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EP2680805B1 - Dispositif d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne - Google Patents

Dispositif d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne Download PDF

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Publication number
EP2680805B1
EP2680805B1 EP12711751.3A EP12711751A EP2680805B1 EP 2680805 B1 EP2680805 B1 EP 2680805B1 EP 12711751 A EP12711751 A EP 12711751A EP 2680805 B1 EP2680805 B1 EP 2680805B1
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EP
European Patent Office
Prior art keywords
balloon
rectum
intestine
insertion element
colon
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12711751.3A
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German (de)
English (en)
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EP2680805A1 (fr
Inventor
Fred GÖBEL
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Advanced Medical Balloons GmbH
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Advanced Medical Balloons GmbH
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Publication date
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Publication of EP2680805A1 publication Critical patent/EP2680805A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H21/00—Massage devices for cavities of the body, e.g. nose, ears and anus ; Vibration or percussion related aspects A61H23/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0207—Characteristics of apparatus not provided for in the preceding codes heated or cooled heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0221—Mechanism for heating or cooling
    • A61H2201/0278—Mechanism for heating or cooling by chemical reaction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
    • A61H2201/105—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy with means for delivering media, e.g. drugs or cosmetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1683—Surface of interface
    • A61H2201/1685—Surface of interface interchangeable

Definitions

  • the invention is directed to a device for the intermittent emptying of stool from the rectum (rectum) or large intestine (colon) of a patient without the entry of a liquid medium.
  • the fluid introduced into the rectum or colon via the anus leads to the triggering of an involuntary, reflex-coordinated defecation in patients with preserved defecation reflex, which largely corresponds to defecation in the healthy.
  • the fluid instilled in the rectum or colon leads to an expansion of the fluid-exposed intestinal wall. This stretching is perceived via intestinal receptors and nerve plexuses and transmitted to a sacral marrow located in the reflex center.
  • the reflex action in the defecation works mainly from the interaction of a peristaltic contraction of the colon and rectum as well as the simultaneous relaxation of the sphincter muscles of the anus. If the content of the left-sided colon is discharged through such "triggered" defecation, the patient will experience a chair-free interval, which can last up to 24 hours and beyond. The chair-incontinent patient can thus move freely in his environment without risk of involuntary Einstuhlung.
  • inlet catheters at the front (distal) end are in many cases equipped with a sealing balloon element.
  • the sealing properties of such stretch-developing balloons are often inadequate because the elastically extensible materials heretofore used often fail to develop a reliably sealing spherical shape when filled.
  • the balloon frequently breaks off, relative to the balloon-carrying shaft, as a lateral protuberance (herniation), which can considerably restrict the sealing performance against the medium instilled in the intestine.
  • continuous active adjustment of the catheter shaft by the user to a sealing position is required. Not least because of the expected leakage, the user is forced to sit on a toilet.
  • the publication DE 10 2004 033 425 A1 relates to a closure system for the supply of rectal or anal incontinence and proposes to improve the Dichtungsverhaltes a double-segmented balloon body, the waist of which is positioned in the anal canal and its intra-rectal and pre-anal balloon share at filling each sealingly to the anus.
  • the balloon has a toroidal structure, which unfolds predominantly in the radial direction and therefore even in the deployed state still surrounds a central catheter.
  • the primarily pressing against the rectal floor and limited in its longitudinal extent balloon is not suitable to trigger a defecation reflex.
  • the publication DE 10 2009 008 594 A1 describes a device for continuous drainage of stool from the rectum of a patient.
  • the shell of the intra-rectal and trans-anal balloon body consists of a molded, thin-walled film, the intra-rectal, the device the rectal floor resting and anchoring balloon portion may have a diameter in the freely unfolded, unstretched state on the anatomical diameter of the Colon goes out.
  • the balloon does not have a defecation reflex sufficiently large, because this would have to be completed completely the rectum.
