WO1992019192A1 - A device for preventing involuntary urination, preferable for females - Google Patents

A device for preventing involuntary urination, preferable for females Download PDF

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Publication number
WO1992019192A1
WO1992019192A1 PCT/DK1992/000131 DK9200131W WO9219192A1 WO 1992019192 A1 WO1992019192 A1 WO 1992019192A1 DK 9200131 W DK9200131 W DK 9200131W WO 9219192 A1 WO9219192 A1 WO 9219192A1
Authority
WO
WIPO (PCT)
Prior art keywords
rod
shaped body
shaped
urethra
enlargements
Prior art date
Application number
PCT/DK1992/000131
Other languages
French (fr)
Inventor
Tage Wenzel Debess
Original Assignee
Coloplast As
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 Coloplast As filed Critical Coloplast As
Publication of WO1992019192A1 publication Critical patent/WO1992019192A1/en

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Classifications

    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/48—Devices for preventing wetting or pollution of the bed
    • 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

Definitions

  • the present invention relates to a device for preventing involuntary urination, preferably in femal ⁇ es and of the kind comprising an oblong mainly rod- shaped body with one ore more diameter increasing en- largements and with an interior conduit opening at a proximal end of the rod-shaped body and serving to receive a pin for use in inserting the device into the urethra, whereas the rod-shaped body is further prov ⁇ ided at its proximal end with a transverse flap or disc.
  • US patent No.3,797,478 discloses a device functioning as a valve, comprising a hollow flexible plastic tube inside which a double-walled tube of a resilient material is arranged, which resilient tube projects beyond both ends of the plastic tube.
  • a pressure med ⁇ ium is injected between the two walls of the double- walled tube whereby the ends of same projecting beyond the plastic tube are inflated and assume the shape of bulb-like enlargements with a larger diameter than that of the plastic tube.
  • the inflation prevents in ⁇ voluntary urination, but at a sufficient high urine pressure a passage is opened through the double-walled tube.
  • SUBSTITUTESHEET will feel irritating during use and, also, manipul ⁇ ation in connection with the insertion process is com ⁇ plicated by the prescribed inflation.
  • the device being intended to,remain in the urethra also during volun- tary urination with the bulb-like enlargements posit ⁇ ioned immediately at the interior and exterior ostium of the urethra, there is a comparatively high risk of infection.
  • US patent No.3,768,102 discloses a urethral plug with a valve function, comprising a mainly egg- shaped body in which one of two conduits which are arranged flush in the ends of the body at its inside serves as a seat for a spring-activated valve.
  • This device is mainly intended for surgical implantation but may be designed for manual insertion through the outer ostium of the urethra to a position in which it is retained by the urethral muscles, possibly by means of a tissue compatible adhesive.
  • SE publication No.463802 discloses an expand ⁇ able plug having two gas-filled chambers separated by a reversible valve. At insertion of this device, pres ⁇ sure is exerted on the chamber positioned at the ex ⁇ tremity of the urethra, whereby the pressure medium via the valve is transferred to and inflates the inner chamber so that it dilates. When the device is to be removed for voluntary urination the valve is opened, e.g. by means of a pull cord, whereby the pressure medium is again equally distributed in the two chambers and the device can be removed.
  • US patent No.4,457,299 discloses a plug design ⁇ ed as an interior spring-biased ellipsoid body which normally will fill up the urethra, but at voluntary urination is affected by the urine pressure to elastic deformation whereby a urine flow passage is opened.
  • This form-stable device must in practice be dimensioned based on a compromise between simple and effortless insertion and retraction and the sphincter- al function.
  • a sufficient sealing of the urethra will normally entail irritation related to the insertion and retraction process, whereas making predominant allowance for manipulation comfort may result in an insufficient sealing function.
  • the invention aims at providing a urinary incontinence device of the type hereinbefore described having a sufficient resilient deformability to permit effortless insertion and re ⁇ traction as a result of its reduced diameter as com ⁇ pared to the urethra, and which after insertion can expand to an efficient sealing condition without re- quiring inflation by means of external devices or in ⁇ terior springs or similar means.
  • the device according to the invention is characterized in that the rod-shaped body is resiliently deformable in its longitudinal direct- ion, and that said diameter increasing enlargements are resiliently deformable so that, when the rod-shap ⁇ ed body has been brought into an extended insertion position by means of the insertion pin, they can be deformed to a reduced outer diameter permitting easy insertion into the urethra with little irritation to the tissue, whereas in a contracted condition of the rod-shaped body attained after retraction of the pin, they can assume an increased diameter so as to come into sealing contact against the surrounding tissue of the urethra.
  • the rod-shaped body is extended or lengthened by means of the insertion pin through, resilient deformation from its tension relieved condition, whereby the likewise resiliently deformable enlargements, possibly as a direct result of the resilient length deformation of the rod-shaped body, will be deformed so as to assume a smaller outer diameter, thus considerably facilitating insertion.
  • the pin When the device has been inserted into the urethra by means of the insertion pin with the transverse flap or disc in position against the outer ostium of the urethra, the pin is retracted and the rod-shaped body will contract longitudinally from the extended or lengthened insertion condition, whereby the resilient ⁇ ly deformable enlargements will assume a larger outer diameter for sealing contact against the surrounding tissue of the urethra.
  • the resiliently deformable en ⁇ largements comprise one or more bellows-shaped port ⁇ ions lengthwise of the rod-shaped body.
  • these bellows-shaped portions will as ⁇ sume a reduced diameter as a result of the resilient length deformation of the rod-shaped body, whereas they will acquire an increased diameter at contraction of the body after retraction of the pin so as to come into selaing contact againstthe urethra.
  • the device is preferably dimensioned so that in a tension relieved condition of the rod-shaped body at least one bellows-shaped portion has an outer diameter exceeding the diameter of the urethra.
  • the bellow-shaped portions also during use, i.e. after contraction of the rod-shaped body, will have a resilient bias for providing efficient sealing.
  • the resiliently deformable enlargements may comprise a number of sub ⁇ stantially transverse lamellae protruding from the rod-shaped body.
  • the resilient de ⁇ formation of the lamellae during insertion will mainly consist in a retroflexion of the lamellae ensuring easy and effortless insertion.
  • At the lengthwise con ⁇ traction of the rod-shaped body after retraction of the insertion pin, particularly the lamellae position ⁇ ed close to the distal end of the device will come into sealing contact against the urethra.
  • the device may comprise both a number of lamellae and one or more bellows-shaped portions.
  • the device according to the invention has the particular advantage that the resil- iently deformable enlargements can be subjected to an additional compression at increased urine pressure, whereby the sealing effect is increased. The device is thus to a certain degree pressure compensating.
