Device for stool drainage

Abstract

Device for the continuous drainage of stool from the rectum of a patient and / or for the supply of irrigation fluid to the rectum, comprising a balloon with an intra-rectal anchor balloon (1) and a trans-anal intermediate segment (2), wherein polyurethane or a material with similar technical elasticity and strength properties is used as the base material, wherein the intra-rectal anchor balloon (1) and the trans-anal intermediate segment (2) are manufactured from a single, common, previously fully formed tubular balloon blank, wherein one end (5a) of the tubular balloon is inverted through the other end (5b) and the two ends (5a, 5b) lie concentrically against each other in the trans-anal section of the device, and wherein the intra-rectal anchor balloon (1) is separated from the trans-anal intermediate segment (2) and permanently sealed in a tightly closing manner by a direct connection of the inverted balloon ends (5a, 5b) in the contact area (6).

Description

[0001] The invention relates to a device for the continuous drainage of stool from the rectum of a patient and / or for the supply of irrigation fluid to the rectum, comprising a balloon with an intra-rectal anchor balloon and a transanal intermediate segment, wherein polyurethane or a material with similar technical elasticity and strength properties is used as the base material, wherein the intra-rectal anchor balloon and the transanal intermediate segment are made from a single, common, previously fully formed tubular balloon blank, wherein one end of the tubular balloon is slipped through the other end and the two ends lie concentrically against each other in the transanal section of the device.

[0002] Devices for the continuous drainage of stool from a patient's rectum into an external, bag-like collection vessel have been known for some years, but are still not widely established in clinical practice.

[0003] For the drainage and collection of stool in immobile, non-cooperative patients, so-called fecal collectors are preferably used. These are bag-like structures that are adhered to the anal cleft directly above the anal opening. Although the pre-anal adhesive is generally sufficiently adhesive and sealing for shorter application intervals, maceration of the exposed skin is frequently observed due to the persistently moist and chemically aggressive environment in the area of ​​application.

[0004] Alternatively, so-called rectal tubes are used, which are inserted into the rectum via the anal canal. Due to the associated risk of intrarectal injury, as well as the permanent dilation and thus potential damage to the sphincter muscle, rectal tubes are generally only used temporarily for stool drainage.

[0005] Systems for largely atraumatic, long-term fecal drainage (indwelling fecal drainage), as recently presented by Zassi Medical Evolutions Inc., Florida, USA, and ConvaTec, New Jersey, USA, are conceptually similar in design to bladder catheters for the continuous drainage of urine. Urine is drained from the bladder via a balloon-bearing catheter element and flows through an attached drainage tube into a collection bag. The balloon element primarily serves to anchor the catheter in the bladder. It also provides a degree of sealing, preventing urine from leaking past the catheter shaft and through the urethra. Similarly, conventional fecal drains have an anchoring and drainage balloon-bearing head, as well as a connecting tube that leads into a collection container.

[0006] Modern stool drainage systems, such as those mentioned above, ensure not only drainage performance but also the active guidance of the patient's stool excretion in the sense of fecal management by the therapist.

[0007] The concept of stool management includes the option of large-volume, anally administered colorectal irrigation. Large-volume enemas into the colon have been used for decades by patients with surgically created colostomies to actively manage bowel movements. The irrigation fluid flowing into the colon mobilizes the colonic contents and essentially flushes them out. Similarly, in immobile, uncooperative patients on long-term bed rest, a large-volume transanal enema can mobilize and drain bowel contents. This allows the therapist to control and manage defecation. With appropriate application, a stool-free, quasi-continent interval of one to two days can be achieved.

[0008] Currently available fecal drainage systems are problematic in several respects: With intended drainage durations of up to four weeks, pressure-related injuries in the terminal rectum (ulcers) and the anal region (fissures) cannot be ruled out. Pressure ulcers are generally the result of tightly inflated balloons anchoring the device in the rectum, which remain in constant contact with the rectal structures and restrict their blood flow. The known systems have balloons that are only partially formed when deflated and are expanded to their working size by pressurizing them with approximately 100 mbar to ensure their anchoring function. Anal fissures, on the other hand, mostly result from the continuous friction caused by the usually collapsed, folded transanal drainage section of the device in the anus.

[0009] Furthermore, the known systems do not offer sufficient sealing performance, especially with thin stools or large-volume enemas into the colon, resulting in permanent soiling and requiring frequent cleaning of the anal fold.

