WO2012116816A1 - Dispositif et méthode d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne - Google Patents

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

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Publication number
WO2012116816A1
WO2012116816A1 PCT/EP2012/000885 EP2012000885W WO2012116816A1 WO 2012116816 A1 WO2012116816 A1 WO 2012116816A1 EP 2012000885 W EP2012000885 W EP 2012000885W WO 2012116816 A1 WO2012116816 A1 WO 2012116816A1
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WO
WIPO (PCT)
Prior art keywords
balloon
rectum
colon
intestine
diameter
Prior art date
Application number
PCT/EP2012/000885
Other languages
German (de)
English (en)
Inventor
Fred GÖBEL
Original Assignee
Advanced Medical Balloons Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Advanced Medical Balloons Gmbh filed Critical Advanced Medical Balloons Gmbh
Priority to EP12711751.3A priority Critical patent/EP2680805B1/fr
Publication of WO2012116816A1 publication Critical patent/WO2012116816A1/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 and a method for the intermittent emptying of stool from the rectum (rectum) or large intestine (colon) of a patient without the ingress 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
  • CONFIRMATION COPY 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 a "triggered" defecation, the patient will have a chair-free interval which can last up to 24 hours and beyond, allowing the patient to stay in his environment without the risk of involuntary admission move freely.
  • 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 published patent application DE 10 2004 033 425 A1 relates to a closure system for the supply of rectal or anal incontinence and proposes to improve the sealing behavior of a double-segmented balloon body whose waist is positioned in the anal canal and the intra-rectal and pre-anal balloon portion each sealed at filling to move 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 published patent application 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. From these disadvantages of the prior art results the problem initiating the invention, an apparatus and a method for the intermittent emptying of stool from the rectum (rectum) or colon (colon) of a patient form such that the use of a in the intestine incoming liquid can be dispensed with.
  • 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 defecation reflex triggered by stretching of the intestinal wall can thus also be triggered independently of entry or "dry.”
  • the patient also gains in mobility and can also move freely to a certain extent during the procedure.
  • 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).
  • the present invention describes a preferably residual-sized balloon body, which is preferably 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 in FIG 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 approximately 2-3 cm into the rectum in the deaerated state, preferably in a compact space and in the least tissue-irritating manner, folded onto the intra-rectal catheter portion, eg as a bellows, the folded balloon lies snugly against the catheter shaft, and thus can be conveniently gripped by the large volume of deployment Anus are introduced.
  • 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. He may also be equipped with a valve device, the simple switching of the conveying direction of the Allows balloons of pumps on suction, and thus allows the rapid emptying of the balloon body at its removal when onset of excretion reflex or peristaltic contraction of the intestine.
  • 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 preforming provides that the balloon, as seen in its longitudinal direction, has a plurality of radially outwardly bulged beads surrounding it annularly or helically, so that the balloon collapses or contracts in a planned manner in the deflated state and does not knot uncontrollably. This is where the adjacent beads lie to each other and thus lead to a controlled shortening of the balloon in the 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.
  • Further advantages result from the fact that within the tapered attachment end no further element of the balloon extends, in particular no second end thereof. Since a central emptying lumen is not provided, the invention deviates from the hitherto frequently used torus shape of the balloon; Thus, the preferably single attachment end of the balloon can be brought directly into contact with the introduction element and, for example, glued or otherwise connected with that.
  • 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.
  • 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 method according to the invention for the intermittent emptying of stool from the rectum (rectum) or large intestine (colon) of a patient is characterized in that a thin-walled balloon body without a 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.
  • Figure 1 is a simple shaft-based embodiment of the device in a perspective view from the side.
  • FIG. 2 shows the embodiment of FIG. 1 in the deflated state, wherein the triggering balloon body bellows on the top of the
  • Fig. 3 shows the expansion of the trigger balloon from the rectum into the sigmoid in situ
  • Fig. 3a shows the arrangement of fig. 3 in a section across the colon, wherein the radial invagination of the residual sized balloon body shell can be seen upon deployment of the trigger balloon in the intestinal lumen;
  • FIG. 4 shows a shaft-based embodiment with a pre-anal balloon segment in a perspective view from the side, partially broken off;
  • Fig. 5 shows an embodiment with pre-anal abutment element in one of
  • FIG. 6 shows a modified, shaft-based embodiment of the invention with bellows-like preforming of the trigger balloon, in a partially unfolded state, in a perspective side view, the balloon being reproduced in a longitudinal section;
  • FIG. 7 shows a modified embodiment of the invention with a retracted balloon and optionally inner bellows preforming
  • FIG. 8 is another perspective view of a further embodiment having an inner, away-looking pilot balloon and surrounding outer trigger balloon, the outer balloon being shown transparent to allow a view of the pilot pilot inside;
  • FIG. 9 shows a still further embodiment with a greatly shortened, suppository-like catheter element for complete intra-rectal placement, in a longitudinal section; 10 shows a modified embodiment without a supporting catheter element with thimble-like proximal receptacle for the inserting finger, in a longitudinal section;