  • the UA 68 194 A discloses a method of treating constipation, wherein the nerve endings are stimulated in the wall of the rectum. For this purpose, the pressure in a balloon introduced into the rectum is changed periodically. However, it is not clear how that balloon can be introduced into the rectum.
  • the UA 68 194 A For this purpose, no auxiliary element can be found.
  • the object of the present invention is to induce the defecation reflex without the ingress of a liquid medium so as to substantially eliminate the previously described problems with trans-anal introduced liquid inlets.
  • the invention essentially proposes a balloon body which, when filled with air in the rectum, unfolds in a tamping over its entire length, optionally also extends into the upward-adjoining sigmoid or the left-sided (descending) colon and the intestinal wall exposed to the balloon taking a uniform, moderate stretch.
  • the triggered by stretching the intestinal wall Defecation reflex can also be triggered infeed-independent or "dry".
  • the patient also gains mobility and can also move freely to some extent during the procedure.
  • the invention in contrast to conventional inlet systems, in which the sealing balloon from a attached at the inlet catheter tip tubular element of highly elastic material (eg silicone, latex or polyisoprene) develops, which breaks under pressure with inflation pressure to the balloon shape, the invention preferably uses very thin-walled Balloon soft films, which already obtain their geometric shape and their working size through the manufacturing process, and preferably have only a low volumendehnbarkeit (compliance).
  • highly elastic material eg silicone, latex or polyisoprene
  • the present invention describes a residual-sized balloon body which is dimensioned in its axial extent such that it fills the rectum in its entire extent and optionally also extends beyond the rectum into the subsequent sigmoid and in a possible further embodiment also into the left-sided descending colon is enough.
  • a residual diameter-sized balloon allows the intestinal wall to be stretched under a moderate strain acting evenly on all portions of the intestinal wall, at least throughout the rectal area, without stretching under a correspondingly high required pressure from a smaller size to a sufficiently large extent reaching the intestinal wall to have to.
  • the filling pressure required for the axial and radial spatial development of the balloon in the intestine can therefore be maintained in the embodiment according to the invention in a range which only slightly exceeds the prevailing intra-abdominal pressure.
  • the force effect of the balloon body on the intestinal wall required for triggering the reflex can be increased very finely by the user, based on intra-abdominal pressure.
  • the barometrically measured pressure in the balloon body can be equated with the respective transmural force acting on the intestinal wall in a good approximation.
  • the device described is therefore particularly suitable for patients who carry out a so-called rectal digital stimulation to trigger the defecation reflex or to support it.
  • the patient or an assistant grab it in the rectum and stimulate the intestinal wall by massage-like movements.
  • this very stressful maneuver could become obsolete for a part of the person concerned.
  • the colorectal-triggering balloon may be provided with a trans-anal and pre-anal balloon segment, which allows the device to be safely ano-rectally positioned and, through a correspondingly large diameter of the waist-like portion between the two segments, also a gasket acting in the anal canal guaranteed against any outgoing intestinal contents or secretions.
  • a catheter element which carries the balloon body at its front tip and whose tip, after trans-anal insertion, preferably extends about 2-3 cm into the rectum.
  • the preferably very thin-walled, membrane-like balloon body is in the vented state, preferably in a compact space and folded in the least tissue-irritating manner on the intra-rectal catheter portion, for example as a bellows, applied.
  • the folded balloon he is the Kathschaftschaft while snuggled on, and can thus be introduced comfortably through the anus despite its large volume of development.
  • the filling of the balloon is preferably carried out with air.
  • a simple connected Handpumpballon can be used.
  • the pumping balloon is preferably provided with a relief valve which eliminates excessive inflation pressures. It can also be equipped with a valve device which allows easy switching of the direction of delivery of the balloon from pumps to suction, thus allowing the rapid deflation of the balloon body as it is removed when the excretory reflex or peristaltic contraction of the intestine begins.
  • the device is preferably disposed of after use, but can also be cleaned and reused by the patient, with appropriate design.
