DE102008055673A1 - Device for continuous drainage of stool from rectum of patient in external, marsupial collecting container or for sealing rectum, comprises inflated balloon with annular structure which is formed from flat and upended hose section - Google Patents

Abstract

The device comprises an inflated balloon with an annular structure which is formed from a flat and upended hose section. The external coating of the upended hose section has a radially enlarged area of an intrarectal balloon section (1) for inserting in the rectum. A narrow area of transanal balloon section (2) is partially provided outside the rectum. The intrarectal balloon section is not connected with the transanal balloon section.

Description

The Invention is directed to a device for continuous Drainage of stool from the rectum of a patient into an external, bag-like collecting vessel and / or for closing of the rectum, comprising an inflatable balloon with an approximately ring-shaped structure, formed from a flat, in turned inside tube section, wherein the outer Position of the everted tube section a radial extended area (intrarectal balloon section) for insertion in the rectum and a rejuvenated on the other hand Area (transanal balloon section), which during the use at least partially outside the rectum remains.

devices for continuous drainage of stool from the rectum of a patient in an external, bag-like receptacle known for some years, but so far in clinical practice only a little established.

to Discharge or to catch the chair will be immobile, not Cooperative patients preferably called fecal collectors used. These represent bag-like structures, which in the Anal creases are glued directly over the anal opening. Although the pre-anal bonding is usually over shorter application intervals sufficiently adhesive and sealing, because of the persistent moist and chemically aggressive environment in the Bonding area, however, are often macerations of to observe exposed skin.

alternative are called intestinal tubes in use, which are over the anal canal be introduced into the rectum. Because of the accompanying intra-rectal injury risk and permanent dilatation and thus possible damage to the sphincter intestinal tubes are usually used only passager for stool removal.

systems for largely atraumatic, long-term applicable chair discharge (indwelling fecal drainage), as recently described by the Fa. Zassi Medical Evolutions Inc., Florida, USA and ConvaTec, New Jersey, USA, are conceptual in their construction Bladder catheters for the continuous drainage of urine. about a balloon-carrying catheter element is derived from the urine from the bladder and flows via a connected drainage tube in a collection bag. The balloon element is used predominantly anchoring the catheter in the bladder. Furthermore it ensures a certain sealing function that prevents that urine passes the catheter shaft through the urethra flows. The well-known chair drainage feature analogous to an anchoring and laxative balloon-bearing headboard, as well as a subsequent Hose element which opens into a collecting container.

modern Chair drainage systems, like those mentioned above, ensure over the pure drainage performance, the active leadership of the Stool excretion of the patient in terms of chair management (fecal management) by the therapist.

The Concept of chair management includes the option of a large-volume, anal applied colo-rectal irrigation. Large volume Intestions into the colon have been around for decades of patients with surgically applied colon exit to active Management of elimination applied. The incoming into the colon Rinse liquid mobilizes the colon contents and wash it out of the colon.

In corresponding way can with immobile, non-cooperative Langliegern through a large-volume trans-anal enema intestinal contents mobilized and drained. The defecation is so from the Therapists controlled and guided. With appropriate Application can be a chair-free, quasi-continental interval of one to two days are produced.

The problem is currently available chair drainage systems in several ways:
If the drainage is intended to last up to four weeks, pressure-related injuries in the area of the terminal rectum (ulcers) and in the area of the anus (fissures) can not be ruled out. Pressure ulcers are usually the result of bulging balloon body anchoring the device in the rectum, which permanently rest on the rectal structures and restrict their perfusion. The known systems have balloons, which are only partially formed in the unfilled state, and are expanded by exposure to about 100 mbar to their working size, so as to ensure their anchor function. On the other hand, anal fissures result in the majority from the continual friction caused by the generally collapsed, convoluted trans-anal drainage portion of the device in the anus.

Of Furthermore, the known systems offer especially for low-viscosity Chair or in a large-volume enema into the colon no really sufficient sealing performance, giving a permanent fitting entails and requires the close-meshed cleaning of the anal folds.

