DE102008055673B4 - Device for stool drainage - Google Patents

Abstract

Device for the continuous drainage of stool from a patient's rectum into an external, bag-like collection vessel and/or for the application of a rectal enema and/or for performing colorectal irrigation and/or for closing the rectum, comprising an inflatable balloon with a torus-shaped structure formed from a flat, inverted tube section (8), wherein the outer layer of the inverted tube section has a radially expanded area (intrarectal balloon section 1) for insertion into the rectum, and proximal thereto a correspondingly tapered area (transanal balloon section 2) for remaining within the anal canal, characterized in that both balloon sections (1;2) each form separate compartments which are to be filled separately from the other compartment.

Description

The invention relates to a device for the continuous drainage of stool from the rectum of a patient into an external, bag-like collection vessel and/or for closing the rectum, comprising an inflatable balloon with a torus-shaped structure formed from a flat, inverted tube section, wherein the outer layer of the inverted tube section has a radially expanded area (intrarectal balloon section) for insertion into the rectum and a correspondingly tapered area (transanal balloon section) which remains at least partially outside the rectum during use.

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

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

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

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

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

The concept of stool management includes the option of large-volume, anally administered colorectal irrigation. Large-volume enemas into the colon have been used for decades by patients with surgically created colostomies to actively manage bowel movements. The irrigation fluid entering the colon mobilizes the colonic contents and essentially flushes them out.

Similarly, in immobile, uncooperative patients who have been bedridden for extended periods, a large-volume transanal enema can be used to mobilize and drain bowel contents. This allows the therapist to control and guide defecation. With appropriate application, a stool-free, quasi-continent interval of one to two days can be achieved.

• Bei angestrebten Liegezeiten der Drainage von bis zu vier Wochen sind druckbedingte Verletzungen im Bereich des terminalen Rektums (Ulcera) sowie im Bereich des Anus (Fissuren) nicht auszuschließen. Druck-Ulcera sind in der Regel die Folge prall gefüllter die Vorrichtung im Rektum verankernder Ballonkörper, welche den rektalen Strukturen dauerhaft anliegen und deren Durchblutung einschränken. Die bekannten Systeme besitzen Ballons, die im nicht befüllten Zustand nur partiell ausgeformt sind, und durch Beaufschlagung mit ca. 100 mbar auf ihr Arbeitsmaß aufgedehnt werden, um so ihre Ankerfunktion zu gewährleisten. Anale Fissuren hingegen resultieren in der Mehrzahl aus der fortwährenden Reibung, die der in der Regel kollabierte, in Faltung liegende trans-anale Drainageabschnitt der Vorrichtung im Anus verursacht.

Currently available stool drainage systems are problematic in several respects:

• With drainage systems intended to remain in place for up to four weeks, pressure-related injuries in the terminal rectum (ulcers) and the anal region (fissures) cannot be ruled out. Pressure ulcers are generally the result of the balloons, which are inflated to anchor the device in the rectum, but remain in constant contact with the rectal structures and restrict their blood flow. The balloons used in these systems are only partially formed when deflated and are expanded to their working size by pressurizing them with approximately 100 mbar to ensure their anchoring function. Anal fissures, on the other hand, mostly result from the continuous friction caused by the typically collapsed, folded transanal drainage section of the device in the anus.

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

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

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

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

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

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

The DE 10 2005 021 081 A1 Disclosing a rectal tube for closing a natural or artificial anus, comprising an inflatable balloon with an approximately torus-shaped structure, formed from a flat, inverted tube section, the two ends of which are approximately coaxial and each connected by a sleeve, wherein the outer layer of the inverted balloon section has a radially expanded, patient-proximal region for insertion into the rectum and a correspondingly tapered, patient-distal region which remains at least partially outside the rectum during use. However, the patient-proximal or intrarectal region and the patient-distal or transanal region are formed from a single balloon, so that these sections are not separate and can only be inflated or deflated together. Thus, the anchoring function of the intrarectal region and the sealing function of the transanal region can only be activated or deactivated together, so that these functions cannot be adequately adjusted in many situations.

