Patent Application
20190358390
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 in a direct manner and also allows shaped fractions to be deposited out of the flushing liquid in the bag. 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 an 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. The permanently trans-anally placed catheter unit can be used for intermittent evacuation or lavage to keep the descending colon and rectum clear of feces and thus bring about a state of quasi-continence.
The irrigation of a patient's colon or rectum by means of combined supply and draining catheter systems is a common part of medical practice and is used in the case of a variety of indications.
However, the previously known design of flushing systems for colorectal irrigation is unsatisfactory in many respects. In particular, in the case of conventional irrigation systems, the catheter part placed trans-anally in the rectum must be removed immediately following the colorectal irrigation. Due to the normally rigid design of the catheter shaft that supports comfortable trans-anal insertion, it is possible for a traumatic perforation of the wall of the intestines to occur in the event of dislocations of the catheter directed towards the intestines. 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. The subsequent bowel movements persisting over many hours normally go hand in hand with substantial soiling of the patient.
So-called return-flow enemas are normally carried out to clean or evacuate the intestines or to mobilize solid stool from a patient's rectum or colon. With this method, irrigation liquid is filled into a container, which is connected to an irrigation catheter normally secured with a retaining balloon and which is inserted trans-anally and extends into the rectum and is placed there via a hose system. The container is lifted above the patient's level to supply the medium and lowered below the patient's level to drain the mobilized intestinal contents. The method is repeated until the stool to be washed out of the intestines has dissolved or is suspended in the irrigation medium enough that it can be drained into the receiving container as much as possible during the concluding evacuation of the intestinal contents. Several successive lifting and lowering cycles are required for an efficient suspension of stool, wherein the method is normally protracted. 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.
As a result, a system that minimizes the number of required flushing and draining cycles as much as possible would be desirable. The system should be suitable as a whole for a rapid and efficient washing out of intestinal contents, in particular also of formed portions of stool. Furthermore, it should also be possible for the irrigation system to remain in the patient's rectum after the end of the irrigation process over several hours to possibly even days in order to be able to receive intestinal contents mobilized by the irrigation that are eliminated in a delayed manner and/or to guide them into a closed collection system.
The solution to this problem succeeds in the context of a generic device, comprising a catheter unit for receiving and draining feces, which can be permanently placed atraumatically and anorectally, and passes through and seals the anal canal preferably over the entire length thereof, a flushing and collecting bag unit with a combined flushing and collecting function, as well as a hose unit connecting the catheter unit to the flushing and collecting bag unit, comprising a single-lumen or multi-lumen, film-like, flatly collapsible hose, by an element with a flow-directing or a flow-direction-dependent throttling function, which throttles the inward flow of liquid to the patient to an atraumatic, non-irritating amount that is compatible with the organ and reduces or rules out the unchecked, high-volume return flow of irrigation liquid already drained into the bag to the patient through a draining hose lumen. As a part of the application, the term “placeable in an atraumatic manner” can/should be interpreted to the effect that it is free of a rigid, shaft-like supporting body. Furthermore, the term “placeable in an anorectal manner” can/should signify that the body in question is placed in the rectum through the anus. “Flow-directing” should be understood as a function which allows different flows, in particular flow amounts, depending on the flow direction. “Throttling” should be understood as a reduction in the flow amount or flow speed.
This structure according to the invention makes it possible to use the same bag to receive the irrigation liquid and to receive the washed-out intestinal contents, because a return flow of already washed-out stool fractions to the patient is completely or largely ruled out.
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.
A complete or partial separation of supplied irrigation medium and drained intestinal contents can take place as a result of corresponding functional elements both in the head-part segment, in the trans-anally placed segment, in the supplying or draining hose segment between the head part and the container, or can even be integrated into the container itself.
Colorectally irrigating catheter systems that are designed to be large lumen and are placed trans-anally are known, however, they are problematic in their application especially in the region of the trans-anal catheter segment. The typically relatively rigidly designed shaft elements thereof dilate the anal sphincter muscle and also go hand in hand with a risk of perforating the exposed sections of the intestines.
An influx of irrigation medium to the intestines that is too rapid and cannot be modulated is also problematic in the case of large-lumen irrigation and enema systems. If too great a volume flows too rapidly into the intestines, this can trigger painful sensations and even spasmodic contractions. As a result, a function restricting the flow towards the patient would be desirable, which, in the simplest case, can be facilitated by a throttling dimensioning in the supplying components.
A further problem with conventional colorectal irrigations is the intake of larger flushing volumes.