Previous systems tend to slip out of the rectum of the patient as they pull on the catheter. The so-called "slippage" is partly a consequence of the strain and deformation properties the currently used materials, primarily silicone. The high compliance of silicone does not allow sufficient dimensional stability of the balloon and leads to a stronger axial train at the drainage to a teardrop-shaped deformation and rejuvenation of the balloon anchor until it is deformed so far that it dislocates through the opening to be sealed to the outside.

conventional Silicone balloons do not have one sufficiently large balloon diameter around on the rectal floor lying open and so the best possible anchor effect against to reach the anal opening.

Around as gentle as possible permanent catheterization of the particularly sensitive trans-anal section, becomes the corresponding segment in conventional systems the drainage as thin as possible, in order to be as soft and tissue-friendly as possible to appear. With such a thin-walled design of the trans-anal segment is usually accompanied by the inclination to Torison or twisting, whereby the Stuhlabfluß crucial obstructed or becomes impossible.

silicones are also not "odorless" and tend to fecal smell after a few days of laying to the patient environment. Silokonoberflächen are also usually uneven and lead because of the crater-like Surface therefore for fast cleaning-resistant contamination. Silicone surfaces are for long-term chair drainage under hygienic aspects only limited suitable.

So far available silicone systems also had a relative complex build up, and are made up of a variety of components, glued in costly manual work.

The The present invention is intended for the known problems in the use of conventional systems for continuous chair drainage Introduce solutions.

This succeeds in that the intrarectal balloon section in no functional or spatial connection with the transanal Balloon section stands.

silicone as previously used in clinical application base material is favored by materials with low volumetric compliance such as As polyurethane (PUR) replaced. The option given by PUR for complete and structurally detailed shaping thin-walled balloon body in the blow-molding process In addition to superior functionality regarding Anchor function and seal, the cost-effective production and allow mounting of the drainage device. The number of components, to lie for the construction of in or near the patient coming head unit of the device is required is reduced become. Assembly and permanent connection of the components should be through extensive plug-in and Rastung the individual elements simplified and to be economized. The described mounting options go on the special mechanical membrane-like properties extremely thin-walled balloon foils. Furthermore, it represents the invention functionally particularly advantageous individual components or segmental designs which, in view of long-term tissue compatibility, Anchoring efficiency, continuous sealing performance and sealing at low-viscosity chair or applied großvolumigem Enema offer an advantage over the prior art.

in the Unlike conventional, silicone-based systems used the invention preferably polyurethane (PUR) as the base material or a material with similar technical elasticity and strength properties.

Similar to in PCT / EP2005 / 007950 , the intra-rectal and the trans-anal drainage part is preferably made of PUR. Both drainage parts are here made from a single continuous, completely recessed in balloon element. The distally directed end of the formed balloon preform is slipped through the lumen of the intra-rectal balloon segment and continued in the lumen of the proximal balloon end to the end thereof. Both balloon ends are fixed parallel to each other, at approximately the same height, on a connector element located in front of the anus. The intra-rectal anchor balloon also has, in the retracted, assembled state, a lobe-like preform for receiving a separately produced funnel element. The trans-anal part is in PCT / EP2005 / 007950 composed of two concentric foil layers. The concentric tubular films are permanently structurally connected to each other by selective connections. The compartment thus defined between the layers communicates freely with the lumen of the intra-rectal anchor balloon. Both rooms are filled via a single supply line.

In contrast to PCT / EP2005 / 007950 In the present invention, the intra-rectal balloon portion is not in functional and spatial association with the trans-anal segment.

Although in the present invention, the trans-anal segment also emerge wholly or partly from the proximally or distally directed sequels of the intra-rectal anchor balloon, both segments, the intra-rectal and trans-anal, but are structurally and functionally separated.

The The invention describes in some embodiments a trans-anal compartment which can be charged with a filling medium on the basis of concentric hose elements. This is however from the separated intra-rectal balloon. Both compartments are separated filled and provide functionally independent Units represent.

The Separation of the two segments is preferred in the invention by a permanent, sealing closure of the shell of the intra-rectal balloon segment on or with the funnel element. However, it may be in the area of the proximal end of the intra-rectal Balloons also by direct connection of the balloon envelope with the surface of portions of the trans-anal segment getting produced.

The Invention also describes the trans-anal portion the device is designed as not exclusively two-ply, but also goes into one-layered variants of this segment.

