WO1996029963A1 - Condom collecteur urinaire masculin, procede de fabrication d'un condom collecteur urinaire et condom collecteur urinaire masculin ainsi produit - Google Patents

Condom collecteur urinaire masculin, procede de fabrication d'un condom collecteur urinaire et condom collecteur urinaire masculin ainsi produit Download PDF

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Publication number
WO1996029963A1
WO1996029963A1 PCT/US1995/007979 US9507979W WO9629963A1 WO 1996029963 A1 WO1996029963 A1 WO 1996029963A1 US 9507979 W US9507979 W US 9507979W WO 9629963 A1 WO9629963 A1 WO 9629963A1
Authority
WO
WIPO (PCT)
Prior art keywords
mandrel
condom catheter
sheath
male condom
polyurethane
Prior art date
Application number
PCT/US1995/007979
Other languages
English (en)
Inventor
Keith G. Munson
Daniel P. Welch
Roger J. Woessner
Original Assignee
Mentor Corporation
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 Mentor Corporation filed Critical Mentor Corporation
Priority to AU29087/95A priority Critical patent/AU2908795A/en
Publication of WO1996029963A1 publication Critical patent/WO1996029963A1/fr

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Classifications

    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • a male condom catheter, a method for making a male condom catheter and a male condom catheter produced by the method are provided.
  • the present invention relates generally to a male external catheter, or condom catheter, and more particularly, to an external male biocompatible polyurethane catheter including a sheath portion and a conical portion as a one piece unit and a method for making the one piece male condom catheter.
  • a sheath of flexible material place over the penis and connected to the receptacle with a tube or other form of flexible conduit. Since urinal devices must be worn for extended periods of time, it is customary for the sheath of such devices to be flexible to allow for patient comfort. It is also desirable for the sheath to possess high moisture transmission because some patients develop skin irritations such as swelling, rashes, sores, etc. due to skin contact with excess moisture, nitrates and protein constituents from urine decomposition as well as from chemicals contained in commonly used materials known in the art. such as rubber latex, for example.
  • Patent No. 4,475,910 entitled Male Condom Catheter Having Adhesive Transfer On Roller Portion, to Conway et al. discloses a male urinal device having a laminated sheath with an inner layer of latex rubber and an outer layer of silicone rubber. Adhesive is stored between the inner and outer layers when the sheath is rolled. As the sheath is unrolled about a penis, adhesive is released from the outer layer and adheres to the inner layer. Upon pressing the sheath to the penis, a leak-free bond is created.
  • U.S. Patent N ⁇ . 4,885,049 entitled Method of Manufacture of an External Caiheterfor Male Urinary Incontinence, to Johannesson (hereinafter " '049”) discloses a method of making an external male urinal device having a body portion, including an internal adhesive component and an external cover layer; both are prefabricated components. This disclosure specifically avoids the use of components in a liquid state. Further, the body portion, or sheath, is manufactured as a soft, thin-walled single layer component, preferably latex or synthetic rubber.
  • U.S. Patent No. 4,626.250 entitled Male Urinary Collection System and External Catheter Therefor, to Schneider (hereinafter " '250”) discloses an external male urinal device and a method for making the same, wherein the catheter is formed in a dipping process which includes a preliminary step of stretching a pre-formed tubular member over a dipping form.
  • the end of the tubular form which is to become a distal tapered opening is treated so that latex will not adhere thereto upon dipping the remainder of the tubular form in a latex bath to form the outer sheath.
  • the adhesive pad is preferably a synthetic or natural rubber and can also be improved with a minor proportion of polyacrylamide resin. These chemicals will come to rest on the skin upon application of the catheter to a patient.
  • U.S. Patent No. 5,376,085. entitled External Urinary Catheter having Integral Adhesive Means, to Conway et al. discloses a method of making a male external silicone catheter having an integral acrylic adhesive affixed to the catheter during processing.
  • the adhesive must be of the type that at least partially cross-links with the silicone catheter during a vulcanization step which occurs when the silicone catheter is in contact with the adhesive. The silicone and the adhesive will contact the skin during use.
