Medical device for fixing and redirecting a catheter tube

Abstract

A medical device (100) configured to fix and redirect a catheter tube (CT), wherein the device comprises the following mutually attached layers: - a carrier layer (10) with an adhesive upper side (10a) which is configured to adhesively hold the catheter tube (CT) and has an adhesive surface (A1) with dimensions which allow for redirection of the catheter tube (CT); - an adhesive layer which is configured to adhere the carrier layer (10) to a skin, such as to the neck of a patient.

Description

[0001] MEDICAL DEVICE FOR FIXING AND REDIRECTING A CATHETER TUBE

[0002] The present invention relates to a medical device for fixing and redirecting a catheter tube, more specifically a catheter tube arrangeable in jugular position.

[0003] An exemplary catheter is a central venous catheter. This can be inserted at different locations, such as in the upper arm, in the chest or in the neck. Hereby, the central venous pressure can be measured and direct access can be provided to the bloodstream for medications and nutrition.

[0004] Nevertheless, there are possible complications and risks that may occur when arranging and inserting a catheter, such as the central venous catheter.

[0005] A risk is possible injury to the patient, such as damage to the vascular wall, which could result in thrombosis and / or perforation of the vascular wall. It is therefore important for the catheter to remain firmly in place where needed. It can however be challenging to secure a catheter securely enough, especially when attempting not to limit the patient's comfort (too much).

[0006] A challenging location to provide a catheter securement is particularly the neck of the patient, since perspiration, hair growth and movement may cause a typical securement with conventional plasters to detach. Conventional techniques for catheter securement and particularly for central venous catheter securement therefore provide securement via suturing, but this impacts patient comfort.

[0007] A possible complication is that catheters bend or kink, resulting in an altered flow pattern, a kink can thus for instance limit the liquid flow.

[0008] An altered flow pattern can furthermore also cause thrombosis.

[0009] The invention has for its object to reduce complications and risks that may occur in arranging and inserting of a catheter, such as a central venous catheter.

[0010] The invention provides for this purpose a medical device configured to fix and redirect a catheter tube. The device comprises the following mutually attached layers. an optional protective layer; a carrier layer with an adhesive upper side and preferably an adhesive underside. The adhesive upper side is configured to adhesively hold the catheter tube, in particular the adhesive upper side is configured to adhesively hold and redirect the catheter tube. The adhesive upper side further preferably has an adhesive surface with dimensions which allow for redirection of the catheter tube; an optional information layer which preferably comprises one or more markings; an adhesive layer, particularly a hydrocolloid adhesive layer which is configured to adhere the carrier layer to a skin, such as to the neck of a patient; an optional backing;

[0011] The invention is based on the inventive insight that the above stated complications and risks can be reduced by providing an adhesive surface which allows for the redirection of the catheter tube, whereby the tube can be stabilized at a different and typically more favourable location. An impact on patient comfort is limited to a minimum in this way. The device can thus for instance be secured to the neck, close to the location where the catheter tube is inserted, in simple manner using the adhesive layer (without suturing), and the tube can be further stabilized at a second location on the chest. In addition, the adhesive upper side of the carrier layer with adhesive surface provides the option for different types of catheter to be redirected. This is because catheters can have different sizes and, owing to the adhesive property of the adhesive surface of the carrier layer, different catheters can be received and be fixed and guided without or with minimal damage to or impact on the patient, such as without sutures. The fixation and guidance further ensure that the catheter remains stably in place close to the insertion location so that the risk of damage due to undesirable movements remains limited.

[0012] Any suitable type of adhesive layer can be used, examples being an adhesive layer on the basis of one of rubber, silicone, acrylic or combinations thereof. The adhesive layer is particularly a hydrocolloid adhesive layer. The hydrocolloid adhesive layer ensures that the carrier layer can be secured to the skin without sutures (stitches), this being beneficial to the comfort of the patient. The hydrocolloid adhesive layer also provides for an improved adhesion to skin surfaces with hair growth (such as beard growth).

[0013] It will be apparent that the carrier layer and the adhesive surface of the adhesive upper side can have many forms, as long as the dimensions are large enough and allow the catheter tube to be redirected easily, particularly without sharp bends or kinks which could limit the potential of flow through the catheter.