When Embodiments are also embodiments of Trans-anal segment described in addition to a one- or two-layered tube layer, have an additional functional element which primarily the axial torsion or the torsion-related closure to counteract this section.

While in PCT / EP2005 / 007950 a passer-by closure of the drainage lumen can be made by a deployment balloon deployed in the intra-rectal funnel, such a closure in the present invention is enabled in the area of the trans-anal drainage portion. In this case, not only the drainage lumen is closed, but also simultaneously sealed against the anal canal through the additionally radially expanding segment during filling.

This in PCT / EP2005 / 007950 also presented completely resp. optionally also residual-sized intra-rectal balloon segment is also found in the invention. In the present invention, in practical use, it is preferably filled with a defined volume which is deliberately chosen to be smaller, such as the volume of the freely deployed (filled but pressureless) fully formed balloon. The intra-rectal balloon segment is thus the rectal floor as a flaccid, only partially filled balloon body. He clings to the respective morphology under the complete folding of his envelope dynamically. It can thus be permanently, with the least possible force acting on the rectal tissue or less likely to cause tissue damage, the individual space completely filling, placed. The filling pressure, which is required to achieve a sufficient anchor function of the drainage in the rectum, ideally can not be more than the physiological pressure prevailing there.

While in the prior art, such a reduction of the filling pressure at the same time the unfolding characteristics and thus drainage properties of the trans-anal segment, this is in the present Invention not the case. Both compartments can be used in their power development on the tissue applied to them separated be regulated.

acts an axially or proximally directed tensile force on such fully formed, partially filled balloon, independent whether this is residual over the assumed rectal dimensions is preformed or in the unfolded state a Dimension that is smaller than the one to be filled rectal space, evolves after the "force equals Counterforce principle, a balloon inflation pressure, the exact one Corresponds to force acting from proximal to the anchor balloon. Leaves the traction after, the Ankerballon returns to his low initial pressure back. The initially introduced Fill volume can be, for example, 70-80% of lie at the freely unfolded preformed volume.

at Do not use or only slightly volume-expandable materials such as z. PUR specification Pellethane 2363 80A, Dow Chemical Corp., is ensures that the anchor balloon under applied pulling action and thus resulting increase in filling pressure its assumes assumed geometry and dimension in the manufacture, these, however, because of its material-related limited deformability (Compliance) can not be deformed as far as the balloon after distally dripping out and finally slips through the anal opening, as with high-volumendehnbaren materials, such as As silicone or latex would be expected and in the daily use is also observed.

The trans-anal segment in the invention preferably consists of However, extended ends of the intra-rectal balloon may also from separately manufactured hose elements or from a separate manufactured hose element are manufactured.

In order to stabilize the trans-anal segment, it is additionally possible to install a tubular element which preferably preferably continuously connects the funnel element to the connecting element. To avoid the lumen-constricting torsion of the trans-ana len segmentes this is preferably carried out as elastically self-righting hose element or as a radially deformable, the anal canal with moderate tension anschmiegendes, and self-opening pipe braid.

has the trans-anal segment via a double-walled design, may be that between funnel and connector element performing Chamber via an appropriate supply line from outside the Patients either evacuated or with a filling medium, preferably air, to be filled.

Becomes evacuated the space between the two concentric tube layers, come to lie close together and stand, from each other inseparable, as a single layer. The central drainage lumen is then open maximum.

Becomes the space between the concentric tube layers filled, separate the two layers in the way that the inner layer unfolds into the drainage lumen and sealingly seals it. The outer layer, however, expands radially towards the wall of the anal canal and leads to its Poetry.

The Filling and unfolding of the trans-anal segment in the described manner is particularly advantageous for the high colo-rectal irrigation, which aims to the greatest extent possible to allow large flush volumes to enter the intestine and thereby escape the rinse solution by the drainage lumen or through the anus, past the trans-anal drainage segment, to avoid.

After all The invention addresses the particular problem of mounting very thin-walled balloon foils one. It provides appropriate, advantageous in the production process suitable assembly techniques.

