Device for the repetitive supply and draining of substances for medical therapy, and system and method for producing faecal continence by intermittent colon lavage by means of a permanently placed trans-anal occluding or access catheter

Abstract

The invention relates to a device, a system and a method for carrying out a lavage-like, repetitive supply and draining of a flushing, cleaning or other therapeutically active substance, in particular in the context of an evacuation by irrigation of a patient's colon. The device has a bag unit or bag/hose unit which has a combined flushing and collecting function and also at least one flow-directing function which prevents flushing liquid which has already been drained into the bag from flowing back towards the patient. The invention also relates to the combination of the bag unit or bag/hose unit with a catheter unit which can be placed in position in a permanent and atraumatic manner, is positioned trans-anally, seals off the anal canal, preferably by means of a dumbbell-shaped balloon component, and can be left in the patient's rectum, preferably after lavage is complete.

1 . A device for carrying out a lavage-like, repetitive supply and draining of a flushing, cleaning or other therapeutically active substance, in particular in the context of a large lumen flushing or draining cleaning of a patient's colon, comprising:
 a catheter unit (SK) for receiving and draining feces, which can be permanently placed atraumatically and anorectally;   a flushing and collecting bag unit ( 5 , SB) with a combined flushing and collecting function; and   a hose unit ( 4 ) connecting the catheter unit (SK) to the flushing and collecting bag unit ( 5 , SB), comprising a single-lumen or multi-lumen, film-like, flatly collapsible, hose;   characterized by at least one element with a flow-direction-dependent throttle function, which allows a large-lumen draining of the patient's intestinal contents, and which facilitates a supply of liquid towards the patient that is throttled in relation to the draining and thereby reduces the supply to a non-irritating amount that is compatible with the organ.   
     
     
         2 . The device according to  claim 1 , characterized in that both the inward flow from the flushing and collecting bag unit ( 5 , SB) towards the patient, as well as the outward flow from the patient to the flushing and collecting bag unit ( 5 , SB) are flow-directed by corresponding elements, for example valves, in particular one-way valves, or by valve-like functional or control elements. 
     
     
         3 . The device according to  claim 1 , characterized in that merely the outward flow from the patient to the flushing and collecting bag unit ( 5 , SB) is flow-directed by a corresponding element, for example a valve, in particular a one-way valve, or by a valve-like functional or control element. 
     
     
         4 . The device according to  claim 1 , characterized in that the supply to the patient takes place either via the same lumen as the draining, or by a separate lumen having a smaller cross-section relative to the draining lumen. 
     
     
         5 . The device according to  claim 1 , characterized by an element with a feces-separating function, which allows shaped fractions in the bag ( 5 , SB) to be separated out of the intestinal contents already drained into the bag and to keep them captive there and/or merely allow the return flow of liquid fractions of the repetitively supplied and drained medium from the bag to the patient. 
     
     
         6 . The device according to  claim 5 , characterized in that the separating element has a mesh-like, a web-like or a sieve-like perforated structure, which allows liquid or feces suspended in liquid to pass through, but prevents formed feces fractions from flowing back to the patient. 
     
     
         7 . The device according to  claim 5 , characterized in that the bag ( 5 , SB) has a separating layer (TL), which either completely separates two compartments ( 5   c,    5   d ) from each other, or is configured as a feces-separating or feces-filtering, mesh-like, fleece-like or sieve-like perforated structure, which separates liquid feces fractions from solid ones. 
     
     
         8 . The device according to  claim 5 , characterized in that an element ( 12 ) with a flow-reducing function and, preferably terminally, an element ( 13 ) with a flow-directing function is integrated or disposed inside the bag ( 5 ), in the terminal extension of the connecting hose unit ( 4 ) having a single-lumen, combined supply and draining structure. 
     
     
         9 . The device according to  claim 1 , characterized in that the catheter unit (SK) passing through and sealing the anal canal over the entire length thereof is configured as a single-walled or a double-walled balloon component ( 2 ), preferably made of polyurethane formed from blow molding to the anatomically required dimensions. 
     
     
         10 . The device according to  claim 9 , characterized in that the single-walled or a double-walled balloon component ( 2 ) is configured to be dumbbell-shaped on the exterior thereof, such that the waist-like tapering passes through the anal canal, while a distal widening is disposed intrarectally and a proximal widening is disposed extracorporeally. 
     
     
         11 . The device according to  claim 1 , characterized in that a preferably tapered hose component ( 4   d ), which is feces-draining, can be placed trans-anally and bears the balloon component is disposed inside a dumbbell-shaped balloon component, which hose component is reinforced in particular by an undulated profile and therefore facilitates comparable elastic straightening properties with lower wall thicknesses in relation to a hose which is formed in a non-undulated manner of the same diameter and material. 
     
     
         12 . The device according to  claim 1 , characterized in that the connecting hose unit ( 4 ) and/or a connector ( 17 ) disposed on the proximal end thereof is flatly collapsible from outside atraumatically with a slight exertion of force in order to thereby prevent the development of pressure spots in the event that the patient lies on it. 
     
     
         13 . A system (S) for establishing and/or maintaining a quasi-continent state of a patient by the greatest possible removal or lavage of intestinal contents, comprising:
 a catheter unit (SK), which can be placed atraumatically and permanently in a trans-anal manner, passing through and sealing the anal canal preferably over the entire length thereof;   a hose unit ( 4 ) attached proximally to the catheter unit (SK) and made of easily collapsible, film-like hose material,   wherein the hose unit ( 4 ) transitions proximally to a likewise atraumatically collapsible connector element ( 17 ); and   a flushing and collecting bag unit ( 5 , SB) having a combined flushing and collecting function according to the invention for a detachable connection to the connector element ( 17 ).   
     
     
         14 . The system (S) according to  claim 13 , characterized by an extracorporeal collecting and/or degassing unit that can be optionally connected to the connector element ( 17 ). 
     
     
         15 . A method for establishing a quasi-continent state of a patient in the case of an ano-rectally incontinent patient, wherein with the permanent trans-anal placement of a large-lumen supply and draining catheter unit, said catheter unit is used as access for an intermittent evacuation or high-volume lavage of the colon, which keeps the descending colon or the rectum clear of feces, and thus temporarily facilitates the state of a so-called quasi-continence, wherein furthermore the combined flushing and collecting bag unit ( 5 , SB) remains connected to the catheter unit following the lavage until the colon is completely evacuated, and wherein the catheter unit (SK) placed in the anus ensures a continuous sealing of anus in the interval between the irrigations and is terminated with a lightweight, film-like, secretion collecting bag acting in a degassing manner or a degassing element filled with gauze-like or absorbent cotton-like material. 
     
     
         16 . The method according to  claim 15 , characterized in that the connection of the catheter unit (SK) to a flushing and collecting bag unit ( 5 , SB) or a terminating, collecting and/or degassing element remaining in the patient preferably takes place close to the patient's body at a distance from the anus of 30 cm to 80 cm.