  • the outer circumference of the balloon should be preformed radially in the radial direction, i. such that its maximum outer circumference in the unstretched state is greater than the diameter of the intestine portion exposed to it.
  • the length of the balloon should be adapted to the rectum, such that the length of the balloon in its free unfolded but unstretched state is at least equal to the length of the entire rectum, so that he can fill it completely without stretching.
  • the length L of the unfolded and stretched, but unstretched balloon defined by the preforming should be greater than the diameter D determined by the preforming of the also radially developed but unstretched balloon: L> D, wherein the length L is preferably one and a half times of the diameter D or more: L> 1.5 * D, in particular twice the diameter D or more: L> 2 * D, or even three times the diameter D or more: L> 3 * D.
  • the balloon is preferably preformed bellows-like.
  • a preformation provides that the balloon seen in its longitudinal direction one behind the other has a plurality of radially outwardly bulged beads, which surround each annular or helical, so that the balloon collapses in the deflated state planned or contracts and not fauxkneu uncontrollably.
  • the adjacent beads attach to each other and thus lead to a controlled shortening of the balloon in its longitudinal direction.
  • the balloon is attached or fastened with one end to an insertion element.
  • this has a channel for supplying the filling medium to the balloon.
  • the invention can be further developed such that the attachment end of the balloon is preformed with a diameter that is narrower than its maximum outer diameter, which corresponds in particular approximately to the outer diameter of an introduction element.
  • the balloon can be easily attached sealingly on the shaft of an elongated insertion element.
  • a radially projecting abutment element can be arranged proximal to the balloon, which allows a layman to easily find the optimal position of the device in the rectum can.
  • the balloon is configured as a removable balloon detachable from the introduction element. This makes it possible to use a large part of the arrangement several times, which can reduce costs.
  • the invention recommends that an anchoring possibility for an edge bead of a detachable change balloon is provided on the introduction element, preferably in the form of an all-round groove for inserting the edge bead of the change balloon, the all-round groove is preferably provided on a radial extension of the introduction element. After donning such a change balloon on the introduction element this is anchored by inserting its edge bead in the groove of the introduction element.
  • the circumference of the edge bead should be slightly smaller than the circumference of the groove provided, so that the edge bead of the change balloon must stretch slightly elastic; As a result, he experiences a mutual fixing effecting contact pressure.
  • Another preferred design rule provides that the balloon has only a single attachment end and is closed at its opposite end. As a result, contamination of the arrangement is excluded as much as possible, which is advantageous especially in the repeated use of the introduction part.
  • the invention provides that the balloon is closed at its distal end by a cap-like element, which is detachably plugged together or plugged together with a cap-like element at its proximal end.
  • the balloon may be inserted for insertion into an approximately cigar-shaped capsule, where it can maintain its well-ordered structure undisturbed during insertion.
  • a balloon according to the invention may have a trans-lateral region preformed in the form of a taper, whereby it can be optimally sealed in the area of the anus.
  • the balloon has a preformation in the form of an anchoring extension beyond its tapered, transanal area.
  • This anchoring extension is responsible for positioning the balloon reliably and permanently.
  • the invention recommends to arrange within the balloon a second, fillable from the outside pilot balloon. If the arrangement is made such that this pilot balloon is filled first, this can look for its location within the rectum, without even apply it radially already on the wall. This is made possible in particular by the fact that the diameter of the inner pilot balloon in the unstretched state is smaller than the diameter of the actual outer trigger balloon, for example. Only 3/4 as large as the diameter of the outer balloon or smaller, preferably only 2/3 so big as the diameter of the outer balloon or smaller, in particular only half as large as the diameter of the outer balloon or smaller.
  • pilot balloon can od punctures od. Like. Perforations. These openings should be minimal, for example, such that without unfolding of the inner pilot balloon, the filling medium hardly passes into the outer balloon.
  • the balloon has a molded recess at its rear end. This can be used to place the balloon on a finger and then use the finger instead of an introducer for digital insertion, similar to a suppository.
