System for independently inserting a catheter unit transanally into the rectum of a person

Abstract

The invention relates to a system for independently inserting a catheter unit transanally into the rectum of a person, wherein the catheter unit comprises a catheter and a balloon attached thereto, the balloon being filled and thereby expanded only after the catheter has been inserted into the rectum of the person, and then retaining the catheter in the rectum and optionally also providing a sealing function, wherein all components and functions required for use of the device, in particular for inserting the catheter and filling the balloon, are arranged or integrated in a single, hand-held outer package which can be carried on the person. The invention provides a particularly compact device, designed to be carried discreetly by the user and approximating in size and shape to a cigar tube or to a fountain pen, for the transanal placement of a balloon-based catheter unit which provides an anorectal seal and remains temporarily in the body of a patient. The device enables the closure catheter to be removed in a ready-to-use state, and integrates all components and functions required for use, in particular also for filling the balloon component, which has a retaining and sealing action. The invention allows users to establish a stool-tight seal in the shortest possible application time, regardless of location and of the particular body position, preferably without an assisting person and without further aids.

Description

[0001] System for the independent, trans-anal insertion of a catheter unit into a person's rectum

[0002] The invention relates to a system for the transanal insertion of a temporarily indwelling catheter unit into the rectum of a person, wherein the catheter unit comprises a shaft component and at least one balloon attached thereto, which is inflated after the catheter is inserted into the rectum, thereby fixing the catheter in its rectal position, and wherein the balloon fulfills a rectally or anorectally sealing function. The systems described within the scope of the invention further comprise a pumping or gas-generating function for inflating the balloon component, wherein the inflation function is preferably integrated into or enclosed by the outer packaging that receives the catheter unit.

[0003] The invention describes compact systems of particularly small size that the user can carry discreetly and that enable the user to perform complex medical procedures completely independently and safely, without additional aids or assisting persons.

[0004] The systems described within the scope of the invention are primarily used in individuals with chronic fecal incontinence who lack sufficient anorectal sphincter function. Fecal incontinence is a common condition that typically results in significant limitations for those affected in their daily lives and social interactions.

[0005] Various forms of therapy for the care of patients with fecal incontinence are described in medical and technical literature. In practice, a wide variety of assistive devices are known and established.

[0006] For temporary anorectal closure, among other methods, tampon-like devices are used today. A suppository-shaped device, usually made of a porous or foam-like, swellable material, is inserted into the rectum via the anus using the fingers or a finger-like tool. Once inside the rectum, it absorbs rectal secretions and expands into a space-occupying structure that lies flat or shell-like against the rectal floor, thus obstructing the excretory passage through the anus. When the device is no longer needed, it is removed from the rectum and anus by means of an attached thread-like pull tab or a stocking-like casing. However, tampon-like devices generally offer insufficient retention and sealing.

[0007] In addition to expanding, viscoelastic closure tampons, balloon-based closure systems are particularly common. These are generally equipped with a rectally positioned balloon that rests on the rectal floor and, besides providing rectal retention, offers a certain degree of sealing against bowel contents.

[0008] The balloon components typically consist of a material with pronounced elastic elongation properties and are inflated with a defined volume of an incompressible liquid medium to form a resiliently elastic body. This body develops a sufficient diameter to ensure the desired retention and sealing effect. The inflated balloon body usually assumes a more or less spherical shape and rests directly on the rectal floor. In many cases, users perceive it as a foreign object, which can trigger not only more complex excretory reflexes but also simple anal opening reflexes, potentially leading to the device being lost from its sealing, retaining position. A sufficiently effective seal cannot generally be guaranteed by a resiliently inflated, rectally positioned balloon body.The use of conventional, balloon-based closure systems is therefore often accompanied by a more or less continuous leakage of intestinal contents, which manifests itself, for example, as persistent soiled stools. Furthermore, sudden abdominal straining, such as during a cough or physical activity, can lead to the passage of larger quantities of stool or secretions despite the use of appropriate devices.

[0009] For temporary anorectal closure, balloon-based systems are also described in which the balloon component has a more complex shape or a segmented design, for example, featuring an extension that transitions from a spherical, rectally positioned expansion of the balloon body into a tapered, anally positioned expansion that partially or completely fills the anal canal. A corresponding product called "Navina" is manufactured, for example, by Minnesota Medical Technologies, USA. In this system, the balloon body has a teardrop-shaped to pear-shaped form, and is closed distally, i.e., towards the rectum, without an open lumen or continuous, catheter-like access to the rectum.The balloon body features an internal channel that opens only proximally, into which a rod-like insertion aid is inserted. The handle of this aid is enclosed in a cup-shaped recess of the balloon body, protecting the user's grasping fingers. The entire Navina balloon is made of a volume-expandable material with silicone-like compliance properties and is manufactured as a completely sealed compartment, pre-filled with a viscous fluid during production. After inserting the closure device into the rectum, the rod-like insertion aid is removed. The resulting seal is conditional and depends on the tone of the anal sphincter and the current intra-abdominal pressure. With a flaccid sphincter tone, the rectal, retention-acting portion of the balloon slips out through the anal canal.The inadequate anchoring properties are exacerbated by the pronounced volumetric elasticity of the balloon wall and the resulting tendency for it to slip out. A further disadvantage of the closed design towards the rectum is the lack of a channel to decompress intestinal gas, which could prevent abdominal bloating in the user during prolonged use of the closure.

[0010] Further designs of balloon-based closure catheters are described, for example, in EP 2004 089 B1. Here, the closure features a firmly integrated, T-shaped internal shaft structure that supports a dumbbell-shaped balloon body. The balloon is made of a very thin-walled material with low volumetric elasticity, preferably a thermoplastic polyurethane molded by blow molding. The balloon body is specifically designed for transanal positioning and sealing, with a central, tapered segment positioned within the anal canal and a rectal segment, which is relatively wider and has a flat shoulder or one with small shoulder radii, resting flat against the rectal floor in a retaining and sealing manner. The internal shaft structure supporting the balloon is flexible and designed for temporary indwelling.It enables the comfortable, transanal insertion of the thin-walled balloon body and the continuous decompression of intestinal gas. To prevent the balloon from dislodging from its transanal position into the rectum, the device described in EP 2 004 089 B1 is equipped with a retaining element arranged transversely to the transanal shaft portion supporting the balloon. This retaining element is protectively embedded in a pre-anal extension of the balloon body. Due to the flat contact of the rectal balloon segment with the rectal floor and the pre-anal counter-support provided by the transverse support, the plug-like device can be worn by the user with a high degree of certainty regarding dislodgement.The balloon body is preferably mounted on the trans-anal shaft element in such a way that the two balloon ends, tapered to the shaft dimensions, are positioned offset towards each other and fixed, whereby the two terminal expansions of the balloon approach each other during inflation and thus, in addition to the radial sealing effect of the central segment within the anal canal, exert an additional axially directed sealing effect on the anal canal.

[0011] Particularly advantageous for an irritation-free wearing experience and for a continuous sealing effect that withstands even abdominal pressure peaks or mass movements of the body is the device's ability to dynamically adapt to continuously changing rectal pressure and forces. The present invention therefore incorporates a technique already described in EP 2 004 089 B1, in which micro-thin-walled balloon films made of only slightly volume-expandable thermoplastic polyurethane are used for anorectal retention and sealing in a tension-free, slack manner. The balloon films are shaped to their full working dimensions or even beyond during manufacturing. They are filled with a compressible medium, preferably air, with a volume that keeps the balloon body in a tension-free, slack state.The rectally positioned, loosely inflated balloon body conforms to the respective anorectal junction with minimal tension. The force exerted by the balloon on the structures adjacent to it is largely homogeneous, thus avoiding pressure peaks on prominent structures extending into the anorectal space. The principle of the tension-free, loose placement of a micro-thin-walled, fully or partially shaped balloon body can be ideally combined with a dumbbell-shaped balloon body extending through the anal canal or a mushroom-shaped balloon body filling the anal canal. In both cases of this "segmented" balloon body design, abdominal or rectal pressure changes are absorbed by the rectal balloon segment and simultaneously converted into a sealing effect within the anal canal, thereby enabling particularly efficient sealing dynamics.On the other hand, the described technology allows for an almost pressure-neutral filling of the balloon body, which means that the filled balloon is not perceived by the user or only minimally, and does not trigger any unwanted opening or expulsion reflexes.

[0012] If mechanically rigid components remain in the immediate pre-anal area after transanal positioning of the closure device, they are often perceived as irritating by the user and can also cause lesions of adjacent skin. WO 2019 / 229597A1 describes special closure device designs in which such irritating, rigid components in the area of ​​the external anus are completely avoided. For example, the balloon bodies have a mushroom-shaped form, with the anterior, distal balloon end being inverted by the balloon body to the area of ​​the posterior balloon end. The two balloon ends are then directly and tightly connected in the pre-anal area, without the need for an additional component to accommodate the balloon ends, thus sealing off an inflatable compartment.Inside the inverted balloon body, a central channel forms, extending from the rectum to the outside. From the pre-anal junction of the two balloon ends, the sealing balloon film transitions directly into an attached peri-anal fixation film, which is adhered to the peri-anal skin or anal cleft using adhesive bonding. No additional receiving or connecting elements are used to create an inflatable space or to attach the fixation film to the sealing balloon film.

[0013] In addition to devices that primarily act as occlusive devices and are intermittently inserted and positioned anorectally, methods are also known for the treatment of chronic fecal incontinence in which a certain amount of fluid is introduced into the rectum at intermittent intervals of 24 to 48 hours via a balloon catheter inserted into the rectum through the anus, or via a pumping mechanism operated by the user. The resulting space-occupying effect in the rectum leads, after a few minutes, to the triggering of physiological, coordinated defecation reflexes, whereby the contents of the left side of the large intestine (colon) are largely emptied, allowing the user a certain stool-free, so-called "pseudo-continent" period.

[0014] The corresponding enema systems, such as the Peristeen-TAI system from Coloplast, Denmark, are structurally complex and rather bulky. They typically feature a reusable base unit with an integrated fluid pump. Access to the rectum is achieved via single-use catheter units, most of which have a balloon to secure the catheter in the rectum during use. However, the balloon component generally does not provide a sufficient seal, resulting in the rectally introduced fluid gradually leaking from the anus during the procedure. Furthermore, the rectally introduced or instilled fluid usually dissolves or liquefies formed bowel contents, which, if triggered by a reflexive bowel movement, can lead to eruptive excretion and significant soiling of the patient and the surrounding area.Furthermore, in users with neurogenic fecal incontinence, such as patients with spinal cord injuries who cannot assist the expulsion of enema fluid or mobilized intestinal contents by abdominal straining, the duration of catheter use can extend to 30 to 45 minutes, which leads many users to reject the method of reflex-triggering, “trans-anal irrigation”.

[0015] WO 2013 / 026565 describes alternative, reflex-triggered bowel evacuation techniques based on pneumatically stimulating or triggering balloon catheters that do not require a rectal enema. A dumbbell-shaped balloon, fully formed during manufacturing, is placed transanally and filled with air. This simulates a certain degree of rectal distension, triggering a coordinated reflex action that empties the left side of the colon. The stools are not loosened or dissolved by fluid and can therefore be expelled in their normal, formed state. Time-consuming and messy procedures are thus largely eliminated. Eruptive evacuations of loose, watery stools, as well as the prolonged subsequent elimination of applied enema fluid from the rectum, are avoided with this "pneumatic triggering" method.

[0016] Persistent episodes of fecal incontinence can also occur as a result of mechanical obstructions of the colon caused by compacted stool masses that can no longer be passed through or excreted by the colon. This leads to so-called "overflow stools" of a thin, liquid consistency, which the patient often cannot control due to insufficient anorectal sphincter function. Such mechanical obstructions are usually treated with so-called "circulating" enema techniques, in which larger volumes of fluid are cyclically introduced into and drained from the colon. Circulating lavage is frequently accompanied by significant anal leakage, making the procedure particularly messy.

[0017] The handling of the aforementioned techniques and devices for the management of anorectal incontinence is often extremely challenging for users and may require the use of additional aids or even assistance or administration by medically trained personnel. An object of the present invention is to develop, using known designs and functions of balloon-based, anorectally applied closure, trigger, and irrigation devices, a novel device concept to create ready-to-use systems and devices that are discreetly wearable, require no special environmental or application conditions, do not require any additional basic devices or aids, can be applied optimally quickly, and can be performed independently and safely by the patient without assistance.

[0018] This problem is solved by a generic system for the independent, transanal insertion of a catheter unit into a person's rectum, wherein the catheter unit comprises a catheter shaft component and at least one balloon attached to it, which is only filled and thereby inflated after the catheter has been inserted into the person's rectum and then holds the catheter in the rectum and optionally fulfills a sealing function, by the fact that the at least one balloon is connected to a filling device via a filling line, wherein all components and functions required for the use of the device, in particular for the insertion of the catheter and the filling of the balloon, including the catheter shaft, the catheter balloon, the filling line and the filling device, are arranged and / or integrated in a single, handy, compact outer packaging that is discreet and convenient to carry around.

[0019] It is highly advantageous if all functions and components required for the device's operation are integrated into a cylindrical, tube-like outer packaging the size of a cigar tube or a larger fountain pen, or into a cylindrical packaging film with pre-formed, tear-open sealing or perforation lines. This virtually miniaturized design allows the products to fit in any handbag, but also, for example, in the inside pocket of a jacket, a travel kit, a cosmetic bag, etc., thus ensuring optimal discretion for the user.

[0020] A chronically fecal incontinent patient, but also, for example, a physically weakened patient who is only temporarily incontinent, is thus enabled to carry all the components and functions required for the application of the catheter according to the invention, and to be able to use the respective catheter quickly and as independently as possible from a specific body position and special environmental conditions when needed.

[0021] The device should be readily available for immediate use whenever the user wishes to prevent the passage of stool or intestinal secretions. To achieve this, in addition to avoiding bulky assemblies and functional units, a design that is as ready for use as possible is crucial, thus eliminating the need for further preparatory measures or additional devices.

[0022] The respective device according to the invention is preferably used while seated, for example on a toilet bowl. However, thanks to its particularly efficient sealing properties, the device can also be used while lying down without significant leakage.

[0023] The invention proposes a conceptual design for the system or device that reduces the entire procedure to a particularly small size. This is achieved in particular by eliminating technically complex, bulky, and pumping devices for delivering rinsing or triggering fluids into the rectum.

[0024] The concept according to the invention further addresses the filling of the balloon components of the respective catheter units, wherein the filling function or the pumping components can be structurally integrated into the sleeve-like outer packaging of the device, or the filling function together with the catheter unit can be included in or enclosed by the outer packaging.

[0025] The user inserts the respective catheter unit into the outer packaging and keeps it there ready for use. Even relatively complex procedures, such as lavage-like irrigations or cleansing procedures in higher segments of the colon, can thus be performed discreetly and largely without regard to location.

[0026] The concept also includes a material-saving reuse of the pumping outer packaging.

[0027] In addition to a particularly compact design of the device, the invention aims especially at a material-saving, environmentally friendly design. The invention includes PVC-free versions or versions that use injection-moldable, lactate-based, biodegradable plastics for the sleeve packaging.

[0028] The invention recommends that the balloon of the respective catheter unit consists of a particularly thin-walled, soft-film-like material of low volumetric elongation (compliance), for example, manufactured in a blow molding process from a thermoplastic polyurethane (TPU) of the hardness range Shore 80A to 95A or Shore 55D to 60D, wherein the wall thickness of the balloon in the area of ​​the largest diameter is approximately 10 to 50 pm, preferably 10 to 30 pm.

[0029] To ensure that the retaining and sealing balloon of the catheter unit, and potentially also the balloon that triggers the stool reflex, or the respective active components of a segmented balloon, can be inflated at a particularly low pressure that is optimally compatible with the perfusion of the adjacent body tissue, the balloon components are shaped during manufacturing to the working dimensions required for their respective functions. Preferably, the shaping is carried out in such a way that the required working dimensions are exceeded "residually," meaning the balloon is shaped "oversized."

[0030] It is within the scope of the invention that the balloon of the catheter unit is made of a material with high volumetric extensibility (compliance), for example, a polyisoprene- or silicone-based polymer, wherein the balloon may have a complete, a partial, or no discernible shape or form. The invention preferably uses balloon components that are either specifically dumbbell-shaped or mushroom-shaped and extend from the rectum across the anal sphincter into the pre-anal region, or that extend only within the anal canal or to the external opening of the anus, thus enabling a particularly efficient, "trans-anal" seal of the anal canal.

[0031] The specific dumbbell-shaped design of a trans-anal sealing balloon body described in the invention ensures that the central, tapered balloon portion is positioned stably within the anal canal. In the preferred catheter design, the distal, rectally positioned extension of the dumbbell-shaped balloon has a residual excess, thus ensuring gradual, stepwise inflation of the balloon within the rectum without requiring the balloon wall to undergo a force-intensive stretching phase. During such a gradually controlled inflation, the balloon wall remains in a tension-free, undeveloped state, enabling a sealing effect even at particularly low pressure values, which approximately correspond to or do not exceed the prevailing physiological intra-rectal pressure.The resulting ability to transmit particularly small forces to the rectal wall sections adjacent to the balloon largely prevents unwanted reflexive openings of the anal sphincter during the use of the catheter unit.

[0032] The catheter units according to the invention are preferably equipped with a dumbbell-shaped balloon element that retains and seals the catheter unit transanally. The segment of the balloon placed in the rectum has a spherical or discoid shape, and the central, tapered segment extending from it is positioned within the anal canal. A spherical or discoid pre-anal segment, positioned immediately before the opening of the anus, adjoins the trans-anal segment. Alternatively, the balloon element can have a mushroom-like shape and lack a pre-anally expanded segment, thus comprising only a rectally placed, spherical or discoid segment and a trans-anal segment that tapers relative to it.Optionally, and less preferred, the balloon body may consist of only a single, rectally placed spherical or discoid extension, without a projection entering the anal canal.

[0033] Both dumbbell-shaped and mushroom-shaped balloon components ensure a special, dynamically adaptive, radially acting trans-anal seal through the balloon sheath, which extends into the anal canal and tamponades it in a tension-free, slack manner. The respective rectal pressure and force effects are absorbed via the rectal segment of the balloon sheath and, without delay, are simultaneously applied in a sealing manner in the area of ​​the trans-anal segment.

[0034] If the balloon has a dumbbell or mushroom shape, with at least one of the ends of the balloon tapered to the shaft length being fixed to the shaft of the catheter unit in such a way that the end(s) are recessed into the balloon body or shifted towards each other, the respective spherically or discoidally expanded segments of the balloon can, during inflation, roll over the relatively tapered portion of the balloon body or approach each other in a rolling motion directed towards each other or develop a converging pressure, whereby the rectally retaining and sealing balloon component dynamically adapts to the respective anorectal anatomy.can adapt to the different functional states of the anorectal sphincter and thus, in addition to a radial sealing effect within the anal canal, can also develop an additional sealing effect directed axially from both sides towards the anal canal.

[0035] In the case of a dumbbell-shaped balloon body, the portion located outside the anus, pre-anal, spherically or discoidally expanded, can have a maximum diameter that is equal to or exceeds the maximum diameter of an injection-molded or otherwise cast pre-anal support element or an annular element receiving the balloon ends.

[0036] The retaining and sealing rectal balloon or the corresponding rectal balloon component can have a flat, discoid shape, wherein the discoid balloon body with its shoulder lies flat against the rectal floor and / or wherein the radial circumferential surface of the discoid balloon body is exposed flat against the lateral parts of the wall of the terminal rectum, and / or wherein the filled, freely unfolded rectal component of the balloon body has an axial height of 30 to 50 mm, preferably 30 to 40 mm.

[0037] In conjunction with a pre-anal support component or other pre-anal holding function, additional axially directed sealing effects can be achieved by appropriately inverting the balloon ends, whereby the respective rectal expansion of the balloon moves towards the inner entrance of the anal canal in a quasi-rolling manner during inflation. To generate this axial rolling motion, the distal end of the balloon body is inserted into the interior of the balloon body on the shaft that supports the balloon and fixed there.

[0038] As an alternative to manufacturing balloon components from materials with low volumetric elongation or compliance that are fully molded or molded to a residual oversize, the sealingly retaining balloon components or their partial segments described in the invention can also be partially molded, i.e., not to their full working dimension. During inflation, they enter or pass through a phase of elastic elongation until the required working dimension is reached. For a corresponding elongation characteristic, TPU-based materials with a Shore hardness of 70A to 80A, or partially molded polyisoprene, TPE, or silicone-based components, can be used, for example.

