Neutral and comfortable-to-wear device for closing body openings

Abstract

The present invention relates to a device for closing a body opening in a manner of minimal irritation and optimal organ tolerance. The device consists of a very thin-walled balloon body that can be filled from the outside. The balloon body has a hose section that connects the interior of the intestine to the anus in front of the anus. The hose section is made of a soft film-like material with low volume expansibility. In a preferred structural form, one end of the balloon, which is integrally formed with its required dimensions during the manufacturing process, is turned inside out through the other end, and the two balloon ends are connected to each other in a sealed and closed manner in the region of the external body opening. A thin-walled, adhesively coated soft film is coupled to the connection region between the proximal end and the two balloon ends. The soft film allows the device to be directly fixed to the human skin, so that in the region of the anal canal and the region in front of the anus, components that are not easily deformable and potentially irritating can be completely avoided.

Description

[0001] In the case of patients under guardianship or supervision, when using catheter products remaining in or on the body, there is generally a problem of irritation-free positioning, which allows the wearer of the product to obtain the greatest possible wearing comfort and minimally affect the patient's body movements. This applies in particular to catheter devices that are used to close body openings, but also to catheters that establish a sealed connection from the interior of the body to the body surface, and for example to tightly seal the supply and / or discharge of substances.

[0002] Especially during physical work or sports activities, there may be multi-directional relative movements between the closure device and the structures and tissues directly covered by the device. After just a few minutes, the patient will feel the degree of irritation annoying enough to end the use of the product and not continue using it.

[0003] In the following, the requirements for wearing comfort in terms of comfort will be exemplarily explained in connection with a catheter-like device that mainly serves to temporarily close the anus of patients with anorectal incontinence.

[0004] In the prior art, devices for intermittent anal closure are usually based on materials with a spongy texture positioned in the rectum and / or anal canal. By absorbing intestinal secretions, the initially dry closure body, which is squeezed into a small size, swells into a mushroom-shaped or shell-like layer structure. Such swellable bodies are generally felt by patients as foreign bodies. Especially when the closure body passes through the anus into the rectum, it can cause a strong sense of irritation and also trigger the urge to defecate.

[0005] In addition to the swellable bodies, balloon-shaped, rectally and transanally positioned closure systems are also known. The sealing balloon components of these devices are usually made of an elastically expandable material that, when filled by the user, expands from a specific manufacturing size to a specific working size required for the function. Due to the relatively high filling pressure in the elastically expanding balloon, multiple balloon-based closures in the rectum and anus are felt by patients as foreign bodies and annoying. The known balloon-based devices for closing the anus also integrate a hose-shaped, relatively rigidly implemented hose element on which a balloon body anchored and sealed to the rectum is placed. To prevent the device from being introduced into the rectum inwardly, the rod-shaped hose can be supplemented, for example, with a rectangular or T-shaped base that fixes the device in the anal fold and prevents dislocation from the transanal position. If the device suddenly changes direction towards the patient and the non-deformable rod part of the device required for easy introduction of the closure body may puncture through the intestinal wall, there is also a basic risk of injury to the intestine with the rod-based balloon closure. Due to the above-mentioned disadvantages, no such product has been established in patient care so far.

[0006] In a similar manner, there is a problem of enabling a patient to have unrestricted movement ability and to have as good a wearing comfort as possible while minimizing the risk of trauma during use for a patient with an artificially placed intestinal outlet (stoma). In particular, due to the continuous flexor contractions, upright postures, and torsions of the torso, the balloon element applied to the catheter rod in a fixed manner may cause a high degree of subjective discomfort to the patient.