  • the device according to the invention can be used, for example, in a method for the intermittent emptying of stool from the rectum or colon of a patient, in the course of which a thin-walled balloon body without central, continuous emptying lumen is introduced into the intestine via the anus. which is dimensioned so that it completely fills the rectum in its entire extent without elastic expansion or optionally extends beyond the rectum into the subsequent sigmoid and / or in the left-side descending colon, and wherein the balloon after insertion into the Intestine with a medium, eg.
  • Fig. 1 shows the reflex-triggering shell of a balloon 1 according to the invention as an approximately cylindrically shaped body, which is preferably dimensioned in its axial extent such that it completely fills the rectum in its entire length.
  • the balloon 1 preferably has a residual radial dimension, wherein the diameter of the freely deployed, not pressurized balloon 1 is greater than the diameter of the intestine portion exposed to it.
  • the balloon 1 is not torus-shaped in the freely deployed state, but purely cylindrical. This is due to the fact that its front end is closed in a direct way, that is without backpulling.
  • the balloon 1 thus has only a single inlet or outlet, namely at its rear end at the transition to the adjacent section 3 of the insertion element. 2
  • the balloon 1 is mounted on the front portion 3 of a catheter-like introducer 2, by means of which it is introduced by the user through the anus (transanal) into the terminal region of the rectum 8.
  • the balloon 1 is acted upon via a filling line 4 through the insertion element 2 away with a filling pressure.
  • the invention proposes to be measured from the rectal floor balloon length or longitudinal balloon extent of at least about 10 cm, and / or a corresponding extent up to 12 cm, possibly even up to 15 cm.
  • a balloon length or longitudinal balloon extent of at least 15 cm, and / or of 25 cm or less. If it is desired to deploy the balloon 1 as far as the descending colon 9 (descending colon), the balloon length should preferably be greater than 25 cm.
  • the radial diameter of the unexpanded, unpressurized balloon 1 should be, for example, 50 mm or more, preferably 60 mm or more, and / or 100 mm or less, more preferably 80 mm or less.
  • Fig. 2 shows the insertion element 2 with a seated in the distal portion 3, compact space-saving folded, largely vented balloon envelope 1.
  • the balloon is preferably threaded in an axially compressed, bellows-like manner on the section 3.
  • the tip 3 of the insertion element 2 is preferably made olive-like or conical. After anal insertion, the distal catheter 2 can thus already be held in the anus to a certain extent.
  • Fig. 3 shows the reflex-triggering balloon body 1 in situ, with the balloon element 1 extending across the rectum 8 into the sigmoid 6.
  • the residual balloon envelope 1 is the intestinal wall 6, 8, 9, without itself in a stretched state, with uniform force on all her detected intestinal wall portions 6, 8, 9 in folding, in particular the rectum 8, the sigmoid colon 6 and the descending colon 9.
  • Fig. 3a shows a transverse section through an acted upon by a trigger balloon according to the invention 1 intestine section 5. Due to their residual design, the balloon envelope 1 inverts in radially inwardly facing reserve folds 1a.
  • Fig. 4 shows the device with a trans-anal and / or pre-anal extension of the balloon 1.
  • the trans-anal section 10 is over the Expansion of the anal canal preferably dimensioned such that it closes the anal canal when filling the balloon 1 without dilation of the balloon envelope sealing.
  • the trans-anal section 10 also has a residual dimensioned diameter in the non-pressurized, freely deployed state.
  • the trigger balloon 1 can be anchored by a relatively enlarged pre-anal section 11 within the anal canal and secured against dislocation.
  • Fig. 5 shows the device with a pre-anal arranged abutment 12, which serves as an abutment for the intra-corporally introduced balloon 1 and fixes the device so dislocation secure in the anus and on the other hand serves as an orienting stop during insertion of the device to ensure the appropriate insertion depth.
