DE102012017144A1 - Device for transanal insertion of irrigations medium, particularly enema in rectum and colon of patient, has trans-anal placed inflatable balloon of dumbbell-or hourglass shape, where balloon ends are positioned on body of catheter shafts - Google Patents

Abstract

The device has a trans-anal placed inflatable balloon of a dumbbell-or hourglass shape. The balloon ends (6) are positioned on a body of catheter shafts (1) in inverted manner. The catheter shaft is packed in a sheet structure that is sealed from sheet layers. Molded compartments of the sheet structure are designed around a catheter. The wetting of the catheter tip is carried out with a lubricant. An independent claim is included for a method for transanal insertion of enema in the rectum and colon of a patient.

Description

The invention is directed on the one hand to a device for trans-anal introduction of an inlet into the rectum or colon of a patient, comprising an inflatable balloon of predetermined by preforming in the production, waisted, especially dumbbell or hourglass-shaped shape, with two terminal balloon sections of larger radius and approximately spherical or discoid shape, as well as an intermediate, central, tapered balloon portion of reduced radius, which is placed trans-anal, such that the distally adjacent, radially expanded balloon portion is placed intra-rectally and the proximal adjacent, radially extended balloon section extracorporeal, and on the other hand, a method for filling the catheter balloon of such a device for trans-anal introduction of an inlet into the rectum or colon of a patient by means of a filling device.

Catheters for the trans-anal application of an inlet into the rectum (rectum) or the large intestine (colon) of a patient have been known in various embodiments for some time.

Inlet catheters can be designed as simple tube elements, but can also be provided with an intra-rectally placed balloon element for improved retention of the catheter in the rectum. Such balloon elements, in addition to ano-rectally anchoring function, also provide a certain sealing effect which keeps the fluid introduced by the irrigation in the intestine. However, the sealing capability of inlet catheters with an exclusive intra-rectal balloon component is in many cases not sufficient and must be established by the user by continuous manual positional correction of the sealing balloon surfaces on the rectal bottom or manipulation of the position of the balloon-mounted catheter shaft.

A significant risk in the application of commercially available, trans-anal introduced into the intestine catheters is still in the perforation of the intestinal wall in case of improper handling or even in previously damaged or correspondingly weakened intestinal wall structures. Such perforations of the intestine can so far only be prevented by appropriate training and sensitization of the user to this particular problem.

Over the past ten years, in addition to the use of conventional trans-anal enemas, a novel inflow technology has emerged, providing intermittent, relatively small intra-rectally introduced enemas, the reflex-coordinated active emptying of the rectum and large portions of the rectum adjacent to the rectum left side colon triggers. The consistent emptying of these intestinal sections, the patient can thus, despite existing incontinence problem, in the state of a so-called "pseudo-continence" be transferred. The procedure of so-called trans-anal irrigation (TAI) can be performed by the patient himself.

The function of rectally instilled enema medium is in addition to a certain mobilization of stool, especially in a moderate elongation of the wall portions of the rectal ampoule (terminal rectum), which leads to the release of the physiological defecation of the stool (reflex triggering). While the rectally placed inlet medium usually causes such a reflex triggering after just a few minutes, the subsequent complete emptying of the applied irrigation volume from the rectum or colon can take significantly longer, up to 30 minutes or more. The relatively high time required by the TAI limits acceptance in many patients, and often excludes the method, although it is generally efficient for the individual.

Another problem is that many users are unable to bring the irrigation catheter of conventional design manually in a sufficiently sealed position and hold.

Furthermore, during the expansion of the balloon component of conventional catheters within the rectum, a reflex-triggering expansion of the wall of the intestine may occur even at the onset of filling, which, inter alia, leads to a reflex-like opening of the anus, and thus under certain circumstances to the anchoring balloon escaping from the rectum.

Devices available on the market for intermittent trans-anal irrigation such. In addition, the system Peristeen-Anal Irrigation, the company. Coloplast, Denmark, are also relatively expensive constructed, and often only partially suitable for use outside the familiar home.

It would be desirable for the improved acceptance of trans-anal irrigation in the user to use a catheter technique that keeps the catheter shaft in its trans-anal position after it has been inserted into the rectum without the need for continuous posture correction and prevents both the potentially traumatic sliding of the shaft body into the intestine, as well as the premature unwanted slipping out of the catheter from the anus reliably avoids.

Better comfort in terms of the trans-anal placement of the catheter in this regard provide inlet catheter with double balloon assembly. The catheter shaft sit here, spaced from each other on the shaft, two separate, usually over a single filling lumen simultaneously filled balloon elements. These come to lie on both sides of the anal canal, ie inside and outside, or take up the structures of the anus between them. The usually elastic design of the balloon material results in expansion of the balloon wall under pressure to a spherical extension of the balloon body and so to a certain axial acting bruising of the anus lying between the balloon bodies. The dislocation-secure positioning of the catheter shaft is to be assumed to be relatively safe in such catheters. The problem is the sometimes high, required for elastic expansion of the envelope filling pressures that are perceived by patients as a disturbing or painful foreign body sensation. Furthermore, the elastic expansion of the intra-rectal balloon can lead to a bulging sphere for immediate triggering of the defecation reflex, which in turn leads to slipping out of the catheter and premature emptying of the irrigating fluid in the event of simultaneous rectal contraction and decreasing sphincter tone.

