Patent ID: 12257404

DETAILED DESCRIPTION

According toFIG.1, a fixing device1is provided for fixing a catheter assembly (not shown in the drawings) to a patient. The catheter assembly to be fixed is in the present case a central venous catheter assembly. Such catheter assemblies are well known and can be designed with a single lumen or with multiple lumens and have at least one hose portion arranged outside of the patient, in the applied state of the catheter assembly. However, the fixing device1can also be used for fixing other kinds of catheter assemblies.

The fixing device1has a receiving unit2, which is provided for connection to a skin surface H (FIG.4) of the patient. The skin surface H is shown in a highly schematic and simplified manner inFIG.4. It will be seen from the latter that the receiving unit2, in the configuration shown inFIG.4, lies with a rear face3flat on the skin surface H, wherein the receiving unit2is connected to the skin surface H in a manner that will be described in more detail. The receiving unit2has a receiving recess4. The receiving recess4is provided to receive a portion of the catheter assembly. In the present case, the receiving recess4is provided to receive said hose portion of the catheter assembly. Moreover, the fixing device1has a closure unit5, which serves to close and open the receiving recess4at least in a vertical direction Z of the fixing device1. For this purpose, the closure unit is movable between an opened state (FIGS.2,3and5), in which the receiving recess4is open for receipt and/or removal of the hose portion of the catheter assembly, and a closed state (FIGS.1and4), in which the receiving recess4is at least partially closed by means of the closure unit5.

In the present case, the closure unit5is joined non-releasably to the receiving unit2, wherein the receiving unit2is designed at least in part with shape elasticity, such that the closure unit5is movable between the opened state and the closed state by means of an elastic deformation of the receiving unit2.

In order to achieve the at least partial shape elasticity and deformability of the receiving unit2, the latter in the present case is made of a flexible plastic K1(FIG.3). By contrast, the closure unit5is made of a substantially dimensionally stable plastic K2. In the present case, a silicone elastomer is chosen as the flexible plastic K1. As will be seen later, particularly in connection withFIG.3, the receiving unit2and the closure unit5are made as one continuous piece. The whole fixing device1is to this extent designed as an integral structure in the form of a multi-component injection molding S. In the present configuration, the multi-component injection molding S is a two-component injection molding. Methods for producing multi-component moldings or in particular two-component moldings made of plastic are well known in the field of plastics technology.

The receiving recess4is designed here in the form of an elongate channel K. The channel K has a longitudinal slit6for the introduction of the hose portion into the channel K and/or for the removal of the hose portion from the channel K. The longitudinal slit6extends, in the axial direction X of the channel K, along the entire length thereof. A slit width B1, B2of the longitudinal slit6is modifiable by means of the elastic deformation of the receiving unit2. In the closed state, the longitudinal slit6has a slit width B1and, in the opened state, it has a by comparison larger slit width B2.

The closure unit5has a latching portion7and a mating latching portion8. The latching portion is designed in the form of a latching hook7. The mating latching portion is in the present case designed in the form of a latching projection8. In the closed state, the latching portion7and the mating latching portion8are secured on each other with form-fit engagement. By contrast, in the opened state, the latching portion7and the mating latching portion8are freed from each other. Here, the latching portion7and the mating latching portion8are pivotable relative to each other about a pivot axis A, wherein the receiving unit2has an elastic flexure portion9which permits the relative pivotability of the latching portion7and of the mating latching portion about the pivot axis A (FIG.3). The pivot axis A and the longitudinal direction X of the receiving recess4and of the channel K are oriented parallel to each other in the present case. The flexure portion9is arranged beneath the channel K in the vertical direction Z and permits an elastic bending mobility of the receiving unit2and thus a corresponding pivotability of the closure unit5for the transfer between the closed state and the opened state. Further functional and structural details of the fixing device1are dealt with in more detail below.

The receiving unit2has a main portion10and, on opposite transverse sides of the main portion10, two laterally protruding wing portions11. The main portion10has a substantially circular cylindrical basic shape, wherein the channel K extends more or less centrally through the main portion10along the longitudinal direction X. At any rate in the closed state (FIGS.1and4), the channel K has a round cross-sectional shape. The two wing portions11each have a plate-like, rectangular basic shape and, in relation to the vertical direction Z, are arranged beneath a horizontally oriented central longitudinal plane of the main portion10. The wing portions11each have a through-bore12. In relation to the longitudinal direction X, the through-bores12are arranged more or less centrally on the wing portions11. The same applies in relation to an arrangement of the through-bores12oriented transversely with respect to the longitudinal direction X. The through-bores12allow the fixing device1to be fastened to the skin surface H by means of medical suture material. This kind of fastening is well known. In an embodiment not shown in detail, the rear face3can be prepared for being adhesively affixed to the skin surface H. At the ends, the main portion10protrudes beyond the wing portions11to both sides in the longitudinal direction X. In the closed state, the wing portions11are oriented flat. By contrast, in the opened state, the wing portions11are pivoted downward relative to each other about the pivot axis A on account of the elastic bending deformation in the region of the flexure portion9. Starting from the round cross-sectional shape described above, the channel K is thus widened in the radial direction and folded open at the top, such that the longitudinal slit6is widened from the slit width B1to the slit width B2.

The closure unit5, to put it simply, is injected molded onto the top of the receiving unit2and connected integrally thereto. The closure unit5has two side portions13that cover the wing portions11two-dimensionally. The through-bores12extend through the side portions13. Starting from the wing portions11, the side portions13engage centrally over the main portion10on both sides of the channel K, wherein the latching portion7is arranged on what is the right-hand side portion13in relation to the drawing planes ofFIGS.4and5, and the mating latching portion8is arranged on the left-hand side portion13. Moreover, the closure unit5has a handling portion14. The latter is arranged on the right-hand side portion13and is designed in the form of a projection protruding in the vertical direction Z. In the closed state, the latching portion7engages over the top of the channel K, such that undesired slipping of the hose portion out of the channel K through the longitudinal slit6is counteracted. Moreover, the present configuration of the closure unit5has the effect that the channel K, in the closed state, is elastically prestressed in the radial direction, such that the hose portion is secured on the channel K with frictional engagement in the axial direction, i.e. in the longitudinal direction X of the channel K. This counteracts undesired slipping of the hose portion along the channel K.

To fix the catheter assembly, the hose portion is introduced into the channel K through the longitudinal slit6in the opened state of the closure unit5. If necessary, the receiving unit2can for this purpose be elastically deformed beyond the deformation state shown inFIGS.2,3and5, such that the hose portion can be easily moved past the latching portion7and into the channel K through the longitudinal slit6. To transfer the closure unit5to the closed state (FIGS.1and4), the fixing device1is pressed down onto the skin surface H by means of manual pressure in the region of the handling portion14. This causes a flexurally elastic deformation of the receiving unit2in the region of the flexure portion9, as a result of which the latching portion7is pivoted about the pivot axis A relative to the mating latching portion8, until a form-fit latched connection is produced. The fixing device1can be sutured to the skin surface H in the manner described above, although this does not necessarily have to be the case. To remove the hose portion from the channel K, the closure unit5can be transferred to the opened state by means of an actuation of the handling portion14and/or by means of pressing the side portions13down manually. The design of the fixing device1according to the invention in principle allows it to be operated with one hand, which makes it considerably easier to manipulate.