METHOD AND DEVICE FOR INTERMITTENTLY TRIGGERING A REFLEX-COORDINATED DEFECATION

Abstract

The invention relates to a method for filling an inflatable 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 a filling pressure prevailing in the catheter balloon is increased in two or more steps until there occurs a gradual, user-controllable, pneumatically initiated expansion of portions of the bowel wall, thus triggering a coordinated defecation reflex, wherein the timing and intensity of the triggering stimulus can be determined to the greatest possible extent by the user.

Claims

1. A method for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising the following steps: providing a catheter, the catheter comprising: a catheter shaft, and a catheter balloon surrounding the catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope: which has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and which, during manufacturing of the catheter balloon, is preshaped to a reference dimension (V.sub.REF) of a balloon filling volume (V.sub.BF) as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF) corresponds to a dimension of the rectum or colon of the user, and which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension (V.sub.REF), the ballon filling volume (V.sub.BF) of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit (V.sub.UDL) at a pressure in the range of 10 to 120 mbar applied to the interior of the balloon:
V.sub.UDL>V.sub.REF; in a first step, inserting the catheter in the rectum or colon of the user and providing an initial fill volume (V.sub.IF,1) or an initial filling pressure (p.sub.IF,1) of air or another fluid in the catheter balloon in order to inflate the catheter balloon below the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF) thereof in a pressure-neutral manner, i.e. wherein the initial filling pressure (p.sub.IF,1) inside the catheter balloon is equal to a physiologically acting intra-rectal acting pressure (p.sub.IR) that is prevailing in the rectum of the user, producing a sealing and anchoring effect without any stretching of the envelope of the catheter balloon and causing neither a trans-mural pressure (p.sub.TM,1) beyond the physiologically intra-rectally acting pressure (p.sub.IF) nor a reflex triggering expansion of portions of the lateral rectal wall exposed to the catheter balloon, according to the following formulas:
p.sub.IF,1=p.sub.TM,1=p.sub.IR, and wherein the initial fill volume (V.sub.IF,1) of the catheter balloon is below the reference dimension of the balloon filling volume (V.sub.REF):
V.sub.IF,2<V.sub.REF; so that the envelope of the balloon is not stretched; and in a second step, increasing such initial fill volume (V.sub.IF,1) or such initial filling pressure (p.sub.IF,1) to an increased fill volume (p.sub.IF,2) or an increased filling pressure (p.sub.IF,2) by pumping, squeezing or injecting air or another fluid into the catheter balloon by the user until there occurs a gradual, user-controllable expansion of portions of the lateral rectal wall exposed to the catheter balloon in such a way that the degree of filling of the balloon is best adapted to the individual anatomy, allowing for an even distribution of the trans-mural pressure (p.sub.TM,2) exerted by the balloon onto the exposed rectal structures, gradually increasing from the physiologically acting intra-rectal pressure (p.sub.IR) to a force level suited for triggering a coordinated physiological defecation reflex of the individual user, according to the following formula:
p.sub.IF,2=p.sub.TM,2>p.sub.IR, and wherein the increased fill volume (V.sub.IF,2) of the catheter balloon is still below the reference dimension of the balloon filling volume (V.sub.REF):
V.sub.IF,2<V.sub.REF; so that the envelope of the balloon is not stretched.

2. The method according to claim 1, wherein if placed in situ, the proximal fixation point of the catheter balloon to the catheter shaft is either suited upstream the anal canal for an intra-rectal unfolding the balloon only, or is suited in the anal canal for an expansion of a rectal balloon segment into the anal canal, or is situated beyond the anal canal for an expansion of the rectal balloon segment throughout the anal canal, forming a pre-anal balloon segment.

3. The method according to claim 1, wherein the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF) is pre-shaped to a volume of 30 ml to 150 ml.

4. The method according to claim 1, wherein, if the balloon filling volume (V.sub.BF) is below the preshaped reference-dimension (V.sub.REF), the envelope of the catheter balloon is not free of wrinkles.

5. The method according to claim 1, wherein, in a reference state where the ballon filling volume (V.sub.BF) reaches the preshaped reference-dimension (V.sub.REF), the balloon adopts a geometrical shape that is unfolding/expanding in a radial direction more than in an axial direction of the catheter shaft.