  • the rod-shaped body with its resiliently deformable en ⁇ largements is preferably manufactured in one of a bio- compatible elastomeric, preferably thermoplastic material and can be supplied as a disposable article together with the insertion pin in a sterile packing.
  • Figs 1-4, 6 and 7 are longitudinal sections of various embodiments of an urinary incontinence device according to the invention.
  • Figs 1 and 2 show the same embodiment seen in an extended insertion condition and a contracted sealing condition, respectively, whereas Fig 5 shows the embodiment shown in Fig 4 in its oper- ational position in the female urethra.
  • the urinary incontinence device comprises an oblong rod-shaped body 1, which on a considerable part of its length is provided with dia- meter increasing enlargements in the form of a bel ⁇ lows-shaped portion 2 and at its closed distal end has a transverse substantially disc-shaped lamella 3.
  • the body 1 is provided with an internal con ⁇ duit 4, which as shown in Fig 1 serves to receive a pin 5, which is used at insertion of the device into the urethra.
  • the device consists of a hollow body with largely uniform wall thickness over its entire length.
  • the parts of the conduit 4, positioned outside the bellows portion 2 at the distal and proximal ends of the device will thus form an adequate guide for the insertion pin 5.
  • the device At its proximal end the device is provided with a transverse pull flap or disc 6 for abutment on the outer ostium of the urethra.
  • the device is manufactured in one piece of biocompat- ible resiliently deformable material, preferably a thermoplastic elastomer, and can be produced in one operational sequence by thermoplastic processing, e.g. an initial injection moulding followed by a combined pull extrusion and blow moulding process of the kind described in the published international patent application W091/17728.
  • the body 1 can be extended lengthwise during insertion by means of the pin 5 to assume the shape shown in Fig 1, in which the individual folds 2a in the bellows portion 2 assume a decreased outer diameter as compared with the tension relieved supply condition of the device.
  • the bellows portion 2 will, when resiliently extended to the condition shown in Fig 1, assume a reduced outer diameter and can effort ⁇ lessly and without irritation be inserted into the urethra.
  • the lamella 3 which in the supply condition may have substantially the same outer diameter as the bellows portion 2 will during insertion be bent backwards, e.g. to the position 3a shown in Fig 1.
  • the pin 5 is retracted, and the device will then contract lengthwise, whereby the bel- lows portion 2 resumes a larger outer diameter and comes into sealing contact against the surrounding tissue of the urethra.
  • the device will not quite revert to its tension relieved condition, but will maintain a certain resilient bias.
  • the distal end of the device will get displaced towards the proximal end, and the lamella 3 will tilt and assume the forwards bent position 3b shown in Fig 2.
  • the advantage is obtained that the device adapts to the actual urethral anatomy in a way causing no significant irritation to the user and is, to a certain extent, pressure com ⁇ pensating, inasmuch as an increase of the urine pres- sure as marked by an arrow P will increase the abut ⁇ ment pressure of the lamella 3 on the surrounding tissue thus improving the sealing property.
  • pressure in ⁇ crease would result in a certain further compression of the bellows portion 2 or the part of it which is positioned closest to the distal end of the device.
  • the comparatively elongated bel ⁇ lows which normally covers at least 40% of the total length of the body 1 results in a high sealing pro- perty due to the gradual pressure reduction lengthwise of the bellows from the distal end.
  • the push pin 5 which for example can be made of a suitable plastic material with an adequate rigid ⁇ ity, e.g. nylon or the like, is provided with a grip 7 for use during retraction.
  • the entire device can be supplied as a sterile packed disposable article with the push pin 5 inserted into the conduit 4.
  • the insertion pin 5 may be provided with one or more, e.g. ball-shaped enlargements 8 having a slightly larger diameter than that of the conduit 4 in the insertion condition shown in Fig 1 so that a pull at the pin during retraction contributes to contract the rod-shaped body.
  • the resilient ⁇ ly deformable enlargements on the rod-shaped body 9 are exclusively designed as transverse lamellae, of which two lamellae 10 and 11 at the distal end of the device have a somewhat larger outer diameter than the remaining lamellae 12.
  • the lamellae 10, 11 and 12 which together provide a sort of labyrinth sealing, will be bent backwards, and when the insertion pin 13 is subsequently retracted the outer lamellae 10 and 11 will tilt in the way explained above and assume a for ⁇ wards bent position.
  • the lamellae 12 may be designed as solid, thin disc-shaped lamellae integral with the rod- shaped body 9, it can be expedient to provide the outer lamellae 10 and 11 with a slit-like cav ⁇ ity 14 in connection with the conduit 15 serving to receive the insertion pin 13. During the resilient extension of the body 1, these lamellae will then to a certain extent be deformed in the same way as the individual folds of a bellows portion and assume a somewhat smaller diameter than in the supply condit ⁇ ion.
  • the resilient ⁇ ly deformable enlargements of the rod-shaped body 16 are designed as two separate bellows-shaped portions 17 and 18 instead of one coherent elongated bellows portion as shown in Figs 1 and 2.
  • this embodiment also comprises a transverse disc-shaped lamella 19 at the distal end of the device as shown in Figs 1 and 2.
  • Such an embodiment with two separate bellows- shaped portions, which at insertion into the urethra as shown in Fig 5 position themselves on both sides of the spot M in the urethra where the pelvic muscles exert maximum sphincteral pressure may be advantageous with a view to supporting what remains of the urethral sphincteral function in cases of incontinence.
  • the same effect can in many cases be obtained by a single shorter bellows portion, e.g. correspond ⁇ ing to the bellows portion 17 in Fig 4.
  • a bellows portion 22 may also as shown in Fig 6 be designed so that the individual folds 22a have an unsymmetrical corbie- step shape so that the side of the fold facing the distal end forms a more acute angle with the longit ⁇ udinal axis of the rod-shaped body 23 than the side of the fold facing the proximal end.
  • a further dist ⁇ inct diameter reduction can thereby be obtained in the resiliently extended insertion condition, and after contraction of the body 23 a retaining function will occur with improved safeguard against the device being pushed out.
  • the conduit 27 for the insertion pin 28 is enveloped by a first permanent magnetic body 29 on a portion of its length measured from the proximal end, whereas another interior permanent magnetic body 30 is arranged close to the distal end of the device in extension of the conduit which, at retraction of the pin 28 is attracted to the first permanent magnetic body 29, thereby supporting the contraction of the body 24 from the resiliently extended insertion con ⁇ dition.
  • This additional measure which will make pro ⁇ duction more expensive is normally not necessary in order to achieve the sealing function which is aimed at.
  • the embodiment of the resiliently deformable enlargements of the rod-shaped body since in partic- ular the bellows-shape can be varied with a view to optimum adaptation.
  • the device may for example con ⁇ ceivably be designed with a coherent bellows portion which in the supply condition has a larger diameter at the distal end of the device than at the proximal end.
  • other types of resiliently deform ⁇ able enlargements can be imagined.