[0010] Current systems tend to slip out of the patient's rectum when the catheter is pulled. This so-called "slippage" is partly a consequence of the stretching and deformation properties of the materials currently used, primarily silicone. The high compliance of silicone does not allow for sufficient shape stability of the balloon and, under strong axial tension on the drainage, leads to a teardrop-shaped deformation and tapering of the balloon anchor until it is deformed to such an extent that it luxates outwards through the insertion opening that needs to be sealed.

[0011] Furthermore, conventional silicone balloons do not have a sufficiently large balloon diameter to lie completely flat on the rectal floor and thus achieve the best possible anchoring effect against the anal opening.

[0012] To enable the gentlest possible long-term catheterization of the particularly sensitive transanal segment, conventional systems use a drainage segment with the thinnest possible walls to ensure a soft and tissue-friendly consistency. However, this thin-walled design of the transanal segment is typically accompanied by a tendency to torsion or twisting, which significantly impedes or even prevents stool drainage.

[0013] Furthermore, silicones are not "odor-proof" and tend to release fecal odors into the patient's surroundings after a few days of in place. Silicone surfaces are also typically uneven, and their crater-like surface leads to rapid and difficult-to-clean soiling. From a hygiene perspective, silicone surfaces are only of limited use for long-term stool drainage.

[0014] Previously available silicone systems also had a relatively complex structure and were glued together from a large number of components in a costly manual process.

[0015] The use of a similar material, namely rubber or latex, is proposed in US Patent 4,686,985 A. This patent describes an anal dilator and occluder with a balloon that—apart from a small valve area between an intrarectal anchor balloon and a transanal intermediate segment—is not inverted and therefore has no contact area of ​​interlocking balloon ends in either the intrarectal anchor balloon or the transanal intermediate segment. The valve between the intrarectal anchor balloon and the transanal intermediate segment is not capable of permanently and tightly separating the two areas. Consequently, the functions of the two balloon sections cannot be separated—if one is inflated and thus activated, the other balloon section is also inflated, and the same applies to deflation.In all embodiments disclosed in US 4 686 985 A, there is always a lack of a substantial inversion point or an inversion of one balloon end by the opposite balloon end.

[0016] A comparable document is DE 10 2005 021 081 A1, which discloses a rectal tube for closing a natural or artificial anus, comprising an inflatable balloon with an approximately torus-shaped structure, formed from an inverted tube section, the two ends of which run approximately coaxially into one another and are each connected by a sleeve, wherein the outer layer of the inverted balloon section has a radially expanded, intrarectal anchor balloon and a transanal intermediate segment. However, the intrarectal anchor balloon and the transanal intermediate segment are formed from a single balloon, so that these sections are not separate from each other and can only be inflated or deflated together.Thus, the anchoring function of the intra-rectal area and the sealing function of the trans-anal intermediate segment can only be activated or deactivated together, meaning that these functions cannot be adequately adjusted in many situations.

[0017] The two patent applications DE 10 2008 055 673 A1 and DE 10 2008 055 674 A1 disclose corresponding arrangements, namely a device for the continuous drainage of stool from a patient's rectum into an external, bag-like collection vessel. Polyurethane or a material with similar technical elasticity and strength properties is used as the base material, and the intra-rectal anchor balloon and the trans-anal intermediate segment can be manufactured from a single, common, previously fully formed tubular balloon blank. While a partial inversion of the tubular balloon through its other end does occur, in most embodiments this inversion is not so pronounced as to create a mutual contact area between the two ends.Rather, the end of a balloon usually ends in the area of ​​a funnel-shaped compartment of the intra-rectal anchor balloon and does not reach the trans-anal intermediate section at all.

[0018] The problem that initiated the invention is to avoid the disadvantages described in the application of conventional systems for continuous stool drainage.

[0019] The solution to this problem in a generic device for the continuous drainage of stool from a patient's rectum is achieved by directly connecting the inverted balloon ends in the contact area, separating the intra-rectal anchor balloon from the trans-anal intermediate segment and permanently sealing it tightly.

[0020] The separation of the two segments – the intrarectal anchor balloon on the one hand and the transanal intermediate segment on the other – is achieved in the present invention by a permanent, sealing closure of the intrarectal balloon segment's sheath to the transanal segment, with the separation of the two segments being effected by a direct connection of the inverted balloon ends. The invention describes the transanal portion of the device not exclusively as being constructed in two layers, but also addresses single-layer variants of this segment, or describes the production of such a single-layer segment from portions of a continuous balloon sheath encompassing both the intrarectal and transanal parts, as well as its possible combination with further elements incorporated into the transanal section of the device, which advantageously influence the mechanical properties of the drainage in the anal canal in terms of its function and biocompatibility.

