Device for the urethral application of a lubricating or lumen-erecting substance through a retractable introducer

Description

[0001] The invention relates to a device for draining urine from the bladder of a patient,

[0002] Bladder catheters for the continuous, closed drainage of urine from a patient's bladder into a collection vessel are established in medical practice and are known in various designs. Indwelling bladder catheters are usually inserted into the bladder by transurethral catheterization. In contrast to catheterization of the bladder with disposable catheters, in which a catheter-like tube is intermittently advanced through the urethra into the interior of the bladder, i.e. only for the actual duration of bladder emptying, catheters for the permanent transurethral drainage of urine are typically equipped with a balloon-like anchor element (retention balloon) at their distal end, the primary function of which is to secure the position of the urine-collecting end of the catheter within the bladder.

[0003] In the vast majority of known designs of so-called indwelling catheters, these retention balloons consist of elastically expandable tubing materials that fit tightly around the catheter shaft and, if possible, without any preformation, as smooth, wrinkle-free, cylindrically shaped tubing (sleeves). When filled with a non-compressible, liquid medium, a nearly spherical balloon expands from the cylindrical tubing at sufficiently high inflation pressure. The main disadvantage of anchor balloons of this type, which are inflated by high inflation pressures, is the hard consistency of the balloon resulting from the expansion of the sleeve. With prolonged indwelling, such rigid, "hard" balloons can result in erosive changes and, in some cases, even severe ulcerations of the bladder mucosa in the area where they rest on the bladder floor, particularly in the area of ​​the bladder trigone.With the persistent presence of bacteria in the urine, chronic inflammation of the urinary tract can develop due to such tissue defects. Current research in the field of urinary tract infections (UTI) considers a preferably intact, preferably non-eroded epithelium of the bladder and urethra to be essential for preventing chronic urinary tract infections.

[0004] In addition to conventional, sleeve-based catheters, retention elements based on preformed balloon components are also known in the literature. Such components are presented, for example, in EP1448259 or PCT / IB2015 / 002282. Retention is ensured by balloon components that are fully or partially formed during catheter manufacture to the working dimensions required for the respective function. The balloon elements are made of membrane-like, thin-walled, yet high-strength materials that, when deflated, impose such a minimal amount of bulk on the catheter shaft that the preformed balloon component can be advanced comfortably and without irritation through the urethra during catheter insertion.

[0005] The preamble of claim 1 is disclosed by EP0935977A2.

[0006] Recent literature on UTI also frequently highlights the traumatic effect of conventional catheter tips on the exposed bladder roof. The generally relatively rigid tip, which extends beyond the retention balloon and into the bladder lumen like a finger, digs into the tissue of the bladder roof with prolonged exposure, thus regularly leading to further, directly catheter-associated lesions.

[0007] A wide variety of catheter tip designs are known, designed to prevent lesions of the urethral wall, particularly during insertion or advancement of the catheter through the urethra, and to facilitate catheter placement overall. Some designs also attempt to prevent injuries to the bladder roof. For example, double-balloon configurations are described, such as the Duette from Poiesis Medical Ltd., in which the catheter tip is protectively held by a spherical, balloon-like element, while another balloon element rests on the bladder floor. With Duette, urine is drained through an opening in the catheter shaft between the two balloons.

[0008] Another direct traumatizing effect on the urinary tract is due to the design of the urinary-draining shaft segment of conventional catheters. The shaft connects proximally to the balloon retained in the bladder and drains urine transurethrally. The shaft elements are typically made of relatively thick-walled silicone-based or natural rubber-based tubing. The thick-walled design of the shaft wall ensures, on the one hand, that the urinary-draining lumen does not close due to kinking upon axial bending or twisting of the shaft. On the other hand, the thick-walled shaft construction ensures that the elastic expansion of the balloon sleeve into a spherical balloon does not lead to collapse of the urinary-draining lumen of the shaft due to the high pressures acting within the balloon.In particular, the shaft wall thicknesses required by balloon inflation pressure limit the structurally achievable diameter of the urinary lumen. Small-lumen diversion devices tend to become encrusted prematurely or gradually closed due to the continuous deposition of urine components. To achieve the longest possible application periods, the largest possible inner diameters are therefore sought, which in turn require large shaft outer diameters. The approximation of the shaft outer diameter to the diameter of the urethra required in conventional catheter designs, combined with the stiffness of the shaft material, frequently leads to pronounced erosion of the epithelium lining the urethra, which, with prolonged indwelling, regularly results in inflammatory processes and, subsequently, scar-like strictures of the urethra.

[0009] Another factor contributing to the development of chronic urinary tract infections is the accumulation of so-called residual bladder urine. Residual urine is slowly drained from the bladder and therefore tends to accumulate larger amounts of bacteria. Various designs are known to reduce urine pooling, primarily by draining the urine through openings in the catheter shaft that are positioned particularly close to the bladder floor.

[0010] To prevent injuries during catheter insertion, gel-like substances have been used successfully. They reduce friction between the catheter shaft surface and the urethral epithelium. In addition to this lubricating effect, gels enable temporary erection or filling of the urethral lumen. With the urethral lumen more or less circularly erected, the catheter tip and catheter shaft can be inserted through the urethral lumen with optimal low-friction performance. Bladder catheters are often packaged in sets containing all the necessary utensils for catheter insertion. These ready-to-use sets are generally unnecessarily large, often confusing to use, and hinder proper application of the product.

[0011] The object of the invention is to avoid the disadvantages of the prior art described above.