Abstract

A device for preventing involuntary urination, preferably in females comprises an oblong mainly rod-shaped body (1) with one or more diameter increasing enlargements (2, 3) and with an interior conduit (4) leading to the proximal end of the rod-shaped body and serving to receive a pin (5) for use in inserting the device into the urethra. The rod-shaped body (1) is resiliently deformable lengthwise, and the diameter increasing enlargements (2, 3) which may comprise one or more bellows-shaped portions (2) and/or transverse lamellae, are resiliently deformable so that, when the rod-shaped body has been brought into an extended insertion condition by means of the insertion pin (2, 28), they are deformed to a decreased outer diameter permitting effortless insertion into the urethra with little irritation to the tissue, whereas in a contracted condition of the rod-shaped body attained after retraction of the pin (5, 28), they can assume an increased diameter so as to come into sealing contact against the surrounding tissue of the urethra.

Description

A device for preventing involuntary urination, prefer¬ able for females.
The present invention relates to a device for preventing involuntary urination, preferably in femal¬ es and of the kind comprising an oblong mainly rod- shaped body with one ore more diameter increasing en- largements and with an interior conduit opening at a proximal end of the rod-shaped body and serving to receive a pin for use in inserting the device into the urethra, whereas the rod-shaped body is further prov¬ ided at its proximal end with a transverse flap or disc.
For remedying such severe cases of urinary in¬ continence in females where the use of absorbent in¬ continence pads is insufficient, devices are known which are designed for insertion into the urethra and serving as a sort of plug preventing involuntary urination.
US patent No.3,797,478 discloses a device functioning as a valve, comprising a hollow flexible plastic tube inside which a double-walled tube of a resilient material is arranged, which resilient tube projects beyond both ends of the plastic tube. After insertion of the device in the urethra a pressure med¬ ium is injected between the two walls of the double- walled tube whereby the ends of same projecting beyond the plastic tube are inflated and assume the shape of bulb-like enlargements with a larger diameter than that of the plastic tube. The inflation prevents in¬ voluntary urination, but at a sufficient high urine pressure a passage is opened through the double-walled tube.
As the surrounding plastic tube must have a certain rigidity despite is flexibility, such a device
SUBSTITUTESHEET will feel irritating during use and, also, manipul¬ ation in connection with the insertion process is com¬ plicated by the prescribed inflation. The device being intended to,remain in the urethra also during volun- tary urination with the bulb-like enlargements posit¬ ioned immediately at the interior and exterior ostium of the urethra, there is a comparatively high risk of infection.
US patent No.3,768,102 discloses a urethral plug with a valve function, comprising a mainly egg- shaped body in which one of two conduits which are arranged flush in the ends of the body at its inside serves as a seat for a spring-activated valve. This device is mainly intended for surgical implantation but may be designed for manual insertion through the outer ostium of the urethra to a position in which it is retained by the urethral muscles, possibly by means of a tissue compatible adhesive.
The design of this device is too complicated and too expensive to manufacture for supply as a dis¬ posable article. In addition, the valve function implies a considerable risk of infection.
SE publication No.463802 discloses an expand¬ able plug having two gas-filled chambers separated by a reversible valve. At insertion of this device, pres¬ sure is exerted on the chamber positioned at the ex¬ tremity of the urethra, whereby the pressure medium via the valve is transferred to and inflates the inner chamber so that it dilates. When the device is to be removed for voluntary urination the valve is opened, e.g. by means of a pull cord, whereby the pressure medium is again equally distributed in the two chambers and the device can be removed.
This device will also normally require a spring bias of the valve between the two chambers. US patent No.4,457,299 discloses a plug design¬ ed as an interior spring-biased ellipsoid body which normally will fill up the urethra, but at voluntary urination is affected by the urine pressure to elastic deformation whereby a urine flow passage is opened.
In order to avoid the manipulatory complicat¬ ions and the risk of infection inherent in devices that remain in the urethra also during voluntary urin¬ ation, the published international patent application WO89/02257 suggests a device of the type mentioned hereinbefore, mainly intended for females and having a rod-shaped body designed as a comparatively thin stem with at least one substantially form-stable bulb-shap¬ ed enlargement at a distance from the proximal end. Even though this device which is meant to be removed during voluntary urination and for this purpose is provided with a transverse flap or disc at its prox¬ imal end remedies some of the disadvantages of the above-mentioned known embodiments, the stationary pos- ition of the form-stable enlargements lengthwise of the device and the very limited compressibility of these enlargements necessary for the form-stability results in the device in a given embodiment not being adapted to natural anatomical variations as concerns the length and diameter of the urethra and the locat¬ ion of the strongest sphincteral pressure in its long¬ itudinal direction. If the device is to function efficiently without significant irritation the bulb- shaped enlargement must be placed immediately behind the place where the strongest pressure from the pelvic muscles occurs.
This form-stable device must in practice be dimensioned based on a compromise between simple and effortless insertion and retraction and the sphincter- al function. A sufficient sealing of the urethra will normally entail irritation related to the insertion and retraction process, whereas making predominant allowance for manipulation comfort may result in an insufficient sealing function. In order to make due allowance for a high mani¬ pulation comfort in connection with insertion and re¬ traction as well as the requirement as to adequate prevention of involuntary urination, the required adaptation to natural anatomical variations and dif- ferences in respect of the incontinence-causing debil¬ itated sphincteral function of the urethra, and a des¬ ign of simple structure and thereby inexpensive, suit¬ able for a disposable article, the invention aims at providing a urinary incontinence device of the type hereinbefore described having a sufficient resilient deformability to permit effortless insertion and re¬ traction as a result of its reduced diameter as com¬ pared to the urethra, and which after insertion can expand to an efficient sealing condition without re- quiring inflation by means of external devices or in¬ terior springs or similar means.
