US20140296831A1 - Trans-anal inflow catheter and method for intermittently triggering a reflex-coordinated defecation - Google Patents

Abstract

A device for transanally introducing an infusion into the rectum of a patient, the device comprising an inflatable balloon having a waisted shape, two terminal sections of larger radius and, a middle section of a reduced radius, and is placed transanally, the distally adjoining radially enlarged balloon section being placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally, wherein both balloon ends taper to the dimension of a shaft supporting the balloon and are fixed on the surface of the shaft such that as the balloon is filled, the two enlarged balloon sections move toward each other in opposite axial directions, and wherein the two radially enlarged balloon sections are enlarged relative to the middle balloon section, such that when the balloon is placed transanally, during the filling process the two radially enlarged balloon sections draw down over the middle, balloon section and contact each other, and to a method for filling the catheter balloon.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The invention relates, on the one hand, to a device for transanally introducing an infusion into the rectum or colon of a patient, said device comprising an inflatable balloon having a waisted shape, particularly a dumbbell or hourglass shape, imparted by preforming during production, with two terminal balloon sections of larger radius and approximately spherical or discoid shape, and, disposed between them, a middle, tapered balloon section that has a reduced radius and is placed transanally, such that the distally adjoining radially enlarged balloon section is placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally, and, on the other hand, to a method for filling the catheter balloon of such a device for transanally introducing an infusion into the rectum or colon of a patient by means of a filling device.
• 2. Description of the Prior Art
• Catheters for transanally administering an infusion into the straight intestine (rectum) or large bowel (colon) of a patient have been known in a wide variety of embodiments for many years.
• Inflow catheters can be implemented as simple tube elements, but for improved retention of the catheter in the rectum they are also provided with an intrarectally placed balloon element. Such balloon elements provide, in addition to an anorectally anchoring function, a certain sealing effect that retains in the bowel the fluid that has been introduced by the irrigation. The sealing capacity of inflow catheters fitted with an exclusively intrarectal balloon component is inadequate in many cases, however, and must be created by the user by continuously manually repositioning the surfaces of the sealing balloon on the floor of the rectum or manipulating the position of the catheter shaft atop the balloon.
• A major risk associated with the use of ordinary commercial catheters that are inserted transanally in the bowel continues to be perforation of the bowel wall due to improper handling or the presence of previously injured or similarly weakened bowel wall structures. Such perforations of the intestine have been preventable heretofore only by suitable education and sensitization of the user with respect to this particular set of problems.
• Over the past ten years, a novel infusion technology that goes beyond the use of conventional transanal infusions has become established; in this new approach, the reflex-coordinated, active evacuation of the rectum and large portions of the left colon adjoining the rectum is triggered by intermittent, relatively small-volume, intrarectally introduced infusions. By consistent voiding of these segments of the intestine, the patient can thus be brought to a state of so-called “pseudo-continence” regardless of existing incontinence problems. The so-called transanal irrigation (TAI) method can be performed by the patient himself.
• The function of the rectally instilled infusion medium, apart from some degree of mobilization of stool, is primarily to moderately expand the wall portions of the rectal ampulla (the terminal rectum), which then results in the triggering of the physiological stool evacuation reflex (reflex triggering). Whereas the rectally placed infusion medium usually causes such reflex triggering within a few minutes, it take can much longer, up to 30 minutes or more, for the administered irrigation volume to be fully voided from the rectum or colon. The relatively long time required for TAI limits its acceptance by many patients, and often rules this method out despite the fact that it is, as a rule, efficient for use by the individual.
• Another problem is that many users are not able to manually bring irrigation catheters of conventional design into an adequately sealing position and keep them there.
• Furthermore, as the balloon component of a conventional catheter is expanded inside the rectum, a reflex-triggering expansion of portions of the bowel wall can occur when the filling process has only just begun, thereby leading, inter alia, to a reflex-like opening of the anus and thus sometimes causing the anchoring balloon to slip out of the rectum.
• Furthermore, commercially available devices for intermittent transanal irrigation, such as, for example, Peristeen Anal Irrigation, made by Coloplast, Denmark, are of relatively elaborate design, and are often only conditionally suitable for use outside the patient's familiar domestic surroundings.
• To improve user acceptance of transanal irrigation, a catheter technique would be desirable which, once the catheter shaft is inserted in the rectum, holds it in its transanal position without the need for continuous repositioning, and both keeps the body of the shaft from sliding on into the bowel, with potentially traumatic consequences, and reliably prevents the catheter from accidentally slipping out of the anus prematurely.