The DE 10 2004 033 425 B4 describes a closure system for the treatment of rectal anal incontinence with a particular embodiment for the tamponade of bleeding hemorrhoids, wherein a waisted balloon element is shown, which has terminal at each end an intra-rectal or pre-anal section. In this case, the balloon envelope is placed on the balloon-carrying shaft body in such a way that the intra-rectal balloon segment moves toward the rectal bottom when filled and exerts a tamponating pressure on the bleeding venous vessels there. Accordingly, the pre-anal balloon segment moves toward the external anal opening. Thus, a tamponade effect directed axially on the anus from both sides occurs. In addition to the axial bleeding tamponade, the central waisted section of the balloon expands radially toward the wall of the anal canal. It is preferably formed with a diameter exceeding the diameter of the opened anal canal. The tip of the shaft body protrudes in the beschrienen device for acute care of venous ano-rectal bleeding in the state of use freely and unprotected in the intestine, and represents a potential risk of injury.

The WO 2007/118621 A1 describes a similar dumbbell or hourglass-shaped balloon closure system. It is based on the task of ensuring a seal against involuntarily exiting stools for intermittent periods of a few hours in chronically ano-rectally incontinent patients. In this device for the supply is also directed from both sides axially to the anus directed towards rolling movement of the terminal balloon segments in the foreground. Again, the tip of the balloon-bearing shaft body protrudes in the trans-anal placed state free and potentially traumatizing in the intestinal space.

Both devices describe an hourglass or dumbbell-shaped balloon shape, wherein the anus is received in the waisted, opposite the terminal portions of the balloon tapered area. By such a shaping of the balloon can be achieved in addition to a relatively good backup of the catheter before dislocation, because of the all-round sealing of the balloon waist within the anal canal and a, over conventional double balloons significantly improved closure performance. Irritation, pain or a defecation-triggering expansion of the balloon envelope can be largely avoided in both devices, since the balloon wall is preferably already formed to their working dimensions or beyond. For filling or unfolding of the balloon in its working state, therefore, only a low filling pressure is required, which corresponds to the pressure prevailing in the rectum or in the abdominal pressure, or only slightly exceeds this.

As particularly disadvantageous in the in DE 10 2004 033 425 B4 and WO 2007/118621 A1 described embodiments, however, turns out when filling the catheter balloon free exposed distal tip of the balloon-bearing shaft body, which protrudes into the intestinal lumen and can lead there in the context of the application to corresponding irritation or injury to the intestinal wall.

The problem initiating the invention is to avoid these disadvantages of the known prior art.

The solution to this problem is achieved in a generic arrangement in that the two balloon ends are tapered to the shaft dimension of the catheter shaft bearing the balloon and are fixed in a simple everted or inverted manner on the preferably outer lateral surface of the catheter shaft such that when filling the balloon the two radially expanded balloon sections in opposite, axial directions to move toward each other, and wherein the two radially expanded balloon portions relative to the tapered central balloon portion are increased such that the trans-anally placed balloon, the two radially expanded balloon sections in the course of filling over the central, rejuvenated balloon section and in the borderline each other directly touch and thereby limit their relative movement and prevent the distal end of the catheter shaft to exceed the apex of the intra-rectal balloon radius at axially maximally deflected position of the shaft body to the distal direction.

In order to prevent shaft tip-related lesions as far as possible, the invention describes a specific, particularly advantageous ratio of the length of the central waist-like balloon segment for bilateral inversion (inversions) of the fixation points of the balloon shaft ends on the catheter shaft. This ratio ensures that the tip of the catheter shaft spontaneously retracts into the intra-rectal balloon segment in the filled, trans-anally positioned state, where it is atraumatically embedded. The atraumatic securing the catheter tip within the intra-rectal balloon segment is still guaranteed according to the invention even if there are application-typical deflections of the shaft axis within the anal canal, as they can easily be adjusted by train or shock to the catheter-leading hose connection.

The invention further addresses the problem of avoiding unwanted or premature triggering effects through the filled, intra-rectally deploying balloon. The triggering of the defecation reflex can be avoided in the majority of cases by preforming the balloon to working size or even beyond (residual dimensioning), since the filling pressures required for anchoring and sealing the catheter largely correspond to the pressures prevailing in the rectum or in the abdomen . only a few millibars above. The atraumatic securing of the catheter tip in the region of the intra-rectal balloon segment is already ensured according to the invention at such low inflation pressures of, for example, 10 to 25 mbar.

The shaping of the balloon to its working size also allows the user to increase the filling pressure or filling volume, from the initial filling state primarily sealing and anchoring acting balloons, a well controllable, gradually increasable expansion of the catheter balloon applied intestinal wall to bring about, which finally, in individually adjusted intensity, leads to the controlled release of the defecation reflex.

In addition to the initial elongation of the wall of the rectum, with a correspondingly further increase in the filling pressure in the dumbbell-shaped catheter balloon, there is also an expansion of the anus or the anal sphincter, which represents a further efficient trigger stimulus.