[0007] Therefore, in terms of the long-term wearing of a closure-like device placed inside or on the body, and in terms of supplying or draining fluids towards or away from the body, there is a need for a device that is novel in design, which combines the best wearing comfort with the best possible sealing performance, and ensures this when a person moves the body continuously or even engages in sports. There is a need for systems that have a high degree of adaptability to dynamics even when the body is in extreme positions or changes direction from a stationary position, and that minimize the risk of injury in such extreme situations. Ideally, such systems can achieve a completely neutral placement of pressure or force inside the body, which will automatically adapt to the forces and pressures present in the respective organs, so that the device is no longer even perceived by the wearer after a short period of sensitive adaptation and can be worn completely neutrally. However, despite this, these systems should still be easy to introduce and remove. These devices should also have as simple and inexpensive a structure as possible. Summary of the Invention

[0008] To address these multiple requirements, the present invention proposes a special combination, namely, a balloon film body implemented with an extremely thin wall and simultaneously serving as a seal and a fastener is combined in a novel way and method with a soft film-like holding structure adhesively applied to the body surface, and this holding structure eliminates any type of potentially irritating, seemingly hard or inflexible components in the transition region of the balloon body leading to the body surface. The film-like thin-walled film material described within the scope of the present invention ideally has a high degree of mechanical stability and can withstand pressure and tensile forces, which allows for a very lightweight, neutral portable structural type and simultaneously a shape-stable combination that is fundamental to the present invention under mechanical load changes. The balloon film used is preferably already formed in the production process with the working dimensions necessary for the sealing and / or fastening functions. Alternatively, the balloon film can be deliberately and conceptually oversized in the single or all section dimensions of the balloon body beyond this specific working dimension.

[0009] A very thin-walled film that adheres to the body surface or skin of a patient in a sticky-fixed manner can optionally be coated with a layer of a gel-like material, for example a polyurethane-based material, whereby the neutral wearing appearance of the film carrying the gel is not changed, but the handling by the user of the thin-walled adhesive film, in particular the self-applying and removal, is facilitated.

[0010] For example, the combination of an ultra-thin, integrally formed, mechanically stable film body and a base element has already been described in DE 10 2005 021 081.3. Here, a balloon body is applied to a rod element carrying the balloon. By fixing the balloon ends in a particularly inverted or offset manner relative to each other on the rod, an axially directed, sealing anti-crimping portion is produced in the balloon placed in the body towards the inner opening of the body opening. PCT / EP2004 / 008256 and PCT / EP2007 / 003099 also describe devices with very thin-walled, integrally formed balloon bodies, where one end of the balloon body is here turned over integrally or almost integrally through the other balloon end, and the two balloon ends are applied at the same height to a sleeve-shaped carrier element and a sealing element. The sleeve element is here placed outside the body or in the inlet channel leading to the body and seals the inwardly turned balloon shape as a fillable compartment in a sealed manner. Similar to DE 10 2005 021 081.3, in this embodiment, when the balloon body is loaded with a filling pressure, the toroidal balloon body also rolls axially towards the inner opening of the body opening.

[0011] In the embodiments described in PCT / EP2004 / 008258 and PCT / EP2007 / 003099, the sleeve element is a structural connection between the balloon body and an end cap element outside the body. In another case, the sleeve is connected to a rod-shaped catheter component, which makes it easier for the user to introduce the device.

[0012] The present invention avoids all components with a hard or inflexible texture, where the film structure of the balloon body placed in the body directly transitions into the film structure of the holding surface outside the body, or rather a direct transition is achieved without functional elements for connection with potential irritation characteristics. The device according to the present invention consists only of thin-walled film components, especially in the transanal and pre-anal regions. The devices proposed within the scope of the present invention are all rodless in the worn state. One end of the formed balloon film preferably turns inwards through the balloon body and is tightly closed and connected to the other balloon end in the transition region leading to the body surface or in the region of the transintestinal access to the organ inlet. This inturned form produces a central, continuously open cavity or inlet channel leading to the respective organ. The channel-shaped inlet can be used, for example, to push in a contractible introduction aid. The channel also allows for continuous exhaust of intestinal gas.

[0013] Connected directly to the connection areas at both ends of the balloon film is a retaining film or its propeller-shaped, strip-shaped, or tongue-shaped protrusions for adhesion to the inner side of the buttocks. The retaining film can be made as a separate film element, but can also be directly molded or formed in such a way that it transitions into one of the ends of the balloon body.

