig. lb, the adhesive layer of the cover sheet 12 is covered by a second release sheet 14. The first release sheet 16 only covers one half of the area of the first surface of the double adhesive sheet 25 and a similar and mirror image release sheet not shown in the drawings covers the other half area of the first surface of the double adhesive sheet 25.

In Fig. lb, a cannula assembly 40 is shown supported on and adhesively attached to one of the symmetrical gripping tabs 22 and covered by the other gripping tab 22, and in Fig. lc, the entire insertion zone comprising the inserted cannula assembly 40 and the lobe-shaped part of the bandage 10 is shown covered by the adhesive side of the cover sheet 12, the contours of the underlying elements being illustrated by phantom lines. The cover sheet may at its central part be provided with an optional hole 30 placed on a longitudinal axis corresponding to the slit 20, which hole 30 allows visual inspection of the cannula insertion area when the cover sheet covers the insertion area. The hole 30 is preferably circular but may have any other shape, such as elliptic, oval, rectangular, quadratic, etc, or a combination of the above mentioned geometric forms. In order to prevent direct contact between the ambient air and the needle insertion point, the hole is preferably covered by a thin, transparent plastic sheet.

The bandage 10 may be applied in the following way. The needle of the cannula assembly 40 is caused to perforate the tissue at the skin surface part of the person at which skin surface part a venous catheter is to be applied, whereupon the bandage 10 is applied onto the skin surface part perforated by the needle of the cannula assembly 40 by arranging the loop-shaped portion of the bandage 10 straddling the needle of the cannula assembly 40 as is illustrated in fig. lb as one of the supporting elements 18 is arranged below and supporting the cannula assembly 40 after the release sheets covering the first surface of the double adhesive sheet 25 such as the release sheet 16 have been removed whereas the other absorbing part is arranged covering the perforation aperture through which aperture the needle of the cannula assembly perforates the skin surface part of the person. The supporting elements are fixated relative to the intentional position of the bandage in relation to the cannula assembly 40 and the skin surface part of the person by sidely pressing the adhesive sections at opposite sides of the pads 18 against the person's skin surface part and the cannula assembly 40 is fixated relative to the bandage and further relative to the skin surface part by pressing the cannula assembly 40 against the adhesive layer of the double adhesive sheet 25 covering the upper surface of the double adhesive sheet 25 on top of the supporting element 18 on which the cannula assembly 40 is resting and supported. Thereupon, the release sheet 14 covering the second or upper surface of the cover sheet 12 of the bandage 10 is removed and the cover sheet 12 is folded over the cannula assembly 40 and the gripping tabs 22 and adhesively attached thereto, care being taken that the circular hole 30, if provided, is superposed the needle insertion area, so that members of the medical staff are allowed visual inspection thereto. In fig. lc, the cannula assembly 40 and the bandage 10 are illustrated after the fixation operation is terminated. As is evident from fig. lc, the cover sheet 12 covers the double sheet 25 in its entirety and provides a complete circumferential seal of the perforation aperture and further fixates in a reliable manner the cannula assembly 40 relative to the skin surface part of the patient. It is to be realized that the overall dimensions including the length and the width of the double adhesive sheet 25 are smaller than the corresponding dimensions of the cover sheet 12 allowing the cover sheet to circumferentially encircle the double adhesive sheet when adhering to the upper surface thereof and adhere to the skin surface of the person. The provision of a supporting element which is adhered to the skin surface of the person and on top of which the cannula assembly 40 is supported and adhered in combination with the folding of the cover sheet onto the supporting element and onto the cannula assembly 40 provides an almost complete circumferential fixation at the outer surface of the cannula assembly 40 and prevents the cannula assembly 40 from rotating and also from being shifted relative to the skin surface part of the person. Dotted lines A, B, C, D indicate possible different separation lines defining the end of contact between the top release sheet 16 and the adhesive sheet 25, as the adhesive sheet 25 may contain a more or less extended sheet-contacting end 24.