The US 4 686 985 A This describes an anal dilator and occluder with a balloon that—apart from a small valve area between a patient-proximal and a patient-distal region—is not inverted and therefore does not have a torus-shaped form in either the patient-proximal or the patient-distal region. Only a single extracorporeal port is provided for inflating the balloon, so the inflation pressure in different areas of the balloon cannot be controlled or influenced independently. The lack of inversion in different areas ultimately leads to an embodiment in which different balloons are attached one after the other on a shaft; however, such a structure is very complex and requires a very complicated manufacturing process.

The present invention is intended to provide solutions for the known problems in the application of conventional systems for continuous stool drainage.

This is achieved by having two balloon sections of the inverted balloon each form separate compartments that can be filled separately from the other compartment.

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

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

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

In contrast to PCT/ EP2005/007950 In the present invention, the intra-rectal balloon component has no functional or spatial connection with the trans-anal segment.

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

In some embodiments, the invention describes a trans-anal compartment, based on concentric tube elements, that can be filled with a filling medium. This compartment is, however, separate from the intra-rectal balloon. Both compartments are filled separately and constitute functionally independent units.

In the invention, the separation of the two segments is preferably achieved by a permanent, sealing closure of the intrarectal balloon segment's outer shell onto or with the funnel element. However, in the region of the proximal end of the intrarectal balloon, it can also be achieved by directly connecting the balloon shell to the surface of portions of the transanal segment.

The invention further describes the trans-anal part of the device as not being exclusively designed in two layers, but also addresses single-layer variants of this segment.

As design variants, configurations of the trans-anal segment are also described which, in addition to a single or double layer of tubing, have an additional functional element that is primarily intended to counteract axial torsion or twisting-related closure of this section.

While in PCT/ EP2005/007950 While a temporary closure of the drainage lumen can be achieved by a closure balloon expanding within the intrarectal funnel, the present invention enables such a closure in the trans-anal drainage portion. Here, not only is the drainage lumen closed, but the segment, which expands radially upon inflation, also simultaneously seals against the anal canal.

The in PCT/ EP2005/007950 The invention also incorporates a fully or, optionally, partially dimensioned intrarectal balloon segment, as presented in the invention. In practical application, this segment is preferably filled with a defined volume, which is deliberately chosen to be smaller than the volume of the fully expanded (filled but unpressurized) balloon. The intrarectal balloon segment thus rests on the rectal floor as a limp, only partially filled balloon body. It dynamically conforms to the respective morphology by folding its outer layer inwards on all sides. In this way, it can be permanently positioned, completely filling the individual space, with the least possible force acting on the rectal tissue and a low probability of causing tissue damage. Ideally, the inflation pressure required to achieve sufficient anchoring of the drainage in the rectum should not exceed the prevailing physiological pressure there.

While in the state of the art such a reduction in filling pressure also simultaneously determines the unfolding characteristics and thus drainage properties of the trans-anal segment, This is not the case with the present invention. Both compartments can have their force output on the adjacent tissue regulated separately.

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

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

In the invention, the trans-anal segment preferably consists of the extended ends of the intra-rectal balloon, but can also be made from separately manufactured tube elements or from a separately manufactured tube element.

To stabilize the trans-anal segment, a tubular element can be additionally installed, preferably connecting the funnel element to the connecting element continuously. To prevent lumen-restricting torsion of the trans-anal segment, this is preferably designed as an elastically self-righting tube element or as a radially deformable, self-opening tubular mesh that conforms to the anal canal with moderate tension.

If the trans-anal segment has a double-walled design, the chamber located between the funnel and connector element can be evacuated or filled with a filling medium, preferably air, via a suitable supply line from outside the patient.

When the space between the two concentric layers of tubing is evacuated, they lie close together and, inseparable from one another, appear as a single layer. The central drainage lumen is then maximally open.

When the space between the concentric layers of tubing is filled, the two layers separate in such a way that the inner layer unfolds into the drainage lumen and seals it. The outer layer, on the other hand, expands radially towards the wall of the anal canal, thus sealing it.

Filling and unfolding the trans-anal segment in the described manner is particularly advantageous for high colorectal irrigation, which aims to allow the largest possible volume of irrigation fluid to flow into the intestine while preventing the irrigation solution from escaping through the drainage lumen or through the anus, past the trans-anal drainage segment.

Finally, the invention addresses the specific problem of assembling very thin-walled balloon films. It presents corresponding assembly techniques that can be advantageously used in the production process.

