Device for stool drainage

Abstract

A device for sealing a colon, and for removing stool therefrom by irrigation, comprising an expandable intrarectal balloon segment formed from an everted tube with two ends, for insertion into the rectum to anchor the device, and a tapered transanal segment adapted to remain at least partially outside the rectum during use, wherein the balloon segment and the transanal segment have no common compartment, wherein both segments comprise drainage parts with a drainage lumen for irrigation of stool from the patient, wherein one of the two ends of the everted tube is passed through the lumen of the intrarectal balloon segment as an inner layer, the inner layer being in contact with a funnel element, and wherein the transanal segment is adapted to collapse upon resting of the sphincter, and comprises part of the intrarectal balloon segment, or a different balloon element.

Claims

1. A device for sealing an opening of the colon or rectum of a patient, and for obturating the same and for removing stool therefrom by a continuous drainage and/or by an intermittent irrigation, the device comprising a radially expanded intrarectal balloon segment with at least one inflatable balloon of approximately ring-shaped structure, formed from a portion of a flat, everted tube with two ends, for insertion into the rectum to anchor the device, and a transanal segment tapered with respect to the radially expanded intrarectal balloon segment and adapted to remain at least regionally outside the rectum during use, wherein said intrarectal balloon segment and said transanal segment have no common compartment, wherein both of said intrarectal and said transanal segment comprises drainage parts with a central drainage lumen to permit a continuous drainage and/or intermittent irrigation of the stool from the colon or rectum of a patient, wherein one end of the two ends of said everted tube is passed at least partially through the lumen of said intrarectal balloon segment as an inner layer, wherein the inner layer of the intrarectal balloon segment is in contact with a separately fabricated funnel element, and wherein said transanal segment is sufficiently flexible to collapse or fold together upon a normal resting tone of the sphincter, and is formed of the same tube as the intrarectal balloon segment, and/or comprises a different balloon element.

2. The device in accordance with claim 1, wherein only said intrarectal balloon segment is provided with a compartment fillable with a fluid.

3. The device in accordance with claim 1, wherein only said transanal segment is provided with a compartment fillable with a fluid.

4. The device in accordance with claim 1, wherein both said intrarectal balloon segment and said transanal segment are provided with a respective compartment fillable with a fluid, the compartments being functionally and spatially separated from each other, and adapted to be separately filled and/or emptied.

5. The device in accordance with claim 1, wherein said transanal segment forms a separately fillable compartment adapted to be filled to improve the seal with respect to the anus by radial expansion of an outer envelope, while under forced filling the central drainage lumen can be constricted toward the center and substantially occluded.

6. The device in accordance with claim 1 wherein in a region of a proximal end of the intrarectal balloon, a e balloon envelope is directly connected to the surface of portions of the transanal segment.

7. The device in accordance with claim 1, wherein the transanal portion of the device is implemented at least regionally as single-ply.

8. The device in accordance with claim 1, wherein said transanal segment has, in addition to a one- or two-ply tube layer, an additional functional element provided to counteract axial torsion or the twisting-induced occlusion of said transanal segment.

9. The device in accordance with claim 1, wherein said transanal segment comprises a selected one of an elastically self-straightening tube element and a radially deformable, self-opening basket-woven element that conforms with moderate tension to an anal canal.

10. The device in accordance with claim 1, wherein said transanal segment is double-walled and a chamber that is formed between said funnel element and said connector element is, via a delivery line from outside the patient, selectively evacuated or fitted with a filling medium.

11. The device in accordance with claim 1, wherein the drainage lumen extends through the intrarectal funnel element within said intrarectal sealing balloon and debouches directly into a bag-type container via a large-lumen tube element connected to said funnel element and extending through the anal canal.

12. The device in accordance with claim 1, wherein a tube attachable to a free end of said transanal segment for drainage into a toilet bowl.

13. The device in accordance with claim 1, wherein during intervals between enemas, the device indwelling in the patient performs a rectal-anal sealing function, wherein the drainage lumen is obturated at its proximal end, outside the anus, such as to be liquid-tight, but allow the passage of gas.

14. The device in accordance with claim 1, and further comprising delivery means for administering an irrigation fluid.

15. The device in accordance with claim 1, wherein a selected one of polyurethane and a material having similar technical properties with regard to elasticity and strength, comprises material for the intrarectal balloon segment or for a balloon seal.

16. The device in accordance with claim 15, wherein at least one of said intrarectal and said transanal segment is of polyurethane.

17. The device in accordance with claim 1, wherein the inner layer of the intrarectal balloon segment has a loge-like preformation for receiving a separately fabricated funnel element within the central drainage lumen.

18. The device in accordance with claim 17, wherein the funnel element seals a compartment inside the inflatable intrarectal balloon in a fluid-tight manner.

19. The device in accordance with claim 1, comprising an element for temporarily obturating a drainage lumen in a region of said intrarectal balloon, or of said transanal segment, or in a preanal, extracorporal region.

20. The device in accordance with claim 19, wherein the element for temporarily obturating a drainage lumen comprises a balloon inside the drainage lumen and which is inflatable and/or deflatable.

21. The device in accordance with claim 1, wherein said transanal segment comprises an at least partially corrugated tube element.

22. The device in accordance with claim 21, wherein said at least partially corrugated piece surrounds said central drainage lumen.

23. The device in accordance with claim 1, and further comprising a pump balloon for administering a fluid or air into a fillable compartment of the balloon, wherein said pump balloon is provided with elastic, self-erecting properties, and/or is filled with a sponge-like porous material with elastic, self-erecting properties.

24. The device in accordance with claim 23, wherein said pump balloon is connected to the fillable compartment by a manually operable valve.