[0012] To solve this problem, the invention provides a functional unit in the context of a device for draining urine from the bladder of a patient, comprising a) a shaft-shaped, draining indwelling part that can be placed in the bladder and urethra in the manner of a catheter, with at least one drainage opening in the region of the distal tip of the shaft-shaped indwelling part; and b) a retractable insertion aid, inserted into the shaft-shaped indwelling part, of tube-like or hose-like construction that facilitates urethral insertion and passage, with an apical opening for the terminal release of a lubricating and / or lumen-enhancing substance through the opening.

[0013] In the context of this patent application, the terms "indwelling part", "indwelling unit", "catheter" and "bladder catheter" are used largely synonymously,

[0014] The present invention is defined by claim 1 and describes, in particular, the application-optimized connection of a urinary catheter with a reversibly removable insertion element inserted into the urinary lumen of the catheter. This insertion element stabilizes the catheter shaft for urethral insertion and allows for the easy-to-use intra-urethral introduction of lubricating or lumen-enhancing gel. The ease of handling of the catheter is taken into account within the scope of the invention through appropriate structural modifications and accessory additions.In particular, the invention offers the possibility of a single-handed catheterization, which ideally includes the lubrication of the catheter tip, the insertion of the anterior third of the catheter, the straightening of the urethral lumen by gel application, the gradual advancement of the catheter using a forceps-like gripping element, and the blocking of the retention balloon. The special design of the device according to the invention allows the size of a catheter set to be reduced to a minimum.

[0015] The invention further describes the particularly atraumatic design of all intracorporeally placed components of a bladder catheter. In particular, the catheter shaft should be as tissue-friendly as possible, preventing erosion in the urethra. Perforating injuries to the bladder roof caused by the catheter tip should be avoided. The catheter balloon should have the best possible retention and sealing effect in the area of ​​the bladder outlet, while minimizing the erosive effect of the balloon wall on the epithelium. The lumen of the catheter shaft, which drains the urine, should be optimally large. Furthermore, the pooling of residual urine in the bladder should be minimized.

[0016] The invention specifically describes a combination of a thin-walled or large-bore, efficiently draining urine, and atraumatically remaining in the urethra, with an insertion aid inserted into the thin-walled shaft tube. This inserter, in addition to providing the stabilizing stiffening of the catheter shaft required for catheter placement, enables the release of a lubricating and / or lumen-enhancing substance into the urethra near the tip. After securing the catheter by inflating the catheter balloon, the inserter is withdrawn from the catheter lumen, leaving a tube body as flexible as possible and with minimal friction in the urethra, thus avoiding the typical erosion-related lesions of the urethra that occur during conventional catheterization.

[0017] In its preferred design, the introducer aid, as a tube-like or tubular body, has an approximately 1.0 to 3.0 mm inner lumen through which a lubricating and / or lumen-enhancing substance is released in the area of ​​the tip of the urinary catheter shaft that accommodates the introducer aid. The respective substance emerges into the draining lumen of the catheter as close as possible to the urinary opening of the urinary catheter. Alternatively, the tip of the introducer aid can extend axially beyond a frontally opening of the catheter shaft, forming an extension of the catheter portion that resides in the bladder. In this design, the introducer aid can be provided with one of the many tip shapes commonly used in transurethral catheterization in the area of ​​its tip, which facilitate the passage of the catheter through critical bends in the urethra.Here, too, the introducer element has an inner lumen for the application of a lubricating and / or lumen-enhancing substance, which in this case is delivered directly from an opening in the introducer element into the urethra. After securing the catheter in the bladder, the introducer aid is removed. After retraction of the introducer aid, a funnel-like opening ideally forms in the anterior radius of the catheter balloon, with the opening of the catheter shaft spontaneously positioning itself at the bottom of the funnel as the balloon inflates.

[0018] Alternatively, the catheter shaft may have a short, nozzle-like tip formation, which is designed in such a way that it does not protrude beyond the anterior radius of the balloon when placed in situ.

[0019] The invention further describes a special shape of the catheter tip, which has a corrugated, tube-like wall that allows the tip to be freely rotated or bent in any direction, thus simplifying the passage of the urethra on the one hand, and on the other hand allowing the tip to be axially bent on all sides within the bladder, so that the bladder roof is not irritated and damaged by a formation pointing towards it when it rests on the distal end of the catheter.

[0020] In all embodiments of the device according to the invention for reducing residual urine formation, the balloon body is preferably shaped as flat or discoid as possible.

[0021] To maximize ease of use during catheterization, the lubricating and / or lumen-enhancing substance can be injected into a hood-like or bag-like sheath during the first handling step. This sheath sits on the distal end of the catheter or the distal end of the introducer with a narrow gap between them. This sheath distributes the substance as evenly as possible within this gap around the catheter tip or distal end of the catheter. The sheath is then removed frontally immediately before the catheter is inserted into the urethra.

[0022] The catheter, which is stiffened by the insertion aid, is inserted approximately 8 to 10 cm into the male urethra in a quasi-lancing manner. In order to enable further passage of the catheter in an optimally atraumatic manner, a second amount of gel is injected into the urethra following the introduction of the front section of the catheter. This gel straightens the lumen of the organ and thus avoids injuries, particularly where the male urethra has a particularly curved course.

[0023] The closure of the drainage lumen by deposits of urinary components is counteracted within the scope of the invention by a maximum-sized design of the urine-draining lumen. To this end, the wall of the transurethral segment of the catheter is reduced as much as possible, in extreme cases to the thickness of a film. To prevent lumen-closing kinks or twists of such a thin-walled shaft, it can be provided with a lumen-stabilizing, corrugated tube-like profile over its entire length, or only in certain, mechanically relevant sections. In combination with materials with high elastic restoring force, such asPolyurethane can be used to equip such a profiled shaft with spontaneous lumen-erecting properties, which allow for an elastic, smooth bending of the shaft as well as an easily induced, temporary, radial collapse of the lumen, but on the other hand ensure a reliable, spontaneous lumen-erecting and unwinding effect.