• Greater convenience in terms of the transanal placement of the catheter is offered in this regard by inflow catheters having a double balloon arrangement. Here, two separate balloon elements, which are usually filled simultaneously via a single filling lumen, are mounted in spaced relation on the catheter shaft. These come to lie on both sides of the anal canal, i.e. the internal and the external, thus mutually taking on the structures of the anus. When the wall of the balloon is expanded under pressure, the usually elastic implementation of the balloon material brings about a spherical enlargement of the balloon bodies and thus a certain axially exerted squeezing of the anus disposed between the balloon bodies. The dislocation-proof positioning of the catheter shaft obtained with such catheters can be assumed to be relatively reliable. A problem resides in the sometimes high filling pressures needed for the elastic expansion of the envelope, which are felt by patients as an uncomfortable or even painful foreign body sensation. Further, the elastic expansion of the intrarectal balloon to a tightly filled sphere can lead to direct triggering of the defecation reflex, which, in turn, in the presence of simultaneous rectal contraction and declining sphincter muscle tone, will in the most unfavorable case cause the catheter to slide out and the irrigation fluid to be voided prematurely. DE 10 2004 033 425 B4 describes a sealing system for the management of rectal or anal incontinence having a particular embodiment for the tamponade of bleeding hemorrhoids, presenting a waisted balloon element having a terminal intrarectal or preanal section. The balloon envelope of the device is placed on the balloon-supporting shaft body in such a way that during the filling process, the intrarectal balloon segment moves in the direction of the rectal floor and there exerts a tamponade pressure on the bleeding venous blood vessels. The preanal balloon segment concurrently moves toward the external anal opening. The result is a tamponade effect oriented axially to the anus from both sides. In addition to the axial tamponade of the bleeding, the middle, waisted section of the balloon expands outward radially to the wall of the anal canal. It is preferably shaped with a diameter that exceeds the diameter of the opened anal canal. In the described device for the acute management of venous anorectal bleeding, in the in-use state the tip of the shaft body protrudes freely and unprotectedly into the intestinal lumen and poses a potential risk of injury.
• WO 2007/118621 A1 describes a similar dumbbell- or hourglass-shaped balloon sealing system. The object there is to provide a seal against involuntary leakage of stool for intermittent periods of a few hours in chronically anorectally incontinent patients. This managing device also prominently features the rolling movement of the terminal balloon segments from both sides axially toward the anus. Here again, in the transanally placed state, the tip of the shaft body supporting the balloon protrudes freely and potentially traumatizingly into the intestinal lumen.
• Both devices describe an hourglass- or dumbbell-shaped balloon configuration, the anus being received in the waisted region of the balloon, i.e. the region that is tapered relative to the terminal portions thereof. Such shaping of the balloon not only results in relatively good securing of the catheter against dislocation, due to the sealing of the balloon inside the anal canal on all sides, but also makes for a considerable improvement in sealing performance over that of conventional double balloons. In addition, both devices make it possible to largely avoid any expansion of the balloon envelope that could trigger irritation, pain or a defecation reflex, since the balloon wall is preferably already shaped to its working dimensions or beyond. Thus, the filling or unfolding of the balloon to its working state requires only a low filling pressure, equal to or only slightly greater than the pressure prevailing in the rectum or abdomen at the time.
• Nevertheless, a particular disadvantage of the embodiments described in DE 10 2004 033 425 B4 and WO 2007/118621 A1 has proven to be that the distal tip of the shaft body supporting the balloon becomes freely exposed during the filling process and protrudes into the intestinal lumen, potentially causing irritation or injury to the bowel wall there during use.
SUMMARY OF THE INVENTION
• The problem initiating the invention is to eliminate these disadvantages of the known prior art.
• This problem is solved, in an arrangement of the cited species, by virtue of the fact that both balloon ends taper to the shaft dimension of the catheter shaft supporting the balloon and are fixed in a simply invaginated or inverted manner on the preferably outer jacket surface of the catheter shaft in such fashion that as the balloon is filled, the two radially enlarged balloon sections move toward each other in opposite axial directions, and wherein the two radially enlarged balloon sections are enlarged relative to the tapered, middle balloon section, such that when the balloon is placed transanally, during the filling process the two radially enlarged balloon sections draw down over the middle, tapered balloon section and in the limit case come into direct contact with each other, thereby limiting their relative movement and preventing the distal end of the catheter shaft from passing beyond the apex of the intrarectal balloon radius when the shaft body is in a position of maximum axial deflection.
• To prevent, insofar as possible, lesions due to the tip of the shaft, the invention describes a specific, particularly advantageous ratio of the length of the middle, waist-like balloon segment to the invagination (inversions), on both sides, of the fixation points of the ends of the balloon shaft to the catheter shaft. This ratio ensures that in the filled, transanally positioned state, the tip of the catheter shaft spontaneously retracts into the intrarectal balloon segment and is nestled atraumatically there. The atraumatic securing of the catheter tip inside the intrarectal balloon segment is also ensured according to the invention when the shaft axis undergoes the deflections inside the anal canal that typically occur during use, of the kind readily caused by a tug or push on the tube connection through which the catheter is guided in.
• The invention further addresses the problem of preventing undesired or premature triggering effects due to the filled balloon as it unfolds in the rectum. Triggering of the defecation reflex can be prevented in most cases by preshaping the balloon to the working dimension or beyond (residual dimensioning), since the filling pressures necessary for anchoring and sealing the catheter are largely the same as, or need be only a few millibars higher than, the pressures prevailing in the rectum or in the abdomen. The atraumatic securing of the tip of the catheter in the region of the intrarectal balloon segment is ensured even at such low filling pressures of, for example, 10 to 25 mbar.
• Shaping the balloon to its working dimension further makes it possible for the user, by increasing the filling pressure or fill volume of the balloon from the initial filled state in which the balloon primarily has a sealing and anchoring effect, to induce a well-controllable and gradually increasable expansion of the bowel wall adjacent the catheter balloon, ultimately leading to controlled triggering of the defecation reflex with individually adjusted intensity.
• In addition to the initial expansion of the wall of the rectum, a further suitable increase in the filling pressure in the dumbbell-shaped, waisted catheter balloon additionally causes a dilation of the anus or the anal sphincter, constituting another efficient trigger stimulus.
