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

Trans-anal inflow catheter and method for intermittently triggering a reflex-coordinated defecation Download PDF

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Publication number
US20140296831A1
US20140296831A1 US14/239,991 US201214239991A US2014296831A1 US 20140296831 A1 US20140296831 A1 US 20140296831A1 US 201214239991 A US201214239991 A US 201214239991A US 2014296831 A1 US2014296831 A1 US 2014296831A1
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United States
Prior art keywords
balloon
catheter
filling
shaft
section
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.)
Abandoned
Application number
US14/239,991
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English (en)
Inventor
Fred Göbel
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Advanced Medical Balloons GmbH
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Assigned to ADVANCED MEDICAL BALLOONS GMBH reassignment ADVANCED MEDICAL BALLOONS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GÖBEL, Fred
Publication of US20140296831A1 publication Critical patent/US20140296831A1/en
Priority to US16/026,669 priority Critical patent/US20180311479A1/en
Priority to US16/026,873 priority patent/US20180311480A1/en
Priority to US17/967,242 priority patent/US20230041626A1/en
Priority to US17/993,340 priority patent/US20230089826A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
    • A61F2/0013—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • A61M25/10186—One-way valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • A61M3/0295—Cannula; Nozzles; Tips; their connection means with inflatable balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0687—Guide tubes having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1009—Balloons anchored to a disc or plate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10187—Indicators for the level of inflation or deflation
    • A61M25/10188—Inflation or deflation data displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0245—Containers therefor, e.g. with heating means or with storage means for cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0262—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb

Definitions

  • the invention relates, on the one hand, to a device for transanally introducing an infusion into the rectum or colon of a patient, said device comprising an inflatable balloon having a waisted shape, particularly a dumbbell or hourglass shape, imparted by preforming during production, with two terminal balloon sections of larger radius and approximately spherical or discoid shape, and, disposed between them, a middle, tapered balloon section that has a reduced radius and is placed transanally, such that the distally adjoining radially enlarged balloon section is placed intrarectally and the proximally adjoining radially enlarged balloon section extracorporeally, and, on the other hand, to a method for filling the catheter balloon of such a device for transanally introducing an infusion into the rectum or colon of a patient by means of a filling device.
  • Catheters for transanally administering an infusion into the straight intestine (rectum) or large bowel (colon) of a patient have been known in a wide variety of embodiments for many years.
  • Inflow catheters can be implemented as simple tube elements, but for improved retention of the catheter in the rectum they are also provided with an intrarectally placed balloon element.
  • balloon elements provide, in addition to an anorectally anchoring function, a certain sealing effect that retains in the bowel the fluid that has been introduced by the irrigation.
  • the sealing capacity of inflow catheters fitted with an exclusively intrarectal balloon component is inadequate in many cases, however, and must be created by the user by continuously manually repositioning the surfaces of the sealing balloon on the floor of the rectum or manipulating the position of the catheter shaft atop the balloon.
  • transanal irrigation (TAI) method can be performed by the patient himself.
  • the function of the rectally instilled infusion medium apart from some degree of mobilization of stool, is primarily to moderately expand the wall portions of the rectal ampulla (the terminal rectum), which then results in the triggering of the physiological stool evacuation reflex (reflex triggering). Whereas the rectally placed infusion medium usually causes such reflex triggering within a few minutes, it take can much longer, up to 30 minutes or more, for the administered irrigation volume to be fully voided from the rectum or colon.
  • the relatively long time required for TAI limits its acceptance by many patients, and often rules this method out despite the fact that it is, as a rule, efficient for use by the individual.
  • Another problem is that many users are not able to manually bring irrigation catheters of conventional design into an adequately sealing position and keep them there.
  • a reflex-triggering expansion of portions of the bowel wall can occur when the filling process has only just begun, thereby leading, inter alia, to a reflex-like opening of the anus and thus sometimes causing the anchoring balloon to slip out of the rectum.
  • a catheter technique would be desirable which, once the catheter shaft is inserted in the rectum, holds it in its transanal position without the need for continuous repositioning, and both keeps the body of the shaft from sliding on into the bowel, with potentially traumatic consequences, and reliably prevents the catheter from accidentally slipping out of the anus prematurely.
  • inflow catheters having a double balloon arrangement.
  • two separate balloon elements which are usually filled simultaneously via a single filling lumen, are mounted in spaced relation on the catheter shaft. These come to lie on both sides of the anal canal, i.e. the internal and the external, thus mutually taking on the structures of the anus.
  • the usually elastic implementation of the balloon material brings about a spherical enlargement of the balloon bodies and thus a certain axially exerted squeezing of the anus disposed between the balloon bodies.
  • the dislocation-proof positioning of the catheter shaft obtained with such catheters can be assumed to be relatively reliable.
  • DE 10 2004 033 425 B4 describes a sealing system for the management of rectal or anal incontinence having a particular embodiment for the tamponade of bleeding hemorrhoids, presenting a waisted balloon element having a terminal intrarectal or preanal section.
  • the balloon envelope of the device is placed on the balloon-supporting shaft body in such a way that during the filling process, the intrarectal balloon segment moves in the direction of the rectal floor and there exerts a tamponade pressure on the bleeding venous blood vessels.
  • the preanal balloon segment concurrently moves toward the external anal opening.
  • the result is a tamponade effect oriented axially to the anus from both sides.
  • the middle, waisted section of the balloon expands outward radially to the wall of the anal canal. It is preferably shaped with a diameter that exceeds the diameter of the opened anal canal.
  • WO 2007/118621 A1 describes a similar dumbbell- or hourglass-shaped balloon sealing system.
  • This managing device also prominently features the rolling movement of the terminal balloon segments from both sides axially toward the anus.
  • the tip of the shaft body supporting the balloon protrudes freely and potentially traumatizingly into the intestinal lumen.
  • Both devices describe an hourglass- or dumbbell-shaped balloon configuration, the anus being received in the waisted region of the balloon, i.e. the region that is tapered relative to the terminal portions thereof.
  • Such shaping of the balloon not only results in relatively good securing of the catheter against dislocation, due to the sealing of the balloon inside the anal canal on all sides, but also makes for a considerable improvement in sealing performance over that of conventional double balloons.
  • both devices make it possible to largely avoid any expansion of the balloon envelope that could trigger irritation, pain or a defecation reflex, since the balloon wall is preferably already shaped to its working dimensions or beyond.
  • the filling or unfolding of the balloon to its working state requires only a low filling pressure, equal to or only slightly greater than the pressure prevailing in the rectum or abdomen at the time.
  • the problem initiating the invention is to eliminate these disadvantages of the known prior art.
  • both balloon ends taper to the shaft dimension of the catheter shaft supporting the balloon and are fixed in a simply invaginated or inverted manner on the preferably outer jacket surface of the catheter shaft in such fashion that as the balloon is filled, the two radially enlarged balloon sections move toward each other in opposite axial directions, and wherein the two radially enlarged balloon sections are enlarged relative to the tapered, middle balloon section, such that when the balloon is placed transanally, during the filling process the two radially enlarged balloon sections draw down over the middle, tapered balloon section and in the limit case come into direct contact with each other, thereby limiting their relative movement and preventing the distal end of the catheter shaft from passing beyond the apex of the intrarectal balloon radius when the shaft body is in a position of maximum axial deflection.
