Catheter fixing device

Abstract

To provide a fixing device for fixing a catheter on the skin of a patient.SOLUTION: A fixing device includes: a base body having a rear lower surface configured so as to be arranged on the skin; a fixing element arranged on the base body and configured so that a catheter hub of the catheter is fixed by shape engagement and / or fixed by press engagement so that the catheter hub can be fixed to the base body; and a guide recessed part arranged on a distal side on the base body with respect to the fixing element, having guide walls extending in a proximal and distal direction over a guide length and opposed to each other in an internal and external side direction. The guide recessed part is configured to receive a slender catheter tube part fixed on a distal side of the catheter hub of the catheter tube of the catheter. The catheter tube part can be guided between the guide walls over the guide length, and is protected against the buckling in the internal and external side direction.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates to a fixation device for fixing a catheter to a patient's skin. [Background technology]

[0002] A catheter typically has a flexible catheter tube extending between proximal and distal ends of the tube and a catheter hub secured to the proximal end of the tube.

[0003] To apply a catheter, the catheter tube is introduced into the patient's body through a skin puncture site with the distal end of the tube facing forward in a known manner, such as the Seldinger technique. The catheter hub, which remains outside the patient's body, serves to fluidly connect the catheter tube to other fluid carrying components, such as the catheter supply line. Furthermore, the catheter tube is typically not inserted into the patient over its entire length, but rather a portion of the catheter tube, also referred to as the free catheter length, remains outside the patient adjacent the distal side of the catheter hub.

[0004] After application, catheters are usually secured to the patient's skin in order to prevent inadvertent slippage of the catheter or unwanted withdrawal of the catheter tube from the puncture site with associated harm to the patient. Various securing devices are known for this purpose.

[0005] For example, fixation devices in the form of adhesive pads are known, which can be adhered to the skin and are designed to fix a catheter filter of the catheter to be fixed, without directly fixing either the catheter hub or the catheter tube. Such fixation devices are currently sold, inter alia, by the company B. Braun Melsungen under the name Perifix® PinPad or by the company Pajunk under the name FixoLong.

[0006] Furthermore, fixation devices are known which can also be adhered to the skin and are configured to fix the catheter hub of the catheter to be fixed. These fixation devices also do not provide fixation of the catheter tube adjacent to the distal side of the catheter hub. Such fixation devices are currently sold, inter alia, by the company Pajunk under the name FixoCath or by the company Bard Medical under the name StatLock®. Summary of the Invention

[0007] SUMMARY OF THE DISCLOSURE The object of the present invention is to make available a fixation device of the type mentioned above, which allows improving patient safety.

[0008] This object is achieved by a fixing device having the features of claim 1. Advantageous embodiments of the invention are the subject matter of the dependent claims, the texts of which are incorporated herein by reference. [Means for solving the problem]

[0009] The fixation device according to the invention comprises a base body, a fixation element and a guide recess. The base body has a proximal-distal longitudinal axis, a medial-lateral transverse axis and a front-to-rear longitudinal axis, and further comprises a rear lower surface. The rear lower surface is configured for at least indirect application to the skin of a patient. The fixation element is arranged on the base body and configured for form-fit and / or pressure-fit fixation of a catheter hub of a catheter. By means of the fixation element, the catheter hub is fixable and / or fastenable to the base body. The guide recess is arranged distal to the base body relative to the fixation element and extends in the proximal-distal direction over a guide length. The guide recess has guide walls facing in the medial-lateral direction. The guide recess is configured to receive an elongated catheter tube section of a catheter, which is fixed distal to the catheter hub. The catheter tube section is guideable between the guide walls over the guide length and is thus protected against buckling in the medial-lateral direction. The solution according to the invention primarily counteracts said lateral buckling or even folding of the catheter tube section and the associated harm to the patient. This allows for improved patient safety. Furthermore, improved patient comfort can be achieved. Guide recesses extending along the longitudinal axis, with the guide walls facing each other along the transverse axis, are present for this purpose. In the fixed state, the catheter tube section adjacent to the distal side of the catheter hub is arranged between said guide walls. In this way, the catheter tube section is held between the guide walls with limited mobility, at least in the medial-lateral and / or lateral direction, and is thus protected against buckling and even folding. The fixing element serves for releasably fixing the catheter hub to the base body. In the fixed state of the catheter, the catheter hub is fixed by the fixing element at least forward, i.e. relative to the base body against upward lifting. Alternatively or additionally, the catheter hub is fixed in the medial-lateral direction. For this purpose, the fixing element interacts with the catheter hub in a form-fitting and / or pressure-fitting manner. The fixing element is designed differently according to the various embodiments, for example as a clamping element, a latching element and / or a plug-in element.The base body can have essentially any suitable shape. It has a longitudinal axis, a transverse axis and a longitudinal axis. These axes are of course understood as geometric axes and form an orthogonal axis system. During use of the fixation device, the rear underside of the base body faces the patient's skin. For fixation, the rear underside is placed directly or indirectly on the skin. Fixation can be performed with the aid of plasters, bandages, etc. Alternatively, the base body can also be glued directly or indirectly to the skin. It is understood that the catheter to be fixed is not part of the fixation device. However, the invention also relates to the arrangement of a fixation device according to the invention and a catheter to be fixed or to be fixed according to the previous description.