Many patients cannot safely accommodate large intake quantities in their intestines, e.g., due to a poor general state of health or because of a weak sphincter muscle. Even though the patient can initially prevent a leakage of the intestinal contents by contracting the sphincter muscle, the sphincter generally becomes fatigued after several minutes. Then it is possible for the intestinal contents to run out past the trans-anally placed shaft of the irrigation catheter.
In the preferred embodiment of the present invention, the catheter has a head unit, which is designed to stay permanently and atraumatically in the rectum. Commercially available stool drainage or fecal management systems are a possibility as a basic design type for continuous stool drainage in this case. These systems have a simple retention balloon with a toroidal design which rests anchored on the base of the rectum. In its extension, the balloon is connected to a simple trans-anally feces-draining hose, which is radially folded over or inside out in the anal canal.
Furthermore, head units with a special trans-anal balloon seal can be used in the context of the invention such as those described for example in EP 1 784 140 B1, WO 2013/026 564 A1 or DE 10 2008 055 674 A1. In addition to a dumbbell-shaped balloon for combined rectal retention and trans-anal sealing, said head units also have a trans-anally positioned, axially and radially compressible shaft component supporting the balloon, which shaft component receives the stool rectally and guides it through the anus. The described design has proven to be especially atraumatic and allows dwell times of several hours to days. In addition, the head units can be adapted to the respective sphincter opening and thereby ensure a dynamic acting, very efficient seal of the anal canal.
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.
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.
The container that stores the intake liquid or receives the intestinal contents eliminated by the patient constitutes an essential component of the flushing system presented in the invention. The invention proposes both single-chamber as well as double-chamber systems in this case.
In the embodiment with one chamber, a feces-separating system is preferably provided, which retains shaped stool fractions and only allows the inflow of suspended stool particles to the intestines. The container functions so to speak as a stool separator. In the two-chamber design, one compartment of the container contains the irrigation liquid, while the other compartment, which is completely separated from the first one, receives the drained intestinal contents.
Flow-directing valve mechanisms are provided in both the single-chamber as well as the double-chamber container system to direct the respective flows double. A flow-directing function can optionally be integrated into the connecting hose system between the catheter element and the container. Installation in the trans-anally placed head unit is also conceivable. In the case of the components to be used, the invention starts with especially lightweight, atraumatically collapsible, preferably film-like, components having a flow-directing function.
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.
Other features, details, advantages, effects and functional aspects of the invention are yielded from the following description of several embodiments of the invention as well as on the basis of the attached drawings, which show:
In the context of the invention,
To separate or deposit already drained, flaky or shaped stool fractions from the bag contents, the device is provided with a depositing inlet element 8, which projects into the interior of the bag preferably up to the upper rim of the bag and ensures that already drained shaped stool fractions are prevented from reentering the intestines during supply phases. The element 8 can be designed for example as a tubular-mesh-like structure or even as a sieve-like tube with multiple perforations. To affix and protect the inlet element in the bag, the element 8 can also be enclosed by a separating film 9 inside the bag, which is likewise perforated, sieve-like or mesh-like, the perforations of which are in turn preferably larger than the perforations of the element, whereby especially large, shaped stool fragments are prevented from infiltrating into the compartment accommodating the element. The occlusion of the inlet element via stool from the repetitive lifting and lowering inflow is prevented in the depicted design by the combination of an inlet element extending an especially long way inside the bag up to the upper rim of the bag as well as by an additional filtering function upstream from the inlet of the supplied liquid. The single-chamber bag is filled through a sealable opening 10.
As another feature, the bag can be provided with an IN scale 14, which indicates the volume filled into the bag. Opposing it is an OUT scale 15, which is located in a position rotated by 180 degrees and measures the outflowing material when the bag is turned upside down following the initial repetitive flushing and draining and then can be used on a sustained basis as the collecting bag. The bag is provided with corresponding mounts 16 for this in the lower region.
The illustration furthermore shows a head unit preferably designed as a part of the invention, which is positioned in the rectum with a trans-anally sealing retention balloon 2, which comprises a rectally placed widening 2a, a preanal widening 2b and trans-anally tapered portion 2c. It also has a special shaft hose 4c bearing the balloon, which shaft hose collapses radially in an elastic manner in the case of anally applied force and spontaneously straightens when the force abates, as well as compresses like an accordion with the axial application of force and thus prevents the intestines from getting perforated.
In the functional transition from a double-chamber system to a single-chamber system, the separating layer TL can be configured as a mesh-like, fleece-like or sieve-like perforated element and thereby prevent the transfer of shaped stool fractions from the compartment 5d into the compartment 5c.