• The intensity of such pneumatic expansion of the bowel wall or the anus can substantially exceed the intensity of reflex-triggering expansion with fluid media. Due to the more intense stimulus, several sequentially occurring cycles of evacuation reflexes can be triggered even though the stimulation is given only once.
• This pneumatic expansion stimulus that can be well controlled by the user can also reduce the necessary amount of infusion fluid in many cases, which in turn can considerably shorten the time needed to evacuate the infusion from the rectum, thereby ultimately opening up the method to many users as a therapeutic option for self-administration.
• The optional combined pneumatic/liquid triggering of reflexes described here eliminates the need for elaborate technical implementation of irrigation appliances, since in the preferred use case the necessary irrigation volume can be kept so small that it can be connected directly, as a compact, ready-to-use solution, via a fixed feed conduit to an inflow catheter designed according to the invention, and thus, in an ideal manner, be used as a disposable product.
• For this purpose, the irrigation solution is preferably filled into a cylindrical, bag-like container, which the user can conveniently introduce intrarectally by squeezing it out with the hand.
• The inflow catheter according to the invention further comprises a preferably fixedly glued-in filling conduit for charging the catheter balloon with filling pressure. The unit for filling the balloon is preferably implemented in reusable form, and can be configured as a hand-operated pump balloon connectable via a coupling, or alternatively a pumped balloon with a pressure-indicating manometer. Alternatively, volume-controlled filling of the balloon is also conceivable. Regardless of the filling arrangement, the user can determine by stepwise approximation the degree of filling of the balloon that is optimal for him, that which is best adapted to his individual anatomy and his current reflex status.
• To ensure the most practicable catheter insertion possible and the reliable transanal placement of the tapered portion of the dumbbell-shaped balloon element, the catheter shaft is preferably equipped in the proximal, preanal region with gripping depressions to accommodate the fingers gripping the catheter during insertion. If the user has no sensitivity in the pelvic or anal region, he guides the catheter in with his fingers until they abut the anus, and can thus avoid uncontrolledly deep insertion.
BRIEF DESCRIPTION OF THE DRAWINGS
• Further features, characteristics, advantages and effects of the invention will become apparent from the following description of preferred embodiments of the invention and by reference to the drawing. Wherein:
• FIG. 1ashows an embodiment of a catheter according to the invention in a schematic longitudinal section, the balloon ends being mounted on a catheter shaft in an inverted manner according to the invention;
• FIG. 1bshows the geometric structure of the apex of the distal balloon radius;
• FIG. 1cshows the balloon body described inFIG. 1ain a freely unfolded state under low filling pressure, outside the anus;
• FIG. 1dshows the balloon body described inFIG. 1ain a transanally placed state, under filling pressure;
• FIG. 1eshows the geometric structure of the distal plane tangent to the intrarectal balloon section;
• FIG. 2 is a representation similar toFIG. 1aof an alternative embodiment of the invention, in which a catheter tip extends beyond the forward fixation line of the end of the balloon shaft;
• FIG. 3 is a representation similar toFIG. 2 showing additional auxiliary lines, such that the reference point for determining the inversion depth B is not the forward balloon radius, but rather the largest diameter D of the intrarectal balloon segment;
• FIG. 4 shows a shaped balloon envelope in the unfilled state, provided in a particularly advantageous manner for rectal insertion and reliable transanal placement and unfolding of the balloon;
• FIG. 5 shows an alternative embodiment of the invention with a catheter shaft waisted in its transanal section,
• FIG. 6 shows a manually operable pump manometer with a pressure scale equipped for multi-stage, sequential filling of the catheter balloon, and
• FIG. 7 shows a further alternative embodiment of the invention with an infusion container fixedly connected to the catheter shaft and a filling tube for charging the catheter balloon with filling pressure.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIG. 1ashows a longitudinal section through an inflow catheter with a dumbbell- or hourglass-shapedballoon element2 disposed at the distal end of thecatheter shaft1. The balloon element has, for example, a spherical or discoid expansion at each end. Disposed in the middle region between the terminal enlargements is a cylindrically or approximately cylindrically shapedsegment3 of reduced diameter, which continuously connects the intrarectal enlargement4 to thepreanal enlargement5.
• Theballoon2 terminally comprises two balloon shaft ends (6,7) for attaching the balloon to the shaft. During the mounting of the balloon, the shaft ends6 and7 are invaginated (inverted) into the inside of the balloon by a defined magnitude B and in this position, in which they are displaced toward each other, are fixed on theshaft1, for example by gluing or welding.
• The sum of the magnitudes B of the inversions at both ends should be at least equal to the length of the tapered intermediate piece A (A smaller than/equal to the sum of the magnitudes B).
• The inversion depth B at the end of the balloon facing the patient or the rectum corresponds to the distance from theapex8 of the distal,intrarectal balloon radius9 to thedistal fixation line11 of theballoon end6 on the catheter shaft.
• Thedistal radius9 corresponds to the frontal radius during free, non-inverted unfolding of the completely filled but not pressurized balloon (broken line). An exemplary rule for geometrically determining the apex8 to good approximation is illustrated in FIG. lb. In particular, the drawing shows the two inflection points WP of the longitudinal section through the distal balloon end, which, by the inversion of the distal region of the balloon, result in the spherical or discoid or approximately semitoroidal region of the intrarectal section of the balloon. Thenormals9e,9fto the tangent to the longitudinal section of the balloon intersect with the longitudinal axis X of the catheter shaft at point M, and a circle K around this point M at the distance M-WP yields theforward apex8, which marks the distal limit for the catheter shaft in its neutral, non-deflected initial position.
• It can be seen in FIG. le that a straight line can also be passed through points WP; this straight line represents the plane Z which after invagination of the forward end of the balloon is now tangent distally to the intrarectal portion of the balloon, and can also be taken as a measure of the distalmost position of the catheter shaft in its neutral, non-deflected initial position.