25. The device in accordance with claim 1, wherein one end of the two ends of the tube portion is adapted to be advanced as an inner layer within a lumen of an outer layer of the tube portion to an end thereof.

26. The device in accordance with claim 25 wherein two ends of said balloon are fixed, parallel to each other at approximately the same level, to a preanally disposed connector element.

27. The device in accordance with claim 26, wherein the inner layer of the intrarectal balloon segment is surrounded by a separately fabricated funnel element placed inside the intrarectal balloon but outside of the central drainage lumen.

28. The device in accordance with claim 27, wherein a pipe element unobstructingly connects said funnel element and said connector element, and operates to stabilize said transanal segment.

29. The device in accordance with claim 1, wherein a transanal compartment comprising concentric tube elements, to which a filling medium can be admitted, is separated from said intrarectal balloon segment and is fillable separately from an intrarectal compartment.

30. The device in accordance with claim 29, wherein a separation between said intrarectal balloon segment and the transanal compartment is effected by durably, sealingly closing an envelope of said intrarectal balloon segment by means of a funnel element.

31. The device in accordance with claim 29, wherein a separation between intrarectal and transanal compartments in the region of a proximal end of said intrarectal balloon segment is achieved by directly connecting an outer layer of the everted tube portion to a surface of portions of said transanal segment.

32. The device in accordance with claim 31, wherein a filling volume of the intrarectal compartment and/or of the transanal compartment initially introduced amounts to 70-80% or to 80-90% of a freely deployed, preformed volume.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Additional features, characteristics, advantages and effects based on the invention will emerge from the following description of various embodiments of the invention and by reference to the drawings, wherein:

(2) FIG. 1 is a diagrammatic illustration of a simplest variant embodiment for the head unit of a device according to the invention;

(3) FIG. 1A is an elevational view of an exemplary preshaping of the balloon blank;

(4) FIG. 1B is a longitudinal sectional view of the everted balloon blank of FIG. 1A;

(5) FIG. 1C is a perspective view of a funnel element for insertion into a balloon;

(6) FIG. 1D is a longitudinal section through a first preformation of a funnel element for insertion into a balloon;

(7) FIG. 1E is a longitudinal half-section through a second preformation of a funnel element inserted into a balloon envelope;

(8) FIG. 1F is a longitudinal half-section through a third preformation of a funnel element inserted into a balloon envelope;

(9) FIG. 1G is a longitudinal half-section through a fourth preformation of a funnel element inserted into a balloon envelope;

(10) FIG. 1H is a longitudinal half-section through a two- or multi-component implementation of the funnel element;

(11) FIG. 1I is a longitudinal half-section through another, entirely assembled funnel element;

(12) FIG. 1J is a longitudinal half-section through the funnel element according to FIG. 1I, partially disassembled;

(13) FIG. 2 is a diagrammatic illustration of another embodiment of the invention;

(14) FIG. 3A illustrates a further modified embodiment of the invention, with a combination of an anchor balloon and a transanal segment protruding from the anchor balloon envelope, as illustrated in FIG. 1, but with a stabilizing pipe piece shown in FIG. 2;

(15) FIG. 3B is a view similar to FIG. 3A, but with the transanal region shaped with a waist;

(16) FIG. 3C is a perspective view of a stabilizing pipe piece in its original shape;

(17) FIG. 3D is a view of the stabilizing pipe piece according to FIG. 3B, partially deformed;

(18) FIG. 4A illustrates a modified embodiment of the invention in which the transanal segment comprises two concentric tube layers;

(19) FIG. 4B is a view similar to FIG. 4A, but with the transanal region unfolded;

(20) FIG. 5 illustrates a further modified embodiment of the invention, which combines the embodiment according to FIG. 4A with the elastically deformable, self-straightening and self-orienting tubular basket weave illustrated in FIG. 3A;

(21) FIG. 6A is a diagrammatic illustration of one embodiment of the head unit according to the invention, with a partly double-ply transanal region;

(22) FIG. 6B is a view similar to FIG. 6A, but with an entirely double-ply transanal region;

(23) FIG. 6C is a longitudinal half-section through a balloon envelope along line VIBA of FIG. 6B, with the integration of a filling tube leading to the intrarectal segment;

(24) FIG. 6D is a horizontal section view through a transanal segment of a balloon along line VIBB of FIG. 6C, with the integration of a filling tube leading to the intrarectal segment;

(25) FIG. 6E is a perspective view of a pump balloon for filling, blocking and/or emptying a balloon of an embodiment according to the present invention;

(26) FIG. 6F is a longitudinal half-section view through a balloon envelope along line VICA of FIG. 6G, with the feed from an irrigation tube to the funnel element;

(27) FIG. 6G is a horizontal section view through a transanal segment of a balloon along line VICB of FIG. 6F, with the feed from an irrigation tube to the funnel element;

(28) FIG. 7A is a perspective view of another preshaped balloon blank,

(29) FIG. 7B is a diagrammatic view of the balloon blank of FIG. 7A in everted state;

(30) FIG. 8A is a diagrammatical showing of a further embodiment of the transanal segment;

(31) FIG. 8B is a perspective view of a tube element for stiffening the transanal segment;

(32) FIG. 8C is a perspective view of another tube element for stiffening the transanal segment;

(33) FIG. 9 is a diagrammatical view of another embodiment of the head unit;

(34) FIG. 10A is a perspective view showing a first way of compartmentalizing a tube element of the device;

(35) FIG. 10B is a perspective view showing a second way of compartmentalizing a tube element of the device;

(36) FIG. 11A is a longitudinal section through a single, continuous support body, onto which a two-chambered balloon can be mounted;

(37) FIG. 11B is a longitudinal half-section through another single, continuous support body, onto which a two-chambered balloon can be mounted;