  • the abutment 12 may preferably be formed as a plate-like, elastic element, which can be folded with moderate force and so, wing-like folded, comes to rest in the Analfalte.
  • T-like anchor element can act as an abutment or as a reference point for the correct insertion depth extending at right angles to the longitudinal axis of the insertion 2, transversely extending or T-like anchor element, which in turn is placed in the Analfalte.
  • the correct depth of insertion of the carrier can be further made possible by trough-like recesses 41 on the surface of the insertion element 2 for receiving the fingers leading the carrier.
  • the shaft of the insertion element is gripped by the user in the region of the wells 41 and inserted to the stop of the fingers on the anus.
  • Fig. 6 shows a bellows-like shape 13 of the trigger balloon 1, which is to facilitate threading on the carrier tip 3 in the deflated state of the balloon, as well as when filling the balloon 1 from the rectal floor outgoing, directed length development of the balloon 1 in the upwardly adjoining bowel parts should allow.
  • the constricted between the bellows-like protuberances 13.1 sections 14 of the trigger balloon preferably have a diameter which corresponds approximately to the diameter of the shaft of the insertion element 2.
  • the distal end 15 of the balloon can be made or preformed to fit the support tip 3 in order to fix the balloon 1 in the deflated, threaded condition additionally, with a slight fit on the end-side section 3 of the insertion 2.
  • Fig. 7 shows a further embodiment of the balloon 1, which instead of a blind end 15 has a central recess 16 which connects the distal end of the balloon with the front portion of the Ein Industrieskatheters 3 throughout and is firmly connected thereto.
  • the recess 16 is preferably bellows-shaped and thus facilitates the threading of the balloon on the front catheter part.
  • the recessed inner portion 16 preferably has a wall thickness which is greater than that of the outer balloon portions facing the intestine. The thus reinforced indentation 16 thus supports a directional development of the balloon axially projecting the balloon from the rectally placed carrier tip 3 into the higher intestine.
  • Fig. 8 shows an embodiment in which the trigger balloon 1 is composed of two separate, concentrically arranged balloon components 18 and 19.
  • the inner balloon 18 has a small diameter of preferably 15 to 25 mm. It is directly connected to the filling line 4 and expands when filling the trigger balloon first.
  • the balloon 18 develops while finger-like, quasi searching and pioneering, into the lumen of the higher intestinal sections inside, and takes him outside sitting large-volume, actual trigger shell 19.
  • About needle-like openings 20 in the inner balloon 18, the filling volume then flows into the outer balloon 19, which thus the intestinal wall finally space filling creates. The transition is facilitated by increasing elongation of the envelope of the inner balloon.
  • the pinhole-like openings 20 then expand in accordance with the respective expansion state of the shell of the inner balloon 18.
  • the openings 20 are preferably dimensioned in their dimensions in coordination with the respective expansion properties of the balloon 18 so that with moderate filling of about 25 cm water pressure (mbar) no or only a very small volume transfer takes place in the outer balloon.
  • mbar 25 cm water pressure
  • the diameter of the openings 20 so that there is a speedy transfer of the filling volume in the balloon 19.
  • Fig. 9 shows a device with a shaft 2 carrying the balloon 1, which is shortened so that it can be introduced digitally in the manner of a suppository and comes to rest completely within the rectum.
  • the carrier 2 preferably has a spindle-like, ellipsoidal or torpedo-like shape.
  • the balloon 1 can be filled, and pulled out again after emptying of the rectum.
  • Fig. 10 shows an intra-rectally placed balloon 1, which does not contain any supporting shaft element and consists only of a balloon element.
  • the balloon 1 after Fig. 10 can preferably be formed with a proximal, finger-like recess 23 and a corresponding, axially aligned, finger-like distal protuberance 24 at the front end of the balloon 1.
  • the two formations 23, 24 allow easy recording or simple threading the unfilled trigger balloon on the introductory finger.
  • Fig. 11 shows an intra-rectal to be paddled balloon 1, the two ends are each provided with a conically rounded or atraumatisch shaped end piece.