• On the side of the balloon facing away from the patient, the inversion depth B corresponds to the distance from the apex12 of the proximal,preanal balloon radius13 to theproximal fixation line14 of theballoon end7 on the catheter shaft.
• Radius13 corresponds to the proximal radius when the balloon is freely unfolded without inversion. The geometric determination of apex12 is similar to the approximation described in FIG. lb.
• The length of intermediate piece A is determined by determining the distance between the transitions of theshoulder radii15 and16 (inflection points) of the mutually facing shoulder surfaces ofballoon segments4 and5.
• The inversion depths, lengths and distances are each determined in the filled state under filling pressure, the filling pressure being so selected that the balloon unfolds completely but there is no elastic expansion of the balloon envelope.
• The inversion depth B is calculated as follows: B>=A/2 (>=represents greater/equal).
• In mounting the balloon on the catheter shaft, the respective points for the inversion of each of the balloon shaft ends are the apex8 of the distal,intrarectal balloon radius9 and the apex12 of the proximal,preanal balloon radius13.
• In the embodiment described in this figure, thedistal fixation line11 also corresponds to the distal end of thecatheter shaft1. The shaft terminates directly at thefixation line11 and does not extend distally past this fixation line in the manner illustrated inFIG. 2.
• FIG. 1bdescribes the geometric derivation of the apex of the distal balloon radius.
• Theforward balloon radius9, frontally facing the intestinal lumen, of the intrarectal balloon segment4 is illustrated as a broken line. It is constructed from the two inflection points9aand9band the twoinflection tangents9cand9drespectively belonging to these inflection points.
• One of the two inflection points9aor9bis used to construct astraight line9eor9fthat is normal to therespective inflection tangent9cor9dand intersects the corresponding inflection point9aor9b. The point of intersection of thesestraight lines9eor9fwith the axis X of symmetry yields the center point of the circle K.
• The circle K, and thus theforward balloon radius9, results from the center point M of the circle and the inflection points9aand9b, which are on the circumference of the circle. In this derivation, apex8 is obtained from the point of intersection of the circumference of the circle with the axis X of symmetry of the balloon.
• For the description of thefrontal apex8 used below, the derivation of the farthest distally ranging point of the filled, unpressurized balloon envelope is performed, for purposes of simplification, using the point of intersection of the connecting line Z between the two inflection points9aand9bwith the axis X of symmetry.
• FIG. 1cshows the behavior of the catheter balloon that was inverted according to the invention inFIG. 1aas it unfolds freely and without pressurization, in the free, non-transanally placed state. The figure illustrates the counter-rolling movement of the twoterminal balloon segments4 and5 made by possible by the specific inversion of the balloon ends6 and7 on the catheter shaft.
• In a preferred, particularly thin-walled and soft-film-like implementation of the balloon body, the two segments move toward each other in response to the slightest, nearly ambient filling pressure and roll over themiddle segment3. When the two segments are in contact in the region of the transition points (15,16) of the shoulder radii, theapex8 of theradius9 is flush or nearly flush with thedistal fixation line11 of the distalballoon shaft end6 on the catheter shaft.
• A configuration of this kind would correspond in situ to a clinical use situation in which the anal canal was maximally shortened in length. Even in this extreme case, it would thus be ensured by virtue of the described inversion rule that the free distal catheter shaft end, which here corresponds to thedistal fixation line11, does not extend into the intestinal lumen and even in the event of maximal lateral deflection of the catheter shaft in the rectum (tilting of the intrarectal portion of the shaft toward the bowel wall) does not come into contact with the wall of the intestine and pass beyond thedistal balloon radius9, as a maximum limit precluding irritation and lesions of the bowel wall.
• FIG. 1dshows how the inversion of the balloon ends in relation to the distal catheter shaft ends described inFIG. 1apresents itself in cases where the anal canal is of normal or only slightly shortened length. In this more common clinical use situation, theforward fixation line11, which here corresponds in turn to the distal free end of the catheter shaft, is shown to be deflected substantially into the interior of the intrarectal balloon4. As the balloon is charged with pressure, the twoterminal balloon segments4 and5 move counter to each other toward the anus and so conform to the particular anal situs. Given a suitably thin-walled implementation and soft-film-like character of the balloon envelope, the counter-rolling of the balloon segments commences even in response to a very low pressure force (filling pressure) that gives an impression of being nearly ambient to the environment.
• The mere individual intra-abdominal pressure bearing against the transanally placed balloon or acting on the balloon is sufficient to produce a combined transanal sealing effect, comprised of radial sealing with respect to the anal canal and axially oriented sealing brought about by the counter-rolling movement of the terminal balloon enlargements at the inner and outer outlets of the anus. The sealing effect thus is not contingent on the balloon initially being filled beyond its volume and unfolding freely until the balloon envelope begins to expand. The balloon can behave in the described axial counter-rolling and radial unfolding fashion, even under partial filling of, for example, 70 to 90% of its volume when freely unfolded on the catheter shaft. This enables the balloon catheter to be placed in the anus in a nearly pressure-neutral and irritation-free manner.
• In the presence of normal or slightly modified anal anatomy, any traumatizing effect of the tip of the catheter shaft on the bowel wall can thus be precluded, even under completely pressure-neutral charging with a filling medium, by the inversion of the shaft tip that occurs according to the invention.
• FIG. 2 shows, by way of example, how sections of the catheter shaft in the form of atip piece18 that extend beyond thedistal fixation line11 in a distal prolongation directed toward the bowel are to be considered in determining the inversion depth of the balloon ends6 and7, in order to ensure atraumatic inversion, according to the invention, of the distal end of the catheter in the intrarectal balloon during transanal placement of the filled catheter balloon. The length C of thetip piece18 is defined as the distance from theforward fixation line11 to theforward apex19 of the tip piece.