Further Features, characteristics, benefits and effects on the basis of Invention will become apparent from the following description of various embodiments the invention and with reference to the drawing. Hereby shows:

1 the simplest embodiment variant for the head unit of a device according to the invention;

1a an exemplary shape of the balloon blank;

1b various preformations of the balloon envelope and the funnel element;

1c a two- or multi-component version of the funnel element;

2 another embodiment of the invention;

3 a combination of anchor balloon with a trans-anal segment resulting from the anchor balloon envelope, as in 1 shown with the in 2 described stabilizing pipe section;

4 a modified embodiment of the invention, the trans-anal segment has two concentric layers of tubing;

5 a modified embodiment of the invention, which the embodiment according to 4 with the in 3 reproduced, elastically deformable, self-up and aligning pipe braid combined; such as

6 the overall device according to the invention with all components.

Intra-rectal anchor balloon 1 and trans-analic intermediate segment 2 are made from a single common hose blank 8th made, with the trans-anal segment 2 the formed balloon foil 8th only has a single-layered wall. Although the intra-rectal and trans-alan segments of the balloon foil form a structural unit in the illustrated device variant, they have a functional separation in the assembled and fixed state on the funnel.

Both segments of the film 8th are formed by the funnel element inserted distally into the anchor balloon 3 separated from each other or sealingly separated. The permanent connection between the anchor ballon shell and the funnel element creates a refillable compartment 6 , which unfolds in the manner of a cuff around the lateral parts of the funnel. The compound may be formed by specially designed and hereinafter described preformations 7 Funnel surface and / or the balloon foil can be simplified or improved.

The trans-anal segment is closed to the proximal end, a connecting element terminating the head unit 4 indicating the transition to the drainage tube 5 forms.

The molded balloon blank 8th has a median spherical formation 9 in the assembled state as a shell of the intra-rectal anchor balloon 1 represents. The proximal extension 10 the sphere has a cylindrical shape and corresponds to the trans-anal section in the assembled product 2 the head unit. The oppositely directed extension forms the funnel box 11 , In each case, parts of the tube blank used in blow molding close at the ends 12 at. The balloon blank may be used to make the in 1 shown head unit, for example, in the cutting planes 13 be dropped off; be discontinued; be deducted; be dismissed.

The figure also describes how the funnel box 11 of the balloon blank during assembly into the interior of the intra-rectal sphere 9 inverted, and as in a subsequent step, the funnel element 3 in the inverted box 11 can be inserted.

The inner contour of the inverted box preferably corresponds exactly to the outer contour of the funnel element inserted into the intra-rectal unit. The box 11 can be shaped or dimensioned for a nearly completely comprehensive, as well as partial uptake of the funnel.

1b shows different preformations of the balloon envelope 8th and the funnel element 3 which, in each case 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 intra-rectal or trans-anal balloon segment, which abut the funnel element in the final assembled state permanently flat, are preferably sized slightly smaller than the corresponding, the balloon receiving structures of the funnel. Thus, it can be ensured that the balloon envelope nestles in the assembled state on all sides with slight stretching wrinkle-free to the funnel. Funnel element and box are geometrically preferably designed so that the funnel when inserted into the box virtually engages in its mounting position. Funnel and box can do this with a suitable basic form such. B. be provided an olive, a sphere or a dumbbell.

To further facilitate the installation of thin-walled balloon foils, the surface of the funnel element may be provided with special circular elevations running around the funnel surface 14 be provided that increase their contact voltage in the contact area with the balloon envelope and thus act quasi-sealing. Such sealing or limiting structures are particularly advantageous when the balloon envelope is applied in the tightly filled state on a shaft base, there moved in the mounting position, and is entwined over the longitudinal axis away and aligned. The targeted introduction of adhesive or solvent between the shaft and balloon envelope in a defined area can be improved. For example, so in one, behind a survey 14 located gap 15 , between funnels 3 and on the funnel adjacent balloon envelope 16 , Spatially limited adhesives are injected without going into the area beyond the annular elevation.

In order to facilitate the positioning and especially axial alignment and fixation of the shell even further, the circularly extending around the circumference of the funnel surface convex elevation 14 through a communicating concave preformation 17 the applied balloon envelope can be improved. It is thus possible a further detent effect in the positioning of the film on the hopper. The shell is virtually splinted in its course, without the precise positioning on the base, or the survey 14 , leave, comfortably unwound over the balloon longitudinal axis and aligned over the longitudinal axis.