• 1 die einfachste Ausführungsvariante für die Kopfeinheit einer erfindungsgemäßen Vorrichtung;
• 1a eine beispielhafte Ausformung des Ballonrohlings;
• 1b verschiedene Präformationen der Ballonhülle und des Trichterelementes;
• 1c eine Zwei- oder Mehrkomponentenausführung des Trichterelementes;
• 2 eine andere Ausführungsform der Erfindung;
• 3 eine Kombination von Ankerballon mit einem aus der Ankerballonhülle hervorgehenden trans-analen Segment wie in 1 dargestellt, mit dem in 2 beschriebenen stabilisierenden Rohrstück;
• 4 eine abgewandelte Ausführungsform der Erfindung, deren transanales Segment über zwei konzentrische Schlauchlagen verfügt;
• 5 eine wiederum abgewandelte Ausführungsform der Erfindung, welche die Ausführungsform nach 4 mit dem in 3 wiedergegebenen, elastisch verformbaren, sich selbst auf- und ausrichtenden Rohrgeflecht kombiniert; sowie
• 6 die erfindungsgemäße Gesamtvorrichtung mit allen Komponenten.

Further features, properties, advantages, and effects based on the invention will become apparent from the following description of various embodiments of the invention and from the drawing. The drawing shows:

• 1 the simplest embodiment for the head unit of a device according to the invention;
• 1a an exemplary shaping of the balloon blank;
• 1b various preformations of the balloon envelope and the funnel element;
• 1c a two- or multi-component design of the funnel element;
• 2 another embodiment of the invention;
• 3 a combination of an anchor balloon with a trans-anal segment emerging from the anchor balloon envelope, as in 1 depicted, with which in 2 described stabilizing pipe section;
• 4 a modified embodiment of the invention, the transanal segment of which has two concentric layers of tubing;
• 5 a further modified embodiment of the invention, which is the embodiment according to 4 with the in 3 reproduced, elastically deformable, self-aligning and self-straightening tube mesh combined; as well as
• 6 the complete device according to the invention with all components.

The intrarectal anchor balloon 1 and the transanal intermediate segment 2 are manufactured from a single, common tube blank 8, with the transanal segment 2 of the formed balloon film 8 having only a single-layer wall. Although the intrarectal and transanal segments of the balloon film form a structural unit in the illustrated device variant, they exhibit a functional separation when assembled and fixed to/on the funnel.

Both segments of the foil 8 are separated or sealed from each other by the funnel element 3, which is inserted distally into the anchor balloon. The permanent connection between the anchor balloon envelope and the funnel element creates a fillable compartment 6, which unfolds around the lateral parts of the funnel like a cuff. The connection can be simplified or improved by specially designed preformations 7 of the funnel surface and/or the balloon foil, which are described in more detail below.

Proximally, the trans-anal segment is followed by a connection element 4 that closes off the head unit and forms the transition to the drainage tube 5.

The formed balloon blank 8 has a central spherical formation 9, which, in the assembled state, forms the shell of the intrarectal anchor balloon 1. The proximal extension 10 of the sphere has a cylindrical shape and, in the assembled product, corresponds to the trans-anal section 2 of the head unit. The oppositely directed extension forms the funnel-shaped compartment 11. At each end, portions of the tube blank 12 used in blow-molding are attached. The balloon blank can be used to produce the 1 The head unit shown, for example, can be placed in section plane 13.

The illustration further describes how the funnel compartment 11 of the balloon blank is inverted into the interior of the intra-rectal sphere 9 during assembly, and how, in a subsequent step, the funnel element 3 can be inserted into the inverted compartment 11.

The inner contour of the inverted chamber preferably corresponds precisely to the outer contour of the funnel element inserted into the intrarectal unit. The chamber 11 can be shaped or dimensioned to accommodate the funnel either almost completely or partially.

• Jene Anteile des intra-rektalen bzw. trans-analen Ballonsegmentes, die dem Trichterelement im endmontierten Zustand dauerhaft flächig anliegen, werden vorzugsweise geringgradig kleiner bemessen wie die entsprechenden, den Ballon aufnehmenden Strukturen des Trichters. So kann gewährleistet werden, dass sich die Ballonhülle im montierten Zustand allseitig unter leichter Dehnung faltungsfrei an den Trichter schmiegt. Trichterelement und Loge werden geometrisch bevorzugt so gestaltet, dass der Trichter beim Einsetzen in die Loge quasi in seiner Montageposition einrastet. Trichter und Loge können hierzu mit einer geeigneten Grundform wie z.B. die einer Olive, einer Sphäre oder einer Hantel versehen sein.