• Length B is increased in comparison toFIG. 1aby the magnitude of length C or C/2.
• The corresponding inversion depth B is preferably calculated taking into account a tip piece in the form: B>=A/2+C.
• Alternatively hereto, the corresponding inversion depth B can, less preferably, be obtained considering a tip piece according to the relation: B>=A/2+C/2.
• FIG. 3 illustrates another, alternative rule for establishing the inversion depth B of the balloon shaft ends6 and7 on thecatheter shaft1 in relation to the distalcatheter shaft end11,19.
• This rule particularly considers a possible axially oriented deflection of the catheter shaft inside the filled, transanally placed balloon. In the context of the inventively described inversion of the balloon shaft ends on the catheter shaft supporting the balloon, such deflection of the shaft in the longitudinal axis could cause the distal end of the catheter shaft to be deflected toward the bowel, thus creating a potential risk of perforation.
• The maximum distal deflection W of theforward fixation line11 is defined as a distance that emanates from theapex8 of theradius9, forming a distally directed prolongation of the longitudinal axis of the shaft, and extends to the apex20 of aradius21, saidradius21 being constructed over the largest diameter D of the intrarectal balloon segment4.
• If the catheter shaft has atip piece18 that extends beyondline11, the maximum deflection path W should be correspondingly selected so that upon maximum deflection W of the shaft, thetip19 of the tip piece does not extendpast radius21.
• Theradius21 defined by the largest diameter D in the intrarectal balloon segment constitutes a fundamentally relevant boundary line for distal portions of the catheter shaft. In the event of lateral tilting of the shaft longitudinal axis of the transanally placed catheter shaft, the fact that the maximum deflection W is referred to the largest balloon diameter D ensures that the catheter shaft tip (11,19) still moves within thepivot radius21 of balloon segment4, thus preventing relatively well any potential traumatizing contact of the tip with the bowel wall adjacent the balloon.
• In determining the inversion depth B, the particular ratio of the distance W to theradius21 or of the diameter D on which it is based is preserved and the inversion depth B is adjusted accordingly as necessary.
• FIG. 4 shows thecatheter balloon2 in its emptied form, in which it lies against the catheter shaft ready for insertion in the anus. The envelope segments of the intrarectal balloon4 and of themiddle segment3 cling to the shaft in folds.
• In this state, the two envelope portions preferably come to lie approximately at the height of the line segment between the fixation points of the balloon ends6 and7 on the surface of the shaft. The envelope of thepreanal balloon segment5, by contrast, is preferably smoothed out in the proximal direction and protrudes past the fingers gripping the catheter for insertion, the preferred gripping point being located just proximal of theproximal fixation line14. Thegripping point22 is preferably implemented as a depression-like receiving surface, one such preferably being provided on each of the opposite, 180°-apart shaft surfaces.
• The evacuated balloon being fixed in such fashion, the user grips with his fingers under the envelope ofsegment5, which envelope is smoothed out in a proximal direction, and guides the catheter into the rectum until the gripping fingers abut the external anus. A defined insertion depth is thereby ensured. It is further ensured that the intrarectal balloon section4 is inserted into the rectal cavity, while theproximal balloon portion5 comes to lie outside the anus (preanally). Reliable transanal positioning of the catheter therefore occurs as the waisted balloon is filled.
• FIG. 5 shows a preferred implementation of theshaft body1 that furnishes some degree of automatic positioning and securing of the shaft in the anus even when the catheter balloon has not yet been filled. Theshaft1 has for this purpose a likewise waisted shape, which is correspondingly tapered in thetransanal region23 and in effect locks the catheter shaft in a transanal position in this region after insertion. The catheter shaft preferably also has a distally terminal, funnel-like, atraumatically shaped opening24 that connects to theduct25 supplying the medium.
• In a particularly large-volume implementation of the intrarectal balloon segment or a longitudinal expansion of the balloon segment that reaches far into the rectum, the balloon segment, in the non-air-filled, ready-to-use state, can optionally be stuffed or packed partially into theopening24. It then slips out of the opening as the inserted catheter is filled.
• Given suitable implementation of the shaft material, thewaist23 can also predefine a certain kinkability of the shaft body, thus improving its atraumatic properties.
• The filling of the balloon takes place through aseparate duct26 integral to the shaft.
• To prevent backflow of irrigation fluid, the inflow catheter can is [sic] equipped with a non-return valve in the region of the fluid-conveyingduct25.
• The valve can preferably consist of a thin-walled tube element having a wall thickness of few, preferably, 5 to 15 micrometers and the diameter of theduct25, the distal end of the tube lying freely in theduct25 over a length of approximately 5 to 10 mm and its proximal end being connected sealingly to the inner wall of theduct25. As the medium flows through the duct in the direction of the tip, the tube element opens and allows the medium to flow freely. In response to flow in the reverse direction, the tube element collapses and closes up sealingly, preventing an effective backflow.
• FIG. 6 schematically illustrates apump manometer27 equipped with ascale28 suitable for the filling of the inventive catheter balloon in multiple steps or with a sequential increase in filling pressure. The scale preferably displays, on the one hand, an initial, low pressure range 29 (app. 10-25 mbar), which is set by the user after inserting the catheter and before introducing the infusion fluid, and which, given the inventive preshaping of the balloon envelope and its fixation on the shaft, is sufficient in most cases to ensure transanal anchoring and sealing of the catheter without a direct reflex-triggering effect on the bowel wall.