It may also have a gap in the apical contact area of the funnels and foil preformations 18 be prepared, a permanently connecting the structures permanently medium, for. B. adhesive, absorbs. The controlled distribution of an adhesive medium between the balloon envelope and the funnel surface may be performed in a similar manner by an apical on the annular protrusion 14 running groove 19 respectively. The bonding medium can be via a channel-like preformation 20 be fed from the funnel lumen and introduced.

circularly around the funnel circumference, convex preformations are due to the so locally achieved increase in the support voltage the film on the pad, beneficial if the two structures should be connected by welding together. A corresponding thermal welding tool can there put on and a reliable convolution-free connection produce the surfaces.

Of the For example, funnel can be made of two pluggable or correspondingly connectable parts. During installation the respective parts are preferably separate with the distal or proximal balloon end permanently, z. B. connected by gluing. Are the funnel components with the balloon envelope permanent These are then connected via the Weaved longitudinal axis of the balloon envelope, and so, axially aligned, without torsion of the balloon envelope, permanently sealing together.

The Connection of balloon envelope and funnel components can also be carried out in such a way that the connection points in the Addition of the funnel components come to rest.

For example, the distal balloon end may be connected to the funnel component 21 in the mating area 200 with the component 22 be glued. The share of lodges 11 The balloon envelope is preferably at the proximal edge of the component 21 glued or permanently attached. Both structures then become common in a congruent receiving structure at the distal edge of the component 22 used and there, after axial alignment, also glued.

In a similar multi-component construction, the proximal sealing closure of the balloon envelope with the funnel element can be achieved. It is based on a separate ring-like element 23 , The ring 23 may be, for example, from the proximal side via the trans-anal segment 2 pushed to the proximal fixation position of the balloon envelope on the funnel (transition from the intra-rectal balloon to the trans-anal segment), where they are optionally fixed by gluing on the on the transanal segment. There may be a latching placement of the ring through a preform corresponding to the ring at the proximal end of the balloon envelope 1 be achieved.

The ring 23 is then, taking along the fixed to him distal end of the trans-anal segment in a correspondingly shaped ringnutartige preformation 24 inserted at the proximal end of the funnel element and fixed there, for example by gluing.

The ring element 23 may have a slightly higher Shore hardness than the remaining funnel components, so as to allow, with slightly increased diameter compared to the receiving preformation, a latching of the two funnel components under slight tension.

The execution of the device in 2 has instead of a resulting from the Ankall balloon, proximally extended balloon end, such. In 1 represented by a separate, trans-anal running thin-walled tube or hose piece, which connects the funnel with the preneural connector throughout. This is a, of an elastic, with high restoring force acting element, which, despite its thin-walled design with radial deformation or torsion on the longitudinal axis independently erects or unwinds and so spontaneously, in its low-tension lumen-open initial state returns.

The figure shows an example of how the connection between the pipe or hose piece 25 and the funnel element 3 through a preformed annular groove 24 can be designed at the proximal funnel end. The proximal end 26 the balloon cover 1 can do this over the distal end of the element 25 placed, slipped or otherwise guided, that this by inserting the distal end of the trans-anal segment in the annular groove 24 permanently sealing with the funnel element 3 get connected.

3 shows a combination of anchor balloon with a trans-anal segment resulting from the anchor balloon envelope, as in FIG 1 shown with the in 2 described stabilizing pipe section. The trans-anal segment forms a separately fillable compartment, which is located between the inner tube section 25 and the outer proximal extended anchor balloon envelope is formed. When filling this compartment 28 can, depending on the volumetric extensibility of the shell or its formed during the production diameter by radial expansion of the outer shell 27 the seal to the anus to be improved. In forced filling, moreover, the drainage lumen of the head unit can be narrowed toward the center and approximately closed. Alternatively to the shape of the shell 27 from the proximal branch of the Ankerballons, the shell can 27 come as a separately manufactured balloon or tubular film body used. The the compartment 28 outwardly limiting envelope 27 may also be preformed dumbbell- or hourglass-shaped. The preferred central waist 29 is formed such that it receives the structures of the anal canal. Becomes the trans-anal compartment 28 pressurized, as z. B. takes place during the instillation of the irrigation fluid, ensures the Präformation described 29 on the one hand, a secure anchoring of the head part of the device, on the other hand, it contributes to the seal against the rectally from her charging rinse liquid.

to Fixation and sealing completion of the for this embodiment required components in the transition area between intra-rectal and trans-anal compartment, the previously described techniques.