[0039] As a particularly simple, non-preferred embodiment, the invention provides for designs of the respective catheter units that have unshaped or nearly unshaped balloon components, based on, for example, polyisoprene polymers, which expand elastically when inflated. Furthermore, fully or partially shaped, spherical or discoid balloons can also be used for the retaining and sealing catheter unit; these balloons expand only in the rectum and are positioned only there, i.e., they have no extension into the anal canal.

[0040] In the peri-anal or pre-anal region, the respective catheter unit of the device according to the invention is optionally equipped with a support element, which can, for example, be designed as a soft, flexibly deformable, injection-molded, disc- or plate-like body. This prevents the balloon from slipping into higher parts of the rectum or into intestinal segments extending beyond the rectum, and ensures the position-dependent, rectally or trans-anally acting seal and retention of the device throughout.

[0041] Alternatively, a pre-anal support function can also be provided by a balloon-like element, which is either manufactured as a separate component, for example, one that can be filled with air, or as a pre-anal extension derived from a dumbbell-shaped, trans-anal balloon segment. Such a separate balloon unit can be filled during manufacturing, for example, with a soft, gel-like substance that brings the balloon into a softly inflated state. This allows it to conform to the peri-anal anatomy as an unstretched, viscous "cushion," thus optimizing comfort. The gel or fluid is preferably encased in a thin-walled balloon shell made of a dimensionally stable material that is not elastically deformable under tensile stress and has low volumetric elasticity, such as that provided by TPU-based film material.

[0042] In addition to deformable abutment components, self-adhesive, film-based components can be used for the pre-anal retention of the respective catheter-like devices. Besides patch-like films made of non-woven or woven material, single- or multi-layered films coated with a skin-compatible adhesive can also be used. TPU-based carrier films, only a few millimeters thick, coated with adhesive polyurethane gel, are particularly suitable. The gel layer, which is significantly thicker than the supporting film, allows for a largely neutral feel in the anal cleft. Polyurethane-based adhesive films with adhesive layers of polymerized PU gels behave mechanically similarly to body tissue and are therefore used, among other things, in prosthetics for the adhesion of prostheses.Due to the relatively voluminous application of the gel, the gel layer also makes it easier for the user to comfortably grip and remove the adhesive film, which can be disadvantageously difficult with particularly thin-walled films.

[0043] In addition to designs that do without a separately manufactured, tube-like or shaft-like component positioned in the anal canal, and in which the connection of the intestinal lumen to the outside is made by the inverted distal balloon end, embodiments are also conceivable within the scope of the invention that have a shaft-like or tube-like component of higher rigidity or whose material hardness exceeds the hardness of the respective balloon material used.

[0044] During the use or wearing of the respective catheter unit, traumatic damage to the anatomical structures and tissues exposed to the catheter must be largely avoided. The device according to the invention addresses mechanically and / or pressure-induced lesions of the rectum and anus originating from the catheter unit in several ways. Perforating injuries are prevented in fully mobile users, for example, patients who run or participate in sports, by preferably omitting a trans-anally integrated, separately manufactured, rigid shaft element in the design and instead using retractable insertion aids for trans-anal insertion of the device.

[0045] In particular, the invention utilizes the special properties of completely or even oversized or residually designed, micro-thin-walled, incompletely limp balloon components. The balloons, positioned without tension in the rectum, make it possible to largely eliminate pressure-induced lesions at nearly ambient or neutral inflation pressures. Compressible air is preferably used to inflate the retaining, sealing balloons. Furthermore, volume-determined pump strokes are used to avoid potentially traumatic overinflation of the balloons. Optional pressure-limiting functions are also provided.

[0046] In addition to a retaining sealing function, the trans-anally positioned closure technology described in the invention enables a pneumatically mediated force from the filled balloon component to act on the portions of the rectal wall in contact with the balloon. This can optionally trigger a reflexively coordinated bowel movement that goes beyond sealing and retention, triggered by stretching. A pneumatically initiated reflex triggering, and the associated emptying of bowel contents, can be performed, for example, immediately before the removal of a sealing closure element that has been worn for a period of time.

[0047] If a user regularly employs such a supplementary pneumatic triggering of a defecation reflex, they can insert the corresponding anorectal closure device, for example, six to twelve hours before the planned administration of another defecation-inducing reflex triggering. This provides the additional security of a comfortable, stool-tight closure towards the end of a pseudo-continent interval. Immediately before removing the primary closure catheter, the user inflates the balloon component of the unit by adding volume to the balloon, moving it from a partially deflated to a fully inflated or stretched state. This creates a reflex-triggering increase in volume within the rectum.

[0048] The described application option can also be used following rectal irrigation or colorectal enemas to achieve temporary leakage protection with the closure device until all residues of the administered irrigation fluid have accumulated in the rectum and are then expelled from there by triggering a coordinated emptying reflex that supports final excretion.

[0049] For the performance of so-called trans-anal irrigation (TAI), for the intermittent, reflexive emptying of the rectum, for example in patients with damage to the spinal cord, special, relatively elaborate irrigation systems designed for self-application by the patient are used today.

[0050] The TAl procedure is based on the manually initiated triggering of a coordinated defecation reflex, which largely corresponds to the reflex process during natural, physiological bowel movements. In intermittent transanal irrigation, the patient inserts an enema catheter, usually equipped with a rectally anchoring (retaining) balloon element, through the anal canal (transanally) into the rectum. After the retaining balloon element is inflated, fluid or water is introduced into the rectum through the catheter shaft. The volume of water instilled in the rectum, typically 100 to 500 ml, exerts a continuous force on the rectal wall. This forceful stimulus is interpreted by the sensory apparatus of the rectum as a feeling of fullness with intestinal contents, which corresponds to the physiological stimulus for triggering a defecation reflex.The excretion reflex is based on an autonomous, coordinated peristaltic contraction that extends across various segments of the terminal large intestine (colon). The reflex that expels the intestinal contents begins in the left descending colon and propagates from there towards the anus.

[0051] In patients with anorectal sphincter insufficiency or impaired function of the anal sphincter, intermittent irrigation, performed at intervals of approximately one to two days, can trigger the defecation reflex and thus achieve a state of so-called "pseudo-continence." Procedures based on transanal irrigation (TAI) are often time-consuming and frequently result in significant soiling of the patient and the application area. The reflex defecation induced by transanal irrigation is recognized as an effective and efficient method for treating chronic fecal incontinence.

[0052] Modern irrigation systems for intermittent defecation are generally based on a combination of a reusable base unit designed for inpatient use and disposable catheters for each rectal application. These systems are technically sophisticated and relatively complex to operate. In addition to systems where manual pumping creates air pressure over the irrigation fluid to deliver it to the patient, electrically operated systems are also available. These pump the irrigation fluid from a reservoir into the patient's rectum, regardless of the patient's position. The transanal irrigation (TAI) procedure is typically performed with the patient in an upright sitting position, directly over a toilet bowl.At the moment peristaltic bowel emptying begins, the balloon retaining the balloon in the rectum is deflated and the catheter unit is withdrawn from the patient's anus.

[0053] For several years, alternative techniques for the intermittent triggering of defecation reflexes have been described that completely or almost completely avoid the introduction of fluid into the rectum. In these systems, the sustained pressure or distension of the rectal wall that triggers the defecation reflex is achieved by filling a rectally positioned catheter balloon or catheter balloon component with a gaseous fluid. The resulting force acts continuously or continuously on the portions of the terminal rectum in contact with the catheter balloon. Air is preferably used to fill the catheter balloon. The advantage of a pneumatically based, balloon-mediated reflex triggering system is, firstly, that higher forces can be exerted in the rectum, if necessary for the success of the reflex.The advantages of pneumatic reflex activation are twofold: firstly, it allows for the generation of higher stretching forces than those achievable with rectally administered fluid columns, and secondly, it reduces the extent of soiling of the patient and the surrounding environment. With a conceptually "dry" reflex trigger, the dissolution of formed stool components in the rectally administered irrigation fluid can be avoided. Pneumatic reflex triggering thus enables the reflexively coordinated elimination of stools of normal, formed consistency, largely corresponding to physiological defecation, without significant soiling from eruptive, abrupt discharges of thin, completely or partially dissolved stools into the toilet.

[0054] The present invention describes particularly compact, ready-to-use, and application-optimized devices for the intermittent, pneumatically balloon-mediated generation of triggering stimuli for initiating coordinated peristaltic defecation reflexes. The described devices, in particular, do not require a complex base unit with intricate operating functions, but rather integrate all the functional components necessary for carrying out the procedure into a cylindrical outer casing, similar in size to a cigar tube or fountain pen, which also houses the trigger catheter. The devices described within the scope of the invention are preferably designed for single use.The devices enable the user to perform combined triggering procedures in addition to purely pneumatic reflex triggering, whereby the primary pneumatic stimulus can be supported by an additional rectal instillation of enema fluid. The invention provides for this purpose a channel-like supply line integrated into the shaft element of the catheter unit, which allows the introduction of liquid substances into the rectum. The rectally administered volumes should not significantly exceed 100 ml in this case. Corresponding commercially available enema preparations are generally packaged in cylindrical foil containers, the contents of which the user typically squeezes into the rectum by closing the pouch with their fist. The foil pouches have an integrated supply tube or a supply cone.These can be connected to the proximal, extracorporeal end of the catheter shaft unit according to the invention.

[0055] Beyond the specific triggering of a defecation reflex, the technology described within the scope of the invention can serve to create a temporary, trans-anal access to the patient's rectum or colon, thereby opening up numerous therapeutic application options. The particularly efficient, dumbbell-shaped, trans-anal design of the catheter balloon component described within the scope of the invention makes it possible to retain even small volumes of fluid, especially a few milliliters, in the rectum without loss or leakage. Thus, for example, so-called micro-enemas of only 5 to 15 milliliters, containing a chemically irritating substance that supports the triggering of the defecation reflex and affects the rectal mucosa, can achieve a sufficiently long exposure time to develop their full effect. The high sealing performance also makes the device suitable for local or regional use.Topically acting therapeutic agents are suitable, for example, those used in the drug therapy of chronic inflammatory processes of the mucosa of the terminal colon. The transanal seal of the described trigger and access device to the rectum allows not only for the loss-free instillation of very small volumes, but also for the retention of very large enema volumes in the intestine without the risk of significant transanal leakage of enema fluid. In particular, high-volume enemas can be administered in a supine position without causing any mess.

[0056] For users who wish to trigger a coordinated defecation reflex, or who wish to use the described options of temporary access to the rectum for drug administration or an enema, the device designs described within the scope of the invention make it possible to carry out the complete procedure of reflex triggering or the establishment of rectal access with the components integrated into the device, and thus to be completely independent of a basic unit supporting the procedure or other aids.

[0057] Preferably, the filling device for inflating the at least one balloon of the catheter unit is manually operated, particularly without auxiliary power. Because of this lack of auxiliary power, all versions of the device can also be used while traveling, even when no power outlet is available.

[0058] A pressure-limiting component or function that limits the balloon's inflation pressure and releases volume can be integrated into the device's supply and / or pumping or gas-generating portion. Its purpose is to prevent a potentially critical pressure increase within the balloon, particularly in cases of incorrect operation, such as excessive pumping. Alternatively, instead of positioning a pressure-limiting component or function in the pumping segments or downstream segments of the device that supply the pumped volume to the balloon of the catheter unit, a corresponding pressure-limiting function can be structurally integrated into the catheter unit itself. In this case, the respective functional assembly is not inserted serially into the connection between the pumping or supply assemblies, but rather in parallel, preferably into the proximal handle of the catheter unit's shaft component.In this arrangement, the volume of the filled balloon component acts as a buffer against peak-like pressure increases, such as those that can occur during forced pumping by the user. Unwanted, momentarily decompressive openings of the system can thus be largely avoided, and defined pump volumes into the catheter balloon can be ensured. Specific effects linked to particular tidal volumes, with one, two, or three pump strokes, can therefore be achieved with good repeatability.

[0059] The pressure-limiting function or assembly can be configured to release volume when critical, safety-relevant pressures are reached. Alternatively, the pressure limiter can be set to release volume from the catheter balloon when the operating pressure required for the specific function is reached. In this case, the user can, for example, perform three or four pump strokes, although only two strokes are required for the respective balloon function, thus reliably preventing over-inflation.

[0060] The invention recommends that the filling device for inflating the at least one balloon of the catheter unit has a cavity whose volume is variable, in particular manually variable. In this way, by manually reducing this volume, the filling pressure within the filling device – and thus also within the balloon of the catheter unit connected to it – can be increased.

[0061] Further pursuing this inventive idea, the invention provides that the filling device for filling the at least one balloon of the catheter unit has a manually operated pumping mechanism.

[0062] In particular, such a pumping mechanism can have at least two telescopically nested, relative-displaceable sleeves and / or cylinders. The volume enclosed by these changes depending on the insertion position of one element within the other. Consequently, with cyclic or oscillating operation or displacement, a predetermined quantity of air or other fluid is delivered into the balloon with each stroke.

[0063] Ideally, the pump mechanism has at least one sleeve-shaped component and a piston-shaped component that is slidably guided within it. While the sleeve-shaped component must have an internal cavity, this is possible for the piston-shaped component, but not necessary.

[0064] Both the piston-shaped component and the sleeve-shaped component should be closed at least on one end face. This creates a closed cavity between two such end faces that are movable relative to each other.

[0065] On the other hand, the sleeve-shaped component and / or the piston-shaped component can be open at one end. If the piston-shaped component is open at one end and closed at the other, the residual volume enclosed in conjunction with the closed end of the sleeve-shaped component when both components are compressed depends on the orientation of the piston-shaped component relative to the sleeve-shaped component.

[0066] If the piston-shaped component is approximately the same length as the sleeve-shaped component, the entire assembly, when fully inserted, will have approximately the same length as one of the two components.

[0067] Furthermore, the piston-shaped component should be sealed against the inside of the sleeve-shaped component, particularly along an annular sealing line, e.g., at least in the area of ​​one end face. This can be achieved by using or inserting a sealing ring.

[0068] Furthermore, the sleeve-shaped component and / or the piston-shaped component of the pump mechanism can be elastically designed so that it can be elastically deformed by clenching a fist or applying finger pressure and elastically returns to its original position when free from external forces. In such an arrangement, in addition to the telescopic change in the enclosed volume, the enclosed volume can be further reduced by squeezing the compressed components when the components are inserted with their closed end faces away from each other.

[0069] Preferably, the piston-shaped component is inserted into the sleeve-shaped component in its unused state in such a way that the respective closed ends face away from each other, so that the respective associated catheter unit can be received and stored in the common enclosed cavity, as well as, if necessary, other elements such as a reservoir bag, which may be rolled up and / or otherwise folded for this purpose, or, for example, a supply tube component that connects a reservoir unit to the catheter unit and may also be compactly folded and / or rolled up.

[0070] On the other hand, the piston-shaped component can be separated from the sleeve-shaped component and reinserted in reverse orientation. If the piston-shaped component is open at one end, different initial and residual volumes result depending on its orientation when inserted into the sleeve-shaped component. While in both insertion directions a maximum volume can be pushed into the balloon with one pump stroke that corresponds to the length of the sleeve-shaped component multiplied by its internal cross-section, when the open ends of both components are joined, the residual volume in the compressed state is approximately half the initial volume. Conversely, if the piston-shaped component is inserted into the sleeve-shaped component in reverse orientation, the residual volume within the pumping device decreases to approximately zero.Therefore, in this case, the pressure within the system can rise more significantly than with the first orientation. In the second case, a pressure relief valve should be provided in the system to limit an uncontrolled or unwantedly high pressure increase. On the other hand, the second insertion direction likely allows more air to be pushed into the balloon per stroke than the first.

[0071] In any case, the piston-shaped component should be connectable to the sleeve-shaped component to form a closed pump body after the removal of the internal catheter unit.

[0072] Furthermore, the invention recommends that the piston-shaped component and the sleeve-shaped component, when connected, are designed to be rotatable relative to each other about a predetermined maximum angle around their common longitudinal direction by a predetermined maximum angle, such that, during a subsequent mutual axial displacement, the piston-shaped component and the sleeve-shaped component are guided in a mutual connection such that (i) under a relative axial tensile force or when the pump is drawn in, the two components can no longer be completely separated from each other by a corresponding mechanical stop, thus defining a maximum compressible volume, and (ii) under a relative axial compressive force or when the pump is expelled, a certain stop cannot be overcome, resulting in an overall defined maximum stroke volume.Therefore, the user does not need to worry about the height of a pump stroke during the pumping process, which is instead determined by the distance between the two stops.

[0073] As an alternative to defining the stroke volume by means of travel-defining mechanical stops, the travel distance of the required axial displacement for a defined stroke volume can also be defined by circular, colored markings on the visible outer surface of the sleeve- or piston-shaped components. The respective marking lines can be positioned serially, with the actual target marking, for example, being red, and the preceding lines approaching the target marking being green, with the width of the green lines gradually increasing as they approach the red line.

[0074] In particular, in the described embodiment with mechanically limiting stops, it can further be provided that the dimensions, especially volumes, of the sleeve-shaped component and / or the piston-shaped component, as well as the structural limitations of the possible relative travel distances of the two components, are set or adjustable to determine the stroke volume such that (i) during a single complete stroke sequence, the balloon of the catheter unit is filled to such an extent that the balloon achieves a sufficient rectal retention effect, and / or that (ii) during a subsequent second complete stroke sequence, an effective trans-anal sealing effect is generated, and / or that (iii) during a subsequent third complete stroke sequence, for example, a stimulus can be generated that can trigger a coordinated defecation reflex, whereby, if necessary,(iv) In addition, during one or more subsequent complete stroke sequences, a pressure increase occurs in the inflated balloon, which can be perceived by the user or recognized as a sign of incipient overinflation. This allows the correct inflation of the catheter balloon to be traced back to the correct number of pump strokes, and the user only needs to count the respective strokes.

[0075] The occlusive, reflex-triggering, or trans-anal irritating catheter unit of the device can be stored before use in a cylindrical packaging sleeve consisting of at least two sleeve sections, which can be joined to form an air-pump-like body after removal of the catheter unit. The sleeve-like outer packaging can then be used to inflate the catheter balloon in several pumping steps, as determined by the user. In its preferred embodiment, the sleeve-like outer packaging is manufactured to such a high standard that it allows for multiple uses or ensures reliable packaging and inflation over a period of, for example, 30 days.

[0076] The invention provides, in particular, for the material- and environmentally-friendly combination of a reusable, sleeve-like, pumping outer packaging with single-use catheter units. The respective single-use unit is preferably packaged in a lightweight, fully enclosed protective film with a tear-off pre-formation, which allows the ready-to-use, and in particular lubricated, catheter unit to be inserted into or received within the sleeve-like outer packaging in a protected manner.

[0077] In addition to filling the balloon component by a mechanically pumping mechanism integrated into the device, another embodiment of the invention may also provide that the filling device for filling the at least one balloon of the catheter unit has at least one manually operated pump balloon. In contrast to an air pump-like design and function, a pump balloon can optionally be operated with just one hand by making a fist.

[0078] The invention recommends that the pump balloon be elastically deformable, e.g. by having a shell made of preformed rubber.

[0079] Further developing this idea, the invention provides that the pump balloon is self-erecting or self-expanding. A simple measure for achieving this property is to preform the pump balloon from a thick, rubber-like material in a spherical or sack-shaped, radially compressible structure. Sufficient wall thickness of the preformed rubber or similar material shell of the pump balloon is required for the self-erecting properties to occur. The invention provides, for example, a thickness of 2 mm or more, preferably a thickness of 3 mm or more, and particularly a thickness of 4 mm or more.

[0080] On the other hand, the self-erecting property can also be achieved by filling the pump balloon with an elastic foam. In this case, a much thinner wall thickness is sufficient, e.g., 1 mm or less, preferably 0.5 mm or less, particularly 0.2 mm or less, or even just 0.1 mm or less. In such a case, the pump balloon does not necessarily have to be made of an elastic material, but could simply be made of a flexible, e.g., film-like material such as a thin polyurethane film. The advantage would be that the casing itself would then have a very small volume and thus take up very little space when deflated and folded. This small space requirement can be achieved particularly well if an elastic foam filling—e.g.,by evacuating the pump balloon - it collapses to a very small residual size.

[0081] On the other hand, the pump balloon can also be provided with a bellows-shaped, axially compressible or compressible structure. Such a structure is also suitable for pre-forming from a material that is more flexible than elastic, so that a material such as polyurethane is also a possibility.