[0021] Silicone, which has been used as a base material in clinical applications to date, is being replaced by materials with low volumetric elongation (compliance) such as polyurethane (PUR). The option offered by PUR for the complete and structurally detailed shaping of extremely thin-walled balloon bodies using the blow-molding process is intended to allow for the cost-effective manufacturing and assembly of the drainage device, in addition to superior functionality in terms of anchoring and sealing. The number of components required to assemble the head unit of the device, which is positioned in or near the patient, is to be reduced. Assembly and permanent connection of the components are to be simplified and made more economical through extensive plug-in and snap-fit ​​connections of the individual elements. The described assembly options take into account the special mechanical, membrane-like properties of extremely thin-walled balloon films.Furthermore, the invention presents functionally particularly advantageous individual components or segment designs which offer an advantage over the prior art with regard to long-term tissue compatibility, anchor efficiency and sealing performance in the case of thin stool or applied large-volume rectal enema.

[0022] In contrast to conventional silicone-based systems, the invention preferably uses polyurethane (PUR) as a base material or a material with similar technical elasticity and strength properties.

[0023] Similar to PCT / EP2005 / 007950, the intrarectal and transanal drainage components are preferably made of PUR. Both drainage components are manufactured from a single, continuous, fully inverted balloon element. The distal end of the molded balloon blank is inverted through the lumen of the intrarectal balloon segment and continued within the lumen of the proximal balloon end until its end. Both balloon ends are fixed parallel to each other, at approximately the same level, to a connector element located in front of the anus. The intrarectal anchor balloon, in its inverted, assembled state, also features a compartment-like preformation to accommodate a separately manufactured funnel element. The transanal component, as described in PCT / EP2005 / 007950, is constructed from two concentric layers of film. These concentric tubular films are permanently structurally bonded together by point connections.The compartment thus defined between the layers communicates freely with the lumen of the intrarectal anchor balloon. Both spaces are filled via a single supply line.

[0024] In contrast to PCT / EP2005 / 007950, in the present invention the intra-rectal balloon part is not in any functional or communicating connection with the trans-anal segment.

[0025] Although in the present invention the trans-anal segment can also arise wholly or partially from the proximal or distal extensions of the intra-rectal anchor balloon, both segments, the intra-rectal and the trans-anal, are functionally separate from each other.

[0026] The intrarectal balloon segment, also presented in PCT / EP2005 / 007950 and optionally dimensioned to a residual extent, is also found in the invention. In the present invention, this segment is preferably filled with a defined volume in practical application, which is deliberately chosen to be smaller than the volume of the freely unfolded (filled but unpressurized) fully formed balloon. The intrarectal balloon segment thus rests on the rectal floor as a limp, only partially filled balloon body. It dynamically conforms to the respective morphology by folding its outer layer inwards on all sides. It can therefore be permanently positioned, completely filling the individual space, with the least possible force acting on the rectal tissue and a low probability of causing tissue damage.The filling pressure required to achieve sufficient anchoring of the drainage in the rectum should ideally not exceed the prevailing physiological pressure there. While in the prior art such a reduction in filling pressure also simultaneously determines the expansion characteristics and thus the drainage properties of the transanal segment, this is not the case with the present invention. The force exerted on the adjacent tissue by both compartments can be regulated separately.

[0027] If an axial or proximally directed tensile force acts on such a fully formed, only partially filled balloon, regardless of whether it is residually pre-formed beyond the assumed rectal dimensions or assumes a dimension in its freely expanded state that is smaller than the rectal space to be filled, a balloon inflation pressure develops according to the "action equals reaction" principle, which corresponds exactly to the force acting proximally on the anchor balloon. If the respective tensile force decreases, the anchor balloon returns to its low initial pressure. The initially introduced inflation volume can, for example, be 70–80% of the freely expanded, pre-formed volume.