  • Silicone catheters such as (CLEAR ADVANTAGE)TM by the Mentor Corporation, arc of tremendous appeal to users because the skin beneath the condom catheter is visible through the sheath. However, some patients' skin also macerate due to low moisture transmission of the silicone. In order to address patients experiencing skin maceration accompanying the use of silicone condom catheters or allergic reactions to rubber latex, it is desirable to utilize a catheter which exhibits high moisture transmission and a low level of chemicals inherent in the sheath material. Further, the cone portion must be flexible enough to withstand insertion of a connecting portion to the receptacle but yet be durable enough to withstand pressure due to excess urine which may accumulate within the catheter. It is further desirable that the sheath and the cone portion are as one unit to eliminate leakage and to accommodate both ambulatory and non-ambulatory patients desiring longer wear external catheters, wherein skin integrity may be examined without catheter removal.
  • the present invention overcomes the apparent problems and attendant disadvantages associated with male condom catheters formed from rubber latex, other synthetic rubber products or silicone.
  • SUMMARY OF THE INVENTION The present invention is directed to a one piece male external condom catheter that addresses the incontinence management needs of male patients who are sensitive to rubber latex, silicone or other rubbers.
  • the preferred embodiment of the present invention includes a one piece condom catheter comprising a conical portion and a sheath portion, wherein both portions are produced from liquid-state biocompatible polyurethane.
  • the present device is particularly advantageous in that the male condom catheter is produced from polyurethane which effectively eliminates the skin irritation problems normally associated with rubber latex sensitivity and skin breakdown due to exposure to excess moisture.
  • Another feature of the present device is that it retains the feel, structure and inherent flexibility characteristics of rubber latex, silicone or other rubbers. Still another feature is the clear colorless appearance desired by physicians and consumers. A release coating and an adhesive may also be applied to the sheath surface.
  • the lowest practicle manufacturing limit for sheath thickness is less than half of the lowest practicle limit for standard silicone sheath thickness.
  • the thinner polyurethane sheath of the present invention has increased "breathability,” durability, user comfort and ease in examining skin condition beneath the sheath without sheath removal.
  • the present invention includes a method for making a male condom catheter device.
  • the conical portion and the sheath portion are produced as a single unit from liquid-state polyurethane. This eliminates the uncertainty of affixing catheter portions composed of different materials which may result in faulty junctions therebetween.
  • the method comprises dipping a mandrel of a desired shape in a first polyurethane formulation; withdrawing the mandrel at a predetermined rate so that a first conical section is formed on the mandrel; curing the first section; dipping the mandrel including the first portion in a second polyurethane formulation; withdrawing the mandrel at a predetermined rate so that a second sheath section is formed on the mandrel and integrally affixed to the first portion; and curing the second section.
  • the steps of dipping and curing the conical portion may be repeated such that a predetermined conical portion thickness is obtained.
  • the steps of dipping and curing the sheath portion may be repeated such that a predetermined sheath portion thickness is obtained.
  • FIG. 1 is a perspective view of a male condom catheter device of the present invention.
  • FIG. 2 is a flow diagram indicating the method for making the male condom catheter in accordance with the present invention.
  • a male condom catheter in accordance with the present invention is designated generally as 10.
  • Device 10 is preferably comprised of a condom portion in the form of a sheath or a sleeve 15 integrally affixed to a conical portion 17 at cone 19.
  • Conical portion 17 more preferably includes cone 19 merging with a surge chamber/anti-kink mechanism 21 which then merges with a neck 23.
  • Neck 23 connects with a tube 24.
  • Surge chamber/anti-kink mechanism 21 may also serve as a backflow prevention device for tube 24. which is then connected to a urine collection receptacle via flexible conduit or tubing (no* shown) .
  • device 10 is not limited to the particular embodiment illustrated, and that other combinations of elements including, but not limited to, constrictions and bulbous surge chambers can be added to device 10 without departing from the spirit and scope of the present invention.
  • Such elements including those illustrated in FIG. 1 , may assume various shapes or be arranged in an order other than that illustrated.
  • male condom catheter device 10 is made by preheating a mandrel (not shown) preferably at a temperature from between about 40 deg. C. to about 60 deg. C for a time sufficient to uniformly preheat the mandrel.