With respect to the left-right changeability of the bandage 10, although the first embodiment of the bandage according to the present invention is in use asymmetrical relative to the axis of symmetry of the cannula assembly (being perpendicular thereto), the symmetric shape of the supporting elements 18 and the gripping tabs 22 allows the application of the bandage with the cover sheet extending both laterally left and laterally right and allowing both right-hand and left-hand individuals to apply the bandage to the skin surface part of a patient or a person.

Fig, 2 is an exploded view of the first embodiment of the bandage shown in figs, la, lb and lc, illustrating the different components of the bandage 10: the top release sheet 16, the supporting element 18, the double adhesive sheet 25, the cover sheet 12, and the release sheet 14. From Fig. 2 it is seen that the release sheet 14 extends over the entire area of the bandage.

Figs. 3a, 3b, 3c are perspective and schematic views of a second embodiment 101 of the bandage 10' according to the present invention for fixating a cannula of a venous catheter relative to the skin surface parts of a person. The second embodiment of the bandage 10' for fixating a cannula of a venous catheter relative to the skin of a person resembles the first embodiment described in Figs, la, lb, lc and 2 in that it presents the same two-layer structure comprising a cover sheet and a double adhesive sheet, but differs from the first embodiment in three aspects: firstly, that two gripping tabs corresponding to the gripping tabs 22 illustrated in fig. la, lb, lc and 2 are designated 21 and 23, respectively, are not identical, the slit 20 being provided offset relative to the axis of symmetry of the bandage, thus creating a wider gripping tab 23 and a narrower gripping tab 21; secondly, that the cover sheet 12' and the release sheet 14' are provided with a lateral cutout 32 on the side of the wider gripping tab 23, which lateral cutout is contiguous with the exterior of the bandage; and thirdly, that the integral release sheet 14 of the first embodiment of the bandage 10 according to the present invention is divided into two release sheet parts, bottom release sheet part 14' covering the cover sheet 12' and a release sheet part 17 covering the double adhesive sheet 25. The wider configuration of the gripping tab 23 provides a larger support and contact area between the cannula assembly 40 and the gripping tab 23, as illustrated in fig. 3c, allowing a better adhesion and, consequently an improved fixation of the cannula assembly 40 relative to the skin. The cutout 32 provides better adhesion between the bandage 10' and the cannula assembly 40, the areas to the left and the right of the cutout being able in this configuration to cover both a larger skin area and a larger part of the side areas of the cannula assembly 40, thus limiting cannula displacements relative to the skin area. The cutout may also serve the purpose of indicating the member of the medical staff the extent to which he or she has to fold the bandage, the position of the cutout corresponding to the position of the inserted cannula.

Fig. 4 is an exploded view similar to the view of fig. 2 of the second embodiment of the bandage shown in figs. 3a, 3b and 3c illustrating the different components of the bandage 10": the top release sheet 16, the supporting element 18, the double adhesive sheet 25, the cover sheet 12', the release sheet part 14' and the release sheet part 17.

Fig. 5a is a perspective and schematic view of a third embodiment 10" of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person. The third embodiment of the bandage 10' differs from the above described embodiment by the absence of the narrower gripping tab 21 of the second embodiment 10'and the offset positioning of the hole 30 of the first embodiment 10. The remaining wider gripping tab is designated the reference numeral 23 and the hole is designated the reference numeral 30'. The absence of the narrower gripping tab together with the offset positioning of the hole 30' ensures visual inspection of the entire zone of insertion of the cannula needle 42, as total visual inspection is often required by members of the medical staff.

Fig. 5b is a perspective and partly cut-away view of the third embodiment 10" illustrating the bandage after the partial removal of the cover sheet on the adhesive side of the sheet.