Analogously, the preferably resulting from the Ankall balloon film tube segment 27 with a radially deformable, the transanal contours under slight tension clinging tube 30 be combined. The pipe mesh 30 has an open lumen of about 2-3 cm in the undeformed, low-tension initial state. The radially directed restoring force on the anus that develops during lumen narrowing is small and precludes the development of pressure ulcers. If the defecation reflex leads to a tonus reduction of the anal sphincter, the canula follows the opening of the trans-anal canal, thus facilitating the outflow of the stool. The braid preferably connects the intra-rectal funnel to the pre-anal connector throughout. It is preferably arranged in the interior of the hose segment, but may alternatively extend over the outer surface thereof. In the radially narrowed Status 30a has the braid, preferably constructed of rigid, bendable deformable filaments a significant increase in length, by a corresponding length specification of the surrounding trans-anal foil tube 27 is taken into account.

The Assembly of the proportional components follows the previously described Techniques.

4 represents an embodiment whose trans-anal segment over two concentric layers of tubing 27a and 27b features. These may be fabricated from the elongated ends of the intra-rectal balloon as previously described. In the preferred embodiment, the inner tube layer goes 27b from the proximal extension of the intra-rectal balloon sphere 9 out. The outer tube layer 27a is preferably designed as a separate thin-walled, cylindrical or even the anal canal congruently preformed molded tubular film element.

alternative Both layers can also be made separately Tubular films exist.

The space created between the two tube layers 28 can over one over the connector 4 guided supply line 31 be extra-corporal with a medium partially or completely filled or completely evacuated. In the evacuated state, the two tube layers are firmly against each other and behave more or less like a single-layered wall. When filled, the two layers separate from each other, the drainage lumen is maximally open.

in the bulging state, the inner layer expands to Center of the drainage lumen out and closes this liquid-tight. The outer situation, on the other hand expands towards the anal wall and hugs it, following the respective anatomy, also sealing against them at.

at partial filling or filling with few Milliliters of filling medium separate the two layers. The Slide both thin-walled films through the filling medium virtually stored, freely displaceable to each other. Through the free game and sliding the film layers can be particularly sensitive Area of the anal canal lesions, as by static fitting, little dynamic films are known, better avoided become.

The connection of the proportionate components to the proximal funnel end may be based on an annular support 23 made into an annular preform 24 at the proximal funnel edge. The inner situation 27b can do it like in 1c be guided over the ring and connected to the funnel. The outer situation 27a can be glued to the ring at its distal end in a previous assembly step.

5 combines the previously described embodiment with the in 3 described elastically deformable, self-up and aligning pipe braid 30 , As an alternative to the pipe mesh, the hose or pipe element described above can be used.

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

In the following, the individual components of the device are described in detail in their technical execution. The overall device with all described proportional components is in 6 shown.

Intra-rectal anchor balloon and trans-anal Segment:

The head part representing balloon element from which the intra-rectal Ankall balloon 1 and the transanal segment 2 is preferably made of a polyurethane with chemically-physical or elasticmechanisch comparable characteristics such as Pellethane 2363 hardness Shore 80A to 60D, the company Dow Chemical Corporation, manufactured.

The the head part forming balloon element is preferably in the blow-molding Process produced. Besides PUR are also suitable with this technique Soft films also PVC and LDPE can be produced.

conditioned suitable, full or almost complete on her later Arbeitsmaß shaped balloon elements, can also in the dipping process, for example made of latex, silicone or synthetic rubbers getting produced.

Conceivable is also the production of one or more layers of film said materials that are too spherical together Structures glued or welded.

The Wall thickness of the intra-rectal balloon envelope should be ranging from 10 to 40 microns. The maximum transverse Diameter of the intra- rectal segment with free, unpressurized Unfolding to the preformed measure should be at about 6-9 cm are. The axial length of the intra-rectal Balloon body is preferably 4-6 cm.

