DEVICE AND METHOD FOR THE LAVAGE-TYPE INTRODUCTION OF A FECAL TRANSPLANT OR OF A THERAPEUTICALLY EFFECTIVE SUBSTANCE INTO THE COLON OF A PATIENT

Abstract

The invention describes a device and a method for a lavage-type introduction of a stool transplant or of another, local or topically effective substance through the anus into the colon of a patient, wherein the substance to be introduced is flushed also into the upper parts of the colon of the patient in a torrent-like manner through correspondingly large-lumen catheters; said device comprises an ano-rectal placed head part remaining inside the patient from the beginning until the end of the application and a system of exchangeable bags, which are connectable to the head part, whereby two different types of bags can be applied, one of which is designed for the cleaning lavage, while the another is designed for the introduction of a substance or a transplant.

Claims

1. Device for a lavage-type introduction of a fecal transplant or of another, local or topically effective substance through the anus into the colon of a patient, wherein the substance to be introduced is spread on the mucous membrane of the colon by a repetitive change of lavage-type inflow and outflow in and out of the colon in such a way, that the mucous membrane is wetted in an area as large as possible, and that especially the upper portions of the colon beyond the rectum can be reached, too, wherein the device comprises a patient-sided head part (2) remaining inside of the patient preferably during all phases of the procedure, which comprises a large-lumen shaft element (4) supporting a dumbbell- or mushroom-shaped anchoring and sealing balloon (3), wherein said balloon (3) consists of an intra-rectal portion (3a) as well as of an extension portion (3b or 3c) proximally adjacent to the intra-rectal portion (3a) and tapering in diameter, which extension portion (3b or 3c) is placed inside the anal channel or extends through the anal channel, wherein the large-lumen shaft element (4) of the head part (2) can be respectively connected to two different vessels or bag systems of specific functionality, whereby one of the vessels is designed as a lavage bag for the lavage-type cleaning preparation of the colon with an irrigation fluid and comprises a function for throttling of the inflow to the patient as well as a function for separating of stool, and wherein the other vessel is designed for the subsequent instillation of a substance and comprises only a throttling function without any separating function, whereby both bag systems can be turned upside down after the repetitive flushing of the respective medium and can be used for the collection of the subsequently drained intestinal contents, characterized in that the flow determining cross section and the length of the supply line from a connected vessel to the patient are adjusted or adjustable in such a way that, in the state of unthrottled inflow to the patient, a volume flow of 1000 mL in less than 30 seconds is achieved, preferably in less than 15 seconds.

2. Device according to claim 1, characterized in that in all inlet and outlet segments of the device, the cross sections are identical or nearly identical, and amount to 12 to 25 mm, preferably to 17 to 22 mm.

3. Device according to claim 1, characterized in that the entire length of the inlet and outlet tubing connection from the head part (2) up to the connected vessel amounts to 1.0 to 1.7 m, preferably to 1.3 to 1.5 m.

4. Device according to claim 1, characterized in that the vessel on the bag's sided portion of the device comprises two scales, wherein one scale is for reading off the input volume during the cyclic inlet and outlet from the patient's colon (In-scale), whereby the vessel is held with its outlet portion (14) downwards by the user at the handle (13), or is placed alternately at a level above and below the patient, and wherein another scale is placed on the vessel 180 inverted and is for reading off the volume drained or, respectively, collected from the colon, whereby the outlet portion (14) points upwards and the vessel remains permanent in this position at a level below the patient, for the purpose of collection.

5. Device according to claim 1, characterized in that the closing function (19) is achieved by a torsion twist of a tube portion (20), which is fixed at its end sides to the inner surface of two tube elements (19a) and (19b) rotating one inside the other, wherein an axial torsion from 90 to 270 degree provides a complete closure of the tube portion.

6. Device according to claim 1, characterized in that the closing function is achieved by a clamp-type element (25) generating in a closed state a tension, which can be set free by releasing of a latch, unlocks the closure and opens the lumen of the inflow and outflow tube element.

7. Device according to claim 1, characterized in that the balloon is fillable with an air volume, which is approx. 10 to 20% below the volume of the freely unfolded balloon which is preformed to the required working dimension during manufacturing.

8. Device according to claim 1, characterized in that the large-lumen shaft element (4) folds elastically at a resting tone of the adjacent sphincter muscle of the patient and expands spontaneously up to its original round shape at a decreasing muscle tone.

9. Device according to claim 1, characterized in that the large-lumen shaft element (4) compresses along its longitudinal axis upon an axial displacement of the head portion from its trans-anal position and/or upon a collision of the dislocated head portion with the structures of the rectum, but returns into its tube-shaped preformed configuration upon a decreasing axial force.