[0028] When using non- or only slightly volume-extensible materials such as PUR of specification Pellethane 2363 80A, Dow Chemical Corp., it is ensured that the anchor balloon, under tensile stress and the resulting increase in inflation pressure, assumes its geometry and dimensions assumed during manufacturing. However, due to its material-related limited deformability (compliance), it cannot be deformed to such an extent that the balloon spreads distally in a teardrop shape and finally slips through the anal opening, as would be expected with highly volume-extensible materials such as silicone or latex, and as is observed in daily use.

[0029] In the invention, the trans-anal segment preferably consists of the extended ends of the intrarectal balloon, but can also be made of separately manufactured tubular elements or a single separately manufactured tubular element, each of which is permanently connected to the intrarectal balloon at its ends. The tubular ends are optionally connected to or permanently attached to an additional tube- or hose-like element. This element can optionally extend into the intrarectal segment and form a funnel-shaped opening there that receives and guides the stool.

[0030] Although the trans-anal segment has a double- or triple-walled structure, it does not form a fillable compartment.

[0031] Further features, properties, advantages, and effects of the invention will become apparent from the following description of preferred embodiments of the invention and from the drawing. The drawing shows: Fig. 1a the simplest embodiment of a head unit according to the invention; Fig. 1b the integration of a filling tube to the intra-rectal segment; Fig. 1c the supply of a flushing hose to the funnel element; Fig. 2 the principle of inversion; Fig. 3 further embodiments of the transanal segment; Fig. 4 another version of the head unit; as well as Fig. 5 possibilities for compartmentalizing hose elements of the device according to the invention.

[0032] According to Fig. 1a. In the device, an intrarectal anchor balloon 1 and a trans-anal intermediate segment 2 are manufactured from a single, common, previously fully formed tubular balloon blank, with the end 5a of the tubular balloon being inverted through the end 5b. The two ends lie concentrically against each other in the trans-anal section of the device and are preferably permanently connected to each other in the contact area 6 by a planar bonding technique. The contact area between the two balloon ends preferably begins at the lower edge of the funnel-shaped recess 7 or a few millimeters proximal to it. It extends over part or the full length of the trans-anal segment of the device.

[0033] The contact area 6 of the tube ends 5a and 5b is thus double-layered. The layers are preferably continuously and firmly bonded together. Partial compartmentation in the contact area or a partially planar connection is conceivable. However, there is no possibility of filling or connecting to any other pressurized space or compartment, with the exception of the surrounding environment. The preferably continuous double layer of material in the contact area 6 provides the transanal segment with greater stiffness and thus counteracts axial torsion and the associated narrowing of the drainage lumen. Furthermore, it ensures an improved tendency for the segment lumen to spontaneously straighten.

[0034] In the device variant shown, the intrarectal and transanal segments of the balloon foil form a structural unit, but are functionally decoupled from each other.

[0035] Proximally, the trans-anal segment 2 is followed by a connection element 8, which forms the transition to the drainage tube 9.

[0036] According to Fig. 1b The integration of a filling tube 10 into the contact area 6 of the two tube ends 5a and 5b is recommended to ensure inflation of the intrarectal balloon. In the simplest case, this can be achieved by inserting it between the two concentrically arranged film layers or tube ends. Fixation and sealing can be accomplished by gluing or welding the components to be joined.

[0037] The insertion of the filling hose 10 into the contact position 6 can be facilitated by corresponding, precisely fitting, groove-like preformation 11 in the hose ends 5a and / or 5b, which receives the intermediate hose.

[0038] To ensure the supply of irrigation fluid to the intra-rectal segment, according to Fig. 1c describes the integration of a flushing tube 12, which is preferably placed inside the drainage lumen or fixed there in a corresponding groove-like preformation 13 inside the trans-anal segment 2.

[0039] In the intrarectal section of the device, the irrigation tube can be received by a suitably shaped preformation 14 in the funnel element, e.g., by being placed onto or inserted into it. The preformation can form an opening 15 to the drainage lumen.

[0040] In the embodiment according to Fig. 2 The formed balloon blank 16 has a central spherical formation 17 which, in the assembled state, forms the sheath of the intrarectal anchor balloon 1. The extension 5a of the sphere preferably has an elongated cylindrical shape and, in the assembled product, corresponds to the trans-anal section 2 of the head unit. During assembly, the end 5a is inverted by the opposite end 5b such that the line 18 (inversion line) is formed at the distal, patient-internal end of the device.

[0041] The extension 5a can optionally form a funnel-shaped compartment 7.

[0042] The inner contour of the inverted compartment preferably corresponds exactly to the outer contour of the funnel element 3 inserted into the intra-rectal unit.