[0024] In addition, in combination with tubular film-like thin-walled shaft walls, rod-like, tube-like, or tubular braid-like structures are also conceivable, which run freely inside such a drainage tube in a torsion-inhibiting, stabilizing manner.

[0025] The invention preferably uses specially shaped balloon components, which are described, for example, in PCT / IB2015 / 002282. These balloons, made of micro-thin-walled yet highly dimensionally stable soft foil, are preferably incompletely filled with air, only flaccidly. Due to their placement in the flaccid, unstretched state, traumatic ablation of the epithelium lining the bladder can be largely avoided. When the balloon is unstretched and flaccidly filled, only the force acting in the bladder is absorbed by the balloon. The inflation pressures are in the low millibar range; when the balloon is not under pressure, they do not exceed, or only slightly exceed, the intravesical pressure prevailing in the patient's bladder.

[0026] As described in PCT / IB2015 / 002282, such a balloon can also be provided with a urethral, ​​cylindrically shaped extension with a tapered diameter. The retaining, vesical balloon portion thus transitions proximally into a sealing, urethral balloon portion. The combined vesical-urethral balloon body is preferably provided with a "residual" diameter in the urethral segment that exceeds the diameter of the urethral lumen by approximately 0.5 to 1.5 times, preferably by 0.5 to 1.0 times. The balloon portion, thus oversized in diameter, thus conforms to the urethral wall without tension, largely independent of its size, forming a radially oriented fold or invagination of the sheath wall. The residual excess ensures that all parts of the urethra can be sealed in a flaccid tamponing manner.The residual diameter can also compensate for caliber fluctuations of the urethral lumen.

[0027] As an alternative, less preferred embodiment, the urethral portion of the shaped balloon body can be dimensioned such that it substantially corresponds to or is smaller than the diameter of the respective urethra.

[0028] The catheter balloons used according to the invention are preferably filled with a gaseous medium or with air. The filling medium is supplied via a supply line integrated into the shaft wall, but can also be supplied via supply lines running freely within the shaft lumen.

[0029] The invention also takes into account, to a lesser extent, designs that do not use the described pre-formed balloon components and instead have conventional retention components that are elastically stretched from a piece of tubing.

[0030] The dwell part and the insertion aid can be made of materials that have the same hardness. However, preferred versions are those in which the materials of the dwell part and the insertion aid differ from each other at least in terms of their hardness.

[0031] Since both parts are made of plastics, preferably thermoplastics, thermosets, or elastomers, the material hardness is preferably measured as Shore hardness. Shore A or Shore D hardness values ​​are particularly preferred.

[0032] The Shore hardness y of the material of the insertion aid should be equal to or exceed the Shore hardness x of the material of the indwelling part: y = x , or y > x , or y ≥ x .

[0033] The difference in Shore hardness, especially Shore A hardness, should be defined as follows: y − x ≥ 0 , or: y − x ≥ 1 , or: y − x ≥ 2 , or: y − x ≥ 5 , or: y − x ≥ 10 , or: y − x ≥ 20 .

[0034] An exemplary, unclaimed method for catheterizing a patient's bladder is characterized in that a lubricating and / or lumen-enhancing substance is released from a compressible reservoir container as a result of digital or manual compression of the reservoir container.

[0035] A ready-to-use catheter device is used, which comprises a shaft-shaped, draining indwelling part that can be placed in the bladder and urethra in the manner of a catheter, with a drainage opening in the area of ​​the distal tip of the shaft, as well as a retractable introducer inserted into the indwelling part, which has a tube-like or hose-like structure and facilitates urethral insertion and passage, with an apical opening for the terminal release of the lubricating and / or lumen-enhancing substance, to the proximal end of which the reservoir container with the lubricating and / or lumen-enhancing substance is connected or can be connected.

[0036] The attached figures describe various embodiments of the bladder catheter device according to the invention, as well as combinations with special, functional accessory components for one-handed catheterization. Herein:Fig. 1: An embodiment in which a substance-applying or catheter-shaft-stabilizing insertion element is inserted into the urinary-draining lumen of the bladder catheter; Fig. 2: An embodiment in which a substance-applying or stabilizing insertion element is inserted into the urinary-draining lumen of the bladder catheter such that the tip of the insertion element extends beyond the distal, terminal opening of the catheter shaft remaining in the body; Fig. 2a: A special design of the tip of the insertion element with a wavy profile; Fig. 26: A corresponding, wavy design of the distal catheter end remaining in the body; Fig.2cAn insertion element formed from a single piece with an integrated, terminal, compressible substance reservoir; Fig. 2dA special design of an insertion element which has a terminal, funnel-like receiving piece for inserting and perforating a structurally separate reservoir container; Fig. 3aA special design of the catheter shaft which is wavy in sections or over the entire catheter shaft; Fig. 3bA further design of the catheter shaft, which has a particularly thin-walled, tubular film-like structure; Fig. 4A reservoir container for lubricating and / or lumen-enhancing substances which can be compressed in a locking manner; Fig. 5A special arrangement of a hood-like element for lubricating the catheter tip; Fig. 6A bellows-like compressible filling device for filling the catheter balloon; Fig.Fig. 7a holding device for the U-shaped looped catheter for optimized, ready-to-use insertion of the catheter with only one hand; Fig. 7aa special forceps or pliers mechanism for gripping the catheter shaft; and Fig. 8a special design of a two-layer perforated drape, which the user can pick up like a glove and guide to the opening to be catheterized.