10. Method for flushing of liquid substances or of substances dissolved in a liquid or of a stool transplant suspended in a liquid into the colon of a patient, comprising the following steps: a) introducing the patient-sided head part (2) of the device into the anus, so that the segment (3b, 3c) of the balloon body with tapered diameter is placed in the area of the sphincter, that is in a trans-anal position; b) filling of the entirely formed balloon (3) for the purpose of trans-anal sealing and fixation of the device with an air volume, which is approx. 10 to 20% lower than the volume of the freely unfolded, entirely shaped balloon element; c) connecting a lavage bag for the preparatory cleaning or, respectively, lavage of the colon to the head part (2); d) raising the lavage bag above the level of the patient's anus, especially above the level of the patient's body, with opened closure on the patient's side, so as to introduce a large liquid volume with a flush into the colon of the patient; e) turning the lavage bag upside down and lowering it below the level of the patient's anus, especially below the level of the patient's body, and the use as a collection bag; f) connecting a bag for the lavage-type introducing of a therapeutical substance or of a transplant to the head part (2); g) raising the bag for the lavage-type introducing of a therapeutical substance or of a transplant above the level of the patient's anus, especially above the level of the patient's body, with opened closure on the patient's side for introducing the volume of the therapeutical substance or of the transplant as a flush into the colon of the patient.

11. Method according to claim 10, characterized in that, before or during one of steps a) to c), the patient's sided portion of the device is closed or is being closed by a closing function (19).

12. Method according to claim 10, characterized in that, during one of steps d) or e), the lavage bag is raised above the patient's level and is subsequently lowered below the level of the patient's body in an alternating or cyclic mode.

13. Method according to claim 12, characterized by multiple repetitions of the cycle of flush-type inlet and outlet, whereby the lavage bag is exchanged, respectively, and replaced by a fresh lavage bag containing fresh liquid, while the patient's sided portion of the device remains inside the patient each time.

14. Method according to claim 10, characterized in that, after step e), the lavage bag is separated from the head unit, which remains in the patient's rectum, and is disposed.

15. Method according to claim 10, characterized in that, before step f), the bag for the lavage-type introduction of a therapeutical substance or of a transplant is closed or is going to be closed by a closing function (19).

16. Method according to claim 15, characterized in that, before step f), the closed bag for the lavage-type introduction is filled in its closed state with the therapeutical substance or with the transplant.

17. Method according to claim 10, characterized in that a lavage bag is used, which is provided with an inflow throttling function and with a separation function, which prevents stool already arrived in the bag from flowing to the patient.

18. Method according to claim 10, characterized in that a lavage bag is used, which is provided with a closure function (19), which is closed before filling with the respective medium and is opened only after the connection to the patient's sided portion of the device.

19. Method according to claim 10, characterized in that a lavage bag or an introductional bag is used, having a filling volume of 1000 to 2000 mL in total, so that the liquid to be introduced reaches the transversal portion of the colon and eventually also the ascending portion of the colon, whereby at least 1000 mL flow to the colon in less than 30 seconds, preferably in less that 15 seconds.

20. Method according to claim 10, characterized by a repetitive lavage-type introduction of the substance from the bag into the colon, analogous to the lavage.

21. Method according to claim 10, characterized in that the flow values are in a range of 1000 mL in 15 to 10 seconds.

22. Method according to claim 10, characterized in thatunlike the lavage bagthe bag used for the introduction of the substance or of the transplant is indeed provided with a fixed or adjustable throttle function, but not with a stool separating function.

23. Method according to claim 20, characterized in that, after a completed repetitive cycle of inflow and outflow of the substance to be introduced, the prepared substance can remain inside the patient for several hours, variably definable by the user, without a leakage of the prepared substance out of the anus.

24. Method according to claim 10, characterized in that, for the subsequent draining of the prepared substance out of the colon, the bag is lowered to a level below the patient and stays there until the colon has completely excreted the introduced substance.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The structural and functional features of the device according to the invention are depicted in the following figures.

[0022] FIG. 1 shows a device for the lavage-type repetitive pivoting introduction of a cleaning liquid into the colon, said device comprising the patient's sided portion as well as the bag's sided portion, in a schematic overview.

[0023] FIG. 2 shows an embodiment of a combined lavage and collection bag for an optional lavage-type cleaning of the colon preceding the instillation of the substance.

[0024] FIG. 3 depicts a special flow limiting or, respectively, throttling function inside of the in- and outflow tube system, on the basis of the torsion of a tube.