[0043] In the embodiment according to Fig. 3 The hose ends 5a and 5b are not connected directly to each other, but each to the surfaces of an intermediate sleeve- or hose-like component 19, the purpose of which is to selectively modify the mechanical properties of the trans-anal structure.

[0044] Ideally, the trans-anal segment, with or without such an addition, is mechanically structured in such a way that, without external force—for example, in its freely unfolded state, without touching the anal canal—it straightens itself into a circular cross-section due to its elastic force. With a slight external force, it should collapse or undergo a deformation that largely closes the lumen.

[0045] Furthermore, a certain degree of torsional rigidity in the trans-anal segment of the device is to be achieved by selecting suitable elastic sleeves 19. The elasticity of the sleeve 19 should therefore be chosen such that, in the event of axial torsion, the trans-anal segment largely unwinds itself in situ and returns to its low-stress initial state.

[0046] The sleeve 19 preferably consists of polyurethanes with hardness grades 30 to 70A, which can be produced by extrusion, injection molding, casting or dipping. Alternatively, silicone or a material with corresponding mechanical or, primarily, elastic properties can be used.

[0047] The sleeve 19 can either be constructed with a uniform wall thickness 19a throughout, or it can also have, for example, single-strand or multi-strand or counter-rotating helical struts or stiffeners 20. The space between the struts can be formed as a thin-walled structure with a thickness of, for example, 0.2 to 0.4 mm, or, in the case of several counter-rotating helical struts, it can also be perforated like a window. The preferably helical struts 20 can have a diameter of, for example, 0.75 to 2.0 mm.

[0048] Furthermore, the sleeve 19 can be made of an elastic soft foam, such as PUR foam.

[0049] Alternatively, the sleeve 19 can also be constructed as an elastic double-walled cylinder, with the space between the walls being filled tightly with a compressible or non-compressible medium.

[0050] The sleeve 19 can be fully or partially connected to the ends 5a and 5b. Its length corresponds at least to the length of the anal canal, i.e., approximately 3 to 5 cm, but preferably extends from the funnel element 3 to the connector 4.

[0051] The sleeve 19 is preferably located between the ends 5a and 5b, but can alternatively also be attached from the outside to layer 5b or from the inside to layer 5a.

[0052] If the attachment is on the inside of the trans-anal segment, i.e. on the inside of layer 5a, the sleeve 19 can, as a further embodiment, also emerge directly from the funnel element 3, quasi in proximal extension, or be continuously and permanently connected to it.

[0053] The sleeve 19 preferably already has corresponding preformations for receiving ventilation and flushing lines.

[0054] If the sleeve 19 is fixed between the hose ends 5a and 5b, a design according to Fig. 4. In this embodiment, the funnel element 3 and the sleeve 19 are conceivable as a unit 21. During assembly of this embodiment, the sleeve 19 is pushed onto the hose end 5a up to the fold line 16 and permanently connected to it over its entire surface. Then, the end 5b is rolled back over the unit 19. The end 5b is then firmly attached to the surface of the trans-anal sleeve segment.

[0055] Fig. Figure 5 shows further possibilities for the design of the transanal segment 2 as well as the chair-propelling segment 9.

[0056] In this process, incoming hose compartments, such as those required for inflating the intrarectal balloon 23 or for supplying irrigation fluid to the intrarectal end 24, are essentially separated or compartmentalized from the raw hose 22 by longitudinal welds 25 applied to the raw hose. The resulting compartments thus acquire a conduit shape.

[0057] The balloon element representing the head section, from which the intra-rectal anchor balloon 1 and the transanal segment 2 are derived, is preferably made of a polyurethane with chemical-physical or elastic-mechanical characteristics comparable to Pellethane 2363, Shore hardness 80A to 60D, from Dow Chemical Corporation.

[0058] The balloon element forming the head section is preferably manufactured using the blow-molding process. Besides polyurethane (PUR), suitable flexible films made of PVC and LDPE can also be produced using this technique.

[0059] Conditionally suitable balloon elements, fully or almost completely shaped to their later working dimensions, can also be manufactured using the dipping process, for example from latex, silicone or synthetic rubber types.

[0060] It is also conceivable to manufacture from one or more layers of foil made from the aforementioned materials, which are glued or welded together to form spherical structures.