[0014] In particular, the present invention proposes a combination of an ultra-thin balloon body composed of a thermoplastic polyurethane balloon film made by blow molding, which balloon body is in turn connected to a retaining film made of thermoplastic polyurethane. This connection can be established by bonding or welding. The retaining film is preferably made by deep drawing and has a sleeve-shaped or conical protrusion pointing towards the anus or also reaching into the anal canal inwardly, which protrusion enables a simple and precise engagement into the concentric hose position of the balloon body. Description of the Drawings

[0015] Additional features, characteristics, advantages, and functions based on the present invention are obtained from the following description and with reference to the drawings, in which preferred embodiments of the present invention are disclosed. Among them:

[0016] Figure 1 An inverting rodless balloon body is shown by taking the natural intestinal outlet as an example, and the balloon body has a retaining film added to the balloon body for adhesion outside the body;

[0017] Figure 2a Shows Figure 1 The device corresponding to the embodiment in, in which the distal balloon end is equipped with a fixed oval-shaped introduction element and a retractable introduction aid there;

[0018] Figure 2b Shows Figure 2a The corresponding device, in which the distal balloon end integrates a fingerstall-shaped introduction element;

[0019] Figure 2c Shows a modification of the structural form according to Figure 2b , in which the device is also received by the user's finger and thus introduced by means of the finger (digital);

[0020] Figure 3a Shows the transition from the balloon film to the retaining film within the scope of an exemplary embodiment;

[0021] Figure 3b Shows another embodiment of the film transition;

[0022] Figure 4 Shows the combination of the retaining film and a gel-like substance that modifies the haptics of the retaining film;

[0023] Figure 5 Shows a special, propeller-shaped embodiment of a holding film for fixing a closure device to the perianal skin on the inner surface of the buttocks;

[0024] Figure 5a Shows a special pad adhered to the skin on the inner surface of the buttocks, to which the propeller-shaped or strip-shaped holding film of the intermittently replaceable closure device can be fixed in a reversible, peelable and adhesive manner;

[0025] Figure 5b Shows a special embodiment of an insertion aid which is used to determine the correct anorectal insertion depth and to facilitate the attachment of the wings or branches to the perianal skin or pad;

[0026] Figure 6 Shows a corresponding embodiment of a seal for the intermittent closure of an artificial intestinal outlet (stoma); and

[0027] Figure 6a Shows a circular or hoop-shaped cut-out, adhesively applied pad for ileostomy, for example. Detailed description

[0028] Figure 1 Shows a device 1 according to the invention, in particular in the form of an anal closure, which comprises a balloon body 2, the two balloon ends 2a and 2b of which extend parallel to each other and are connected to each other in a tightly closed manner, forming a space that can be filled with a preferably gaseous medium, by means of a respective adaptation at the end diameter in the region 2c, and the device is further composed of a holding film 3 which acts adhesively and fixes the closure device perianally on the inner side of the patient's buttocks, and thus it should be avoided that the device undesirably dislocates from the sealing, transanal positioning which is characteristic of the invention into the rectum, as is often observed especially when the patient changes from a standing position to a sitting position in the absence of a corresponding perianal fixing component.

[0029] The holding film 3 is directly connected to the proximal end of the fillable body defined by the region 2c without any connecting or intermediate elements. The holding film has an adhesive surface 3a facing the patient. The holding film has a sleeve-shaped protrusion 3b which overlaps with the inner or outer surface of the region 2c and is directly connected to this inner or outer surface, for example by bonding or welding. In the joining region 2c of the two balloon ends, a hose supply line 4 for filling the balloon body is sealedly inserted between two concentric film or hose layers, and a measuring balloon 5 with an integrated filling valve is connected to the end of this supply line.