[0010] The position and direction information used herein, such as proximal, distal, proximal-distal direction, medial, lateral, medial-lateral direction, anterior, posterior and anterior-posterior direction, are for ease of explanation and refer to the use state of the fixation device in which the fixation device may be placed on the patient's skin together with the catheter. "Distal" refers to the direction of the puncture site. "Proximal" refers to the direction away from the puncture site. "Rear" refers to the direction of the patient's skin below the fixation device. "Anterior" refers to the direction away from the skin. "Medial" and "lateral" refer to both opposite directions parallel to the skin below the fixation device. Alternatively or additionally, the designations "proximal" and "distal" refer to opposite directions along the longitudinal axis. The same applies to the designations "medial" and "lateral" as well as the designations "anterior" and "rear" relative to the longitudinal axis.

[0011] In one embodiment of the invention, the guide walls and / or the base body have length markings spaced apart from one another in the proximal-distal direction and distributed over the guide length, each length marking representing a defined length portion of the guide length, and the base body is cuttable at least in the area of ​​the length markings. This embodiment of the invention takes into account that the catheter tube sections, i.e. the free catheter length, can be of different lengths. Due to the fact that the available length markings and the base body are cuttable, the guide length, and thus the length of the guide recess and the guide wall, can be easily adapted to the proximal-distal length of the catheter tube section to be guided, in particular by shortening. The length markings are preferably distributed equidistantly. In different embodiments, the length markings are designed differently, for example as countersinks, bulges, numbers, letters, characters (including symbols), etc. The ability of the base body to be cut can be achieved in particular by suitable geometrical design and / or material selection. Preferably, the length markings form, so to speak, predefined separation points for a predefined cutting of the base body. Each predefined separation point forms a mechanical weakening of the base body.

[0012] In a further embodiment of the invention, the guide wall and / or the base body have predefined separation points that are spaced apart from one another in the proximal-distal direction and distributed over the guide length, each separation point forming a mechanical weakening and cuttable in a defined manner. This embodiment of the invention also takes into account that the length of the free catheter can vary depending on the application. By means of the predefined separation points, the guide length can be easily adapted to the length of the catheter tube section to which the guide is directed, in particular by shortening it. For this purpose, the base body is cut in a defined manner in the region of the predefined separation points, for example by the base body being torn, cut or otherwise divided in the region of one of the predefined separation points. Each of the predefined separation points forms a mechanical weakening. For this purpose, each of the predefined separation points can form a local reduction in wall thickness, a notch, etc. Furthermore, it is also conceivable and possible that the predefined separation points are provided in the form of perforations that can separate the base body at each separation point. Preferably, each of the predefined separation points forms a length marking that represents a defined length portion of the guide length at each separation point.

[0013] In a further embodiment of the invention, the guide walls are each formed by web elements spaced apart in the proximal-distal direction with an intermediate gap. The web elements form two web rows arranged opposite each other in the medial-lateral direction, i.e. along the transverse axis, each one of the web rows being assigned to one of the two guide walls. The web elements and / or the intermediate gap are preferably spaced apart equidistantly from each other. Preferably, the web elements and / or the gaps are each arranged in the front upper part of the base body. The web elements with an intermediate gap allow in particular an improved view of the catheter tube section received in the guide recess.

[0014] In a further embodiment of the invention, each gap arranged between the web elements serves as one of the length markings and / or one of the predetermined separation points. With regard to the properties and functions of the length markings and / or the predetermined separation points, the descriptions relating to the previous embodiment apply by analogy and, to avoid repetition, explicit reference is made to these descriptions.

[0015] In a further embodiment of the invention, the guide length in the proximal-distal direction is between 10 mm and 60 mm, preferably between 40 mm and 50 mm. The above-mentioned value range of the guide length was found to be particularly consistent with the requirements for effectively counteracting the outward buckling of the catheter tube section. If the guide wall and / or the base body are provided with length markings and / or predefined break points, the guide length can be adapted in the above-mentioned manner. For example, the guide length, which in this case is 60 mm, can be shortened to 10 mm, intermediate values ​​are of course also possible according to the available length markings and / or predefined break points.

[0016] In a further embodiment of the invention, the fixing element and the guide recess are respectively arranged at the front upper part of the base body. The upper part is located opposite the lower part along the longitudinal axis. When the fixation device is in use, the upper part faces away from the patient's skin. By arranging the fixing element and the guide recess at the upper part of the base body, the visibility of the fixation part of the catheter is improved. This allows for an improved detection of incorrect fixation.

[0017] In a further embodiment of the invention, the fixing element and the guide recesses, respectively, are front-opening, so that the catheter hub and the catheter tube section, respectively, can be inserted rearwardly into the fixing device. Due to the fixing element being open at the top, the catheter hub can be inserted rearwardly along its longitudinal axis, i.e. from the top downwards, into the fixing element in a simple and ergonomic manner, as can the insertion of the catheter tube section into the guide recesses. Furthermore, this embodiment allows for an advantageous distribution of the forces acting on the patient's skin during the insertion of the catheter hub and the catheter tube section.