Figs. 6a, 6b, 6c are perspective and schematic views of a fourth embodiment 50 of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person. Fig. 6a shows a cover sheet 52, a release sheet 56 with two gripping tabs 62, a supporting element 58, and a cover sheet 66. The fourth embodiment may, like the above described embodiments, be formed as a unitary structure. The longitudinally symmetrical bandage assembly 50 has a first, interior cutout portion 60 extending from about the centre of the cover sheet 12 to the vicinity of the supporting element 18 and a second cutout portion 61 at the end of the bandage 10 starting from the supporting element 18, contiguous with the exterior of the bandage and forming the two gripping tabs 62. The rounded T-shape of the first cutout 60, narrow inside the rectangular part of the sheet 52 and extended in the vicinity of the supporting element 58 allows, as seen in Fig. 6b, the placement of a cannula 40 on the supporting element 58 with the needle 42 pointing outwards from the bandage 50 and the folding of the bandage 50 over the cannula 40 so that the areas around the narrow portion of the first cutout 60 conform with the side areas of the cannula 40 and the sheet 12, ensuring adhesion between the cannula 40 and the bandage 10. Optionally, to ensure visual access to the point of insertion 42 of the cannula needle, the sheet 12 may be provided with a centrally placed hole 30" shown in dotted line in Fig. 6b.

Fig. 7a is a perspective and schematic view of a fifth embodiment of a bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person. The bandage 70 comprises a cover sheet 72 which is of a substantially rectangular configuration extending into a gripping tab section 82 shaped in the form of the letter F, to which a supporting element 78 is adhesively attached, the cover sheet 72 and the supporting element 78 being covered by a top release sheet 76 and adhered to an cover sheet 74. The cover sheet has a central, longitudinal cutout 80 extending from the edge opposite the gripping tab 82 towards the central part of the cover sheet 72 and an optional hole 30'".

Fig. 7b is a perspective view of the fifth embodiment 70 of the bandage shown in fig. 7a seen from the lower or second side of the cover sheet 72, with the cover sheet 74 partly removed and exposing the adhesive material of the cover sheet 72, and supporting a winged valve/cannula assembly 40' in an intermediate stage of a fixation operation. The cannula assembly 40' comprises a plug 43 for controlling the flow of fluid into the cannula and two wings 41 for preventing the rotation of the cannula relative to its longitudinal axis after the cannula needle has been introduced in a vein of the person. The cannula wings 41 are seen to rest on the broad, top portion of the F-shaped gripping tab 82, whereas the insertion point of the cannula needle lies under the shorter portion of the F-shaped gripping tab 82.

Fig. 7c is a perspective view of the fifth embodiment 70 of the bandage shown in the figs. 7a and 7b supporting the cannula assembly 40' in the final stage of the fixation operation where the rectangular part of the cover sheet 72 covers the gripping tab 82 and the corresponding part of the cannula assembly 40', which underlying elements are visualised by phantom lines. The central, longitudinal cutout 80 leaves the protruding part of the cannula assembly 40' comprising the plug 43 uncovered by the sheet 72 and allows the sides of the sheet 72 to adhere tightly and on a larger area to the cannula wings 41 and the skin of the patient.

Fig. 7d is a perspective and partly cut-away view of the embodiment of Fig. 7a, illustrating the cannula 40 supported thereupon. Fig. 7d shows that the fixation of the cannula 40 of the conventional non-winged shape is also possible by means of the fifth embodiment 70.

Fig. 8a is a perspective and schematic view of a sixth embodiment 10'" of a bandage according to the present invention, which embodiment is similar in shape to the first embodiment 10 of Fig. la, but here the intermediate double adhesive sheet 25 is lacking. Thus, the bandage assembly 10'" comprises an integral cover sheet 12" of a rectangular form extending into a longitudinally split lobed section forming two gripping tabs 22, the supporting element 18 adhesively attached to the sheet 12", and a release sheet 14" covering the cover sheet 12". The bandage 10'" is provided with adhesive only on one side, which apparently makes the fixation of the bandage by folding the rectangular portion of the bandage over the gripping tabs impossible, but the provision of two transversal slits 33 in the sheet 12" allows the end part of the sheet 12" opposite the gripping tabs 22 to be twisted 180° so that it can adhere to the non-adhesive side of the gripping tabs 22 which keeps the cannula assembly 40 in place, as can be seen in Fig. 8b. A hole 30 placed centrally in the twisted sheet side is optionally provided, ensuring visual inspection of the cannula insertion area.