1b Figure 1 shows various preformations of the balloon envelope 8 and the funnel element 3, which each, or especially in combination, facilitate the convenient assembly, the torsion-free longitudinal axial alignment and permanent sealing connection of balloon foil and funnel:

• Those portions of the intrarectal or transanal balloon segment that lie permanently in contact with the funnel element in the fully assembled state are preferably slightly smaller than the corresponding structures of the funnel that receive the balloon. This ensures that the balloon sheath, when assembled, fits snugly against the funnel on all sides with slight stretching and without wrinkling. The funnel element and the socket are preferably designed geometrically such that the funnel essentially snaps into its mounting position when inserted into the socket. For this purpose, the funnel and socket can be provided with a suitable basic shape, such as an olive, a sphere, or a dumbbell.

To further facilitate the assembly of thin-walled balloon films, the surface of the funnel element can be provided with special ring-shaped protrusions 14 extending circularly around the funnel surface. These protrusions increase the contact tension with the balloon envelope in the contact area, thus acting as a seal. Such sealing or limiting structures are particularly advantageous when the balloon envelope, fully inflated, is placed on a shaft base, moved into the assembly position, and then unwound and aligned along its longitudinal axis. The targeted application of adhesive or solvent between the shaft and the balloon envelope in a defined area can also be improved in this way. For example, adhesive can be injected in a spatially limited area into a gap 15 located behind a protrusion 14, between the funnel 3 and the balloon envelope 16 adhering to the funnel, without spreading into the area beyond the ring-shaped protrusion.

To further facilitate the positioning, and especially the axial alignment and fixation, of the envelope, the convex protrusion 14 extending circumferentially around the funnel surface can be enhanced by a communicating concave preformation 17 of the adjacent balloon envelope. This provides an additional locking effect when positioning the foil on the funnel. The envelope is essentially guided in its path without... to leave the precise positioning on the base, or the elevation 14, comfortably unwound via the balloon's longitudinal axis and aligned via the longitudinal axis.

Furthermore, a gap 18 can be created in the apical contact area of the preformations of the funnel and the film, which accommodates a medium that permanently bonds the structures, e.g., adhesive. The controlled distribution of an adhesive medium between the balloon envelope and the funnel surface can be achieved accordingly by a groove 19 running apically on the annular protrusion 14. The bonding medium can be supplied and introduced from the funnel lumen via a channel-like preformation 20.

Circular convex preformations around the funnel's circumference are advantageous when the two structures are to be joined by welding, due to the locally achieved increase in the contact tension of the film on the substrate. A suitable thermal welding tool can then be positioned there and create a reliably wrinkle-free bond between the surfaces.

The funnel can, for example, consist of two parts that can be inserted into one another or connected in a similar manner. During assembly, the respective parts are preferably permanently attached separately to the distal and proximal ends of the balloon, for example by gluing. Once the funnel components are permanently attached to the balloon envelope, they are then unwound along the longitudinal axis of the balloon envelope and thus, axially aligned and without torsion of the balloon envelope, permanently sealed together.

The connection between the balloon envelope and the funnel components can also be made in such a way that the connection points are located in the area where the funnel components are joined.

For example, the distal end of the balloon with the funnel component 21 can be bonded to component 22 in the joining area 200. The compartment portion 11 of the balloon envelope is preferably bonded or permanently joined to the proximal edge of component 21. Both structures are then inserted together into a congruent receiving structure at the distal edge of component 22 and, after axial alignment, are also bonded there.

A similar multi-component design can be used to achieve the proximal sealing closure of the balloon sheath with the funnel element. This design is based on a separate ring-like element 23. The ring 23 can, for example, be slid from the proximal side over the transanal segment 2 to the proximal fixation position of the balloon sheath on the funnel (transition from the intrarectal balloon to the transanal segment), and optionally fixed there by adhesive bonding to the transanal segment. A snap-fit placement of the ring can be achieved by means of a preformation corresponding to the ring at the proximal end of the balloon sheath 1.