  • the invention describes a specific, particularly advantageous ratio of the length of the middle, waist-like balloon segment to the invagination (inversions), on both sides, of the fixation points of the ends of the balloon shaft to the catheter shaft.
  • This ratio ensures that in the filled, transanally positioned state, the tip of the catheter shaft spontaneously retracts into the intrarectal balloon segment and is nestled atraumatically there.
  • the atraumatic securing of the catheter tip inside the intrarectal balloon segment is also ensured according to the invention when the shaft axis undergoes the deflections inside the anal canal that typically occur during use, of the kind readily caused by a tug or push on the tube connection through which the catheter is guided in.
  • the invention further addresses the problem of preventing undesired or premature triggering effects due to the filled balloon as it unfolds in the rectum. Triggering of the defecation reflex can be prevented in most cases by preshaping the balloon to the working dimension or beyond (residual dimensioning), since the filling pressures necessary for anchoring and sealing the catheter are largely the same as, or need be only a few millibars higher than, the pressures prevailing in the rectum or in the abdomen.
  • the atraumatic securing of the tip of the catheter in the region of the intrarectal balloon segment is ensured even at such low filling pressures of, for example, 10 to 25 mbar.
  • Shaping the balloon to its working dimension further makes it possible for the user, by increasing the filling pressure or fill volume of the balloon from the initial filled state in which the balloon primarily has a sealing and anchoring effect, to induce a well-controllable and gradually increasable expansion of the bowel wall adjacent the catheter balloon, ultimately leading to controlled triggering of the defecation reflex with individually adjusted intensity.
  • a further suitable increase in the filling pressure in the dumbbell-shaped, waisted catheter balloon additionally causes a dilation of the anus or the anal sphincter, constituting another efficient trigger stimulus.
  • the intensity of such pneumatic expansion of the bowel wall or the anus can substantially exceed the intensity of reflex-triggering expansion with fluid media. Due to the more intense stimulus, several sequentially occurring cycles of evacuation reflexes can be triggered even though the stimulation is given only once.
  • This pneumatic expansion stimulus that can be well controlled by the user can also reduce the necessary amount of infusion fluid in many cases, which in turn can considerably shorten the time needed to evacuate the infusion from the rectum, thereby ultimately opening up the method to many users as a therapeutic option for self-administration.
  • the irrigation solution is preferably filled into a cylindrical, bag-like container, which the user can conveniently introduce intrarectally by squeezing it out with the hand.
  • the inflow catheter according to the invention further comprises a preferably fixedly glued-in filling conduit for charging the catheter balloon with filling pressure.
  • the unit for filling the balloon is preferably implemented in reusable form, and can be configured as a hand-operated pump balloon connectable via a coupling, or alternatively a pumped balloon with a pressure-indicating manometer. Alternatively, volume-controlled filling of the balloon is also conceivable. Regardless of the filling arrangement, the user can determine by stepwise approximation the degree of filling of the balloon that is optimal for him, that which is best adapted to his individual anatomy and his current reflex status.
  • the catheter shaft is preferably equipped in the proximal, preanal region with gripping depressions to accommodate the fingers gripping the catheter during insertion. If the user has no sensitivity in the pelvic or anal region, he guides the catheter in with his fingers until they abut the anus, and can thus avoid uncontrolledly deep insertion.
  • FIG. 1 a shows an embodiment of a catheter according to the invention in a schematic longitudinal section, the balloon ends being mounted on a catheter shaft in an inverted manner according to the invention
  • FIG. 1 b shows the geometric structure of the apex of the distal balloon radius
  • FIG. 1 c shows the balloon body described in FIG. 1 a in a freely unfolded state under low filling pressure, outside the anus;
  • FIG. 1 d shows the balloon body described in FIG. 1 a in a transanally placed state, under filling pressure
  • FIG. 1 e shows the geometric structure of the distal plane tangent to the intrarectal balloon section
  • FIG. 2 is a representation similar to FIG. 1 a of an alternative embodiment of the invention, in which a catheter tip extends beyond the forward fixation line of the end of the balloon shaft;
  • FIG. 3 is a representation similar 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;
  • FIG. 4 shows a shaped balloon envelope in the unfilled state, provided in a particularly advantageous manner for rectal insertion and reliable transanal placement and unfolding of the balloon;
  • FIG. 5 shows an alternative embodiment of the invention with a catheter shaft waisted in its transanal section
  • FIG. 6 shows a manually operable pump manometer with a pressure scale equipped for multi-stage, sequential filling of the catheter balloon, and
  • FIG. 7 shows a further alternative embodiment of the invention with an infusion container fixedly connected to the catheter shaft and a filling tube for charging the catheter balloon with filling pressure.
  • FIG. 1 a 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 .
  • the balloon 2 terminally comprises two balloon shaft ends ( 6 , 7 ) for attaching the balloon to the shaft.
  • 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.
  • the sum of the magnitudes B of the inversions at both ends should be at least equal to the length of the tapered intermediate piece A (A smaller than/equal to the sum of the magnitudes B).
  • the inversion depth B at the end of the balloon facing the patient or the rectum corresponds to the distance from 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.
  • 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. lb.
  • 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.
  • 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.
  • 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.
  • 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. lb.
  • 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 .
  • the inversion depths, lengths and distances are each determined in the filled state under filling pressure, the filling pressure being so selected that the balloon unfolds completely but there is no elastic expansion of the balloon envelope.
  • the 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 .
  • 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 .
  • FIG. 1 b describes the geometric derivation of the apex of the distal balloon radius.
  • 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 9 a and 9 b and the two inflection tangents 9 c and 9 d respectively belonging to these inflection points.
  • One of the two inflection points 9 a or 9 b is used to construct a straight line 9 e or 9 f that is normal to the respective inflection tangent 9 c or 9 d and intersects the corresponding inflection point 9 a or 9 b .