[0014] In an embodiment a first edge of the carrier layer is provided with a cut-out. The cut-out can be provided in any suitable manner and increases the chances of a correct redirection of the catheter tube. The cut-out preferably extends inward over a distance di with a size in the range of 7-80%, more preferably 10-70%, still more preferably 15-60% of a width Bd of the carrier layer and / or wherein distance di has a size of at least 2 mm, preferably at least 3 mm, more preferably at least 5 mm, such as 7 mm. This increases the chances of a correct redirection of the catheter tube still further, since (venous) catheters should ideally not run in twisted or kinked manner.

[0015] The first edge of the carrier layer preferably lies at a distance drfrom the nearby edge of the adhesive layer and optionally also the edge of the information layer, wherein this distance dris smaller than 4.5 mm, more preferably smaller than 3.5 mm, still more preferably smaller than 3 mm. In this way the device provides a greater utility of an end portion of the catheter which may have a limited available length.

[0016] The cut-out preferably has a contour which is at least partially parallel to a second edge opposite the first edge or wherein the contour of the cut-out has the same shape as an edge of the carrier layer other than the first edge. For instance wherein the edge of the carrier layer other than the first edge has an arcuate form, and wherein the cut-out follows this arcuate form. In this way a desired redirection of the catheter tube can be realized.

[0017] In a preferred embodiment the cut-out has a contour in the shape of an arcuate form, and wherein the contour of the carrier layer has along an edge other than the first edge an arcuate form. The arcuate forms increase the chances of the catheter tube being arranged on the carrier layer without twists and / or kinks. This has the advantage that the flow pattern is maintained and / or remains constant, for instance when the patient moves. The danger of thrombosis can be reduced by providing a correct flow pattern. In a preferred embodiment the cut-out extends inward over a distance di which is at most 80% of the width Bd of the carrier layer, preferably at most 75%, more preferably at most 60% and / or which is at least 10%, preferably at least 15%, more preferably at least 20% of the width Bd of the carrier layer.

[0018] The width Bd of the carrier layer can be seen as the smallest dimension of a rectangular two- dimensional plane having a minimum size and comprising the carrier layer. The length Ld of carrier layer can be seen as the largest dimension of the surface comprising the carrier layer with a minimum size.

[0019] The whole device which is adhered to the skin preferably has limited dimensions, particularly a maximum length of at most 12 cm, preferably at most 10 cm, still more preferably at most 8 cm, such as a length of about 4 cm and / or width of at most 11 cm, preferably at most 9 cm, still more preferably at most 7 cm, such as a width of about 3 cm. In this way the negative impact on patient comfort is minimal.

[0020] The adhesive surface preferably has dimensions which are configured to allow an arcuate redirection of the catheter tube, wherein the arcuate form preferably has a radius n of at least 0.9 cm, preferably at least 1 cm, more preferably at least 1.5 cm. A good flow pattern for different types of catheter tube is ensured in this way. For larger catheter tubes it is best to opt for a sufficiently large radius n of the arcuate form, so that the risk of undesired bends or kinks in the tube is precluded.

[0021] The adhesive surface of the carrier layer is preferably a substantially flat adhesive surface. In this way different types of catheter can be fixed and redirected on the surface of the carrier layer. One and the same device can hereby be used for different types of catheter (of different sizes).

[0022] The carrier layer is preferably a double-sided adhesive film. This for reasons of advantages in terms of production engineering and in order to provide a desired internal cohesion of the device.

[0023] In a preferred embodiment the adhesive surface of the carrier layer has a form chosen from the group comprising: a U-shape, a half donut shape, an arcuate form. In this way the chances of correct redirection are increased and the chances of undesired kinks or twists are reduced. The adhesive layer, and particularly the hydrocolloid layer, preferably has rounded corners. This means corners that are not 90°. This provides for a better securement of the hydrocolloid layer to the skin.

[0024] The carrier layer preferably has rounded corners. This can reduce the chances of the carrier layer coming loose.

[0025] The carrier layer preferably has an overall surface area which is smaller than the overall surface area of an underlying layer, such as the hydrocolloid layer or an optional information layer. This enhances patient comfort and it is thus also ensured that any markings on the optional information layer are visible.