[0082] A flow-directing valve can be arranged at the outlet of each pump balloon. This valve allows the flow of a filling medium, particularly air, from the cavity in the pump balloon into the filling line, while preventing backflow from the filling line to the cavity. The pressure within the filling line, and thus also within the catheter balloon, can therefore be gradually increased with each pumping action.

[0083] Furthermore, the pump balloon should be equipped with an inlet that allows air to flow into the enclosed cavity as soon as the pressure inside the cavity is lower than the ambient pressure.

[0084] The invention is further improved by the inclusion of a flow-directing valve at the inlet. This valve allows the flow of a filling medium, particularly air, from the surroundings into the cavity, while preventing backflow from the cavity into the surroundings. Thus, the pumping balloon automatically refills after each pumping cycle as soon as it is released or loosened and its shell returns to its upright position, since the pressure inside the pump balloon drops significantly during this process. Similarly, the cavity in a pump mechanism refills when a piston engaging a sleeve is retracted. The invention also provides an optional connection point for the catheter's tubing supply line at the inlet opening of the pump body, allowing the user to actively deflate the catheter balloon using the pumping unit.The respective terminal components of the supplying hose segments are designed to be congruent in shape with the inlet openings of the respective housing.

[0085] As an alternative to mechanically pumping units, the filling device can be designed to carry out a gas-generating chemical reaction. For this purpose, a system according to the invention can comprise gas-releasing or gas-generating components that can fill the balloon of the catheter unit completely independently of a mechanical pumping process. For example, carbon dioxide can be released from a dry substance by bringing the substance into contact with an aqueous solution. The respective solution is released from a rupturable container by mechanically squeezing pressure. The chemical reaction with the dry substance takes place in a surrounding, sealed compartment, from which the evolving gas is conveyed to the balloon of the catheter unit via a tube.The amount of gas produced is adjusted, for example, by the specific gas-releasing capacity of the agents used and the respective quantities or ratios of the gas-generating substances within the scope of the invention, such that the balloon of the catheter unit fully unfolds, but the wall of the balloon does not yet enter a stretched state.

[0086] The gas-generating chemical reaction can be activated by manual action of the user, for example by applying pressure, in particular by pressing a finger, thumb or key, e.g. by catalytically stimulating various substances to react, or by allowing a previously suppressed reaction to proceed freely.

[0087] To implement the latter variant, the filling device can have at least two compartments that were originally separate from each other, each containing one of two different chemical substances, the mixing of which produces a gas.

[0088] Further developing this inventive concept, the invention provides that at least one compartment contains water (H₂O) or an aqueous solution. Water or aqueous solutions are inert in themselves, but can nevertheless be made to react with other substances.

[0089] On the other hand, at least one (other) compartment can contain at least one dry substance, e.g., in powder or granular form, such as sodium bicarbonate (NaHCO3) and / or a citrate, in particular C6H8O7. The latter is capable of reacting with water.

[0090] To initiate such a reaction, a continuous but initially interrupted flow connection can be provided between at least two compartments, whereby the interruption of the flow connection can be lifted or the flow connection opened by a manual action.

[0091] After the originally interrupted flow connection between the two compartments is opened, a liquid stored in one compartment, for example water H2O, can react chemically with at least one dry substance in another compartment, for example sodium bicarbonate NaHCO3 and / or a citrate such as C6H8O7, in such a way that a physiologically acceptable gas is released, e.g. carbon dioxide CO2:

[0092] For example, a citrate such as C6H8O7 is reacted by adding water according to the following formula:

[0093] C6H8O7 + H2O - C6H5O7 + H3O.

[0094] Then, together with the baking soda, the following reaction can be triggered: NaHCO3 + H3O Na + CO2 + H2O,

[0095] carbon dioxide is released as a gas.

[0096] Once a gas-generating reaction, e.g., a carbon dioxide-generating reaction, is initiated by the physical exposure or combination of water with at least one dry substance, such as sodium bicarbonate and / or citrate, it preferably proceeds until the complete conversion of the reagents involved. Therefore, the total amount of gas produced can be precisely controlled.

[0097] Furthermore, the invention provides a balloon- or balloon-foil-like enclosure for containing the gas released during the chemical reaction. This prevents the uncontrolled escape of the resulting gas into the atmosphere; instead, the gas collects inside the balloon- or balloon-foil-like enclosure and initially creates pressure or overpressure there.

[0098] By connecting or making connectable the balloon- or balloon-foil-like enclosure to the filling line, e.g. via a valve, the gas released by the reaction is directed from the balloon- or balloon-foil-like enclosure to the balloon of the catheter unit in order to fill it.

[0099] By appropriately measuring the amounts of reagents, the amount of gas produced can be adjusted so that the balloon of the catheter unit, which is connected to the gas-generating filling device, fills completely, but its balloon wall does not yet enter a stretched state.

[0100] The invention is further optimized by providing a gas-permeable but water-impermeable component, e.g., a membrane, in the filling device and / or in the filling line. This component is responsible for allowing a gaseous medium, such as carbon dioxide, to equalize the pressure between the filling device and the catheter balloon, while preventing the escape of liquid from the reaction chamber of the filling device into the filling line leading to the balloon of the catheter unit.

[0101] The pneumatically balloon-mediated triggering of a defecation reflex described in the invention does not require a liquid irrigation medium to elicit a defecation reflex. Instead, it triggers the defecation reflex through a gradually adjustable pneumatic distension of the rectum by the catheter balloon. The rectally stimulating balloon is shaped to its functionally required working dimensions during manufacturing. It has a dumbbell-like shape, with the central, tapered balloon portion positioned within the anal canal. In the preferred design of the catheter described therein, the distal rectal extension of the dumbbell-shaped balloon has a residual excess, ensuring that the balloon wall does not have to undergo a force-intensive stretching phase for a gradual, stepwise filling or distension of the rectum.The triggering of the reflex can occur in a relaxed, unstretched state. The flaccid inflation of the balloon allows the user to determine, with good approximation, the transmural pressure transmitted from the balloon to the adjacent rectal wall by barometric measurement of the balloon's inflation pressure.

[0102] As an alternative to manufacturing the individual balloon components fully formed or forming them to a residual excess, the present invention allows all balloons, or their partial segments, to optionally enter a phase of elastic stretching during inflation. In the case of the dumbbell-shaped catheter balloon, it is functionally advantageous for the balloon wall to undergo elastic stretching if the intrarectal segment of the dumbbell-shaped balloon body exhibits a relatively greater radial stretch than the transanal segment.

[0103] The invention provides, in addition to the use of dumbbell-shaped, trans-anally positioned balloon components, also for fully or partially formed balloon components that extend into the anal canal from a rectally positioned, retaining balloon segment, but do not extend beyond the anus. Furthermore, the invention optionally provides for the use of fully or partially formed, spherically or discoidally shaped balloons that only encompass or are positioned within the rectum. As a particularly simple, non-preferred embodiment, the invention also provides for designs of the catheter unit that have unformed or largely unformed, elastically expanded balloon components and do not offer the particular functional advantages of residually formed balloons with low balloon wall compliance.

[0104] While the rectally feeding channel extending through the shaft and handle of the catheter unit has only a small, preferred diameter of approximately 1 to 1.5 mm in the reflex-triggered designs of the device, designs with a channel diameter of, for example, 4 to 7 mm can be used for administering rectal enemas, or designs with channel diameters of 12 to 16 mm can be used for administering higher-reaching colon enemas.

[0105] A wide variety of devices are available for administering enemas into the rectum of a user or patient. Typically, systems used for the application of enema fluid consist of a transanal access catheter inserted into the rectum, a supply tube for the administered fluid, and a reservoir container to collect the fluid. Rectal enemas can be easily performed by the user themselves by raising the filled reservoir container above body level. The fluid begins to flow into the rectum when the set hydrostatic pressure in the system exceeds the pressure present in the rectum.

[0106] In many cases, enemas are now performed using so-called "swivel techniques." Following the inflow directed towards the patient, a corresponding outflow is generated by lowering the reservoir below the user's level. With repeated cycles of inflow and outflow, some of the formed intestinal contents dissolve and liquefy. Furthermore, a lavage-like procedure with a sufficiently high flow rate can mobilize solid, formed, or even persistently compacted intestinal contents, moving them along with the flow and thus "washing" or removing them from the intestine.

[0107] Enemas are often accompanied by leakage of fluid or intestinal contents from the anus, both during and after the procedure, which can lead to significant soiling of the user and the application environment, especially in patients with a weak anal sphincter muscle.

[0108] Enema systems are increasingly offered as single-use systems. These devices typically consist of PVC-based components and are generally characterized by bulky, unwieldy designs. Reusable systems are mostly only partially portable and largely preclude use in unfamiliar, non-domestic environments.

[0109] To secure the intrarectal position of an anally inserted enema catheter, the catheter unit of many systems is equipped with an anchoring (retaining) balloon component. The retaining balloon rests on the rectal floor and prevents the catheter from slipping out of the anus. A sufficiently tight seal cannot usually be guaranteed by the rectally retaining balloon alone. With conventional balloon catheters, enemas are generally accompanied by some leakage and contamination. To prevent fluid from escaping the anus, users often voluntarily tense the sphincter muscles, but this tension usually fatigues after a few minutes. To improve the seal, users often manipulate the rectally inserted balloon catheters into a temporarily tightening position.It is placed under slight tension, which draws the balloon to the bottom of the rectum in a sealing manner.

[0110] Most enemas are administered while lying down. Performing an enema without soiling while sitting, for example on a toilet, is often difficult. In confined spaces and without the option of lying down, a rectal enema, or a colorectal enema involving a larger portion of the colon, is largely impossible today.

[0111] A further problem with conventional enema systems is that the catheter, which extends into the rectum, cannot remain in its rectal position immediately after the enema procedure. To avoid traumatic injury to adjacent structures from the catheter shaft, it must be removed from the rectum or anus after the enema has been administered. In particular, rectal perforations must be prevented, as these remain a dreaded complication due to the combination of catheter tips designed to be easily penetrated and the often rigid, stiff shaft.

[0112] In addition to administering a rectal enema, catheter systems equipped with a rectally retaining and sealing balloon component also offer the possibility of triggering a defecation reflex. In this process, for example during transanal irrigation, several hundred milliliters of irrigation fluid are introduced into the rectum and held there long enough to trigger a defecation reflex. This reflex empties the left colon or its terminal portions through a coordinated peristaltic contraction. Similarly, a defecation reflex can be triggered by gradually inflating or expanding the balloon component of the enema catheter in the rectum, thereby exerting a sustained force on the rectal wall. This force is perceived by the rectum as filling with intestinal contents and is responded to by a coordinated reflexive defecation.

[0113] Thus, the present invention describes, in particular, very compact, especially discreetly portable, ready-to-use, and application-optimized designs of devices for the transanal administration of enema fluid into the rectum, which conceptually enable two application options. Firstly, rectal bowel contents can be emptied by the enema; secondly, a rectally introduced volume of fluid can trigger a defecation reflex. Furthermore, a catheter for rectal irrigation described within the scope of the invention can generate a combined, both pneumatic and fluid-based, reflex-triggering stimulus that empties the rectum. In addition, an effect that dissolves the stool or suspends it can be combined with a subsequent pneumatically triggered reflex effect.

[0114] This also applies accordingly to the lavage-acting device designs described in the scope of the invention, for emptying or cleaning the higher colon segments. Following an initial mobilizing emptying of the upper colon, achieved through lifting and lowering and a washing effect, a reflex-coordinated emptying of the left colon can be triggered by a pneumatic stimulus emanating from the catheter balloon.

[0115] The specific, self-adapting sealing properties of the catheter units described within the scope of the invention also enable the user to perform a rectal enema in a contamination-free manner and with considerable freedom of both hands, regardless of whether the body is lying down, for example in a sitting position on a toilet bowl, at any location, even under confined spatial conditions.

[0116] The various designs of the irritating or lavage devices incorporate, among other things, particularly thin-walled reservoir bags that can be rolled and / or folded to a very compact size, or arranged in an optimized, space-saving manner within the sleeve-like cylindrical outer packaging, wrapped around the catheter portion of the device. In the preferred embodiment, the bags are structurally connected to the catheter unit, ready for use. The user fills them with the enema fluid and raises or holds them at the required level above the rectum.

[0117] The invention utilizes, in particular, multi-layered film composite material for the construction of the bag components, which ensures high mechanical stability even in very thin-walled versions. The thin-walled design of the film enables the production of elongated cylindrical bags that can hold a volume of 300 to 1500 ml of liquid, preferably 500 to 1000 ml. The bag features a recess at the top for gripping by hand and a simple and easy-to-use closure mechanism, for example, a clip or zipper, thus eliminating the need for bulky, rigid, typically injection-molded components such as lids or other closures.

[0118] The device also describes particularly compact, coilable and / or foldable supply tubes that connect the respective bag to the respective catheter unit and are based on thin-walled tubing films in the micrometer range. Due to their small volume requirement, these can be optimally integrated into the sleeve-like outer packaging in a space-saving manner, thereby achieving the required tube lengths of approximately [missing information] for hydrostatic, gravity-based enemas.

[0119] 1 to 1.5 m. The foil tubes also enable particularly flow-efficient inner tube diameters, which range up to 15 to 20 mm and not only allow the rapid, low-resistance, bidirectional movement of large volumes of liquid, but also the washing out of formed stool components into the reservoir bag, which continues to serve a collecting function for several minutes after the lavaging inflow and outflow procedure.

[0120] The wall thickness of the pouch film material is 20 to 100 µm, preferably 30 to 50 µm. A tubing system approximately 100 to 130 cm long, also made of thin, film-like material, is attached to the lower end of the pouch. Optionally, this tubing can be heat-sealed together with the pouch, forming a single, continuous unit from two layers of film. The use of thin-walled tubing films allows for particularly large, flow-optimizing inner diameters of the tubing component leading to the rectally inserted catheter. While these diameters can also be achieved with conventionally extruded tubing material, the significantly greater wall thicknesses of such materials prevent them from being packaged in a sleeve roughly the size of a cigar.The micro-thin-walled foil tubes described in the invention, with wall thicknesses ranging from 10 to 50 µm, preferably 20 to 30 µm, allow for a supply line up to 150 cm long, which can be rolled or folded and inserted into the packaging sleeve. To achieve flow rates sufficient for rectally administered enemas to enable cleansing procedures with a swiveling motion, the supplying foil tube, when rounded or erected in a circular shape, has an inner diameter of 4 to 10 mm, preferably 7 to 8 mm. Similarly, the rectally supplying channel, which extends through the shaft and handle of the catheter unit, has a channel diameter of, for example, 4 to 10 mm, preferably 6 to 8 mm.For a pivoting inflow and outflow lavage of higher colon sections, inner diameters of 10 to 20 mm, in particular of 14 to 18 mm, are required, and can also be structurally integrated into the outer packaging according to the invention on the basis of band-like collapsed, rolled or folded film tube components.

[0121] For the administration of a rectal enema, a reservoir and / or collection bag for receiving irrigation fluid and / or intestinal contents can also be connected or connected to the proximal end of a reflex-triggering catheter unit, in particular via an inlet and / or outlet tube extending between the catheter and the bag.

[0122] The invention prefers that such an inlet and / or outlet tube connecting the catheter unit with the reservoir and / or collection bag consists of a thin-walled, foil-like material, wherein the foil-like component collapses into a flat, band-like structure when not filled and therefore, with appropriate rolling or folding, allows for particularly compact, space-saving storage.

[0123] Such an inlet and / or outlet hose can be made from a film-extruded or tubular film-extruded material, or from two overlapping layers of thin-walled films welded or welded together to form a hose-shaped structure.

[0124] The invention recommends polyurethane, PVC or LDPE-based materials, or a composite material consisting of several, preferably different, material layers, wherein, among other things, polyamide can be integrated as a mechanically stabilizing layer, or EVOH as an odor-proof sealing layer.

[0125] To ensure that the inlet and / or outlet hose can be folded or rolled up in an optimally space-saving manner, the hose wall thickness should be only 20 to 100 µm, preferably 30 to 50 µm. Such thin wall thicknesses allow the inlet and / or outlet hose, in its ribbon-like state, to be folded into one or more segments, coiled like a roll or folded like a package, for storage. In particular, the inlet and / or outlet hose, folded into one or more segments, coiled like a roll or folded like a package, with hose lengths of 100 to 150 cm, should fit into a cylindrical volume with an outer circular diameter of 2.0 to 5.0 cm, preferably 2.5 to 3.0 cm, and a cylindrical length of 15 to 25 cm, preferably 15 to 20 cm.

[0126] The inlet and / or outlet tube should be dimensioned to allow rapid, lavage-like flushing of the intestine with high flow rates and to permit the passage of floating, formed, or semi-solid stool components; for this purpose, it should have a circular inner diameter of 10 to 20 mm when filled, preferably an inner diameter of 14 to 18 mm.

[0127] The reservoir and / or collection bag can also be made of polyurethane, PVC, or LDPE; alternatively, it can be constructed from a multi-layered composite of film layers of the aforementioned materials, with at least one layer preferably consisting of a polyamide-based material that reinforces the bag. Optionally, EVOH can also be incorporated into the layer composition, which provides a barrier function against unwanted odors.

[0128] The reservoir and / or collection bag according to the invention should, when fully unfolded, be able to hold the amount of fluid necessary for a lavaga-like enema; for this purpose, a bag volume of 500 to 2000 ml is generally sufficient, preferably 500 to 1250 ml. To allow for space-saving storage, the invention recommends that the reservoir and / or collection bag be made of a thin-walled film material, with wall thicknesses of 20 to 100 pm proving particularly effective, preferably 30 to 50 pm.

[0129] Such thin wall thicknesses allow the reservoir and / or collection bag according to the invention to be wound into a roll and / or folded into a package when empty, preferably unused.

[0130] In particular, the reservoir and / or collection bag, wound into a roll or folded into a package, should fit into a cylindrical volume which (i) has an outer circular diameter of 2.0 to 5.0 cm, in particular an outer circular diameter of 2.5 to 3.0 cm, and / or (ii) has a cylindrical length of 15 to 25 cm, preferably a cylindrical length of 15 to 20 cm.

[0131] It is within the scope of the invention that the reservoir and / or collection bag has a closable opening at its upper end, preferably with a clip- and / or zipper-like closing component capable of sealing the reservoir and / or collection bag after filling in a user-friendly and liquid-tight manner. This opens up, for example, the possibility of performing a swivel inlet, whereby, following the cyclical inlet and outlet phase, the bag is lowered below the user's level and may also hang down with the handle pointing downwards, so that its initially top opening then forms the bottom of the bag, thus requiring a particularly reliable, leak-free closure of the bag.In particular, a sufficiently efficient and airtight seal of the bag should enable a subsequent, draining phase of the procedure lasting several minutes, during which the bag is placed, for example, on the floor, allowing the administered fluid, along with the mobilized bowel contents, to drain into the bag and be collected there. Ideally, the lavage procedure can thus be carried out completely closed, without the need for direct emptying of bowel contents into a toilet bowl.

[0132] Also for reasons of space, the components of the clip- and / or zipper-like closing device should have a height that does not exceed 5 mm above the level of the film of the reservoir and / or collection bag integrating them.

[0133] The devices described within the scope of the invention correspond in size and proportion, for example, to a cigar tube or a larger fountain pen. All components and functions for carrying out the respective procedure described within the scope of the invention are contained within the device. The respective device contains the components required for the application, prepared in a ready-to-use manner. Additional aids are not required in the respective preferred embodiments.

[0134] For the application of administering or delivering enemas, the corresponding catheter units preferably use balloon components that are specifically shaped in a dumbbell form, extend over the anal sphincter, and thus enable a particularly efficient, trans-anal seal of the anal canal. The dumbbell shape of the balloon ensures, on the one hand, a radial seal of the balloon sheath extending through the anal canal, and, in optional versions, also allows for a supplementary, axially directed sealing effect, whereby the terminal, spherical extensions of the dumbbell-shaped balloon, during inflation, move towards each other in a quasi-rolling manner, towards the inner entrance and the outer exit of the anal canal.To generate the described axial counter-rolling, the two balloon ends of the dumbbell-shaped balloon sheath are positioned towards each other and placed on the shaft body that supports the balloon, or fixed offset within the balloon body. This offset of the balloon ends also allows the distal end of the catheter shaft to be drawn in below the level of the distal balloon radius pointing towards the rectum, thus preventing direct contact with the intestinal wall. The exceptional sealing performance of dumbbell-shaped balloon components makes it possible to retain particularly large, high-volume enemas in the bowel, largely independent of the user's body position, without any significant leakage of enema fluid from the anus during the application process.Unlike conventional systems with a simple rectal balloon component, the trans-anal, dumbbell- or mushroom-shaped balloon allows for a reliable seal even when the user relaxes the anal sphincter.