  • the point of intersection of these straight lines 9 e or 9 f with the axis X of symmetry yields the center point of the circle K.
  • the circle K and thus the forward balloon radius 9 , results from the center point M of the circle and the inflection points 9 a and 9 b , which are on the circumference of the circle.
  • apex 8 is obtained from the point of intersection of the circumference of the circle with the axis X of symmetry of the balloon.
  • 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 9 a and 9 b with the axis X of symmetry.
  • FIG. 1 c shows the behavior of the catheter balloon that was inverted according to the invention in FIG. 1 a 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.
  • the two segments move toward each other in response to the slightest, nearly ambient filling pressure and roll over the middle segment 3 .
  • 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.
  • 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.
  • FIG. 1 d shows how the inversion of the balloon ends in relation to the distal catheter shaft ends described in FIG. 1 a presents itself in cases where the anal canal is of normal or only slightly shortened length.
  • 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 .
  • the two terminal balloon segments 4 and 5 move counter to each other toward the anus and so conform to the particular anal situs.
  • the counter-rolling of the balloon segments commences even in response to a very low pressure force (filling pressure) that gives an impression of being nearly ambient to the environment.
  • the mere individual intra-abdominal pressure bearing against the transanally placed balloon or acting on the balloon is sufficient to produce a combined transanal sealing effect, comprised of radial sealing with respect to the anal canal and axially oriented sealing brought about by the counter-rolling movement of the terminal balloon enlargements at the inner and outer outlets of the anus.
  • the sealing effect thus is not contingent on the balloon initially being filled beyond its volume and unfolding freely until the balloon envelope begins to expand.
  • the balloon can behave in the described axial counter-rolling and radial unfolding fashion, even under partial filling of, for example, 70 to 90% of its volume when freely unfolded on the catheter shaft. This enables the balloon catheter to be placed in the anus in a nearly pressure-neutral and irritation-free manner.
  • any traumatizing effect of the tip of the catheter shaft on the bowel wall can thus be precluded, even under completely pressure-neutral charging with a filling medium, by the inversion of the shaft tip that occurs according to the invention.
  • FIG. 2 shows, by way of example, how sections of the catheter shaft in the form of 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.
  • Length B is increased in comparison to FIG. 1 a by the magnitude of length C or C/ 2 .
  • 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 .
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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 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 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.
  • 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.
  • 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.
  • 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.
  • the waist 23 can also predefine a certain kinkability of the shaft body, thus improving its atraumatic properties.
  • the filling of the balloon takes place through a separate duct 26 integral to the shaft.
  • the inflow catheter can is [sic] equipped with a non-return valve in the region of the fluid-conveying duct 25 .
  • 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 .
  • the tube element opens and allows the medium to flow freely.
  • the tube element collapses and closes up sealingly, preventing an effective backflow.
  • 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.
  • the user 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.
  • by intentionally causing an increase in pressure in the balloon he can generate an intense, relatively prompt-acting reflex-triggering stimulus, which can, if necessary, exceed in intensity the triggering effect of a column of colorectal fluid.
  • the catheter balloon is preferably filled with air, through a fill line integrated into the shaft wall of the catheter body 1 .
  • volume-controlled filling can be achieved with the use of an additional syringe element that specifies the preferred fill volume by means of a suitable marking on the syringe body.
  • the filling of the balloon is preferably partial, in the form of one-step filling. In the ideal case, therefore, in loose, unexpanded form, the balloon lies against the structures of the bowel and the anus.
  • the balloon envelope thus absorbs the forces acting on the balloon in the rectum, the anus and the preanal region and brings the balloon into the configuration in which it performs the anchoring and sealing function.
  • the respective physiologically acting forces are absorbed by the catheter balloon and thus enable the balloon to be placed anorectally in as pressure-neutral a manner as possible, largely precluding undesired and premature triggering effects.
  • a volume-controlled filling of the balloon can also be a two-step process, in which incomplete filling is first performed and the balloon is then, in the second filling step, filled with a volume that has a triggering effect.
  • the pressures developed in the transanal balloon in response to the particular volume should preferably fall within the pressure ranges ( 29 , 30 ) described 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.
  • 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.
  • 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.
  • 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.
  • the container is preferably shaped as cylindrical, with a diameter of approximately 4-6 cm.
  • 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.
  • Another feed conduit 34 can be connected directly to a pump manometer 27 or a filling syringe.
  • 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.
  • 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.
  • 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 ⁇ m, and preferably less than 15 ⁇ m, in the typical filling pressure range during use of 10 to 120 ⁇ m.
  • non-volume-expandable materials can also be used, such as polyethylene, PVC or mixtures of the aforesaid materials with polyurethane.
  • Balloon films according to the invention can also be shaped directly from the extruded, still soft, largely amorphous tube molding compound (in-line molding), in which case the achievable strengths of the films are much lower than those of pre-extruded tubes and the attainable wall thicknesses are much higher than in the case of forming from pre-extruded material.
  • 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.
  • the balloon 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.
  • 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.
  • 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.
  • the described catheter technique may also be contemplated for use in surgically created stomata/openings or other natural body openings.