[0018] In a further embodiment of the invention, the fixing element and the guide recess are respectively rearwardly opening, so that the fixing device can be attached to the catheter hub and the catheter tube section in the rearward direction. The guide recess is downwardly opening along the longitudinal axis, so that the fixing device can be attached to the catheter tube section in the rearward direction, i.e. from above downward along the longitudinal axis. The same applies to the fixing element for the catheter hub. This is a particularly preferred embodiment of the invention. In particular, in contrast to the previous embodiment, the rearwardly open design of the guide recess and the fixing element allows the fixing to be performed while avoiding little or even completely manipulating the already applied catheter. In short, the fixing device in this embodiment of the invention can be applied from above downwards on top of the already applied catheter. In contrast to this, in the conventional embodiment, the already applied catheter must first be manually lifted off the skin. The fixing device can then be pushed under the latter while the catheter is lifted, and the catheter can be inserted into the fixing device from the rear.

[0019] In a further embodiment of the invention, the underside has a recess extending in the proximal-distal direction over the entire length of the base body, dividing the base body into an inner body half and an outer body half and formed partly by a guide recess, the two base body halves being connected to each other, preferably elastically movably, at least by a fixing element. With this embodiment of the invention, the fixing device can be attached in the rearward direction to an already applied catheter in a particularly simple and ergonomic way. The recess extends continuously along the longitudinal axis, preferably along the longitudinal axis, between the rear underside and the front upper part of the base body. This also preferably applies to the guide recess forming part of said recess. The inner body half and the outer body half are opposite each other along a transverse axis. This elongated recess preferably forms a line of symmetry. Preferably, the base body is mirror-symmetrical with respect to the elongated recess. The inner body half and the outer body half are connected to each other at least by a fixing element. It will be understood that there may be further transverse connections between the two halves of the body. In a preferred embodiment, there is a flexure bearing connecting the body halves, which is preferably formed by a fixing element, by which the two body halves are hingedly, preferably elastically, connected to one another in a limited range of movement. In this case, the relative movement between the body halves takes place around a virtual articulation axis oriented parallel to the elongated recess. In such a design, the two body halves can be rotated away from one another to simplify the application of the fixing device to an already applied catheter. The pivoting movement of the two body halves widens the guide recess in the medial-lateral direction. After application, an opposite pivoting movement is performed, and the catheter hub is fixed by the fixing element in a form-fitting and / or pressure-fitting manner, so that the catheter tube section is again guided into the narrowed guide recess.

[0020] In a further embodiment of the invention, there is a stop element arranged proximally relative to the fixing element on the base body, which can actively limit at least the proximal mobility of the catheter hub and / or the fluid-carrying components of the catheter attached to the catheter hub. The stop element serves as a tension relief for proximally directed pulling forces. In this way, unintentional withdrawal of the catheter tube from the puncture site can be countered in a further improved manner. To limit the proximal mobility of the catheter hub, the stop element preferably actively interacts directly with the catheter hub. Alternatively or additionally, the stop element actively acts directly on said components, such that the mobility of the catheter hub is indirectly actively limited.

[0021] In a further embodiment of the invention, the base body is made of a dimensionally stable plastic material. In particular, sufficient mechanical strength is achieved in this way. Despite being manufactured from a dimensionally stable plastic material, the base body can be designed to be dimensionally flexible by corresponding design, in particular by corresponding dimensions of its wall thickness.

[0022] In a further embodiment of the invention, the base body is designed thin along its longitudinal axis with respect to its proximal-distal extent and its medial-lateral extent and / or in the form of a planar plate in the proximal-distal and medial-lateral directions. Due to the thin and / or plate-like design of the base body, the base body is relatively close to the patient's skin during use. This increases the comfort of the patient. Furthermore, the thin and / or plate-like design prevents the base body from catching on the patient's clothing or the like and thus being moved inadvertently. Furthermore, this embodiment allows a particularly advantageous distribution of the forces acting on the patient's skin during insertion of the catheter hub and the catheter tube section. This is particularly evident when the fixing element and the guide recess, respectively, are forwardly opening, so that the catheter hub and the catheter tube section, respectively, can be inserted in the rearward direction into the fixing device.

[0023] In a further embodiment of the invention, there is a dimensionally flexible cushion body, to whose front upper part the base body is applied firmly and whose rear underside is configured to be placed on the skin, in particular the contact surface formed by the underside of the cushion body is 1.2 to 3.0 times, preferably 1.5 to 2.5 times, larger than the underside of the base body. By means of a dimensionally flexible cushion body, the comfort of the patient can be further improved. For this purpose, the cushion body is arranged between the patient's skin and the base body relative to the longitudinal axis and is dimensionally flexible. The improvement of the comfort of the patient is achieved by the dimensional flexibility of the cushion body. In a preferred embodiment, the cushion body consists of a foamed plastic material and / or is elastic. In this embodiment of the invention, during the use of the fixation device, the underside of the base body is applied only indirectly to the skin. The actual contact surface of the fixation device is formed by the underside of the cushion body. This surface is preferably larger than the underside of the base body by a factor within the abovementioned values. As a result of this, the pressure load on the skin is reduced. This further improves the comfort of the patient.