To accomplish this the device according to the invention is characterized in that the rod-shaped body is resiliently deformable in its longitudinal direct- ion, and that said diameter increasing enlargements are resiliently deformable so that, when the rod-shap¬ ed body has been brought into an extended insertion position by means of the insertion pin, they can be deformed to a reduced outer diameter permitting easy insertion into the urethra with little irritation to the tissue, whereas in a contracted condition of the rod-shaped body attained after retraction of the pin, they can assume an increased diameter so as to come into sealing contact against the surrounding tissue of the urethra. During insertion of the urinary incontinence device according to the invention the rod-shaped body is extended or lengthened by means of the insertion pin through, resilient deformation from its tension relieved condition, whereby the likewise resiliently deformable enlargements, possibly as a direct result of the resilient length deformation of the rod-shaped body, will be deformed so as to assume a smaller outer diameter, thus considerably facilitating insertion. When the device has been inserted into the urethra by means of the insertion pin with the transverse flap or disc in position against the outer ostium of the urethra, the pin is retracted and the rod-shaped body will contract longitudinally from the extended or lengthened insertion condition, whereby the resilient¬ ly deformable enlargements will assume a larger outer diameter for sealing contact against the surrounding tissue of the urethra.
In a preferred embodiment of the device accord- ing to the invention the resiliently deformable en¬ largements comprise one or more bellows-shaped port¬ ions lengthwise of the rod-shaped body. In the insert¬ ion condition these bellows-shaped portions will as¬ sume a reduced diameter as a result of the resilient length deformation of the rod-shaped body, whereas they will acquire an increased diameter at contraction of the body after retraction of the pin so as to come into selaing contact againstthe urethra.
The design comprising such bellows-shaped port- ions which may cover a considerable part of the length of the rod-shaped body entails a good adaptation to natural anatomical variations.
The device is preferably dimensioned so that in a tension relieved condition of the rod-shaped body at least one bellows-shaped portion has an outer diameter exceeding the diameter of the urethra. This entails that the bellow-shaped portions also during use, i.e. after contraction of the rod-shaped body, will have a resilient bias for providing efficient sealing. According to another embodiment the resiliently deformable enlargements may comprise a number of sub¬ stantially transverse lamellae protruding from the rod-shaped body. In this embodiment the resilient de¬ formation of the lamellae during insertion will mainly consist in a retroflexion of the lamellae ensuring easy and effortless insertion. At the lengthwise con¬ traction of the rod-shaped body after retraction of the insertion pin, particularly the lamellae position¬ ed close to the distal end of the device will come into sealing contact against the urethra.
In a further preferred embodiment the device may comprise both a number of lamellae and one or more bellows-shaped portions. The device according to the invention has the particular advantage that the resil- iently deformable enlargements can be subjected to an additional compression at increased urine pressure, whereby the sealing effect is increased. The device is thus to a certain degree pressure compensating.
When the device according to the invention is to be removed from the urethra in connection with vol¬ untary urination, this can easily be done by pulling the traverse flap or disc at the proximal end of the device, thereby extending the rod-shaped body somewhat so that the device can be removed without difficulty. In the device according to the invention the rod-shaped body with its resiliently deformable en¬ largements is preferably manufactured in one of a bio- compatible elastomeric, preferably thermoplastic material and can be supplied as a disposable article together with the insertion pin in a sterile packing. The invention is further explained in the following with reference to the schematical drawing, in which
Figs 1-4, 6 and 7 are longitudinal sections of various embodiments of an urinary incontinence device according to the invention. Figs 1 and 2 show the same embodiment seen in an extended insertion condition and a contracted sealing condition, respectively, whereas Fig 5 shows the embodiment shown in Fig 4 in its oper- ational position in the female urethra.
In the embodiment shown in Figs 1 and 2 the urinary incontinence device according to the invention comprises an oblong rod-shaped body 1, which on a considerable part of its length is provided with dia- meter increasing enlargements in the form of a bel¬ lows-shaped portion 2 and at its closed distal end has a transverse substantially disc-shaped lamella 3.
The body 1 is provided with an internal con¬ duit 4, which as shown in Fig 1 serves to receive a pin 5, which is used at insertion of the device into the urethra.
In practice, the device consists of a hollow body with largely uniform wall thickness over its entire length. The parts of the conduit 4, positioned outside the bellows portion 2 at the distal and proximal ends of the device will thus form an adequate guide for the insertion pin 5.
At its proximal end the device is provided with a transverse pull flap or disc 6 for abutment on the outer ostium of the urethra. In the embodiment shown, the device is manufactured in one piece of biocompat- ible resiliently deformable material, preferably a thermoplastic elastomer, and can be produced in one operational sequence by thermoplastic processing, e.g. an initial injection moulding followed by a combined pull extrusion and blow moulding process of the kind described in the published international patent application W091/17728.
With* the illustrated design of the bellows and as a result of the resilient deformability the body 1 can be extended lengthwise during insertion by means of the pin 5 to assume the shape shown in Fig 1, in which the individual folds 2a in the bellows portion 2 assume a decreased outer diameter as compared with the tension relieved supply condition of the device.