  • Preheating the mandrel is an optional step in the present invention, although preheating facilitates mandrel wetting in subsequent dipping steps.
  • the mandrel was preheated at about 50 deg. C. for about 10 minutes.
  • the preheated mandrel is dipped in a first conical polyurethane formulation.
  • the first polyurethane formulation comprises at least about 90% liquid-state biocompatible polyurethane and about 10% of a liquid-state polyurethane thickener.
  • the first formulation comprises at least 95% liquid-state polyurethane and about 5% liquid-state polyurethane thickener. Most preferably, about 99% polyurethane and about 1% polyurethane thickener are used.
  • the liquid-state polyurethane utilized must be suitable for medical purposes and is readily available from various sources, such as Polyurethane Specialties Company, Inc. or Miles Inc.
  • the polyurethane thickener addition to the first conical formulation imparts durability to the final conical portion
  • the conical portion must be durable enough to withstand the tension of inserting and removing tubing which connects the male condom catheter to a urine receptacle and the pressure due to excess urinary pressure which may accumulate within the catheter.
  • the conical portion must also be flexible for patient comfort as the body shifts. While not being bound by theory, it is believed that the polyurethane thickener increases the polyurethane chain lengths resulting in a thinner yet durable conical portion.
  • the polyurethane thickener utilized in the present embodiment is (PMS 836)TM from Polyurethane Specialties Company, Inc.
  • Other polyurethane chain extenders known in the art may also be utilized, such as polyalkene glycol ethers, for example.
  • the mandrel is withdrawn from the first formulation at a predetermined rate, which determines the thickness of the conical section layer that remains on the mandrel for further processing.
  • the rate utilized in the present embodiment is about 4 inches per minute for five minutes. A faster rate would produce a thinner layer, while a slower rate would produce a thicker layer.
  • the mandrel including the conical section is cured.
  • the temperatures and times of curing are related to the extent that lowering the curing temperature requires longer curing times. While not being bound by theory, it is believed that curing in a single high temperature step would cause the polyurethane carrier (either water or a solvent) to evaporate too rapidly by escaping through bubbles in the polyurethane matrix, which then yeilds small holes in the final catheter product. In the present embodiment, curing takes place over a series of increasing temperatures ranging from between about 60 deg. C. to about 190 deg. C. for about 40 minutes.
  • the mandrel including the conical section is cured by heating at about 70 deg. C. for about 5 minutes, heating at 80 deg. C.
  • the mandrel including the conical section is cooled to about 60 deg. C. for about 10 minutes.
  • the dipping and curing steps may be repeated until a desired conical portion thickness is obtained.
  • a conical portion thickness of about 0.32 inches was found to retain flexibility required for patient comfort.
  • the sheath portion may be formed by dipping the mandrel including the cured conical portion in a second sheath polyurethane formulation.
  • the second formulation comprises at least about 90% biocompatible polyurethane.
  • the second polyurethane formulation may utilize the same biocompatible polyurethane as in the first conical formulation or it may be any comparable equivalent thereof.
  • the second sheath formulation comprises at least about 93% biocompatible polyurethane, about 6% wetting agent and about 1% defoaming agent. More preferably, the wetting agent is selected from the group consisting of emulsifiers, surfactants and combinations thereof.
  • the term "wetting agent" is generally applied to any substance that increases the ability of an aqueous solution to displace air from a liquid or a solid surface.
  • a surfactant is added to the second polyurethane formulation to decrease the interfacial tension between the liquid polyurethane and the solid mandrel surface to facilitate evenly coating the mandrel. Further, it is also desirable to reduce the surface tension of the liquid polyurethane because the spreading ability of an aqueous liquid on a solid surface is directly related to the reduction of surface tension in that liquid.
  • surfactants used in the present invention include those which are suitable for liquid state aqueous thermoplastic resin applications and can be selected from the group consisting of organic surfactants, organosiloxanes and silicone-based surfactants.
  • Organic surfactants include, but are not limited to, nonyl phenols, fatty acid ethylene oxide condensates, alkylene oxide block co-polymers and diols.
  • the surfactant utilized in the present embodiment is (SURFYNOL)TM, from Air Products and Chemicals, Inc.