[0024] In a further embodiment of the invention, there is an adhesive coating applied to the underside of the base body, which is configured for releasably attaching the fastening device to the skin. The adhesive coating can be arranged directly on the underside of the base body. If a cushion body is present, the adhesive coating is preferably arranged on its underside. In the delivered state of the fastening device, the adhesive coating is preferably covered by a release film. After the film has been peeled off, the fastening device can be applied to the patient's skin with the adhesive coating facing forward and thus attached in a releasable manner. This allows a particularly simple fastening without the use of other auxiliary tools. [Brief description of the drawings]

[0025] Further advantages and features of the present invention will become apparent from the following description of preferred exemplary embodiments of the invention, as illustrated in the claims and the drawings. [Figure 1] 1 is a schematic plan view of one embodiment of a fixation device according to the present invention for fixating a catheter. [Diagram 2] FIG. 2 is a schematic side view of the fixation device according to FIG. 1; [Diagram 3] FIG. 3 is a schematic plan view of a catheter that can be fixed by the fixation device according to FIGS. 1 and 2 . [Figure 4] FIG. 4 is a schematic plan view of an example of a situation in use in which the catheter according to FIG. 3 is fixed on the skin of a patient by means of the fixation device according to FIGS. 1 and 2; [Diagram 5] 3 is a schematic plan view of a further embodiment of a fixation device according to the invention; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] According to figures 1, 2 and 4, a fixation device 1 is provided for fixing a catheter 100 (figure 3) to the skin S of a patient. The fixation device 1 is suitable for fixing conventional catheters, for example of the kind used in infusion therapy, blood transfusion therapy and / or pain therapy.

[0027] The catheter 100 shown by way of example in FIG. 3 has a structure known to those skilled in the art. The catheter 100 comprises a catheter tube 101 extending between a distal catheter tube end 102 and a proximal catheter tube end 103. In the region of the distal catheter tube end 102, the catheter tube 101 comprises a lumen (not shown in detail) which opens into a catheter outlet 104. The catheter outlet 104 allows the ejection of medical fluids from the lumen of the catheter tube 101 and the aspirating of bodily fluids or other fluids into the lumen. The catheter 100 also comprises a catheter hub 105. The catheter hub 105 is rigidly connected to the proximal tube end 103. The catheter hub 105 mainly serves to fluidly connect the catheter tube 101 to further fluid-carrying components, such as the catheter supply line 200 (see FIG. 4). The catheter tube 101 is made of a flexible plastic material. The resulting deformability of the catheter tube 101 is indicated in FIG. 3 by dashed lines. It will be appreciated that the design of the catheter 100 shown in FIG. 3 is greatly simplified and is purely illustrative.

[0028] The fixing device 1 comprises a base body 2 , a fixing element 3 and a guide recess 4 .

[0029] The base body 2 has a longitudinal axis L, a transverse axis Q and a longitudinal axis H. These axes L, Q, H form a Cartesian coordinate system and are mutually orthogonal. The longitudinal axis L is oriented in the proximal-distal direction. The transverse axis Q is oriented in the medial-lateral direction. The longitudinal axis H is oriented in the anterior-posterior direction.

[0030] With respect to the use situation of the fixation device 1 shown in Fig. 4, said position and orientation information can be understood as follows: "distal" means in the direction of the distal catheter tube end 102 and / or the catheter outlet 104, "proximal" means in the direction away from the distal catheter tube end 102 and / or in the direction of the proximal catheter tube end 103, "rear" means in the direction of the patient's skin S, "forward" means in the direction away from the skin S, and "inner" and "outer" mean two opposite directions parallel to the patient's skin S. It will be understood that said position and orientation information is not strictly necessary for a complete understanding of the underlying invention, but merely serves the purpose of a brief explanation.

[0031] The base body 2 also has a lower surface 5 configured to rest at least indirectly on the skin S (see FIG. 2).

[0032] The fastening element 3 is arranged on the base body 2 and serves for form-fit and / or pressure-fit fastening of the catheter hub 105 of the catheter 100 to be fastened. The fastening element 3 is accordingly configured and in the illustrated embodiment is designed in the manner of a latch element. Alternatively, the fastening element can also be designed as a plug-in and / or clamp element. As a result, the catheter hub 105 can be latched, clamped and / or plugged into the fastening element 3 for the purpose of fastening the catheter hub 105 to the base body. The design details of the fastening element 3 in this respect are not essential in the context of the invention. It is only important that the fastening element 3 is configured for form-fit and / or pressure-fit fastening of the catheter hub 105. The fastening element 3 interacts directly with the catheter hub 105 for this purpose and has, for example, a latch, clamp and / or plug-in shape designed to complement the shape of the catheter hub 105. The fastening element 3 is configured to be releasably fastened, so that, if necessary, a previously fastened catheter hub can be released again from the base body 2 at any time.