Attached to said connector element in cyclical alternation, as another component of the set, is a bag system 5, SB for the combined high-volume irrigation and subsequent drainage, or, alternatively, a simple, lightweight collection bag SLB for receiving outgoing secretions with a degassing function according to
Connecting the head unit, which remains trans-anally in the patient on a sustained basis, to the respectively attached components SB, SLB and SG is preferably established by a connector element 17 whose design corresponds preferably to that of
The special structural design of the device described here as a set of product components is conceived primarily for immobile patients, who are continuously fecally incontinent or for sporadic, in some cases, prolonged intervals and predominantly produce feces of normal, shaped consistency. The especially high-volume, reliably trans-anally sealing lavage of the colon that can be executed with the system prevents stool from being able to form and harden in the colon, and keeps the descending colon going towards the rectum largely clear of feces, so that, in an ideal case, no feces can advance into the rectum, and thus quasi-continence is facilitated.
The method according to the invention for establishing a quasi-continence combines the following functional features of the set:
The method for achieving a quasi-continence through a high-volume washout of intestinal contents is described as follows:
In the case of the head piece depicted in
The two segments 101, 102 of the film 108 can be separated from each other and/or be separated in a sealing manner by a funnel element 103 inserted distally into the anchor balloon 101. Due to the permanent connection of the balloon film 108 in the region of the intra-rectal anchor balloon segment 101 to the funnel element 103, a fillable compartment 106 forms that can unfold like a type of collar around the lateral sections of the funnel element 103. The connection can be simplified and/or improved by specially designed preformations 107 of the funnel surface and/or the balloon film 108, which are described in more detail in the following.
Following the trans-anal segment 102 towards the proximal direction is a hose unit 105 connecting the head unit 101, 102 to a flushing and collecting bag or to a collecting and degassing unit.
The embodiment of a head piece for a device according to the invention depicted in
The previously described techniques can be used for affixing and for the sealing termination of the components required for this embodiment in the transition area between the intra-rectal and trans-anal compartments 106, 127.
Analogously, the tubular film segment 127 preferably emanating from the intra-rectal anchor balloon segment 101 can be combined with a radially deformable tubular mesh 130 fitting snuggly under slight tension to the trans-anal contours. In a non-deformed, tension-free initial state, the tubular mesh 130 has an open lumen of approx. 2 to 3 cm. The radially directed restoring force on the anus that develops with lumen constriction is low in this case and rules out the development of pressure ulcers. If there is a tone reduction of the anal sphincter with a defecation reflex, the tubular mesh 130 follows the then opening trans-anal canal and thus facilitates the outflow of stool. The tubular mesh 130 connects the intra-rectal funnel 103 with a preanal connecting element or connecting hose 104 preferably continuously. It is preferably arranged inside the hose segment, but alternatively can also run over the outer surface thereof. In a radially constricted state 130a, the mesh 130 that is constructed preferably of rigid, flexibly deformable filaments has a considerable increase in length, which is taken into consideration by a corresponding length requirement of the surrounding trans-anal tubular film 127.
Assembling the components thereof follows the previously described techniques.
Alternatively, the two hose layers 127a, 127b can also be made of separately fabricated tubular films.
The space 128 that forms between the two hose layers 127a, 127b can be filled partially or completely extracorporeally with a medium via a supply 131 guided via a connecting element or connecting hose 104 or even be completely evacuated.
In an evacuated state, the two hose layers 127a, 127b fit closely next to each other and behave virtually as a one-layer wall. In a filled state, the two layers 127a, 127b separate from each other, and the drainage lumen is opened to a maximum.
In a bulgingly filled state, the inner layer 127b expands towards the center of the drainage lumen and seals it so that it is impervious to liquid. The outer layer 127a, on the other hand, expands towards the anal wall and fits snugly against it, likewise in a sealing manner following the respective anatomy.
In the case of partial filling or filling with a few milliliters of filling medium, the two layers 127a, 127b separate. The two thin-walled film layers 127a, 127b slide freely displaceably to each other, virtually supported by the filling medium. Due to the free play and the sliding of the film layers 127a, 127b, lesions in the especially sensitive region of the anal canal, such as those known from statically abutting, less dynamic films, can be better prevented.
Connecting the components thereof to the proximal end of the funnel can take place on the basis and/or by means of an annular support 123, which is inserted into an annular preformation 124 on the proximal rim of the funnel. In this case, the inner layer 127b can be guided via the ring 123, as in
The previously described elements 125, 130 are preferably installed between the two film layers 127a and 127b, connecting the funnel 103 to a connecting element or connecting hose 104.
In the case of all embodiments according to
All these head parts 101, 102 according to one of the
The device 201 is used for flushing and/or sealing a natural or artificial outlet from the bowel. It comprises a preformed hose 202 that is folded back on itself made of a thin-walled material, for example polyurethane with a Shore hardness degree of A 90 and a wall thickness of less than 25 μm.