The intensity of such pneumatic stretching of the intestinal wall or the anus can clearly exceed the intensity of a reflex-triggering stretch with liquid media. Due to the more intense stimulus, it is possible to initiate several sequential evacuation reflex cycles despite a one-time stimulation.

In addition, the user-controllable pneumatic expansion stimulus can in many cases reduce the amount of inflow fluid required, which in turn can significantly reduce the time required to empty the rectal enema, and ultimately provide the method of treatment for many users Self-application opens up.

On a complex technical design of Irrigationsgeräten can be omitted in the optional pneumatic-liquid combined Reflextriggerung shown here, as in the preferred application, the required irrigation volume can be kept so small that it as compact ready to use prepared solution directly with an inventively designed inlet catheter via a solid Supply line can be connected, and so can come in an ideal way as a disposable product for use.

The irrigating solution is for this purpose preferably filled in a cylindrical, bag-like container, which can be conveniently introduced by the user intra-rectal by pressing out by hand.

The inlet catheter according to the invention further has a preferably permanently glued filling line for acting upon the catheter balloon with filling pressure. The unit for filling the balloon is preferably designed in a reusable form, and can be designed as a simple, connectable via a clutch hand pumping balloon or pumping balloon with pressure-indicating pressure gauge. Alternatively, a volume-controlled filling of the balloon is conceivable. Regardless of the type of filling, the user can determine by step-by-step approximation, the optimum balloon filling for himself, which is best adapted to his individual anatomy and his respective reflex status.

To ensure a catheter insertion which is as practicable as possible and a secure trans-anal placement of the tapered part of the dumbbell-shaped balloon element, the catheter shaft in the proximal, pre-anal region is preferably provided with recessed grips for receiving the fingers engaging the catheter during insertion. If the user has no sensitivity in the pelvic or Anal, he introduces the catheter with his fingers as far as the stop on the anus and can thus avoid an uncontrolled deep insertion.

Further features, properties, advantages and effects of the invention will become apparent from the following description of preferred embodiments of the invention and from the drawing. Hereby shows:

1a an embodiment of a catheter according to the invention in a schematic longitudinal section, wherein the balloon ends are applied according to the invention in an inverted manner on the catheter shaft;

1b the geometric construction of the vertex of the distal balloon radius;

1c the in 1a described balloon body in freely deployed, acted upon with low inflation pressure state, outside the anus;

1d the in 1a described balloon body in pressurized, trans-anal placed state;

1e the geometric construction of the distal tangential plane to the intra-rectal balloon section;

2 one of the 1a corresponding representation of another embodiment of the invention, wherein a catheter tip extends beyond the front fixing line of Balonschaftendes out;

3 one of the 2 corresponding representation, wherein further auxiliary lines are drawn, such that the reference point for the determination of the inversion depth B is not the front balloon radius, but the largest diameter D of the intra-rectal balloon segment;

4 a molded balloon envelope in an unfilled state, which is particularly advantageously provided for rectal insertion and secure trans-anal placement and deployment of the balloon;

5 a modified embodiment of the invention with in its trans-anal section waisted catheter shaft;

6 a manually operable pump gauge with a pressure scale equipped for multi-stage, sequential filling of the catheter balloon;

7 a modified embodiment of the invention with firmly connected to the catheter shaft inlet container and filling hose for acting on the catheter balloon with filling pressure;

8th shows an exemplary embodiment of the invention in which various elements for the administration of a trans-anal enema in a film-sealed container are packaged packaged or ready for use;

8a schematically shows how the film layers are firmly connected by preferably welds together and form a compartment between them; and

9 shows a further particular embodiment of the invention in a broad analogy to in which the packaging units of the section 48 are already separated from the compartments containing the media, and in addition to a liquid receiving compartment are also equipped with one or more compartments for receiving, for example, air for the filling of the catheter balloon.

1a shows a longitudinal section through an inlet catheter with a distal on the catheter shaft 1 terminally applied dumbbell or hourglass-shaped balloon element 2 , The balloon element has, for example, at the ends, for example, spherical or disc-like extensions. In the central area between the terminal extensions is a reduced diameter, cylindrical or approximately cylindrically shaped segment 3 , which is the intra-rectal extension 4 with the pre-anal enlargement 5 consistently connects.

The balloon 2 has terminal two balloon shaft ends ( 6 . 7 ) for attaching the balloon to the shaft. The shank ends 6 and 7 are in the balloon assembly on both sides by a certain amount B in the balloon inside inverted (inverted) and in this offset to each other position on the shaft 1 fixed by, for example, gluing or welding.

The sum of the amounts B of the bilateral inversion should correspond at least to the length of the tapered intermediate piece A (A less than or equal to the sum of the amounts B).

The inversion depth B on the side of the balloon facing the patient or the rectum corresponds to the distance of the vertex 8th of the distal, intra-rectal balloon radius 9 to the distal fixation line 11 of the balloon end 6 on the catheter shaft.