[0026] In an embodiment the device has an overall length Lt and the carrier layer has a length Ld. The length Ld preferably has a size in the range of 50-98% of the overall length Lt of the device, preferably in the range of 60-95%. This ensures that the longitudinally extending edge zones of the device are better able to follow the form of the patient’s skin.

[0027] In an embodiment the device has an overall width Bt and the carrier layer has a width Bd. Width Bd preferably has a size in the range of 50-98% of the overall width Bt, preferably in the range of 60-95%. This ensures that the transversely extending edge zones (transversely of the longitudinal direction of the device) of the device are better able to follow the form of the patient’s skin.

[0028] In an embodiment the hydrocolloid layer comprises a mixture of one or more adhesives such as polyisobutene and gelling and / or absorbent components such as gelatine, pectin and carboxymethylcellulose. The hydrocolloid layer can further contain one or more elastomeric materials. An exemplary hydrocolloid layer is manufactured with an adhesive on the basis of polyisobutene and one or more of gelatine, pectin and carboxymethylcellulose. In this way securement to the skin is realized with minimal impact on patient comfort. The hydrocolloid layer can comprise a support layer which is made of polyurethane. With the support layer the dimensional (spatial) strength of the layer can be increased.

[0029] The hydrocolloid layer preferably contains adhesives and / or an adhesive material which provide for a high tack so that the device can stay stuck to the skin of the patient properly. The adhesive strength of the layer is also described by the inventors as Hi-Tech. Such hydrocolloid adhesive layers are sufficiently known and commercially available. Adhesives for use in medical applications are described in: Mcnichol, Laurie & Lund, Carolyn & Rosen, Ted & Gray, Mikel. (2013). Medical Adhesives and Patient Safety: State of the Science Consensus Statements for the Assessment, Prevention, and Treatment of Adhesive- Related Skin Injuries. Orthopaedic nursing / National Association of Orthopaedic Nurses. 32. 267-281.

[0030] In a determined embodiment the adhesive layer has a peel strength of between 1-14 N, preferably 2-12 N, as measured using test method ASTM DI 876 (version applicable to 2019) at 12 in / min. This ensures a particularly good adhesion to the skin, which is advantageous when adhering the medical device onto difficult-to-adhere-to surfaces such as a skin with beard growth and / or folds.

[0031] In an embodiment the device further comprises a first backing which is arranged on the adhesive layer, particularly the hydrocolloid adhesive layer, on a side remote from the carrier layer. The first backing (lower backing) can thus protect the adhesive layer during transport. The backing preferably comprises a pull-tab so that it is easily removable, even with medical protective gloves.

[0032] More preferably, a second backing is further also provided, this being arranged on the adhesive layer, particularly the hydrocolloid adhesive layer, on the side remote from the carrier layer. The first backing is arranged on a first part of the adhesive layer and the second backing is arranged on a second part of the adhesive layer. Arranging of the device on the skin can be facilitated in this way.

[0033] Preferably further provided is a protective layer which is connected removably to the carrier layer and covers this carrier layer. This enables the adhesive surface of the carrier layer to be protected. The protective layer is preferably transparent, such that the carrier layer is visible.

[0034] The medical device is preferably free of latex, more specifically, the adhesive layer is free of latex.

[0035] A further aspect of the invention provides a kit comprising a catheter arrangeable in jugular position and a medical device configured to fix and redirect the catheter tube, wherein the device has one or more features as described above. The kit can further comprise an attaching means such as an attaching device for securing the catheter onto the skin at a different location. A further aspect of the invention provides an assembly for holding a catheter arrangeable in jugular position. The assembly comprises:

[0036] - the medical fixation device described here for securing the catheter to the skin at a first location, typically close to an insertion location of the catheter, such as the neck.

[0037] - an attaching device which is configured to secure the catheter to the skin at a second location, such as the chest.

[0038] The assembly preferably further comprises a catheter arrangeable in jugular position. The medical fixation device ensures that the catheter remains arranged correctly while the attaching device allows the tube to be further stabilized at a different and typically more favourable location. This enables the risk of damage to the vascular wall to be reduced and ensures patient comfort. The first location close to the insertion location typically lies within a distance of 20 cm, more preferably within 15 cm from the insertion location, for instance a location on the neck close to the position where the catheter is inserted. The second location typically lies further away from the insertion location than the first location, for instance a location on the chest, such as just below the shoulder.