(38) FIG. 11C is a longitudinal half-section through still another embodiment of the invention, wherein a two-chambered balloon is mounted on a single, continuous support body;

(39) FIG. 11D is a perspective view of another embodiment of the invention in which a two-chambered balloon is mounted on a single, continuous support body;

(40) FIG. 11E is an elevational view of a transanal portion of the embodiment according to FIG. 11A, in which the two-chambered balloon is mounted on a single, continuous support body;

(41) FIG. 11F is an elevational view of a corrugated transanal portion of a further embodiment of the invention;

(42) FIG. 11G is view similar to FIG. 11F, but with the corrugated transanal portion flexed one time;

(43) FIG. 11H is view similar to FIG. 11F, but with the corrugated transanal portion flexed two times;

(44) FIG. 12A is a diagrammatic illustration of an embodiment of the invention in which a single-chambered balloon is mounted on a single, continuous support body; and

(45) FIG. 12B is a diagrammatic illustration of another embodiment of the invention in which a single-chambered balloon is mounted on a single, continuous support body.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(46) Intrarectal anchor balloon 1 and transanal intermediate segment 2 are made from a single, common tube blank 8, the transanal segment 2 of the preshaped balloon film 8 having only a single-layered wall. Intrarectal and transanal segments 1, 2 of the balloon film 8 form a structural unit in the illustrated variant of the device, but present no functional separation in the state of being assembled and fixed on/against a funnel. As FIG. 1 shows, the tube blank 8 is tucked back into itself in the region of the intrarectal anchor balloon 1, particularly inwardly or in such a way that any gap remaining between the end edge of the everted tube 8 and a middle tube section of the tube 8 facing said end edge is inside the intrarectal anchor balloon 1; as a result of the eversion, the intrarectal anchor balloon 1 has essentially a toroidal structure.

(47) The two segments 1, 2 of the film 8 are segregatingly or sealingly separated from each other by an approximately rotationally symmetrical element, a so-called funnel element 3, which is inserted from the distal direction into the inner, central hollow of the anchor balloon 1. The body of the funnel element 3 covers any gap that may remain on the inside of the intrarectal anchor balloon 1 between the end edge of the everted tube 8 and a middle tube section facing said end edge. By durable, firm connection of the anchor balloon envelope 1 to the funnel element 3, a compartment 6 is created which itself is closed or sealed in the region of a remaining gap on the balloon envelope 8 and is therefore fillable with a fluid, and which extends in like a cuff around the lateral or radially outlying portions of the funnel element 3 and thus unfolds during filling. The connection can be simplified or improved by specially configured preformations 7 of the funnel surface and/or of the balloon film, which preformations will be described in more detail hereinbelow.

(48) The transanal segment 2 is followed in the proximal direction by a connecting element 4, which terminates the head unit and forms the transition to a drainage tube 5.

(49) The preshaped balloon blank 8 comprises a medially disposed region 9 which is preshaped into an approximately outwardly spherical form, and which in the assembled state forms the radially outwardly disposed envelope of the intrarectal anchor balloon I. An extension 10 extending proximally from the region 9 has a cylindrical shape and corresponds, in the assembled product, to the transanal section 2 of a head unit. An oppositely directed extension is configured as a funnel encasing compartment 11 for receiving the funnel element 3, analogously to the encasement of a muscle group by fascia in a muscle compartment. Joined to each end are portions of a tube blank 12 used in the blow molding process. To fabricate the head unit illustrated in FIG. 1, the balloon blank can, for example, be tapered in section planes 13, as can be seen from FIG. 1a.

(50) FIG. 1b, the right-hand drawing, further shows how a balloon-blank region forming the funnel encasing compartment 11 is tucked back into the interior of the intrarectal sphere 9, and how, in a subsequent step, the funnel element 3 can be inserted or mated into the now-inverted encasing compartment region 11.

(51) The inner contour of the inverted encasing compartment region 11 here corresponds, preferably with an exact fit, to the outer contour of the funnel element 3 inserted into the intrarectal balloon unit 1. Encasing compartment 11 can be preshaped or dimensioned either to almost fully embrace or to only partially embrace the periphery of the funnel element 3 it receives.

(52) FIG. 1c shows a funnel element 3 which can be used within the encasing compartment 11 of the intrarectal balloon unit 1 according to FIG. 1. The funnel element 3 is provided with an annular geometry with a recess in its center. Preferably, it shows a rotational symmetry and surrounds a rotational axis in the middle of its recess.

(53) The shape of an outer surface 210 is similar to a hogshead or a bulbous barrel. Preferably, an inner surface 211 is of hollow cylindrical shape. Annular end areas 212 are soft rounded or radiused. Furthermore, the outer surface 210 and/or the inner surface 211 can comprise indentations 213, for example in the form of smooth, longitudinal troughs extending in an axial direction, parallel to the rotational axis running through the central recess of the funnel element 3. Such indendations 213 reduce the stiffness of the funnel element 3, especially along their longitudinal axes. Therefore, if necessary, the funnel element 3 can fold together along the indendations 213, for example during the application of the device into the rectum of a patient. Inside the rectum of a patient, the funnel element 3 expands due to its self-erecting properties.

(54) The funnel element 3, as well as the connecting element 4, may be manufactured from a foam. It can be molded, for example by injection molding, especially from a thermoplastic material. According to another method, it can be manufactured from a cold-curing two-component resin. Preferably, the material is flexible and/or elastic, and/or with self-erecting properties preferably polyurethane.