  • Emulsifiers generally stabilize a liquid system which comprises two immiscible liquids.
  • the type of emulsifier used depends on the type of emulsion to be stabilized.
  • two types of emulsions exist: an oil-in-water (o/w) where the water is the continuous phase with an oil dispersed within it and a water-in-oil (w/o) where water is dispersed within a continuous oil phase.
  • an emulsifier stabilizes an emulsion because the emulsifier adsorbs at the liquid- liquid interface as an oriented interfacial film by performing several functions: 1 ) reducing the interfacial tension between the two liquids and thus the thermodynamic instability of the system and 2) decreasing the rate of coalescence of the dispersed liquid particles.
  • Emulsifiers suitable for the present invention include those which are suitable for aqueous thermoplastic resin emulsification, such as alkali soluble emulsifiers.
  • the emulsifier utilized in the present embodiment is the acrylic copolymer (ACRYSOL ASE-95)TM.
  • the addition of the emulsifier and surfactant decrease the surface tension of the polyurethane formulation and decrease the interfacial tension between the formulation and the mandrel. These reductions facilitate uniform mandrel coating upon dipping the mandrel in the second formulation.
  • an antifoaming agent/defoamer may be added to the second polyurethane formulation.
  • Antifoaming agents appear to counteract the foam stabilizing effect of the surfactant by becoming part of the surface film. While not being bound by theory, it is believed that the addition of a defoamer substantially eliminates surface elasticity and thus decreases the formation of air bubbles upon mixing. It is essential in the present invention that substanially no air bubbles are present in the second formulation because air bubbles may result in holes or tears in the sheath portion of the male condom catheter.
  • the dcfoamers include those which are suitable for viscous aqueous systems, such as latex or thermoplastic systems.
  • the defoamer utilized in the present embodiment is (DEE FO 97-3)TM from Ultra Additives, Incorporated.
  • the second polyurethane formulation comprises about 93% biocompatible polyurethane, about 1% surfactant, about 5% emulsifier and about 1% defoaming agent.
  • the mandrel including the first portion is coated with the second polyurethane formulation
  • the mandrel is withdrawn from the second formulation at a predetermined rate, which determines the thickness of the sheath section layer that remains on the mandrel for further processing.
  • the rate utilized in the present embodiment is about 4 inches per minute for 7 minutes.
  • the mandrel including the conical portion and the sheath section is cured.
  • the temperatures and times for curing the sheath section are related to the extent that lower temperatures require longer time periods for curing. In the present embodiment, curing takes place over a series of increasing temperatures ranging from between about 70 deg. C. to about 190 deg. C. for about 30 minutes.
  • the mandrel including the conical portion and the sheath section is curing by heating at about 80 deg. C. for 5 minutes, heating at about 95 deg. C. for about 5 minutes, heating at about 115 deg. C. for about 5 minutes and heating at about 180 deg. C. for about 15 minutes.
  • the mandrel including the conical portion and the sheath section is cooled to about 60 deg. C.
  • the dipping and curing steps for the sheath portion may be repeated until a desired sheath portion thickness is obtained.
  • a sheath portion thickness of about 0.01 1 inches provided desirable comfort and physical characteristics, as discussed below.
  • a release coating and/or an adhesive coating may also be applied to male condom catheter 10.
  • Polyurethane sheaths possess a moisture vapor transmission rate substantially equivalent to that found with normal human skin perspiration. Uncovered skin has a moisture transmission rate of about 41.3 +/- 3.5 i g/cm /min. while a polyurethane sheath, having a thickness of about 8.5 mils., has a moisture transmission rate of about 41.23 Hg/c ⁇ r/min. Further, it was found that the moisture vapor transmission value for the present invention improves both comfort and function. For example, it was found that a moisture vapor transmission at least about equal to that found in skin, i.e., about 41 ug/cm /min. avoids both skin maceration and excess moisture retention in an adhesive layer on the sheath portion.
  • **The units represent grams/100 in 2 /24 hours at 95% relative humidity.
  • the polyurethane sheath is up to about 5 times more stretchable and durable than the silicone sheath, as shown by the percent elongation and the pounds per square inch required to break the sheath upon stretching. Therefore, the polyurethane sheath is stronger, more moisture vapor transmissive and yet is less than half as thick as the silicone sheath.