[0039] Any suitable attaching device can in principle be used. An example of an attaching device is a device provided with a clamping means for holding the catheter tube and adhesive for securing the clamping means to the skin.

[0040] The attaching device is preferably a device with one or more features as described in W02022002870A1 in the name of applicant.

[0041] Brief description of the figures

[0042] The invention will now be further described on the basis of several drawings illustrating embodiments of the invention.

[0043] Figure 1 shows an exemplary embodiment of a medical device as seen in exploded perspective view.

[0044] Figure 2 shows the medical device of figure 1 as seen in cross-sectional side view.

[0045] Figure 3 shows a second exemplary embodiment of a medical device as seen in exploded perspective view. Figure 4 shows the medical device of figure 3 as seen in cross-sectional side view.

[0046] Figure 5 shows the medical device of figure 1 as seen in top view.

[0047] Figure 6 shows an operating principle of the medical device of figure 1.

[0048] In the figures the same or similar features have the same reference numeral.

[0049] In the shown embodiments the same or similar features with the same reference numeral have the same advantages.

[0050] Extensive description

[0051] Figure 1 shows a medical device comprising a plurality of layers. The device has the following order of layers, as seen from top to bottom:

[0052] - an (optional) protective layer 50 (on the upper side - distally of the skin side);

[0053] - a carrier layer 10;

[0054] - an (optional) information layer 20 which preferably comprises or provides one or more markings;

[0055] - an adhesive layer 30, preferably a hydrocolloid adhesive layer which is configured to adhere carrier layer 10 to the skin;

[0056] - an (optional) backing 40 (on the underside - proximally of the skin side).

[0057] The terms “under” and “upper” can be understood here in the sense that the underside refers to a position or side close to (proximally of) the skin when the device is arranged thereon. The upper side refers to the side of the device remote from (distally of) the skin. The device typically takes the form of a laminate with a plurality of mutually attached layers.

[0058] Figure 1 and figure 5 show a medical device 100 with the carrier layer 10 with adhesive upper side 10a and adhesive underside 10b. The adhesive underside adheres the carrier layer to an underlying layer, particularly the optional information layer 20 or the adhesive layer 30. The adhesive upper side 10a is able to adhesively hold the catheter tube CT (as can be seen in figure 5 or 6). The adhesive upper side further has an adhesive surface Ai with dimensions which allow for redirection of the catheter tube. It will be apparent that the carrier layer can have different forms and therefore dimensions, as long as a redirection of the catheter tube, particularly without acute bends or kinks which may limit the potential of flow through the catheter, is possible. An example of a carrier layer with a suitable form and dimensions is shown in figure 1. Carrier layer 10 has a first edge Ila with cut-out 12. The cut-out can be provided in any suitable manner and, by delimiting the adhesive surface, increases the chances of a correct redirection of the catheter tube. Cut-out 12 extends inward over a distance di (as can be seen most clearly in figure 5) with a size in the range of 7-80%, such as about 40%-50%, of the width Bd of carrier layer 10. The inward cut contributes to a guided redirection of the catheter, this further reducing the chances of it being placed with a sharp bend or kinks. In an embodiment distance di has a size of at least 2 mm, preferably at least 3 mm, more preferably at least 5 mm, such as 7 mm and / or a size of at most 40 mm, preferably at most 30 mm, more preferably at most 20 mm, most preferably at most 15 mm.

[0059] It is further shown that cut-out 12 has a contour 12a. The contour is partially parallel to the second edge 11b of carrier layer 10. The second edge 11b is the edge of the carrier layer opposite the first edge Ila. In the shown embodiment a segment of contour 12a runs parallel to the second edge of the carrier layer.

[0060] The contour 12a of the cut-out can also have the same form as the edge of the carrier layer other than the first edge Ila. The edge (edges 11c, 11b, lid) of the carrier layer other than the first edge Ila preferably has an arcuate form (not shown). In that case the cut-out 12 preferably has a (similar) arcuate form, the contour 12a then having the shape of a smaller arch. The arcuate forms have the advantage that a redirection of the catheter tube CT without kinks is enhanced.