[0033] The guide recess 4 is arranged on the base body 2 and extends along a longitudinal axis L over a guide length F. In the present embodiment, the guide recess 4 is parallel to the longitudinal axis L. The fixing element 3 is arranged at the proximal end of the guide recess 4 (not shown in detail). The guide recess 4 has two guide walls 6, 7 facing each other along a transverse axis Q. In the present embodiment, the guide walls 6, 7 can also be referred to as the inner guide wall 6 and the outer guide wall 7, or vice versa. The guide recess 4 is configured to receive a catheter tube section 101' of the catheter tube 101. The catheter tube section 101' to be received originates from the catheter hub 105 and / or the proximal catheter tube end 103 and extends distally. In other words, the catheter tube section 101' that can be received by the guide recess 4 is directly adjacent to the catheter hub 105. In other words, the catheter tube section 101' to be received is the proximal part of the catheter tube 101. The catheter tube portion 101 ′ can be guided between the guide walls 6 , 7 of the guide recess 4 .

[0034] In the context of use of the fixation device 1 shown in FIG. 4, the catheter 100 is applied in a manner known to those skilled in the art. To apply the catheter 100, the catheter tube 101 is inserted, with the distal catheter tube end 102 forward, through the puncture site P into the patient's skin S and the underlying body tissue. This can be done, for example, by a method known as the Seldinger technique. The catheter hub 105 remains outside the patient and is spaced proximally from the puncture site P. Furthermore, the catheter tube 101 is not inserted completely through the puncture site P, and at least the catheter tube section 101' directly distal from the catheter hub 105 remains outside the patient. The catheter tube section 101' is often also referred to as the free catheter length. Depending on how far the catheter tube 101 is advanced distally from the puncture site P, the length of the catheter tube section 101' will vary.

[0035] In the illustrated use situation of the fixation device 1, the base body 2, preceded by the underside 5, is applied (at least indirectly) to the skin S and releasably connected to the skin S in a manner that will be described in more detail. The catheter hub 105 is releasably fastened to the base body 2 by the fixation element 3, in this case by being hooked to the fixation element 3. In the illustrated embodiment, the catheter hub 105 is fixedly held in a form-fitting and / or pressure-fitting state relative to the base body 2 at least along the transverse axis Q and along the longitudinal axis H. Furthermore, the catheter hub 105 in this case is held in a form-fitting and / or pressure-fitting state by the fixation element 3 at least in the distal direction, along the longitudinal axis L.

[0036] Furthermore, the catheter tube section 101' is received in the guide recess 4 and guided between its guide walls 6, 7, so that it is protected against buckling at least in the medial-lateral direction. In the illustrated embodiment, an unspecified lateral distance between the guide walls 6, 7 is dimensioned such that the catheter tube section 101' is held with limited mobility between the guide walls 6, 7 along its radial, i.e. lateral, axis Q. As a result, the catheter tube section 101' is not clamped or elastically deformed by the guide walls 6, 7. In a non-illustrated embodiment, the lateral distance between the guide walls can be dimensioned such that the guide recess exerts a clamping effect on the catheter tube section.

[0037] In the illustrated embodiment, the guide recess 4 and thus the guide walls 6, 7 have a guide length of 50 mm. In a not illustrated embodiment, the guide length is between 10 mm and 60 mm, preferably between 40 mm and 50 mm.

[0038] In the illustrated embodiment, the guide walls 6, 7 do not extend continuously and / or uninterrupted throughout the guide length F. The guide walls 6, 7 are formed by web elements 61 to 67 and 71 to 77, respectively, spaced apart from one another in the proximal-distal direction.

[0039] The web elements 61 to 67 are assigned to the inner guide wall 6 and can therefore also be called inner web elements.

[0040] The web elements 71 to 77 are assigned to the outer guide wall 7 and can therefore also be called outer web elements.

[0041] Web elements 61 to 67 and 71 to 77 are spaced equidistant proximally from one another over the guide length F.

[0042] In the illustrated embodiment, the webs each have a length of 5 mm. In a non-illustrated embodiment, the webs each have a length of 5 mm to 20 mm. The gap (not numbered) between two adjacent web elements in the proximal-distal direction is dimensioned accordingly. The guide walls 6, 7 run parallel to each other, as do the mutually opposing inner web elements 61 to 67 and outer web elements 71 to 77.

[0043] In the illustrated embodiment, the gaps disposed between the web elements function as length markings M1 through M6 and / or predetermined separation points B1 through B6, respectively.

[0044] The length markings M1 to M6 formed by the gaps each represent a defined length portion of the guide length F. The length markings M1, M2 can also be referred to as the first length marking M1 and the second length marking M2. The same applies to the designation of the further length markings M3 to M6. The first length marking M1 represents the first guide sub-length F1. The third length marking M3 represents the third guide sub-length F3. The same applies to the further length markings. In other words, the length markings M1 to M6 form a defined division of the length of the guide recess 4 and its guide walls 6, 7.