The ring 23 is then inserted, taking with it the distal end of the trans-anal segment fixed to it, into a correspondingly shaped ring-groove-like preformation 24 at the proximal end of the funnel element and fixed there, for example, by gluing.

The ring element 23 can have a slightly higher Shore hardness than the remaining funnel components in order to enable the two funnel components to be locked together under slight tension, with a slightly increased diameter compared to the receiving preformation.

The execution of the device in 2 instead of a proximally extended balloon end emerging from the anchor balloon, as in e.g. 1 This is shown via a separate, trans-anal, thin-walled tube or hose section that continuously connects the funnel to the pre-anal connector. This element consists of an elastic component with a high restoring force, which, despite its thin-walled design, automatically straightens or unwinds itself under radial deformation or torsion along its longitudinal axis, thus spontaneously returning to its stress-free, open-lumen initial state.

The figure shows an example of how the connection between the pipe or hose section 25 and the funnel element 3 can be designed by means of a pre-formed annular groove 24 at the proximal end of the funnel. The proximal end 26 of the balloon sheath 1 can be placed, slipped over, or otherwise guided over the distal end of the element 25 so that, by inserting the distal end of the trans-anal segment into the annular groove 24, it is permanently and sealingly connected to the funnel element 3.

3 shows a combination of an anchor balloon with a trans-anal segment emerging from the anchor balloon envelope, as in 1 depicted, with which in 2 The stabilizing tube section described. The trans-anal segment forms a separately fillable compartment located between the inner tube section 25 and the outer, proximally extended anchor ball. A balloon sheath is formed. When this compartment 28 is filled, the seal towards the anus can be improved by radial expansion of the outer sheath 27, depending on the sheath's volumetric extensibility or its diameter formed during manufacturing. With forced filling, the drainage lumen of the head unit can also be narrowed towards the center and almost completely closed. As an alternative to forming the sheath 27 from the proximal extension of the anchor balloon, the sheath 27 can also be used as a separately manufactured balloon or foil tube body. The sheath 27, which externally delimits the compartment 28, can also be preformed in a dumbbell or hourglass shape. The preferably central waist 29 is shaped in such a way that it accommodates the structures of the anal canal. When the trans-anal compartment 28 is pressurized, as is the case, for example, during the instillation of the irrigation fluid, the described preformation 29 ensures, on the one hand, a secure anchoring of the head part of the device, and on the other hand, it contributes to the seal against the rinsing fluid acting from the rectum.

The techniques described above can be used to fix and seal the components required for this embodiment in the transition area between the intra-rectal and trans-anal compartments.

Similarly, the foil tube segment 27, preferably emerging from the anchor balloon, can be combined with a radially deformable tubular mesh 30 that conforms to the transanal contours under slight tension. In its undeformed, low-tension initial state, the tubular mesh 30 has an open lumen of approximately 2-3 cm. The radially directed restoring force on the anus that develops when the lumen narrows is low and thus prevents the formation of pressure ulcers. If the anal sphincter muscle tone decreases during the defecation reflex, the tubular mesh follows the opening of the transanal canal, thereby facilitating stool passage. The tubular mesh preferably connects the intrarectal funnel to the pre-anal connector continuously. It is preferably located inside the tube segment but can alternatively extend over its outer surface. In the radially constricted state 30a, the mesh, preferably made of rigid, flexibly deformable filaments, exhibits a significant increase in length, which is taken into account by a corresponding length specification of the surrounding trans-anal foil tube 27.

The assembly of the individual components follows the techniques described above.

4 This represents an embodiment in which the trans-anal segment has two concentric tubing layers 27a and 27b. These can be manufactured, as previously described, from the extended ends of the intrarectal balloon. In the preferred embodiment, the inner tubing layer 27b is formed from the proximal extension of the intrarectal balloon sphere 9. The outer tubing layer 27a is preferably designed as a separate thin-walled, cylindrical, or pre-formed foil tubing element congruent with the anal canal.

Alternatively, the two layers can also consist of separately manufactured tubular films.

The space 28 formed between the two layers of tubing can be partially or completely filled with a medium from outside the body via a supply line 31 routed through the connector 4, or it can be completely evacuated. In the evacuated state, the two layers of tubing lie firmly against each other and behave almost like a single-layer wall. In the filled state, the two layers separate from each other, and the drainage lumen is maximally open.