[0025] FIG. 3a depicts a preferred arrangement of the throttling function at the proximal end of the patient's sided catheter unit.

[0026] FIG. 4 shows a preferred embodiment of a head unit with a shortened balloon body, remaining inside the patient during the procedure.

[0027] FIG. 5 shows a head unit with a mushroom-shaped distal insertion element.

[0028] FIG. 6 shows a further vessel implemented as a bag, which is optimized for the large-volume lavage-type instillation of a therapeutical substance into the patient's colon.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] FIG. 1 shows a device according to the invention, for the lavage-type washing in of a substance into the colon of a patient, comprising an anorectal placed head portion 2 remaining in the patient's anus over the whole duration of the procedure and comprising a dumbbell-shaped or a mushroom-shaped balloon element 3, which combines the functions of a rectal retension and a trans-anal sealing and is mounted on a shaft element 4 which becomes elastically radially deformed or, respectively, folded when a force is applied on the wall of the shaft, and when the force in the anal channel is decreasing, spontaneously said shaft element 4 straightens up elastically. Upon an axial deflexion of the shaft's tube, said shaft element transforms from its trans-anal rest position into a single or multiple axial buckling, whereby any likelihood of potential perforations of the colon wall due to a shifting of the head portion of the drainage device into the upper intestines is almost excluded. Herein, the shaft element optionally has a corrugated, wavy profile, whereby, upon use of elastic materials such as for example polyurethane, good self-erecting properties can be achieved even at relatively small wall thicknesses of the shaft element on the one hand, and on the other hand, after overcoming of a special initial force for the transition of the shaft into the folded or compressed state, the radial folding and the axial compression of the shaft wall can proceed with a lower necessary force in the course of the further deformation of the shaft profile, or, respectively, the radial and axial deformation is relieved in comparison to the initial deformation.

[0030] A tube part 5 adjoins to the shaft tube proximally, which transitions at the free end into a catheter-sided connector element 6. The connector enables a reversibly detachable connection to a preferably bag-shaped vessel 7, which can be filled through a closable opening 8. The vessel 7 comprises a tube element 10, which changes over into a connector element 11, which is compatible with the connector 6. In the transition area to the tube 10, the vessel 7 integrates a flow restricting function 9, which either presets the outflow from the vessel fixedly through the number and size of openings, or is variably adjustable. Additionally to a bag-sided integrated throttling or, respectively, closing element, a separately implemented, simple, clamp-type or slidable closing element 12 can be inserted into the tube element optionally, preferably close to the connector.

[0031] FIG. 2 shows a vessel 7 according to the invention, which is implemented as a foil bag and primarily performs the function of a lavage-type cleaning colon rinsing, which preceds the washing in of the substance to be instilled in the application procedure. The bag comprises a handle 13 at the upper end. Preferably, the bag comprises only a single chamber, in which, during the pivoting procedure, the fresh flushing medium mixes with the content drained from the colon. The chamber is filled through an opening 8 at the upper end of the bag and is closed in a leakproof manner. At the bottom, the bag comprises an outlet portion 14, where a tube connector 10a is welded. Outwardly, the combined inlet and outlet tube 10 adjoins to said tube connector. Inwardly, said tube connector lines up with a thin-walled tube portion 10b, which has a valve-like function within the bag. The portion of said tube connector 10a, which protrudes inside the bag, is perforated. On the one hand, this special type of construction of said tube connector allows to separate formed stool, which is already in the bag, and to feed back only fluid content of the bag to the patient for the further irrigation. On the other hand, the volume stream can be throttled or, respectively, restricted through the perforations 15 of said tube connector in a fixed, that means not adjustable manner. The tube 10 outgoing from said tube connector should have a length from approx. 1.0 to 1.7 m, preferably from 1.3 to 1.5 m.

[0032] By means of the handle 13, the bag can be pivoted comfortably during the cleaning procedure. After the completion of the raising and lowering cycles, the bag is turned upside down and fastened at a level below the patient in a thenceforth collecting function. On its bottom edge, the bag comprises respective openings 16 for an upside down hanging position. Furthermore, it comprises a scale 17a for the detection of the inlet volume used for the cleaning (in-scale) and an out-scale 17b for the detection of the volume entirely received from the colon of the patient. Therefore, a balance can be made for the cleaning procedure, and the rest volume remaining inside the colon can be determined.