[0135] In addition to a particularly compact, load-bearing-optimized design of the device, the invention aims in particular at a material-saving, economical design.

[0136] The invention is intended to allow users to perform an enema and / or trigger a defecation reflex in the shortest possible time, in any location, discreetly and inconspicuously, with minimal soiling of the user and the environment, and with minimal resulting waste, preferably without an assisting person and without further aids, independent of an unwieldy, structurally complex and complicated-to-operate base unit.

[0137] Provided that a cylindrical and / or tube-like outer packaging, when closed or unopened, has the size and / or shape of a cigar tube, fountain pen, or larger fountain pen, it can be discreetly carried anywhere by the user or kept readily accessible on their person. To further enhance discretion, the outer packaging may also be provided with components characteristic of the respective tube or packaging type, such as cigar-like bands or fountain pen-like clips for placement in a vest pocket.

[0138] In another embodiment, a cylindrical and / or sleeve-like outer packaging in the closed or unopened state can have the size and / or shape of a cylindrical packaging film, in particular the size and / or shape of a chocolate or caramel bar.

[0139] Further advantages arise from the fact that grip-like recesses or formations are provided on the posterior, proximal portion of the handle at a defined distance from the distal tip of the shaft component or an olive-shaped insertion element of the catheter unit. Besides facilitating a firm grip, these grip-like recesses are intended to enable the user to find the correct insertion depth during transanal catheter insertion by resting the fingers grasping the catheter or a pre-anal support element against the anus, with the distance between the handle and the catheter tip being 60 to 100 mm, preferably 70 to 90 mm.

[0140] To facilitate the insertion of the catheter unit, the invention recommends that the catheter unit be coated or be coated with a lubricating substance in the area of ​​the distal, rectally positioned catheter portion.

[0141] The lubricating substance should be viscous enough that, regardless of the spatial orientation of the catheter unit, it does not extend beyond the catheter unit from distal to proximal over more than half its length.

[0142] Suitable lubricating substances include those with a gel-like or ointment-like consistency. In particular, the anterior segment of the catheter unit can be coated with a lubricating substance based on a thin layer or film of a fatty, ointment-like substance, or on a viscous silicone oil or silicone grease.

[0143] To prevent a lubricating substance applied as a layer or film from drying out, the invention recommends that the lubricating surfaces of the catheter unit exposed inside the outer packaging are enclosed within the packaging interior, which receives the catheter unit ready for use, in a hermetically sealed or sealing-optimized manner.

[0144] Furthermore, the foil-like outer packaging of the catheter unit can be so thin-walled, supple, and conforming so closely to the catheter unit that the catheter, along with its enclosing foil, can be inserted into the rigid cylindrical outer packaging that receives it. At the moment of use, the foil-wrapped catheter unit is then removed from the packaging cylinder and exposed by opening pre-formed sealing or perforation lines in the foil packaging.

[0145] Within the scope of the invention, designs are also proposed in which the catheter unit is moistened with a lubricating substance in the area of ​​the distal catheter portion only immediately before removal from the outer packaging.

[0146] The lubricating substance can be packaged within the outer packaging in a separate compartment and / or in a housing that can be plastically deformed and / or ruptured by finger pressure, whereby design measures should ensure that if the compartment is squeezed or compressed by the user, it opens or the housing tears open, and the lubricating substance then spreads over the catheter unit up to a design-defined expansion point.

[0147] In practical terms, the outer packaging can contain a rupturable enclosure for the lubricating, gel- or ointment-like substance, which can be opened by the user by pressing on a marked area, by squeezing between the thumb and forefinger, or by pressing on a piston-like element.

[0148] During lubrication, the penetration of the lubricating substance into a central channel of the catheter unit's shaft component, whether leading to or from the intestine, should be prevented. This can be achieved with a plug-like closure that seals a corresponding channel in the occluding and / or reflex-triggering catheter unit, causing the lubricating substance to spread instead over the outer balloon and / or shaft surface. Additional structural features or components within the sleeve portion that accommodates the anterior catheter segment, such as hood-like tubing sheets or space-filling inner sleeve elements, can create a defined space within which the lubricating substance is distributed evenly and sparingly to all surfaces requiring lubrication, thus ensuring efficient wetting.

[0149] The cylindrical, sleeve-like outer packaging preferred within the scope of the invention consists of at least two sleeve sections which, after removal of the catheter unit, can be connected to form a body that functions like an air pump. For filling the catheter balloon, the device utilizes the sections of the sleeve-like outer packaging by, for example, connecting the sleeve sections to form a pump body with a bicycle pump-like function after removal of the catheter unit. The sleeve-like outer packaging can then be used to fill the catheter balloon in several pumping steps, each delivering a defined pumping volume.

[0150] Optionally, the balloon component of the respective catheter unit can be filled by a gas-generating function described within the scope of the invention, whereby no pumping action is required by the user and chemical gas generation can be triggered simply by finger pressure. For example, carbon dioxide can be released from a dry substance by bringing the substance into contact with an aqueous solution. The chemical reaction with the dry substance takes place in a surrounding, sealed compartment, from which the developing gas is conveyed via a tube to the balloon of the catheter unit.

[0151] In the preferred embodiment, the catheter unit is removed from its outer sleeve immediately before the insertion of the closure catheter into the rectum. The catheter balloon is inflated with air via a tube that connects proximally to the catheter shaft. The proximal end of the inflation tube can be equipped with a female Luer connector, which is supplemented by a backflow preventer that, after disconnection from the pump unit, prevents air from escaping the catheter balloon, as is known, for example, in tracheal tubes.

[0152] The invention preferably describes designs that allow for ready-to-use removal and transanal insertion of the catheter. The catheter is therefore provided in its anterior region with a lubricating substance, which is applied to the respective surface of the catheter shaft and / or the catheter balloon during manufacturing. This substance can, for example, be based on highly viscous silicone oils or silicone greases, which, due to their inorganic nature, allow for correspondingly long-lasting effectiveness of the lubricating function within the packaging.As an alternative to substances applied during manufacturing, lubricating, viscous, or gel-like substances can be encased in a container that can be ruptured by finger pressure or other squeezing action in the front portion of the packaging cylinder, adjacent to the anterior, distal segment of the catheter unit. This allows the substance to be stored for extended periods without loss of function. For water-soluble, lubricating substances, encased containers made of multilayer film material are preferably used, incorporating a water vapor-tight layer of an EVOH-based material. The multilayer film wall preferably consists of plastically deformable, soft film materials, such as LDPE-based layers, which herniate and burst easily under finger pressure.

[0153] To ensure correct insertion depth of the catheter unit into the patient's rectum, the various catheter units of the device are optionally equipped with prominent, intuitively easy-to-grip finger grips. The distance between the gripping fingers and the catheter tip is approximately 70 to 100 mm, preferably 70 to 80 mm, for adults and children up to about 14 years of age.

[0154] Further features, properties, advantages and effects based on the invention will become apparent from the following description of preferred embodiments of the invention and from the drawing. Figure 1 shows a device according to the invention for the compact, portable, ready-to-use insertion and filling of a balloon-based anorectal closure device, consisting of a closing catheter unit with a retractable insertion aid and a sleeve-like cylindrical packaging with an integrated pumping or filling function.

[0155] Fig. 1a-1d shows various exemplary structural designs of the anorectally closing catheter unit that remains temporarily in the patient;

[0156] Fig. 1e shows an overview of a device according to the invention for creating a temporary, trans-anal access to the rectum of a patient, in particular for triggering a physiologically coordinated peristaltic defecation reflex, consisting of a catheter unit, a filling tube and a sleeve-like cylindrical packaging with integrated pump and filling function;

[0157] Fig. 1f shows a device according to the invention for creating a temporary, trans-anal access to the rectum, colon or also to a surgically created, artificial access to the intestine of a patient, in particular for administering a enema into the rectum and for carrying out a higher-volume enema and drainage enema into higher parts of the colon, in schematic overview, consisting of a trans-anally inserted catheter unit, a reservoir bag with a foil-like tube connection to the supply channel of the catheter unit, and a sleeve-like cylindrical packaging with integrated pumping function;

[0158] Fig. 2 shows a trans-anal sealing catheter unit equipped with a dumbbell- or mushroom-shaped balloon, coated with a lubricant, and ready for removal, inserted into the front portion of a packaging sleeve according to the invention; Fig. 2a shows a lubricated catheter unit, in particular for triggering a bowel movement effect, ready for removal, inserted into the front portion of a packaging sleeve;

[0159] Fig. 3 shows the front and rear parts of the sleeve-like packaging in longitudinal section, the two sleeve parts being connected to form a pumpable, air-pump-like functioning, closed body;

[0160] Fig. 3a shows a special, manually separable assembly for the valve-integrating closure of the filling line to a catheter balloon, with a male connection cone and a connected beak valve;

[0161] Fig. 3b shows a corresponding assembly for the valve-integrating closure of the filling line to a catheter balloon, with a female connection cone and an associated spring-based valve;

[0162] Fig. 3c shows a design in which a simple hose connection to the catheter unit can be connected to a valve-integrated inlet portion of the pumping housing;

[0163] Fig. 3d shows a design with circular marking lines on the sleeve parts of the repacking, pumping cylinder, which enable a specific functionally relevant pumping volume;

[0164] Fig. 4 shows another type of pump mechanism which is operated by the user by manual, radial compression of elastically deforming and straightening sleeve components;

[0165] Fig. 5 shows a design of a pumping sleeve packaging, wherein the pumping function is provided by an additional piston-like housing element which, supported by a spring-like mechanism, moves relative to the rear sleeve portion; Fig. 6 shows a structure of the front packaging sleeve, exemplary for a sealing catheter unit, with a housing of a lubricating substance integrated in the tip of the sleeve element, which can be ruptured by finger pressure, wherein the filling line to the balloon is accommodated in the rear portion of the packaging sleeve;

[0166] Fig. 6a shows an alternative design of a packaging sleeve to Fig. 6, wherein in the front area of ​​the packaging sleeve a gap space for the distribution of the lubricating substance released from a reservoir is defined by additional, sleeve-like components.

[0167] Figs. 6b-6d show further lubricating designs and functions in the area of ​​the front sleeve portion;

[0168] Fig. 6e shows a fully packaged catheter unit, for example for triggering a defecation reflex, in a sleeve-like outer packaging, with a capsule-like enclosure of a lubricating substance integrated into the front area of ​​the front packaging sleeve, which can be ruptured by finger pressure, for the surface wetting of the front catheter portion;

[0169] Fig. 7 shows an alternative design of the device which does not require a manually pumping, air-pump or pump-balloon-like mechanism, and in which the filling of the catheter balloon is made possible by gas-generating chemical substances;

[0170] Fig. 7a shows an alternative structural design of a gas-generating function;

[0171] Fig. 8 shows an assembly of a combined sealing and reflex-triggering catheter unit, wherein the primary, sealing-retaining filling of the catheter balloon is carried out by the pump-like function of the repacking sleeve, and a subsequent, triggering, secondary filling is carried out by a chemically gas-evolving function or assembly that is integrated into the filling line of the catheter balloon;

[0172] Fig. 9 shows a foil-wrapped design that integrates all components and functions required for the application of the device, wherein the balloon component of the catheter unit is filled by an elastically deformable, sponge-like component which can be squeezed by the user by making a fist;

[0173] Fig. 10 shows a catheter unit, for example for administering a rectal enema and / or for performing a higher-volume colorectal swivel enema, which is inserted into the front sleeve portion of a packaging sleeve ready for removal, wherein a thin-walled, foil-like reservoir bag is wrapped cylindrically around the shaft portion of the catheter, and wherein the tubular foil-based supply line to the catheter unit is folded compactly in a package-like manner and connected to the exposed handle of the catheter unit;

[0174] Fig. 11 shows a catheter unit, for example for administering a rectal enema and / or for performing a higher-volume swivel enema, in an embodiment without a retaining balloon component, which is inserted into a foil-based unit enclosing the catheter for the controlled release or area-defined distribution of a lubricating substance released from a rupturable reservoir;

[0175] Fig. 12 shows a rear part of a packaging sleeve, with a catheter handle enclosed therein, a compactly folded packaged supply tube film, a flow-limiting throttle, and a spirally wound filling line to the catheter balloon;

[0176] Fig. 12a shows an exemplary design of a flow-throttling mechanism; Fig. 13a shows an elastically opening and closing, clip-like mechanism at the upper edge of the bag, viewed from above;

[0177] Fig. 13b shows a zipper-like mechanism integrated into the upper edge of the bag, viewed from above;

[0178] Fig. 13c shows a compactly rollable reservoir bag with a zipper-like mechanism integrated into the upper part of the bag, viewed from the front;

[0179] Fig. 13d shows a compactly rollable reservoir bag with a bag-closing combination of a clip closure and a zipper-like assembly, in a front view.

[0180] Fig. 13e shows a self-closing clip for the temporary opening of the tubing from the reservoir bag to the catheter unit;

[0181] Fig. 14a shows a simple catheter unit without a balloon component, for example for administering a rectal enema and / or for performing a higher-volume swivel enema, which is ready for removal and sealed in a foil package with all components and functions required for the procedure, wherein the foil-based reservoir bag is wound cylindrically around the package-like folded, supply tube component in the rear area of ​​the foil package;

[0182] Fig. 14b shows a catheter unit corresponding to Fig. 14a, also foil-wrapped, whose foil-based reservoir bag is wrapped around the catheter shaft, and wherein the supplying tube component is arranged in a package-like folded manner parallel to the cylindrically wound bag;

[0183] Fig. 15 shows a particularly large-lumen, trans-anally positioned catheter unit that enables particularly high flow rates emptying the colon in a lavaging manner;

[0184] Fig. 16 shows a pressure-limiting assembly that is integrated into the handle of the catheter unit parallel to the balloon's filling supply line;

[0185] Fig. 17 shows a pressure-indicating assembly that is integrated end-to-end into a sleeve portion of the packaging cylinder;

[0186] Fig. 8 shows an exemplary set configuration designed for monthly use, comprising a single, reusable packaging and pump unit, and 20 to 30 single-use catheter units compactly packaged in folio;

[0187] Fig. 18a a foil-based outer packaging of a catheter unit for the controlled, area-defined wetting of the catheter with a lubricating substance;

[0188] Fig. 1 shows a device 1 for the space-saving, compact and discreetly portable, ready-to-use system of an intermittently placed, anorectally sealing closure catheter, comprising a trans-anally inserted catheter unit 2 with an associated, retractable insertion aid 2a, a filling line 3 for filling the retaining and sealing balloon component of the catheter unit, and a cylindrical sleeve-like outer packaging 4, consisting of a front and a rear sleeve part 4a and 4b.

[0189] In the illustrated embodiment, the catheter unit comprises a dumbbell-shaped balloon 5 made of a particularly thin-walled, yet dimensionally stable, soft film. The anterior, distal segment 5a of the dumbbell-shaped balloon is spherically, discoidally, or conically expanded and, when used in the patient, lies in the region of the terminal rectum or rests directly on the floor of the rectum. The middle segment 5b of the balloon is tapered in diameter relative to the distal balloon segment and is positioned within the anal canal AK. In the pre-anal region outside the body, located in front of the anus, the balloon body transitions into a spherically discoidally expanded pre-anal segment 5c. In this design, the anterior, distal, shaft-like tapered balloon end 5d is inverted by the balloon body into the region of the posterior, proximal, shaft-like tapered balloon end 5e.Together with the rear end of the balloon, it is tightly connected to a ring-like structure 6 positioned directly in front of the anus, forming a fillable chamber. The inflation line 3 to the balloon is inserted into an opening 6a of the ring structure and secured there. The hose-like inflation line has a Luer-format female connector 3a at its proximal end, which can optionally be equipped with a spring-loaded, self-closing check valve, such as those used in tracheal tubes. The connector and valve unit is integrated here into a so-called pilot balloon 3c, which qualitatively indicates to the user the degree of inflation of the retaining-seal balloon 5. The inflation line is optionally equipped with a pressure-relieving component 13, which prevents safety-critical pressures from being reached in the balloon component of the device.

[0190] The connector 3a is connected to the pumping and filling outer packaging by a congruently shaped counterpart 3b, which is integrated into one of the sleeve parts 4a or 4b of the packaging housing.

[0191] The counterpart 3b has a flow-directing valve combination 18 installed inside the sleeve part, which on the one hand prevents the backflow of gas from the balloon into the pump body, which is made up of the two sleeve parts 4a and 4b, and on the other hand allows air from the environment to enter the pump body and closes when a back pressure develops in the pump body.

[0192] The packaging housing is shaped like a cigar tube or a larger fountain pen. After removing the catheter unit housed inside, the two tube sections 4a and 4b are inserted into one another, allowing the user to operate the pump with axially directed movements towards and away from each other, creating an air-pump-like function. The two tube sections have one or more sealing, ring-shaped or lip-like formations 20, which enable the generation of sufficient pump pressure. To open the pump body, the two tube sections are separated by a simple, axially opposite pull. During pump operation, the two tube sections are rotated relative to each other by, for example, 90 degrees, which then creates a mechanical stop torque acting in both directions when the two tube sections are moved axially relative to each other.When the sleeves are extended or when ambient air is drawn in, the mechanical stop prevents the sleeves from disconnecting and opening the pump body. Conversely, when the sleeves are retracted or the compressed volume within the pump body is expelled, the stop limits the axial travel, ensuring that a specific, defined volume of air is transferred from the cylinder into the balloon, provided the respective limiting stop is reached during both intake and expulsion. For example, the stroke volume of the pumping mechanism can be structurally matched to the respective balloon volume such that a single, fully completed stroke inflates the balloon, anchoring or securing the catheter unit in its transanal position. A second stroke then creates a seal against the adjacent rectum.This allows the balloon to enter the anal canal, but only about 80% of its freely inflated volume is added, leaving the balloon wall in a relaxed, uninflated state. A third pump then inflates the balloon to such an extent that the added volume exceeds the volume of the freely inflated balloon, stretching it. This stretched state exerts a reflex-triggering force on the rectal wall tissue within the balloon's reach. With further pumping volumes beyond three pumps, the balloon wall becomes increasingly stretched, resulting in a corresponding increase in pressure within the balloon.When thermoplastic polyurethanes are preferably used for the production of the balloon films, in durometer ranges of Shore 80A to 95A or even Shore 55D to 60D, which allow only a small volume expansion of the formed balloon shells even in a very thin-walled design with wall thicknesses in the range of 10 to 30 pm, an oversized, over-compressed volume supplied to the balloon is accompanied by a resistance during the pumping process that is clearly perceptible to the user.

[0193] The insertion aid 2a comprises a rod-like segment ST and a handle segment 8. The handle segment is equipped with grip recesses 9 for determining the correct insertion depth of the device. The tip of the rod-like segment is loosely inserted into a firmly positioned, olive-shaped component 10 made of soft plastic, gel, or foam in the region of the distal balloon segment 5a. This component consists, for example, of injection-molded TPU or TPE-based material with a Shore hardness of 40A to 90A, preferably 50A to 70A. The component 10 is embedded in, or firmly fixed to, a recessed formation of the inverted distal balloon end 5d. In conjunction with the attached olive, the insertion aid enables the comfortable transanal insertion and positioning of the rectal balloon or rectal balloon segment.Following inflation of the balloon, the rod-like aid is withdrawn from the central, open lumen 11 of the balloon body. To allow the release of intestinal gas while preventing the leakage of secretions or stool, the olive is optionally equipped with a filter-like component 12, for example, made of porous sintered material. The ring-like component 6 transitions into, is surrounded by, or is protectively embedded in a disc-shaped component 7. The disc is preferably made of a soft, gel-like, cast material. It has a diameter of 20 to 40 mm, preferably 20 to 25 mm.

[0194] Once the insertion aid is inserted into the inner channel 11 of the closing unit, the front edge of the grip recess is aligned with the disc component. During insertion, the user grasps the disc component with their fingers in the area of ​​the grip recesses. The unit is then inserted until the disc component stops against the external anus, thus determining the correct insertion depth of the device, which the user can then verify.