When fully filled, the inner layer expands towards the center of the drainage lumen, sealing it tightly against fluid. The outer layer, on the other hand, expands towards the anal wall and conforms to its anatomy, also creating a tight seal.

When partially filled or filled with just a few milliliters of filling medium, the two layers separate. The two thin-walled films, supported by the filling medium, slide freely relative to each other. This free movement and sliding of the film layers helps to better prevent lesions in the particularly sensitive area of the anal canal, such as those caused by statically adherent, less dynamic films.

The connection of the partial components to the proximal funnel end can be effected on the basis of an annular support 23, which is inserted into an annular preformation 24 at the proximal funnel edge. The inner layer 27b can be configured as in 1c The outer layer 27a is guided over the ring and connected to the funnel. In a prior assembly step, the outer layer 27a can be glued to the ring at its distal end.

5 combines the previously described design with the one in 3 described elastically deformable, self-aligning and self-straightening pipe mesh 30. Alternative to the pipe mesh The hose or pipe element described above can be used.

The elements described above are preferably installed between the two foil layers 27a and 27b, connecting the funnel 3 with the connector 4.

The individual components of the device are described in more detail below, including their technical specifications. The complete device, with all described components, is presented in 6 depicted.

• Das den Kopfteil darstellende Ballonelement, aus dem der intra-rektale Ankerballon 1 und das transanale Segment 2 hervorgehen, wird vorzugsweise aus einem Polyurethan mit chemisch-physikalischen bzw. elastizitätsmechanisch vergleichbaren Charakteristika wie Pellethane 2363, der Härte Shore 80A bis 60D, der Fa. Dow Chemical Corporation, gefertigt.

Intrarectal anchor balloon and transanal segment:

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

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

Conditionally suitable balloon elements, fully or almost completely shaped to their later working dimensions, can also be manufactured using a dipping process, for example from latex, silicone or synthetic rubbers.

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

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

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

Funnel element:

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

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

The surface of the funnel can be provided with circular preformations (both convex and concave) to facilitate assembly with the balloon element. In the axial direction, longitudinal recesses in the form of grooves can be produced in the area of the inner surface or the funnel lumen to accommodate any supply lines 32 introduced proximally through the trans-anal segment (balloon filling or irrigation lumens). Likewise, special longitudinal notches can be arranged such that the funnel can be deformed into a slimmer configuration by moderate manual pressure during insertion into the anus and spontaneously returns to its original shape in the rectum due to its mechanical restoring force.

The funnel element is preferably shaped like an olive, a cone, or a torpedo. The maximum outer diameter should be between 4 and 5 cm, and the inner lumen receiving the stool should have an inner diameter of at least 3 cm. The length of the funnel should be between 3 and 5 cm.

Connector piece:

The connector piece 4 is equipped at its distal end with corresponding grooves, annular ridges and diameter steps for ease of assembly. The table is designed to accommodate the required trans-anal elements. At the proximal end, appropriate pre-formations can be formed to receive and connect the drainage tube leading to the bag. It should be made of a deformable, preferably self-righting material with properties essentially equivalent to those of the funnel element.

The connector can, via specific perforations or preformations, provide external access to a balloon inflation tube and a lumen for intrarectal irrigation. A supply line 33, directed towards the bag, can also be introduced via the connector for flushing the drainage tube.

Drainage or emptying hose:

The drain hose 5 should consist of a thin-walled, tear-resistant, and preferably non-stretchable or only slightly stretchable hose casing. It should have a diameter of approximately 2.5 to 3.5 cm and, when empty, spontaneously collapse into a flat band or deform into such a band with moderate force, allowing its contents to be easily squeezed out manually. Its length should be approximately 20 cm. A wall thickness of approximately 0.1 to 0.2 mm is particularly suitable for this purpose. The length of the draining hose can be approximately 1.30 to 1.60 meters.

A drain hose according to the invention, which collapses into a band-like structure with low force, can also be manufactured from welded film material of the aforementioned PUR material qualities. PVC or LDPE are also suitable, for example.

Unlike silicone, which has been the predominant base material until now, PUR materials do not prevent odors from passing through. PUR also has a very smooth surface, which improves its hygienic properties during prolonged wear in the patient.