[0061] Cut-out 12 is preferably formed such that contour 12a or a segment thereof is shaped like an arch. The opposite edge (edges 11c, 11b, lid) of carrier layer 10 preferably has a corresponding form. The contour of edge 11c, 11b, lid can thus have an arcuate form with a radius which is at least 2 or 3 times greater than the radius of the arcuate form of cut-out 12. Carrier layer 10 can for instance have a half donut shape.

[0062] Figure 1 further shows that carrier layer 10 has an adhesive surface Ai which is substantially flat, the upper side of the carrier layer more specifically being flat so that different types of catheter tube can be fixed on the adhesive surface Ai of carrier layer 10. The whole upper side of carrier layer 10 is preferably provided with an adhesive property, for instance with an adhesive agent such as an adhesive. Carrier layer 10 has an overall upper surface area, the adhesive surface Ai preferably being equal to the overall upper surface area so that substantially the whole upper surface of carrier layer 10 has an adhesive property.

[0063] Figure 2 shows the medical device of figure 1 as seen in cross-sectional side view. The carrier layer has an upper side 10a and an underside 10b. The upper side has a surface which is configured to be adhesive such that a catheter tube can be secured thereto (as can be seen in figures 5 and 6). In the shown embodiment the underside 10b is attached to the upper side of information layer 20, for instance using an adhesive or by fusion.

[0064] The other side of the information layer itself is not typically adhesive. The information layer can be made of a woven polyester material or paper, optionally provided with one or more markings. It will however be apparent that woven or non-woven polymer or non-polymer textile materials can be used in other embodiments. The information layer can further be provided to impart some stability to the medical device, the information layer can thus be configured to impart a dimensional stability to a nearby adhesive layer. Carrier layer 10 can be arranged in the form of a double-sided tape, an adhesive being present on either side of the carrier layer.

[0065] Figure 2 further shows an adhesive layer 30 which is intended to adhere carrier layer 10 to the skin of the patient, and can contain a medical-grade adhesive which may or may not be draining, depending on the specific application. In some embodiments the lower adhesive layer can contain additional types of medical adhesive. In some embodiments the lower adhesive layer can also contain antibacterial or antimicrobial material, such as dynamic metal salts or oxides, or combinations thereof.

[0066] The adhesive layer can be a solid layer or can take the form of an intermittent layer, such as in the pattern of dots or strips. In a preferred embodiment adhesive layer 30 is a hydrocolloid layer. More specifically a hydrocolloid layer comprising a mixture of one or more adhesives such as polyisobutene and gelling and / or absorbent components and / or particles, such as gelatine, pectin and carboxymethylcellulose. Securement to the skin is in this way realized with minimal negative impact on patient comfort. The hydrocolloid layer can comprise a support layer which is preferably made of polyurethane, dimensional (spatial) strength can be imparted to the layer in this way.

[0067] Figure 2 shows that protective layer 50 is arranged on the upper side of carrier layer 10. The protective layer is removably connected and covers the carrier layer so as to protect it. The protective layer is for instance a protective film, such as a transparent film. The film can be made of a flexible polymer film material. The protective layer is preferably transparent, such that the underlying carrier layer 10 and the optional information layer 20 are visible.

[0068] Figure 2 further shows a lower backing 40 which is removably arranged. The lower backing covers the underside of adhesive layer 30 and is present before the device is arranged on the skin. Backing 40 can be manufactured in one piece or be divided into two or more adjacent or overlapping pieces (pieces 40a and 40b) in order to facilitate removal. The backing can be made of any suitable material, examples being paper, polymers such as high-density polyethylene, polypropylene, polyolefin or paper with silicone coating or combinations thereof. In a determined embodiment the backing is made of a polished, siliconized paper or another suitable material.

[0069] Figure 3 and figure 4 show an embodiment wherein the underside of adhesive layer 30 is covered with a first backing 40 and a second backing 41. The first backing 40 is provided with a fold line which divides the backing into a first and second part. The first part is arranged removably on adhesive layer 30 and the second part functions as pull-tab. The second backing 41 is further provided with fold line 41a which divides backing 41 into a first part 41b and second part 41c. The first part 41b is arranged removably on adhesive layer 30 and the second part 41c functions as pull-tab. In this way the device can be protected during transport and subsequently be easily arranged on the skin of a patient. The backings (see layers 40, 40a, 40b, 41) are typically made of the same material. The backing 40 can consist of different materials, including paper, polymers or combinations thereof. In an embodiment the backing can contain a polycarbonate material. Other suitable materials for the backing are for instance polyethylene, polypropylene, polyolefin or a silicone coated paper.