(55) FIG. 1d to 1g show various preformations of the balloon envelope 8 and of the funnel element 3, which, respectively or chiefly in combination, facilitate convenient assembly, twist-free longitudinal axial straightening, and durable, sealing interconnection of the balloon envelope 8 and the funnel element 3:

(56) Those portions of the intrarectal and/or transanal balloon segment 1, 2 that are in permanent areal contact with the funnel element 3 in the final assembled state are preferably sized to be slightly smaller than the corresponding structures of the funnel element 3 that are in contact with the balloon 8. In this way it can be ensured that in the assembled state, the balloon envelope 8 conforms to the funnel element 3 on all sides with slight stretching and with no folds. Funnel element 3 and the encasing compartment 11 are preferably shaped geometrically in such a way that the funnel 3 virtually snaps into its mounted position when inserted into the encasing compartment 11. The outer contour of the funnel 3 can be provided, for this purpose, with a suitable three-dimensional basic shape such as, for example, that of an olive, a sphere or a barbell; the inner contour of the encasing compartment 11 is shaped as a counterpart thereto. Preferably, the outer contour of funnel element 3 is doubly convexly curved, i.e., in both the axial direction and the azimuthal direction, in at least one region, and it is preferably doubly convexly curved in its entirety, i.e., over the entire region of the outer contour. Corresponding thereto is an inner contour of funnel encasing compartment 11, which is at least regionally doubly concavely curved, i.e., in both the axial and the azimuthal direction; preferably, the entire region in contact with the funnel element 3 is doubly concavely curved.

(57) FIG. 1d shows that, to further simplify the assembly of thin-walled balloon films 8, the surface of a funnel element 3′ can be provided with special annular protrusions 14 which extend circularly about the surface of the funnel, and which increase their contact stress in the region of contact with the balloon envelope 8 and thus have a quasi-sealing effect. Such sealing or delimiting structures are advantageous, especially when the balloon envelope 8, in the tightly filled state, is placed on a shaft base, there moved into the mounted position, and untwisted and straightened out along the longitudinal axis. The targeted placement of glue or solvent between a shaft element and/or the funnel element 3′, on the one hand, and the balloon envelope 8, on the other, particularly in a limited and/or defined region, can also be improved in this way.

(58) FIG. 1e shows that, for example, an adhesive can, in a spatially limited manner, be placed in, particularly injected into, a gap 15 located behind a protrusion 14″ and between the funnel 3″, on the one hand, and a region 16 of the balloon envelope 8″ that is in contact with the funnel 3″, on the other, without any risk of this adhesive straying into the region on the other side of the annular protrusion 14″.

(59) FIG. 1f shows that, to further simplify the positioning and, above all, the axial straightening and fixation of the envelope, the convex protrusion 14.sup.(3) extending annularly or circularly about the periphery of the surface of funnel element 3.sup.(3) can be improved by providing the adjacent balloon envelope with a corresponding concave preformation 17 that is approximately complementary to the protrusion 14.sup.(3). This permits a further interlock effect in positioning the film on the funnel. The envelope 8.sup.(3), 16 is as if rail-guided in its movement, without deviating from being precisely positioned on the underlying element, i.e., the protrusion 14.sup.(3), and can be conveniently untwisted along the balloon's longitudinal axis and straightened out along the longitudinal axis.

(60) In addition, an interspace 18 receiving a medium, e.g. adhesive, that lastingly bonds the structures together can be provided between the funnel element 3.sup.(4) and the balloon film 8.sup.(4), 16, preferably in the region of their preformations, particularly in the apical contact region of the preformations. Correspondingly, the controlled distribution of an adhesive medium between the balloon envelope and the funnel surface can be accomplished by means of a groove 19 running apically on the annular protrusion 14.sup.(4). The adhesive bonding medium can be conveyed to the area from the funnel lumen and fed in via a conduit-like preformation 20, which can be seen in FIG. 1g.

(61) The invention further provides that the funnel element 3″ and the balloon film 8″, 16 are connected to each other by welding, preferably in the region of at least one convex preformation extending annularly and/or circularly about the periphery of the funnel. Due to the thus locally obtained increase in the contact stress of the film 8″ on the substrate, this is advantageous for welding the two structures together, since a suitable thermal welding tool can be positioned there and create a reliably fold-free joint between the surfaces.

(62) As FIG. 1h shows, the funnel element 3 can be composed, for example, of two mateable or otherwise suitably interconnectable parts, for example of annular parts 21, 22 disposed one behind the other in the axial direction. During assembly, the parts 21, 22 are, preferably separately, lastingly connected, for example by gluing, respectively to the distal and the proximal end of the balloon. If the funnel components 21, 22 are at least regionally-lastingly connected to the balloon envelope 8, they can then be untwisted over the longitudinal axis of the balloon envelope 8 and thus, axially straightened, without any twisting of the balloon envelope 8, permanently sealingly joined together.

(63) The interconnection of the balloon envelope 8 and the funnel components 21, 22 can also take place in such a way that the connection points come to be located in the region of the joint between of the funnel components.

(64) For example, the distal end of the balloon can be glued to the funnel component 21, particularly in a joint region 200 with the component 22. To accomplish this, the encasing compartment portion 11 of the balloon envelope 8 is glued or lastingly joined to the proximal edge of the component 21. Both structures are then inserted together into a congruent receiving structure at the distal edge of the component 22, and, after axial straightening, are also adhesively bonded there.

(65) In a similar multi-component construction according to FIGS. 1i and 1j, the proximal tight sealing of the balloon envelope 8.sup.(5) can be achieved by means of the funnel element 3.sup.(5). This assembly technique is based on a separate ring-shaped element 23. The element 23 can, for example, be advanced from the proximal direction through transanal segment 2.sup.(5) to the proximal fixing position of the balloon envelope 8.sup.(5) on the funnel 3.sup.(5), particularly to the transition from intrarectal balloon 1.sup.(5) to transanal segment 2.sup.(5), and there optionally fixed to the transanal segment 2.sup.(5) by gluing, welding, or the like. Snap fit placement of the ring 23 can be achieved by means of a preformation corresponding to the ring 23 and located at the proximal end of the balloon envelope 1.