6. The method according to claim 1, wherein the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF) is designed in such a way, that, if the balloon is inflated up to this reference dimension (V.sub.REF) or beyond, it adopts a discoidal geometrical shape.

7. The method according to claim 6, wherein the discoidal shape is characterized in that a distance between a peripheral-most extension of the toroidal balloon and the lateral surface of the catheter shaft is at least equal to the distance between the two fixation points of the envelope of the catheter balloon to the catheter shaft.

8. The method according to claim 1, wherein the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF) is designed in such way, that, if the balloon is inflated up to this reference dimension (V.sub.REF) or beyond, it does not extend beyond the distal-most tip of the shaft.

9. The method according to claim 1, wherein the unvarying dimension limit (V.sub.UDL) of the balloon filling volume (V.sub.BF) is designed in such way, that, if the balloon is inflated up to this unvarying dimension limit (V.sub.UDL), it does not extend beyond the distal-most tip of the shaft.

10. The method according to claim 1, wherein the unvarying dimension limit (V.sub.UDL) of the balloon filing volume (V.sub.BF) is within a range of 100% to 150% of the reference dimension (V.sub.REF) of the balloon filling volume (.sub.VBF).

11. The method according to claim 1, wherein, if the balloon filing volume (V.sub.BF) is further increased to a further increased balloon filing volume (V.sub.IF,3) above the reference dimension (V.sub.REF):
V.sub.IF,3>V.sub.REF, then the balloon filling pressure (p.sub.IF,3) is at a higher level than a regarding trans-mural pressure (p.sub.TM,3):
p.sub.IF,3>p.sub.TM,3>p.sub.IR.

12. The method according to claim 1, wherein the material of the catheter balloon is polyurethane (PUR).

13. The method according to claim 1, wherein the material of the catheter balloon is selected from the group consisting of polyethylene, PVC and mixtures of polyethylene or PVC with polyurethane.

14. The method according to claim 1, wherein, in the first step, the initial fill volume (V.sub.IF,1) is between 10 ml and 20 ml.

15. The method according to claim 1, wherein, in the first step, the initial filling pressure (p.sub.IF,1) is between 10 mbar and 30 mbar, or between 10 mbar and 25 mbar.

16. The method according to claim 1, wherein, in the second step, the increased fill volume (V.sub.IF,2) is below the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF), so that the envelope of the balloon is not wrinkle-free.

17. The method according to claim 1, wherein, in the second step, the increased fill volume (V.sub.IF,2) is between 30 ml and 150 ml.

18. The method according to claim 1, wherein, in the second step, the increased filling pressure (p.sub.IF,2) is between 30 mbar and 60 mbar.

19. The method according to claim 1, wherein a safety range is provided at or above the reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF), to ensure that the envelope of the balloon will not substantially enlarge beyond such reference dimension (V.sub.REF) of the balloon filling volume (V.sub.BF).

20. The method according to claim 1, wherein during the second step, the catheter balloon remains in a pressurized state for about 1 minute to 5 minutes, until a coordinated physiological defecation reflex is triggered, wherein an uncoordinated and only partially productive defecation reflex is avoided.

21. The method according to claim 1, wherein, in the first and or second step, the air or fluid is pumped, squeezed or injected manually, especially by the user himself.

22. The method according to claim 1, wherein, between the first and second step, a liquid irrigation inflow fluid is introduced directly into the rectum of the user.

23. The method according to claim 22, wherein the liquid irrigation inflow fluid is introduced into the rectum of the user via a central lumen of the catheter shaft, which is open at a distal tip of the catheter shaft.

24. The method according to claim 22, wherein the liquid irrigation inflow fluid is introduced into the rectum of the user by squeezing it out of a container.

25. The method according to claim 24, wherein the liquid irrigation inflow fluid is delivered as a ready-to-use solution through a fixed feed conduit to the catheter, as a disposable product.

26. The method according to claim 22, wherein the liquid irrigation inflow fluid is introduced into the rectum of the user in a volume (V.sub.LIIF) of up to 120 ml, or in a volume (V.sub.LIIF) of 80 to 120 ml, or in a volume (V.sub.LIIF) of even less than 80 ml.

27. The method according to claim 1, wherein a volume (V.sub.LIIF) of a liquid irrigation inflow fluid introduced directly into the rectum of the user outside of the catheter balloon acts together with the balloon filling volume (V.sub.BF) as a pneumatic expansion stimulus that can be controlled by the user.