The distal radius 9 corresponds to the frontal radius with free, not inverted unfolding of the completely filled, but not pressurized balloon (dashed line). An exemplary rule for the geometric determination of the vertex 8th with a good approximation, is in 1b shown. In particular, the two points of inflection WP of the longitudinal section through the distal end of the balloon can be seen, from which the spherical or discoid or approximately half-toroidal region of the intra-rectal balloon section results due to inversion of the distal balloon region. The perpendiculars 9e . 9f at the tangent to the balloon longitudinal section, the longitudinal axis X of the catheter shaft intersects at the point M, and a circle K around this point M at the distance M-WP provides the anterior apex 8th marking the distal border for the catheter shaft in its neutral, undeflected home position.

In 1e It can be seen that points WP can also be used to form a straight line which represents plane Z, which, after everting the anterior end of the balloon, just tangles the intra-rectal balloon section distally and also measures the most distal position of the catheter shaft in the latter neutral, undeflected starting position can be viewed.

On the side of the balloon facing away from the patient, the inversion depth B corresponds to the distance of the vertex 12 of the proximal, pre-anal balloon radius 13 to the proximal fixation line 14 of the balloon end 7 on the catheter shaft.

The radius 13 corresponds to the proximal radius with free, not inverted unfolding of the balloon. The geometric determination of the vertex 12 corresponds to the in 1b described approximation.

The determination of the length of the intermediate piece A is carried out by determining the distance between the transitions of the shoulder radii 15 and 16 (Turning points) of the mutually facing shoulder surfaces of the balloon segments 4 and 5 ,

The determination of the inversion depths, lengths and distances takes place in each case in the filled, subjected to misprints state, the filling pressure is chosen so that the balloon fully unfolds, but does not set elastic expansion of the balloon envelope.

The inversion depth B is calculated as follows: B> = A / 2 (> = equals: greater / equal).

When mounting the balloon on the catheter shaft, the reference point for the respective inversion of Balonieschaftenden is the one the apex 8th of the distal, intra-rectal balloon radius 9 , on the other hand, the vertex 12 of the proximal, pre-anal balloon radius 13 ,

In the embodiment described in this figure, the distal fixation line corresponds 11 also the distal end of the catheter shaft 1 , The shaft closes directly with the fixation line 11 off and is not enough, as in shown, beyond this fixation line to the distal out.

1b describes the geometric derivation of the vertex of the distal balloon radius.

The anterior, frontal to the intestinal lumen pointing balloon radius 9 of the intra-rectal balloon segment 4 is shown as a dashed line. He will be out of the two turning points 9a and 9b as well as the two, each of these points associated Wendetangenten 9c and 9d constructed.

With the help of one of the two turning points 9a or 9b becomes a straight line 9e or 9f designed, which on the one hand perpendicular to the respective Wendetangente 9c or 9d is and the corresponding turning point 9a or 9b cuts. The intersection of this line 9e or 9f with the axis of symmetry X gives the center of the circle K. The circle K, and thus the front balloon radius 9 results from the circle center point M and the turning points 9a and 9b , which are located on the circumference. The vertex 8th results in this derivation from the intersection of the circumference with the axis of symmetry X of the balloon.

For the description of the frontal vertex used in the following 8th For the simplified derivation of the furthest distal point of the filled, not pressurized balloon envelope, the point of intersection of the connecting line Z of the two inflection points 9a and 9b used with the axis of symmetry X.

1c shows how the in 1a In accordance with the invention, the inverted catheter balloon behaves in the free, non-trans-anally placed state with free unfolding and without pressure. This is shown by the specific inversion of the balloon ends 6 and 7 on the catheter shaft enabled counter-roll movement of the two terminal balloon segments 4 and 5 ,

In a preferred particularly thin-walled and soft foil-like design of the balloon body, the two segments move towards each other even at the lowest, almost ambientem filling pressure and roll over the central segment 3 , Upon contact of the two segments in the area of the transition points ( 15 . 16 ) of the shoulder radii closes the vertex 8th of the radius 9 flush or nearly flush with the distal fixation line 11 of the distal balloon end 6 on the catheter shaft.

Such a configuration would correspond in situ to a clinical application situation with a maximum shortened length of the anal canal. Even in this extreme case, it would thus be ensured, due to the described inversion rule, that the free distal catheter shaft end, which here is the distal fixation line 11 does not extend into the intestinal lumen and does not come into contact with the wall of the intestine even at maximum lateral deflection of the catheter shaft in the rectum (tilting of the intra-rectal shaft portion to the intestinal wall) and the distal balloon radius 9 exceeds a maximum limit excluding irritations and lesions of the intestinal wall.

