Medical holding and fixation device

Abstract

Medical holding and fixing device for a drainage catheter (11), with an elastically formable surface element (1), to which a circular ring-shaped surface shape can be assigned, with a radially inner (2) and a radially outer ring circumference (3) and with a circular ring sector-shaped cutout (4) which is delimited by two radially oriented surface element edges (5, 6), one of which (6) is connected to an elastically formable surface element tab (7) which, at least after deformation of the elastically formable surface element (1) to form a funnel shape in the direction of the ring circumference, projects beyond the other surface element edge (5) at least in sections and overlaps the surface element (1) in regions, as well as with a longitudinally slotted tubular extension (9), one extension end of which is connected at least along one region to the radially inner ring circumference (2) of the elastically formable surface element (1), characterized in that another,the end of the tubular extension (9) opposite the one end connected to the surface element (1) is connected to a further longitudinally slotted tubular extension (9') via a solid-body joint (15).

Description

Technical FieldThe invention relates to a medical holding and fixing device for a drainage catheter, preferably in the form of a bladder catheter.A common pathology in urology is the enlargement of the prostate in men. The enlargement leads to a constriction of the urethra, which can lead to more difficult drainage or a complete urinary stay.To discharge the urine, a bladder catheter is introduced into the urinary bladder via the urethra and blocked with a balloon inside the bladder. The balloon prevents the bladder catheter from slipping out of the urinary bladder and at the same time allows urine to drain.In the case of surgical interventions on the bladder or the prostate, what are known as irrigation catheters are also used. Compared with a bladder catheter, which generally has a hollow channel for urine outflow and a dilation channel for dilation of the balloon, these have an additional flushing channel, via which the bladder can be flushed in order to prevent blood coagel. In addition to the fixing of the catheter in the bladder, the balloon performs an additional function during transurethal resections of the prostate (TUR-P), which is intended to reduce or prevent compression of the surgical area and a subsequent bleeding associated therewith.Moreover, after surgical interventions, various drainage discharges are used to discharge body fluids, which can arise postoperatively, from the body in a controlled manner. These tubes, usually made of plastic, are introduced through a surgically placed access tract to the target cavity.Prior ArtDue to the anatomical physiological conditions of the urinary tract, urinary catheters are made of biologically compatible, often hydrophilic materials. As a result, the catheter is partially mobile, i.e. relatively movable within the urethra, which has the result that a temporally continuous compression of the surgical area by the balloon is not ensured. In order to at least limit the mobility, it is necessary to attach a suitable counter bearing extracorporeally along the urinary bladder catheter, by means of which counter bearing force is immobilized within the urethra under the action of a tensile force on the balloon placed inside the bladder.In order to put the bladder catheter under tension and to fix the bladder catheter in the surgical area, non-uniform and non-standardized methods are used. The surgeon pulls on the bladder catheter and presses and adhesive strips are applied to the bladder catheter directly at the urethral outlet in the region of the oakle as counter-bearings. This is a tedious and time consuming operation. Added lubricant on the catheter and body fluids make the contact and fixing of the adhesive strips additionally difficult. This method is only used temporarily, since the adhesion-based fixation by moisture loses its function. A further disadvantage is that the oak and foreskin may become tied up, which can result in tissue necrosis. Likewise, the manual fixing process can lead to the catheter channel being narrowed and no flow taking place any longer. It is not uncommon for the fixation to have to be renewed by means of presses and adhesive tape. This is usually associated with a considerable time outlay for physicians and / or caregivers. Moreover, the constant manipulations on the penis are not only unpleasant for the patient, but can be entirely painful.The publication US 2021 / 0128880 A1 discloses a medical holding and fixing device for a drainage catheter, preferably in the form of a bladder catheter, which has a dilatable balloon on the distal side and for the fixing of which a funnel-shaped fixing element, as it were a longitudinally slotted horn tip, is provided. With the aid of a tension band, the funnel-shaped fixing element can be fixed axially fixed along the bladder catheter at a suitably selected distance from the balloon, wherein the open funnel shape is oriented axially facing the balloon.However, the known fixing device helps to avoid the mobility of a bladder catheter placed in a urethra to a large extent, unpleasant stress pains caused by pressure and squeezing can occur to the patient during the bladder catheter application.CN 205252273 U describes a transurethal catheter fixation with a funnel-shaped surface element, the funnel shape of which is stabilized by an adhesive strip, comparable to a device for detecting the escape of urine from a ureter according to DE 21 2006 000 048 U1, in which in one embodiment a semicircular surface element is shaped to form a funnel, the shape of which is maintained using an adhesive adhesive adhesive field.CN 2 14 018 126 U discloses a