Cleaning clip:

For emptying or cleaning the drainage tube x, the device can be equipped with a clamp-like, freely movable squeezing device 34 for stool along the entire length of the drainage tube.

The spreading device preferably takes the form of a clamp that surrounds the drainage tube as a partially closed, ring-like structure. It allows for different opening states of the drainage lumen to be set. When the tube 5 is moved to position A within the clamp, the drainage lumen is fully open. When the tube is in position B, its lumen is narrowed by the jaws x of the clamp in such a way that the tube spreads out between them into a flat band with no residual lumen. Any stool inside the tube can be manually moved towards the chisel in this clamp position.

The clip can also be used to seal the drainage lumen tightly, as shown in position C, and thus serve as a temporary seal during bag changes.

Bag with connector:

The stool collection bag 35 is designed for a volume of approximately 1 to 2 liters. It is preferably connected to the drainage tube via a connector element 36 with a screw thread. The tube connector may have a conical push-fit connection 37, which is inserted into a corresponding opening of the bag-side connector 38, which may have an external thread. A cap nut 39 secures the connector 36 to the bag 35 in a liquid-tight manner. After changing the bag, the filled bag can be tightly sealed with a cap 40 attached to the bag.

Inlet device:

The administration of irrigation fluid can, for example, be gravity-driven. In this case, the therapist raises a defined volume of irrigation solution to a suitably high level above the patient. The flow occurs spontaneously.

A cuff-like device, such as those used for pressure-driven rapid intravascular infusion, can also be used as the driving force for the enema. A bag-like container filled with enema solution is inserted into the open center of a compressed air cuff and, as the pressure in the cuff increases, is essentially expelled towards the patient. The required pressure is usually generated with a hand pump. Besides a gaseous medium for pressure build-up in the cuff, liquid media such as tap water are also conceivable.

A vacuum drive using a water jet pump is also conceivable. The bag containing the rinsing solution is installed inside a completely surrounding bag, which is then subjected to a vacuum, for example, created by a water jet pump. The tap can be generated by using a water jet pump.

Application of the device in intermittent trans-anal irrigation: In addition to the continuous drainage of stool from the rectum of a patient, the application of the head unit described in the invention, consisting of an intra-rectal anchor balloon and a trans-anal segment, is also conceivable for intermittent use in incontinent or only partially cooperative patients.

Well-known enema devices, such as the Peristeen Anal system from Coloplast, Denmark, feature rectally sealing balloon components that sit on a catheter shaft and are elastically expanded to their working size. While the relatively small lumen of the enema catheter allows for the rapid infusion of irrigation fluid, it generally does not permit the free outflow of fluid containing stool particles. Therefore, the catheter usually has to be removed once peristalsis begins, and the enema then empties naturally.

However, an enema application would be desirable in which emptying could be easily accomplished via the rectally placed catheter. This would be advantageous, for example, for bedridden patients who could be comfortably and hygienically enemad while lying in bed and transitioned to a continent phase. The transanal drainage lumen described in the invention, with its diameter of up to 3 cm, allows the free passage of even solid stool.

The in the All of the described versions of the drainage device's head units are suitable for use in this context. Instead of the drainage hose 5, a bag-like collection container can be connected directly to the connector 4, or via a short hose extension.

Due to the large drainage lumen, swivel enemas are also conceivable, in which the rinsing volume oscillates between the bag and the patient.

Alternatively, for self-treating patients who defecate while sitting on the toilet, a short, nozzle-like tube or foil tube can be connected.

Although the two ends of the inverted hose section can run approximately coaxially into each other and may be connected by a sleeve (each); however, this is not the case in a preferred embodiment of the invention.

Claims (1)

Device for the continuous drainage of stool from a patient's rectum into an external, bag-like collection vessel and/or for the application of a rectal enema and/or for performing colorectal irrigation and/or for closing the rectum, comprising an inflatable balloon with a torus-shaped structure formed from a flat, inverted tube section (8), wherein the outer layer of the inverted tube section has a radially expanded area (intrarectal balloon section 1) for insertion into the rectum, and proximal thereto a correspondingly tapered area (transanal balloon section 2) for remaining within the anal canal, characterized in that both balloon sections (1; 2) each form separate compartments which are to be filled separately from the other compartment.