• When the user then initiates an increase in the filling pressure in the balloon into range 30 (30-60 mbar, with increasing corresponding expansion of the rectal portions of the bowel wall) or into range 37 (60-120 mbar, with increasing additional expansion of the anal sphincter), the user is ultimately able to generate a trigger stimulus of largely reproducible intensity in order to trigger a defecation reflex. The user thus has the advantage of being able to avoid an evacuation reflex in the presence of an initially low balloon pressure merely having an anchoring and sealing action, and thus of being able to retain the infusion fluid in the bowel long enough for his individual needs, resulting in better dissolution or suspension of stool in the fluid. On the other hand, by intentionally causing an increase in pressure in the balloon, he can generate an intense, relatively prompt-acting reflex-triggering stimulus, which can, if necessary, exceed in intensity the triggering effect of a column of colorectal fluid.
• The catheter balloon is preferably filled with air, through a fill line integrated into the shaft wall of thecatheter body1.
• In addition to pressure-controlled filling of the balloon using a pump manometer, as illustrated inFIG. 6, volume-controlled filling can be achieved with the use of an additional syringe element that specifies the preferred fill volume by means of a suitable marking on the syringe body. The filling of the balloon is preferably partial, in the form of one-step filling. In the ideal case, therefore, in loose, unexpanded form, the balloon lies against the structures of the bowel and the anus. The balloon envelope thus absorbs the forces acting on the balloon in the rectum, the anus and the preanal region and brings the balloon into the configuration in which it performs the anchoring and sealing function. The respective physiologically acting forces are absorbed by the catheter balloon and thus enable the balloon to be placed anorectally in as pressure-neutral a manner as possible, largely precluding undesired and premature triggering effects.
• A volume-controlled filling of the balloon can also be a two-step process, in which incomplete filling is first performed and the balloon is then, in the second filling step, filled with a volume that has a triggering effect. The pressures developed in the transanal balloon in response to the particular volume should preferably fall within the pressure ranges (29,30) described inFIG. 6, and are to be determined by and for the user on an individual basis, as in the case of pressure-controlled filling.
• To limit the filling pressure or prevent critically high balloon filling pressures, in the case of both manometer- and syringe-actuated filling apressure limiting valve31 can be interposed between the filling element and the catheter, to prevent, for example, balloon filling pressures over 120 mbar.
• FIG. 7 shows a preferred embodiment of an inflow catheter, which transitions at the proximal end to two feed conduits that are preferably fixedly connected to the shaft, feedconduit32 being fixedly connected to a preferably bag-like container33 containing infusion medium, and thus constituting a ready-to-use unit comprised of catheter and medium.
• The volume of thecontainer33 must be dimensioned in this case to accommodate approximately 80 to 120 ml of irrigation solution. The relatively small quantity is squeezed out manually by the user and thus introduced into the rectum by repeated squeezing. To make it possible to grip the container even with impaired hand motor function, the container is preferably shaped as cylindrical, with a diameter of approximately 4-6 cm.
• Connection32 is preferably equipped with aseal35 that can be broken by bending and that releases the irrigation solution. It is also advantageous to provide anon-return valve36, which is integrated into the fluid-conveying arm of the ready-to-use device and which permits the directed emptying of the container without backflow.
• Anotherfeed conduit34 can be connected directly to apump manometer27 or a filling syringe.
• Theballoon element2 consists of a thin-walled soft film in the wall thickness range of 5 to 100 micrometers. Films in the thickness range of 5 to 40 micrometers are advantageous. Wall thicknesses of 5 to 15 micrometers, on the other hand, are particularly preferable.
• The use of only slightly volume-expandable materials, such as, for example, polyurethane (PUR), for example of the specification Pellethane 2363 80 A to 90 A, Dow Chemical Corp., is preferred, since these materials have good dimensional stability in the lowest wall thickness range, including as balloon films, in the pressure range of approximately 10 to 120 mbar.
• Such thin-walled PUR balloon films formed into complex shape can preferably be produced by hot molding from previously extruded raw tubing material, which, with suitable stretching of the tube blank before tempering, permits a polymer orientation and lends the shaped balloon films exceptional mechanical strength.
• It is also conceivable to use polyurethanes of low Shore hardness, for example in the range of 60 to 75 A, to impart a volume-expandable behavior, with a relative loss of dimensional stability, to the catheter balloon in the wall thickness range of less than 40 μm, and preferably less than 15 μm, in the typical filling pressure range during use of 10 to 120 μm.
• Alternatively, for example non-volume-expandable materials can also be used, such as polyethylene, PVC or mixtures of the aforesaid materials with polyurethane.
• Balloon films according to the invention can also be shaped directly from the extruded, still soft, largely amorphous tube molding compound (in-line molding), in which case the achievable strengths of the films are much lower than those of pre-extruded tubes and the attainable wall thicknesses are much higher than in the case of forming from pre-extruded material.
• Dipping processes using liquid PVC or PUR materials can also be contemplated for production.
• The welding together of single layers of film to form balloon bodies is also conceivable.
• The connection of the balloon to the shaft body is effected by gluing, by thermal methods, or alternatively by shrinking the balloon ends onto the shaft body.
• In the freely unfolded, unpressurized state, the balloon should preferably have a diameter of approximately 30-60 mm in the intrarectal section4, approximately 10 to 30 mm in the middle,waisted region3, and approximately 30-50 mm in thepreanal region5. Themiddle segment3 should have a length of approximately 20-40 mm and each of the terminal segments4 and5 a length of approximately 20-40 mm.
• If, as a special measure for sequential filling, the catheter balloon is provided with optional intrarectal balloon triggering, the intrarectal balloon section4 in the freely unfolded, unpressurized state preferably has a diameter of approximately 40-80 mm and a length of preferably 30-60 mm.
• In addition to the transanal use of the inflow catheter, the embodiments according to the invention can also be used for perforation-safe placement of a transanally inserted drainage tube for, among other purposes, the ongoing drainage of stool from a patient's intestine. Further, the described catheter technique may also be contemplated for use in surgically created stomata/openings or other natural body openings.