1d shows how the in 1a described inversion of the balloon ends with respect to the distal end of the catheter at normal or only slightly shortened length of the anal canal. In this, rather normal clinical application situation, the anterior fixation line arises 11 which in turn corresponds to the distal free end of the catheter shaft, clearly into the interior of the intra-rectal balloon 4 offset. The two terminal balloon segments 4 and 5 When the balloon is pressurized, they move in opposite directions to the anus, sealingly nestling against the respective anal site. With a correspondingly thin-walled design and soft-film-like character of the balloon envelope, the counter-rolling of the balloon segments likewise already occurs at a very low pressure force (filling pressure), which is almost ambient to the surroundings. The individual, intra-abdominal pressure applied to the balloon placed on the trans-anal balloon or leading to the balloon leads to a combined trans-anal sealing effect of radial seal against the anal canal and a sealing movement of the terminal balloon extensions on the inner and outer seals outer exit of the anus. The sealing effect, therefore, is not dependent on an initial filling of the balloon beyond its volume on free deployment, until incipient expansion of its balloon envelope. The balloon may also behave in partial filling, for example, 70 to 90% of its freely unfolded on the catheter shaft volume in described axially gegenrollender and radially unfolding manner. As a result, a virtually pressure-neutral and irritation-free placement of the balloon catheter in the anus is possible.

A traumatizing effect of the catheter tip on the intestinal wall can thus be excluded with normal or little changed anal anatomy by inventively adjusting inversion of the shaft tip even when completely pressureless exposure to a filling medium.

2 shows by way of example how portions of the catheter shaft containing the distal fixation line 11 in a distal, intestine-oriented continuation as a point piece 18 in determining the inversion depth of the balloon ends 6 and 7 must be taken into account in order to ensure an inventive atraumatic inversion of the catheter distal end in the intra-rectal balloon in trans-anal placement of the filled catheter balloon. The length C of the lace piece 18 is defined as the distance of the front fixation line 11 to the front vertex 19 the top piece.

The length B is extended compared to by the amount of length C or C / 2.

The corresponding inversion depth B is preferably calculated according to: B> = A / 2 + C when considering a tip piece.

Alternatively, the corresponding inversion depth B, taking into account a tip piece, may be less preferred as follows: B> = A / 2 + C / 2.

3 provides another alternative rule for determining the inversion depth B of the balloon endings 6 and 7 on the catheter shaft 1 relative to the distal end of the catheter 11 . 19 represents.

In particular, a possible axially directed displacement of the catheter shaft within the filled, trans-analally placed balloon is taken into account. Such a deflection of the shaft in the longitudinal axis could, in the context of the invention described inversion of the Balonieschaftenden on the balloon-carrying catheter shaft lead to intestinal displacements of the distal catheter shaft end, and thus represent a potential risk of perforation.

As the maximum distal deflection path W of the front fixation line 11 A distance is defined as the distally directed extension of the shaft longitudinal axis from the vertex 8th of the radius 9 goes out and to the vertex 20 a radius 21 ranges, with the radius 21 above the largest diameter D of the intra-rectal balloon segment 4 is being built.

The catheter shaft has a tip piece 18 which over the line 11 extends, the maximum deflection W should be chosen accordingly so that the peak 19 of the tip piece at maximum deflection W of the shank not over the radius 21 enough.

The radius defined by the largest diameter D in the intra-rectal balloon segment 21 represents a principally relevant boundary line for distal catheter shaft portions. With a lateral tilting of the shaft longitudinal axis of the trans-anally placed catheter shaft, the reference of the maximum deflection W to the largest balloon diameter D ensures that the catheter tip ( 11 . 19 ) still within the swing radius 21 of the balloon segment 4 moves, and thus a potentially traumatizing contact of the tip with the balloon adjacent intestinal wall can be relatively well excluded.

Preferably, when determining the inversion depth B, the respective ratio of the distance W to the radius 21 or the underlying diameter D and the inversion depth B are adjusted accordingly if necessary.

4 shows the catheter balloon 2 in deflated form, attached to the catheter shaft, as provided for insertion into the anus. The shell segments of the intra-rectal balloon 4 as well as the central segment 3 lie snugly against the shaft in folding.

In this case, the two shell portions preferably come about at the level of the distance between the fixation points of the balloon ends 6 and 7 lying on the shaft surface. The shell of the pre-anal balloon segment 5 On the other hand, it is preferably struck proximally and projects beyond the finger engaging the catheter during insertion, the preferred grip point being immediately proximal to the proximal fixation line 14 located. The grip point 22 is preferably designed as a trough-like receiving surface, which are preferably applied to the two, offset by 180 degrees, opposite shank surfaces.

The user engages with such a fixation of the evacuated balloon with his fingers under the proximal smeared shell of the segment 5 and insert the catheter into the rectum as far as the attacking fingers on the outer anus stop. Thus, a defined insertion depth is guaranteed. It also ensures that the intra-rectal balloon portion 4 is introduced into the rectal cavity, while the proximal balloon portion 5 outside the anus (pre-anal). During the filling of the waisted balloon, therefore, a secure trans-anal positioning of the catheter is established.

5 shows a preferred embodiment of the shaft body 1 which already provides some self-positioning and securing of the shaft in the anus when the catheter balloon is not yet filled. The shaft 1 for this purpose has a likewise waisted shape, in the trans-anal area 23 is correspondingly tapered, and the catheter shaft in this area after insertion in quasi trans-anal position snaps. The catheter shaft preferably also has a distal terminal, funnel-like opening, atraumatisch formed opening 24 on, which is the medium supplying channel 25 followed.

In a particularly large-volume design of the intra-rectal balloon segment or a far reaching into the rectum longitudinal extent of the balloon segment, this can be in the vented, ready-to-use state optionally partially in the opening 24 be stuffed or packed. When filling the inserted catheter, it then slips out of the opening.