As the device is dimensioned so that the folds 2a in the bellows portion 2 in the tension relieved supply condition have an outer diameter which is slightly larger than the normal diameter of the urethra, e.g. 10 mm, the bellows portion 2 will, when resiliently extended to the condition shown in Fig 1, assume a reduced outer diameter and can effort¬ lessly and without irritation be inserted into the urethra. The lamella 3 which in the supply condition may have substantially the same outer diameter as the bellows portion 2 will during insertion be bent backwards, e.g. to the position 3a shown in Fig 1. After the device has been inserted into the urethra to a maximum depth as determined by the abut¬ ment of the flap or disc 6 on the exterior ostium of the urethra and corresponding to the normal length of same, e.g. 55 mm, the pin 5 is retracted, and the device will then contract lengthwise, whereby the bel- lows portion 2 resumes a larger outer diameter and comes into sealing contact against the surrounding tissue of the urethra. However, with the dimensioning as described above, the device will not quite revert to its tension relieved condition, but will maintain a certain resilient bias. During contraction the distal end of the device will get displaced towards the proximal end, and the lamella 3 will tilt and assume the forwards bent position 3b shown in Fig 2. In addition to easy insertion the advantage is obtained that the device adapts to the actual urethral anatomy in a way causing no significant irritation to the user and is, to a certain extent, pressure com¬ pensating, inasmuch as an increase of the urine pres- sure as marked by an arrow P will increase the abut¬ ment pressure of the lamella 3 on the surrounding tissue thus improving the sealing property. Even if the lamella 3 had been left out, such a pressure in¬ crease would result in a certain further compression of the bellows portion 2 or the part of it which is positioned closest to the distal end of the device.
Furthermore, the comparatively elongated bel¬ lows which normally covers at least 40% of the total length of the body 1 results in a high sealing pro- perty due to the gradual pressure reduction lengthwise of the bellows from the distal end.
The push pin 5 which for example can be made of a suitable plastic material with an adequate rigid¬ ity, e.g. nylon or the like, is provided with a grip 7 for use during retraction. The entire device can be supplied as a sterile packed disposable article with the push pin 5 inserted into the conduit 4.
At or in the vicinity of its distal end the insertion pin 5 may be provided with one or more, e.g. ball-shaped enlargements 8 having a slightly larger diameter than that of the conduit 4 in the insertion condition shown in Fig 1 so that a pull at the pin during retraction contributes to contract the rod-shaped body. In the embodiment shown in Fig 3 the resilient¬ ly deformable enlargements on the rod-shaped body 9 are exclusively designed as transverse lamellae, of which two lamellae 10 and 11 at the distal end of the device have a somewhat larger outer diameter than the remaining lamellae 12. During insertion, with the body 9 in its extended resiliently deformed insert¬ ion condition, the lamellae 10, 11 and 12, which together provide a sort of labyrinth sealing, will be bent backwards, and when the insertion pin 13 is subsequently retracted the outer lamellae 10 and 11 will tilt in the way explained above and assume a for¬ wards bent position.
Whereas the lamellae 12 may be designed as solid, thin disc-shaped lamellae integral with the rod- shaped body 9, it can be expedient to provide the outer lamellae 10 and 11 with a slit-like cav¬ ity 14 in connection with the conduit 15 serving to receive the insertion pin 13. During the resilient extension of the body 1, these lamellae will then to a certain extent be deformed in the same way as the individual folds of a bellows portion and assume a somewhat smaller diameter than in the supply condit¬ ion. In the embodiment shown in Fig 4 the resilient¬ ly deformable enlargements of the rod-shaped body 16 are designed as two separate bellows-shaped portions 17 and 18 instead of one coherent elongated bellows portion as shown in Figs 1 and 2. In addition, this embodiment also comprises a transverse disc-shaped lamella 19 at the distal end of the device as shown in Figs 1 and 2.
Such an embodiment with two separate bellows- shaped portions, which at insertion into the urethra as shown in Fig 5 position themselves on both sides of the spot M in the urethra where the pelvic muscles exert maximum sphincteral pressure may be advantageous with a view to supporting what remains of the urethral sphincteral function in cases of incontinence. The same effect can in many cases be obtained by a single shorter bellows portion, e.g. correspond¬ ing to the bellows portion 17 in Fig 4.
In cases of incontinence where the natural sphincteral effect where the urethra 20 joins the bladder 21 may be heavily debilitated it has proved, as also mentioned in the above-mentioned international patent application, that maximum sphincteral pressure exerted by the pelvic muscles occurs over a very short length, e.g. 5 mm of the urethra and normally in a distance of 15-25 from the vesical ostium.
Whereas the bellows portions in the embodiments in Figs 1-2 and 4 are provided with folds as shown at 2a in Fig 1 which are all symmetrical in relation to a plane at right angles to the rod-shaped body 1, so that the sides of the fold facing the distal and prox¬ imal ends of the device form equal angles with the longitudinal axis of the body 1, a bellows portion 22 may also as shown in Fig 6 be designed so that the individual folds 22a have an unsymmetrical corbie- step shape so that the side of the fold facing the distal end forms a more acute angle with the longit¬ udinal axis of the rod-shaped body 23 than the side of the fold facing the proximal end. A further dist¬ inct diameter reduction can thereby be obtained in the resiliently extended insertion condition, and after contraction of the body 23 a retaining function will occur with improved safeguard against the device being pushed out.
In the embodiment shown in Fig 7, in which the resiliently deformable enlargements of the rod-shaped body 24 in the same way as in the embodiment of Fig 4 comprises two separate bellows portions 25 and 26, the conduit 27 for the insertion pin 28 is enveloped by a first permanent magnetic body 29 on a portion of its length measured from the proximal end, whereas another interior permanent magnetic body 30 is arranged close to the distal end of the device in extension of the conduit which, at retraction of the pin 28 is attracted to the first permanent magnetic body 29, thereby supporting the contraction of the body 24 from the resiliently extended insertion con¬ dition. This additional measure which will make pro¬ duction more expensive is normally not necessary in order to achieve the sealing function which is aimed at.
Within the framework of the invention there will be numerous possibilities of variation as con¬ cerns the embodiment of the resiliently deformable enlargements of the rod-shaped body, since in partic- ular the bellows-shape can be varied with a view to optimum adaptation. The device may for example con¬ ceivably be designed with a coherent bellows portion which in the supply condition has a larger diameter at the distal end of the device than at the proximal end. In addition, other types of resiliently deform¬ able enlargements can be imagined. As an example can a resiliently deformable rod-shaped body lengthwise be provided with a single rib-like projection wound helically around a portion of its length.