(66) The ring 23, carrying along the thereto-attached distal end of transanal segment 2.sup.(5), is then mated into a correspondingly preshaped, annular-groove-like preformation 24 at the proximal end of the funnel element 3.sup.(5), and can be fixed there, for example, by adhesive bonding, welding, or the like.

(67) The ring element 23 can have a slightly higher Shore hardness than the rest of the funnel components 21, 22, so that, if the diameter is made to be slightly larger or smaller than that of the receiving preformation, the two funnel components 21, 22 can be snap-locked together under slight stress.

(68) The embodiment of the device shown in FIG. 2 comprises, instead of a proximally extended balloon end arising from the anchor balloon 1.sup.(6), as illustrated, for example, in FIG. 1, a separate, transanally extending, thin-walled pipe piece, or tube piece, which continuously connects the funnel 3.sup.(6) to the preanal connector 4.sup.(6). This element is fabricated of an elastic material with a high restoring force, so that despite being made as thin-walled as possible, it automatically straightens out or untwists when radially deformed, or twisted, about its longitudinal axis, and thus spontaneously returns to its low-stress, open-lumened initial state.

(69) The figure shows exemplarily how the joint between the pipe piece and/or a tube piece 25 and the funnel element 3.sup.(6) can take the form of a preformed annular groove 24 at the proximal funnel end 26. In this arrangement, the proximal end 26 of the balloon envelope 1.sup.(6) can be laid over, pulled onto or otherwise guided over the distal end of tube piece 25, such that the latter is lastingly sealingly connected to funnel element 3.sup.(6) by the insertion of the distal end of the transanal segment into the annular groove 24.

(70) FIGS. 3a and 3b show a combination of anchor balloon 1.sup.(7) with a transanal segment 2.sup.(7) arising from the anchor balloon envelope 8, as depicted in FIG. 1, with the stabilizing tube piece and/or pipe piece 25 described in FIG. 2. The transanal segment here forms a separately fillable compartment 28 created between the inwardly disposed pipe piece and/or tube piece 25 and the outer, proximally extended anchor balloon envelope 27. As the compartment 28 is filled, regardless of the volume expandability of the envelope or the diameter to which it is preshaped during production, the seal with respect to the anus is improved by radial expansion of the outer envelope 27. Under forced filling, the drainage lumen of the head unit can additionally be constricted toward the center and nearly occluded. Alternatively to preshaping the envelope 27 from the proximal tail of the anchor balloon 1.sup.(7), a separately fabricated balloon body, or tubular film body, can also be used as the envelope 27. The envelope 27 outwardly defining compartment 28 can further be preformed into a barbell or hourglass shape. In such a configuration, the preferably medially disposed waist 29 is preshaped to accommodate the structures of the anal canal. If the transanal compartment 28 is placed under pressure, as occurs, for example, during the instillation of the irrigation fluid, the described waist preformation 29, on the one hand, serves to securely anchor the head portion of the device and, on the other hand, helps to form a seal against irrigation fluid leaking from the rectum.

(71) The previously described techniques—for example, adhesive bonding, welding, optionally in the region of a preformation, etc.—can be used to fix and tightly seal the components necessary for this embodiment in the region of transition between the intrarectal and the transanal compartments 6, 28.

(72) Analogously, the envelope 27 preferably arising from the anchor balloon 1.sup.(7) can be combined with a radially deformable tubular basket weave 30 according to FIG. 3c, that conforms, with light stress, to the transanal contours. In the non-deformed, low-stress, initial state, tubular basket weave 30 has an open lumen of approximately 2-3 cm. The radially directed restoring force exerted on the anus as the lumen constricts is very low and precludes the formation of pressure ulcers. If there is a decrease in the tone of the anal sphincter during the defecation reflex, the tubular basket weave conforms to the then-opening transanal canal, thus facilitating the expulsion of stool. The tubular basket weave 30 preferably continuously connects the intrarectal funnel 3.sup.(7) to the preanal connector 4.sup.(7). It is preferably disposed in the interior of tube segment 8, but can also, alternatively, extend beyond the outer surface thereof. In the radially constricted state 30a according to FIG. 3d, the basket weave 30, which is preferably constructed of rigid, flexurally deformable filaments, undergoes a marked increase in length, for which allowance is made in a corresponding length specification of the outer envelope 27.

(73) The assembly of the component parts is performed by the previously described techniques.

(74) FIGS. 4a and 4b present an embodiment whose transanal segment comprises two concentric tube layers 27a and 27b. As previously described, these can be composed of the extended ends of the intrarectal balloon 1.sup.(8). In the preferred embodiment, the inner tube layer 27b arises from the proximal extension of the intrarectal balloon sphere 1.sup.(8). The outer tube layer 27a is preferably configured as a separate, thin-walled tubular film element, which is preshaped so as to be preformedly cylindrical or, alternatively, congruent with the anal canal.

(75) Alternatively, the two layers can be composed of separately fabricated tubular films.

(76) The compartment 28 formed between the two tube layers 27a, 27b can be partially or completely filled with a medium from outside the patient's body, or completely evacuated, via a supply line 31 routed through the connector 4.sup.(8).

(77) In the evacuated state (corresponding, for instance, to FIG. 4a), the two tube layers 27a, 27b lie firmly one inside the other and behave virtually as a single-layered wall. In the filled state (corresponding, for instance, to FIG. 4b), the two layers 27a, 27b separate from each other and the compartment 28 is maximally open.

(78) In the tightly filled state, the inner layer 27b expands toward the center of the drainage lumen and occludes it fluid-tightly. The outer layer 27a, by contrast, expands toward the anal wall and conforms to it also leak-tightly, following the particular anatomy.