  • FIG. 11 shows a further embodiment of the device in which the balloon is applied to a suppository-like carrier element decoupling during filling into two parts, in a partially filled state and in a longitudinal section;
  • FIG. Fig. 12 is yet another, zäpchen shame embodiment in which the balloon is folded in the interior of the opening at filling suppository body packed, in the deflated state of the balloon and in longitudinal section;
  • Fig. 13 shows another, compared to FIG. 12 slightly modified
  • Embodiment in which a channel is provided through the rectal sigmoid balloon member for introducing a medium into the bowel section located above the balloon;
  • Containers which can receive inlet fluid and which can be connected to those variants of the described balloon trigger devices which are suitable for entry of fluid into intestinal sections above the trigger balloon;
  • Fig.15 an insertion with preferably permanently connected
  • a change balloon can be spanned, in a perspective, partially broken side view; such as Fig. 16 shows an exemplary embodiment of a filling tube with a terminal filling valve, in a perspective side view and partially broken off.
  • Fig. 1 shows the reflex-triggering shell of a balloon 1 according to the invention as an approximately cylindrical 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 expansion of at least 15 cm is proposed, and / or of 25 cm or less.
  • the balloon length should preferably be greater than 25 cm.
  • 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, wherein the balloon element 1 extends 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 a intestine section 5 which is acted upon by a trigger balloon 1 according to the invention. Due to its residual dimensioning, the balloon envelope 1 inverts into reserve folds 1a pointing radially inward.
  • Fig. 4 shows the device with a trans-anal and / or pre-anal extension of the balloon 1.
  • the trans-anal section 10 is preferably across the extent of the anal canal away such that it is the anal canal during filling of the balloon 1 without Expansion of the balloon envelope sealingly closes.
  • 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 extended pre-anal section 1 within the anal canal and secured against dislocation.
  • 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.
  • Fig. 6 shows a bellows-like formation 13 of the trigger balloon 1, which is to facilitate threading on the carrier tip 3 in the deflated state of the balloon, and upon filling of the balloon 1 outgoing from the rectal bottom, 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 balloon end with the front portion of the Ein manufacturedkatheters 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 made up 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 finally engages the intestinal wall space filling. 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 in their dimensions in coordination with the respective expansion properties of the balloon 18 Measure 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. When filling the balloon to about 50 to 100 mbar and corresponding envelope elongation, 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 lie 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.
  • the balloon 1 shows a balloon 1 to be placed intra-rectally, which does not contain any supporting shaft element and only consists of a balloon element.
  • the balloon 1 according to 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 the simple recording or the simple Thread the unfilled trigger balloon on the inserting finger.
  • FIG. 11 shows a balloon 1 which is to be placed intra-rectally and whose two ends are each provided with a conically rounded or atraumatically formed 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, but in contrast to Fig. 11 the balloon 1 is packed inside the cavity formed by the cap elements 29, 30 loosely fitted together lies.
  • the balloon 1 When filling the balloon 1 separates the two Kappenhrs. Capsule portions 29, 30 from each other and the balloon 1 may develop into the intestine.
  • a hose-like 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.
  • liquids, therapeutics or other media can be introduced into the colon located above the balloon.
  • 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 receiving liquid media.
  • a connector connection 34 these can be connected to those variants of the balloon devices according to the invention which have a hose-like supply of media into the intestine, as shown in FIG.
  • the user can thus supplement the "dry irrigation" with a liquid active component, such as a microenrichment enriched with pharmaceutical therapeutics.
  • the containers 33 are preferably designed as portioned ready-to-use solutions, for example by gravity or by 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 is closed, for example, by a hook and loop fastener 36 well-fitting over the container filled with the medium.
  • a chemical-thermal element can also be envisaged, as it is used in the form of so-called "pocket warmers" which operate on the basis of a latent heat accumulator (phase change materials, eg sodium acetate trihydrate) be inserted into corresponding pocket-like insulating containers together with the container 35, and ensure after activation of heat generation, with appropriate coordination of the amount of liquid, heat output and insulation for a temperature of the inlet medium at body temperature level.
  • phase change materials eg sodium acetate trihydrate
  • FIG. 15 shows an embodiment of the triggering device in which the carrier element 2 is connected to a pumping balloon 21 directly or via a releasable coupling.
  • 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, as described for example in DE 10 2010 021 883.9, which is preferably designed as a push button and reverses the conveying direction of the valve from pumps 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.
  • FIG. 16 shows a preferred embodiment of the filling line 4, 28 with a one-way valve 42 with self-closing spring mechanism connected end-to-end thereon.
  • 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 volumendehn sadness also, for example, by latex, Polyisoprene or silicone allows.
  • 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 moieties are also formed to be residual sized using these materials.
  • Balloon component 42 one-way valve