[0037] Fig.1represents a variant of the catheter device 1, in which the catheter shaft 2 of the device is equipped with a balloon 3, which is already shaped during production to the working dimension required for retention of the catheter in the bladder, wherein the balloon is preferably made of thin-walled, only slightly expandable polyurethane film. A hose-like or tube-like insertion aid 4 is inserted into the urine-draining lumen 2a of the catheter shaft. The tip 5 of the catheter shaft has at least one drainage opening 6. Preferably, two or more drainage openings 6 can also be provided, which are preferably arranged at the same intermediate angle over the circumference of the catheter shaft 2. For example, two drainage openings could be diametrically opposite one another, i.e. offset by 180°, while three drainage openings would be offset by 120° from one another. The tip of the insertion aid orWhen fully inserted, its distal opening 7 is located immediately proximal to the drainage opening or in direct alignment with the drainage opening. Preferably, the tip of the introducer fits snugly against the inner wall of the catheter's drainage lumen, for example, in a conically sealed or locking manner, such that the administering substance cannot escape retrogradely into the proximal part of the catheter's drainage lumen or into the proximally adjoining gap between the introducer and the catheter's inner wall during application or injection through the lumen of the introducer.

[0038] In the preferred embodiment, a reservoir-like, preferably bellows-like, container 8 is located at the proximal end of the insertion aid. This container holds the substance to be administered and from which the substance is preferably conveyed to the tip of the catheter by pressing or squeezing the container. In its preferred embodiment, the container transitions into an axially or radially locking state upon application of an axially compressing or, alternatively, radially squeezing force, which prevents the container from elastically restoring its position when the applied force decreases. This prevents aspiration of already applied gel back into the container.

[0039] For improved fixation of the relative position of catheter and introducer, the distal part of the container 8 has a cone-like segment 9, which can be inserted precisely and optionally in a locking manner into the connector 10 of the catheter.

[0040] Fig. 2 shows an embodiment of an insertion aid 4, with a formed or molded-on tip formation 7a, which can be made of soft, plastisol-like material, for example, and sits at the end of the shaft 11 of the insertion aid, which is harder than the tip, for the most atraumatic passage through the urethra possible. The tip 7a preferably has a lumen 12 opening at the end, through which a lubricating substance can be released into the urethra in extension of the shaft 11 of the insertion aid, which is also provided with a lumen.

[0041] The tip 7a of the introducer can have a special, bead-like thickening 7b at the transition to the distal end 5 of the catheter shaft, which elastically narrows under axial tension and thus slides out of its relative position at the transition to the catheter tip during retraction. The bead 7b can optionally be provided with longitudinal, strip-like weakenings, which, when a certain tensile force is overcome, lead to the collapse of the bead, thus facilitating the retraction of the bead-like formation through the lumen of the catheter. The bead 7b, in conjunction with the front opening 5 of the catheter, forms a transition that is as seamless and atraumatic as possible.The bead also allows the substance applied into the urethra during catheter insertion to be dammed up in front of the distal catheter end 5 and pushed forward of the catheter end, ensuring that a sufficient amount of the substance remains available in the area in front of the catheter tip during urethral passage of the catheter. This allows for an optimal lumen-uprighting effect during insertion of the catheter into the urethra, particularly when applying gels.

[0042] Fig. 2a . When using harder materials or materials with a higher elastic restoring force, the tip 7 of the insertion aid 4 can also be provided with a wavy profile 7c, which makes the tip flexible and axially bendable on all sides, but retains the lumen 11 of the insertion aid. When catheterizing through the urethra, particularly advantageous, atraumatic insertion properties can be achieved by the wavy profiling.

[0043] Fig. 2b A correspondingly corrugated profile 7c can also be formed in the area of ​​the catheter tip 5 of the bladder catheter shaft. When placed in situ, the tip can be bent into a laterally bent position P, thereby avoiding direct, lancing irritation and, in the case of long-term placement, ulcerative lesions of the bladder roof resting on the tip.

[0044] Fig. 2cshows a special design of the insertion aid 4, in which all functional segments, including the substance-absorbing container 8 at the proximal end, are formed from a single blank, preferably by blow molding from a tubular base body. The distal portion of the insertion aid can optionally be provided with a corrugation to support axial bending. Furthermore, proximal shaft portions of the insertion aid can also be provided with a corresponding, corrugated profile in certain sections advantageous for facilitated urethral passage. In addition, the insertion aid can be provided in the proximal segment with a congruently precisely shaped segment 9 to support the position-securing fit in the urinary catheter connector 10.As an alternative to complete blow molding from a single blank, the insertion aid according to the invention can also be partially or completely manufactured by injection molding, casting or by dipping processes.

[0045] The insertion aid is preferably made of a material with good gliding properties, which is crucial for comfortable retraction from the indwelling part of the device. To achieve this gliding property, the base material used can, for example, be treated with a wax additive that forms a film on the surface that reduces frictional resistance.

[0046] Fig. 2d shows a modified version of the Fig. 2cpresented design, wherein the reservoir container 8a represents a self-contained unit, structurally unconnected to the insertion aid 4, which has a connector-like extension 9a that is precisely inserted into a shape-congruent receiving funnel 9b. The apical end of the container has a particularly thin-walled or otherwise preformed surface 9c, which is perforated, for example, by a thorn-like extension 9d of the shaft portion, which extends into the receiving funnel, when the container is inserted, and thus allows the transfer of substance into the inserted combination of catheter and insertion aid prepared for use. This design is particularly necessary for substances that require special sterilization methods that differ from the sterilization of the actual catheter set, as may be the case, for example, for gel-like compounds.The container can therefore be added separately to the catheter set and only inserted into the end piece of the introducer immediately before catheterization.