[0195] The rectally positioned, retaining and sealing balloon element or segment can be dimensionally designed such that it rests on the rectal floor or the internal entrance to the anal canal, or extends from the internal entrance into or through the anal canal. The radial diameter of the spherically or discoidally shaped balloon can then be approximately 25 to 50 mm. These small dimensions require sufficient sphincter tone. In cases of reduced sphincter tone, the radial diameter should be increased to the range of 50 to 80 mm, preferably 50 to 65 mm. The balloon then rests on the rectal floor with a flat shoulder and against the lateral wall of the rectum. It is preferably flat and discoid in shape, with small shoulder radii of approximately 5 to 8 mm. The rectal segment of balloon 5a has an axial length of approximately 30 to 50 mm, preferably 30 to 40 mm.The length of the centrally tapered segment 5b is approximately 30 to 50 mm, preferably 35 to 45 mm. The diameter of the pre-anal segment 5c is, for example, half that of the rectal segment.

[0196] The supply of filling volume to the balloon or the connection of the catheter unit with the respective filling device is effected by a small-diameter filling line 3, which in the packaged state, within the outer packaging sleeve, is wound, for example, in a helical manner around the handle 8 of the insertion aid inserted into the catheter, or can also be arranged serially following the handle within the rear packaging sleeve.

[0197] Fig. 1a shows an embodiment of the catheter unit in which a disc-like support component 7 is omitted, and the pre-anal support function is instead provided by a rod-like support component 14, positioned horizontally in the anal fold and extending forward (ventrally) and backward (dorsally). The preferably injection-molded support component is designed here such that a ring component 6 can be omitted, and the reception or space-closing connection of the two balloon ends 5d and 5e is enabled by corresponding balloon-end-receiving projections 14a and 14b of the support component.

[0198] Fig. 1b shows another design of the catheter unit, in which it has a mushroom-shaped balloon 5 instead of a dumbbell-shaped one. While the balloon extends into the anal canal and fills it in a sealing manner, it lacks a pre-anal extension. The support component consists of a gel-filled container, the gel-like mass 15 preferably being contained within a dimensionally stable, disc-shaped or spherical, thin-walled, membrane-like foil enclosure 15a.

[0199] Fig. 1c describes a support function which, in addition to a ring-shaped component 6, a disc-shaped, for example gel-based component 7, also includes an adhesive film 16 by which the catheter unit is fixed to the perianal skin of the anal fold.

[0200] Fig. 11 shows a special adhesive fixation 17, wherein the adhesive phase consists of a gel-like polyurethane material, which is sealed on the side facing away from the body by a thin TPU-based carrier film. The adhesive gel layer 17a has a thickness of 1 to 3 mm. It exhibits deformation properties similar to skin and subcutaneous tissue and can be comfortably grasped by the user with their fingers, detached from the skin, and peeled off when removing the device.

[0201] Fig. 1e shows a device T for the pneumatic triggering of a coordinated defecation reflex, comprising a catheter unit 2' for trans-anal placement, a hose line 3' for filling the balloon component of the catheter unit, and a cylindrically designed packaging housing 4', consisting of a front and a rear sleeve part 4a' and 4b'.

[0202] In the illustrated embodiment, the catheter unit comprises a dumbbell-shaped balloon 5' made of a particularly thin-walled, yet dimensionally stable, soft film. The anterior, distal segment 5a' of the dumbbell-shaped balloon 5' lies in the region of the terminal rectum or rests directly on the rectal floor during application. The middle segment 5b' of the dumbbell-shaped balloon 5' is tapered in diameter relative to the distal balloon segment and is positioned within the anal canal. In the region outside the body, anterior to the anus, the balloon body 5' transitions into a spherically discoid, expanded pre-anal segment 5c'. The rectally positioned segment 5a', which lies against or expands the lateral wall of the rectum, has a diameter of, for example, 40 to 80 mm, preferably 50 to 60 mm. It is preferably flat, discoid, with small shoulder radii of approximately 5 to 10 mm.The discoid segment 5a' has an axial length of approximately 30 to 60 mm, preferably 40 to 50 mm. The length of the central, waist-shaped tapered segment 5b' is approximately 30 to 50 mm, preferably 35 to 45 mm. The diameter of the pre-anal segment 5c' is at least 2 / 3, preferably at least 3 / 4, of the diameter of the rectal segment 5a'.

[0203] The dumbbell-shaped balloon 5' is mounted on a finger-like catheter shaft 52, which transitions into a handle at its proximal end and together with this forms the shaft element 53. It has a total length of approximately 60 to 120 mm, preferably 80 to 100 mm. The handle 8' is held by the user between the thumb and forefinger. It has trough-like formations or grip recesses 9' that accommodate the user's grasping fingers. The grip recesses are formed as indentations directly adjacent to the proximal shoulder of the pre-anal balloon segment 5c' or directly adjacent to the proximal fixation point of the balloon 5' on the finger-like shaft element. They allow the user to determine the correct insertion depth of the device. This depth is achieved when the fingers grasping the catheter shaft or the finger-like shaft element 53 touch the external anus during insertion.The handle 8' has a connection or connector 54 at its proximal end for receiving a male cone, through which, optionally, mucosal irritants, substances supporting the effect of the mechanical stimulus generated by the inflated balloon, or other therapeutically active substances can be applied to the rectum via a channel-like supply line inside the handle 8' or shaft. These substances exit through an opening 61 in the region of the anterior tip or the distal end 62 of the catheter shaft. A tubing 3' is also connected or connectable to the proximal end of the handle 8', through which the catheter balloon 5' can be filled with air or another, preferably gaseous, fluid. The anterior balloon end 5d', which tapers to the shaft length, can be fixed to the shaft element 53 in a proximally inverted or offset manner towards the handle 8'.Due to the offset of the fixation of the front end of the balloon 5d' towards the handle 8', the balloon 5' develops an axially directed rolling moment when inflated, causing the spherical or discoid terminal extensions 5a' and 5c' of the balloon 5' to move towards each other or roll towards each other over the central segment 5b'. In addition to the radially acting seal of the central balloon segment 5b' within the anal canal AK, an additional, bilaterally axially directed sealing effect against the anal sphincter can thus be established. The described counter-rolling moment contributes to the catheter unit 2' being able to adapt independently to the respective motile and contractile functional state of the rectum and to follow contractile mass movements of the intestine without any significant loss of the sealing effect of the device 1'.

[0204] The supply of filling volume to the balloon 5' or the connection of the catheter unit 2' to the respective filling device is effected by a hose 3', which, when packaged, is stored inside the sleeve 4', for example, wound helically around the handle 8'. The hose 3' has at its end, for example, a female, Luer-standard, pluggable connector 55, thus enabling optional connection of the catheter unit 2' to conventional pump manometers or other conventional filling devices, such as fist-operated pump balloons. The female Luer connector 55 can be connected to a male Luer counterpart 56, which can be attached to or integrated in the tip area of ​​the front sleeve element 4a'.The counterpart 56 is connected inside the sleeve 4a' to a flow-directing valve element 57, which prevents the backflow of gas from the balloon 5' into the pump body 58, which is assembled from the two sleeve parts 4a' and 4b'. An inlet valve 59 is located in the rear part of the sleeve. This valve closes when a back pressure develops in the pump body, but opens when there is a negative pressure relative to the atmosphere. A pressure-limiting element 13' can also be installed in the hose 3' or the air supply system. This element releases supplied volume from the system when a maximum pressure is reached, thus preventing a potentially dangerous overinflation of the balloon 5'.

[0205] In this embodiment, the packaging housing or the sleeve-like outer packaging 4' has the shape of a larger fountain pen. To further emphasize this specific design, the outer packaging can be provided with an integrated retaining clip 60, similar to those used on fountain pens for attaching to a pocket of clothing. Before use, the two sleeve parts 4a' and 4b' initially enclose the catheter unit 2' to be applied. After removal of the catheter unit 2', they are reassembled and then, through axially directed stroke movements moving towards and away from each other, enable an air pump-like function, as is known, for example, from bicycle pumps. The two sleeve parts 4a', 4b' have one or more sealing, lip-like formations, in particular in the form of a circular seal 20', which allow for the generation of sufficient pump pressure.In its unused state, the two sleeve sections 4a', 4b' can be separated from each other by a simple, axial pull. In the pumping state, the two sleeve sections 4a', 4b' can be rotated relative to each other by, for example, 90 degrees about their aligned longitudinal axes, so that when the two sleeve sections 4a', 4b' are axially displaced relative to each other, a mechanical stop element is provided for each stroke direction. When the sleeves are pulled apart or when suction is applied, the at least one mechanical stop prevents the two sleeve sections 4a', 4b' from disconnecting in a way that would open the pump body 58, while when the sleeve sections 4a', 4b' are pulled together or when the volume is expelled, it limits the axial stroke.The volume of air is limited in such a way that a specific, defined volume is conveyed from the cylindrical pump body 58 into the balloon 5', provided the user reaches the respective end stop during suction and expulsion. For example, the stroke volume of the pumping mechanism 58 can be structurally or mechanically matched to the respective balloon volume 5' such that a single stroke in the balloon 5' results in sufficient inflation to anchor the catheter unit 2' in its transanal position or secure it in a retaining manner, with a second stroke then exerting a reflex-triggering effect on the rectum adjacent to the balloon body. A third stroke finally inflates the balloon 5' to such an extent that the supplied volume corresponds to the volume of the respective, freely inflated balloon 5' on the catheter shaft 52, or that the balloon 5' is completely inflated, but the balloon wall is not yet in a stretched state.With further volumes supplied beyond three pump strokes, the outer wall of the balloon 5' expands, accompanied by a corresponding pressure increase within the balloon 5'. When thermoplastic polyurethanes are preferably used for the production of the balloon films, with durometer values ​​from Shore 80A to 95A or even Shore 55D to 60D, which, even in very thin-walled versions with a wall thickness of 10 to 30 pm, ensure only low volumetric expansion of the molded balloon shells, an excessive volume introduced into the balloon 5' and compressed accordingly results in a pressure increase within the pump body 58 connected to the balloon, which is clearly perceptible to the user.

[0206] Fig. 1f shows a device 1" for the space-saving, compactly packaged, ready-to-use administration of a rectal enema, comprising a catheter unit 2" for transanal insertion and positioning, a hose line 3" for filling the balloon component 5" of the catheter unit, a foil-like supply hose 63, a reservoir bag 64, and a cylindrically designed, sleeve-like outer packaging 4", consisting of a front sleeve part 4a" and a rear sleeve part 4b".

[0207] In the illustrated embodiment, the catheter unit 2" has a dumbbell-shaped balloon 5" made of particularly thin-walled, yet dimensionally stable, soft film. The anterior, distal segment 5a" of the dumbbell-shaped balloon lies in the region of the terminal rectum during application, or rests directly on the rectal floor. The middle segment 5b" of the balloon 5" is relatively tapered in diameter and is positioned within the anal canal. In the area outside the body, anterior to the anus, the balloon body transitions into a spherically discoid, pre-anal segment 5c". The rectally positioned segment 5a”, sealing against the lateral wall of the rectum, has a diameter of 40 to 80 mm, preferably 50 to 60 mm. It is preferably discoidally flat, with small shoulder radii of approximately 5 to 8 mm. The distal segment 5a” of the balloon 5” preferably has an axial length of approximately…

[0208] 30 to 60 mm, preferably 30 to 50 mm. The length of the centrally tapered segment 5b” is approximately 30 to 50 mm, preferably 35 to 45 mm. The diameter of the pre-anal segment 5c” is at least 2 / 3, preferably at least 3 / 4, of the diameter of the rectal or distal balloon segment 5a”.

[0209] The dumbbell-shaped balloon 5" is mounted on a shaft element 53", with a length of approximately...

[0210] The shaft element is fixed or applied at a length of 60 to 120 mm, preferably 80 to 90 mm. At its posterior, proximal end, the shaft element has a grip 8" which can be grasped by the user between the thumb and forefinger. The grip 8" has trough-like formations or molded-in grip recesses 9" that accommodate the grasping fingers. The grip recesses 9" are located directly adjacent to the proximal shoulder of the pre-anal balloon segment 5c" on the catheter shaft or shaft element 53". They allow the user to determine the correct transanal insertion depth of the catheter shaft into the rectum. This depth is achieved when the fingers grasping the catheter shaft in the area of ​​the grip recesses touch the external anus during insertion. A foil-like, thin-walled supply hose 63 is connected to the rear, proximal end of the handle 8", which leads into a channel-like supply line inside the shaft element orthe handle extends and provides access to the rectum via a front, distal opening 61" of the catheter shaft or shaft element. The tube-like inflation line 3" is also connected to the posterior, proximal end of the handle 8", through which the catheter balloon 5" is inflated.

[0211] The balloon 5" can be fixed to the shaft element according to the embodiment V described above, in particular such that the counter-rolling moment described above is generated between the distal balloon segment 5a" and the proximal or preanal balloon segment 5c". This counter-rolling moment allows the catheter unit to dynamically adapt to the respective functional states of the rectum and anus and to follow the respective motility and tone of the rectum and anus without any significant loss of the device's sealing effect. Due to the self-adapting, trans-anal anchoring retention of the catheter unit, both of the user's hands remain free after inflation of the balloon 5", and continuous manipulation of the catheter unit 2" to prevent leakage of bowel contents during the irrigating or lavage procedure is not necessary.

[0212] The supply of filling volume to the balloon or the connection of the catheter unit to the respective filling device is effected by a small-diameter filling tube 3", which, in its packaged state, can be wound around the handle 8" inside the sleeve 4", for example, in a helical fashion. As in the previously described embodiment, the filling tube 3" can have a female, Luer-standardized connector 55" at its end, thus enabling, as an alternative to an integrated filling device, optional filling of the catheter balloon 5" by conventional pump gauges or other filling devices. The female Luer connector 55" can be connected to a male Luer counterpart 56", which can be located, for example, in the cap area of ​​the rear sleeve element 4b".The counterpart 56" can be fitted with a flow-directing valve combination 57" inside the sleeve 4b" that, on the one hand, prevents the backflow of gas from the balloon 5" into the pump body 58" (assembled from the two sleeve parts 4a" and 4b"), and on the other hand, allows air to enter the pump body 58" and closes when back pressure develops in the pump body 58". A pressure-limiting valve or element 13" can also be installed in the hose 3" or the air supply system. This valve releases the supplied volume from the system when a maximum pressure is reached, thus preventing a potentially dangerous over-inflation of the balloon 5" by the user.

[0213] The packaging housing 4” can also have the shape of a larger fountain pen here - as in the embodiment 1’ described above - so that the handling of the pump device 58” is the same as described above.

[0214] A zipper-like mechanism 65 can be integrated at the upper edge of the reservoir bag 64, or at the end of the bag opposite a connection for the supply hose 63. This mechanism can be opened to fill the bag 64 and subsequently allows for a liquid-tight, load-resistant closure. When the zipper 66 is moved, interlocking, rib-like structures are joined or separated. The rib-like structures remain closed even when a fully filled bag is placed in a hanging or lying position, or when the user grasps the fully filled bag or applies moderate pressure to it.

[0215] Furthermore, the reservoir bag 64 can have a circular, oval, elongated, or dumbbell-shaped cutout 67 in its upper area, by which the user can grasp the filled reservoir bag 64 and / or suspend it at a certain level above the rectum, so that the enema then follows gravity and a comfortable and efficient flow is achieved. The resulting volume flow can be conveniently adjusted by the user by varying the enema level.

[0216] The reservoir bag 64 transitions at its lower end into an outlet area 68, which tapers downwards from the bag's cross-section, preferably in a funnel shape. The outlet area finally opens into a connector 69, to which the supply tube 63 leading to the catheter unit 2" is connected or can be connected. It is also conceivable to mold the supply tube 63 directly onto the connector.

[0217] The supply hose 63 preferably consists of a thin-walled, film-like material, so that when empty, it collapses or folds into a flat, ribbon-like structure and can thus be compactly packed into the sleeve-like assembly 4". To save space, the supply hose 63 can be stored in the respective assembly 1" in a spirally coiled state or, for example, folded in layers and / or folded into a package-like manner within the sleeve-like packaging 4". The supply hose 63 connected to the reservoir bag 64 can further comprise a throttling and / or sealing element 70, which limits or regulates the volume flow to the user.

[0218] The film of the reservoir bag 64 is preferably made of a particularly thin-walled, film-like soft plastic with high mechanical resistance, such as polyurethanes with Shore hardnesses of 90A to 95A and 55D to 65D. Alternatively, the wall of the reservoir bag 64 can also be made of a thin-walled composite film, which, for example, integrates or sandwiches a layer of a strong, mechanically resilient polyamide between two layers of LDPE material. The total wall thickness of the respective film is in the range of 20 to 100 µm, preferably 30 to 50 µm. Polyamide-reinforced, micro-thin-walled film bags ensure high tear resistance, which makes the films suitable even for filling with larger inlet volumes of up to 2.0 liters.

[0219] Preferably, the invention proposes such basic shapes for the reservoir bag 64 in which the reservoir bag 64 assumes an elongated, cylindrical shape when filled with a volume of approximately 1000 to 2000 ml. For example, the bag designed for a volume of 1000 ml can have a diameter of 8 cm and a length of 20 cm when filled. In its flat, collapsed, unfilled state, the reservoir bag 64 then has a width of approximately 12 cm, which corresponds approximately to the length of the catheter component 2", so that the width of the reservoir bag 64, when wound into a cylinder, is equal to the length of the catheter shaft of the catheter unit 2". Within the respective outer packaging, the reservoir bag 64 can be wound coaxially around the catheter unit 2", or positioned in a cylindrically wound or package-like folded state, in an arrangement parallel or serial to the catheter unit 2".

[0220] Figures 2 and 2a each show a schematic longitudinal section through a front sleeve portion 4a or 4a' of the device 1 according to Fig. 1 or of the device 1' according to Fig. 1e. The catheter unit 2 or 2' inserted therein, ready for removal, can be seen in each case. The deflated balloon 5 or 5', shaped like a dumbbell or mushroom, lies against or closely against the insertion aid 2a or the catheter shaft 52.

[0221] In the front quarter of the balloon 5', a lubricating substance LU can be applied – as shown, for example, in Fig. 2a – which may consist, for instance, of a fat-based, ointment-like material. Alternatively, an inorganic, for example, silicone-based grease can be applied as a thin film. Viscous, water-soluble gels are also conceivable for lubrication, as are preferably hydrophilic dry substances applied to the balloon surface that swell upon exposure to water and become slippery.

[0222] As shown in Fig. 2, an olive-shaped formation 10 as described in Fig. 1 can also be provided in the front area of ​​the empty balloon 5, which can optionally consist of solid, for example cast, soft PVC material.

[0223] Furthermore, a preferably channel-like opening 11 of the catheter shaft 52 or of the olive-shaped formation 10 (Fig. 2) surrounding the insertion aid 2a can be slid onto a finger-like extension 21, which holds the catheter unit 2 centered in the sleeve 4a and preferably seals the channel 11 airtight in a plug-like manner under moderate tension. In the rear region of the arrangement, a correspondingly sealing and fixing structure 22, extending prominently into the interior of the sleeve and, for example, lip-like, can be provided, which closes off the space between the sleeve 4a and the catheter unit 2 in such a way that a lubricating substance LU is not, or as little as possible, altered by atmospheric oxygen or water vapor.

[0224] The catheter unit 2 or 2* is removed by grasping the handle 8, the insertion aid 2a, or the grip-like formations 9' on the handle 8' of the catheter shaft 52 between the thumb and index finger. In this grip position, the catheter unit 2, 2' is inserted transanally by the user until the fingers stop or until a pre-anal support component stops against the external anus. The balloon 5, 5' is then inflated by the user to a volume suitable for their individual sealing situation. The embodiments described below with reference to Figures 3 to 5 are applicable to all devices 1, T, 1" according to the invention.

[0225] Fig. 3 describes an exemplary design of a closed pump body PK, which is assembled or plugged together from the two sleeve parts 4a and 4b of the packaging cylinder after removal of the catheter unit. In the assembled state, the two sleeve parts can be moved relative to each other in a telescopic manner in the axial direction. The two halves fit each other as precisely as possible and, in the preferred embodiment, have one or more additional circularly sealing components 20, for example, O-rings or other lip-like sealing formations. A mechanical stop 23 is integrated inside the rear sleeve part, which limits the travel distance between the two cylinders during compression. A combined-action valve mechanism 24 is attached to the rear blunt end of the cylinder, which on the one hand allows air from the environment into the cylinder and on the other hand releases air from the cylinder.The backflow of air from the connected balloon into the pump body is prevented. The combined mechanism has a male, Luer-standardized connector 25 to which the balloon-filling tubing 3 of the catheter unit can be connected.