[0070] Figure 5 shows that cut-out 12 extends inward over a distance di. This distance is smaller than the maximum width Bd of carrier layer 10, and preferably amounts to at most 80% thereof. It is further preferred for distance di to be greater than 10% of width Bd of carrier layer 20. The shape of cut-out 12 thus enhances a correct redirection of the catheter tube CT. As described above, carrier layer 10 can have different forms. The width Bd of carrier layer 20 can typically be seen as the smallest dimension of a rectangular two-dimensional theoretical plane (not shown) having a minimum size and comprising the carrier layer. The length Ld of carrier layer 20 can be seen as the largest dimension of the theoretical surface comprising the carrier layer.

[0071] Figure 5 further shows that cut-out 12 has contour 12a, a segment of which is parallel to the second edge 11b opposite the first edge Ila of carrier layer 10. In other preferred embodiments the contour 12a of cut-out 12 has an arcuate form. The edge, see edges 11c, 11b, lid, of the carrier layer other than the first edge Ila preferably has an arcuate form. Preferably an arcuate form corresponding with the arcuate form of cut-out 12. In this way a desired redirection of the catheter tube can be realized and, moreover, the risk of (venous) catheters being arranged twisted or kinked on the adhesive surface is reduced.

[0072] Figure 5 further shows that the adhesive surface Ai has dimensions which allow for an arcuate redirection of the catheter tube CT. The arcuate form of the redirection preferably has a sufficiently large radius n, such as at least 0.9 cm, preferably at least 1 cm, more preferably at least 1.5 cm. For larger catheter tubes it is best to opt for a sufficiently large radius n of the arcuate form, so that the risk of undesired bends or kinks in the tube is precluded. A good flow pattern for different types of catheter tube is ensured in this way. The adhesive surface Ai on the upper side 10a of carrier layer 10 preferably has an arcuate form with dimensions which guide the catheter tube and allow for a redirection of the catheter tube without the catheter tube developing kinks which could adversely affect the flow pattern.

[0073] Figure 5 further shows that the upper surface of the optional information layer 20 is provided with several markings 21 which provide information for correctly redirecting the catheter tube. The outer corners of carrier layer 10 are rounded in order to reduce the risk of accidental detachment. It is also preferred for the corners of adhesive layer 30 and optionally the information layer 20 arranged thereon to be rounded in order to enhance patient comfort (not shown).

[0074] Figure 5 further shows that carrier layer 10 is smaller than the underlying layer 30. The overall surface area of the carrier layer is smaller than the overall surface area of an underlying layer (for instance hydrocolloid layer 30 or optional information layer 20). The overall length Lt of the device 100 as shown in figure 5 is greater than the length Ld of carrier layer 10. This ensures that the longitudinally extending edge zones of the device are better able to follow the form of the patient’s skin. The overall width Bt of the device is greater than the width Bd of carrier layer 10.

[0075] Figure 5 further shows distance drbetween the first edge Ila of carrier layer 10 and an edge of adhesive layer 30 and optional information layer 20. The distance drwhich is measurable between the nearby adjacent edge of adhesive layer 30 is preferably limited to 4.5 mm, more preferably limited to 3.5 mm, still more preferably limited to 3 mm. This improves the utility of the catheter CT (with optional limited length) and the arranging thereof at the position of the insertion location on the skin of the patient. In determined embodiments distance drhas a value lying between 0-10 mm, preferably one between 0.1-5 mm, more preferably 0.2-4 mm. If the edges of the carrier layer and the adhesive layer overlap, the distance dris substantially 0 mm.

[0076] Figure 6 shows a possible application of the medical device 100 described here. As shown, catheter C is a arranged in jugular position (in the neck). The catheter tube CT is secured very close to the insertion location of the catheter (represented by point PI) using medical device 100. The catheter tube CT is further held on the chest of the patient using attaching device 201. This is because the chest is a more favourable location than the neck for providing a stronger fixation. A fixation, even by means of suturing onto the chest, is additionally less uncomfortable for the patient.