The waist 23 can also pretend, with adapted design of the shaft material a certain buckling of the shaft body, which improves its atraumatic properties.

The filling of the balloon takes place through a separate shaft integrated channel 26 ,

To avoid the backflow of irrigation fluid of the inlet catheter in the region of the liquid-conducting channel 25 equipped with a check valve.

The valve may preferably consist of a thin-walled hose element of a few, preferably 5 to 15 microns wall thickness and the diameter of the channel 25 exist, with the distal end of the tube over a length of about 5 to 10 mm freely in the channel 25 lies, and its proximal end tightly closing me the inner wall of the channel 25 connected is. When the medium flows through the channel in a point-wise direction, the hose element opens and allows free flow of the medium. When the flow is in the opposite direction, the hose element collapses and closes tightly to prevent effective return flow.

6 schematically shows a pump gauge 27 with a, to a multi-step or sequential filling pressure increasing filling of the catheter balloon according to the invention suitable scale 28 , The scale preferably represents, on the one hand, an initial, low pressure range 29 10-25 mbar), which is set by the user after insertion of the catheter and before introducing the inlet liquid, and in accordance with the invention preforming and shank fixation of the balloon envelope in the majority of cases already a trans-anal anchorage and sealing of the catheter ensured without having an immediate reflex-triggering effect on the intestinal wall.

In the event of an increase in inflation pressure in the balloon caused by the user in a row 30 (30-60 mbar, assuming corresponding elongation of rectal wall parts) or in the area 37 (60-120 mbar, assuming additional elongation of the anal sphincter), the user can finally generate a trigger stimulus whose intensity can be largely reproduced in order to trigger a defecation reflex. The user thus has the advantage of being able to largely avoid an emptying reflex at an initially low, merely anchoring and sealing-acting balloon pressure, and thus to be able to keep the inflow fluid sufficiently long in the intestine for its individual requirements, resulting in a better solution or suspension of the Chair in the liquid leads. On the other hand, it can produce an intense, relatively prompt-acting, reflex-triggering stimulus by an arbitrarily induced pressure increase in the balloon, which goes beyond the triggering effect of a colo-rectal fluid column in terms of its intensity, if necessary.

The filling of the catheter balloon is preferably carried out by air via a into the shaft wall of the catheter body 1 integrated filling line.

In addition to one, as in shown pressure-controlled filling of the balloon with a pump gauge, for the volume-controlled filling an attached syringe element can be used, which dictates the preferred filling volume by a corresponding mark on the syringe body. The filling of the balloon takes place in a single-step filling preferably partially. The balloon is therefore in the ideal case, the structures of the intestine and the anus in flabby, non-stretched form. The balloon sheath thus absorbs the forces acting on the balloon in the rectum, anus, and pre-anal, and brings the balloon into its configuration, which performs the anchoring and sealing function. The respective physiological forces are absorbed by the catheter balloon, thus allowing a largely pressure-neutral ano-rectal balloon placement, which largely precludes the likelihood of unwanted and premature trigger effects.

A volume-controlled filling of the balloon can also be carried out in two steps, initially with an incomplete filling, and the balloon is filled with a triggering volume in the second filling step. The pressures occurring in the respective volumes in the trans-anal balloon should preferably be in the in 6 described pressure ranges ( 29 . 30 ), and are to be determined individually by the user, as in the pressure-controlled filling.

To limit the filling pressure or avoiding critically high balloon filling pressures, a pressure relief valve can be used both with pressure gauge and syringe-actuated filling 31 be inserted between the filling element and the catheter, which avoids, for example, balloon filling pressures over 120 mbar.

7 shows a preferred embodiment of an inlet catheter, which merges at the proximal end into two, preferably firmly connected to the shaft leads, wherein the supply line 32 with a preferably bag-like container 33 is firmly connected to inlet medium, and thus represents a ready for use unit of catheter and medium.

The volume of the container 33 is sized so that it absorbs about 80 to 120 ml irrigation solution. The relatively small amount is manually squeezed out by the user and thus introduced by repeated pressing in the rectum. In order to allow gripping of the container even with limited hand motor, the container is preferably cylindrical, shaped with a diameter of about 4-6 cm.

The connection 32 is preferably with a breakable by buckling seal 35 be equipped, which releases the irrigation solution. Also advantageous is an integrated in the liquid-carrying leg of the ready-to-use device check valve 36 , which allows the directed emptying of the container without backflow.

Another supply line 34 can directly with a pump gauge 27 or a filling syringe.

7 shows an embodiment of the invention, which particularly addresses the application of a prefabricated unit of catheter and Irrigationsvolumen, the unit represents the functionally relevant elements and structures, which is beyond the inlet catheter itself, as compartments or medium-carrying leads, which by flat , spot or linear welding 38 for example, two layers of film 37a and 37b arise, and in the manner of a tear-open package from the patient to the application, as conceptually in 8a is shown.

shows such a foil-welded structure 39 , whose two film layers by tear tabs 40 and for example preformed weakenings 41 the welding lines 38 in certain areas can be opened by the user, such as a catheter element 43 with connected hose feed line ( 32 . 34 ) from a pocket-like compartment 42 to be able to remove.