28. The method according to claim 27, wherein volume (V.sub.LIIF) of a liquid irrigation inflow fluid fills the rectum or colon of the user above the balloon filling volume (V.sub.BF) which is located near by or adjacent to the anus of the user.

29. The method according to claim 1, wherein the catheter further comprises a filling conduit for charging the catheter balloon with filling pressure.

30. The method according to claim 1, wherein a reusable filling device is provided for filling the balloon in the first and/or second step.

31. The method according to claim 30, wherein the reusable filling device is a hand-operated pump balloon connectable to the catheter balloon via a coupling.

32. The method according to claim 30, wherein the reusable filling device is a pump balloon with a pressure-indicating manometer.

33. The method according to claim 32, wherein the pressure-indicating manometer has a scale which displays one or more pressure ranges, recommended for various filling steps when applying the device.

34. The method according to claim 1, wherein the filling operation of the balloon with the initial or increased fill volume is conducted by controlling a balloon filling volume (V.sub.BF).

35. The method according to claim 34, wherein the filling operation is conducted by use of a syringe element.

36. The method according to claim 35, wherein a syringe body is used which comprises a suitable marking that specifies a preferred balloon filling volume (V.sub.BF).

37. The method according to claim 1, wherein the catheter shaft is equipped in a proximal, preanal region with gripping depressions, to accommodate fingers gripping the catheter during insertion and to ensure a safe catheter insertion.

38. The method according to claim 37, wherein the gripping depressions are disposed on the catheter shaft in direct proximal adjacency to a rear fixation line of the catheter balloon.

39. The method according to claim 1, wherein the balloon filling pressure (p.sub.BF) is limited by a pressure limiting valve which is interposed between a filling element and the balloon of the catheter.

40. The method according to claim 1, wherein, upon a further increase of the balloon filling pressure (p.sub.BF) prevailing in the catheter balloon to approximately 60 to 120 mbar, the anal canal of the user is also caused to expand.

41. The method according to claim 1, wherein, as soon as a coordinated physiological defecation reflex is triggered, the catheter balloon is deflated and the catheter is extracted from the rectum.

42. A device for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising a catheter, the catheter comprising: a catheter shaft, and a catheter balloon surrounding said catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope: which has has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and which, during manufacturing of the catheter balloon, is preshaped to a reference dimension of a balloon filling volume as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension of the balloon filling volume corresponds to a dimension of the rectum or colon of the user, which is laid in wrinkles if the balloon is inflated to a reference dimension of the filling volume below the preshaped reference dimension of the filling volume, and which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension, the ballon filling volume of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit at a pressure in the range of 10 to 120 mbar applied to the interior of the balloon; a manually operable pump, optionally with an integrated manometer for a pressure-controlled filling of the catheter balloon by the user, or a manually operable syringe element for a volume-controlled filling of the catheter balloon by the user: by providing an initial fill volume or an initial filling pressure to the catheter balloon in order to inflate it to a balloon filling volume below the reference dimension, which is sufficient to achieve an anchoring effect of the catheter balloon in the rectum or colon in a pressure-neutral manner, but without causing a reflex triggering expansion of portions of the bowel wall adjacent to the catheter balloon, and by pumping, squeezing or inserting air or another fluid into the catheter balloon in order to to increase said initial fill volume or said initial filling pressure to an increased fill volume or to an increased filling pressure until there occurs a gradual, user-controllable expansion of portions of the bowel wall adjacent to the catheter balloon, thus triggering a coordinated defecation reflex.

