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.

Description

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS[0001]This patent application claims benefit of International (PCT) Patent Application No. PCT / IB2017 / 001458, filed 27 Nov. 2017 by Advanced Medical Balloons GmbH for DEVICE FOR THE REPETITIVE SUPPLY AND DRAINING OF SUBSTANCES FOR MEDICAL THERAPY, AND SYSTEM AND METHOD FOR PRODUCING FECAL CONTINENCE BY INTERMITTENT COLON LAVAGE BY MEANS OF A PERMANENTLY PLACED TRANS-ANAL OCCLUDING OR ACCESS CATHETER, which claims benefit of German Patent Application No. DE 10 2016 014 053.4, filed 25 Nov. 2016, which patent applications are hereby incorporated herein by reference.FIELD OF THE INVENTION[0002]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 collect...

AI Technical Summary

Benefits of technology

[0009]For the efficient drainage of shaped stool fractions, all segments of the catheter system are preferably equipped with a diameter large enough for the passage of the stool. As a part of the invention, functional components are described which separate the shaped stool fractions from the repetitively supplied irrigation medium in the system so that only aqueously suspended stool flows back to the patient. The efficient diversion and separation of shaped stool portions reduces the number of irrigation cycles substantially in that the stool fragments do not have to be brought to the patient's intestines in an aqueous suspension in order to be drained, as required with conventional systems that normally have small-lumen catheter shafts.

[0017]According to the invention, an extracorporeal supply and draining hose connects to the head unit, and said hose is terminally connected to a flushing and collecting bag. In its preferred embodiment, the draining hose is thin in a film-like manner so that, even in a filled state, a large drainage lumen can be achieved, but in an unfilled state, the hose collapses into a flat, strip-like structure and thereby optimally causes little irritation to the patient and prevents pressure spots in the event that the patient lies on the hose.

[0018]The hose segment connecting the head unit to the flushing and collecting bag can have one or a plurality of lumens. Said lumens can be arranged, for example, concentrically to each other or even be disposed in parallel. Both structures are preferably made of a collapsible tubular film structure. The double-lumen arrangement makes it possible to completely separate the supplied liquid from the drained intestinal contents. In this special case, both lumens terminate at the distal end of the device at approximately the same height. If flow-directing components are used in the respective supply and draining hose portions, the supply liquid can be virtually completely protected from being contaminated by already drained intestinal contents or by surfaces contaminated with intestinal contents.

[0022]The invention describes a device 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, wherein the device has a bag or bag / hose unit with a combined flushing and collecting function, which has at least a flow-directing function, which rules out the direct return flow of irrigation liquid that has already been drained into the bag to the patient, and also allows the deposit of shaped fractions from the already drained flushing liquid in the bag. The combination of the bag or bag / hose unit according to the invention with an atraumatic, trans-anally placed catheter unit, which seals the anal canal preferably with a dumbbell-shaped balloon component, makes large-volume inflows possible which enable a virtually complete evacuation or lavage of the colon without causing irrigation liquid to leak out of anus during the inflow. The atraumatic placeability of the catheter unit furthermore allows the catheter to be left in the patient's rectum after lavage is complete, and not to be removed until the colon is completely evacuated, whereby soiling of the patient from subsequent stool evacuations can be prevented. In the case of the permanent trans-anal placement of the catheter unit, it is possible for it to be used for an intermittent evacuation or lavage, which keeps the descending colon or the rectum clear of feces, and thus facilitates the status of a quasi-continence. In the interval between irrigations, the catheter unit placed in the anus ensures a continuous sealing of the anus. It is then terminated with an especially lightweight, film-like, degassing and / or secretion-collecting element. The connection of the irrigating bag / hose unit as well as the terminating, degassing units is accomplished with an atraumatic, flatly collapsible connector unit, which prevents the development of pressure spots.

Problems solved by technology

However, the previously known design of flushing systems for colorectal irrigation is unsatisfactory in many respects.

The unguaranteed option of long-term positioning of the catheter in the rectum which precludes trauma is problematic in clinical use in this respect, since even though the intestinal contents are mobilized by the irrigation, they are frequently only evacuated in many subsequent fractions following the irrigation.

In addition, when the cycle is repeated multiple times, irrigation liquid increasingly gets into higher sections of the colon, which leads to a further delay in eliminating the mobilized intestinal contents.

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