[0030] The positioning of the closure in or on the patient is effected in such a way that two concentrically extending balloon ends 2a and 2b pass through the anus A and the toroidal balloon body 2 is placed against the rectal base R. The transanal section of the balloon body resulting from the two balloon ends tapers in diameter relative to the torus located in the rectum. The diameter of the balloon end 2b is preferably implemented to be about 15 to 30 mm, particularly preferably 20 to 25 mm. The diameter of the inner balloon end 2a is about 15 mm, and ideally, it allows the device to be accommodated on the user's finger or allows the balloon body to be introduced transanally with the help of a finger. As an alternative to the balloon end 2a protruding directly from the balloon or integrally formed, the central cavity L that coherently connects the distal balloon end to the proximal balloon end can also be made of a separately manufactured hose section 9.

[0031] The balloon body is preferably not completely filled in situ. The filling volume used is about 80% of the volume of the freely formed or freely deployed balloon body. Thus, the balloon transitions into a relaxed, tension-free filling state that is particularly advantageous for the function of the device. In the relaxed state, the balloon body absorbs the respective major prevailing rectal forces, but does not itself transmit permanently acting forces to the anatomical structures and tissues against which it abuts. The filling pressure prevailing in the balloon exhibits the characteristic of being almost temporally synchronous with the pressure acting on the rectum or abdomen, and thus ensures the coherent, mucosa-directed, sealing deployment of the outer balloon end 2b positioned transanally. During this period, due to the influence of the force action of the filling pressure prevailing in the balloon body, the central cavity L formed by the inner balloon end 2a atrophies in a manner that almost closes the cavity under the precondition of corresponding deformability.

[0032] Figure 2a Shows an embodiment of the device corresponding to Figure 1 in which an oval introduction element 6 is firmly connected to the distal or front opening of the cavity L. The introduction element has a central channel 7, into the proximal end of which is inserted a rod-shaped introduction aid 8 that can be retracted from the oval. The inner layer 2a of the device can alternatively be manufactured as a separately formed hose film element 9, which is connected to the oval towards the proximal end and is tightly closed to the outer layer 2b in the region 2c.

[0033] The introduction aid 8 can be provided with a disc-shaped and / or saucer-shaped element 8a, which shows the user the correct introduction depth through the mechanical stop of the disc at the anus during the introduction of the device. The retaining film 3 is placed distally, that is, towards the patient, against the element 8a.

[0034] Figure 2bshows an embodiment corresponding to Figure 2a In this embodiment, a finger - sleeve - shaped element 10 is firmly connected to the opening at the distal end of the cavity L, and the distal phalanx of the introduced finger can be inserted into this element. To decompress intestinal gas, the finger - sleeve 10 is preferably provided with an opening 11 at its distal end. This opening can be provided with a breathable but liquid - resistant fiber mesh.

[0035] Figure 2c shows an embodiment corresponding to Figure 1 and Figure 2b In this embodiment, a stenosis 12 is formed into the inner or internal balloon end 2a in the region of the distal end of the cavity L. This stenosis also allows the finger accommodating the device to be inserted. The cavity 13 in the region of the stenosis ensures continuous discharge of intestinal gas.

[0036] Figure 3a Details are shown of the transition of the balloon body to the balloon film 3 for pre - anal retention. A sleeve - shaped or funnel - shaped attachment 3b for holding the film abuts against the region 2c from the outside or from the inside. This transition region is preferably placed in the outer third of the anal canal A. The particularly pressure - sensitive anal orifice (Rosette) of the anus is only covered by the retaining film 3 and not by the region where the balloon end engages with the retaining film. The sleeve - shaped protrusion 3b of the retaining film can be molded into the film during manufacture, for example, by a corresponding deep - drawing method.