[0226] Fig. 3a shows a specifically designed, valve-receiving housing unit 301, consisting of two nesting, tightly sealing housing parts 302a and 302b, wherein part 302a receives the distal, free end of the tubing 3 leading to a catheter balloon. Part 302b, on the other hand, has a conical, male-shaped connector 303 at its end, which can be inserted into a congruently shaped, female inner cone 304 in the wall of a pumpable packaging cylinder 4. The respective cones conform to the standardized Luer standard. Inside the housing part 302b, a valve component 305 is installed, which regulates a directed flow from the pumping packaging cylinder to the balloon of the respective catheter unit, or excludes a reverse flow.The respective valve function can be achieved, for example, by a simple, low-complexity duck valve or valve plate. To enable the user to deflate the catheter balloon as easily and quickly as possible without tools, the two housing parts can be separated by grasping them between the thumb and forefinger of one hand and pulling on them in opposite directions. The two parts 302a and 302b are equipped with corresponding grip wings 306 and grip recesses 307 for this purpose.

[0227] Fig. 3b. As an alternative to a low-complexity, plate- or beak-like valve, a spring-based, self-closing valve unit 308, independent of the filling pressure prevailing within the catheter balloon, can also be installed in the housing portion. In the inserted, connected state, this valve unit is opened by a fixed, piston-like structure 309 in the center of the female-shaped connection cone 310. In the connected state, a backflow of medium from the balloon into the pump housing is prevented by a valve function 311, which is arranged within the pump-like packaging cylinder 4.

[0228] Fig. 3c shows a cylindrical pump body 4, consisting of two sleeve sections 4a and 4b. Openings are provided in the end, blind-sealed ends of the sleeve sections, which can be connected to the terminal, connector-like assemblies of the tubing connection of the respective catheter unit. Section 4a has a conical opening 312 that connects to a congruent, male-shaped cone. A flow-directing valve unit 313 is located adjacent to the opening. Sleeve section 4b has an opening 314 into which the open sleeve section 302a can be inserted. A flow-directing valve unit 315 is integrated downstream of the opening into the sleeve cylinder 4b. While unit 313 only allows outflow, unit 315 only allows the inflow of volume into the pumping housing.

[0229] In the described case of two valve units integrated into the pumping body, one valve component in the end piece of the catheter unit's tubing can optionally be omitted; however, in this case, the pump body must remain connected to the catheter during use. With this design, the catheter balloon's deflation can be facilitated by inserting the respective end piece of the catheter's tubing into opening 314, allowing the user to actively remove volume from the balloon by pumping the pump body.

[0230] In the preferred embodiment of the pump body 4, it has only one valve function integrated into the body, which allows flow-directed inflow into the pump housing, while the second component required for a pump function is integrated in the final component of the supplying hose to the balloon of the catheter unit.

[0231] Fig. 3d describes a combination of a mechanical stop and optical marking lines that allow the user to introduce or remove defined volumes from the respective catheter balloon. During the compressive, volume-increasing compression of the sleeve sections 4a and 4b, a circular, ring-shaped stop structure 316 is activated, while during the suction-like intake of the filling medium, circular, ring-shaped marking lines 317 indicate the correct filling state of the pump body. The marking can be designed such that several lines of lower width 317a follow one another, followed by a line of greater width 317b that indicates the target volume. Optionally, the marking lines can be of different colors, with a red line, for example, marking the stroke required for the function.

[0232] Fig. 4 describes a similar setup to the embodiment described in Fig. 3. However, for filling, the two sleeve halves 4a and 4b are moved into a terminal, maximally open position, where they are brought into a stable, locking position, for example, by axially rotating the two sleeve sections by 90 degrees. The pumping effect is achieved by the user squeezing the front sleeve half 4a by radial compression K using a fist. The front sleeve half exhibits special elastic deformation and recovery properties for this purpose, whereby, after radial compression and partial emptying of the pump body, the sleeve section promptly and elastically returns to its respective cylindrical shape, thereby drawing air into the pump body PK.The flow-directed delivery and intake of the respective volume is effected by a combined valve unit 24, which is preferably integrated into a non-deformable sleeve portion. The connection to the respective catheter to be filled is made via a corresponding cone of the valve unit. The deformable sleeve portions can be made, for example, of injection-molded, elastic polyurethane or of silicone or TPE-based material. The described design is particularly suitable for one-handed operation.

[0233] Fig. 5 describes another air-pump-like mechanism for filling the catheter balloon or for pressurizing the catheter balloon, wherein the pumping or compressing mechanism is completely integrated into the rear half 4b of the packaging sleeve. After separation from the front half of the sleeve, the rear sleeve portion can be used independently of the front half as a functionally independent pump unit that can be operated by the user with one hand. Half 4b has two nested, axially movable cylindrical sleeves 26 and 27, each with a cap-like end.A variable space PV is created between the cylinders, wherein, in particular by a mutual movement of the cylindrical sleeves, the air volume in the space PV is compressed, and / or wherein an air volume is expelled from the variable space PV in one direction towards the catheter balloon by a flow-directing valve system. A flow-directing valve component 24a, 24b is installed in each of the two cylinder caps. In the intake state, valve 24a allows air to flow from the outside into the space PV, and valve 24b releases the volume compressed in the space PV towards the catheter and prevents the backflow of air from the catheter balloon into the compression chamber.

[0234] A sealing lip 20a or other sealing function is integrated between the two cylindrical sleeves. The volume compressed in the PV chamber is conveyed to the catheter balloon via a nozzle 28 located inside the sleeve and a filling line 3 attached to the nozzle. The line is preferably equipped with a female, Luer-standardized connector at the connection point to the nozzle. This connector is fitted onto the male nozzle, which is also Luer-standardized. By pulling axially on the hose, the user can disconnect the connection between the hose and the respective nozzle 28. By pulling the hose off the nozzle or by releasing the Luer connection, the pumping mechanism is disconnected from the catheter, causing the filling to be released from the catheter balloon into the surrounding environment. The catheter can then be removed from the rectum or anus by pulling on the handle. The cyclically pumping process...The displacement of the two sleeve components 26, 27 can be assisted by a spring-like element 29, which is arranged between the sleeve parts 26 and 27. This element compresses under pressure, developing spring tension, and separates the two cylinders from each other when the pressure is released or suction is applied. The user's fist encloses the sleeve part 26, while the thumb rests on the rear end of the sleeve part 27. In the described embodiment, the front sleeve part 4a is discarded after removal of the catheter or can be used to dispose of the used catheter unit.

[0235] Figures 6 and 6a each show a schematic longitudinal section through the sleeve-shaped outer packaging 4, 4' of the device 1 according to Fig. 1, which is assembled by joining the front and rear sleeve parts 4a, 4b and 4a', 4b' respectively.

[0236] 1 or the device 1' according to Fig. 1e, each with a reflex-triggering or closing catheter unit 2, 2' inserted therein, and a rupturable capsule-like housing 31, 31' integrated into the tip or cap area 30, 30' of the front packaging sleeve 4, 4' for receiving a lubricating substance LU for wetting the front, distal catheter portion 2, 2' with the, for example, gel- or ointment-like, lubricating substance LU.

[0237] The anterior half of the sheath 4a or 4a' each has a dome-shaped or berry-shaped, flexibly deformable segment 30, 30' in the region of its anterior, blunt end, which can be deformed or collapsed by squeezing between the user's thumb and forefinger. The segment integrates within it a specially enclosed volume of a lubricating substance LU. The enclosure 31, 31' can be designed as a balloon-like container which ruptures under pressure and releases its contents into the region of the anterior, distal catheter unit 2, 2', thus coating its surface with the respective substance. The quantity of the lubricating substance is measured such that its distribution is limited to the anterior half and preferably to the anterior third of the catheter unit 2, 2'.The posterior, proximal segment of the catheter unit 2, 2', which is grasped by the user when removing the catheter from the anterior sheath element 4a, 4a', is not affected by the released substance. The substance is preferably viscous or thickly flowing, or exhibits non-flowing, largely stationary behavior, as is the case, for example, with gel-like or ointment-like substances. The released substance should remain confined to the distal catheter segment, especially when the catheter unit 2, 2' is facing upwards or held in this position.

[0238] In the packaged, unopened state of the device 1, 1', the rear sleeve portion 4b, 4b' covers the proximal catheter segment accessible to the user. When the sleeve portion 4b, 4b' is separated from the other sleeve portion 4a, 4a' by axial pulling, the catheter unit 2, 2' remains in the front sleeve portion 4a, 4a'. The helically coiled or package-folded, tube-like supply line 3, 3' for inflating the catheter balloon 5, 5' then becomes visible, its proximal end being fitted with a preferably female Luer cone 3a, 55. Optionally, a filling volume-releasing component 13, 13', which limits the filling pressure, can be integrated into the supply system for inflating the balloon 5, 5'.

[0239] In Fig. 6a, the proximal end of the handle 8' is provided with a cone-shaped recess 54 that transitions into the transanal catheter lumen 71. The channel-like supply line 71 to the patient's rectum is preferably small-diameter, i.e., has a diameter of approximately 0.8 to 2 mm, preferably 1.0 to 1.5 mm. Funnel-shaped or cone-shaped connectors, such as those known from commercially available, ready-to-use enema solutions in ampoules, can be attached to the cone 54. Such enemas can, for example, contain mucosal irritants that promote reflex response and have a volume of only a few milliliters. In addition to particularly small, ampoule-like packaged volumes of liquid, ready-to-use, usually foil-wrapped enemas in the size of so-called mini-enemas with approximately 1.5 mm of volume are also available.A 100 ml volume can be easily connected to the proximal end of the catheter unit via corresponding cone-shaped connectors. Optionally, larger-volume bag systems with infusion volumes of 0.5 to 1.0 liters can also be connected via the funnel-shaped cone 54.

[0240] The sequence of application steps for these embodiments 1, 1' is thus as follows: The user pulls the rear sleeve portion 4b, 4b' off the front sleeve portion 4a, 4a'. He then connects the terminal connector of the filling line 3a, 55 to the connector 3b, 56 of the valve element 13a, 24, 57 integrated into the rear sleeve portion 4b, 4b'. He then crushes the housing 31, 31' of the lubricating substance LU, whereupon it is distributed homogeneously and spatially confined in the space SR. He then withdraws the moistened catheter unit 2, 2' from the front sleeve portion 4a, 4a' and inserts it into the rectum via the anus. He then places the rear sleeve portion 4b, 4b' onto the front 4a, 4a'. By cyclical movement of the two sleeve parts 4a, 4b respectively.4a', 4b' is compressed in the packaging cylinder 4, 4' air and conveyed into the catheter balloon 5, 5' until the balloon 5, 5' has expanded to a retaining and sealing size.

[0241] The embodiments described below with reference to Figures 6b to 6d are applicable to all devices 1, 1', 1" according to the invention.

[0242] Fig. 6b shows an alternative embodiment in which a piston-like or button-like element 32 is integrated into the front end of the sleeve 4a, and a capsule-like housing 31 containing a lubricating substance LU is lined inside the sleeve. When the thumb of the hand grasping the cylinder presses on the button, the housing is pressed against a grid-like perforated abutment 33 and thus ruptured. The substance then spreads, in a structurally or spatially guided manner, for example through appropriately defined wall thicknesses 34 of the front sleeve portion, onto the distal portion of the catheter unit, distributing itself in a gap space SR that is as close as possible to the contour of the distal portion of the catheter.

[0243] Fig. 6c shows a further embodiment of the front sleeve portion 4a, in which a tubular, foil-tube-like, or tube-like sheathing 35 is connected to the housing 31 inside the sleeve. This sheathing defines a specific gap SR remaining between the sheathing and the shaft of the catheter. When the housing structure ruptures, the substance LU released is distributed evenly around the front catheter segment and its spread is limited. The gap is preferably dimensioned such that, in conjunction with the respective viscosity of the lubricating substance, it prevents the substance from flowing out of the gap even when the catheter is held vertically with the catheter tip pointing upwards.

[0244] Figures 6d and 6e show further embodiments of the capsule-like enclosure 31, which incorporate a special, plug-like sealing component that prevents the lubricating substance from entering the lumen CL of the catheter when the enclosure is opened. For this purpose, the enclosure has a cone-shaped extension 36 that is reversibly inserted into the front opening of the olive component and seals the opening. The capsule-like or balloon-like enclosure containing the substance is connected, either at a single point or over a flat area, to the squeezable segment 29 of the front sleeve portion. When the catheter unit is removed, if tension is applied to the container, the catheter detaches from the cone.

[0245] Fig. 7 describes an alternative design of a device for inserting an anorectally sealing access or closure device, wherein the device integrates all components and functions required for catheter insertion and enables the user to dispense with manual pumping, such as operating an air pump, when inflating the balloon component of the respective catheter unit. The user triggers this by pressing a button-like device 37 with their thumb. This device is integrated, for example, into the cap area of ​​the rear sleeve portion 4b, thereby combining several agents stored in the area of ​​the button and initiating a gas-generating chemical reaction. A balloon-like compartment 38 rests beneath the button 37 and abuts a structure 39 that serves as a support.The balloon-like compartment has an outlet 40 connected to the hose 3 leading to the balloon. Inside the compartment is another film-based compartment 41 containing a defined quantity of water or an aqueous solution. The compartment is preferably made of a special, multi-layered film that prevents or minimizes water loss by integrating a waterproof layer into the film structure. A corresponding barrier function can be ensured, for example, by EVOH (ethylene-vinyl alcohol). Preferably, the EVOH layer is embedded between two LDPE-based polyethylene layers. The respective layer composite can be manufactured micro-thin, with wall thicknesses ranging from approximately 10 to 50 µm, preferably 20 to 30 µm. It is easily plastically deformable and can be ruptured by a corresponding external crushing-compressive force.Balloon compartment 38 also contains a dry substance 42 in powder or tablet form, which, in combination with water, releases CO2 gas. The invention preferably uses sodium bicarbonate (baking soda, NaHCO3) combined with citric acid (citrate, C6H8O7) as the dry substance. Upon addition of water, the citric acid dissolves. H3O+ ions are formed, and a reaction begins in which gaseous carbon dioxide (CO2) is produced. The respective amounts of the agents are selected such that, after the reaction is complete, a quantity of gas results that fills a fully formed balloon to such an extent that its balloon envelope fully unfolds, but the balloon wall does not yet begin to expand. To retain the water for a complete reaction with the dry substance in the balloon compartment, or to ensure that the water is not yet fully expanded, the balloon compartment is filled with a small amount of gas.To prevent water from flowing back to the catheter unit, the device has a gas-permeable but water-impermeable separating layer 43 in the area of ​​the transition from the compartment to the filling line 3. The length of the filling line is preferably dimensioned such that the respective filling or valve unit can be guided from the anus to the user's trouser pocket. Fig. 7a shows another embodiment of a gas-generating unit, in which the gas generation takes place in a closed compartment 44 inside the sheath. Here, the reagents W and 42 are enclosed in a sack-like container made of a Gore-Tex-like material, which allows gas to escape but retains water inside. By pressing on the deformable cap 30 with a finger, the water-containing container is ruptured, and the gas-generating reaction is initiated.The gas from compartment 44 is directed via a discharge nozzle 40a to the respective catheter balloon via the filling line 3.

[0246] Fig. 8 shows the terminal components of a filling line 3 of a reflex-triggering, irritating, or sealing catheter device 1, wherein a gas-generating unit GE is integrated into the filling line 3, preferably at its proximal end, adjacent to a connector 3a. This unit GE comprises the components and gas-generating functions described in Figure 7a. Within a flexibly deformable, balloon-like compartment 30a with an outlet opening, the unit is enclosed on all sides in a bag-like housing 45 made of semi-permeable, Gore-Tex-like material. Inside the housing, a compartment W containing water and a gas-generating dry substance 42, which can be ruptured by finger pressure, is contained.

[0247] The gas-generating unit (GE) can be activated by the user either for the initial filling of the balloon catheter, or for a subsequent filling by a connected pump unit, whereby a second, higher pressure level is set in the balloon component of the respective catheter unit, which, for example, transforms the balloon from its initial sealing and retaining function into a reflex-triggering function.

[0248] Fig. 9 describes a design of a device for the compact and application-oriented packaging of an anorectal closure device 1, wherein all components required for the insertion of the closure catheter 2 are contained in a film-based container 46, which is approximately cylindrical or tubular in shape. The device 1 comprises, in the front part of the packaging, a capsule-like or balloon-like enclosure 31a containing a lubricating substance LU. The film-based container 46 consists of two layers of film welded together around their outer edges. The weld lines are designed in certain sections 47 such that they can be separated from each other by pulling on tab-like extensions of the film layers, thus releasing the respective contents for removal.The lines, which can be separated by oppositely directed pulling, optionally extend from the outer, circumferential edge to the center 47a of the packaging bag, thus allowing, for example, a separation of the space in which the lubricating substance LU is released in a controlled manner, wetting only the front end of the catheter, after opening the housing containing it.

[0249] The sequence of application steps is as follows. The user grasps the two tabs 48a and 48b and opens the foil container sufficiently to remove a filling cylinder 49, which operates like a pump-action balloon, from the outer packaging. The filling tube 3, which connects the cylinder to the catheter unit, is then unfolded. Next, the housing 31a containing the lubricating substance is ruptured by finger pressure, causing the substance to flow into the separate compartment 50. There, it moistens the anterior catheter segment. The user then grasps the two tabs 51a and 51b. By pulling on them, the user releases the weld line 47a, allowing the moistened catheter to be lifted out of the pocket-like outer packaging without contaminating the grasping hand and then inserted rectally.The filling cylinder 49 is then preferably emptied by a single fist closure, whereby a defined amount of air is forced into the balloon of the sealing catheter, which establishes the sealing retaining function of the catheter.

[0250] The filling cylinder 49 can alternatively consist of a foam-like, elastically deformable material contained in a bag-like, fully enclosed housing. The housing has an outlet cone on one end face of the cylinder, which is detachably connected to the check valve of the catheter unit. Preferably, the filling cylinder has a simple valve function that prevents the backflow of volume from the catheter balloon into the cylinder. In another embodiment of the filling cylinder, it can be equipped with a combined valve that, after a squeezing maneuver, allows air to flow into the expanding sponge and closes outwards as the pressure in the cylinder increases. The filling cylinder can then be used for several pump strokes.

[0251] As a further structural embodiment of an anorectally closing catheter device, which is compactly packaged in a foil cylinder to save space, a gas-generating unit or function 51, as described analogously in Figure 8, can be integrated into the foil packaging instead of a pump-like component 49.

[0252] To prevent potentially dangerous or damaging overinflation of the catheter balloon, all embodiments of the device 1 are preferably equipped with an element that limits the inflation pressure or the volume supplied. This element may, for example, be equipped with a pressure-limiting spring mechanism that opens to the environment when a maximum pressure is reached, allowing volume to escape from the system. Overinflation can also be prevented by using a polymer with low volumetric elongation or compliance for the balloon component, such as thermoplastic polyurethanes (TPU) of higher hardness grades, in the Shore A range of 80 to 95 or in the Shore D range of 55 to 65.In the transition zone between the free, tension-free expansion of the balloon and the beginning of the balloon wall's stretching, the pressure inside the balloon rises sharply and can be perceived by the user as corresponding resistance during manual pumping. The described TPU types also ensure that the balloon's shape and dimensions, as determined during manufacturing, are maintained or largely retained in both stretched and overstretched states. The ability to avoid uncontrolled deformation or dimensional expansion at higher pressures is essential for the device's operational safety. Unlimited volume absorption, with the risk of rupture of a balloon wall that thins progressively with over-inflation—a common issue with polyisoprene-based balloons, for example—can be largely eliminated with TPU-based balloons.The user cannot usually achieve the corresponding burst pressures using manual pumps.

[0253] Fig. 10 shows a schematic longitudinal section illustrating an exemplary relative arrangement of a trans-anally inserted catheter unit 2" of a device 1" according to the invention and a reservoir bag 64 wound coaxially around the shaft portion 52" of the catheter 2". The front portion 4a" of the sleeve-like outer packaging accommodates the coaxial arrangement of the shaft 52" and bag 64. The rear, diameter-enlarged handle 8" of the catheter 2" protrudes from the outer packaging 4" and can thus be grasped by the user and, together with the tightly wound bag 64, pulled out of the sleeve portion 4a". A folded, layered tubular film, collapsed into a compact package, connects to the unit of bag 64 and catheter 2" as a spatially compressed supply line 63. In the illustrated embodiment 1", the catheter unit 2" does not have an inflatable balloon component.