funnel-shaped covering pad for preventing leakage of the urethral opening, which covering pad provides a surface element which is adapted intramuscularly to the oak, and for the purpose of maintaining its shape an adhesive adhesive is likewise used.The publication CN 2 11 024 715 U describes a transurethal catheter fixation with a funnel-shaped surface element, which can be fixed along the transurethal catheter with the aid of a cable tie-like fixation means.SUMMARY OF THE INVENTIONThe invention is based on the object of developing a medical holding and fixing device for a drainage catheter, preferably in the form of a bladder catheter, in such a way that, on the one hand, the loads explained above, which are directly caused by the fixing device and perceived as painful by a patient, are to be avoided and, moreover, the possibility is to be provided of configuring the holding and fixing device individually adaptable to the patient's own shape and size relationships of the oakler. In addition, it should be possible to fix the drainage catheter as closely as possible to the body of a patient.The object on which the invention is based is achieved is specified in claim 1. Features which advantageously develop the concept of the invention can be taken from the subject matter of the dependent claims and from the further description with reference to at least one exemplary embodiment.The medical holding and fixing device for a drainage catheter, preferably in the form of a bladder catheter, has an elastically formable planar element, to which an annular planar shape can be assigned, which has a radially inner and a radially outer annular periphery and the annular planar shape of which is interrupted by an annular sector-shaped cutout, which is bounded by two radially oriented planar element edges, one of which is connected to an elastically formable planar element tab, which at least after deformation of the elastically formable planar element to form a funnel shape in the annular peripheral direction protrudes beyond the other planar element edge at least in sections and overlaps the planar element in regions. Furthermore, a longitudinally slotted, tubular extension is provided, one extension end of which is connected at least along a region to the radially inner ring circumference of the elastically formable surface element. According to the solution, the medical holding and fixing device is characterized in that another extension end of the tubular extension opposite the extension end connected to the surface element is connected via a solid joint to another longitudinally slotted tubular extension.The moldable surface element and the tubular extension preferably integrally connected thereto consist of a skin-friendly material, preferably a polymer, such as silicone, polyethylene, polypropylene, polyurethane. The choice of material and also the thickness of the elastically formable planar element are preferably chosen such that the planar element is largely dimensionally stable with respect to its lateral planar extent and shape, i.e. the planar element is merely capable of limited extensibility or compression, but is flexibly deformable, i.e. from a planar shaped state into a three-dimensionally funnel-shaped shaped state and vice versa elastically deformable. In a selected embodiment variant, which is explained with reference to the figures, it is expedient to make the elastically deformable surface element extensible at least in limited surface areas.In a preferred exemplary embodiment, the elastically formable planar element is preformed by a material-inherent form impression into a funnel shape which the elastically formable planar element assumes automatically without the action of an external force. The cone angle, which is limited by the funnel-shaped elastically formable surface element in this state, can be increased or decreased by the action of an external force, depending on whether a force spreading from the inside onto the funnel shape or a force acting in the circumferential direction of the funnel acts on the surface element.The above change in shape is made possible by the cutout in the shape of a circular ring sector within the otherwise circular ring-shaped, elastically formable surface element which expands or reduces sectorally as a function of force.The surface element tab connected to one of the two surface element edges, which is preferably made of the same material as the elastically formable surface element itself and is thus integrally connected thereto, i.e. monolithically connected thereto, is designed in terms of shape and size such that it covers the cutout in the form of a circular ring sector, preferably over the full surface, and overlaps the surface element directly adjoining it in regions beyond the opposite surface element edge.The preferably complete overlap of the circular-ring sector-shaped cutout by the surface element tab ensures that no open clamping gap forms radially along the funnel-shaped surface element, whereby the risk of squeezing or jamming for the patient can be ruled out. Preferably, after the funnel shape has been formed, the flat element flag is brought into loose contact with the surface of the elastically formable flat element which is oriented facing the inner conical funnel region.In a preferred embodiment, a fixing device for mutual fixing is attached to the elastically formable planar element and / or to the planar element tab in order to transfer the funnel shape into an invariable shape state in this way after adaptation of the shape and size of the elastically formable planar element formed into a funnel to the circumstances on the patient side. Any mechanisms that appear suitable to the person skilled in the art are suitable for realizing the fixing device, for example in the form of a latching, clamping or clipping