Claims

P A T E N T C L A I M S 1. A device for preventing involuntary urinat¬ ion, preferably in females and of the kind comprising a oblong mainly rod-shaped body (1, 9, 16, 23, 24) with one or more diameter increasing enlargements (2, 3, 10-12, 17-19, 22, 25, 26) and with an interior con¬ duit (4, 15, 27) opening at a proximal end of the rod-shaped body and serving to receive a pin (5, 28) for use in inserting the device into the urethra, whereas the rod-shaped body is further provided at its proximal end with a transverse flap or disc (6) , c h a r a c t e r i z e d in that the rod-shaped body (1, 9, 16, 23, 24) is resiliently deformable in its longitudinal direction, and that said diameter in¬ creasing enlargements (2, 3, 10-12, 17-19, 22, 25, 26) are resiliently deformable so that, when the rod-shap¬ ed body has been brought into an extended insertion condition by means of the insertion pin (5, 8), they can be deformed to a decreased outer diameter permit¬ ting easy insertion into the urethra with little irritation to the tissue, whereas in a contracted con¬ dition of the rod-shaped body attained after retract¬ ion of the pin (5, 28) , they can assume an increased diameter, so as to come into sealing contact against the surrounding tissue of the urethra.
2. A device as claimed in claim 1, c h a r ¬ a c t e r i z e d in that said resiliently deformable enlargements comprise one or more bellows-shaped port¬ ions (2, 17, 18, 22, 25, 26) extended in the longitud¬ inal direction of the rod-shaped body (1, 16, 23, 24) and having a transverse resilient deformability depending on the longitudinal deformation of the rod- shaped body.
3. A device as claimed in claim 2, c h a r ¬ a c t e r i z e d in that at least one bellows-shaped portion (2, 17, 22, 25) assumes in a tension relieved condition of the rod-shaped body an outer diameter exceeding the diameter of the urethra.
4. A device as claimed in claim 2 or 3, c h a r a c t e r i z e d in that each fold (2a) of a bellows-shaped portion (2) is symmetrical relative to a plane at right angles to the rod-shaped body (1) , so that the sides of a single fold (2a) facing the distal and proximal ends of the device form equal angles with the longitudinal axis of the body (1) .
5. A device as claimed in claim 3, c h a r ¬ a c t e r i z e d in that each fold of a first bel- lows-shaped portion close to the distal end of the device has a larger diameter and a larger angle be¬ tween its sides and the longitudinal direction of the rod-shaped body than the individual folds in a second bellows-shaped portion positioned closer to the prox- imal end of the device.
6. A device as claimed in either of claims 2-5, c h a r a c t e r i z e d in that it comprises a bel¬ lows-shaped portion (22) , the individual folds (22a) of which are shaped so as to form a more acute angle with the longitudinal axis of the rod-shaped body on the side facing the distal end of the device than on the side facing the proximal end of the device.
7. A device as claimed in claim 1, c h a r ¬ a c t e r i z e d in that the resiliently deformable enlargements comprise a number of lamellae (10-12) projecting from the rod-shaped body and extending sub¬ stantially transverse thereto.
8. A device as claimed in claim 7, c h a r ¬ a c t e r i z e d in that at least one lamella (10, 11) positioned in the vicinity of the distal end of the device is provided with a larger outer diameter than a number of lamellae (12) positioned closer to the proximal end of the device.
9. A device as claimed in claim 7 or 8, c h a r a c t e r i z e d in that said at least one lamella (10, 11) has an interior slit-like cavity (14) in connection with said conduit (15) .
10. A device as claimed in either of the pre¬ ceding claims, c h a r a c t e r i z e d in that it comprises at least one lamella (3, 19) as well as one or more bellows-shaped portions.
11. A device as claimed in any of the preceding claims, c h a r a c t e r i z e d in that said pin (5) at or close to its distal end is provided with at least one enlargement (8) having a larger transverse measurement than the diameter of the insertion conduit (4) in its extended insertion condition.
12. A device as claimed in any of claims 1-10, c h a r a c t e r i z e d in that the conduit (27) on a portion of its length measured from the proximal end is enveloped by a pipe-shaped first permanent magnetic body (29) and that another interior permanent magnetic body (30) is arranged close to the distal end of the device in extension of the conduit which at retraction of the pin (28) is attracted to the first permanent magnetic body (29) .
13. A device as claimed in either of the pre¬ ceding claims, c h a r a c t e r i z e d in that the resiliently deformable enlargements together cover a substantial part of the length of the rod-shaped body, preferably at least 40% of its length.
14. A device as claimed in either of the pre¬ ceding claims, c h a r a c t e r i z e d in that the rod-shaped body with said enlargements is manufactured in one piece of a biocompatible elastomeric, preferab¬ ly thermoplastic material.
PCT/DK1992/000131 1991-04-25 1992-04-24 A device for preventing involuntary urination, preferable for females WO1992019192A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK0774/91 1991-04-25
DK77491A DK77491A (en) 1991-04-25 1991-04-25 SELF-ADJUSTING PRESSURE-COMPENSATING DEVICE WITH THE PURPOSE OF PREVENTING THE IMPROPER DISPOSAL OF URINE, INCLUDING INCONTINENCE, PRIOR TO WOMEN