Fig. 9 is a perspective view of a preferred method of producing the first embodiment 10 of a bandage according to the present invention, according to which a system of rollers feed and attach to each other by superposition a series of layers of material. Roller 90 feeds release sheet 14, roller 92 feeds cover sheet 12 which contains an adhesive layer on its underlying side, roller 94 feeds double adhesive sheet 25 which overlaps cover sheet 12 partially, roller 96 feeds supporting element 18 which adheres to double adhesive sheet 25, and roller 98 feeds top release sheet 16 which covers the double adhesive sheet 25, the supporting element 18 and a portion of the cover sheet 12. The resulting multilayer structure is thereafter fed through a stamping machine which shapes the multilayer material into the desired profile.

Fig. 10a is a perspective and schematic view of a seventh embodiment 10 IV of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person, which embodiment is basically similar to the third embodiment shown in

IV figs. 5a and 5b. The seventh embodiment 10 comprises a cover sheet 112 connected to a laterally placed gripping tab 122 constituted by a double adhesive sheet which is provided with an adhesive on both sides and supports a pad 118 and a release sheet 124. The cover sheet 112 is provided with an offset, substantially rectangular hole 130, which hole is covered by a transparent sheet, and also provided with a lateral cutout 108 having the same width as the hole 130 and being provided on the same side as the gripping tab 122. The substantially rectangular hole 130 has rounded corners and its position on the cover sheet 112 corresponds to the cannula insertion area and overlies said area when the cover sheet 112 is folded over the cannula-supporting gripping tab 122. The absence of a second gripping tab together with the offset positioning of the hole 130 ensures visual inspection to the entire zone of insertion 42 of the cannula needle assembly 40. Fig. 10b illustrates the application of the embodiment of Fig. 10a in connection with a cannula, and the fact that the lateral cutout 108 provided in the cover sheet 112 provides a narrow strip 110 which ensures compliance of the adhesive side of the cover sheet 112 with the cannula 40 and, consequently, adhesion.

Fig. 11a is a perspective and schematic view of an eighth embodiment 10 of the bandage according to the present invention for fixating a cannula of a venous catheter relative to the skin surface of a person. The

10V eighth embodiment is similar in the cannula-gripping area to the second embodiment shown in Figs. 3a and 3b, and to the seventh u embodiment 10 shown in Figs. 10a and 10b. Thus, the eighth embodiment is provided in the cannula-gripping area with two gripping tabs 122 of different width and in the opposite, rectangular area of the cover sheet 112 with an optional, rectangular hole 130 and a lateral cutout. As described in connection with Figs. 3a, 3b and 3c, the wider configuration of one of the gripping tabs 122 provides a larger support and contact area between the cannula assembly 40 and the gripping tab, allowing better adhesion and, subsequently, fixation of the cannula relative to the skin. The cutout provides better adhesion between the bandage 10^v and the cannula assembly 40, due to the better compliance of the strip 110 with the cannula assembly contours, and limits cannula assembly displacements relative to the skin area. The cutout and the hole may also serve the purpose of indicating the member of the medical staff the extent to which he or she has to fold the bandage, the position of the cutout or the hole when folding the bandage corresponding to the position of the inserted cannula. Fig. lib is a perspective view of the embodiment of Fig. 11a, illustrating its application in connection with a cannula.

Exampl e

The bandage shown in figs. 10a and 10b was made from the following materials: The cover sheet 112 was made from a non-woven polyamide sheet

2 of approx. 45 g/m . The overall length of the cover sheet 112 was 60 mm and the overall width of the maximum lateral dimension of the cover sheet 112 was 45 mm. The adhesive material applied to the cover sheet 112 was a medical grade acrylic adhesive. The double adhesive sheet constituting the gripping tap 122 was a polyethylene foil coated on both sides with a medical grade acrylic adhesive. The supporting element 118 was a thermal bonded viscose-rayon fiber supporting element and of a thickness of 1.1 mm and measuring 16 mm x 12 mm. The transparent sheet covering the rectangular hole 130 was a semi -permeable polyurethane sheet. The adhesives of the bandage were covered by a sil iconized release paper.