43. A method for intermittently triggering a coordinated defecation reflex in the rectum or colon of a user with an individual anatomy of the rectum or colon and a current reflex status, comprising: providing a catheter, the catheter comprising: a catheter shaft, and a catheter balloon surrounding the catheter shaft and being fixed to it, wherein the catheter balloon comprises a balloon envelope: which has a tubular or an annular geometry with two ends which are fixed to the catheter shaft at two fixation points in a fluid-tight manner in order to encompass a fluid-tight fillable compartment, wherein the distal fixation point of the catheter balloon is near the distal end of the catheter shaft, and which surrounds the catheter shaft between the two ends of the balloon in a freemoving manner, as the balloon envelope is not attached or fixed to the catheter shaft at any third location between the two fixation points of the ends of the balloon envelope at the catheter shaft, and which, during manufacturing of the catheter balloon, is preshaped to a reference dimension of a balloon filling volume as a maximum filling volume of the compartment in the balloon, which is achievable by inflation, but without any stretching of the balloon envelope, and which reference dimension of the balloon filling volume corresponds to a dimension of the rectum or colon of the user, and which is manufactured from a material which, although being flexible, is non-stretchable or only slightly stretchable so that, at or above the reference dimension, the ballon filling volume of the catheter balloon instantly assumes or asymptotically approximates an unvarying dimension limit at a pressure in the range of 60 to 120 mbar applied to the interior of the balloon; inserting the catheter in the rectum or colon of the user, providing an initial fill volume or an initial filling pressure of air in the catheter balloon in order to inflate the catheter balloon to a catheter balloon volume below its reference dimension without any stretching of the envelope of the catheter balloon, thereby achieving an anchoring effect of the catheter balloon in the rectum or colon of the user, and expanding portions of the bowel wall adjacent to the catheter balloon in order to trigger a coordinated defecation reflex by raising the initial filling pressure to an increased filling pressure in the range of 30 to 60 mbar, by additionally pumping, squeezing or inserting air or another fluid into the catheter balloon by the user until there occurs a gradual, user-controllable expansion of portions of the bowel wall adjacent to the catheter balloon in such a way that the degree of filling of the balloon is best adapted to the individual anatomy and current reflex status of the user in order to trigger the defecation reflex.

44. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0055] 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. Therein:

[0056] FIG. 1a shows an embodiment of a catheter according to the invention in a schematic longitudinal section, the balloon ends being mounted on the catheter shaft in an inverted manner according to the invention;

[0057] FIG. 1b shows the geometric structure of the apex of the distal balloon radius;

[0058] FIG. 1c shows the balloon body described in FIG. 1a in a freely unfolded state under low filling pressure, outside the anus;

[0059] FIG. 1d shows the balloon body described in FIG. 1a in a transanally placed state, under filling pressure;

[0060] FIG. 1e shows the geometric structure of the distal plane tangent to the intrarectal balloon section;

[0061] FIG. 2 is a representation similar to FIG. 1a of another embodiment of the invention, in which a catheter tip extends beyond the forward fixation line of the end of the balloon shaft;

[0062] FIG. 3 is a representation similar to FIG. 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;

[0063] 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;

[0064] FIG. 5 shows a modified embodiment of the invention with a catheter shaft waisted in its transanal section,

[0065] FIG. 6 shows a manually operable pump manometer with a pressure scale equipped for multi-stage, sequential filling of the catheter balloon,

[0066] FIG. 7 shows a further modified 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.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] FIG. 1a shows a longitudinal section through an inflow catheter with a dumbbell- or hourglass-shaped balloon element 2 disposed at the distal end of the catheter shaft 1. 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 shaped segment 3 of reduced diameter, which continuously connects the intrarectal enlargement 4 to the preanal enlargement 5.

[0068] The balloon 2 terminally comprises two balloon shaft ends (6, 7) for attaching the balloon to the shaft. During the mounting of the balloon, the shaft ends 6 and 7 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 the shaft 1, for example by gluing or welding.

[0069] 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).

[0070] The inversion depth B at the end of the balloon facing the patient or the rectum corresponds to the distance from the apex 8 of the distal, intrarectal balloon radius 9 to the distal fixation line 11 of the balloon end 6 on the catheter shaft.

[0071] The distal radius 9 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 apex 8 to good approximation is illustrated in FIG. 1b. 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. The normals 9e, 9f to 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 the forward apex 8, which marks the distal limit for the catheter shaft in its neutral, non-deflected initial position.

[0072] It can be seen in FIG. 1e 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.

[0073] On the side of the balloon facing away from the patient, the inversion depth B corresponds to the distance from the apex 12 of the proximal, preanal balloon radius 13 to the proximal fixation line 14 of the balloon end 7 on the catheter shaft.

[0074] Radius 13 corresponds to the proximal radius when the balloon is freely unfolded without inversion. The geometric determination of apex 12 is similar to the approximation described in FIG. 1b.

[0075] The length of intermediate piece A is determined by determining the distance between the transitions of the shoulder radii 15 and 16 (inflection points) of the mutually facing shoulder surfaces of balloon segments 4 and 5.

[0076] 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.