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US14/239,991 2011-08-20 2012-08-20 Trans-anal inflow catheter and method for intermittently triggering a reflex-coordinated defecation Abandoned US20140296831A1 (en)

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US16/026,669 US20180311479A1 (en) 2011-08-20 2018-07-03 Method for intermittently triggering a reflex-coordinated defecation
US16/026,873 US20180311480A1 (en) 2011-08-20 2018-07-03 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation
US17/967,242 US20230041626A1 (en) 2011-08-20 2022-10-17 Method and device for intermittently triggering a reflex-coordinated defecation
US17/993,340 US20230089826A1 (en) 2011-08-20 2022-11-23 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation

Applications Claiming Priority (11)

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DE102011111225 2011-08-20
DE102011111225.5 2011-08-20
DE102011118943.6 2011-11-21
DE102011118943 2011-11-21
DE102011121202 2011-12-16
DE102011121202.0 2011-12-16
DE102012005607.9 2012-03-22
DE102012005607 2012-03-22
DE102012008361.0 2012-04-25
DE102012008361 2012-04-25
PCT/EP2012/003535 WO2013026565A1 (fr) 2011-08-20 2012-08-20 Cathéter de lavement transanal et procédé pour déclencher par intermittence une défécation réflexe coordonnée

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US16/026,873 Continuation-In-Part US20180311480A1 (en) 2011-08-20 2018-07-03 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation
US16/026,669 Division US20180311479A1 (en) 2011-08-20 2018-07-03 Method for intermittently triggering a reflex-coordinated defecation
US16/026,889 Continuation-In-Part US11324932B2 (en) 2011-08-20 2018-07-03 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation

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US14/239,991 Abandoned US20140296831A1 (en) 2011-08-20 2012-08-20 Trans-anal inflow catheter and method for intermittently triggering a reflex-coordinated defecation
US16/026,669 Abandoned US20180311479A1 (en) 2011-08-20 2018-07-03 Method for intermittently triggering a reflex-coordinated defecation
US16/026,889 Active 2033-09-16 US11324932B2 (en) 2011-08-20 2018-07-03 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation

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US16/026,889 Active 2033-09-16 US11324932B2 (en) 2011-08-20 2018-07-03 Trans-anal inflow catheter for intermittently triggering a reflex-coordinated defecation

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US20180311481A1 (en) 2018-11-01
EP2744445A1 (fr) 2014-06-25
US20180311479A1 (en) 2018-11-01
JP6995729B2 (ja) 2022-01-17
JP2014524293A (ja) 2014-09-22
WO2013026565A1 (fr) 2013-02-28
JP2019048072A (ja) 2019-03-28
EP2744445B1 (fr) 2018-01-31
US11324932B2 (en) 2022-05-10

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