(79) Under partial filling, or filling with a few milliliters of fluid medium, the two layers 27a, 27b separate. The two thin-walled films 27a, 27b, supported virtually frictionlessly by the fluid medium, glide freely displaceably with respect to each other. Lesions of the kind known to be caused in the particularly sensitive region of the anal canal by minimally dynamic films that remain in static contact with the tissues can be avoided more effectively by the free interplay and the gliding of film layers 27a, 27b.

(80) The connection of the component parts or film layers 27a, 27b to the proximal end 26 of the funnel can be accomplished on the basis of the annular support 23 that is inserted into an annular preformation 24 at the proximal edge of the funnel element 3.sup.(8). The inner layer 27b can in this case be passed over the ring 23, as illustrated in FIG. 1g, and connected to, or snapped together with, the funnel 3.sup.(8). The outer layer 27a is adapted to be adhesive-bonded at its distal end to the ring 23 in a preceding assembly step.

(81) FIG. 5 combines the previously described embodiment with the elastically deformable, self-straightening and self-orienting tubular basket weave 30 described in FIG. 3. The tube element or pipe element can be used alternatively to the tubular basket weave 30.

(82) The previously described elements 30, 31 are preferably disposed between the two film layers 27a and 27b, thus connecting the funnel element 3.sup.(9) to the connector 4.sup.(9).

(83) FIGS. 6a and 6b show further, rather similar embodiments of the invention. Here, intrarectal anchor balloon 1.sup.(10) and transanal intermediate segment 2.sup.(10) are made from a single, common, tubular balloon blank 8.sup.(10) that has been completely preshaped in advance, one end 105a of the balloon tube 8.sup.(10) being pulled through its other end 105b. The two ends 105a, 105b lie concentrically against each other in the transanal segment 2.sup.(10) of the device and are preferably lastingly connected to each other in a contact region 106 by an areally acting connection technique. The contact region 106 between the two balloon ends 105a, 105b preferably begins at the bottom edge 107 of the funnel encasing compartment 11.sup.(10), or a few millimeters proximally therefrom. It extends over the partial length of the transanal segment 2.sup.(10) of the device (FIG. 6a) or over the full length of the transanal segment 2.sup.(10) of the device (FIG. 6b).

(84) The contact region 106 of the tube ends 105a and 105b is therefore constituted as double-layered. The layers are, of course, preferably continuously firmly connected to each other. Partial chambering in the contact region 106, hence a partially areal connection, may be envisaged. But there is no possibility of filling by means of, or connection to, another pressurizable space in any other compartments, except for the environment; in particular, there is no continuous connection of any kind to the compartment 6.sup.(10) inside the intrarectal balloon 1. The preferably continuous double layer of material in the contact region 106 gives the transanal segment 2.sup.(10) higher rigidity, and thus—and most important, counteracts axial twisting and the attendant constriction of the drainage lumen. It also guarantees the improved tendency of the segment lumen to straighten out spontaneously.

(85) Although, in the illustrated variant of the device, the intrarectal and the transanal segment 1.sup.(10), 2.sup.(10) of the balloon film 8.sup.(10) form a structural unit, they are functionally decoupled from each other.

(86) Connected proximally to the transanal segment 2.sup.(10) is a connecting element 108 that forms the transition to drainage tube 109.

(87) For purposes of filling the intrarectal balloon 1.sup.(11), it is recommended to integrate a filling tube 110 into the region 106.sup.(11) of contact between the two tube ends 105a.sup.(11) and 105b.sup.(11). In the simplest case, this can be done by interposing the filling tube 110 between the two concentrically disposed film layers or tube ends 105a.sup.(11), 105b.sup.(11), as illustrated in FIGS. 6c and 6d. The fixing and sealing can be accomplished by adhesive-bonding or welding together the components 105a.sup.(11), 105b.sup.(11), 110 to be joined.

(88) The task of accommodating the filling tube 110 in the contact position 106.sup.(11) can be simplified by means of suitable, exactly fitted, groove-like preformation(s) 111 disposed in tube ends 105a.sup.(11) and/or 105b.sup.(11), and receiving the interposed tube 110, as can be seen in FIG. 6d.

(89) At the free end of a filling tube 110, a filling device 220 can be provided as can be seen in FIG. 6e. Such filling device 220 can comprise a pump balloon 221, preferably with elastic, self-erecting properties, and/or filled with a sponge-like porous material with elastic, self-erecting properties. The pump balloon 221 may have a spherical or globular shape. At one side, there is an opening, which is connected to the filling tube 110 via a valve element 222.

(90) Preferably, this valve element 222 is manually operable and may comprise a push-button 223 which commands the behaviour of the valve element 222. If pushed in one direction, the valve 222 is closed, blocking any flow of a fluid out from or into the pump balloon 221. By pushing the button 223 in another direction, the valve is opened, allowing a fluid to flow out from or into the pump balloon 221.

(91) If in this latter condition the pump balloon 221 is compressed, especially by hand, the contained fluid—air, water or the like—flows through the filling tube 110 into the appropriate compartment 6, 28 of the intrarectal balloon 1, or inside the transanal region 2. If the pump balloon 221 is released while the valve 222 is open, the self-erecting properties of its material or of a contained sponge-like material unfold the pump balloon 221, sucking the fluid out of the compartment 6, 28 of the intrarectal balloon 1, or of inside the transanal region 2. The result can be fixed by closing the valve 222.

(92) Such filling device can be used for additional elements, too, for example for filling and/or emptying of an occlusion balloon inside a central lumen of the intrarectal or transanal region.