[0047] Fig. 3ashows a special design of the transurethral shaft segment 12 of the catheter. To ensure the largest possible drainage diameter inside the shaft, the shaft wall is preferably made of thin-walled PUR, PVC, or PVC / PUR blend material. To stabilize the thin-walled shaft structures and prevent possible lumen closure due to kinking or torsion of the shaft, the invention proposes a wavy profile 13 of the shaft wall in the manner of a corrugated hose. The wavy "corrugation" of the shaft makes the respective hose flexible and reduces any elastic recovery effects or stresses caused by the bending.These restoring effects exert permanent forces on the exposed tissue. Particularly when using PUR, the achievable, kink-free bending radius of the catheter shaft is limited without appropriate profiling of the shaft. Furthermore, in contrast to PVC, PUR exhibits a significantly higher elastic recovery effect when bent. The described corrugation 13 of the catheter shaft can be applied continuously over its entire length or only in specific areas where, when placed in situ, a particularly small bending radius with correspondingly low elastic stress is required.

[0048] For example, the corrugated shaft can have the following features: outer diameter 6.0 mm, inner diameter 5.4 to 5.9 mm, preferably 5.6 to 5.8 mm, polyurethane with a Shore hardness of 85A or 90A, corrugation amplitude 1.0 to 1.5 mm, peak-to-peak distance of the corrugation 0.5 to 1.5 mm.

[0049] Fig. 3b shows a particularly thin-walled transurethral shaft tube 14 of the indwelling unit 2, the wall of which is reduced to a film thickness of approximately 0.05 mm, for example. One advantage that can be achieved is that such a thin shaft tube 14 can optimally adapt to the course of the urethra, so that even with extended use, for example, one or more weeks, there is no risk of injury to the inner wall of the urethra.

[0050] To avoid lumen-closing kinks and torsions of the tubular film 14, this is supplemented, for example, with a preferably freely located, rod-, tube- or hose-like element SE1, which is Fig. 3bshown above, and connects the intravesical segment VS of the catheter across the length of the urethra to the extracorporeal connector part KO in a correspondingly stabilizing manner. In the case of a tube-like design of the SE1 element, its lumen can be used to fill the retaining balloon.

[0051] On the other hand, to stabilize a thin-walled tubular film-like shaft hose 14, its wall can also be reinforced, for example, by a net-like structure SE2, which is preferably applied to the inner surface of the hose 14 in a flat and firmly bonded manner. A corresponding net-like braid SE2 can also be permanently installed between two coaxially arranged tubular film layers, for example, coextruded with these layers. Instead of a net-like braid, a spiral arrangement or another flat arrangement with sufficient self-erecting properties can also be used.

[0052] It is precisely these self-righting properties that give the otherwise very flexible tubular film 14 the ability to resist tendencies toward kinking and / or to reverse or reset any torsion that has occurred in the tubular film 14. Both measures serve to keep the lumen within the film-like tubular film 14 open.

[0053] Fig. 4shows a reservoir-like container 8, which allows for the precise, controlled delivery of a lubricant into the urethra. The container is preferably designed as a bellows-like vessel, which locks into the inserted position when the bellows is pushed together by pressure on the base 15 of the container, thus not returning to its upright initial position due to elastic action when the bellows is released. The container can have colored areas 16 that correspond to specific quantities of the substance to be applied. If the marked segments are compressed or collapsed together, the volume corresponding to the marked segments is released.

[0054] Fig. 5shows the front section of a bladder catheter with an introducer aid 4 positioned therein for the application of a lubricating and / or lumen-enhancing substance. In order to prevent the substance stored in the introducer aid from drying out, the front outlet opening 12 of the introducer element is provided with a closure element 17, which hermetically seals the opening 12 of the introducer aid. The lower part of the element 17, which closes the opening, is surrounded by a bag- or fingerstall-like film sleeve 18, which surrounds the catheter shaft with a certain gap SR. The film sleeve preferably has a length of approximately 8 to 12 cm. If the closure 17 is removed from the outlet opening of the front opening of the introducer aid, gel can be injected into the gap by compressing the reservoir container, where it is evenly distributed.The amount of gel required to fill the gap can be specified, for example, by color-coding segments of the reservoir container. The user collapses the marked segment by applying axial thumb pressure to the bellows base, thus delivering the required volume into the gap.

[0055] In addition to color-coding bellows segments, differentiated sections of the reservoir container, particularly differentiated segments of a bellows, can enable tactilely detectable or oriented partial release. For example, the proximal bellows folds directly adjacent to the bellows base can be softer or stiffer relative to the distal bellows folds.be designed to be compressible with less resistance, so that the user, after an initial compression of the bellows to release a first portion of the lubricating and / or lumen-erecting substance from the proximal segment of the bellows, perceives a palpable, increased resistance at the transition to the distally adjacent bellows segment, which signals to him that the first portion has now been released and that the distal end of the catheter device should first be inserted into the urethra before the second portion of the lubricating and / or lumen-erecting substance is released.

[0056] Immediately before inserting the catheter into the urethra, the cap is then pulled frontally away from the catheter using the closure element attached to it at the apical point. To prevent accidental insertion of the foil cap into the ostium, the cap is preferably provided with a thumb-sized, leaf-like projection at the apical point, which also facilitates the removal or removal of the cap.

[0057] Fig. 6shows an optional, bellows-like container 19 for filling the retention balloon, preferably with air. The bellows also preferably has a locking fold, which ensures that the bellows 19 does not elastically straighten upon release, thus sucking the filling medium out of the retention balloon. To determine the air volume, the bellows 19 can be provided with color markings 20, which accordingly specify the desired inflation level of the retention balloon, so that, for example, it can be partially inflated with approximately 10 ml of air.80% of its free balloon volume can be filled, indicating complete inflation, or even creating an inflation that places the balloon into a moderately pressurised, expanded state. The bladder catheter is accordingly equipped with a closure or valve element for filling the retention balloon, which allows self-sealing decoupling of the container from the catheter following inflation. The connection cone 21 of the container is preferably designed such that, when attached, it opens the valve and allows inflation. If the cone is withdrawn from the valve, the valve closes.