mechanism. Alternatively or in combination, it is equally possible to use adhesion-based joining mechanisms or a hook and loop connection.The surface element which can be shaped elastically to form a funnel shape serves as a supporting surface which is brought to bear on the oak of the patient in the form of a dome for one-sided bearing. In order to further improve the pressure distribution of the funnel-shaped surface element, a further preferred embodiment provides for the bending elasticity of the elastically formable surface element in an annular surface region between the radially inner and radially outer ring peripheries to be configured to be lower than in the radially inner and radially outer surface regions adjoining said surface region. In precisely this surface region having a higher bending elasticity, the elastically formable surface element ideally fits closely to the dome-shaped surface shape of the oak in a contour-preserving manner and in this way increases the surface contact. A preferred possibility for increasing the bending elasticity in just the aforementioned annular surface area is to make the thickness of the surface element smaller in the annular surface area between the radially inner and radially outer ring peripheries than in the surface areas adjoining it.For the purpose of axially releasably fixed joining connections between the elastically deformable surface element formed into a funnel along a drainage catheter, the radially inner ring periphery of the elastically deformable surface element is connected, at least in regions, to an extension end of a longitudinally slotted tubular extension, preferably in one piece. The longitudinal section of the tubular extension overlaps in the axial direction with the circular-ring sector-shaped cutout within the circular-ring-shaped surface shape of the elastically deformable surface element, so that a direct lateral contact of the medical holding and fixing device along a drainage catheter in general and a bladder catheter in particular is possible.The longitudinally slotted tubular extension, which is preferably connected via a solid joint at least in regions along the radially inner ring circumference to the elastically deformable surface element, has a tube inner wall with a tube inner diameter which corresponds at most to an outer diameter assigned to the drainage catheter. In addition, on the outer side of the tubular extension connected to the surface element, a tension and fastening means is attached which wraps around the tubular extension and by means of which a compression force directed radially inward onto the tubular extension can be generated in an adjustable manner. With corresponding radially inwardly directed compression, the tubular extension and the drainage catheter passing through it form a local frictional connection which leads to an axially fixed joining connection between the two components, whereby the tubular extension and the elastically formable surface element connected to it and formed into a funnel form a mechanically stable counter bearing which, as mentioned at the beginning, is essential for immobilization of the bladder catheter placed in a urethra.In a further preferred embodiment, local structural elements raised over the inner wall of the tube, for example in the form of round or angular ribs or knobs, are attached to the inner wall of the tube of the tubular extension. Such structural elements reduce the surface contact between the drainage catheter guided through the tubular extension and the tubular extension and at the same time increase the contact forces acting between the two components. The intimate point or line contact between the structural elements and the outer surface of the drainage catheter displaces the commonly used slip gel for catheter insertion into the urethra or other fluids and, moreover, does not in any way impair subsequent fixation.According to the solution, the other extension end of the tubular extension, which is situated opposite the elastically formable planar element, is connected via a solid joint to a further longitudinally slotted tubular extension. This further tubular extension, which has a pulling and fastening means encircling the tubular extension in the same way as the first extension, is not only able to improve the axial joining force between the drainage catheter and the medical holding and fixing device, but at the same time serves for deflecting an elastic drainage catheter by up to 90°, as can be seen below and with reference to the drawings.BRIEF DESCRIPTION OF THE INVENTIONThe invention is described below by way of example without limiting the general concept of the invention on the basis of exemplary embodiments with reference to the drawing. The following are shown: FIGS. 1-6 show different views of a medical holding and fixing device according to the invention (not subject matter of the invention), FIG. 7 shows a medical holding and fixing device according to the invention with a solid joint, and FIGS. 8a, b, c show an alternative embodiment.WAYS OF CARRYING OUT THE INVENTION, INDUSTRIAL APPLICABILITYFIGS. 