The hose 202, whose original diameter is approximately between 15 mm and 30 mm, obtains two radial widenings 203, 204 as a result of the preformation. The one, preferably larger, widening 203 is located approximately in the center of the hose, which forms the patient-proximal end of the device 201 after fold-over. The other preformation 204 is located approximately in the center of the outward hose section 205 after the fold-over, while the inward hose section 206 does not have this kind of widening, but has a constant cross-section.
One or both of the free ends 207, 208 of the two hose sections 205, 206 can be connected to a connector piece 209, which is sleeve-shaped for example. The connector piece 209 can have, in particular in the region of its patient-distal end, an internal and/or external thread for connecting various medical apparatuses, for example a flushing and collecting bag 5, an extracorporeal degassing unit or the like.
It is preferred that the outer layer 205 of the balloon 202 be adhesively bonded to the exterior of the connector piece 209, and the inner layer 206 of the balloon 202 can be adhered to the inside thereof. As a result, the cavity 210 between the inner and outer layers 205, 206 of the balloon 202 is sealed in an airtight manner; located only in the region of the connector piece 209 is a connection to the outside (not shown in the drawing) to which a source with a medium that can be pressurized can be attached for deploying the balloon 202. Instead of a sleeve-shaped connector piece 209, the two balloon layers 205, 206 can also be fastened directly to each other, for example adhered together.
Due to the relatively great material hardness of the balloon 202, said balloon is only marginally elastic and, in an inflated state, assumes its shape predetermined by the preformation that is recognizable in
The spherical widening 203 is placed in a deflated state in the patient's rectum (indorectal section), while the subsequent, cylindrical section 211 up to the annular or discoid widening 204 leads through the anal canal to the outside (transrectal region), [and] the patient-distal widening 204 is located in the anal fold.
In the transrectal region 211 between the two widenings 203, 204, the two layers of the balloon 202, namely the outer layer 205 and the inner layer 206, are connected to one another, preferably by welds 212 or bonds. In doing so, these can be punctiform, linear or laminar welds. The depicted embodiment foresees four welding lines 212 running in the axial direction, each of which is offset from one another by approximately the same circumferential angle. Thanks to said welded connections 212, the inner lumen 213 within the inner layer 206 of the balloon 202 can open more easily when the intestines are supposed to be evacuated.
In the region of the patient-proximal widening 203, the inner lumen 213 is kept open by a reinforcing sleeve 214, the length of which is preferably the less than or equal to the axial extension of the radial, indorectal widening 203 of the balloon 202. The material hardness of the reinforcing sleeve 214 is preferably less than or equal to the material hardness of the balloon; the sleeve 214 obtains its rigidity from its increased wall thickness. The same material as for the hose or balloon 202 can preferably be used for the sleeve 214. This facilitates the affixing of the sleeve 214 inside the inner lumen 213, in particular by adhesion with the inner layer 206 of the balloon 202, wherein, in such a case, a means solubilizing the material in question can be used as the adhesive or for welding.
A hose 215 extends preferably inside the inner lumen 213 from the patient-proximal end 203 to other side of the connector piece 209. An irrigation medium can be introduced into the patient's intestines through said hose 215, which can be affixed to the balloon 202, preferably on the inner layer 206 thereof, for example by adhesion. The opening of the hose 215 is located at the forward-most region of the indorectal end 203 of the device 201 so that, in such a case, no bacteria can be washed into the intestines from the transrectal region 211 or from the region on the other side of the transrectal widening 204. The hose 215 can be fed internally through the reinforcing sleeve 214 or between the same and the inner layer 206.
An occlusion balloon 216 is also provided in order to be able to optimally block the central lumen 213 during an inflow. Said balloon preferably sits inside the reinforcing sleeve 214 and, in the case of the embodiment according to
Discharging at the occlusion balloon 216 is another hose 217, with which a preferably liquid pressure medium can be guided into the occlusion balloon 216 in order to seal the lumen 213 in the region of the reinforcing sleeve 214. The hose 217 is guided through the connector piece 209 on the inside of the balloon inner layer 206, and is therefore accessible from the outside. Approximately in the region of the discharging of the hose 217 into occlusion balloon 216, the latter is affixed to the reinforcing sleeve 214, for example adhered approximately in a punctiform manner.
A short hose piece can be formed on the respective head unit 2, 101, 102, 201, 201′, which hose piece then can merge into or discharge into a hose 4, whereby then there is proximally a connector 17 for optionally connecting a flushing and collecting bag 5 or a collecting and degassing unit or a further peripheral element.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2016 014 053.4 | Nov 2016 | DE | national |
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.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2017/001458 | 11/27/2017 | WO | 00 |
