Cannula protection device

Abstract

The invention relates to a protective device for intravenous cannulas (4) with a connecting element (7) having two wings (13) and with a two-way stopcock valve (8). During assembly, this connecting element (7) is encompassed by a recess (10") located on the underside of the base plate (16) of the cannula support body (2) such that the intravenous cannula (4) is securely attached to the skin surface of the respective body part after being adhered, resisting tension, pressure, and rotation. Additionally, the connecting element (7) is secured against pressure and rotation by a recess (10) that is matched to its shape and height. The central part of the cannula support body (2), which is essentially shaped like a trapezoidal prism, is tunnel-shaped and rounded on all sides, as are the corners of the base plate (16). The fixation film (3), which covers the cannula (5), the insertion site, and the sheathed cannula (11), is self-adhesive on its underside and has a removable release liner.This is also the case with the cannula support (2). The transparent fixation film (3) and the cannula support (2) are made of flexible material, ensuring a snug fit against the skin of the respective body part. To facilitate application of the fixation film (3), it is provided with a circumferential border (14) and an attached tab (15). Both aids are removed after the fixation film (3) has been applied. The cannula support (2) is also provided with a viewing window (12) for checking the insertion site.

Description

I. Area of ​​application

[0001] The invention relates to a protective device for venous cannulas according to the preamble of claim 1. II. Technical background

[0002] Needle protectors serve as a kind of band-aid to protect the needle insertion site from contamination, as well as to protect the needle from tensile, compressive, and transverse stresses. These stresses are perceived as quite painful. Particularly if the needle gets caught on the bedclothes, it may even become dislodged, which can result in bleeding.

[0003] Various needle protection devices are already known. For example, EP 1 685 868 B1 describes a protection device that allows the connection element to be secured. However, its design is tailored to a special, grooved connection element. Furthermore, this design lacks a protective film for the puncture site.

[0004] The fixation system described in DE 36 43 985 A1 for securing catheters, cannulas, or the like consists of a sandwich-bonded lower and upper plaster. The lower plaster, consisting of a bacteria-proof skin film with a skin adhesion layer, is applied to the skin before the needle is inserted, which may complicate the insertion process.

[0005] Furthermore, US 2006 / 0 217 669 A1 discloses a device for attaching a blood vessel cannula to a body. This device has a fastening means for detachably attaching the device to the skin, preventing movement of the cannula. The device is also provided with a transparent adhesive film for observation and fixation of the cannula. It is also equipped with two self-adhesive wings to ensure greater hold.

[0006] However, the protective device is tailored to a specific catheter shape, is therefore designed completely differently and would therefore not be considered as a protective device for a venous catheter commonly used in this country with a two-way stopcock valve.

[0007] Likewise, the devices described in US 9 561 348 B2, WO 2020 / 214 856 A1 and WO 2020 / 160 318 A1, although they comprise individual elements of the protective device described in the present patent application, are not suitable as fastening means for venous cannulas according to the preamble of claim 1.

[0008] In addition, protective devices are known from DE 20 2006 007 541 U1, DE 10 2017 128 321 A1 and AT 009 187 U1, which, however, are also not suitable for indwelling cannulas with a two-way stopcock valve.

[0009] Finally, protective devices for indwelling cannulas with a two-way stopcock valve are also known from EP 3 380 182 B1 and DE 10 2022 001 026 A1, but these have disadvantages with regard to stability and protective effect compared to the device described here. III. Description of the inventionTechnical task

[0010] The object of the present invention is therefore to provide a cannula protection device for venous cannulas with a two-winged fixing device which is designed in such a way that the cannula can be fixed to a skin surface in a tension-, pressure- and rotation-resistant manner and that the puncture site is protected from contamination and can also be observed. Solution to the task

[0011] This object is achieved according to the invention by the features specified in claim 1. The subclaims contain advantageous further developments.