[0077] The fixation and guidance of device 100 ensures that the catheter remains stably in place close to the insertion location PI so that the risk of damage due to undesirable movements of the catheter tube remains limited. The catheter tube CT is redirected using the carrier layer 10 so that it can further be secured onto the chest.

[0078] As shown in Figure 6, the catheter tube CT follows a path parallel to the skin during the redirection. More specifically and generally applicable herein, "the redirection" as described herein involves the catheter tube CT undergoing a reorientation without significant vertical movements relative to the patient's skin. Even more specifically, redirection as described herein involves a 180° ± 85° reorientation of the catheter. Such reorientation allows the catheter to be secured at the chest and inserted into the neck from a better position after being redirected.

[0079] Carrier layer 10 is secured to the skin using an adhesive layer, preferably a hydrocolloid adhesive layer. As shown, device 100 is optionally provided with an information layer with markings indicating a correct arrangement of the device and the placement of the catheter on the device.

[0080] An optional protective dressing (not shown) can be arranged once the device has been arranged and the catheter tube has been adhered thereto and redirected thereon. An example is a protective dressing formed from a transparent film.

[0081] The catheter tube can have different sizes depending on type, kind and intended application. The catheter tube can further be provided with one or more suture wings 202, preferably two suture wings. Two suture wings result in less discomfort on the skin and in a balanced securement. The suture wings are preferably located at a position distally of the insertion location of the catheter and at a location where the suture is less uncomfortable for the patient, such as a position further along on the chest. Using a suture wing 202 the catheter tube can be secured directly to the skin via stitching.

[0082] The attaching device 201 can be configured in any suitable manner, as long as it is able to hold the catheter tube and secure it to the skin sufficiently, preferably by clamping the catheter tube and securing it adhesively to the skin. The catheter tube can for instance be held by the attaching device 201, for instance using a clamping means. In a preferred embodiment the attaching device is configured correspondingly to the suture wing(s) of the catheter tube and configured to hold the suture wing(s). In this way the catheter can be connected via the suture wing(s) to the attaching device without having to put in a stitch.

[0083] Attaching device 201 can further comprise a system or can be configured to receive a system which is configured to enable leakage-free connections between the arranged catheter tube CT and further catheter tubes. For instance using a luer lock (also known as a luer taper). In this way the attaching device can form an intermediate station between the inserted catheter tube and further catheters, each with their own function. For instance further catheters intended to administer different types of nutrition and medication.

[0084] The device which is adhered to the skin preferably has limited dimensions, particularly a maximum length of at most 12 cm, preferably at most 10 cm, still more preferably at most 8 cm, such as a length of about 4 cm and / or width of at most 11 cm, preferably at most 9 cm, still more preferably at most 7 cm, such as a width of about 3 cm. In this way the impact on patient comfort is minimal.

[0085] The application shown in figure 6 is purely illustrative and it will be apparent that further applications are possible in which principles and advantages of the invention are useful, examples being application in catheters which are inserted at different locations, such as arm, groin, chest and so on.

[0086] The skilled person will appreciate on the basis of the above description that the invention can be embodied in different ways and on the basis of different principles. The invention is not limited to the above described embodiments. The above described embodiment or embodiments and the figures are purely illustrative and serve only to increase understanding of the invention. The invention is not therefore limited to the embodiments described herein, but is defined in the claims.

Claims

Claims1. A medical device (100) configured to fix and redirect a catheter tube (CT), wherein the device comprises the following mutually attached layers:- a carrier layer (10) ;- an adhesive layer which is configured to adhere the carrier layer (10) to a skin, such as to the neck of a patient; characterized in that the carrier layer (10) has an adhesive upper side (10a) configured to adhesively hold the catheter tube (CT) and has an adhesive surface (Ai) with dimensions which allow for redirection of the catheter tube (CT), wherein a first edge (Ila) of the carrier layer (10) is provided with a cut-out (12) that extends inward over a distance di with a size in the range of 7-80% of a width Bd of the carrier layer (10).

2. The device according to claim 1, wherein the adhesive layer is a hydrocolloid adhesive layer (30).

3. The device according to claim 1 or 2, wherein wherein the cut-out (12) extends inward over a distance di with a size in the range of 10- 70% of the width Bd of the carrier layer (10).

4. The device according to claim 1 , wherein the cut-out (12) extends inward over a distance di with a size in the range of 15- 60% of the width Bd of the carrier layer (10).