  • the distal cap member 25 may be connected to the proximal end 26 at rest or in the pre-insertion condition through the anus by an easily detachable connector 27.
  • the balloon 1 is filled from the outside through a tube-like feed line 28, which runs through the proximal segment 26. About this connection 28, he is pulled out after the vent by the user from the rectum.
  • the middle section of the wearer may be slimmed to accommodate the evacuated balloon in the resulting waist-like depression.
  • Fig. 12 shows an embodiment in which the ends of the trigger balloon 1 are also connected to cap-like elements 29 and 30, wherein the balloon 1 in contrast to Figure 11 however, is packed inside the cavity formed by the cap members 29, 30 loosely fitted together.
  • the balloon 1 separates the two capsule portions 29, 30 from each other, and the balloon 1 can develop into the intestine.
  • Fig. 13 shows another embodiment, but not in accordance with the present invention, in which a tubular connection 31 extends longitudinally through the balloon body 1 and opens in the front, distal region of the device or the trigger balloon body 1 via an opening 32.
  • a tubular connection 31 may be liquids, therapeutics or other media in the intestine located above the balloon be introduced.
  • a supply of media to the distal end of the device can also take place through a hose-like element around the outer surface of the balloon in loose or firm connection therewith. It is also conceivable opening the mouth 32 to the interior of the distal cap 29 (if present), in order to avoid direct irradiation of the intestinal wall with liquid.
  • Fig. 14 shows containers 33 for holding liquid media. Via a connector connection 34, these can be connected to those variants of balloon devices which, via a hose-like supply of media into the intestine, as in Figure 13 shown have.
  • the user can thus complement the "dry irrigation" by a liquid active component, such as a microenrichment enriched with pharmaceutical therapeutics.
  • the containers 33 are preferably designed as portioned finished solutions.
  • the shrinkage of the liquid can be done for example by gravity or manual squeezing.
  • the figure also shows a pocket-like, preferably electric heating device 35, which is used for controlling the temperature of the medium to body temperature.
  • the heating device may be bag-like or designed as a flat element, which is wrapped around the container 33 and, for example, by a hook and loop fastener 36 well-sealed over the container filled with the medium.
  • a chemical-thermal element is also conceivable, as it is used in the form of so-called “pocket warmer", which work on the basis of a latent heat accumulator (phase change materials, for example sodium acetate trihydrate).
  • Such "heat packets" can be plugged into corresponding bag-like Isolier techniquesnisse together with the container 35, and provide after activation of heat generation, with appropriate coordination of liquid volume, heat output and Insulation for tempering the inlet medium at body temperature level.
  • the packages are conceivable as reusable components or as one-off components.
  • Fig. 15 shows an embodiment of the trigger device, in which the carrier element 2 is connected directly or via a releasable coupling with a pumping balloon 21.
  • the balloon 1 is fastened on the front end 3 of the carrier, which is preferably atraumatically blunt.
  • a pumping balloon 21 is applied directly on the shaft of the wearer, which can be conveniently held between the legs and operated by the user after insertion into the anus with sufficient shaft length of the wearer.
  • the pumping balloon may be provided with a valve device 37, such as in FIG DE 10 2010 021 883.9 described, which is preferably designed as a push button and reverses the direction of the valve from pump to suction on actuation of the button.
  • the support member or the pumping balloon may further be provided with a pressure limiting valve 22 which limits the maximum inflation pressure in the trigger balloon to non-traumatic values of preferably less than 150 mbar.
  • a fastening element 38 may be attached, which is provided for example with a special shape for receiving and securing a Kondominwulstes 40.
  • the locking of the bead on the fastener can be done for example by an additional flange screw or clamping mechanism.
  • the locking of the "condom" on the support shaft is preferably carried out on the pre-anal section but can also take place in the region of the trans-anal or intra-rectal shaft segment.
  • the described triggering device can also work with actual condoms, which are thus used as an exchangeable triggering balloon.