Although the present invention has been described above with reference to specific, presently preferred embodiments of the bandage according to the present invention, the present invention is, however, by no means to be construed as limited to the above embodiments, as numerous modifications, combinations and amendments are readily perceivable by a person having ordinary skill in the art, within the scope of the present invention as defined in the appended claims.

Claims

PATENT CLAIMS

1. A bandage for fixating a cannula of a venous catheter relative to a skin surface part of a person, said cannula being positioned obliquely relative to said skin surface part and perforating said skin surface part in a perforation aperture, comprising: a supporting element to be arranged adjacent to said perforation aperture and below said cannula for supporting said cannula in a position resting on said supporting element, a connecting foil defining a cover foil area, a cover sheet of a foil material having opposite first and second surfaces and defining a first end, said first surface of said cover sheet defining an area substantially exceeding said cover foil area, and an adhesive material applied to said first surface of said cover sheet, said connecting foil being connected to said cover sheet at said first end thereof and constituting an extension thereof, said supporting element being connected to and supported by said connecting foil, said connecting foil defining a transition area between said supporting element and said cover sheet, a folding line being defined within said transition area, said cover sheet being foldable onto said supporting element along said folding line for covering said cannula supported by and resting on said supporting element, for covering said perforation aperture, and for arranging said first surface of said cover sheet facing towards said supporting element, covering said supporting element and said connecting foil, adhering to said skin surface part and fixating said cannula onto said supporting element.

2. The bandage according to claim 1, said connecting foil being constituted by a separate foil component, or alternatively said connecting foil being integral with said cover sheet.

3. The bandage according to any of the claims 1 or 2, said supporting element being constituted by a first absorbing pad.

4. The bandage according to any of the claims 1-3, said cover sheet adhering to said skin surface along at least a part of the perimeter of said connecting foil .

5. The bandage according to any of the claims 1-4, said connecting foil being provided with an adhesive covering a surface thereof coextensive with said first surface of said cover sheet.

6. The bandage according to any of the claims 1-5, said connecting foil being provided with an adhesive covering at a surface thereof opposite to said first surface of said cover sheet.

7. The bandage according to any of the claims 1-6, said supporting element being provided with an adhesive covering for causing said cannula to adhere to said supporting element.

8. The bandage according to any of the claims 1-7, said supporting element being provided with an adhesive covering for adhering said supporting element to said skin surface part of said person.

9. The bandage according to any of the claims 1-8, further comprising a second absorbing pad to be arranged covering said perforation aperture.

10. The bandage according to claim 9, said second absorbing pad being constituted by a separate absorbing pad component.

11. The bandage according to claim 4 and 9, said first absorbing pad and said second absorbing pad being made from the same absorbing pad material .

12. The bandage according to claim 11, said second absorbing pad being separated from said first absorbing pad through a slit cut through said absorbing pad material.

13. The bandage according to any of the claims 1-12, said cover sheet having a transparent area allowing visual inspection of said perforation aperture.

14. The bandage according to any of the claims 1-13, said folding line extending substantially parallel with said cannula when said bandage is applied to said skin surface part of said person and said cover sheet being foldable substantially transversly relative to said cannula when folded onto said supporting element.

15. The bandage according to any of the claims 1-13, said folding line extending substantially transversly relative to said cannula when said bandage is applied to said skin surface part of said person and said cover sheet being foldable along the longitudinal orientation of said cannula when folded onto said supporting element.

16. The bandage according to claim 15, said cover sheet being foldable along said folding line from said perforation aperture towards said supporting element.

17. The bandage according to claim 15, said cover sheet being foldable along said folding line from said supporting element towards said perforation aperture.

18. The bandage according to any of the claims 1-17, further comprising a release foil covering said adhesive material of said first surface of said cover sheet.

19. The bandage according to any of the claims 1-18, said cover sheet being of a rectangular configuration; a quadratic configuration, a circular configuration, an elliptic configuration or a combination of the above configurations.

20. The bandage according to any of the claims 1-18, said cover sheet being made of a water-permeable material.

21. The bandage according to any of the claims 1-18, said cover sheet being made of a water- impermeable material.