Landscapes

  • 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)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne des dispositifs utilisés pour permettre à un patient d'évacuer de manière intermittente les selles se trouvant dans le côlon et le rectum, au moyen d'un corps de ballonnet à paroi fine introduit dans l'intestin en passant par l'anus, ledit corps de ballonnet rempli d'air déclenchant un réflexe de défécation sous l'effet d'une dilatation de la paroi intestinale induite de manière délicate et avec des forces exercées de manière homogène. L'invention permet, indépendamment de l'état individuel du patient, de ne plus faire appel à des moyens d'activation fluides, de manipulation complexe.
PCT/EP2012/000885 2011-03-01 2012-03-01 Dispositif et méthode d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne WO2012116816A1 (fr)

Priority Applications (1)

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EP12711751.3A EP2680805B1 (fr) 2011-03-01 2012-03-01 Dispositif d'activation pneumatique du réflexe de défécation par voie rectosigmoïdienne

Applications Claiming Priority (2)

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DE102011012779.8 2011-03-01
DE102011012779 2011-03-01

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WO2012116816A1 true WO2012116816A1 (fr) 2012-09-07

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EP (1) EP2680805B1 (fr)
WO (1) WO2012116816A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103705374A (zh) * 2012-10-07 2014-04-09 杨廷旭 子宫后倾治疗仪
CN113425223A (zh) * 2021-06-22 2021-09-24 天津市人民医院 一种肠液回收式储便排便装置
US11596422B2 (en) 2016-11-03 2023-03-07 Hollister Incorporated Adjustable bowel treatment arm

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994020059A1 (fr) * 1993-03-10 1994-09-15 Nen, Inc. Procede de traitement des coliques et de la constipation
JP2003159323A (ja) * 2001-11-26 2003-06-03 Shigenobu Takane 排便方法及び排便器具
UA68194A (en) * 2003-11-12 2004-07-15 Univ Oo Bohomolets Nat Medical Method for treating inertness of rectum
DE102004033425A1 (de) 2004-06-01 2006-01-05 Microcuff Gmbh Verschlußsystem zur Versorgung rektaler bzw. analer Inkontinenz
DE102009008594A1 (de) 2009-02-12 2010-08-19 Advanced Medical Balloons Gmbh Vorrichtung zur Stuhldrainage
DE102010021883A1 (de) 2009-05-29 2010-12-02 Advanced Medical Balloons Gmbh Applikator für Spülflüssigkeit

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994020059A1 (fr) * 1993-03-10 1994-09-15 Nen, Inc. Procede de traitement des coliques et de la constipation
JP2003159323A (ja) * 2001-11-26 2003-06-03 Shigenobu Takane 排便方法及び排便器具
UA68194A (en) * 2003-11-12 2004-07-15 Univ Oo Bohomolets Nat Medical Method for treating inertness of rectum
DE102004033425A1 (de) 2004-06-01 2006-01-05 Microcuff Gmbh Verschlußsystem zur Versorgung rektaler bzw. analer Inkontinenz
DE102009008594A1 (de) 2009-02-12 2010-08-19 Advanced Medical Balloons Gmbh Vorrichtung zur Stuhldrainage
DE102010021883A1 (de) 2009-05-29 2010-12-02 Advanced Medical Balloons Gmbh Applikator für Spülflüssigkeit

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103705374A (zh) * 2012-10-07 2014-04-09 杨廷旭 子宫后倾治疗仪
US11596422B2 (en) 2016-11-03 2023-03-07 Hollister Incorporated Adjustable bowel treatment arm
CN113425223A (zh) * 2021-06-22 2021-09-24 天津市人民医院 一种肠液回收式储便排便装置

Also Published As

Publication number Publication date
EP2680805A1 (fr) 2014-01-08
EP2680805B1 (fr) 2019-06-19

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