[0058] Fig. 7The illustrated U-shaped configuration of the catheter set device S shown here, consisting of a bladder catheter 1 according to the invention, an insertion aid 4 inserted into the draining lumen of the catheter, and coupled reservoir containers 8, 19, is ensured by a holding device 22 whose shape is adapted to the palm of the user's hand, which on the one hand receives and fixes the proximal, connector-side end of the catheter, and on the other hand grips the distal shaft portion of the catheter. The holding device optionally has a palmar handle 23 for secure gripping of the holding device. The thumb-side portion of the holding device DH receives the proximal part of the catheter arrangement. In a preferred embodiment, the connector portions of the catheter arrangement are fixed in precisely fitting preformations of the handle or the holding device, for example in a locking manner.The fixation provides sufficient abutment so that, for example, thumb pressure on the reservoir base can transport gel to the catheter tip without the pressure of the thumb causing the connector parts to become detached from the fixation. On the other hand, after the catheter has been inserted or secured in the bladder, the entire proximal connector part must be able to be removed from the locked position by the user with appropriate resistance. C-shaped recesses that accommodate the catheter shaft or the connector parts are advantageous in this case. The respective parts of the device snap into a preferably elastically deformable holding clasp. By convex deformation or curvature of the holding device, for example by squeezing the holding clasp in the palmar hand, the C-shaped profile of the recess can be opened and the catheter released.

[0059] In particular, the gel container 8 is positioned in the clip or handle in such a way that it can be easily compressed by the user using thumb pressure. The filling container for blocking the balloon can be arranged adjacent to the gel container. It can be compressed or squeezed out in a similar manner using thumb pressure. A balloon-like, air-filled version can, for example, be embedded in a spoon-like recess 24 in the clip or handle, where it rests on a counter-bearing.

[0060] To ensure protection against contamination of the catheter during catheter insertion, the holding device is equipped with a thin-walled, bag-like film 27. The bag film protects, in particular, the catheter section extending from the gripping forceps or pliers 25 to the connector of the catheter device. The protective bag is designed to accommodate the looped, central catheter shaft. The film protection allows the user to forgo the use of sterile gloves and to insert the catheter equipped with the invention or fixed in the holding device in a sterile manner.

[0061] Fig. 7adescribes a special, tweezer-like or forceps-like clamp 25 that is attached to the side of the holding device 22. If the rocker 26 is loaded with thumb pressure, the clamp grips the catheter shaft 2 to be inserted. If the rocker is released, the clamp can be moved into a new position relative to the catheter shaft. The rocker-like or forceps-like clamp is preferably designed such that the gripping elements are claw-like, and the claws have a certain projection 36, which, while allowing the catheter to be axially moved within the claw when the forceps are not loaded, prevents the catheter from being fully released from the holding device, and only enables this when the rocker is actuated in the opposite direction.

[0062] Once the approximately front ten centimeters of the catheter shaft, which has been moistened with a lubricating substance, have been inserted into the urethra, the catheter shaft is released from the clamp by releasing the rocker. This rocker is then moved proximally along the shaft, where the clamp re-engages the shaft when pressure is applied to the rocker. The catheter shaft can then be gradually advanced into the urethra by the user, similar to a forceps or pliers-like guide. Once approximately two-thirds of the shaft length has been inserted into the urethra, the catheter is secured by inflating the balloon, and the catheter is completely removed from the retaining depressions or formations of the holding device.

[0063] Fig. 8shows a special design of a perforated cloth 28, which consists of two layers of a preferably nonwoven material, wherein the two layers are tightly connected to one another in the area of ​​the centrally arranged hole 29 by a seam 30 by means of adhesive or welding. The user picks up the cloth by reaching into the space Z between the two layers with the C-shaped open hand and finally grasping the hole 29. The direct guidance of the hole by a C-shaped grasp with the thumb and index finger allows the opening to be brought closer to the areas surrounding the orifice to be cleaned in an optimally modelled manner, or to grip the penis in an optimally supportive manner or to spread the labia.As an alternative to a gap Z, the perforated sheet 28 can be equipped on the side 28a facing the patient with a generously dimensioned, stylized, glove-like element 31, the back of which is flatly connected to the side 28a facing the patient. As a further, less preferred embodiment, the element 31 on the palmar side can be connected to the side 28b of the perforated sheet facing away from the patient. The perforated sheet can be provided with a continuous slit 32 towards the periphery of the sheet, starting from the hole. The sheet can furthermore be equipped with blister-like compartments 34 preformed for the individual absorption of soaked swabs, preferably arranged in a line above the ulnar edge 33 of the hand receiving the perforated sheet. The blister is sealed towards the user with a tear-open film 35.The individual swabs are grasped by the user using a stamp-like extension enclosed in a protective film and are then removed from the blister.

[0064] The invention further describes a method for catheterizing a patient's bladder, wherein the number of required components for the cleaning and insertion process is reduced to a minimum. The catheter device described in accordance with the invention, which is prepared ready for use, is advantageously combined with a glove-like perforated drape 28 that directly grips the penis or spreads the labia. Like the catheter device, this perforated drape is specifically designed for one-handed handling. Combining the two functional units—the glove drape and the catheter device—allows the user to perform the entire catheterization procedure without the need for an assistant.

[0065] Both functional units are packaged together in a single set. After opening the outer packaging of the set, the user reaches directly into the glove-like perforated drape unit and removes it from the set. The user then directly grasps the penis or spreads the labia. This allows the drape to be positioned in an optimally protective position relative to the orifice to be cleaned and catheterized. The user then unfolds the lateral sections of the drape as needed and attaches them to the patient's abdomen, thighs, or buttocks using appropriate self-adhesive areas.