Claims (20)

1. A device for transanally introducing an infusion into the rectum or colon of a patient, said device comprising an inflatable balloon having a waisted shape, comprising two terminal balloon sections of larger radius and generally spherical or discoid shape, and, disposed between them, a middle, tapered balloon section having a reduced radius, the device being adapted to be placed transanally, such that the distally adjoining radially enlarged balloon section is placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally, wherein both balloon ends taper a shaft dimension of a catheter shaft supporting the balloon and, beginning at an inflection point of their longitudinal section, are inwardly invaginated, or inverted, and in the inverted or invaginated state are fixed on the outer jacket surface of the catheter shaft such that as the balloon is filled, the two radially enlarged balloon sections move toward each other in opposite axial directions, and wherein the two radially enlarged balloon sections are enlarged relative to the tapered, middle balloon section, such that when the balloon is placed transanally, during the filling process the two radially enlarged balloon sections draw down over the middle tapered balloon section and come into direct contact with each other, thereby limiting their relative movements, as a result of which the distal tip of the catheter shaft, in its non-deflected, resting state, retracts into a protected, injury-preventing position inside the intrarectal balloon section and in so doing comes to lie entirely proximally of a distal apex of a circle about a center point which is located on an axis of symmetry and whose tangent in an inflection point corresponds to a tangent to the non-invaginated longitudinal section of the balloon.

