BLADDER CATHETER FOR THE MINIMALLY INVASIVE DISCHARGE OF URINE

Abstract

The invention is directed to a device in the form of a tube or catheter for draining and/or sealing a natural or artificial bladder outlet, comprising a shaft body that can be applied from extracorporeal into a bladder of the patient, as well as a balloon that surrounds the shaft body like a cuff and is placed in the bladder for the purpose of a vesical anchoring of the shaft body in the bladder, wherein the shaft body, which is produced by means of molding, is having a profile with a wavy corrugation, providing the shaft body with a radial stability and with a kink-free axial bending property.

Claims

1. A device in the form of a tube or catheter for draining and/or sealing a natural or artificial bladder outlet, comprising a shaft body that can be applied from extracorporeal into a bladder of the patient, as well as a balloon that surrounds the shaft body like a cuff and is placed in the bladder for the purpose of a vesical anchoring of the shaft body in the bladder, wherein the shaft body, which is produced by means of molding, is having a profile with a wavy corrugation, providing the shaft body with a radial stability and with a kink-free axial bending property.

2. The device according to claim 1, characterized in that the balloon is made from a thin-walled balloon soft-foil material, having a wall-thickness of 5 to 15 micron, and is preferably manufactured by a blow-molding process from a pre-extruded tubing.

3. The device according to claim 1, characterized in that the balloon is pre-shaped to its working dimensions during manufacture and rests upon the shaft body in an only incompletely filled, flaccid state, the filling pressure inside the balloon thereby adapting to a pressure that is acting inside the bladder physiologically.

4. The device according to claim 1, characterized in that an envelope of the balloon has a durometer reading of 70A to 80A, or 85A to 95A or of 55D to 65D on the Shore Scale.

5. The device according claim 4, characterized in that the intra-vesical catheter balloon (IV) comprises a urethral or trans-urethral elongation (TU), that is preferably pre-formed with a “residual” diameter, that exceeds the diameter of the urethral lumen of the patient by 0.5 to 1.0 times.

6. The device according to claim 1, characterized in that the catheter balloon is or can be filled with a gaseous medium, in particular with air.

7. The device according to claim 5, characterized in that the anchoring intra-vesical portion (IV) of the balloon and the sealing urethral or trans-urethral portion (TU) of the balloon placed in situ is to be filled with an incomplete or partial filling medium, which is dimensioned such that the balloon as a whole remains in a flaccid state of expansion, i.e. that the balloon wall is not exposed to a permanent expanding force.

8. The device according to claim 1, characterized by a feed line, that opens directly into a proximal end of the balloon for conducting a filling medium into the balloon.

9. The device according to claim 1, characterized by a feed line gap between a proximal end of the balloon and an outer surface of the shaft body for conducting a filling medium into the balloon.

10. The device according to claim 1, characterized by a feed line, that is positioned inside the urine draining lumen of the catheter shaft, connecting to the catheter balloon through a perforation of the shaft body and connecting outside of the body of the patient to a terminal, preferable one-way valve, which opens when a filling syringe is applied and automatically closes when a syringe cone is removed.

11. The device according to claim 5, characterized in that the urethral or trans-urethral portion (TU) of the shaft body is housed into a mechanically protecting, sheath-like, thin-walled and soft, non-fillable tube-foil component, reaching from the proximal end of the intra-vesical portion (IV) of the balloon or its urethral elongation into or through the urethra.

12. The device according to claim 1, characterized by an antibacterial coating on the surface of the vesical balloon (IV) and/or on the surface of the urethral or trans-urethral balloon portion (TU), and/or on the shaft body, and/or on the sheath-like protecting structure housing in the shaft body inside the urethra.

13. The device according to claim 1, characterized in that the shaft body is made of polyurethane (PUR), PUR-containing or PUR-blended materials or materials with equivalent elastic properties as PUR, with Shore hardness of 60A to 95A or 60A to 90A, or 55D to 65D, preferably in the hardness range of 70A to 90A or of 70A to 85A.

14. The device according to claim 1, characterized in that the outer diameter of the shaft body lies in a range of 2 to 7 mm, or preferred in a range of 3 to 5 mm.

15. The device according to claim 1, characterized in that the wall-thickness of the shaft body is in the range of 0.03 to 0.5 mm, preferably in the range of 0.04 to 0.2 mm, and more preferably in the range of 0.05 to 0.15 mm.