[0066] As a special feature, the glove wipe 28 optionally features blister-like, deep-drawn film compartments 34 integrated into the wipe. These compartments are opened by tearing or peeling off a protective film 35 with the free hand. They contain ready-to-use, antiseptic-soaked swabs for skin and mucous membrane cleansing. The swabs are removed from the blister using a stamp-like grip, which is protected by a closed, deep-drawn film, thus allowing the user to grip them directly and without contamination. The swabs can then be dispensed onto the perforated wipe or into a pocket-like formation attached to it.

[0067] After cleaning, the user grasps the catheter device with their free hand and inserts the distal catheter portion, lubricated with gel and stabilized by the insertion aid, into the urethra. Reinforced by the insertion aid and guided like a lance by the holding device, they then apply any remaining substance in the reservoir into the urethra using thumb pressure and advance the catheter into the bladder by successively grasping and releasing the catheter shaft with the clamp of the holding device. During catheter insertion, the user adjusts the penis through the perforated drape to the optimal position by direct gripping or maintains optimal labia open by digital spreading.

[0068] Once the two anterior thirds of the catheter have been inserted into the urethra, the catheter balloon is blocked by squeezing the filling container with the thumb. The hand is then removed from the glove and cloth combination, and the proximal portion of the catheter is retracted from the holding device.

[0069] The introducer is then retracted from the device and the filling container is removed from the catheter valve. The catheter is then connected to a urinary tubing-bag unit.

[0070] The retaining balloon component of the urinary catheter is preferably blow-molded from a polyurethane tubing blank previously blown in a separate manufacturing step, preferably in the Shore durometer range of 80A to 95A, particularly preferably between 85A and 90A. The wall thickness is preferably 5 to 25 µm, particularly preferably 7 to 12 µm. Using materials such as PUR from the Elastollan 1100 group from BASF or PUR from the Pellethane 2363 grade from Lubrizol, soft film-like structures can be blow-molded from pre-extruded material, ideally combining minimal wall thickness with high dimensional stability. Micro-thin PUR balloon components ensure a reliable anchoring effect, particularly under high outward axial tensile forces.

[0071] In addition to polyurethane, the balloon element can, less preferably, be made from comparable soft films of alternative materials, such as polyethylene-based blends or TPE-based base materials. Coextruded starting materials are also conceivable for blow molding, combining, for example, PUR and PVC in a coaxially extruded manner in the raw tube.

[0072] Also less preferred is the use of conventional sleeve-based, non-preformed, elastically expandable balloon elements. List of reference symbols

[0073] 1 device 20 Color marking 2 Indwelling part, catheter 21 Connection cone 2a gap space 22 Holding device 3 balloon 23 handle 4 Insertion aid 24 spoon-like hollow 5 Great 25 pliers, clamp 6 Drainage opening 26 seesaw 7 opening 27 protective bag 7a Top, top formation 28 perforated cloth 7b bulge, thickening 28a patient-facing side 7c wavy profile 28b side facing away from the patient 8 Reservoir tank 29 Hole 8a Reservoir unit 30 hem 9 segment 31 element 9a Portion 32 slot 9b funnel-like shape 33 edge 9c perforable surface 34 Foil compartment 9d thorn-like extension 35 film, protective film 10 connector 36 Overhang 11 shaft DH thumb-side holding part 12 lumens KO Connector part 13 Section, profile P laterally bent position 14 shaft hose S Set, catheter set 15 Floor SR gap space 16 Segment, area SE1 rod-shaped element 17 Element, closure SE2 Tubular element 18 hood-like element VS intra-vesical segment 19 bellows, container Z space

Claims

1. A system for a catheterization of the bladder of a patient, comprising a device (1) and a compound, wherein the device comprises a) a shaft-shaped, draining indwelling part (2) that can be placed in the bladder and in the urethra in the manner of a catheter, having a urine draining lumen (2a) and at least one drainage opening (6) in the region of the distal tip (5) of the shaft-shaped indwelling part (2); and b) a retractable insertion aid (4) that is inserted into the urine draining lumen (2a) of the shaft-shaped indwelling part (2), which facilitates insertion into and passage through the urethra and has a tubular or hose-like construction with an apical opening (7) for terminal release of a substance in the region of the distal tip of the indwelling part (2); characterized in that c) the substance which is released through the apical opening (7) has lubricating and / or lumen-straightening properties; and d) the shaft portion of the indwelling part (2) which encompasses the urine draining lumen extends from a retention balloon (3) up to a proximal connector (10).

2. The system according to claim 1, characterized in that the substance can be applied from the apical opening (7) of the insertion aid (4) through a draining opening (6) in the region of the catheter tip in such a sealing manner that a reverse flow of the substance into the gap area (2a) between the insertion aid and the draining catheter lumen, which gap area is proximally adjacent at the opening of the insertion aid, is reliably prevented.

3. The system according to claim 1 or 2, characterized in that the distal opening (7) of the insertion aid (4) opens into the draining lumen of the indwelling part (2) directly adjacent to the distal draining opening (6) of the indwelling part (2), or is located in a direct coincidence or common alignment with the draining opening (6) of the indwelling part (2).