[0077] The inversion depth B is calculated as follows: B>=N2 (>=represents greater/equal).

[0078] In mounting the balloon on the catheter shaft, the respective points for the inversion of each of the balloon shaft ends are the apex 8 of the distal, intrarectal balloon radius 9 and the apex 12 of the proximal, preanal balloon radius 13.

[0079] In the embodiment described in this figure, the distal fixation line 11 also corresponds to the distal end of the catheter shaft 1. The shaft terminates directly at the fixation line 11 and does not extend distally past this fixation line in the manner illustrated in FIG. 2.

[0080] FIG. 1b describes the geometric derivation of the apex of the distal balloon radius.

[0081] The forward balloon radius 9, frontally facing the intestinal lumen, of the intrarectal balloon segment 4 is illustrated as a broken line. It is constructed from the two inflection points 9a and 9b and the two inflection tangents 9c and 9d respectively belonging to these inflection points.

[0082] One of the two inflection points 9a or 9b is used to construct a straight line 9e or 9f that is normal to the respective inflection tangent 9c or 9d and intersects the corresponding inflection point 9a or 9b. The point of intersection of these straight lines 9e or 9f with the axis X of symmetry yields the center point of the circle K.

[0083] The circle K, and thus the forward balloon radius 9, results from the center point M of the circle and the inflection points 9a and 9b, which are on the circumference of the circle. In this derivation, apex 8 is obtained from the point of intersection of the circumference of the circle with the axis X of symmetry of the balloon.

[0084] For the description of the frontal apex 8 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 points 9a and 9b with the axis X of symmetry.

[0085] FIG. 1c shows the behavior of the catheter balloon that was inverted according to the invention in FIG. 1a as it unfolds freely and without pressurization, in the free, non-transanally placed state. The figure illustrates the counter-rolling movement of the two terminal balloon segments 4 and 5 made by possible by the specific inversion of the balloon ends 6 and 7 on the catheter shaft.

[0086] 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 the middle segment 3. When the two segments are in contact in the region of the transition points (15, 16) of the shoulder radii, the apex 8 of the radius 9 is flush or nearly flush with the distal fixation line 11 of the distal balloon shaft end 6 on the catheter shaft.

[0087] 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 the distal fixation line 11, 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 the distal balloon radius 9, as a maximum limit precluding irritation and lesions of the bowel wall.

[0088] FIG. 1d shows how the inversion of the balloon ends in relation to the distal catheter shaft ends described in FIG. 1a presents itself in cases where the anal canal is of normal or only slightly shortened length. In this more common clinical use situation, the forward fixation line 11, 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 balloon 4. As the balloon is charged with pressure, the two terminal balloon segments 4 and 5 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.

[0089] 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.

[0090] 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.

[0091] FIG. 2 shows, by way of example, how sections of the catheter shaft in the form of a tip piece 18 that extend beyond the distal fixation line 11 in a distal prolongation directed toward the bowel are to be considered in determining the inversion depth of the balloon ends 6 and 7, 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 the tip piece 18 is defined as the distance from the forward fixation line 11 to the forward apex 19 of the tip piece.

[0092] Length B is increased in comparison to FIG. 1a by the magnitude of length C or C/2.

[0093] The corresponding inversion depth B is preferably calculated taking into account a tip piece in the form: B>=A/2+C.

[0094] 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.

[0095] FIG. 3 illustrates another, alternative rule for establishing the inversion depth B of the balloon shaft ends 6 and 7 on the catheter shaft 1 in relation to the distal catheter shaft end 11, 19.

[0096] 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.

[0097] The maximum distal deflection W of the forward fixation line 11 is defined as a distance that emanates from the apex 8 of the radius 9, forming a distally directed prolongation of the longitudinal axis of the shaft, and extends to the apex 20 of a radius 21, said radius 21 being constructed over the largest diameter D of the intrarectal balloon segment 4.

[0098] If the catheter shaft has a tip piece 18 that extends beyond line 11, the maximum deflection path W should be correspondingly selected so that upon maximum deflection W of the shaft, the tip 19 of the tip piece does not extend past radius 21.

[0099] The radius 21 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 the pivot radius 21 of balloon segment 4, thus preventing relatively well any potential traumatizing contact of the tip with the bowel wall adjacent the balloon.