[0037] Figure 3b Shows another implementation option for the transition of the balloon film and the retaining film. For example, a flange - shaped enlargement 2d can be formed on the proximal end of the inner balloon end 2a, and the retaining film 3 is flange - connected thereto. The diameter of the flange 2d should be approximately 4 to 5 cm here to ensure that the double - layer connection surface of the connection region is positioned at a sufficient distance from the anal orifice. Alternatively, the flange 2d can be formed to be large in diameter in such a way that no additional retaining film 3 is required, and then the adhesive 3a can be directly applied to the patient - facing inner side of this flange. The adhesive - coated bonding surface should be at least 15 mm away from the edge of the anal orifice.

[0038] Figure 4A special combination of a holding film 3 with an adhesive, gel-like substance is shown, which can be applied either on the side 14 facing the patient or on the side 15 facing away from the patient. If the gel is directed toward the patient, sufficient adhesive properties can be achieved with a polyurethane-based gel, for example, to allow the device to adhere to the patient's skin. The advantageous effect of gels is their close-to-tissue properties and good, less irritating skin tolerance. If the gel is applied on the side facing away from the patient, the corresponding gel-like surface or part of the surface can facilitate both the manual application of the holding film by the patient and the peeling or removal of the holding film from the skin. For this purpose, the gel is provided with a suitable coating or shell 15a on the side facing away from the patient, which maintains the natural adhesiveness of the soft PUR gel.

[0039] Figure 5 The propeller-shaped holding surface 16 is particularly advantageously cut for a less irritating wearing comfort, and its two wings are respectively attached to the perianal skin of the buttocks adjacent to the anal opening. The particularly tight middle part 17 is located directly in front of the anus. By tightening the side wings towards the middle part 17, it is greatly prevented that the part on the buttocks will shear or twist the part of the closure device that is positioned at the anus or transanally when walking. Decoupling the movement of the gluteal muscles or the overall movement of the body from the tight and sealed balloon body is crucial for a wearing feeling that is as neutral as possible for the user.

[0040] Figure 5a In particular, it concerns the comfort when removing the adhesive retention film from the patient. In order to avoid painful peeling of the adhesive film from the sensitive perianal skin, a flat pad 16a is adhered to two skin parts of the perianal gluteal muscles, the pad consisting of a preferably transparent film material that is preferably suitable for permanent skin concealment. For example, the invention preferably provides for a pad an adhesive film with properties such as the product type Tegaderm Absorbent from the manufacturer 3M Health Care. This product has a central flat section, which has a significant wall thickness and a higher resistance to deformation compared to the surrounding welt, and thus allows a tactile perception of the pad's particularly favorable area for the attachment of the retention film. If the user can directly see the perianal area when introducing and fixing the balloon closure, for example by using a mirror, the relative positioning of the retention film with respect to the pad can also be facilitated by coloring the pad 16a in this advantageously positioned area.

[0041] The described adhesive film pad 16a is preferably made of a hydrocolloid, breathable material that is waterproof and allows regular showering and normal toileting. The transparency of the material can, if necessary, well identify changes in skin reactivity.

[0042] The propeller-shaped or strip-shaped retaining film 16 is adhered to two pads 16a, which can be perianally positioned for several days up to a week. The adhesive action of the pads 16a on the patient's skin is greater here than the adhesive action of the retaining film on the pads. In addition, the contour of the pads 16a should extend beyond the contour of the fixed branch portion 16 of the retaining film 3, so that the retaining film can be applied to the pads by the patient with a certain degree of safety. For such a technique, a polyurethane-based gel applied in a very thin layer is particularly suitable as the adhesive for the fixing action between the retaining film 3 and the pads, and this gel allows a "Post-it" - like peeling effect to occur from the underlying film. The overall moderately acting attachment of the film pads is sufficient to prevent the closure device from dislocating from the transanal position into the rectum.

[0043] In order to make it easier to peel the propeller-shaped or strip-shaped retaining film from the pads, the end of the film branch portion 16 is provided with a non-adhesive film area 16b, which can be easily grasped by the user.