To all necessary for the user components in the application of such tear-open as possible in the film structure 39 to integrate exemplifies a specific arrangement of functional elements. Thus, the portion of the inflow catheter to be placed intra-rectally or its intra-rectal balloon element 4 in a separate compartment 44 stored in which it is for example by a connected or incorporated therein gel reservoir 45 can be wetted by the user by expressing the contents with lubricant immediately before use. The compartment 44 and the compartment 42 are hereby preferred by a waisted Abweißung of the two film layers of the structure 39 connected as closely as possible to the shaft of the catheter, and prevents or reduces the onset of gel. In the opposite part of the structure 39 can additionally a compartment 33 trained yours, which already contains the irrigation fluid optionally required for the application. This compartment is connected to the catheter by a corresponding tubing supply line 32 firmly connected. Further, at the proximal end of the catheter shaft is a hose member 34 connected to the connection to an external filling device 27 allowed. The administration 43 is preferably arranged so that it is terminal in the range of the compartment 33 from the film structure 39 protrudes.

The application of the described tear-open and disposable film structure in the sequence is as follows. The user opens the gel reservoir 45 by squeezing or crushing, thus wetting the intra-rectal catheter portion within the compartment 44 , Then opened with both hands, the tabs 40 gripping, the compartment 42 in which the distal end of the catheter 43 is exposed and the tubing leads exposed 32 and 34 packed in a space-saving and compact way. The opening of the film structure 39 is preformed via corresponding weakenings 41 the welding lines 38 , The weakenings are preferably formed so that they in the range of sidecut 46 or beyond in the area 44 range, and so facilitate the removal of the distal catheter portion of the film structure. The weakenings 41 can also be in the transition area 47 between compartment 42 and compartment 33 after the withdrawal of the catheter 43 the entire front part 48 the film structure can be separated and discarded, leaving only the catheter 43 the compartment connected to the catheter 33 remain. The user therefore removes the catheter or places it by separating the portion 48 the film structure free. He then connects the thigh 34 for ventilating the balloon with a filling device attached to the leg at the end 27 , He then introduces the wetted catheter into the anus, and fills the balloon portion of the catheter with a volume which anchors the catheter in the anus and seals against bowel contents or irrigating solution. Afterwards he breaks a seal 35 , which in the broken state, the outflow of liquid from the compartment 33 allowed in the intestine. The fluid-carrying leg 32 is also preferred with a check valve 36 or a different type of return liquid-preventing element. Following the squeezing out of the liquid into the intestine and a certain exposure time in the intestine, the user can induce reflex-triggering stretching of the balloon-exposed intestinal components by increasing the filling volume in the catheter balloon. When inserted, the balloon is opened to the environment and, when opened, is pulled out of the anus, allowing the contents of the intestine to deflate.

Alternatively, the film structure can only be the catheter 43 include, thus dispense with a liquid-filled compartment, and essentially exclusively from one of the section 48 entprechenden segment exist.

The supply lines 32 and 34 are in the range of the compartment 42 preferably stowed in a space-saving manner in wound or folded form and allow unfolding to an application-appropriate length of about 50 to 80 cm.

In the described embodiment, a simple sequence of application steps directed across the product is ensured, which on the left side is at the gel reservoir 45 begins (wetting the distal end of the catheter), to the right over the compartment receiving the proximal catheter and the feeding tube member 42 (Removal of wetted catheter) and the irrigation fluid receiving compartment 33 (Pressing the liquid) continues.

8a schematically illustrates how the film layers 37a and 37b the film structure 39 preferably by welds 38 are firmly connected and form a compartment between them.

describes a comparable device as ., In which case, however, one or more compartments are additionally introduced into the film structure, which already contain an air volume for the filling of the catheter balloon, whereby the connection of an external filling device can be completely dispensed with. The In this case, compartments are preferably arranged in such a way that the process sequence of application steps required or correct for the process is established by their extrusion in a specific linear sequence. For example, the compartment 50 contain an air volume required for the initial anchoring and sealing of the catheter in the anus. To the right, ie away from the patient directed end of the film structure, then closes the filled with liquid compartment 33 at. To the right of it can be another air filled compartment 49 be arranged, which increases by squeezing the volume in the catheter balloon, and thus sets the trigger stimulus. The individual compartments are similar to crushed seals 35 to open. All compartments have a backflow of air or liquid preventing element analogous to element 36 , Furthermore, the air-bearing common supply line from the compartments 49 and 50 to the catheter 43 with a vent line 53 connected, which makes it possible to discharge the volume of the balloon to the environment in, and thus to empty the balloon. The administration 53 must communicate with the catheter balloon so that a free flow of filling volume is ensured from the balloon.

Here is, analogous to 9 , also given an application-appropriate arrangement of the compartments or components, wherein the applied from the left (patient facing side) to the right sequence of compartments or components corresponds to the correct sequence of application steps. Starting with wetting followed by catheter removal, initial filling of the balloon, introduction of fluid into the intestine, and an optional second triggering balloon filling.