[0033] FIG. 3 shows a possible embodiment of the functional element 19, which combines the throttling, that means flow restricting function and the closing function. The mechanism comprises two sleeves 19a and 19b coaxially to each other, which can rotate against each other around their common axis or, respectively, be twistable relative to each other to a certain angle value, whereby a foil tube element 20a is arranged inside the sleeves 19a, 19b preferably coaxially to the common axis of the both sleeves 19a, 19b in such a way that one of its ends is connected to the inner wall of one sleeve part 19a and the other of the both ends is connected to the inner wall of the other sleeve part 19b, which is positioned in an axial alignment. If the sleeves 19a, 19b are twisted relatively to each other around their common axis, for example for an amount from 90 to 270, or even beyond that, said tube element 20 gradually transitions from its axial aligned, open lumen rest position into a twisted position with closed lumen, whereby the free lumen L of the tube increasingly narrows with increased rotation and finally closes completely. The functional element 19 can be integrated both in the catheter-sided tube segment of the device and also in the bag-sided tube segment, whereby it is preferably arranged as close as possible to the connector.

[0034] As an example, FIG. 3a shows the positioning of the flow controlling functional element 19 in the terminal connector 6 at the tube 5 of the head unit 2. Here, the element 19 serves for sealing the tube during the phase of exchanging the bags, so that the fluid remaining in the intestinals can be kept safe inside the colon, and a leakage through the temporarily opened connector into the surroundings can be avoided. A transparent sleeve element 23 can adjoin immediately distally to the throttle, that means towards the patient, which renders the in- and outflowing fluid or, respectively, its particular quality and the actual volume flow visible. Optionally, a sleeve element or both sleeve elements 19a, 19b can be made out of transparent material.

[0035] FIG. 4 shows an exemplary head unit 2 in detail, whereby it comprises a balloon component 3, which is not dumbbell-shaped, but in a shortened form mushroom-shaped. The proximal portion 3b of the balloon body extends through the anal channel, the distal portion 3a is placed inside the rectum. The trans-anal portion 3b can optionally terminate in line with the outer opening of the anus, the anal ring, or may also extend beyond the plane of the anus as a connector. As a less preferred embodiment, lengths of the portion 3b can be chosen, which would only reach into the anal channel, but do not extend up to its outer opening. The shaft element 4 comprises an olive-shaped or a ring-type extension 21, which facilitates the insertion into the anus. Preferably, the shaft element is made of polyurethane and comprises within its area supporting the balloon a wavy profile 22 aiding the elastic self-erection of the shaft.

[0036] FIG. 5 shows a further embodiment of the head unit 2, whereby this comprises shaft element 4a supporting the balloon body 3, which has a special mushroom-shaped, conical/tapered tip 4b. Contrary to the aforementioned embodiments like e.g. in FIG. 4, the balloon body is shortened in its distal intra-rectal portion 3a, but alltogether yet of a dumbbell shape. Its middle portion 3c is tapered and provides, upon a respective positioning of the balloon tapering, a dynamically adaptive, trans-anally effective seal performance adjusting to the respective rectal pressure, as described in context with the invention. The whole shaft body, that is the tip 4b, the proximally adjoining shaft portion 4b as well as the pre-anal adjoining portion 4c, can be cast or injection molded from a soft, foam-like or jelly-like material.

[0037] The implementations depicted in FIGS. 4 and 5 of the balloon body comprising an intra-rectal balloon segment with a large diameter and a trans-anal segment extending through the anus or even only into the anus, enable a special sealing dynamics, whereby the respective rectal effecting force is absorbed by the segment 3a, and provides a continuous sealing in the anal channel in the segment 3b in a temporarily synchronous and corresponding manner. All segments of the balloon body are preformed during their manufacturing to their entire working dimensions or alternatively even beyond, that is residually dimensioned. Preferably, the fully shaped balloon is in situ filled incompletely, that is slackly, so the perception of the device as a foreign body is largely avoided. In its slacky filled shape, the balloon adapts in an optimum manner to the respective anal-rectal anatomy an to the respective prevailing rectal force.

[0038] FIG. 6 shows a bag-type vessel, which is optimized for the lavage-type washing in or, respectively, instillation of a substance into the colon of a patient. A sleeve-like handpiece 24 designed for gripping with a hand adjoins to the connector 11, wherein a clamping-type or tongs-like closing element 25 is embedded, which in case of single-handed operation is opened by the thumb of the operator, and in its open state releases the entire lumen of the clamped tube section. For example, the element builds up a curved tension in its closed state, which relaxes through releasing of a latch 25a and leads to a rapid opening of the closure 25. Again, a transparent element 23 can adjoin to the handpiece. The portion of the tube, which is installed in the lower end of the bag, comprises two or several lateral openings 26 of large lumen, so that the bag content is received in a most efficient way from the bag and a potential shift of a single terminal lumen of the connector is avoided. The tube portion 9 extends in its open form into the bag and comprises neither a one-way function nor a stool separation function.

