Device for stool drainage

Abstract

Device for the continuous drainage of stool from a patient's rectum into an external bag-like collection vessel and / or for closing the rectum, comprising a) a single-chambered balloon (8) with a balloon element forming only a single fillable intra-rectal chamber (48), or b) a double-chambered inflatable balloon (8) having an intra-rectal section (9) and a trans-anal section (10), wherein the single- or double-chambered balloon (8) is fixed to a single supporting carrier body (41), preferably manufactured in one piece, which has an inner lumen, characterized in that the carrier body (41) comprises an olive-shaped funnel element (3) and a connector element (4), as well as a central segment (25) arranged between them, wherein the in situ trans-anal placed,The central segment (25) of the support body (41) has such elastic and self-righting properties that it collapses in a lumen-closing or -constricting manner when a small external force is applied, and spontaneously returns to its lumen-opened circular original shape due to its elastic restoring force when the external force decreases.

Description

The invention relates to a device for the continuous drainage of stool from the rectum of a patient into an external bag-like collection vessel and / or for closing the rectum, comprising a) a single-chambered balloon with a balloon element forming only a single fillable intra-rectal chamber, or b) a double-chambered inflatable balloon having an intra-rectal section (9) and a trans-anal section, wherein the single- or double-chambered balloon is fixed on a single supporting carrier body, preferably made entirely from one piece, which has an inner lumen. DE 10 2005 021 081 A1 describes a device for closing a natural or artificial anus, comprising an inflatable balloon with an approximately torus-shaped structure, formed from a flat, inverted tube section, the two ends of which run approximately coaxially into one another and are connected to a sleeve each, wherein the outer layer of the inverted tube section has a radially widened, patient-proximal area for insertion into the rectum and a correspondingly tapered, patient-distal area that remains at least partially outside the rectum during use. This balloon is not fixed to a carrier body. In the absence of a carrier body, the inner and outer tube sections are instead fixed to one another in a transanal balloon section by means of spot or line welds.In this embodiment, the elastic properties within the trans-anal balloon area are always linked to the pressure inside the balloon, since the balloon material, which is only a few micrometers thick and preferably made of polyurethane, does not itself exert any restoring forces. German patent DE 10 2004 033 425 B4 relates to a closure system for the treatment of rectal or anal incontinence. Depending on the embodiment, one or two balloons are provided, which are fixed to a carrier body. However, this carrier body is either completely or almost completely closed at its distal end, so that drainage of stool from a patient's rectum is not possible. US 4 686 985 A is an anal dilator occluder which may have a carrier body to which one or more balloons are attached. However, this carrier body is also completely closed at its distal end and therefore unsuitable for drainage. The disadvantages of the described prior art result in the problem initiating the invention, namely to find an arrangement in which the elastic properties of an internal element surrounding a central lumen are not caused by a filling pressure. The solution to this problem is achieved in a generic arrangement by the fact that the support body comprises an olive-shaped funnel element and a connector element, as well as a central segment arranged between them, wherein the in situ trans-anally placed central segment of the support body has such elastic and self-erecting properties that it collapses in a lumen-closing or -constricting manner under a small external force and, when the external force decreases, spontaneously returns to its lumen-opened circular initial shape due to its elastic restoring force. Further features, details, advantages and effects based on the invention will become apparent from the dependent claims, from the following description of a preferred embodiment of the invention and from the drawing. Figures 1a and 1b describe embodiments of the invention in which a two-chambered balloon is mounted on a single continuous carrier body. Figures 2a and 2b describe embodiments of the invention in which a single-chambered balloon is mounted on a continuous carrier body. Fig. 1a describes an embodiment of the invention in which the funnel element 3, the trans-anal stiffening element 25 and the connector element 4 consist of a preferably continuous manufactured unit 41. All three segments of the unit are preferably manufactured in a single operation from an elastic plastic material. Suitable processes include, for example, injection molding, hot casting, dipping, pressure molding, or sintering. The funnel-shaped olive 3 and the connector 4 are preferably provided with perforations 45 in their proximal portion during molding in the tool, which allow for the easy insertion or connection of supplying hose connections, such as a flushing line 46 or a filling line 47 of the intrarectal compartment. Unit 41, for example, is manufactured from polyurethanes with a hardness of 80A to 60D, preferably with a continuous wall thickness of 0.2 to 0.4 mm. When using polyurethanes with a hardness of 30A to 70A, the wall thickness can be increased to up to 1.0 mm. The self-righting of the segment under external deforming force is a key factor in determining the functionally relevant balance between wall thickness and material hardness. Ideally, the inner lumen of segment 41 should be circular in cross-section without any external force. When a force equivalent to a water column of 15 to 25 cm, preferably 5 to 15 cm, applied uniformly and from all sides over a central 3 cm section of the segment, the segment wall collapses, sealing the lumen. Opposing wall sections should at least come into partial contact, i.e., touch each other. Likewise, spontaneous alignment to the ground state should be achieved during longitudinal axial torsion of the segment, or spontaneous alignment in trans-anal position should be supported. Fig. 2a illustrates once again the attachment points 51 of the two-chambered balloon body on the continuous support 41, and indicates the balloon shape that develops when the compartments thus created are filled, provided they are properly fixed. According to Fig. 1b, the described lumen-closing deformability of segment 25 can be supported by helical struts 43 extending over the inner or outer surface of segment 25, which can be arranged parallel to each other in the same direction, offset at a certain angle. The struts can also be arranged singly or in multiple (offset) opposite directions. The resulting mesh-like structure can have thin-walled areas 44 in the regions 44 between the struts, which can be reduced to wall thicknesses as low as 0.1 mm. In casting processes, the struts also serve to ensure a sufficiently fast flow of the plastic mass in the mold if the very thin-walled surfaces 44 described above are to be successfully formed. Fig. 2a shows the previously described continuous base body 41 combined with a balloon element, which forms only a single fillable intrarectal chamber 48. The balloon is attached to the attachment points 51, which run circularly around the circumference of the funnel section 3. A second trans-anal balloon segment is not provided. Fig. 2b shows an embodiment in which only a trans-anal balloon component 49 is applied, but an intra-rectal balloon component is missing. The trans-anal balloon can preferably be hourglass-shaped to optimally conform to the contours of the anal canal for better in-situ anchoring. Accordingly, the balloon-less, funnel-shaped olive can have a correspondingly larger diameter and offer sufficient contact surface 53 to anchor the device adequately in the rectum.