1-6 show a preferred exemplary embodiment of a medical holding and fixing device designed according to the invention in different views. FIGS. 1 and 2 show perspective views from different viewing directions onto the holding and fixing device, FIGS. 3 and 4 show side views from different viewing directions, FIG. 5 shows a plan view and FIG. 6 shows an axial view from below onto the medical holding and fixing device. The further explanations relate overall to FIGS. 1-6.The medical holding and fixing device has an elastically formable surface element 1, to which an annular surface shape having a radially inner ring circumference 2 and a radially outer ring circumference 3 can be assigned. The otherwise circular base surface shape is interrupted by a circular-ring sector-shaped cutout 4 which is geometrically bounded by two radially oriented surface element edges 5, 6. The surface element edge identified in FIGS. 1-6 by the reference numeral 6 is connected in one piece to a surface element tab 7. In the exemplary embodiment shown, the surface element tab 7 is triangular and overlaps both the surface element edge 5 and a partial region of the funnel-shaped elastically formable surface element 1 in the state of the elastically formable surface element 1 formed into a funnel. The overlapping of the surface element tab 7 is preferably carried out in such a way that the cutout 4 in the form of a circular ring sector is completely covered in a state of a closed funnel shape. The arrangement of the flat element tab 7 shown in FIGS. 1-6 radially outside the elastically formable flat element 1 formed into a funnel is shown merely for reasons of clearer illustration. In the application of the medical holding and fixing device by contact with the oak of a penis, surface element tab 7 abuts the inner wall of the elastically formable surface element 1 shaped into a funnel, so that the skin surface of the oak is not irritating by any edges on the part of the medical holding and fixing device.A fixing device 8 attached to the radially outer ring circumference serves for the surface element lug 7 which otherwise bears loosely against the inner wall of the elastically deformable surface element 1 to assume its position relative to the surface element 1 in an invariable manner. This reduces the possibility of injury and increases the wearing comfort for the patient. Alternative or combined configurations for the fixing device 8 represent, for example, clamping and latching or clamping connections, such as pushbuttons. Adhesion connections or also joints based on the hook and loop principle also serve as alternative joining techniques.Along the radially inner ring periphery 2 of the elastically formable surface element 1, a tubular extension 9 is preferably attached in one piece. In a particularly preferred embodiment, the one-piece connection between the radially inner ring periphery 2 and the tubular extension 9 is formed by a solid-state joint, in order to thus enable elastic deflection or folding on or off of the elastically formable surface element 1 relative to the tubular extension 9. Such a solid joint at the location of the radially inner ring circumference 2 extends the possibility of using the medical holding and fixing device beyond a bladder catheter fixing. For example, it is conceivable to form the elastically formable sheet from the funnel shape illustrated in FIGS. 1-6 for total area support on a planar or substantially planar surface. In this case, the entire radial inner ring circumference 2 is not necessarily connected to the tubular extension 9, as shown.The tubular extension 9 has a longitudinal section 10 which axially overlaps the circular sector-shaped cutout 4, so that the medical holding and fixing device illustrated in FIGS. 1-6 can be placed laterally around a drainage catheter 11 by appropriately spreading the tubular extension 9, as can be seen schematically in FIG. 4. The drainage catheter 11 illustrated in FIG. 4 also represents a bladder catheter which provides a dilatable balloon 12 on the distal side.The tubular extension 9 is preferably manufactured and dimensioned mechanically so stably that a drainage catheter 11 inserted into the extension 9 enters into a frictional connection caused by clamping force, whereby the drainage catheter 11 is held largely axially firmly within the medical holding and fixing device. Optionally, a closure mechanism in the form of a tension and fastening means 13 is additionally attached to the tubular extension 9, by means of which a compression force directed radially inward onto the tubular extension 9 can be generated individually in an adjustable manner. In the simplest case, a releasable cable tie serves for this purpose.Raised structural elements 14 in the form of knobs are preferably attached to the inner wall of the tubular extension 9 via the inner wall of the extension 9, as a result of which an increased contact pressure force can be achieved between the outer wall of the drainage catheter 11 and the tubular extension 9 and slipping of the drainage catheter 11 through the tubular extension 9 is made more difficult or impossible. Even the use of slip gels for the purpose of catheter insertion into the urethra or other fluids is forced away by the studs 14 and thus does not impair the fixation.The individually adjustable funnel shape with regard to its cone angle and the associated opening width of the circle diameter surrounded by the radially inner ring circumference 2 allow drainage catheters 11 of different dimensions to be fixed by a single holding and fixing device.In FIG. 7 a modified embodiment of the tubular extension 9 is illustrated, which has a further solid joint 15. The solid-state joint 15 connects the tubular extension 9 directly connected to the elastically formable planar element 1 to a further tubular extension 9', which is preferably of identical construction and is embodied as slotted and enables direct contact along a drainage catheter. In FIG. 7, the already angled state is illustrated, in which the drainage catheter is bent over by 90 degrees. Such a constellation is desirable in cases where the drainage catheter 11 is to be placed as closely as possible to the body of a patient.FIGS. 8 a, b show in side view and FIG. 8 cin plan view a further preferred embodiment with a funnel-shaped, elastically formable surface element 1, on the outer side of which ring-shaped rib trains 16 are arranged in a sequence selected concentrically spaced apart from one another, which are capable of stabilizing the funnel shape and