[0039] Preferably, the balloon as well as the shaft tube of the head unit are made of an elastically deforming material with a preferentially low volume extensibility. For the balloon, especially thin-walled preformed balloon foils of polyurethane (PUR) are preferred, which provide the required combination of a geometrical stability during load and a low membrane-type wall thickness. An elastic expansion of the balloon envelope is not required and in the context of the invention conceptually rather undesirable. The balloon body is preferably filled with air, whereby it adopts in situ a slacky incompletely filled state, which ensures that the filled body in the rectum will, after a phase of adaption, attain a filling pressure, which in a good approximation corresponds to the respective intra-rectal pressure, and therefore allows a nearly pressure-neutral placement, which is comfortable for the patient. The balloon body is preferably formed as a dumbbell, whereby the middle tapered section of the balloon is placed in the anal channel. The balloon body is preferably extruded from a pre-extruded tube material, and in a subsequent step of blow molding shaped to the balloon. In a respective manner, the shaft element supporting the balloon body can be shaped from a pre-extruded foil tube to the required dimensions. Especially, the blow molding enables the shaping of a wavy, corrugated profile.

[0040] For both components, PUR types of hardnesses Shore 80A to 95A and 55D to 60D are deployed particularly advantageously, for example the type Pellethane 2363 of the company Lubrizol.

[0041] Furthermore, the invention describes a method for the washing of liquid substances or, respectively, of substances solved in a liquid into the colon of a patient, starting with the insertion of the patient's sided head unit 2 of the device into the anus, whereby the segment 3b, 3c, which is tapered in its diameter, is placed in the region of the sphincter. Then, the entirely formed balloon 3 is filled with an amount of air, which is smaller than the freely unfolded, fully shaped volume of the balloon component. The balloon filled in this manner and clinging slacky to the rectum and anus absorbs the respective force in the rectum and uses it synchronously for the sealing in the anal channel, whereby the trans-anal segment of the balloon envelope follows the respective opening and closing state of the anus. The shaft element 4 supporting the balloon comprises the ability of a radial and axial, elastic folding and straightening. Then, the patient's sided portion of the device is closed by a closing function 19. Subsequently, the connecting of the lavage-type bag for the preparatory cleaning or, respectively, lavage of the colon takes place. The bag comprises a throttling function as well as a stool separating function. Before the connecting, the lavage bag is closed by the closing function 19 and subsequently is filled up with the lavage fluid. After the opening of the closures on both sides, a lavage-type large fluid volume is instillated into the colon of the patient through a cycling procedure comprising a respective cyclic raising of the bag above and lowering it below the patient's level, which volume entirely comprises 1000 to 1200 mL of fluid, so that it reaches the transversal and potentially even the upper portion of the colon. Therefor, at least 1000 mL of fluid are displaced from the lavage bag into the colon in less than 30 seconds, preferably in less than 15 seconds. After repeting the cycle of inlet and outlet several times, the lavage bag is placed upside down and used as a collecting bag, which, during extended periods of time up to several hours, receives the parts of stool mobilized and drained belatedly after the lavage, without the fear of a perforating injury of the intestines through the head portion remaining in the rectum during the subsequent drainage. After the collection of the mobilized intestinal contents, the lavage bag is disconnected from the head unit, which remains inside the patient's rectum, and is disposed. The lavage-type cleaning of the colon can be repeated several times, whereby the lavage bag is exchanged each time or, respectively, is replaced by a fresh bag with fresh fluid. Thereby, the patient's sided part of the device remains inside the patient.

[0042] After completion of the preparative lavage of the colon, the bag for the lavage-type instillation of a therapeutical substance or of a transplant is prepared. It is terminally closed by means of the optional closing function 19, then it is filled with the preparation and finally connected to the head portion of the device, which is inside the patient. Through the repetitive lavage-type introduction of the substance from the bag into the colon, analogously to the lavage, again the upper colon parts can be reached. The required flow rates are in the range of 1000 MI in 30 to 15 seconds. In difference to the lavage bag, the bag used for the introduction of the substance or of the transplant comprises a fixed or variably adjustable throttling function, but no stool separating function. After a completed repetitive cycle of inflow and outflow of the substance to be introduced, the preparation can remain inside the patient for a duration several hours, variably adjustable by the applicant, without any leakage of the preparation out from the anus. Thereby, the patient can adopt a comfortable, semisitting or sitting posture. For the final outflow of the preparation from the colon, the bag is lowered below the level of the patient and rests there until the substance is completely secreted.