4. The system according to one of the claims 1 to 3, characterized in that the tip (7a) of the insertion aid (4) extends beyond the distal, draining opening (6) of the indwelling part (2), preferably whereby the tip (7a) of the insertion aid (4) a) comprises a curved preformation for facilitating passage through the urethra, and / or b) is preformed for an increased flexibility, in particular in a corrugated manner, in order to facilitate a flexible bending of the tip (7a) of the insertion aid (4), which bendability preferably reaches beyond 90 degrees, or in an ideal case beyond 135 degrees, and / or c) in the transition region to the distal opening (6) of the indwelling part (2) comprises a bulge-shaped, bulb-shaped or spindle-shaped cross-section expansion (7b) smoothing the transition, which, under the effect of tensile force, deforms from the proximal side in such a way that the cross-section expansion (7b) can be pulled out through the lumen of the preferably catheter-shaped indwelling part (2).

5. The system according to one of the preceding claims, characterized in that, in the region of a connector (10) of the urinary catheter or of the indwelling part (2), the insertion aid (4) can be secured in terms of its position by slight pressing or locking in its position, and hereto comprises a region (9) formed with a custom-fit and congruent shape.

6. The system according to one of the preceding claims, characterized in that the insertion aid (4) a) has a distal region which is made of a tubular or hose-like extension, optionally reinforcing the device (1), preferably from which a substance-accommodating reservoir unit (8) emerges in a one-piece design, and / or b) has a proximal region which comprises a funnel-like formation (9b), into which a structurally separate reservoir unit (8;8a) can be inserted in a tightly sealing manner via a portion (9a) that is formed with a congruent shape, especially wherein the inserted reservoir unit (8;8a) comprises on the distal end a perforable surface (9c), which can be opened by a thorn-like extension (9d) of the distal region of the insertion aid (4) in the case of a complete, terminal insertion of the reservoir (8;8a).

7. The system according to one of the preceding claims, characterized by a reservoir unit (8;8a) made of a material formed to be bellows-like, which, during compression of the bellows, immobilises in the respective position in an engaging manner and prevents a re-erection of the bellows, preferably wherein the reservoir unit (8;8a) a) comprises segments (16) marked in color, by which, during the engaging compression thereof, the release of a specific volume can be coded, and / or b) comprises segments (16), which, during the manual compression, develop respectively specific folding and / or collapsing resistances, and thus facilitate a tactilely perceptible transition from a first volume quantity to be dosed to a subsequent second volume quantity.

8. The system according to one of the preceding claims, characterized in that the shaft portion of the indwelling part (2) in one or more sections (13) of the shaft is preformed in a corrugated manner, by ehich the axial bending of the shaft is facilitated and elastically acting restoring forces can be reduced in the shaft.

9. The system according to one of the preceding claims, characterized in that the shaft portion in the urethral section or in the section between the retention balloon (3) and the proximal connector (10) of the indwelling part (2) is made of a film-like, thin-walled tube material (14), preferably comprising a) one or more rod-like or tubular structure(s) (SE1) arranged preferably exposed in the inner lumen of the tubular film (14), in particular in order to prevent the occlusion of the drainage lumen as a result of axial twisting or kinks of the tubular film (14), and / or b) a net-like reinforcement (SE2) permanently connected to the tubular film (14) or integrated therein, which reinforcement elastically straightens the lumen of the tubular film (14), in particular in order to hinder axial twisting and / or to return any occurred twisting back into the non-torqued starting position.

10. The system according to one of the preceding claims, characterized in that the distal region of the indwelling part (2) and / or of the insertion aid (4) is provided with a hood-like element (18), preferably wherein the gap space (SR) between the hood (18) and the indwelling part (2) can be filled by a particularly lubricating and / or lumen-straightening substance that is fed into the gap space (SR).

11. The system according to one of the preceding claims, characterized in that the hood (18) apically comprises an e.g. tap-like closure element (17), which is permanently connected to the hood (18), and which seals the outlet opening of the insertion aid (4) in a plug-like manner, and which, after disengagement thereof from the insertion aid (4), facilitates the release of the lubricating and / or lumen-straightening substance from the inner lumen of the insertion aid (4) along with the terminal, reservoirlike expansion (8;8a) thereof.

12. The system according to one of the preceding claims, characterized in that the unit, which consists of the indwelling part (2) and an insertion aid (4) inserted into the indwelling part (2), is inserted in a holding device (23, 25) and is reversibly fastened there, and thereby is put into a U-shaped, sling-like configuration, wherein the distal part of the unit (2, 4) is held by a device (25) opening and closing in a tongs-like or rocker-like manner, and the proximal region of the unit (2, 4) bearing the connector (10) is accommodated in the holding device (25) in preferably C-shaped recesses in such a way that a filling bellows or filling vessel (19) inserted or plugged into the connector part (10) and / or a reservoir vessel (8, 8a) possibly inserted or plugged in there can be compressed or emptied by thumb pressure.

13. The system according to claim 12, characterized in that the proximal region of the indwelling part (2), preferably approximately the proximal half of the indwelling part (2), in particular approximately the proximal two thirds of the indwelling part (2), is accommodated in a surrounding film-like protective pouch (27), which is connected to the holding device (23,25) that is accommodating the indwelling part (2) in a preferably permanent or even detachable manner.

14. The system according to claim 12 or 13, characterized in that the tongs-like or rocker-like device (25) facilitates, in the opening lateral part, an overbite-like gripping (36) of the shaft of the indwelling part (2), which, in case of a disengaging of the indwelling part (2), prevents the shaft (2) of the indwelling part (2) from being able to move out of the grip of the tongs (25) and thus being released from the holding device (25), and the overbite (36) thereof first opens in the case of a maximum opening of the rocker (26) and thereby releases the catheter shaft (2).

15. The system according to one of the preceding claims, characterized in that the material of the indwelling part (2) comprises a Shore hardness (x), and that the material of the insertion aid (4) comprises a Shore hardness (y), wherein the Shore hardness (y) of the material of the insertion aid (4) corresponds to or exceeds the Shore hardness (x) of the material of the indwelling part (2), in other words: y = x , or y > x .