thus ensure a shape-conforming contact of the funnel inner side with the dome-shaped or dome-shaped shape of a oakrel. The rib trains 16 are preferably made of the material from which the elastically formable planar element 1 is manufactured and are monolithically connected to the planar element 1. Preferably, the selection of material and / or thickness of the elastically deformable surface element 1 is carried out at least in an annular surface element region 17 bounded by two ridge lines 16 in such a way that the surface element is expandable in this region, in order to thus enable a surface-enlarging contact with the oak shape. As in the case of the above-described medical holding and fixing devices, the flat element tab 7 monolithically adjoins the elastically formable flat element 1 and has no rib features 16. When the surface element tab 7 is in contact, it nestles against the inside of the funnel-shaped, elastically formable surface element 1 in a shape-retaining manner, i.e. without any protruding portion. For the size- and shape-maintaining fixing of the funnel-shaped, elastically formable surface element 1, a lower edge section 18 of the surface element tab 7 can be joined into the fixing device 8 forming a frictional connection. For this purpose, the fixing device 8 is attached to the radially outer ring periphery 2 of the elastically formable planar element 1 and has a groove-shaped recess 19 for joining the lower edge portion 18 of the planar element 7 to apply clamping force.List of reference characters1 Surface element that can be shaped elastically 2 Radially inner ring periphery 3 Radially outer ring periphery 4 Circular sector-shaped cutout 5, 6 Radially oriented surface element edge 7 Surface element flag 8 Fixing device 9 Tubular extension 9' Further tubular extension 10 Longitudinal section 11 Drainage catheter 12 Balloon 13 Pulling and fastening means 14 Structural element 15 Solid joint 16 Rib pull 17 Annular surface element region 18 Lower edge section 19 Groove-shaped recess

Claims

Medical holding and fixing device for a drainage catheter (11), having an elastically formable planar element (1) to which an annular planar shape can be assigned, having a radially inner (2) and a radially outer annular periphery (3) and having a cutout (4) which is in the form of a circular ring sector and is bounded by two radially oriented planar element edges (5, 6), one (6) of which is connected to an elastically formable planar element tab (7) which, at least after deformation of the elastically formable planar element (1) to form a funnel shape in the circular ring peripheral direction, projects beyond the other planar element edge (5) at least in sections and overlaps the planar element (1) in regions, and having a longitudinally slotted tubular extension (9) whose one extension end is connected at least along one region to the radially inner annular periphery (2) of the elastically formable planar element (1), characterized in that another extension end is connected to the radially inner annular periphery (2) of the elastically formable planar element (1) in some regions, The tubular extension (9) is connected to a further longitudinally slotted tubular extension (9') by a solid joint (15).Medical holding and fixing device according to claim 1, characterised in that a fixing device (8) for mutual fixing is attached to the elastically deformable surface element (1) and / or to the surface element tab (7).Medical holding and fixing device according to claim 1 or 2, characterised in that the extension end of the tubular extension (9) is connected to the surface element (1) via a solid joint.Medical holding and fixing device according to one of claims 1 to 3, characterised in that at least the tubular extension (9) connected to the surface element (1) has a tube inner wall with a tube inner diameter which corresponds at most to an outer diameter assigned to the injection catheter (11).Medical holding and fixing device according to claim 4, characterised in that local structural elements (14) raised over the inner wall of the tube are attached to the inner wall of the tube.Medical holding and fixing device according to one of Claims 1 to 5, characterized in that a tension and fastening means (13), which wraps around the tubular extension (9) and by means of which a compression force directed radially inwards onto the tubular extension (9) can be adjustably generated, is attached to an outer side of at least the tubular extension (9) connected to the planar element (1).Medical holding and fixing device according to one of Claims 1 to 6, characterized in that the flat element tab (7) is connected integrally to the elastically formable flat element (1).Medical holding and fixing device according to one of Claims 1 to 7, characterized in that the elastically formable surface element (1) has a surface element thickness which is less in an annular surface region between the radially inner (2) and radially outer ring periphery (3) than in the surface regions of the elastically formable surface element (1) adjoining said surface region.Medical holding and fixing device according to one of Claims 1 to 8, characterized in that the drainage catheter (14) is a bladder catheter.Medical holding and fixing device according to one of Claims 1 to 9, characterized in that rib trains (16) which are spaced apart concentrically are fitted on an outer side of the elastically deformable surface element (1) deformed to form a funnel shape, said rib trains in each case defining a ring-shaped surface element region (17) in pairs.Medical holding and fixing device according to claim 10, characterised in that the elastically deformable surface element (1) is elastically stretchable in at least one of the annular surface element regions (17).

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