In addition to a serial arrangement of the compartments also a concentric arrangement is conceivable, in which, for example, the air-filled compartment 50 inside a compartment filled with irrigating fluid 33 is attached as separated from this Folienkompartiment. Here, too, both compartments would each be equipped with a break seal and a backflow-preventing element. The concentric arrangement described can be in the sense of in 9 illustrated embodiment also contain three compartments.

In the 8th and 9 described embodiments of the compartmentalized film structures that summarize various application-relevant components in a single packaging or vorrätigenden unit can, in a corresponding manner, even in Einlaufkatheterelementen with a conventional intra-rectal balloon without trans-anal or pre-anal balloon portion or even with catheter elements without any sealing or anchoring balloon component is advantageously used.

The balloon element 2 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 are particularly preferred.

The use of only slightly volume-expandable materials such. For example, polyurethane (PUR), for example, the specification Pellethane 2363 80 A to 90 A, Dow Chemical Corp., is preferred because these materials have good dimensional stability even with balloon films in the lowest wall thickness range in the pressure range of about 10 to 120 mbar.

Such thin-walled PUR balloon sheets molded in complex form may preferably be made by hot-molding previously extruded tubular tubing, which, with appropriate stretching of the tubing blank prior to tempering, allows for polymeric orientation, and the shaped balloon sheets to an extraordinary degree gives mechanical strength.

Also conceivable is the use of polyurethanes low Shore hardness, such. B. the range of 60 to 75 A, the catheter balloon in the wall thickness range of less than 40 microns, and preferably below 15 microns, in the application typical filling pressure range of 10 to 120 microns, with a relative loss of dimensional stability, equip with a volumendehnbaren behavior.

Alternatively, for example, non-volumendehnbare materials such as polyethylenes, PVC or mixtures of said materials with polyurethane can be used.

Balloon films according to the invention can also be formed directly from the extruded, still soft, largely amorphous tube mass (in-line molding), the achievable strengths of the films being significantly smaller than in pre-extruded tubes or the achievable wall thicknesses being significantly higher than in the case of pre-extruded molding Material are.

Also conceivable for the production are immersion methods when using liquid PVC or PUR materials.

The welding of singular film layers to balloon bodies is conceivable.

The connection of the balloon with the shaft body is made by gluing, by thermal Method or alternatively by shrinking the balloon ends on the shaft body.

The intra-rectal balloon portion 4 should in the freely unfolded, not pressurized state, preferably have a diameter of about 30-60 mm, in the central waist region 3 about 10 to 30 mm and in the pre-anal area 5 about 30-50 mm. The central segment 3 should be about 20-40 mm in length, the terminal segments 4 and 5 each a length of about 20-40 mm.

If the catheter balloon is specifically designed for sequential loading, with optional intra-rectal balloon triggering, the intra-rectal balloon portion will have 4 in the freely unfolded, not pressurized state, preferably has a diameter of about 40-80 mm and has a length of preferably 30-60 mm.

In addition to the trans-anal application of the inlet catheter, the embodiments of the invention can also be used for the perforation-safe placement of a trans-anal inserted drainage tube, among other things, for the permanent discharge of stool from the gut of a patient. Furthermore, an application of the catheter technique described in surgically created stomata / openings or other natural body openings is conceivable.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 102004033425 B4 [0012, 0015]
• WO 2007/118621 A1 [0013, 0015]

Claims (2)

Device for trans-anal insertion of an inlet into the rectum or colon of a patient, preferably with a trans-anally placed inflatable balloon of a dumbbell or hourglass-shaped shape, wherein the balloon ends are positioned on the body of the catheter shaft so inverted that the terminal balloon portions when filled over the central tapered balloon portion away from each other to move in a counterpart manner, and the distal opening of the catheter shaft while the vertex of the front, frontal balloon radius in axially undeflected rest position of the shaft body in trans-anally placed balloon not distally towards exceeds, characterized in that the catheter shaft is packaged in a sealed foil layers of film structure, the molded compartments are created in such a way around the catheter, that a meaningful, on the product of time directed linear sequence of application steps e which begins with the wetting of the catheter tip with a lubricant, continues with the removal of the wetted catheter from a rupturable pocket-like compartment and concludes with the introduction of a ready-to-use integrated in the product amount of irrigation fluid into the rectum. A method for trans-anal insertion of an inlet into the rectum or colon of a patient, preferably with a device a trans-analally placed inflatable balloon of a dumbbell or hourglass shape, the balloon ends are positioned on the body of the catheter shaft so inverted that The terminal balloon portions when filled over the central, tapered balloon portion away, in opposite directions to each other to move, and the distal opening of the catheter shaft while the apex of the front, frontal balloon radius at axially non-deflected rest position of the shaft body in the trans-analally placed balloon not distal to the distal end, the catheter shaft being packaged in a sheet-like film structure having its shaped compartments applied around the catheter, characterized by a meaningful, product-directed, linear sequence of the following applications gsschritte: - In a first step, the catheter tip is wetted with a lubricant; In a second step, the wetted catheter is removed from a rupturable pocket-like compartment; In a third step, an amount of irrigating fluid integrated into the product ready for use is introduced into the rectum.

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