16. The device according to claim 1, characterized in that the wall of the shaft body is having a corrugated profile, wherein the corrugation is having a sinusoidal or a rectangular shape, and wherein the respective wave form can be molded into a ring-like or into a helical structure.

17. The device according to claim 16, characterized in that the amplitude (AP) of the sinusoidal or rectangular wave is less than one third of the outer diameter (OD) and larger than one tenth of the outer diameter of the shaft body.

18. The device according to claim 16, characterized in that the distance (PPD) between the adjacent upper peaks and between the adjacent lower peaks of the wave profile is equal or less than the wave amplitude (AP) of the wave and is larger than one third of the wave amplitude.

19. The device according to claim 1, characterized in that the balloon consists of a single continuous balloon envelope.

20. The device according to claim 1, characterized in that the vesical portion (IV) of the balloon, and/or a urethral or a the transurethral portion (TU) of the balloon is made from one or more separately molded balloon segments of different or of identical polymer materials and/or of different or of identical material durometers, whereby the segments are connected to each other by thermal welding or adhesive or solvent bonding, permitting a freely communicating filling of the balloon segments, whereby the a wall-thickness of the urethral or transurethral segment is preferably equal to or lower than the wall-thickness of the vesical balloon portion.

21. The device according to claim 1, characterized in that the segment of the shaft body that is carrying the vesical balloon and optionally the vesical balloon portion is reinforced by a separately manufactured, tube-like component of preferably elastic material, keeping the draining lumen of the shaft body inside the vesical balloon and optionally the vesical balloon portion open, withstanding a collapse of the lumen at normal intra-vesical pressure.

22. The device according to claim 21, characterized in that the lumen reinforcing tube-like element is made from extruded tubing or made by an injection molding process or casting process.

23. The device according to claim 21, characterized in that the tube-like reinforcing component is carrying a specifically shaped tip formation, facilitating the atraumatic trans-urethral insertion of the catheter through the urethra of the patient, e.g. a so called Tieman tip formation.

24. The device according to claim 1, characterized in that both, the balloon and the shaft body are molded from a single piece of pre-extruded tubing, and whereby the distal, free balloon end is folded back over the shaft body and glued or welded to the outer surface of the shaft body, thereby forming a fillable balloon compartment.

25. The device according to claim 1, characterized in that the corrugated profile of the shaft body is reaching from the bladder to the urethral orifice of the patient or to the proximal end of the catheter, or is molded only into defined segments of the shaft body, preferably where the catheter is positioned inside kinking or bending portions of urethra, reducing the elastic erection effect of the shaft body inside the urethra, thus reducing pressure induced tissue damage.

26. The device according to claim 1, characterized in that the shaft body is able to be elastically deformed radially or is able to be radially folding or invaginating or collapsing inside the urethra by a regarding force exertion onto the shaft body, and is elastically erecting to its pre-formed profile and lumen, when the force exerted onto the shaft body is reduced.

27. The device according to claim 1, characterized in that the shaft body can be axially bent by 60 to 180 degrees, preferable by 90 to 180 degrees, whereby the draining lumen of the catheter is kept open or is only partially reduced, whereby a drainage occluding collapse or a kinking of the shaft body can be avoided.

28. The device according to claim 1, characterized in that the shaft body can be elastically detorquing in axial direction, spontaneously regaining the axially straightened pre-formed shape, when the torquing force is released.

29. The device according to claim 1, characterized in that the shaft body can be axially stretched to a larger length when exerting an axially directed pull force from the outside to it, and is elastically regaining its pre-formed length, once the axially stretching force is released.

30. The device according to claim 1, characterized in that the urethral portion of the balloon body can be dimensioned such that it corresponds to or falls just below the diameter of the respective urethra.

31. The device according to claim 1, characterized in that, alternatively to a partial filling, the balloon body can also be filled with a volume that corresponds to or slightly exceeds the volume of the freely shaped balloon.