  • Fig. 16 shows a preferred embodiment of the filling line 4, 28 with terminal connected thereto one-way valve 42 with self-closing spring mechanism.
  • the trigger balloon preferably consists of a thin-walled soft film in the wall thickness range of 10 to 100 micrometers. Particularly advantageous are films in the thickness range of 10 to 30 micrometers.
  • Non or low volume expandable materials e.g. Polyurethane (PUR) of the Pellethane 2363 80A specification, Dow Chemical Corp.
  • PUR Polyurethane
  • polyethylene, polypropylene or PVC films with similar mechanical properties may be used.
  • Such thin-walled, structured balloon foils can preferably be produced by blow molding from previously extruded raw tube material.
  • Balloon films according to the invention can also be formed directly from the extruded tube mass (in-line molding).
  • sufficiently thin-walled tubular film material can also be used directly, which can be separated from the endless roll and welded or welded to achieve the embodiments described here.
  • a balloon body with high volumetric extensibility can also be made possible, for example, by latex, polyisoprene or silicone.
  • the preparation of such bodies is preferably carried out in the dipping process in the manner of the production of condoms.
  • the volumetric extensibility of the material should be adjusted in such a way that the filling pressure of the balloon required for dilation of the intestine is in a low range which does not impair the perfusion of the intestinal tissue even during prolonged application and does not exceed the forces required to trigger the reflex.
  • the triggering components are also formed in a residual manner when these materials are used.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Reproductive Health (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (15)

  1. Dispositif destiné à évacuer de manière intermittente les selles du rectum et du côlon d'un patient sans alimentation en fluide liquide, comportant un corps de ballonnet (1) pouvant être rempli de fluide, à paroi fine, pouvant être introduit dans l'intestin en passant par l'anus sans lumière d'évacuation continue, centrale, caractérisé en ce que le ballonnet (1)
    a) comporte seulement une entrée ou une sortie unique,
    b) est fixé à une extrémité à un élément d'introduction (2 ; 25 ; 26 ; 29, 30) en forme de cathéter ou de suppositoire ou à un élément en forme de capuchon qui est assemblé de façon amovible ou susceptible d'être assemblé avec un élément en forme de capuchon à l'autre extrémité du ballonnet (1),
    c) peut être alimenté en une pression de remplissage via une conduite de remplissage (4) par l'élément d'introduction (2 ; 25 ; 26 ; 29, 30),
    d) comporte un préfaçonnage tel que lors du remplissage avec un fluide, par exemple avec de l'air, est davantage déployable sans dilation élastique dans son sens longitudinal que dans son sens radial,
    e) est dimensionné de manière résiduelle de sorte qu'il peut remplir le rectum sans dilatation élastique ou bien qu'il peut se déployer au-delà du rectum également dans le sigmoïde adjacent et/ou voire dans le côlon descendant côté gauche, et qu'il peut finalement déclencher un réflexe de défécation par légère dilation de la paroi intestinale au moins dans l'ensemble de la zone rectale.
  2. Dispositif selon la revendication 1, caractérisé en ce que la circonférence extérieure du ballonnet (1) du point de vue radial est préfaçonné de manière résiduelle, c'est-à-dire que sa circonférence extérieure maximale (D) à l'état non dilaté est supérieure au diamètre de la partie d'intestin qui lui est exposée.
  3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que le ballonnet (1) comporte un préfaçonnage en forme de soufflet.
  4. Dispositif selon l'une des revendications précédentes, caractérisé en ce que l'extrémité de fixation du ballonnet (1) est préfaçonnée avec un diamètre rétréci par rapport à son diamètre extérieur maximal (D), lequel diamètre correspond en particulier approximativement au diamètre extérieur d'un élément d'introduction (2).
  5. Dispositif selon la revendication 4, caractérisé en ce qu'aucune autre partie du ballonnet (1) ne s'étend à l'intérieur de l'extrémité de fixation rétrécie du ballonnet (1).