2. The device according toclaim 1, wherein a distal tip of the catheter shaft in its non-deflected, resting state comes to lie entirely proximally of a plane which is intersected perpendicularly by the axis of symmetry and which is fully tangent distally to the intrarectal balloon section.

3. The device according toclaim 1, wherein the middle, tapered balloon section is separated from each of the generally spherical or discoid balloon sections by a respective inflection point of the cross-sectional radius, and in the non-expanded filled state exhibits an axial length larger than a minimum diameter thereof.

4. The device according toclaim 1, wherein the non-expanded filled state, the invaginated or inverted balloon ends each have an axial extent (B₁, B₂) greater than a minimum diameter thereof.

5. The device according toclaim 1 wherein in the non-expanded filled state, the sum of axial extents (B₁, B₂) of the inversions of the two balloon ends is at least equal to the length of the middle, tapered balloon section (A):

B₁+B₂≧A.

6. The device according toclaim 2, wherein the catheter distal tip projects by a dimension (C) beyond a forward fixation line of the forward balloon end on the catheter shaft, and the inversion depth (B) is greater than, or equal to, half of balloon section length (A) plus the length (C) of a projecting tip piece (18):

B₁=B₂≧A/2+C,

or alternatively:

B₁=B₂≧A/2+C/2.

7. The device as according toclaim 1, wherein upon axial deflection of the catheter shaft toward the bowel in response to forces that occur during use, a catheter tip does not move more than a distance (W) beyond the distal apex of the forward balloon radius, and the distance (W) is obtained from the distance between the distal apex and an apex comprising a forward intersection point of the axis of symmetry with a circle of diameter around a center point on the axis of symmetry at the level of the attachment of the intrarectal balloon section to the catheter shaft.

8. The device according toclaim 1, wherein the envelope of the evacuated, ready-to-use catheter balloon is placed on the shaft, or clings closely thereto, in such fashion that the intrarectal and the transanal balloon sections lie in a shaft region between the fixations of the upper and lower balloon ends, and a preanal balloon portion extends in the proximal direction in a pocket-like manner over gripping depressions.

9. The device according toclaim 8, wherein the gripping depressions are disposed on the shaft in direct proximal adjacency to a rear balloon fixation line.

10. The device according toclaim 1, wherein the catheter shaft is provided with a waist portion in the region of the transanal placement inside the anal canal.

11. The device according toclaim 1, wherein inserted in a duct of the catheter shaft is a non-return element adapted to prevent retrograde backflow of fluid directed away from the patient through the catheter.

12. The device according toclaim 11 wherein the non-return element in the duct comprises a thin-walled tube element having a wall thickness of 5 to 15 micrometers, and having a diameter of the duct, such that the distal end of the tube lies freely in the duct over a length of approximately 5 to 10 mm, and the tube proximal end is sealingly connected to an inner wall of the duct, thereby ensuring that the tube element opens in the presence of a flow of medium through the duct toward a tip thereof, and the tube element closes by collapsing in the presence of flow in an opposite direction.

13. The device according toclaim 1, wherein the catheter is connected by a fixed tube connection to a bag-like container for irrigation fluid, as a ready-to-use, disposal product.

14. The device according toclaim 13, wherein the fixed tube connection is provided with a breakable seal and/or with a non-return valve.

15. The device according toclaim 1 wherein the catheter comprises a disposable catheter, connectable via a filling conduit to a reusable filling device, the filling device being implemented as a manually operable pump balloon with a manometer indicating balloon filling pressure.

16. The device according toclaim 15, and comprising a manometer indicating the balloon filling pressure, wherein the manometer comprises a scale on which the filling pressure ranges required for use of the catheter are specified by markings.

17. The device according toclaim 1, wherein a valve element limits the balloon pressure, and is disposed in or on a reusable filling device or is integrated into a selected one of the balloon filling conduit of the single-use catheter and the catheter-bag unit.

18. A method for filling the catheter balloon of a device for transanally introducing an infusion into the rectum or colon of a patient by means of a filling device, wherein a fill volume or the filling pressure prevailing in the balloon is increased in a plurality of steps until there occurs a gradual, user-controllable, pneumatically initiated expansion of portions of the bowel wall, thereby triggering a coordinated defecation reflex, wherein the timing and intensity of the triggering can be determined by the user.

19. The method according toclaim 18, wherein:

a) the pressure in the transanally placed catheter balloon is initially set to a first, low pressure range of approximately 10 to 25 mbar, which anchors and seals the catheter in the anus;

b) the inflow fluid is introduced into the rectum by squeezing it out of the container;

c) after a suitable retention time, the filling pressure in the catheter balloon is raised to approximately 30 to 60 mbar, causing only the rectal bowel wall to be initially included in the expansion, and at which the defecation reflex is triggered in most users;

d) upon a further increase in the filling pressure in the catheter balloon, to approximately 60 to 120 mbar, the anal canal is also caused to expand, to increase intensity of the stimulus triggering the defecation reflex.

20. The method according toclaim 19, wherein by the sequential pneumatic triggering of a defecation reflex, a volume of the irrigation fluid is reduced to a value of about 80 to 120 ml per administration, the fluid being delivered as ready-to-use solution through a fixed feed conduit to the catheter, and the balloon is disposable.

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