32. The device according to claim 1, characterized in that the wavy corrugated shaft body, made from elastically deforming and erecting material, at axial bending of the shaft, is developing a decreased erecting force, elastically straightening the shaft back to its molded shape, avoiding or reducing permanent pressure exertion onto catheter exposed tissues.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Further features, properties, advantages and effects based on the invention arise from the following description of several embodiments of the invention and with the aid of the accompanying drawing. In the drawing:

[0038] FIG. 1 is a longitudinal section through an embodiment variant of the device transurethrally placed in a male urethra;

[0039] FIG. 2a shows a preferred embodiment with free deployment of the balloon, wherein the balloon body has a conical or cone-like shape in the transition from the intravesical to the transurethral segment, and the urethral portion extends into the upper portion of the urethra;

[0040] FIG. 2b discloses a particular embodiment of the balloon body with the balloon freely deployed, wherein the balloon body does not form a bearing surface in the region of the bladder floor or trigone, and is instead positioned within a prostate resection cavity, and transitions from there into a portion of the balloon that is positioned urethrally or transurethrally;

[0041] FIG. 2c is a horizontal section of a balloon segment described in FIG. 2b for the tamponade of a surgically created prostatic fossa;

[0042] FIG. 3a shows a single-lumen shaft variant, wherein the transurethral segment of the balloon body extends beyond the outer urethral opening and is filled directly from the proximal end of the balloon body;

[0043] FIG. 3b is a longitudinal section through a modified embodiment of the device described in FIG. 3a, wherein the proximal balloon end that extends beyond the outer orifice can be fixed or caught by a sleeve- or disk-like element;

[0044] FIG. 3c discloses a further embodiment of the device described in FIG. 3a;

[0045] FIG. 4a is a longitudinal section through an embodiment variant of the catheter for the transurethral sealing of the female urethra;

[0046] FIG. 4b discloses a modification of the device described in FIG. 4a, with a conical embodiment of the urethrally tamponaded transurethral balloon segment;

[0047] FIG. 5 shows another particular embodiment of a catheter shaft, wherein crystalline deposits on the inner and outer shaft surfaces can be avoided by the bellows-like corrugation of the shaft;

[0048] FIG. 5a is a longitudinal section through an example of a molded, urine draining catheter shaft, having a sinusoidal profile;

[0049] FIG. 5b discloses another embodiment of the invention, with an alternative wave form of the corrugation, having a rectangular profile;

[0050] FIG. 6 shows a particularly cost-effective embodiment of the catheter, which is constructed out of a single continuously molded element.

[0051] FIG. 7 discloses another embodiment of a bladder catheter, wherein the lumen of the shaft segment is reinforced by a separately manufactured, preferably injection-molded tipping-component; and

[0052] FIG. 7a shows an embodiment of the device, wherein the complete catheter shaft is made from one single piece of a molded tube.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] FIG. 1 shows a sectional view through a male urinary tract, with a transurethrally placed device 1 according to the invention in the form of an indwelling bladder catheter with a catheter shaft. In this embodiment, the shaft body 2 of said shaft is covered by a balloon 3, which surrounds the shaft body 2 like a cuff over its entire vesical and urethral extent. Preferably, all sections of the balloon 3—both in the vesical region and in the urethral region—are completely formed to the working dimensions that are necessary for the untensioned tamponade of the particular hollow organ. In an especially preferred embodiment, the diameter in the urethral region slightly exceeds the diameter of the urethra. The anchoring and sealing balloon 3 has a bulbous or conical expansion in its intravesical portion IV. According to the invention, configurations of the balloon are preferred that permit the balloon to fit into the outlet portion of the bladder such that it seals as large an area as possible and in this way, in addition to subjecting the bladder trigone BT to force that is as uniform and atraumatic as possible, permit the most efficient seal possible with the lowest possible filling pressure.

[0054] The urethra-side end of the balloon element 3 transitions into a streamlined urethral extension TU. As is shown here, the urethral extension can extend over the entire length of the urethra and beyond the outer ostium.

[0055] The diameter ratio of the vesical expansion IV to the urethral extension TU is preferably 2:1 to 6:1, especially preferably 3:1 to 4:1. The wall thickness in the region of the intravesicular expansion IV is preferably 5 to 30 micrometers, especially preferably 10 to 15 micrometers. In the transurethral segment TU, the balloon is preferably 10 to 30 micrometers, and especially preferably 12 to 20 micrometers.