[0044] Figure 5b A particular embodiment of the closure device according to the invention is shown, in which the closure body to be positioned transanally and in the rectum is applied to a finger-shaped element 8b, and the insertion depth is predetermined by the user via a flange-shaped, disc-shaped or plate-shaped stop 8a. The finger-shaped element transitions into a retaining handle 8c at the proximal end pointing away from the patient, and this retaining handle 8c facilitates manual insertion into the anus. The stop has two cutouts 8d facing away from each other, and the retaining film 16 to be adhered to the buttocks is placed parallel to the retaining handle into these cutouts. Thus, the hand performing the insertion grasps the retaining handle together with the retaining film, whereby the retaining film does not interfere with the insertion of the device into the anus. After the disc stop of the insertion aid has been positioned on the anus, the retaining film 16 is unfolded from the cutout 8d and, after removing or tearing off the protective film, the retaining film is adhered to the buttocks. Then the finger-shaped element 8b is pulled out of the central cavity L of the balloon body and removed.

[0045] Figure 6 A particular embodiment of the retaining film 3 for closing an artificial intestinal outlet, in particular a so-called ileostomy, is shown, where the artificial intestinal outlet establishes a direct connection between the patient's small intestine and the abdominal skin surface. Here, the retaining film 3 or 18 is pulled out in a bell-shaped depression. The depression accommodates the intestinal segment S of the stoma that has been turned up onto the abdominal wall and grown there. The outer side of the film 3 can here be surrounded by a protective gel layer 19, which optionally is in the form of an end cap or dome 19a above the external stoma, or follows closely the bell-shaped contour 19b of the film.

[0046] Figure 6aShows a stoma-conforming variant of the pad 16a, which facilitates the removal of the closure device from the skin around the stoma. In this case, it is cut out circularly and preferably consists of a very thin-walled, breathable, waterproof and washable film, similar to Figure 5a the pad described in. The pad enables the closure body positioned in the stoma to be detached from the perianal skin without trauma and pain. The pad is cut with different circular opening diameters 16c. It also has a non-adhesive edge section 18b, which can be safely grasped by the patient and allows the film to be removed from the skin.

[0047] The balloon body is preferably filled with a specific, predetermined volume of air. For this purpose, the user uses, for example, a conventional syringe, which is provided with a corresponding volume marking. The volume for filling the balloon body is determined such that the balloon is only partially filled, that is, remains in a relaxed, tension-free state. In situ, the balloon filled in this way abuts against the patient's unique anorectal anatomy in an optimal sealing manner. The filling pressure occurring in the balloon approximately corresponds to the respective dominant rectal pressure. This is usually achieved with a filling volume corresponding to approximately 70% to 80% of the freely formed balloon body of the ready-to-use device.

[0048] Alternatively, the closure device can also be adjusted in a pressure-controlled manner, for example, by means of a conventional manual pump manometer. Then the pressure required for the closure function is uniquely known.