[0254] Fig. 11 shows a particular design for wetting the front portion of the catheter 2" with a lubricating substance LU. The substance LU is enclosed in a capsule-like or balloon-like component 31" which the user can grasp between their fingers and rupture or open by applying finger pressure. The contents of the enclosure 31" then flow into a tube-like extension 72, which forms a gap SR towards the surface of the catheter shaft 52". The spread of the substance LU can thus be limited to a specific surface area, or the portion grasped by the user can be kept free of the substance LU. The properties of the substance LU are preferably chosen such that it is flowable, but, particularly when the catheter unit 2" is held vertically with the tip pointing upwards, does not leak out of the gap SR or reach the rear grip 8" of the catheter unit 2".The quantity of substance LU is also measured such that, when the housing 31" is completely squeezed out in the space SR, it reaches the anterior half of the catheter, but does not exceed the anterior two-thirds of the catheter unit 2". The tubular extension 72 extends proximally to the area of ​​the catheter handle 8". In the area of ​​the handle 8", it forms tab-like extensions 73, which prevent unwanted separation of the lubricating unit from the catheter unit 2" when it is withdrawn from the surrounding sleeve 4". When grasping the catheter, the user grasps both the handle 8" and the tab-like extension 73, thus moving both elements together. The capsule-like housing 31" and the tubular extension 72 further ensure that the lubricating coating of the catheter unit 2" can be conveniently applied after separation from the surrounding film-like container 46".Wetting is also possible within a surrounding reservoir bag 64 without contaminating the reservoir bag 64. In this design, the preferred relative arrangement of the reservoir bag 64 to the wetting unit is such that the reservoir bag 64 is coiled cylindrically around the catheter shaft 52" and positioned between the enlarged, capsule-like housing 31" and the enlarged handle 8".

[0255] Fig. 12 shows an embodiment of the device, which has a specific linear or sequential arrangement of functional components. At the front of the arrangement is the reservoir pouch 64, which is wrapped around the catheter shaft 52". Extending proximally into the lumen of the rear sleeve portion 4b from the handle 8 of the catheter unit 2, is a layered package of the supply tube 63, followed by a throttling unit 70 and a spirally coiled filling supply line 3. As an alternative to a longitudinally folded supply tube 63, it can also be spirally wound in one or more sections and received in this form in the packaging sleeve.

[0256] The sequence of application steps for this embodiment is as follows. The user pulls the rear sleeve section 4b" off the front sleeve section 4a". He then connects the connector 55" of the filling line 3" to the connector 56" of the valve element 57" integrated into the rear sleeve section 4b". He then removes the unit consisting of the catheter 2" and reservoir bag 64 from the front sleeve section 4a", strips the reservoir bag 64 off the catheter shaft 52", and then unrolls the reservoir bag 64. He then places the rear sleeve section 4b" onto the front sleeve section 4a". He unfolds the supply tube 63 and closes the throttling element 70. He then crushes the casing 31" of the lubricating substance LU, whereupon it is distributed homogeneously and spatially confined in the space SR. The user then pulls the tube-like extension 72 off the moistened catheter shaft 52".The user then inserts the catheter unit 2” transanally into the rectum. By cyclically moving the two sleeve components 4a” and 4b” in the packaging cylinder 4” air is compressed and conveyed into the catheter balloon 5” until the balloon 5” has inflated to a retaining and sealing size. After filling the reservoir bag 64 with an enema fluid, the user raises it to a level above the rectum. The closure and / or throttling element 70 is opened, and the enema begins. Once the desired irrigation volume has been introduced into the rectum, the user can subsequently increase the balloon volume to exert an additional stretching effect on the rectal wall, thereby supporting the triggering of a defecation reflex, if desired.When the excretion reflex occurs, the user disconnects the connector 55" of the filling line 3" from the valve cone 56" of the sleeve 4", whereupon the filling volume empties from the balloon 5" and the catheter unit 2" can be withdrawn from the rectum by the user.

[0257] Fig. 12a shows a closing and / or flow-regulating element 70, which can be designed, for example, in the shape of a disc or a sphere. It consists of an upper part 70a and a lower part 70b, each connected to one end of the supply hose 63. The two parts 70a, 70b lie against each other without gaps in a contact area 70c and each open into an opening 70d, which is spaced apart from the longitudinal center axes of the respective parts 70a, 70b, in particular by equal distances. The two parts 70a, 70b are permanently connected to each other, but can be rotated relative to each other about their aligned longitudinal center axes. With at least one initial rotation position of both parts 70a, 70b, the openings of the lumina within these parts 70a, 70b are shifted relative to each other to such an extent that there is no flow connection - the closing element 70 is blocked.In the event of an axial rotation of the upper relative to the lower portion 70a, 70b by, for example, 90 degrees, a connection is established between the two lines 63 in the end-face contact area 70c of the two portions 70a, 70b. By rotating in the opposite direction, the supply line 63 can be fully or partially closed again at any time. If, on the other hand, a smaller relative rotation angle is set, the flow cross-section in the contact area 70c is gradually reduced – the flow is throttled.

[0258] Fig. 13a shows a detailed view of the upper edge of a reservoir bag 64 according to the invention, from above. It illustrates the two parts of a closure strip 74, consisting of the elastically deformable strips 74a and 74b, which are connected to each other at their lateral ends 74c by hinges. The strips 74a and 74b are continuously and firmly connected to the front or rear film layer of the reservoir bag 64. When a force K directed towards each other is exerted on the two hinges 74c, the two parts of the closure strip 74 deform away from each other or outwards in a convex manner, and the closure strip 74 opens in a mouth-like shape. Upon corresponding release of the force, the mouth-like opening of the reservoir bag 64 returns to a closed state, as the two strips 74a and 74b press against each other in a sealing manner or their profiles interlock tightly.The reservoir bag 64, which the user opens by applying lateral pressure to the joints 74c, can, for example, be slid over the outlet of a tap, comfortably held with one hand, filled, and then automatically and elastically reclosed by releasing the opening force K. In addition to its ease of use, the described closure also allows for an optimally compact design. The described closure strip 74 can be integrated into a cylindrically wound or rolled reservoir bag 64 with a particularly advantageous, small footprint.

[0259] Fig. 13b shows a further embodiment of the reservoir bag 64 in a top view, wherein the two strips 74d and 74e opening and closing the reservoir bag 64 are tightly connected or separated or opened by a zipper-like sliding component 75, wherein the closing strips 74d, 74e do not assume a sealing end position that spontaneously adjusts elastically.

[0260] Fig. 13c shows a front view of the reservoir bag 64 with a frontally arranged inlet opening in the upper area of ​​the reservoir bag, which can be closed in the manner of a zipper 65. This zipper 65 comprises two interlocking closure strips 65a and 65b, wherein the strips are tightly closed or opened by a zipper-like mechanism or a slider component or zipper 66 that joins the strips 65a and 65b together.

[0261] Fig. 13d shows a reservoir bag 64 featuring a combined, parallel arrangement of a sealing strip 74 and a zipper-like component 75, with the sealing strip positioned above the zipper in the top-filled bag. This ensures that the zipper absorbs and resists the pressure exerted by the liquid, while the strip closure above it, freed from any direct force, reliably seals any small residual amounts of liquid that may penetrate the area between the two closures. An absolute seal is particularly necessary when the bag is laid flat on the floor and collects intestinal contents over several minutes.

[0262] Fig. 13e shows a closing, clip-like mechanism CL, which functions analogously to the closing mechanism described in Fig. 5a. By applying transverse, directed finger pressure to corresponding preformations 74f, which receive the fingertips, in the direction of force F, the two elastic, interlocking, rib-like structures 74a and 74b, which are structurally connected to each other in a hinge-like manner at points 74c, open. The lumen of the film tube component 63 can thus be opened by applying pressure with the fingers of one hand by a squeezing force between the thumb and forefinger. When the force or squeezing is released, the mechanism closes automatically. Fig. 14a shows an alternative outer packaging form as a film-based packaging 46". The one in Fig.The device 1" shown in Figure 14a comprises, in the front part of the packaging 46", a capsule-like enclosure 31a" for receiving a lubricating substance LU, which can be opened or ruptured by the user by squeezing it between the thumb and forefinger, and an enema catheter 2" with an attached tubing 63. The film-based container 46" consists of two layers of film welded together around the outer edges. The weld lines 47" are designed in sections such that they can be separated from each other by pulling on tab-like extensions 48a" and 48b", thus releasing the contents. The lines 47" that can be separated by pulling preferably extend from the outer edge to the center of the bag 47a", thus allowing, for example, the separation or opening of the space in which the lubricating substance LU is located or remains confined to the front end of the catheter.

[0263] The sequence of application steps in the described embodiment is as follows. The user grasps the two tabs 48a" and 48b" and opens the foil container 46" sufficiently to remove the catheter unit 2" and the reservoir bag 64, together with the supply tube 63 enclosed by the coiled reservoir bag 64. The reservoir bag 64 is then unrolled. The housing 31a" of substance LU is then crushed, whereupon the released substance LU escapes into the space 50" separated by the weld 47a". There, it wets the anterior catheter segment. The user then grasps the two tabs 76a" and 76b". By pulling on them, he releases the weld 47a", whereupon the wetted catheter unit 2" can be removed upwards from the foil or pouch-like outer packaging 46" without contaminating the grasping hand and then inserted rectally.

[0264] The embodiment further describes non-separable areas 47b" of the weld lines, which remain stable when the various tabs are pulled. The embodiment of the device 1" described here does not use a catheter balloon.

[0265] Fig. 14b shows another embodiment of a ready-to-use, film-based device 46", comprising a catheter unit 2", a film pouch for wetting FT, a tubing supply line 63, and a reservoir bag 64. The reservoir bag 64 is rolled up around the catheter unit 2" to form a cylinder. The catheter unit 2" is inserted into the sheath-like assembly for wetting, which comprises a housing 32" for a lubricating substance LU, a tube-like extension 72, and a tab-like extension 73. The tubing line 63, which connects the reservoir bag 64 to the catheter unit 2", is folded in layers across the width of the reservoir bag 64 and arranged parallel to the cylindrically rolled reservoir bag 64 within the film outer packaging 46".The two film layers of the outer packaging 46" can be separated from each other by pulling on the tabs 48a" and 48b" and by means of the correspondingly pre-formed welded joints 47" between the film layers, starting from the end face. The contents of the film-based container 46" or the unit consisting of the catheter unit, bag and connecting tubing component, can then be grasped by the user, removed from the outer packaging, unrolled or unfolded ready for use and applied.

[0266] Upon removing the compactly arranged package contents, the user, after opening the outer packaging, grasps the catheter shaft handle, which is enclosed in a flap-like film 73. He unrolls the pouch 64 and unfolds the tubing 63. Immediately before transanal insertion of the catheter unit, he ruptures the casing 32 by pressing with the fingers of his other, free hand, thereby releasing the lubricating substance into the film extension 72 and spreading it, limited to the distal portions of the catheter unit, in a wetting manner. The user then grasps the catheter handle with the fingers of one hand and subsequently pulls the film pouch FT distally away from the catheter with the fingers of the other hand.

[0267] Fig. 15 shows an embodiment of the device 1", whose catheter unit 2" enables a particularly high-volume inflow of fluid into the higher sections of the colon of a patient that adjoin the rectum, and ensures a correspondingly high-volume outflow of intestinal contents, whereby the appropriately large inner lumen of the catheter unit 2" also allows mobilized, formed stool components to be drained from the colon. For this purpose, the catheter unit 2" has a catheter shaft 52" or a shaft component 53", which is preferably made of extruded tubing material that is subsequently shaped by a blow molding process.

[0268] The segment of the shaft component 53" positioned in the region of the anus and rectum is preferably provided during manufacturing with a corrugated or wavy profile or corrugation that stabilizes the lumen of the tube, thereby giving the shaft component 53" a particularly favorable ratio of outer to inner diameter. The inner diameter is preferably 10 to approximately 20 mm, and particularly preferably 12 to 16 mm. An outer shaft diameter of 22 mm, which would impede the anal passage of the catheter shaft 53", should not be exceeded. The special profile of the shaft wall also provides the shaft component 53" with axial flexibility, which, under moderate force acting on the shaft 52", allows for an all-around deflection of the shaft axis by approximately...

[0269] The 45-degree angle allows the catheter shaft to follow movements of the pelvic organs or the patient. The shaft component 52" is designed to resist the tone of the anal sphincter acting upon it, and thus not collapse in the anal canal under the action of the sphincter, while remaining open under the pressure of the balloon inflation. The tubular shaft component 53" is preferably made of an elastic material such as polyurethane with a Shore hardness of 90A to 95A or 55D to 65D. The wall thickness of the shaft component 53" is approximately 0.6 to 1.5 mm, depending on the specific material hardness. The shaft component 53" is equipped with a dumbbell-shaped balloon body 5" as described in the invention, which positions and secures the catheter unit 2" in its transanal position.The two lateral extensions 5a”, 5c” of the balloon body 5” have an approximately equal diameter. They act as abutments positioned in front of and behind the anal canal AK. The centrally positioned, trans-anally positioned part 5b” of the balloon body 5” conforms tightly to the respective lumen of the anal canal AK. The tubing 63, which connects to the proximal end of the catheter unit 2” and links the catheter unit 2” to the reservoir bag 64, consists, according to the invention, of a particularly thin-walled tubular film, which can be produced, for example, by vertical tubular film extrusion or by thermal welding from two thin film layers to form a tubular structure. The circularly rounded inner diameter of the tubular film corresponds to or can exceed the inner diameter of the shaft component 53”.Preferably, the supply line 63 consists of thin-walled polyurethane or PVC film with wall thicknesses of 20 to 100 µm, preferably 30 to 50 µm. The low wall thickness of the tubular film allows the respective supply line to collapse into a flat, ribbon-like structure, which can be coiled spirally or folded into a package and packaged in a particularly compact, space-saving manner. The design of the supply line 63 as a ribbon-like collapsible film tube makes it possible to reduce even large-diameter tubes, with inner diameters of 20 mm or more, in tube lengths of up to 1.5 meters, to a compact minimum size. This is impossible with conventionally extruded tube material due to the resulting wall thicknesses, which also makes correspondingly miniaturized formats of this product type impossible.

[0270] Fig. 16 describes a pressure-limiting function or assembly integrated into the proximal handle 77 of the shaft component 78 of the catheter unit 2. The pressure-limiting assembly DB is spring-based and preferably comprises a helical spring component 79 and a ball-shaped closure component 80, wherein the tension of the compressed spring continuously presses the closure component against a circular, sealing saddle 81. When a certain inflation pressure of the catheter balloon is exceeded or when the sealing spring force is overcome, air can escape from the interior of the catheter balloon into the environment.

[0271] In the described design, the pressure-limiting assembly DB is structurally separated from the affected supply line 82 to the catheter balloon and from its associated components and assemblies. Short-term pressure peaks caused by resistance or flow, which can occur within the lumens leading to the balloon during a forced pump pulse, therefore have no effect or only a dampened effect on the pressure-limiting function of the assembly.

[0272] Furthermore, the pressure-limiting assembly, particularly in the parallel-separated arrangement shown in this figure within the handle, can be adjusted so that the deflation function does not open upon reaching a safety-relevant overpressure, but rather upon reaching the specific working pressure required for the respective catheter type. The user can thus perform more pump strokes than necessary, if required, without exceeding the pressure required for the catheter's function. To ensure that a specific, functionally relevant working pressure is reached in the balloon, the product instructions may specify three pump strokes for application, even if, for example, only two pump strokes are actually required. These three strokes may be partially or incompletely executed.

[0273] The opening of the pressure-limiting function at a specific pressure in the catheter balloon can be achieved by an adjusting element 83, which sets the respective degree of spring tension to be overcome by a corresponding compression or preload of the spring. To set particularly precise closing and opening pressures, the adjusting element can be threaded, allowing the element to be screwed into the corresponding thread of the handle during catheter assembly using a screwdriver-like tool until the desired closing force is achieved.

[0274] The pressure-limiting or pressure- or volume-relieving function can also be supplemented by the generation of an acoustic signal, which, for example, manifests as a whistling sound for the duration of the overcurrent.

[0275] Fig. 17 describes a pressure-indicating function or assembly DA, which is integrated into one of the sleeve portions of the cylindrical pump body 4, 4b. The pressure-indicating function is provided by a spring element 84, wherein an indicating rod element 93 protrudes from the housing due to a gradually increasing compression of the spring element as the pressure in the pump housing increases, with the operating and safety pressure ranges relevant for the respective catheter application being indicated on the rod element by ring-like markings 94.

[0276] Fig. 18 describes an economically and ecologically advantageous configuration of a set for the regularly intermittent patient self-application of all catheter types described in the scope of the invention, for an application period of 30 days, wherein the respective set comprises 15 to 30 single-use catheter units 85, as well as a reusable packaging and pump unit 86 belonging to the respective set.

[0277] The catheter units, preferably prepared ready for use, in particular lubricated, are each enclosed in lightweight, hermetically sealed foil outer packaging 86, which is as slim and congruent with the shape as possible and avoids excess foil material, and in this compactly packaged form, which protrudes only minimally on the catheter enclosed therein, are inserted into the interior of the pump body belonging to the set or are protected there.

[0278] The packaging and pump body are manufactured to a sufficiently high technical and mechanical standard to ensure reliable use for at least 30 days. The exceptionally lightweight, film-based outer packaging of the individual catheter units results in particularly small and environmentally friendly waste volumes for the sets described in the application.

[0279] The film-based outer packaging can be destructively opened by manually separating it along pre-formed weld or perforation lines, but it can also be provided, for example, with a self-adhesive closure flap X. This flap allows for a hermetic seal of the catheter within the outer packaging and enables the user to place a used catheter back into the film packaging and seal it in a contamination-preventing manner. Fig. 18a shows another film-based outer packaging for a catheter unit, structurally derived from Fig. 18. This outer packaging is equipped in the front area 87 with a separate, tightly sealed container or compartment 88 for holding a wetting agent LU. The container has a spike-like projection 89 pointing into the interior of the packaging, which is inserted into the central, open lumen 90 of the catheter unit.where it is inserted. The extension prevents the released substance from entering the lumen of the catheter shaft if the container is ruptured, for example, by being squeezed between the thumb and forefinger of a hand. This ensures that a relatively constant, defined quantity of the medium is available for distribution in the gap SR between the film wall and the wettable surface of the catheter unit. The released volume of the substance is dimensioned such that it distributes itself within the gap in such a way that the proximal portions of the catheter remain free of the substance.

[0280] The film-based outer packaging can be destructively opened by manual separation along pre-formed weld or perforation lines, but can also be provided, for example, with a closure flap 91 with self-adhesive coated edges running around the edges 92 of the flap, which on the one hand enables a tightly sealed closure of the catheter from the environment, and on the other hand allows a used catheter to be placed back into the outer packaging and sealed by means of the self-adhesive closure of the flap in a way that prevents contamination. Reference numeral list

[0281] Device 13a Valve

[0282] Catheter unit 13b valve

[0283] a Insertion aid 14 Carrier component Filling line 14a Receptacle for balloon end a Female connector 14b Receptacle for balloon end b Male connector 15 Gel-like mass

[0284] c Pilot balloon 15a Foil housing sleeve-like outer packaging 16 adhesive foil

[0285] a front sleeve portion 17 adhesive fixation

[0286] b rear sleeve portion 17a adhesive gel layer balloon 18 flow-directing valve assembly a distal balloon segment 20 circular seal

[0287] b middle balloon segment 20a sealing lip

[0288] c preanal balloon segment 21 finger-like extension d coaxial inner balloon end 22 lip-like structure e outer / posterior balloon end 23 mechanical stop ring-like structure 24 valve mechanism a opening in the ring 24a valve

[0289] disc-shaped component 24b valve handle segment 25 Luer-standardized fitting handle recess 26 sleeve portion

[0290] 0 olive-shaped component 27 pod portion

[0291] 1 continuous lumen, 28 nozzles

[0292] 2 filter-like component 29 spring-like element 3 pressure-relieving component 30 flexible, deformable segment housing 51b tab

[0293] piston-like element 52 catheter shaft pre-forged abutment 53 finger-like shaft element wall thickness 54 connector

[0294] 55. Tubular enclosure; 56. Female Luer connector; 57. Pin-like extension; 58. Male Luer connector; 59. Sensor-like device; 50. Flow-directing valve element; 51. Balloon-like compartment; 52. Pump body; 53. Abutment structure; 54. Inlet valve

[0295] Outlet 60 retaining bracket

[0296] a Outlet nozzle 61 Distal opening Compartment 62 Distal end Dry substance 63 Supply tube Separation layer 64 Reservoir bag Compartment 65 Zipper Sack-like enclosure 65a Closure strip Film-based container 65b Closure strip Welding line 66 Zipper

[0297] a welding line 67 punching

[0298] a tab 68 outlet area

[0299] b Tab 69 Connector Filling cylinder 70 Throttle / closing element Separated space 701 Upper part Gas-evolving function 70b Lower part

[0300] a tab 70c contact area trans-anal catheter lumen 89 extension tubular extension 90 lumen

[0301] flap-like extension 91 Closure flap Closure strip 92 Edge

[0302] a) Bar 93 indicating rod element b) Bar 94 ring-like marking c) Lateral end AK Anal canal

[0303] d groin CL catheter lumen

[0304] e bar DA pressure-indicating assembly f preformation DB pressure-limiting assembly slide GE gas-evolving unit a tab K force

[0305] b Tab LU lubricating substance proximal handle PK pump body shaft component PV variable space spring component SR gap space closure component ST rod-like segment sealing saddle W reagent compartment supply line

[0306] Adjustment element

[0307] spring element

[0308] Catheter unit

[0309] Packaging and pump unit

[0310] Area

[0311] compartment

Claims

Patent claims 1. System (1;1'; T) for the independent, trans-anal insertion of a catheter unit (2;2';2") into the rectum of a person, wherein the catheter unit (2;2';2") comprises a catheter (2a;52;52") and at least one balloon (5;5';5") attached thereto, which is filled and thereby inflated only after the catheter (2a;52;52") has been inserted into the rectum of the person and then holds the catheter (2a;52;52") in the rectum and, if necessary,a sealing function, characterized in that the at least one balloon (5;5';5") is connected to a filling device via a filling line (3;3';3"), wherein all components and functions required for the application of the device, in particular for the insertion of the catheter (2a;52;52") and the filling of the balloon (5;5';5"), including the catheter (2a;52;52"), the balloon (5;5';5"), the filling line (3;3';3") and the filling device, are arranged and / or integrated in a single, handy, portable outer packaging (4,46;4',46';4",46").