[0056] In the embodiment shown, the balloon element 3 is filled through a filling channel, which is integrated into the catheter shaft and transitions to a tube-like filling line 6 at the proximal end of the shaft. For the greatest possible reduction of the filling pressure or of the forces exerted on the adjacent tissue by the device, the balloon body is filled only incompletely, e.g. to 60 to 80% of its freely formed and unpressurized volume. The conceptually preferred flaccid or untensioned property of the balloon 3 filled in this way permits the flaccid balloon envelope to nestle intravesicularly against the individually distinct wall of the outlet portion of the bladder in a way that creates an optimal seal. The pressure taken on intravesicularly from the flaccidly filled balloon 3 has a sealing effect over the surface in the urethral segment TU of the balloon 3. Ideally, the lower urinary tracts can thereby be sealed while placing the catheter in a way that is nearly pressure-neutral overall.

[0057] The balloon 3 can be filled both with gaseous and with liquid media.

[0058] In the preferred polyurethane embodiment of the balloon element 3, gaseous media, such as ambient air, offer the further advantage of tissue-conserving compressibility. Additionally, in contrast to liquids, they can be applied easily and can also be monitored and adjusted with the aid of a pressure regulator.

[0059] The urethral extension TU can project directly out of the vesical segment 4 of the balloon 3, but it can also be affixed to the vesical balloon in the proximal extension as a structurally independent compartment. The vesical balloon segment 4 and the adjoining urethral balloon segment 5 are then communicatingly connected with each other.

[0060] In a sequential arrangement such as this, various materials can optionally also be combined. If required, extremely thin walls in the range of 5 to 10 micrometers can also be produced in the urethral balloon section 5, and they correspondingly improve the urethral sealing performance over the wall thickness-related seal that is achieved by molding from a single blank.

[0061] In addition to polyurethane, the balloon element 3 can be manufactured from comparably thin-walled soft films, alternative materials such as polyethylene, polyvinyl chloride or TPE-based basic materials. However, the specific properties of polyurethane with a Shore hardness of 70A to 95A are preferred, and Shore hardness of 85 A to 90 A are especially preferred. The production is preferably carried out by blow molding pre-extruded tubing material. Coextruded starting materials, which combine e.g. PUR and PVC in a coaxially extruded way, can also be considered for the blow molding.

[0062] FIG. 2a presents a preferably molded balloon body 3 that is freely deployed. Here the intravesical portion IV of the balloon 3 tapers conically in the transition area toward the transurethral extension TU of the balloon 3. In this particular embodiment for the male urethra, the transurethral extension TU extends only up to the transition from the upper third to the central third of the urethra.

[0063] Preferably, the distal end of the balloon is provided with a funnel-like inversion TM, the outlet SM of which is positioned approximately at the level of the transition or bladder trigone BT when filled and placed in the vesicle. The stability of the funnel formation can be stabilized by a separate funnel-like element TMV consisting, for example, of reinforcing film.

[0064] In this instance, the filling line 6 to the catheter balloon is provided with a display mechanism 7 at its free end that displays the filling pressure and allows changes to be made in vesicular, and largely analogously, in intra-abdominal pressure in a simple way. For this purpose, the balloon is preferably filled with an incomplete filling volume, which leaves the balloon in a flaccid and unexpanded state, which in turn allows it to accurately take on the respective prevailing vesical and intra-abdominal pressures. The device can thus be used as a technically simple alternative to systems with complex designs for measuring the absolute intra-abdominal pressure and can display relative changes in pressure in the abdomen.

[0065] FIG. 2b shows an embodiment of the balloon body 3, in which said balloon body does not form a particular bearing surface in the region of the bladder floor or trigone, but is instead positioned within a prostate resection cavity PH, and transitions from there into a balloon segment TU that is positioned in the urethra. The balloon portion TP that is molded for placement in the cavity formed after the resection of the prostate nestles against the situs in a space-filling way. The balloon portion TP is preferably dimensioned such that it exceeds the measurements of the respective prostate resection cavity and that it lies folded against the wall of the respective cavity in such a way that it is optimally untensioned while also providing an optimal seal.

[0066] This embodiment is advantageous primarily for patients whose bladders close insufficiently as a result of a resection or in whom urine permanently penetrates into the resection cavity and from there drains into the urethra. In order to optimize the untensioned snug fit of the balloon envelope in the prostate cavity, the balloon portion TP can be provided with an axially attached, bellows-like profile TPF. Resection cavities with irregularly shaped diameters can thus be tamponaded in a particularly advantageous way with a dynamic effect on the structures abutting the balloon that is as homogeneous as possible. If the external sphincter of the bladder is also affected in addition to the internal sphincter, the insufficient closure caused by this can be efficiently sealed by the urethral extension TU of the balloon body, which is elongated beyond the structures of the pelvic floor.