If the trans-anal segment is made of separate parts, the required thin-walled tubular film layers are also preferred Glass shaping made according to thin-walled cylindrical balloon or hose body. A film welding or gluing process as described above may also be used. The materials used are preferably identical to those used to make the intra-rectal anchor balloon. If an elastically resetting hose or pipe element integrated, this can also be made of dipped or sprayed cylindrical elements. PUR hardness 70A to 90A provides the required self-righting elasticity. Less suitable are made of silicone elements.

Funnel element:

The Funnel element is preferably made of a material, which is identical to the balloon envelope or one has identical Shore hardness. It is preferably in Injection molding produced, alternatively, a dipping method is conceivable.

The Material should have reliable elastic rebuilding properties show after passing mechanical deformation, and possible appear soft and body friendly. He should continue glued with common solvents or adhesives can be. The required mechanical and chemical Properties are z. B. of polyurethanes of Shore hardness 70 to 90 guaranteed. By way of example, materials with physicochemical properties like Pellethane's family 2363 can be used.

The surface of the funnel may be provided with circular preformations on its surface (both convex and concave) for ease of assembly with the balloon member. In the axial direction can be made in the form of grooves in the region of the inner surface and the funnel lumen longitudinal recesses, the eventual from proximal, brought up by the trans-anal segment supply lines 32 take up (balloon filling or Spüllumina). Also, particular longitudinal notches may be arranged such that upon insertion into the anus, the funnel may be deformed to a slimmer configuration by moderate manual pressure, and spontaneously rearranged to its original shape in the rectum, due to its mechanical restoring force.

The Funnel element is preferred as an olive, suppository or formed torpedo-like. The maximum outside diameter should be between 4 and 5 cm, the inner lumen receiving the stool do not fall short of an inner diameter of 3 cm. The length of the funnel should be in the range of 3 to 5 cm.

Connector piece:

The connector piece 4 is designed at its distal end by corresponding grooves, annular beads and diameter gradations for the montagekompfortable recording of the required respective trans-anal elements. At the proximal end, corresponding preformations for receiving and connecting with the draining drainage tube to the bag can be formed. It should be made of a deformable, as self-erecting material as possible, with properties substantially corresponding to the funnel element.

The connector can divert a balloon filling tube and a lumen for intra-rectal irrigation to the outside via specific perforations or preformations. Likewise, a lead directed to the bag 33 to flush the drainage tube over the connector.

Drainage or drain hose:

The drain hose 5 should consist of a thin-walled, tear-resistant and preferably not or only slightly stretchable hose sleeve. It should have a diameter of about 2.5 to 3.5 cm and in the unfilled state spontaneously collapse into a flat band or deformed with moderate force to such a band and as such its contents can be easily spread out manually. Its length should be about 20 cm. A wall thickness of about 0.1 to 0.2 mm is particularly suitable for this purpose. The length of the emptying or draining tube can be about 1.30 to 1.60.

One according to the invention, with little force to a band-like structure collapsing drain tube can also made of welded sheet material of the aforementioned PUR Material qualities are produced. Also come For example, PVC or LDPE in question.

PURE Prevent materials, in contrast to previously predominantly used Base material silicone, furthermore no permeability for Odors. PUR also has a very smooth surface on what the hygienic properties in prolonged situation in the Improved patients.

Cleaning clip:

For emptying or cleaning the drainage tube x, the device can be a clasp-like, over the entire length of the drainage tube freely displaceable spreading device 34 be attached for chair.

The streamer preferably corresponds in shape to a clip which surrounds the drainage tube as an annular structure closed in a preferred manner. It allows to set different opening conditions of the drainage lumen. Will the hose 5 moved to position A within the clasp, the drainage lumen is fully open. If the tube is in position B, its lumen is so narrowed by the jaws x of the clip that the tube passes between them to a flat band with no residual lumen. Any chair inside the hose can be moved manually to the chisel in this clip position.

The Clasp can also for liquid-tight closure be provided of the drainage lumen, as shown in position C, and serve as a passer-by closure when changing bags.

Pouch with connector:

The collection bag 35 for chair is designed for about 1 to 2 liters volume. It is preferably via a screw-threaded connector element 36 connected to the drainage tube. The connector of the hose can via a conical plug connection 37 which is in a corresponding opening of the bag-side connector 38 inserted, which may be provided with an external thread. Through a union nut 39 can the connector 36 so liquid-tight with the bag 35 be secured. The filled bag may be closed by a cap attached to the bag 40 be sealed tight after changing the bag.