Publications (1)

Publication Number Publication Date
WO1992019192A1 true WO1992019192A1 (en) 1992-11-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK1992/000131 WO1992019192A1 (en) 1991-04-25 1992-04-24 A device for preventing involuntary urination, preferable for females

Country Status (3)

Country Link
AU (1) AU1685692A (en)
DK (1) DK77491A (en)
WO (1) WO1992019192A1 (en)

Cited By (32)

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Publication number Priority date Publication date Assignee Title
WO1995034253A1 (en) * 1994-06-14 1995-12-21 Iotek, Inc. Incontinence treatment
EP0699060A1 (en) * 1993-05-17 1996-03-06 UroMed Corporation Expandable urethral plug
EP0769931A1 (en) * 1994-06-29 1997-05-02 UroMed Corporation An assembly and method for prevention of urinary incontinence in humans
WO1997025947A1 (en) * 1996-01-19 1997-07-24 Uromed Corporation Device and method to control urinary incontinence
WO1997039697A1 (en) * 1996-04-25 1997-10-30 Rochester Medical Corporation Urethral urine retention device
EP0780105A3 (en) * 1995-12-19 1998-02-11 José Manuel Doladé Guardia Device for women suffering from incontinence
US5724994A (en) * 1990-12-31 1998-03-10 Uromed Corporation Fluidly expandable urethral plug assembly which receives fluid from an external source and method for controlling urinary incontinence
US5752525A (en) * 1990-12-31 1998-05-19 Uromed Corporation Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly
US5769091A (en) * 1993-09-20 1998-06-23 Uromed Corporation Urethral plug having adhesive for enhanced sealing capabilities and method of using said plug
US5813974A (en) * 1995-12-19 1998-09-29 Dolade Guardia; Jose Manuel Device for women suffering from incontinence
US6030337A (en) * 1998-07-30 2000-02-29 American Medical Systems, Inc. Continence augmentor and methods for urinary control
US6056687A (en) * 1997-12-04 2000-05-02 American Medical Systems, Inc. Device for alleviating urinary incontinence
EP1015061A1 (en) * 1997-08-19 2000-07-05 Abbeymoor Medical, Inc. Urethral device with anchoring system
US6200261B1 (en) 1998-03-04 2001-03-13 American Medical Systems, Inc. Valve and methods for urinary control
US6231501B1 (en) 1997-01-28 2001-05-15 Tama Medical, Inc. Urinary occlusion device
EP1261296A2 (en) * 2000-03-08 2002-12-04 Clemson University Intra-urethral device for incontinence and method for making and using same
DE10304614A1 (en) * 2003-02-05 2004-08-26 Willital, Günter Heinrich, Prof. Dr.med. Device controlling urine flow, employs plug on or in urethra, dimensioned to close its cross section, preventing flow
JP2005506389A (en) * 2000-12-13 2005-03-03 エフ　エム　シー　コーポレーション Production of carrageenan and carrageenan products
WO2006041408A2 (en) * 2004-10-14 2006-04-20 Eutech Medical Ab A device for cleaning and sealing a through hole of an assembly for controlling emptying of a female urine bladder and an assembly comprising the device
DE102011119160A1 (en) * 2011-11-22 2013-05-23 Largentec Gmbh Device for preventing and / or treating urinary tract infections
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US9707065B2 (en) 2009-07-29 2017-07-18 Life360 Innovations Inc. Urinary incontinence device
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
USD835273S1 (en) 2017-07-25 2018-12-04 Life360 Innovations Inc. Urethral plug inserter
USD835784S1 (en) 2017-07-25 2018-12-11 Life360 Innovations Inc. Urethral plug
US10441396B2 (en) 2017-08-22 2019-10-15 Life360 Innovations Inc. Urethral plug and system for addressing urinary incontinence
US10485644B2 (en) 2017-08-22 2019-11-26 Life360 Innovations Inc. Inserter for urethral plug
US10857324B2 (en) 2014-08-26 2020-12-08 C. R. Bard, Inc. Urinary catheter
EP3981460A1 (en) * 2020-09-28 2022-04-13 Salvador Vilar Correia Lima Self-sustainable urinary catheter
US11547599B2 (en) 2017-09-19 2023-01-10 C. R. Bard, Inc. Urinary catheter bridging device, systems and methods thereof