[0067] FIG. 2c shows the fold F in the residually dimensioned balloon envelope TP, which is accommodated in the transversal section when positioned in the prostate cavity. In particular for prominent structures that protrude into the fossa or for parts of the cavity wall, a uniformly efficiently sealing tamponade of the resection cavity can be established by the residual sizing of the balloon.

[0068] FIG. 3a describes an embodiment of the invention in which the proximal end of the urethral balloon segment PU projects beyond the outer end of the urethra. The balloon element 3 is filled through a feed line here, which is connected directly to the extracorporeal, proximal end of the urethral balloon segment PU. The balloon envelope is closed proximally by a separate element 8, which closes the balloon 3 in the proximal direction and which is clamped into the proximal end of the envelope PU. The closure element 8 has an opening 9 that sealingly accommodates the urine-discharging catheter shaft 2. The opening 9 itself can be provided with a lip-like or ring-like sealing element 10, which makes the closure element, as well as the pre-urethral balloon end PU attached to it, displaceable relative to the shaft 2. The balloon end of the urethral tamponading balloon portion, which extends beyond the urethral opening, can thus be compressed toward the glans in the manner of a bellows or its length can be adjusted.

[0069] Alternatively, an extension of the balloon envelope itself that is suitable for connecting a flexible supply line can be formed in the region of the proximal balloon envelope.

[0070] FIGS. 3b and 3c show two alternative embodiments which concern fixing the pre-urethral portion of the tamponading balloon 3 in place and cutting it to size. For one thing, according to FIG. 3b, the proximal balloon end can be provided with a disk 11 consisting of an elastic material and having a central opening 12, said disk being mounted on the catheter shaft 2 with sealing tension. By its pressing effect on the shaft, the disk 11 limits the pre-urethral expansion of the tamponading balloon and prevents the balloon portion proximal to the disk from filling. According to FIG. 3c, a sleeve-like elongate element 13 can be integrated into the device and is displaced from the proximal end of the shaft over the pre-urethral end of the balloon PU, and the area of deployment of the balloon envelope upstream of the urethral opening is limited in this way.

[0071] FIG. 4a shows a specifically shortened embodiment of the urethral tamponade TU for the female urethra. In this embodiment, the urethral segment TU preferably extends through the urethra. It has a length of 2 to 6 cm, preferably 3 to 4 cm. The proximal end of the trans-urethral segment TU transitions to a preferably spherical or discoidal expansion of the balloon envelope 14, which is deployed directly upstream of the outer urethral opening.

[0072] Because the length of the urethra varies among individuals, this embodiment is preferably equipped with a claimed element 11 and/or 13 which, as is shown in FIG. 3a, permit a pre-urethral sizing and fixation of the balloon envelope.

[0073] Since the female urethra is generally similar in length but has a variable diameter, depending upon the individual sphincter tone, the invention proposes a conical expansion of the diameter of the trans-urethral segment TU extending from the inner entrance of the urethra to the outer outlet of the urethra, as is shown in FIG. 4b.

[0074] In the embodiments according to FIGS. 4a and 4b, the closure element 8 described in FIG. 3a, which can be displaced relative to the shaft body 2, can be used advantageously to receive the proximal end of the pre-urethral segment PU. It permits the length-adapting compression of the extracorporeal end toward the orifice, wherein the element 8 advantageously immerges into the pre-urethral, spherically or discoidally expanded segment and is thereby protected from direct contact with the sensitive orifice. The elements 11 and/or 13 for fixing the extracorporeal balloon in place or cutting it to size can likewise be combined with this design.

[0075] The embodiments described in FIGS. 4a and 4b can also advantageously be utilized for so-called supra-pubic catheters, in which the transcutaneous puncture channel is similarly tamponaded by a balloon extension that is adjacent to the vesical balloon portion. The techniques described in the invention for fixing the extracorporeal balloon segment in place and cutting it to size can be used here, as well.

[0076] Furthermore, the embodiments described in FIGS. 4a and 4b can be employed as a urethra closure device in cases of functionally insufficient sphincters and urinary incontinence. In this case, the draining shaft element can be replaced by a blind tubule, which in particular is designed to be so kink-resistant that it allows for self-catheterization by the patient. When the balloon body is correspondingly thin-walled with a thickness in the micrometer range, e.g. 5 to 15 μm, minimally irritating, easy-to-wear stopper-like closure products can be produced in particular for women with stress incontinence.