[0100] In determining the inversion depth B, the particular ratio of the distance W to the radius 21 or of the diameter D on which it is based is preserved and the inversion depth B is adjusted accordingly as necessary.

[0101] FIG. 4 shows the catheter balloon 2 in its emptied form, in which it lies against the catheter shaft ready for insertion in the anus. The envelope segments of the intrarectal balloon 4 and of the middle segment 3 cling to the shaft in folds.

[0102] 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 ends 6 and 7 on the surface of the shaft. The envelope of the preanal balloon segment 5, 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 the proximal fixation line 14. The gripping point 22 is preferably implemented as a depression-like receiving surface, one such preferably being provided on each of the opposite, 180°-apart shaft surfaces.

[0103] The evacuated balloon being fixed in such fashion, the user grips with his fingers under the envelope of segment 5, 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 section 4 is inserted into the rectal cavity, while the proximal balloon portion 5 comes to lie outside the anus (preanally). Reliable transanal positioning of the catheter therefore occurs as the waisted balloon is filled.

[0104] FIG. 5 shows a preferred implementation of the shaft body 1 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. The shaft 1 has for this purpose a likewise waisted shape, which is correspondingly tapered in the transanal region 23 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 opening 24 that connects to the duct 25 supplying the medium.

[0105] 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 the opening 24. It then slips out of the opening as the inserted catheter is filled.

[0106] Given suitable implementation of the shaft material, the waist 23 can also predefine a certain kinkability of the shaft body, thus improving its atraumatic properties.

[0107] The filling of the balloon takes place through a separate duct 26 integral to the shaft.

[0108] To prevent backflow of irrigation fluid, the inflow catheter can is [sic] equipped with a non-return valve in the region of the fluid-conveying duct 25.

[0109] 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 the duct 25, the distal end of the tube lying freely in the duct 25 over a length of approximately 5 to 10 mm and its proximal end being connected sealingly to the inner wall of the duct 25. 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.

[0110] FIG. 6 schematically illustrates a pump manometer 27 equipped with a scale 28 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.

[0111] 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.

[0112] The catheter balloon is preferably filled with air, through a fill line integrated into the shaft wall of the catheter body 1.

[0113] In addition to pressure-controlled filling of the balloon using a pump manometer, as illustrated in FIG. 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.

[0114] 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 in FIG. 6, and are to be determined by and for the user on an individual basis, as in the case of pressure-controlled filling.

[0115] To limit the filling pressure or prevent critically high balloon filling pressures, in the case of both manometer- and syringe-actuated filling a pressure limiting valve 31 can be interposed between the filling element and the catheter, to prevent, for example, balloon filling pressures over 120 mbar.

[0116] 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, feed conduit 32 being fixedly connected to a preferably bag-like container 33 containing infusion medium, and thus constituting a ready-to-use unit comprised of catheter and medium.

[0117] The volume of the container 33 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.

[0118] Connection 32 is preferably equipped with a seal 35 that can be broken by bending and that releases the irrigation solution. It is also advantageous to provide a non-return valve 36, 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.

[0119] Another feed conduit 34 can be connected directly to a pump manometer 27 or a filling syringe.

[0120] 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, on the other hand, are particularly preferable.

[0121] The use of only slightly volume-expandable materials, such as, for example, polyurethane (PUR), for example of the specification Pellethane 2363 80A to 90A, 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.

[0122] 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.

[0123] 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.

[0124] Alternatively, for example non-volume-expandable materials can also be used, such as polyethylene, PVC or mixtures of the aforesaid materials with polyurethane.

[0125] 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.

[0126] Dipping processes using liquid PVC or PUR materials can also be contemplated for production.

[0127] The welding together of single layers of film to form balloon bodies is also conceivable.

[0128] 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.

[0129] In the freely unfolded, unpressurized state, the balloon should preferably have a diameter of approximately 30-60 mm in the intrarectal section 4, approximately 10 to 30 mm in the middle, waisted region 3, and approximately 30-50 mm in the preanal region 5. The middle segment 3 should have a length of approximately 20-40 mm and each of the terminal segments 4 and 5 a length of approximately 20-40 mm.

[0130] If, as a special measure for sequential filling, the catheter balloon is provided with optional intrarectal balloon triggering, the intrarectal balloon section 4 in the freely unfolded, unpressurized state preferably has a diameter of approximately 40-80 mm and a length of preferably 30-60 mm.

[0131] 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.