[0045] As mentioned above, the gaps (without reference numbers) alternatively or additionally form the predetermined separation points B1 to B6. The predetermined separation points B1 to B6 each form a local mechanical weakening of the base body 2. These local mechanical weakenings allow a clean cut of the base body 2 at said predetermined separation points B1 to B6. In this embodiment, the mechanical weakening is provided by a reduction in the material thickness of the base body 2 in the region of the gaps. At the points of the reduced material thickness, i.e. at the gaps and / or the predetermined separation points B1 to B6, the base body 2 can therefore be cut very easily. For example, the base body 2 can be cut by hand or with a cutting tool or the like. Tearing is also conceivable and possible. Alternatively or additionally, the length markings M1 to M6 and / or the predetermined separation points B1 to B6 can be formed at the respective points by perforations in the base body 2, which perforations run parallel to the transverse axis Q. The predetermined separation points B1, B2 can also be referred to as the first predetermined separation point B1 and the second predetermined separation point B2. The same applies to the designation of the further predetermined separation points B3 to B6.

[0046] The length markings M1 to M6 and / or the predefined separation points B1 to B6 allow the guide length to be easily adapted to the actual free length of the catheter tube 101 and in particular to be shortened. In comparison with the use situation shown in FIG. 4, if the catheter tube 101 is advanced further distally through the puncture site P, the guide length can be easily shortened by cutting the base body 2 at a position suitable for this purpose. For example, the guide length F can be shortened to a guide sub-length F1 by cutting the base body 2 at the gaps formed between the web elements 61 and 62, 71 and 72 (length markings M1, predefined separation points B1). If the catheter tube 101 is advanced further distally, the base body 2 can be shortened, for example, to a third guide sub-length F3. For this purpose, the base body 2 is cut in a predefined manner at the gaps located between the guide webs 63, 64 and 73, 74 (third length markings M3, third predefined separation points B3).

[0047] In the embodiment shown in Figures 1, 2 and 4, the guide recess 4 and the fixing element 3 each open in the forward direction. Through the respective front openings, the catheter hub 105 and the catheter tube section 101' can each be inserted in the rearward direction into the fixing device 1. More specifically, in this embodiment, the catheter hub 105 is latched onto the fixing element 3 from above, and the catheter tube section 101' is inserted into the guide recess 4 from above. For fixing purposes, the already applied catheter 100 is lifted forward and away from the skin S. The fixing device 1 is pushed, preferably laterally, under the lifted catheter 100 and applied to the skin S. The lifted catheter 100 can then be lowered and inserted into the fixing device 1 in the manner described above.

[0048] In the embodiment shown in Figures 1, 2 and 4, the fixing element 3 and the guide recess 4, respectively, are arranged in a front upper part 8 of the base body 2. In other words, the guide walls 6, 7 and the fixing element 3, respectively, protrude forward from the base body and / or its upper part 8.

[0049] In this embodiment, the fixation device 1 also comprises a stop element 9. The stop element 9 is arranged on the base body 2 and is spaced proximally from the fixation element 3 and / or the guide recess 4. The stop element 9 is configured to actively limit the proximal mobility of the catheter hub 105. In other words, the stop element 9 serves as a direct or indirect stop for the catheter hub 105. In this way, the stop element 9 serves as a strain relief and counteracts the proximal withdrawal of the catheter tube 101 from the puncture site P.

[0050] In the illustrated embodiment, the stop element 9 directly interacts with the proximal end of the catheter hub 105 (not shown in detail). To limit mobility, the stop element 9 contacts said proximal end of the catheter hub 105. In a not illustrated embodiment, the stop element interacts instead with the catheter supply line 200 (FIG. 4). The stop element 9 is located on the upper portion 8 of the base body 2 and protrudes forward therefrom.

[0051] In the embodiment shown, the base body 2 is designed in the form of a plate 10 extending planarly in the proximal-distal and medial-lateral directions. The plate 10 can also be called a base plate. In this example, the base body 2 is therefore relatively thin along the longitudinal axis H and has a low material thickness compared to its planar extent.

[0052] In the present embodiment, the base body 2 is elongated along the longitudinal axis L and relatively slender along the transverse axis Q. It is also symmetrical with respect to the longitudinal axis L and thus with respect to the guide recess 4. It will be understood that the design of the entire fastening device 1, and in particular the base body 2, shown in the figures is to be regarded as purely exemplary.

[0053] Furthermore, the fixation device 1 comprises a cushion body 11, which in this embodiment is dimensionally flexible. The cushion body 11 has a front upper part 12 and a rear lower surface 13. The cushion body 11 is arranged between the base body 2 and the skin S with respect to the longitudinal axis H and serves as a soft elastic support for improving the comfort of the patient. The base body 2 is rigidly connected to the upper part 12 of the cushion body 11. The lower surface 13 of the base body 2 is configured to be arranged on the skin S. Thus, in this embodiment, the lower surface 5 of the base body 2 lies only indirectly on the skin S. In the illustrated embodiment, the cushion body 11 is an extension of an elastic plastic material. The cushion body 11 can therefore also be referred to as a foam or foam support. The lower surface 13 of the cushion body 11 is larger than the lower surface 5 of the base body 2. As a result, the surface load on the skin S is reduced. In the illustrated embodiment, the contact surface (without reference number) formed by the lower surface 13 of the cushion body 11 is 2.5 times larger than the surface area of ​​the lower surface 5 of the base body 2. In an embodiment not shown, this factor is between 1.2 and 3.0.