[0061] The wall thickness of the intrarectal balloon sheath should be in the range of 10 to 40 micrometers. The maximum transverse diameter of the intrarectal segment, when freely and without pressure inflated to the pre-formed size, should be approximately 6 to 9 cm. The axial length of the intrarectal balloon body is preferably 4 to 6 cm.

[0062] If the transanal segment is manufactured from separate parts, the required thin-walled tubular film layers are also preferably produced by blow molding corresponding thin-walled cylindrical balloon or tube bodies. A film welding or bonding process, as described previously, can also be used. The materials used are preferably identical to those used for manufacturing the intrarectal anchor balloon. If an elastically rebounding tube or pipe element is integrated, this can also be manufactured from dipped or injection-molded cylindrical elements. PUR with a hardness of 70A to 90A provides the necessary self-righting elasticity. Elements made of silicone are less suitable.

[0063] The funnel element is preferably made of a material identical to that of the balloon envelope or having the same Shore hardness. It is preferably manufactured by injection molding; alternatively, a dipping process is conceivable.

[0064] The material should exhibit reliable elastic recovery properties after temporary mechanical deformation and be as soft and skin-friendly as possible. Furthermore, it should be bondable with common solvents or adhesives. The required mechanical and chemical properties are, for example, ensured by polyurethanes with Shore hardnesses of 70 to 90. Materials with physicochemical properties such as those found in the Pellethane family 2363 can be used as an example.

[0065] The surface of the funnel can be provided with circular preformations (both convex and concave) to facilitate assembly with the balloon element. Longitudinal recesses, resembling grooves, can be produced in the axial direction of the inner surface or the funnel lumen. These grooves may accommodate supply lines (balloon filling or irrigation lumens) that may be introduced proximally through the transanal segment. Additionally, special longitudinal grooves can be arranged so that the funnel, when inserted into the anus, can be deformed into a slimmer configuration by moderate manual pressure and then spontaneously returns to its original shape in the rectum due to its mechanical restoring force.

[0066] The funnel element is preferably shaped like an olive, a cone, or a torpedo. The maximum outer diameter should be between 4 and 5 cm, and the inner lumen receiving the stool should not be less than 3 cm in diameter. The length of the funnel should be between 3 and 5 cm.

Claims

[1] Device for the continuous drainage of stool from the rectum of a patient and / or for the supply of irrigation fluid to the rectum, comprising a balloon with an intra-rectal anchor balloon (1) and a trans-anal intermediate segment (2), wherein polyurethane or a material with similar technical elasticity and strength properties is used as the base material, wherein the intra-rectal anchor balloon (1) and the trans-anal intermediate segment (2) are manufactured from a single, common, previously fully formed tubular balloon blank, wherein one end (5a) of the tubular balloon is inverted through the other end (5b) and the two ends (5a, 5b) lie concentrically against each other in the trans-anal section of the device, and wherein the intra-rectal anchor balloon (1) is separated from the trans-anal intermediate segment (2) and permanently sealed in a tightly closing manner by a direct connection of the inverted balloon ends (5a, 5b) in the contact area (6). [2] Device according to claim 1, characterized by , that the intra-rectal anchor balloon (1) and the trans-anal intermediate segment (2) are not in any communicating connection with each other. [3] Device according to claim 1 or 2, characterized by , that the intrarectal anchor balloon (1) and the trans-anal intermediate segment (2) represent two functionally separate segments. [4] Device according to claim 2 or 3, characterized by , that the intrarectal anchor balloon (1) and the trans-anal intermediate segment (2) are separated from each other by a continuous connection along the inverted balloon ends. [5] Device according to any one of the preceding claims, characterized by , that the trans-anal segment (2) is formed from the extended ends of the intra-rectal balloon (1). [6] Device according to any one of the preceding claims, characterized by, that the intra-rectal balloon segment (1) is residually dimensioned, i.e. preformed beyond the assumed rectal dimensions. [7] Device according to any one of the preceding claims, characterized by , that the section of tubing (5a) of the tubular balloon whose end is inverted through the opposite end (5b) of the tubular balloon forms a funnel-shaped recess (7) for a funnel element (3) in the area of ​​the intrarectal anchor balloon (1). [8] Device according to claim 7, characterized by that the inner contour of the funnel recess (7) preferably corresponds exactly to the outer contour of the funnel element (3) inserted into the intrarectal anchor balloon (1). [9] Device according to any one of the preceding claims, characterized by , that the funnel element (3) is arranged between the hose ends (5a, 5b).

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