(93) To ensure the delivery of irrigation fluid to the intrarectal segment 1.sup.(12), it is preferred to integrate an irrigation tube 112, which preferably is disposed inside the drainage lumen or fixed there in a corresponding groove-like preformation 113 inside the transanal segment 2.sup.(12), as illustrated in FIGS. 6f and 6g.

(94) In intrarectal section 1.sup.(12) of the device, the irrigation tube 112 can be received and held in the funnel element 3.sup.(12) by a suitably preshaped preformation 114, e.g. by being mated thereonto or thereinto. Preformation 114 can form a debouchment 115 to the drainage lumen.

(95) As can be seen from FIG. 7a, a preshaped balloon blank 116 has a medially disposed spherical formation 117, which in the assembled state constitutes the envelope of the intrarectal anchor balloon 1.sup.(13). The extension 105a.sup.(13) of the sphere 117 preferably is provided with an elongated cylindrical shape and corresponds, in the assembled product, to the transanal section 2.sup.(13) of the head unit. During assembly, the end 105a.sup.(13) is pulled back through the opposite end 105b.sup.(13), such that a line 118 comes to be the fold-back line, directly at, or near, the distal, patient-internal end of the device, according to FIG. 7b.

(96) Extension 105a.sup.(13) can optionally form the funnel encasing compartment 11.sup.(13).

(97) In that case, the inner contour of the inverted encasing compartment 11.sup.(13) corresponds, preferably with an exact fit, to the outer contour of the funnel element 3.sup.(13) inserted into the intrarectal unit.

(98) In the embodiment according to FIG. 8a, the tube ends 105a.sup.(14) and 105b.sup.(14) are not connected directly to each other, but are instead each connected to the surfaces of a sleeve- or tube-like component 119 disposed between them, the purpose of which is to modify the mechanical properties of the transanal segment 2.sup.(14).

(99) In the ideal case, the transanal segment 2.sup.(14), with or without supplementation of this kind, is so designed mechanically that without the application of external force, i.e., for example, in the freely unfolded state, it straightens out by virtue of its elastic force, exhibiting a circular cross section, without entering into contact with the anal canal. Under a slight force acting from the outside, segment 2.sup.(14) will collapse or to undergo deformation that largely occludes the lumen.

(100) In addition, a certain degree of protection against twisting in the transanal segment 2.sup.(14) of the device is provided by the choice of a suitable elastic sleeve 119. The elasticity of sleeve 119 should therefore be so selected that after being axially twisted, even in situ, the transanal segment 2.sup.(14) untwists, for the most part automatically, and returns to its low-stress initial state.

(101) The sleeve 119 preferably consists of polyurethane with a hardness rating of 30 to 70 A, which material can be manufactured or processed by extrusion, injection molding, casting, or dip molding. Alternatively, it is also feasible to use, for example, silicone or a material with similar mechanical or, especially, elastic properties.

(102) The sleeve 119 can be constructed as uniformly thick-walled throughout, as illustrated by the sleeve 119a at the upper right in FIG. 8b, or, for example, as single-turn or multi-turn-where appropriate, counterwound-helical struts or stiffeners 120, as illustrated at the lower right in FIG. 8c. The area between the struts or stiffeners 120 can be preshaped as a thin-walled structure with a thickness of, for example, 0.2 to 0.4 mm, or, in the case of the counterwinding of a plurality of spirally or helically extending struts 120, can also be perforated as if by windows. The preferably helically extending struts 120 can be provided with a diameter of, for example, 0.75 to 2.0 mm.

(103) The sleeve 119 can further consist of an elastic soft foam, for example PUR foam.

(104) Alternatively, the sleeve 119 can be constructed as an elastic, double-walled cylinder, the space between the walls being tightly filled with a compressible or incompressible medium.

(105) The sleeve 119 can be connected to the ends 105a.sup.(14) and 105b.sup.(14) areally, particularly over the entire area, or a large area, or only a portion thereof. Its length is at least equal to the length of the anal canal, i.e., approximately 3 to 5 cm, but preferably reaches from the funnel element 3 to the connector 4.

(106) The sleeve 119 preferably lies between the ends 105a.sup.(14) and 105b.sup.(14); alternatively, however, it can also be disposed externally to the outer layer 105b.sup.(14), or internally to the inner layer 105a.sup.(14).

(107) If placed in the interior of transanal segment 2.sup.(15), i.e., in the interior of layer 105a.sup.(15), the sleeve 119.sup.(15) can also, as a further embodiment, arise directly, so to speak in proximal extension, from the funnel element 3.sup.(15), or be lastingly continuously connected thereto, as can be seen in FIG. 9.

(108) The sleeve 119.sup.(15) preferably is provided with suitable preformations to receive venting lines and irrigation supply lines.

(109) In the case of the sleeve 119.sup.(15) being fixed between the tube ends 105a.sup.(15) and 105b.sup.(15), an embodiment would also be conceivable in which the funnel element 3.sup.(15) and the sleeve 119.sup.(15) constitute a unit 121. To assemble this embodiment, the sleeve 119.sup.(15) is advanced on the tube end 105a.sup.(15) to the fold-back line 118 and is areally lastingly connected thereto. The end 105b.sup.(15) is then rolled back over the unit formed by the sleeve 119.sup.(15) and the inner tube end 105a.sup.(15). The end 105b.sup.(15) is then fastened to the surface of the transanal sleeve segment 2.sup.(15).

(110) FIGS. 10a and 10b show further options for the design of transanal segment 2 and stool conveying segment.

(111) Here, supply tube compartments, for example of the kind needed to fill the intrarectal balloon 1, or to deliver irrigation fluid to the intrarectal end, are partitioned off from a base tube 122, or compartmentalized by longitudinally oriented weld seams 125 applied to the base tube 122 of the transanal and/or stool-conveying segment 109. Compartments 123, 124 so created are thus given the form of a conduit.