5. The device according to any one of the previous claims, wherein the cut-out (12) has a contour (12a) which is at least partially parallel to a second edge(11b) opposite the first edge (Ila) and / or wherein the contour of the cut-out has the same shape as an edge (11c, 11b, lid) of the carrier layer other than the first edge (Ila).

6. The device according to any one of the previous claims, wherein a contour of the cut-out (12) has an arcuate form and wherein the contour of the carrier layer (10) has along an edge (11c, 11b, lid) other than the first edge (Ila) an arcuate form.

7. The device according to any one of the previous claims, wherein the cut-out (12) extends inward over distance di which is at least 20% of the width Bd of the carrier layer (10).

8. The device according to any one of the foregoing claims, wherein the adhesive surface (Ai) has dimensions which are configured to allow an arcuate redirection of the catheter tube (CT), wherein the arcuate form preferably has a radius n of at least 0.9 cm, preferably at least 1 cm, more preferably at least 1.5 cm.

9. The device according to any one of the foregoing claims, wherein the adhesive surface (Ai) of the carrier layer (10) is a substantially flat adhesive surface.

10. The device according to any one of the foregoing claims, wherein the carrier layer is a double-sided adhesive film.

11. The device according to any one of the foregoing claims, wherein the adhesive surface (Ai) of the carrier layer has a form chosen from a U-shape, a half donut shape, an arcuate form.

12. The device according to any one of the foregoing claims, wherein the adhesive layer (30) has rounded corners.

13. The device according to any one of the foregoing claims, wherein the carrier layer (10) has rounded corners.

14. The device according to any one of the foregoing claims, wherein the carrier layer has an overall surface area which is smaller than the overall surface area of the adhesive layer.

15. The device according to any one of the foregoing claims, wherein the device (100) has an overall length Lt and wherein the carrier layer (10) has a length Ld with a size in the range of 50-98% of the overall length Lt, preferably in the range of 60-95%.

16. The device according to any one of the foregoing claims, wherein the device (100) has an overall width Bt and wherein the carrier layer (10) has a width Bd with a size in the range of 50-100%, preferably 50-98% of the overall width Bt, more preferably in the range of 60-97%.

17. The device according to any one of the foregoing claims, wherein the first edge (Ila) of the carrier layer (10) lies at a distance drfrom the nearby edge of the adhesive layer (30), wherein this distance dris smaller than 4.5 mm, more preferably smaller than 3.5 mm, still more preferably smaller than 3 mm.

18. The device according to any one of the foregoing claims and claim 2, wherein the hydrocolloid layer (30) comprises a mixture of one or more adhesives and gelling and / or absorbent components.

19. The device according to any one of the foregoing claims and claim 2, wherein the hydrocolloid layer comprises a support layer which is made of polyurethane.

20. The device according to any one of the foregoing claims, further comprising a first backing (40) which is arranged on the adhesive layer on a side remote from the carrier layer (10); wherein the backing preferably comprises a pull-tab.

21. The device according to the foregoing claim, which further comprises a second backing (41) which is arranged on the adhesive layer on a side remote from the carrier layer (10); wherein the first backing (40) is arranged on a first part of the adhesive layer and the second backing (41) is arranged on a second part of the adhesive layer.

22. The device according to the foregoing claim, wherein the first part and / or second backing (40, 41) has a fold line (41a) which divides the backing in question into a first part (41b) which is arranged on the adhesive layer and a second part (41c) which forms a pull-tab.

23. The device according to any one of the foregoing claims, further comprising a protective layer (50) which is connected removably to the carrier layer (10) and covers the carrier layer.

24. The device according to the foregoing claim, wherein the protective layer (50) is transparent such that the carrier layer is visible.

25. A kit comprising a catheter (C), preferably a catheter arrangeable in jugular position, and a medical device (100) according to any of the previous claims.

26. Assembly for holding a catheter (C) arrangeable in jugular position; wherein the assembly comprises:- the medical device (100) according to any one of the claims 1-24 for securing the catheter to the skin at a first location close to an insertion location of the catheter;- an attaching device (201) which is configured to secure the catheter to the skin at a second location.

27. Assembly according to the foregoing claim, wherein the assembly further comprises a catheter arrangeable in jugular position.

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