Inlet device:

Of the Inlet of rinsing liquid can, for example Gravity-driven done. In this case, the therapist brings a defined volume of rinse solution on a suitable high level above the patient. The feed takes place spontaneous.

When The driving force for the inlet is also a cuff-like Device conceivable, as for example for the pressure-driven, fast intravascular infusion is used. A bag-like Container with rinse solution is doing in the open central of a pressurizable cuff plugged in and from there, with increasing filling pressure in the cuff quasi expressed or to the patient emptied. The required pressure is usually generated with a hand pump. In addition to a gaseous medium to build up pressure in the cuff are also liquid media, such as. B. tap water conceivable.

Conceivable is also a vacuum drive using a water jet pump. The the Rinsing solution receiving bag is doing in a installed this bag surrounding all sides, which exposed to a vacuum which, for example, at the faucet by using a Water jet pump can be generated.

Application of the device in intermittent trans-anal Irrigation:

Next the continuous drainage of stool from the rectum of a patient is the application of the head unit described in the invention, consisting of intra-rectal anchor balloon and trans-anal segment also for intermittent use with incontinent or only partially cooperative patients conceivable.

Known Enema devices, such. B. the system Peristeen Anal the Fa. Coloplast, Denmark, have rectally-sealing balloon components sitting on a catheter shaft and stretched elastically to their working size become. Although the relatively small lumen of the inlet catheter allows the rapid inflow of rinsing liquid, As a rule, however, it does not allow the free outlet of stool particles loaded rinsing liquid. The catheter must therefore usually drawn at the onset of peristalsis, the enema then empties via naturalis.

Desirable however, would be an enema application in which the emptying easily done via the rectally placed catheter can. This would be advantageous, for example, in bedridden patients, lying in bed flushed comfortably and hygienically and be transformed into a continent phase can. The trans-anal drainage lumen described in the invention, with a diameter of up to 3 cm, allows free passage also firm stool mass.

The in the 1 to 5 described embodiments of the head units of the drainage device are all suitable for use in this context in question. Instead of the drainage tube 5 can directly, or via a short hose adapter, to the connector 4 a bag-like receptacle are connected.

conditioned through the large drainage lumen are also swivel enemas conceivable in which the rinsing volume between bag and Patient commutes, so to speak.

Alternatively, in self-medicated patients, sitting on the toilet can dissipate, a short, spout-like hose or film tube connected.

Though can the two ends of the inverted Hose section approximately coaxially into each other and possibly be associated with (each) a sleeve; at a preferred However, this is not the embodiment of the invention case

1

intrarectal balloon portion

2

transanal balloon portion

3

funnel member

4

Konnektionselement

5

drain hose

6

compartment

7

preformations

8th

balloon sheet

9

spherical formation

10

proximal extension

11

Trichterloge

12

hose blank

13

cutting plane

14

annular survey

15

gap

16

balloon envelope

17

concave preformation

18

gap

19

groove

20

channel-like preformation

21

funnel component

22

component

23

ring-like element

24

annular groove preformation

25

Pipe- or hose piece

26

proximal The End

27

outer Cover, foil tube

28

compartment

29

sidecut

30

cane

31

supply

32

Intake

33

irrigation lumen

34

expelling

35

collection bag

36

connector

37

Plug connector

38

bag-side connector

39

Nut

40

cap

200

bonding region

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - EP 2005/007950 [0020, 0020, 0021, 0027, 0028]

Claims (1)

Apparatus for continuously draining stool from the rectum of a patient into an external, bag-like receptacle and / or closing the rectum, comprising an inflatable balloon with an approximately annular structure, formed from a flat, inwardly everted tube portion (US Pat. 8th ), wherein the outer layer of the everted tube section has a radially expanded area (intrarectal balloon section 1 ) for insertion into the rectum and a tapered area (transanal balloon section 2 ), which remains at least partially outside the rectum during use, characterized in that the intrarectal balloon portion ( 1 ) in no functional or spatial connection with the transanal balloon portion ( 2 ) stands.