[0049] List of reference numerals

[0050] 1 Device 16 Retaining surface

[0051] 2 Balloon body 16a Pad

[0052] 2a Balloon end 16b Film area

[0053] 2b Balloon end 16c Opening diameter

[0054] 2c Area, joining area 17 Part

[0055] 2d Flange-like enlargement 18 Retaining film

[0056] 3 Retaining attachment 19 Gel layer

[0057] 3a Adhesive surface 19a Vault, end cap

[0058] 3b Funnel-shaped attachment 19b Bell-shaped contour

[0059] 4 Hose supply A Anus, anal canal

[0060] 5 Measuring balloon L Chamber

[0061] 6 Introduce component R at the bottom of the rectum

[0062] 7 Central channel S in the intestinal segment

[0063] 8 Introduce auxiliary device

[0064] 8a Disc-shaped component

[0065] 8b Finger-shaped component

[0066] 8c Holding handle

[0067] 8d Empty space

[0068] 9 Hose segment

[0069] 10 Finger cot

[0070] 11 Opening

[0071] 12 Narrow part

[0072] 13 Cavity

[0073] 14 Side

[0074] 15 Side

Claims

1. An apparatus (1) for closing a cavity (L) that opens as an orifice in a region on the body surface in a manner of minimal irritation and optimal organ tolerance, said cavity being a natural or artificial intestinal outlet (A) of a patient, said apparatus being constituted by a very thin-walled, implantable balloon body (2) that can be filled from the outside, said balloon body being made of a soft, film-like material with low volume expansibility, said balloon body having a central cavity that extends from the distal end of the apparatus (1) to the proximal end, characterized in that, a) One end (2a) of the formed balloon film is folded back over the other end (2b) of the balloon body (2), the two ends (2a, 2b) of the balloon body (2) being parallel to each other and being tightly connected to each other in a region (2c) due to the corresponding equality of the respective terminal diameters, so that the apparatus (1) in the perianal and anal regions consists only of a thin-walled film component, b) The central cavity is not surrounded by a rod inside the implantable balloon body (2), and potential irritating components are completely avoided in the region of the orifice and in the connected, external region, and c) At least one planar external holding attachment (3) is constituted by a film structure coated with skin-tolerant adhesive and is connected to the proximal end of the balloon body (2), said holding attachment allowing the apparatus (1) to be directly fixed to the skin of the patient, d) wherein, The film structure of the external holding attachment (3) is formed in a directly transitional manner in one of the ends (2a, 2b) of the balloon body (2) without using rigid connecting elements or functional elements with potential irritating characteristics.

2. The device (1) according to claim 1, characterized in that, The balloon body (2) is fully formed to the required size during the manufacturing process.

3. The device (1) according to claim 1 or 2, characterized in that, The cavity of the balloon (2) is sealed towards the surrounded cavity by a layer made of a soft, film-like material.

4. The device (1) according to any one of claims 1 to 2, characterized in that, The layer made of a soft, film-like material that defines the cavity of the balloon (2) towards the surrounded cavity is made integrally with or connected to the shell layer of the balloon body (2).

5. The device (1) according to any one of claims 1 to 2, characterized in that To manufacture the balloon body (2), one end (2a) of an initially hose-shaped balloon blank is turned inwards and passed through the other end (2b) of the balloon blank.

6. The device (1) according to claim 5, characterized in that, The two balloon ends (2a, 2b) guided nestedly are connected to each other in a sealed and closed manner so as to thereby establish a space that can be filled from the outside.

7. The device (1) according to claim 6, characterized in that, The two balloon ends (2a, 2b) guided nestedly are directly connected to each other, i.e., without passing through a sleeve or another spacer holder interposed between them.

8. The device (1) according to any one of claims 1 to 2, characterized in that, The external region of the balloon body (2) does not radially expand relative to the balloon section through the orifice.

9. The device (1) according to any one of claims 1 to 2, characterized in that, The balloon body (2) is made by blow molding.

10. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is made of a thin, soft film.

11. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is made of thermoplastic polyurethane.

12. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is made by deep drawing.

13. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is coated with a layer of gel-like material.

14. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) has one or more tongues or wings that radially project away from the proximal balloon ends (2a, 2b).

15. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) has a symmetric bottom surface.

16. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is directly coupled to the connection region (2c) of the two end portions (2a, 2b) of the balloon membrane.

17. The device (1) according to claim 5, characterized in that, The two balloon end portions (2a, 2b) guided to be nested with each other are connected to each other in a sealed and closed manner in the region of the orifice or lumen or in the directly adjacent extracorporeal region, so as to thereby establish a space that can be filled from the outside.

18. The device (1) according to any one of claims 1 to 2, characterized in that The balloon body (2) is made of a thermoplastic polyurethane film by blow molding.

19. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is composed of a sheet-like soft film.

20. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) is coated with a gel-like polyurethane-based material layer.

21. The device (1) according to any one of claims 1 to 2, characterized in that, The holding attachment (3) has a tongue-shaped, wing-shaped or propeller-shaped bottom surface.

22. The device (1) according to claim 15, characterized in that, The bottom surface has two diametrically opposed extensions (16).

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