[0054] For the purpose of fastening, in this embodiment the base body 2 is glued to the cushion body 11. However, basically other joining techniques for fastening the base body 2 to the cushion body 11 are conceivable and possible.

[0055] In the illustrated embodiment, the underside 13 of the cushioning body 11 also has an adhesive coating 14. The adhesive coating 14 is configured to releasably adhere the fastening device 1 to the skin S. The adhesive coating 14 may be made of a glue suitable for this purpose. In an embodiment not illustrated, the fastening device does not have a cushioning body, and therefore the underside of the base body 2 lies directly on the skin. In this embodiment, the underside of the base body 2 may be provided with an adhesive coating. In the delivered state of the fastening device 1, the adhesive coating 14 is covered with a film (not illustrated in detail). This film can be peeled off.

[0056] Figure 5 shows a further embodiment of the fixation device 1a. In terms of its structure and function, the fixation device 1a according to Figure 5 is substantially identical to the fixation device 1 according to Figures 1, 2 and 4. In order to avoid repetition, only the main differences between the fixation device 1a according to Figure 5 and the fixation device 1 according to Figures 1, 2 and 4 are described below. Otherwise, what has been disclosed with respect to the fixation device 1 also applies to the fixation device 1a, and therefore explicit reference is made to what has been said with respect to the embodiment according to Figures 1, 2 and 4.

[0057] The fixation device 1a differs from the fixation device 1 mainly in that the guide recesses 4a and the fixation elements 3a are rearwardly opening, allowing the fixation device 1a to be applied from above downwards along the longitudinal axis H onto an already applied catheter 100.

[0058] In this embodiment, the fixation device 1a has a recess 15a extending in the proximal-distal direction, which divides the base body 2a into an inner body half 16a and an outer body half 17a. The recess 15a in this embodiment extends over the entire length of the base body 2a. In this embodiment, the guide recess 4a forms part of the recess 15a.

[0059] The fixing device 1a comprises an optional cushion body 11a, which is also divided into two body halves 18a, 19a by a recess 15a, which in this case extends over the entire length of the cushion body 11a.

[0060] The inner and outer body halves 16a, 17a of the cushion body 11a are symmetrical with respect to the longitudinal axis L and / or the recess 15a. The same applies analogously for the two body halves 18a, 19a of the cushion body 11a.

[0061] The two body halves 16a, 17a of the base body 2a are in this case connected to one another by a fixing element 3a which bridges the guide recess 15a along the transverse axis Q and is connected at one end to the inner body half 16a and at the other end to the outer body half 17a.

[0062] The fixing device 1a comprises an optional stop element 9a, which in this embodiment bridges the recess 15a and forms an additional mechanical connection between the two body halves 16a, 17a.

[0063] In this embodiment, the stop element 9a has a gripping portion 20a which serves to facilitate handling of the fastening device 1a. The gripping portion 20a is arranged on the outside of the stop element 9a along the transverse axis Q and can be grasped, for example, between the thumb and index finger of a hand.

[0064] In the illustrated embodiment, the fixing element 3a and the stop element 9a function in the manner of an articulation between the two body halves 16a, 17a, in other words, the fixing element 3a and / or the stop element 9a form a flexure bearing between the two body halves 16a, 17a, allowing a pivotal movement about the longitudinal axis L.

[0065] By gripping the grip part 20a between the thumb and index finger, the body halves 16a, 17a are pivoted forward towards each other, in this embodiment about the longitudinal axis L. In this way, the guide walls 6a, 7a are moved away from each other relative to the transverse axis Q, which widens the guide recess 4a. In this way, the fixation device 1a can be applied in a simplified manner to an already applied catheter 100. With an appropriate selection of materials, the hinge properties are in this embodiment elastic, such that the body halves 16a, 17a automatically pivot towards each other about the longitudinal axis L after the fingers are released from the grip part 20a.

[0066] In a non-illustrated embodiment, the fixation elements and the guide recesses are open on both sides relative to the longitudinal axis, such a design allows the fixation device to be applied behind an already applied catheter, or conversely, the catheter can be inserted into the fixation device by lifting and lowering it backwards.