(112) FIGS. 11a to 11c depict embodiments of the invention in which the funnel element 3.sup.(16), 3.sup.(18), transanal stiffening element 25.sup.(16), 25.sup.(17), 25.sup.(18), and connector element 4.sup.(16), 4.sup.(18), comprise a continuous manufactured unit 141, 141.sup.(18).

(113) The three segments 3.sup.(16), 4.sup.(16), 25.sup.(16) of the unit 141 are preferably made from an elastic synthetic material in a common operation. Injection molding, hot molding, dip molding, compression molding, or sinter molding, are examples of processes that can be used for this purpose. The funnel-like element 3.sup.(16) and the connector 4.sup.(16) are provided in their respective proximal portions, preferably while being formed in the mold, with punctures 145 to permit the assembly-facilitating lead-through, or the attachment of incoming tube connections, such as, for example, an irrigation line 146 or a filling line 147 serving the intrarectal compartment 6.

(114) The unit 141 is made, for example, from polyurethane with a hardness between 80A to 60D, and in that case is preferably implemented with a consistent material wall thickness of 0.2 to 0.4 mm. If polyurethanes with a hardness rating of 30A to 70A are used, the wall thickness can be increased to up to 1.0 mm.

(115) An important factor to consider in seeking the best functional match between wall thickness and material hardness is the self-straightening of the segment 141 under an externally applied deforming force. In the ideal case, the inner lumen of the segment 141 is circular in cross section when no external force is being applied.

(116) Under a force equivalent to a water column 15 to 25 cm high, but preferably 5 to 15 cm high, pressing uniformly and on all sides of a 3 cm central section of the segment, the segment walls will collapse and occlude the lumen, as a result of which opposite portions of the wall should come at least into direct partial contact, that is, should touch one another.

(117) Spontaneous straightening should also be achieved in the basic state when the segment 141 is twisted about its longitudinal axis; that is, spontaneous straightening should be promoted in the transanal position.

(118) FIG. 11c, there are shown the attachment points 151 of the two-chambered balloon body 1.sup.(18), 2.sup.(18) to the unit 141.sup.(18) serving as a continuous support, and indicates the balloon shape that develops in the presence of such a fixing arrangement when the compartments 6.sup.(18), 28.sup.(18) so created are filled.

(119) FIG. 11d shows an embodiment with lumen-occluding deformability of the stiffening segment 25.sup.(19) by helical struts 143 which extend over the inner or outer surface of segment 25.sup.(19), and which can be arranged as a plurality of parallel turns running in the same direction at a given angular offset.

(120) The struts 143.sup.(20) can also be mounted as one or more turns running (mutually offset) in opposite directions, like at FIG. 11e. The resulting mesh-like structure can be provided, in its regions 144 located between the struts, with thin-walled areas that can be reduced to wall thicknesses of as little as 0.1 mm.

(121) In a casting operation, the struts 143.sup.(20) further serve to ensure a sufficiently rapid flow of plastic compound into the mold, if the described very thin-walled regions 144 are to be preshaped successfully in advance.

(122) FIGS. 11f to 11h show a transanal region 2.sup.(23) or a transanal stiffening segment 25.sup.(23). The transanal region 2.sup.(23) is corrugated, with annular elevations 201 and indentations 202 therebetween, alternating in an axial direction of the transanal region 2.sup.(23), and/or with helical elevations 203 and indentations 204 therebetween, alternating in an axial direction of the transanal region 2.sup.(23). Such preformations of a tube-like foil 205 give the material a higher stiffness, but still allow a flexing of the transanal region 2.sup.(23), as can be seen in FIGS. 11g and 11h.

(123) From FIG. 11g, one can see that up to a flexure 206 of at least 45° the cross-section of the inner lumen inside the transanal region 2.sup.(23) is not narrowed or tapered. According to FIG. 11h, only a bending 207 at angles of substantially more than 45°, for example at bending angles of 60° or more, the corrugated tube begins to fold, whereby its inner lumen narrows.

(124) Therefore, such corrugations 201 to 204 on the one hand serve to keep the inner lumen open as long as possible, and on the other hand improve the self-erecting and self-unfolding properties of the material. This is achieved without a shaft-like element and without a bigger wall thickness of the foil.

(125) FIG. 12a shows the previously described continuous base body unit 141.sup.(21) combined with a balloon element 1.sup.(21) that forms only a single fillable intrarectal compartment 6.sup.(21). The balloon 1.sup.(21) sits against the attachment points 151.sup.(21), which extend circularly about the periphery of the funnel element 3.sup.(21). A second transanal balloon segment is not provided in this case.

(126) FIG. 12b shows an embodiment with the unit 141.sup.(22) on which is mounted only a transanal balloon component 148 with a compartment 149, there being no intrarectal balloon component.

(127) The transanal balloon 148 can preferably be fashioned in an hourglass shape, to enable it to conform optimally to the contours of the anal canal in situ, so as to provide better anchoring. Correlatively, a balloonless, funnel-shaped olive 152 can have a correspondingly increased diameter and can present a large enough outer contact face 153 to anchor the device sufficiently well in the rectum.

(128) In the prior art, an anally sealing balloon and the balloon arrangements are mounted on a shaft element. As a modification over DE 102004033425 A1 and WO 2007/118621 A1, and within the context of large-volume colorectal irrigation to achieve a continent interval, the shaft element bearing the sealing device can have a correspondingly increased draining inner diameter of approximately 2 to 3 cm. In addition, the length of the balloon-equipped shaft element can advantageously be increased to such an extent that the extracorporeal portion is also suitable for comfortable self-introduction of the irrigation catheter.

(129) The two ends of the everted tube section 8 can, of course, extend generally coaxially, one inside the other, and may (each) be connected to a sleeve.