[0077] FIG. 5 shows a particular embodiment of a urine-discharging catheter shaft 14 which is made of an elastic material, and which has walls that are provided with a wave-like profile 15 over the entire wall, wherein the profile gives the shaft bellows-like compression and extension mechanics. The intermittent axial stretching of the bellows-like shaft body 2 makes it possible to break off the crystalloid urine deposits, which lead to a progressive narrowing of the lumen during the course of drainage in conventional urine-discharging catheters, in a way that opens the lumen and to remove them from both the inner and outer walls of the catheter. If the pulling effect decreases, the shaft's particular elastic deformation property results in a prompt restoration of the bellows-like profile. The axial increase in the length of the shaft triggered by the axial pulling effect preferably arises even in response to small relative movements between the patient and catheter or minor tensile forces. The wave-like, corrugated profile of the catheter shaft further reduces rebouncing effects of the catheter shaft bodies, made of elastic materials, spontaneously erecting axially bent or kinked catheter shafts back to their straight, molded base shape, thereby exerting a local force onto the catheter exposed portions of the urethra, that are bent or kinked, causing a local impairment of perfusion and associated tissue damage. Furthermore, the corrugation of the thin-walled wall of the elastically performing shaft body provides it spontaneous, elastically lumen opening and stabilizing properties at radially directed deformation as well as at axially directed bending or torquing.

[0078] FIG. 5a is showing an example of a molded, urine draining catheter shaft, having a sinusoidal profile, whereby the peak to peak distance PPD and the amplitude AP of the corrugation wave is following the geometrical description: The amplitude AP of the sinusoidal wave is less than one third of the outer catheter shaft diameter OD, and is larger than one tenth of the shaft OD. The distance between the adjacent upper peaks as well as the distance between the adjacent lower peaks of the profile (PPD) is equal or less than the amplitude of the wave profile and is larger than one third of the wave amplitude.

[0079] FIG. 5b is showing an alternative wave form of the corrugation, having a rectangular profile, characterized by small radiuses R, preferably in the radiuses being in the order of equal or less than 0.1 mm. The molded profile follows the description: The amplitude AP of the rectangular wave is less than one third of the outer catheter shaft diameter OD and larger than one tenth of the shaft OD. The distance PPD between the adjacent upper peaks as well as the distance between the adjacent lower peaks of the profile is equal or less than the amplitude of the wave profile and is larger than one third of the wave amplitude.

[0080] For both above specified wave forms, a preferably thermoplastic polyurethane is used, made form material with a durometer of 70A to 95A, or a durometer of 55D to 65D. Alternatively to a thermoplastic TPU, blended materials, containing TPU can be used, as e.g. TPU/PVC blends, or materials with TPU comparable elastic properties.

[0081] The catheter shaft component is preferably manufactured in a blow-molding process, whereby pre-extruded tubing is blow-molded into a shape-giving molding heated tool and then cooled down to a demolding-temperature, thereby adapting the profile of the tool.

[0082] Both wave forms can be molded on the basis of individual ring-like structures or as continuous helix-like/spiral-like structures.

[0083] Depending on the combination of material type, material durometer and an above specified wave form, the molded shaft body can have a thickness, ranging between 0.03 mm and 0.50 mm, preferably ranging from 0.04 mm to 0.20 mm and most preferably ranging from 0.05 mm to 0.15 mm.

[0084] FIG. 6 represents an embodiment of the urine-discharging device, the components of which are molded almost completely from one single material blank, preferably by blow molding. In so doing, the end of the molded balloon body 2a is inverted through the other end 2b of the balloon. The end 2b is then sealed to the surface of the end 2a that is elongated to the discharging tube. The claimed anchoring and sealing balloon body with a vesical IV and a transurethral portion TU is formed in this way. To configure the urine-discharging shaft portion 2 to be sufficiently kink-resistant and flexible, the shaft is provided with a wavy corrugation 15, in the manner of a corrugated tube, over its entire length or else only in some sections. For example, polyurethane types advantageous for balloon molding, having a higher durometer of 70A to 85A, of 90A to 95A, and of 55D to 65D of the Shore scale can be used; when combined with a lumen-stabilizing, corrugated tube-like profile, these polyurethanes provide sufficient stability for the lumen in the shaft area, even in a thin-walled embodiment, as well as sufficient untensioned flexibility of the shaft. The shaft body can be preferably molded with the features, described in FIGS. 5A and 5B, or can comprise the following features, for instance: Outer diameter 3.5 mm, inner diameter 3.2 mm, polyurethane with Shore hardness 95 A, corrugation amplitude 0.7 mm, peak-to-peak spacing of the corrugation 0.5 mm. The molded balloon portion comprises: Wall thickness vesical −10 μm with a maximum diameter of 25 mm, wall thickness transurethral −20 μm with a maximum diameter of 10 mm. The balloon is filled preferably through a feed line 17, which is inserted into the joining region of the balloon end 2b on the shaft, between the shaft and balloon end, and empties here into the balloon. The feed line is preferably retained in an enveloping tubular film 18 that attaches to the balloon end 2b and preferably extends over the entire length of the shaft.