  6. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'un élément de butée radialement en saillie (12) est disposé au niveau de l'élément d'introduction (2) à proximité du ballonnet (1).
  7. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le ballonnet (1) est conçu comme ballonnet interchangeable (39) désolidarisable de l'élément d'introduction (2).
  8. Dispositif selon la revendication 7, caractérisé en ce qu'une possibilité d'ancrage pour un bourrelet périphérique (40) d'un ballonnet interchangeable (39) désolidarisable est prévue au niveau de l'élément d'introduction (2), de préférence sous forme d'un évidement périphérique, par exemple une rainure ou cavité, pour insérer le bourrelet périphérique (40) du ballonnet interchangeable (39), en ce que la rainure périphérique est prévue de préférence au niveau d'une extension radiale (38) de l'élément d'introduction (2).
  9. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le ballonnet (1) ne comporte qu'une seule extrémité de fixation et qu'il est fermé au niveau de son extrémité opposée, en particulier fermé au niveau de son extrémité distale par un élément en forme de capuchon (25 ; 29) qui est assemblé de façon amovible ou susceptible d'être assemblé avec un élément en forme de capuchon (26 ; 30) à son extrémité proximale.
  10. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le ballonnet (1) est constitué d'une feuille souple à paroi mince d'une plage d'épaisseur de paroi comprise entre 10 et 100 micromètres.
  11. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le ballonnet (1) comporte une zone transanale (10), préfaçonnée sous forme d'un rétrécissement.
  12. Dispositif selon la revendication 11, caractérisé en ce que le ballonnet (1) comporte au-delà de sa zone transanale rétrécie (10) un préfaçonnage sous forme d'une extension d'ancrage (11).
  13. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'un composant de ballonnet interne (18), remplissable par le biais d'une conduite d'alimentation est disposé dans un composant de ballonnet externe (19).
  14. Dispositif selon la revendication 13, caractérisé en ce que le composant de ballonnet interne (18) présente des piqûres ou des perforations (20) similaires.
  15. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le ballonnet (1) comporte au niveau de son extrémité arrière une cavité moulée (23).
EP12711751.3A 2011-03-01 2012-03-01 Dispositif d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne Active EP2680805B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011012779 2011-03-01
PCT/EP2012/000885 WO2012116816A1 (fr) 2011-03-01 2012-03-01 Dispositif et méthode d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne

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EP2680805A1 EP2680805A1 (fr) 2014-01-08
EP2680805B1 true EP2680805B1 (fr) 2019-06-19

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WO (1) WO2012116816A1 (fr)

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CN103705374A (zh) * 2012-10-07 2014-04-09 杨廷旭 子宫后倾治疗仪
WO2018085196A1 (fr) 2016-11-03 2018-05-11 Hollister Incorporated Bras de traitement intestinal réglable
CN113425223B (zh) * 2021-06-22 2022-09-02 天津市人民医院 一种肠液回收式储便排便装置

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WO1994020059A1 (fr) * 1993-03-10 1994-09-15 Nen, Inc. Procede de traitement des coliques et de la constipation
JP4091760B2 (ja) * 2001-11-26 2008-05-28 重信 高根 排便器具
UA68194A (en) * 2003-11-12 2004-07-15 Univ Oo Bohomolets Nat Medical Method for treating inertness of rectum
DE102004033425B4 (de) 2004-06-01 2006-07-27 Microcuff Gmbh Verschlußsystem zur Versorgung rektaler bzw. analer Inkontinenz
DE102009008594B4 (de) 2009-02-12 2025-12-11 Advanced Medical Balloons Gmbh Vorrichtung zur Stuhldrainage
DE102010021883A1 (de) 2009-05-29 2010-12-02 Advanced Medical Balloons Gmbh Applikator für Spülflüssigkeit

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WO2012116816A1 (fr) 2012-09-07
EP2680805A1 (fr) 2014-01-08

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