2. System (1; T;1") according to claim 1, characterized in that the filling device for filling the at least one balloon of the catheter unit is manually operable, in particular without auxiliary energy.

3. System (1;1'; T) according to one of claims 1 or 2, characterized in that the filling device for filling the at least one balloon of the catheter unit has a cavity whose volume is variable, in particular manually variable.

4. System (1 according to one of claims 1 to 3, characterized in that the filling device for filling the at least one balloon of the catheter unit has a manually operable pumping mechanism.

5. System according to claim 4, characterized in that the pumping mechanism comprises at least two telescopically nested, relatively has sleeves and / or cylinders that can be moved relative to each other.

6. System according to claim 5, characterized in that the pumping mechanism comprises at least one sleeve-shaped component and a piston-shaped component slidably guided therein.

7. System (1;1';1") according to claim 6, characterized in that the piston-shaped component and / or the sleeve-shaped component is closed at one end face.

8. System (1; 1 1 “) according to claim 6 or 7, characterized in that the sleeve-shaped component and / or the piston-shaped component is open at one end face.

9. System (1 according to one of claims 6 to 8, characterized in that the piston-shaped component is approximately the same length as the sleeve-shaped component.

10. System according to one of claims 6 to 9, characterized in that the piston-shaped component is sealed at least in the area of ​​an end face against the inside of the sleeve-shaped component.

11. System (1;1 ';1“) according to one of claims 6 to 10, characterized in that the sleeve-shaped component and / or the piston-shaped component of the pump mechanism is elastically designed, so that it can be elastically deformed by clenching the fist or pressing with the finger and elastically straightens itself in a state free from external forces.

12. System (1;1 ';1 “) according to one of claims 6 to 11, characterized in that in the unused state the piston-shaped component is inserted into the sleeve-shaped component in such a way that the respective closed ends are turned away from each other, and that the catheter unit is received in the common enclosed cavity.

13. System (1;1 ';1“) according to one of claims 6 to 12, characterized in that the piston-shaped component can be separated from the sleeve-shaped component and reinserted in reverse orientation.

14. System (1;1';1") according to one of claim 13, characterized in that the piston-shaped component can be connected to the sleeve-shaped component to form a closed pump body after the removal of the internal catheter unit.

15. System (1; 1 1 “) according to one of claims 6 to 14, characterized in that the piston-shaped component and the sleeve-shaped component, when connected, are designed to be rotatable relative to each other about a predetermined maximum angle about their common longitudinal direction by a predetermined maximum angle, such that the piston-shaped component and the sleeve-shaped component are guided in a mutual connection during a subsequent mutual axial displacement in such a way that the two components (i) cannot be completely separated from each other by a corresponding mechanical stop when a relative axial tensile force is applied or when the pump is drawn in, so that a maximum compressible volume is defined, and (ii) a certain stop cannot be overcome when a relative axial compressive force is applied or when the pump is pressed out, so that an overall defined maximum stroke volume results.

16. System (1; 1 '; 1 “) according to any one of claims 6 to 15, characterized in that the dimensions, in particular volumes, of the sleeve-shaped component and / or the piston-shaped component, as well as the structural limitations of the possible relative travel distances of the two components, are set or adjustable such that (i) during a single complete stroke sequence, the balloon of the catheter unit is filled to such an extent that the balloon achieves a sufficient rectal retention effect, and / or that (ii) during a subsequent second complete stroke sequence, an effective transanal sealing effect is generated, and / or that (iii) during a subsequent third complete stroke sequence, a stimulus can be generated which a coordinated defecation reflex may be triggered, and (iv) in addition, one or more subsequent complete stroke sequences may result in a pressure increase in the filled balloon, which can be perceived by the user or recognized as a sign of incipient overfilling.

17. System (1;1';1") according to one of the preceding claims, characterized in that the filling device for filling the at least one balloon of the catheter unit has at least one manually operable pump balloon.

18. System (1;1';1“) according to claim 17, characterized in that the pump balloon is elastically deformable.

19. System (1;1';1") according to claim 17 or 18, characterized in that the pump balloon is self-erecting or self-expanding.

20. System (1;1';1") according to claim 19, characterized in that the pump balloon is filled with an elastic foam.

21. System (1;1';1") according to claim 19 or 20, characterized in that the pump balloon is preformed from a thick, rubber-like material in a spherical or sack-shaped, radially compressible structure.

22. System (1;1';1“) according to one of claims 19 to 21, characterized in that the pump balloon is provided with a bellows-shaped, axially compressible structure.

23. System (1; 1 ';1“) according to one of claims 4 to 22, characterized in that the pumping mechanism or the pump balloon is provided with an outlet for connecting a filling line.

24. System (1;1';1 “) according to claim 23, characterized in that a flow-directing valve is arranged in the area of ​​the outlet, which It allows the flow of a filling medium, especially air, from the cavity into the filling line, but not a return flow from the filling line to the cavity.

25. System (1; 1 1 “) according to one of claims 4 to 24, characterized in that the pumping mechanism or the pump balloon is provided with an inlet for air to flow into the enclosed cavity, provided that the pressure inside the cavity is lower than the ambient pressure.

26. System (1;1 1 “) according to claim 25, characterized in that a flow-directing valve is arranged in the area of ​​the inlet, which allows the flow of a filling medium, in particular air, from the environment into the cavity, but does not allow a backflow from the cavity into the environment.

27. System (1;1',r) according to one of the preceding claims, characterized in that the filling device is designed to carry out a gas-generating chemical reaction.

28. System (1;1';1") according to claim 27, characterized in that the gas-generating chemical reaction can be activated by manual action of the user, for example by applying pressure, in particular by pressing a finger, thumb or key.

29. System (1; T;1”) according to claim 27 or 28, characterized in that the filling device has at least two compartments originally separate from each other for receiving a chemical substance each, the mixing of which generates a gas.

30. System according to one of claims 27 to 29, characterized in that at least one compartment contains water H2O or an aqueous solution.

31. System (1;1';1") according to one of claims 27 to 30, wherein characterized in that at least one compartment contains at least one dry substance, e.g., in powder or granular form, e.g., sodium bicarbonate NaHCO3 and / or a citrate.

32. System (1; T;1") according to one of claims 27 to 31, characterized in that a continuous but originally interrupted flow connection is provided between the two compartments, wherein the interruption of the flow connection can be opened by a manual action.

33. System (1;1';1") according to claim 31 in conjunction with claim 32, characterized in that, after opening the originally interrupted flow connection between the two compartments, the liquid, for example water H2O, reacts chemically on the one hand with the at least one dry substance, for example sodium bicarbonate NaHCO3 or citrate, on the other hand, in such a way that a physiologically acceptable gas is released, e.g. carbon dioxide CO2.

34. System (1; T;1”) according to claim 33, characterized in that a carbon dioxide-generating reaction is initiated by the physical exposure or combination of water with sodium bicarbonate and citrate, each in dry form, and preferably proceeds until the complete conversion of the reagents involved.

35. System (1; T;1") according to one of claims 27 to 34, characterized by a balloon- or balloon foil-like enclosure for receiving the gas released during the chemical reaction.

36. System (1;1';1") according to claim 35, characterized in that the balloon- or balloon-foil-like enclosure is connected or connectable to the filling line, e.g. via a valve, so that the gas released by the reaction is directed from the balloon- or balloon-foil-like enclosure to the balloon of the catheter unit.

37. System according to one of claims 27 to 36, characterized in that by appropriate dimensioning of the reagent quantities the amount of gas developed is adjusted such that the balloon of the catheter unit connected to the gas-generating filling device fills completely, and its balloon wall transitions into a stretched or even a slack, yet undeveloped state.

38. System (1;1';1“) according to one of claims 27 to 37, characterized in that a gas-permeable but water-impermeable component is provided in the filling device and / or in the filling line, which prevents the escape of liquid from the reaction chamber of the filling device into the filling line leading to the balloon of the catheter unit.

39. System (1;1';1") according to one of the preceding claims, characterized in that a volume-releasing component or function limiting the filling pressure of the balloon is integrated in the portion of the device leading to the balloon and / or in the pumping or gas-generating portion.

40. System (1;1';1") according to one of the preceding claims for carrying out a rectal enema, and / or for carrying out a higher-volume swivel enema, in particular for a bowel-emptying or cleansing, cyclically lavaging supply and drainage of larger volumes of fluid into the parts of the colon located above the rectum, characterized in that a reservoir and / or collection bag for receiving irrigation fluid and / or intestinal contents can be connected at the proximal end of the catheter unit via an inlet and / or outlet tube between the catheter and the bag.

41. System (1;1';1") according to claim 40, characterized in that the inlet and / or outlet tube, which connects the catheter unit to the reservoir and / or collection bag, is made of a thin-walled, foil tube- consists of a material that, when unfilled, collapses into a flat, ribbon-like structure.

42. System (1 according to claim 40 or 41, characterized in that the inlet and / or outlet hose is made of a film-extruded material or is welded or welded together from two adjacent layers of thin-walled films to form a hose-shaped structure, 43. System (1;1';1") according to one of claims 40 to 42, characterized in that the inlet and / or outlet hose is made of polyurethane, PVC or LDPE-based material, or is constructed from several different material layers as a composite material.

44. System (1;1';1") according to one of claims 40 to 43, characterized in that the wall thickness of the inlet and / or outlet hose is 20 to 100 pm, preferably 30 to 50 pm, and / or has a circular inner diameter of 5 to 25 mm, preferably 8 to 20 mm, when filled.

45. System (1;1';1") according to one of claims 40 to 44, characterized in that the inlet and / or outlet tube, which connects the catheter unit to the reservoir and / or collection bag, is folded or can be folded in its ribbon-like state into one or more segments wound in a roll-like manner or folded in a package-like manner.

46. ​​System (1;1';1") according to claim 45, characterized in that the inlet and / or outlet hose, which is folded into one or more coiled or package-like segments, with hose lengths of 100 to 150 cm, fits into a cylindrical volume with an outer circular diameter of 2.0 to 5.0 cm, preferably 2.5 to 3.0 cm, and a cylindrical length of 15 to 25 cm, preferably 15 to 20 cm.

47. System (1;1';1") according to one of claims 40 to 46, characterized in that the reservoir and / or collection bag is made of polyurethane, PVC or LDPE, or is constructed from a multilayer composite of film layers of the aforementioned materials, preferably wherein at least one layer consists of a polyamide-based material.

48. System (1;1';1") according to one of claims 40 to 47, characterized in that the reservoir and / or collection bag consists of a thin-walled film material with wall thicknesses of 20 to 100 pm, preferably 30 to 50 pm, and / or has a bag volume of 500 to 2000 ml, preferably 500 to 1250 ml.

49. System (1;1';1") according to one of claims 40 to 48, characterized in that the reservoir and / or collection bag is wound or can be wound into a roll in an empty, preferably unused state and / or is folded or can be folded into a package.

50. System (1;1';1") according to claim 49, characterized in that the reservoir and / or collection bag, wound into a roll or folded into a package, fits into a cylindrical volume with an outer circular diameter of 2.0 to 5.0 cm, preferably 2.5 to 3.0 cm, and a cylindrical length of 15 to 25 cm, preferably 15 to 20 cm.

51. System (1;1';1") according to one of claims 40 to 50, characterized in that the reservoir and / or collection bag has a preferably clip- and / or zipper-like closing device in the region of its upper end, which is able to close the reservoir and / or collection bag in a liquid-tight manner after it has been filled.

52. System (1;1';1“) according to claim 51, characterized in that the components of the closing device do not protrude more than 5 mm above the level of the film of the reservoir and / or collection bag integrating them.

53. System (1 according to one of the preceding claims for the discreetly portable, ready-to-use device for a temporary, balloon-based, anorectal seal against intestinal contents in fecal incontinent patients, comprising a catheter unit that can be inserted trans-anally into the rectum and remains trans-anally in the inserted state, with at least one sealing and retaining balloon, a filling device for filling the balloon, and a filling line connecting the filling device to the balloon, characterized in that the handy, portable outer packaging has a cylindrical and / or sleeve-like shape.

54. System (1;1';1") according to claim 53, characterized in that a cylindrical and / or sleeve-like outer packaging in the closed or unopened state has the size and / or shape of a cigar tube or a fountain pen or a case, e.g. for a fountain pen and / or ballpoint pen.

55. System according to claim 54, characterized in that the outer packaging is provided with additional components characteristic of the respective sleeve type or packaging type, such as cigar-typical bands or fountain pen-typical retaining clips for placement in a vest pocket.

56. System (1 according to claim 53 or 54, characterized in that a cylindrical and / or sleeve-like outer packaging in the closed or unopened state has the size and / or shape of a packaging film, in particular the size and / or shape of a chocolate bar.

57. System according to claim 56, characterized in that the outer packaging is provided with additional components characteristic of the respective sleeve type or packaging type, such as end-side, pre-formed, tearable sealing lines.

58. System according to one of the preceding claims, characterized in that the balloon of the catheter unit consists of a particularly thin-walled, soft-film-like material of low volumetric elongation (compliance), for example produced in a blow molding process from a thermoplastic polyurethane of the hardness range according to Shore 80A to 95A or according to Shore 55D to 60D, preferably wherein the wall thickness of the balloon in the area of ​​the largest diameter is approximately 10 to 50 pm, preferably 10 to 30 pm.

59. System (1;1';1") according to one of the preceding claims, characterized in that the balloon of the catheter unit is made of a material with high volumetric extensibility (compliance), for example a polyisoprene or silicone-based polymer, and wherein the balloon may have a complete, a partial or no discernible shape.

60. System (1;1';1") according to one of the preceding claims, characterized in that the retaining and sealing balloon of the catheter, and optionally also the stool reflex triggering balloon, or the respective effective segments of a segmented balloon, are already shaped during manufacturing to the working dimension required for the respective function, or that the working dimension required for the respective function exceeds or exceeds 61. System (1;1';1") according to one of the preceding claims, characterized in that the anorectally sealing catheter unit is equipped with a dumbbell-shaped balloon element that positions and seals the catheter unit trans-anally, wherein the segment of the balloon placed in the rectum has a spherical or discoid shape, and the central, tapered segment emerging from it is placed within the anal canal, and a spherically or discoidally shaped pre-anal segment is connected to the trans-anal segment, which is positioned immediately before the opening of the anus, or wherein the balloon element has a mushroom-like shape and lacks a pre-anal extended segment, i.e. having only a rectally placed, spherically or discoidally shaped segment and a relatively tapered, trans-anal segment, or wherein the balloon body has only a single, rectally placed spherical or discoid extension.

62. System (1;1';1") according to one of the preceding claims, characterized in that the balloon has a dumbbell shape or a mushroom shape, wherein at least one of the ends of the balloon tapered to the shaft dimension is fixed on the shaft of the catheter unit in such a way that the end or ends are set into the balloon body or are shifted towards each other, whereby the respective spherically or discoidally expanded segments of the balloon, during inflation, roll over the relatively tapered portion of the balloon body or approach each other in a rolling motion directed towards each other, whereby the rectally retaining and sealing balloon component can dynamically adapt to the respective anorectal anatomy or to the various functional states of the anorectal sphincter apparatus and thus develop, in addition to a radial sealing effect within the anal canal, an axial sealing effect on the anal canal.

63. System (1; 1 1 “) according to claim 61 or 62, characterized in that, in the case of a dumbbell-shaped form of the balloon body, the pre-anal, spherically or discoidally expanded portion located outside the anus has a maximum diameter which is equal to or exceeds the maximum diameter of an injection-molded or simply cast pre-anal abutment element or an annular element receiving the balloon ends.

64. System (1;1';1") according to one of the preceding claims, characterized in that the retaining and sealing rectal balloon or the corresponding balloon portion has a flat, discoid shape, wherein the discoid balloon body with its shoulder lies flatly, directly on the rectal floor and wherein the radial circumferential surface of the discoid balloons are exposed to the lateral portions of the wall of the terminal rectum, and wherein the filled, freely unfolded balloon body has an axial height of 30 to 50 mm, preferably 30 to 40 mm.

65. System (1;1';1") according to one of the preceding claims, characterized in that grip-like recesses or formations are provided at a defined distance from the distal tip of an olive-shaped insertion element of the catheter unit on the posterior, proximal portion of the handle, which enable the user to determine the correct insertion depth during transanal insertion of the catheter by striking the fingers grasping the catheter or a pre-anal support element against the anus, wherein the distance of the handle from the catheter tip is 60 to 100 mm, preferably 70 to 90 mm.

66. System (1;1';1") according to one of the preceding claims, characterized in that the catheter unit is coated or can be coated with a lubricating substance in the region of the distal catheter portion.

67. System (1;1';1") according to claim 66, characterized in that the lubricating substance has a gel- or ointment-like consistency.

68. System (1;1';1") according to claim 66 or 67, characterized in that the lubricating substance is adjusted to be viscous in such a way that it does not extend or flow over half the length of the catheter unit, from distal to proximal, regardless of the spatial orientation of the catheter unit.

69. System (1;1';1") according to one of claims 66 to 68, characterized in that the front segment of the catheter unit is coated with a lubricating substance based on a thin layer or film of a fatty, ointment-like substance, or also on the basis of coated with a viscous silicone oil or silicone grease.

70. System (1;1';1") according to one of claims 66 to 69, characterized in that the correspondingly coated surfaces are enclosed in the packaged state within the front sleeve element in a hermetically tightly closing manner, thereby preventing the drying out of the lubricating substance applied as a layer or film.

71. System (1;1';1") according to claims 66 to 70, characterized by a lubrication device for moistening the catheter unit in the area of ​​the distal catheter portion with a lubricating substance immediately before removal from the outer packaging.

72. System (1;1';1") according to claim 71, characterized in that the lubricating substance is packaged within its own compartment and / or in an enclosure that can be plastically deformed and ruptured by finger pressure.

73. System (1;1';1") according to claim 71 or 72, characterized in that within the outer packaging a housing for the lubricating, gel- or ointment-like substance is arranged which can be ruptured by external force and which can be opened by the user by thumb pressure, for example by direct finger pressure or by means of an intermediary, piston-like element.

74. System (1;1';1") according to one of claims 66 to 73, characterized in that a plug-like closure of the central, decompressing and / or supply channel in the closing catheter unit prevents the lubricating substance from entering the channel and allows the substance to spread over the balloon surface, and wherein additional, optional structural additions or components inside the sleeve portion receiving the front catheter segment, such as hood-like tubing films or space-filling Inner sleeve elements form a gap in which the lubricating substance can be applied evenly and sparingly to the surfaces to be wetted.

75. System (1;1';1") according to one of the preceding claims, characterized in that the coated catheter portion is inserted airtight into a sleeve-shaped component or, in the packaged state, is protected within the sleeve-shaped outer packaging from drying out and chemical changes caused by atmospheric oxygen. * * *

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