[0085] The figure is further showing a particular lumen stabilizing tube component 19, which is glued or welded onto the inside or the outside of the catheter shaft body, within the segment of the catheter shaft, that is carrying the vesical retention balloon IV as well as, optionally, the urethral extension TU of the balloon. Preferably, the reinforcing tubing component is made from softer grade, injection-molded PUR material, whereby the distal tip of the molded component is atraumatically rounded, so that injuries of the urethra during urethral insertion can be reduced.

[0086] FIG. 7 shows a specific design of a bladder catheter, whereby the lumen of the shaft segment, that is carrying the balloon and, optionally, the balloon extension into the urethra, is reinforced by a separately manufactured, preferably injection-molded, softer grade tipping-component 21, having a characteristic tip shaping, according to established tip shapings, as e.g. the so-called Tiemann tip 22. The tipping-component can have an in-molded opening 23 for insertion of a feed line for filling the balloon, whereby the feed line 24 is running freely through the draining lumen of the catheter shaft. The molded component 21 can be connected to the molded catheter-shaft 25 by gluing or welding it to an accordingly shaped, adaptor segment 26, which is molded into the distal end of the catheter-shaft, taking up the component in a female connection. The balloon ends BE are fixed onto the outer surface of the insertion piece.

[0087] Due to the low wall-thickness and therefore reduced stiffness of the catheter shaft body, the urethral insertion can be facilitated by a removable, rod-like insertion aid 27, which is positioned inside the urine draining lumen, providing the catheter shaft the necessary mechanical stiffness and guidance for insertion.

[0088] FIG. 7a shows an embodiment of the device, whereby the complete catheter shaft, reaching from the proximal connector outside of the patient to the catheter tip, is made from one single piece of molded tube, comprising a tip formation 28 that has a molded, corrugated profile, providing the tip with particular bending properties, reducing the traumatizing effect of the tip during urethral insertion of the catheter and a potential chronical erosive trauma of the bladder roof, further comprising a balloon carrying segment 29 with or without a corrugated shaft wall, and comprising the proximal catheter portion 30, leading through the urethra to the outside of the body. The outside of the balloon carrying shaft segment 29 can be reinforced with a lumen stabilizing component 19. The insertion of the catheter can be facilitated by an insertion aiding rod or tube component 27.

LIST OF REFERENCE SIGNS

[0089] 1 Device [0090] 2 Shaft body [0091] 3 Balloon [0092] 4 Vesical balloon segment [0093] 5 Urethral balloon segment [0094] 6 Filling line [0095] 7 Display mechanism [0096] 8 Closure element [0097] 9 Opening [0098] 10 Annular sealing element [0099] 11 Disk [0100] 12 Opening [0101] 13 Sleeve [0102] 14 Catheter shaft [0103] 15 Wave-like profile [0104] 17 Feed line [0105] 18 Tubular film [0106] 19 Tube component [0107] 21 Tipping component [0108] 22 Tiemann tip [0109] 23 Opening [0110] 24 Feed line [0111] 25 Catheter shaft [0112] 26 Adaptor segment [0113] 27 Tube component [0114] 28 Tip formation [0115] 29 Shaft segment [0116] 30 Proximal catheter portion [0117] IV Intravesical portion [0118] BT Bladder trigone [0119] TU Transurethral extension [0120] TM Funnel outlet [0121] TMV Funnel reinforcement element [0122] PH Prostate resection cavity [0123] TP Balloon envelope [0124] TPF Bellows-like profile [0125] F Fold [0126] PU Envelope end