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Cited By (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5724994A (en) * 1990-12-31 1998-03-10 Uromed Corporation Fluidly expandable urethral plug assembly which receives fluid from an external source and method for controlling urinary incontinence
US5752525A (en) * 1990-12-31 1998-05-19 Uromed Corporation Urethral plug assembly having adhesive for enhanced sealing capabilities and method of using said plug assembly
EP0699060A1 (en) * 1993-05-17 1996-03-06 UroMed Corporation Expandable urethral plug
EP0699060A4 (en) * 1993-05-17 1997-05-21 Uromed Corp Expandable urethral plug
US5769091A (en) * 1993-09-20 1998-06-23 Uromed Corporation Urethral plug having adhesive for enhanced sealing capabilities and method of using said plug
WO1995034253A1 (en) * 1994-06-14 1995-12-21 Iotek, Inc. Incontinence treatment
EP0769931A1 (en) * 1994-06-29 1997-05-02 UroMed Corporation An assembly and method for prevention of urinary incontinence in humans
EP0769931A4 (en) * 1994-06-29 2000-07-27 Uromed Corp An assembly and method for prevention of urinary incontinence in humans
EP0780105A3 (en) * 1995-12-19 1998-02-11 José Manuel Doladé Guardia Device for women suffering from incontinence
US5813974A (en) * 1995-12-19 1998-09-29 Dolade Guardia; Jose Manuel Device for women suffering from incontinence
WO1997025947A1 (en) * 1996-01-19 1997-07-24 Uromed Corporation Device and method to control urinary incontinence
WO1997039697A1 (en) * 1996-04-25 1997-10-30 Rochester Medical Corporation Urethral urine retention device
US5906575A (en) * 1996-04-25 1999-05-25 Rochester Medical Corporation Urethral urine retention device
US6479000B2 (en) 1996-04-25 2002-11-12 Rochester Medical Corporation Urethral urine retention device
US6315711B1 (en) 1996-04-25 2001-11-13 Rochester Medical Corporation Urethral urine retention device
US6231501B1 (en) 1997-01-28 2001-05-15 Tama Medical, Inc. Urinary occlusion device
EP1015061A4 (en) * 1997-08-19 2000-09-13 Abbeymoor Medical Inc Urethral device with anchoring system
EP1015061A1 (en) * 1997-08-19 2000-07-05 Abbeymoor Medical, Inc. Urethral device with anchoring system
US6461291B1 (en) 1997-12-04 2002-10-08 American Medical Systems Inc. Device for alleviating urinary incontinence
US6056687A (en) * 1997-12-04 2000-05-02 American Medical Systems, Inc. Device for alleviating urinary incontinence
US6200261B1 (en) 1998-03-04 2001-03-13 American Medical Systems, Inc. Valve and methods for urinary control
US6443886B2 (en) 1998-03-04 2002-09-03 American Medical Systems Inc. Valve and methods for urinary control
US6030337A (en) * 1998-07-30 2000-02-29 American Medical Systems, Inc. Continence augmentor and methods for urinary control
EP1261296A4 (en) * 2000-03-08 2006-11-22 Univ Clemson Intra-urethral device for incontinence and method for making and using same
EP1261296A2 (en) * 2000-03-08 2002-12-04 Clemson University Intra-urethral device for incontinence and method for making and using same
JP4776867B2 (en) * 2000-12-13 2011-09-21 エフ エム シー コーポレーション Production of carrageenan and carrageenan products
JP2005506389A (en) * 2000-12-13 2005-03-03 エフ　エム　シー　コーポレーション Production of carrageenan and carrageenan products
DE10304614B4 (en) * 2003-02-05 2005-02-24 Willital, Günter Heinrich, Prof. Dr.med. Continence device
DE10304614A1 (en) * 2003-02-05 2004-08-26 Willital, Günter Heinrich, Prof. Dr.med. Device controlling urine flow, employs plug on or in urethra, dimensioned to close its cross section, preventing flow
WO2006041408A3 (en) * 2004-10-14 2006-10-26 Eutech Medical Ab A device for cleaning and sealing a through hole of an assembly for controlling emptying of a female urine bladder and an assembly comprising the device
WO2006041408A2 (en) * 2004-10-14 2006-04-20 Eutech Medical Ab A device for cleaning and sealing a through hole of an assembly for controlling emptying of a female urine bladder and an assembly comprising the device
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US9248058B2 (en) 2005-04-12 2016-02-02 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Male external catheter with absorbent and adhesive
US9707065B2 (en) 2009-07-29 2017-07-18 Life360 Innovations Inc. Urinary incontinence device
US10569051B2 (en) 2011-03-14 2020-02-25 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US11607524B2 (en) 2011-03-14 2023-03-21 Rochester Medical Corporation Catheter grip and method
DE102011119160A1 (en) * 2011-11-22 2013-05-23 Largentec Gmbh Device for preventing and / or treating urinary tract infections
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
US11730919B2 (en) 2012-11-20 2023-08-22 Rochester Medical Corporation Catheter in bag without additional packaging
US10780244B2 (en) 2012-11-20 2020-09-22 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter in a bag without additional packaging
US11850370B2 (en) 2014-08-26 2023-12-26 C. R. Bard, Inc. Urinary catheter
US10857324B2 (en) 2014-08-26 2020-12-08 C. R. Bard, Inc. Urinary catheter
US10874825B2 (en) 2014-08-26 2020-12-29 C. R. Bard, Inc. Urinary catheter
USD835784S1 (en) 2017-07-25 2018-12-11 Life360 Innovations Inc. Urethral plug
USD835273S1 (en) 2017-07-25 2018-12-04 Life360 Innovations Inc. Urethral plug inserter
US10441396B2 (en) 2017-08-22 2019-10-15 Life360 Innovations Inc. Urethral plug and system for addressing urinary incontinence
US10485644B2 (en) 2017-08-22 2019-11-26 Life360 Innovations Inc. Inserter for urethral plug
US11547599B2 (en) 2017-09-19 2023-01-10 C. R. Bard, Inc. Urinary catheter bridging device, systems and methods thereof
GB2603028A (en) * 2020-09-28 2022-07-27 Vilar Correira Lima Salvador Permanent, removable and self-sustainable urinary catheter
EP3981460A1 (en) * 2020-09-28 2022-04-13 Salvador Vilar Correia Lima Self-sustainable urinary catheter

Also Published As

Publication number Publication date
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DK77491D0 (en) 1991-04-25
DK77491A (en) 1992-10-26

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