[0012] To solve this problem, it is planned that - the transparent fixation film is covered on its adhesive-coated underside in a known manner by a removable protective film, while on the upper side it has a border made of thin cardboard and a flap to cover the indentation in the fixation film, which serves as a stabilizer to facilitate application to the skin surface and is removed after attachment. In terms of its floor plan, the fixation film is narrower in area in the area of ​​the intended puncture site for the cannula than in the rest of the area and is designed in such a way that both the puncture site with the cannula and the covered part of the indwelling cannula can be covered and fixed by it. This fixes the indwelling cannula in such a way that it cannot be removed or at least can only be removed with the application of greater pulling force. The two-way stopcock valve lies above the associated indentation in the fixation film and thus remains free. - The underside of the cannula support body is also coated with adhesive and provided with a removable protective film. The cannula support body is designed to be flexible so that it sits flush when applied to a body part, preferably the arm. The cannula support body located in the middle section is designed so that the two-way stopcock valve fits into a corresponding recess so that it can withstand pressure and rotational forces. The height of the cannula support body, which is essentially designed like a trapezoidal prism, is matched to the height of the two-way stopcock valve. On its underside, the cannula support body has a recess to accommodate the coated part of the cannula. To ensure that the puncture site can be monitored for possible inflammation, the cannula support body is provided with a preferably circular recess in this area - opposite the two-way valve.The cannula support body is rounded on all four sides to prevent it from snagging on clothing, bedding, etc. To ensure the most stable attachment possible to the skin of a body part, the cannula support body also features a flexible base plate that extends laterally beyond the fixation film, thus increasing the holding force of the cannula protection device.

[0013] An embodiment according to the invention is described in more detail below by way of example.

[0014] They show: Fig. 1 a commonly used venous cannula in a top view when attached to an arm. Fig. 2 a fixing film with a border made of thin cardboard at the moment of application in a top view. Fig. 3 a fixing film at the moment of detaching the edge or border with attached flap in a top view. Fig. 4 a finished applied fixing film in a top view. Fig. 5 a cannula support body being placed on the fixation film in a top view. Fig. 6 the underside of a cannula protection body in an oblique view. Fig. 7 the underside of a cannula protection body with arranged venous cannula. Fig. 8 a fully installed needle protection device in an oblique view.

[0015] In Fig. 1 shows a venous cannula 4 with a cannula support body 2 having two wings 13. The venous cannula 4, which has a two-way stopcock valve 8, is located on an arm 9. The two wings 13 lie flat on the skin surface of the arm 9 and primarily serve the purpose of preventing twisting of the venous cannula 4 or the two-way stopcock valve 8.

[0016] In Fig. Figure 2 shows a transparent fixation film 3 with a surrounding edge 14 during application. The edge 14 and the attached tab 15 are made of thin cardboard and serve to facilitate installation. The fixation film 3 is wider in the area where it overlaps the indwelling cannula 4 than in the rest of the area. The fixation film 3 has an indentation 6 that accommodates the two-way stopcock valve. To facilitate installation, this indentation 6 is overlapped by the tab 15.

[0017] Fig. Figure 3 shows how the edge 14, which serves to facilitate the installation of the fixing film 3, can be removed. After the fixing film 3 has been applied and pressed into place, the edge 14 with the attached tab 15 is lifted with two fingers, while the fixing film 3 is held with two fingers of the other hand.

[0018] In Fig. Figure 4 shows the fixation film 3 in its assembled state. The fixation film 3 rests flush and firmly against the arm 9, with the connecting element 7 with the two-way stopcock 8 located within the recess 6 and thus remaining freely accessible. However, the two wings 13 of the connecting element 7, as well as the cannula 5 and the coated cannula 11, are covered by the fixation film 3.

[0019] The top view according to Fig. Figure 5 demonstrates the assembly process of the cannula support body 2. This has a recess 10 that serves to accommodate the two-way stopcock valve 8. On the opposite side, there is a viewing window 12 that serves to monitor the puncture site. The flexible cannula support body 2 is designed such that it has a tunnel in the central section and, in the remaining area, a similarly flexible base plate 16 that is essentially designed like two wings 13'. These wings 13' facilitate the placement of the cannula support body 2 and, on the other hand, serve to ensure a firm hold on the skin surface of the respective body part. The underside of the base plate 16 is designed to be self-adhesive, just like the underlying fixation film 3.

[0020] The oblique view according to Fig. Figure 6 shows the underside of the cannula support body 2 with the base plate 16. The recess 6 is—as mentioned—intended to accommodate the two-way stopcock valve. The recess 10' serves to accommodate the coated cannula 11, and the cutout serves as a viewing window 12 for monitoring the puncture site. The recess 10" is designed so that the associated connecting element with the two wings 13 can be precisely covered and thus secured.

[0021] In plan view according to Fig. Figure 7 again shows the underside of the base plate 16. It shows how the connecting element 7, with its two wings 13, is precisely inserted into the corresponding recess 10". In this way, it is fixed by the cannula support body 2 in a tension-, pressure-, and rotation-resistant manner. In this case, the exposed cannula 5 protrudes slightly beyond the base plate 16.