Claims

1. A fixing device (1, 1a) for fixing a catheter (100) to the skin (S) of a patient, comprising: a base body (2, 2a) having a proximal-distal longitudinal axis (L), a medial-lateral transverse axis (Q), and an anterior-posterior longitudinal axis (H), the base body having a posterior lower surface (5, 5a) configured for placement on the skin (S); a fixing element (3, 3a), the fixing element (3, 3a) being arranged on the base body (2, 2a) and configured for a form-fit and / or pressure-fit fixation of a catheter hub (105) of the catheter (100), whereby the catheter hub (105) is fixable relative to the base body (2, 2a); a guide recess (4, 4a) arranged on the base body (2, 2a) distally with respect to the fixing element (3, 3a), extending in the proximal-distal direction over a guide length (F) and having guide walls (6, 6a, 7, 7a) facing each other in the medial-lateral direction, The guide recess (4, 4a) is configured to receive an elongated catheter tube portion (101') of the catheter (100) fixed distally to the catheter hub (105), the catheter tube portion (101') being guideable between the guide walls (6, 6a, 7, 7a) over the guide length (F) and protected against buckling in the medial-lateral direction, said catheter tube portion (101') being configured to receive an elongated catheter tube portion (101') of the catheter (100) fixed distally to the catheter hub (105), said catheter tube portion (101') being guideable between the guide walls (6, 6a, 7, 7a) over the guide length (F) and protected against buckling in the medial-lateral direction, said catheter tube portion (101') being guideable between the guide walls (6, 6a, 7, 7a) over the guide length (F).

2. 2. The fixation device (1, 1a) according to claim 1, characterized in that the guide walls (6, 6a, 7, 7a) and / or the base body (2, 2a) have length markings (M1 to M6) spaced apart from one another in the proximal-distal direction and distributed over the guide length (F), each of the length markings representing a defined length portion of the guide length (F), and the base body (2, 2a) is cuttable at least in the region of the length markings (M1 to M6).

3. 2. The fixation device (1, 1a) according to claim 1, characterized in that the guide walls (6, 6a, 7, 7a) and / or the base body (2, 2a) have predetermined separation points (B1 to B6) spaced apart from one another in the proximal-distal direction and distributed over the guide length (F), each of the predetermined separation points forming a mechanical weakening and being cuttable in a predefined manner.

4. 2. The fixation device (1, 1a) according to claim 1, characterized in that the guide walls (6, 6a, 7, 7a) are formed by web elements (61 to 67, 71 to 77) spaced apart in the proximal and distal direction, respectively, with an intermediate gap.

5. The fastening device (1, 1a) according to claim 4 and claim 2, characterized in that the gaps arranged between the web elements (61 to 67, 71 to 77) each form one of the length markings (M1 to M6) and / or one of the predetermined separation points (B1 to B6).

6. 2. The fixation device (1, 1a) according to claim 1, characterized in that the guide length (F) in the proximal-distal direction is between 10 mm and 60 mm, preferably between 40 mm and 50 mm.

7. The fixing device (1, 1a) according to any one of claims 1 to 6, characterized in that the fixing element (3, 3a) and the guide recess (4, 4a) are respectively arranged in a front upper part (8, 8a) of the base body (2, 2a).

8. 2. The fixation device (1) according to claim 1, characterized in that the fixation element (3) and the guide recess (4) are each forwardly opening, so that the catheter hub (105) and the catheter tube section (101'), respectively, can be inserted in the rearward direction into the fixation device (1).

9. 2. The fixing device (1a) according to claim 1, characterized in that the fixing element (3a) and the guide recess (4a), respectively, are rearwardly opening, so that the fixing device (1a) can be attached to the catheter hub (105) and to the catheter tube section (101') in the rearward direction.

10. 10. The fixing device (1a) according to claim 9, characterized in that the underside (5a) of the base body (2a) has a recess (15a) which extends in the proximal-distal direction over the entire length of the base body (2a) and divides the base body (2a) into an inner body half (16a) and an outer body half (17a) and which is partly formed by the guide recess (4a), the two body halves (16a, 17a) being connected to one another at least by the fixing element (3a), preferably in a resiliently movable manner.

11. 2. The fixing device (1, 1a) according to claim 1, characterized in that there is a stop element (9, 9a) on the base body (2, 2a) which is arranged proximally with respect to the fixing element (3, 3a), by means of which the mobility at least in the proximal direction of the catheter hub (105) and / or of a fluid carrying component (200) of the catheter (100) attached to the catheter hub (105) can be actively limited.

12. 2. The fastening device (1, 1a) according to claim 1, characterized in that the base body (2, 2a) is made of a dimensionally stable plastic material.

13. 2. The fixation device (1, 1a) according to claim 1, characterized in that the base body (2, 2a) is designed thin along the longitudinal axis with respect to its proximal-distal extent and its medial-lateral extent and / or in the form of a planar plate (10, 10a) in the proximal-distal and medial-lateral directions.

14. 2. The fixing device (1, 1a) according to claim 1, characterized in that there is a dimensionally flexible cushion body (11, 11a) on whose front upper part (12, 12a) the base body (2, 2a) is firmly applied and whose rear lower surface (13, 13a) is arranged to be placed on the skin (S), in particular in that the contact surface formed by the lower surface (13, 13a) of the cushion body is 1.2 to 3.0 times, preferably 1.5 to 2.5 times, larger than the lower surface (5, 5a) of the base body.

15. 2. The fastening device (1, 1a) according to claim 1, characterized in that there is an adhesive coating (14, 14a) applied to the underside (5, 5a) of the base body (2, 2a), the adhesive coating (14, 14a) being configured for releasably attaching the fastening device (1, 1a) to the skin (S).

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