Claims

Device for the continuous drainage of stool from a patient's rectum into an external bag-like collection vessel and / or for closing the rectum, comprising: a) a single-chambered balloon (8) with a balloon element forming only a single fillable intra-rectal chamber (48), or b) a double-chambered inflatable balloon (8) having an intra-rectal section (9) and a trans-anal section (10), wherein the single- or double-chambered balloon (8) is fixed to a single supporting carrier body (41), preferably manufactured in one piece, which has an inner lumen, characterized in that the carrier body (41) comprises an olive-shaped funnel element (3) and a connector element (4), as well as a central segment (25) arranged between them, wherein the in situ trans-analThe central segment (25) of the support body (41) has such elastic and self-righting properties that it collapses in a lumen-closing or -constricting manner when a small external force is applied, and spontaneously returns to its lumen-opened circular original shape due to its elastic restoring force when the external force decreases. Device according to claim 1, characterized in that the support body (41) is manufactured from a single piece throughout. Device according to claim 2, characterized in that the support body (41) is manufactured in one operation from an elastic plastic material, preferably by means of an injection molding, hot casting, dipping, pressure or sintering process. Device according to one of claims 1 to 3, characterized in that the support body (41) consists of polyurethane of hardness 80A to 60D, preferably in a continuous material wall thickness of 0.2 to 0.4 mm. Device according to one of the preceding claims, characterized in that the support body (41) consists of polyurethane of hardness 30A to 70A, with a wall thickness of up to 1.0 mm. Device according to one of the preceding claims, characterized in that the central segment (25) collapses in a lumen-closing manner when subjected to a force equivalent to a water column of 15 to 25 cm acting uniformly and on all sides over a central distance of 3 cm of the segment (25), or to a water column of 5 to 15 cm acting uniformly and on all sides. Device according to one of the preceding claims, characterized in that the central segment (25) has helical struts (43) extending over the inner or outer surface of the segment. Device according to claim 7, characterized in that the helical struts (43) are arranged parallel to each other in the same direction, offset at an angle. Device according to claim 7, characterized in that the helical struts (43) are arranged in a single or multiple counter-rotating manner, so that a mesh-like structure is formed. Device according to claim 9, characterized in that the mesh-like structure has thin-walled surfaces in the areas (44) between the struts, with a wall thickness of 0.1 mm or more.

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