[0022] The oblique image representation according to Fig.Figure 8 shows the complete cannula protection device 1 in the assembled state. The fixing film 3, which extends slightly beyond the cannula support body 2 in the longitudinal direction on both sides, is adhered flush and without creases to the skin surface of an arm 9, covering and thus fixing the cannula 5 and the coated cannula 11. The recess 6 allows the connecting element 7, which has a two-way stopcock 8, to remain freely accessible. For this purpose, the cannula support body 2 is also provided with a recess 10, which is designed such that the connecting element 7 is fixed in a pressure- and rotationally fixed manner. The coated cannula 11, which is arranged in a recess 10', protrudes slightly from the tunnel-shaped central section of the cannula support body 2. The puncture site with the cannula 5 covered by the fixation film 3 can be checked for possible inflammation through the viewing window 12.

[0023] The central section of the cannula support body 2, essentially designed like a trapezoidal prism and tunnel-shaped, is matched to the height of the two-way valve 8 and is rounded on all sides to virtually eliminate the risk of it getting caught on clothing, a bed cover, or the like. The corners of the base plate 16 are also rounded.

[0024] To ensure a secure connection to the underlying skin surface of a body part, the entire cannula protection device 1 is made of flexible material. The fixation film is also made of breathable material.

[0025] The cannula protection device according to the invention therefore works as follows: After the cannula needle is inserted into a vein, a fixation film 3 is applied. First, the cover film is removed from the adhesive-coated underside of the fixation film 3 and then placed over the cannula 5 and the connecting element 7 so that the tab 15 is located above the connecting element 7, which consists of a two-way stopcock 8. The narrow part of the fixation film 3 points away from the cannula 5. The fixation film 3 is then pressed onto the relevant body part, with the tab 15, under which there is no fixation film 3, being lifted by the connecting element 7.

[0026] After smoothing the fixing film 3, the edge 14, made of thin cardboard, is lifted and removed together with the flap 15. The edge area of ​​the fixing film 3 is then pressed firmly again.

[0027] The connecting element 7, designed as a two-way tap valve 8, is thus not covered by the fixing film 3 and therefore remains freely accessible.

[0028] The cannula support body 2 is attached as follows: After removing the protective film from the adhesive-coated underside of the base plate 16, the cannula support body 2 is grasped by the two wings 13' and guided diagonally from behind toward the connecting element 7 so that the connecting element 7 is located within the associated recess 10. The cannula support body 2 is then pressed firmly against the underlying fixation film 3 and, in the protruding area, against the skin surface, ensuring a secure connection.

[0029] The venous cannula 4 is fixed in a tension-, pressure- and rotation-resistant manner by means of the recess 10" located on the underside of the base plate 16, which is matched to the shape of the connecting element 7 with the two lateral wings 13.

[0030] The tunnel-shaped middle part of the cannula support body 2, which is matched to the height of the connecting element 7 and rounded on all sides, also prevents the venous cannula 4 from getting caught, for example, on a piece of clothing or the bedclothes.

[0031] It goes without saying that the invention also includes further embodiments which include a tension-, pressure- and rotation-resistant fastening of a venous cannula 4 having a two-way valve 8 and two wings 13. List of reference symbols: 1 cannula protection device 2 cannula support bodies 3 Fixing film 4 venous cannula 5 cannula 6 indentation 7 Connection element 8 two-way tap valve 9 Arm 10; 10', 10" recess 11 coated cannula 12 viewing windows 13; 13' Wing 14 edge 15 tab 16 Base plate

Claims

[1] Protection device for venous cannulas (4) with a connecting element (7) having a two-way valve (8) and two wings (13), characterized by that the protective device is designed in such a way that it can be virtually ruled out that it will get caught on clothing, bed covers or the like, the combination of cannula support body (2) and fixing film (3) is firmly connected to the underlying skin and thus forms a compact, stable unit with it and the venous indwelling cannula (4) is fixed to the relevant body part, e.g. arm, in a tension-, pressure- and rotation-resistant manner and that the fixing film (3) has an indentation (6) for receiving a two-way tap valve (8). [2] Protection device for venous cannulas (4) according to claim 1, characterized by that the fixing film (3) is provided with a peripheral edge (14) and a flap (15) made of thin cardboard covering the indentation (6) to facilitate attachment.

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