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  • Health & Medical Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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Abstract

Un condom collecteur urinaire masculin (10) comprend une partie conique (17) et une partie gaine (15). Ces deux parties se composent d'au moins 90 % de polyuréthanne biocompatible. La partie conique (17) comprend une sous-section de cône (21) qui devient ensuite une sous-section formant chambre d'expansion/mécanisme anti-déviation (21). Cette dernière est réunie à son tour à une sous-section étranglée (23) destinée au raccordement à un tube ou un conduit (24) pour laisser passer l'urine dans un sac collecteur. La présente invention traite également d'un procédé de fabrication d'un condom collecteur urinaire masculin et d'un condom collecteur urinaire masculin ainsi produit. Le procédé consiste à plonger un mandrin dans une formulation de polyuréthanne à l'état liquide, à retirer ce mandrin, à le soumettre à une opération de cuisson pour former une partie conique, à plonger le mandrin dans une deuxième formulation de polyuréthanne à l'état liquide, à retirer ce mandrin, et à le soumettre à une opération de cuisson pour former la partie gaine, ce qui permet d'obtenir le condom collecteur urinaire masculin.
PCT/US1995/007979 1995-03-31 1995-06-22 Condom collecteur urinaire masculin, procede de fabrication d'un condom collecteur urinaire et condom collecteur urinaire masculin ainsi produit WO1996029963A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU29087/95A AU2908795A (en) 1995-03-31 1995-06-22 A male condom catheter, a method for making a male condom ca theter and a male condom catheter produced by the method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41448695A 1995-03-31 1995-03-31
US08/414,486 1995-03-31

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WO1996029963A1 true WO1996029963A1 (fr) 1996-10-03

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PCT/US1995/007979 WO1996029963A1 (fr) 1995-03-31 1995-06-22 Condom collecteur urinaire masculin, procede de fabrication d'un condom collecteur urinaire et condom collecteur urinaire masculin ainsi produit

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AU (1) AU2908795A (fr)
WO (1) WO1996029963A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004004796A1 (fr) 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475910A (en) * 1981-10-02 1984-10-09 Mentor Corporation Male condom catheter having adhesive transfer on roller portion
GB2152380A (en) * 1981-09-29 1985-08-07 Downs Surgical Plc Incontinence appliance for male personal wear
US4626250A (en) * 1981-06-05 1986-12-02 Hollister Incorporated Male urinary collection system and external catheter therefor
US4722344A (en) * 1986-05-23 1988-02-02 Critikon, Inc. Radiopaque polyurethanes and catheters formed therefrom
EP0595500A2 (fr) * 1992-10-26 1994-05-04 Becton, Dickinson and Company Polyuréthane non-gonflable, ramollissant par contact avec un liquide
US5374704A (en) * 1992-12-23 1994-12-20 Bayer Aktiengesellschaft Pure, in particular catalyst-free polyurethanes
US5376085A (en) * 1990-11-09 1994-12-27 Rochester Medical Corporation External urinary catheter having integral adhesive means

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4626250A (en) * 1981-06-05 1986-12-02 Hollister Incorporated Male urinary collection system and external catheter therefor
GB2152380A (en) * 1981-09-29 1985-08-07 Downs Surgical Plc Incontinence appliance for male personal wear
US4475910A (en) * 1981-10-02 1984-10-09 Mentor Corporation Male condom catheter having adhesive transfer on roller portion
US4722344A (en) * 1986-05-23 1988-02-02 Critikon, Inc. Radiopaque polyurethanes and catheters formed therefrom
US5376085A (en) * 1990-11-09 1994-12-27 Rochester Medical Corporation External urinary catheter having integral adhesive means
EP0595500A2 (fr) * 1992-10-26 1994-05-04 Becton, Dickinson and Company Polyuréthane non-gonflable, ramollissant par contact avec un liquide
US5374704A (en) * 1992-12-23 1994-12-20 Bayer Aktiengesellschaft Pure, in particular catalyst-free polyurethanes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004004796A1 (fr) 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe

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Publication number Publication date
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