WO1989011258A1 - Preservatif et son procede de fabrication - Google Patents

Preservatif et son procede de fabrication

Info

Publication number
WO1989011258A1
WO1989011258A1 PCT/US1989/001532 US8901532W WO8911258A1 WO 1989011258 A1 WO1989011258 A1 WO 1989011258A1 US 8901532 W US8901532 W US 8901532W WO 8911258 A1 WO8911258 A1 WO 8911258A1
Authority
WO
WIPO (PCT)
Prior art keywords
condom
styrene
sheath portion
tubular main
main sheath
Prior art date
Application number
PCT/US1989/001532
Other languages
English (en)
Inventor
Robin G. Foldesy
Robert G. Wheeler
Original Assignee
Family Health International
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 Family Health International filed Critical Family Health International
Publication of WO1989011258A1 publication Critical patent/WO1989011258A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • 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
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/02—Contraceptive devices; Pessaries; Applicators therefor for use by males
    • A61F6/04—Condoms, sheaths or the like, e.g. combined with devices protecting against contagion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7538—Condoms

Definitions

  • the present invention relates to a condom article and method for making the same.
  • STD's sexually transmitted diseases
  • STD's sexually transmitted diseases
  • Another factor has been the absence of any effective cure for acquired immunodeficiency syndrome (AIDS).
  • AIDS acquired immunodeficiency syndrome
  • the diseases with which AIDS has been or is suspected to be linked include Pneumocystis carinii pneumonia, Kaposi's sarcoma, esophageal or bronchopulmonary candi- Q) diasis, extra-pulmonary cryptococcosis, cytomegalovirus internal organ infection, disseminated Mycobacterium avium complex or M. kansasii infection, chronic herpes simplex
  • SUBSTITUTE SHEET old is coated with a thin layer of the latex material.
  • the thickness of the latex coating on the mold is dependent on the viscosity of the latex, and the speed of extracting the mold from the latex bath.
  • Similar latex dipping processes have been employed with suitably shaped molds to form tight-fitting gloves such as surgical gloves.
  • U.S. patent 4,576,156 issued March 18, 1986 to Manfred F. Dyke discloses a condom formed of a thermo ⁇ plastic polyurethane material, having a generally cylindrical configuration with an open proximal end and a closed distal end.
  • the disclosed condom has a thickness of from about 0.01 millimeters, or less, to about 0.25 millimeters.
  • the thermoplastic polyurethane employed to form the condom is disclosed as having: an average Shore A hardness of from about 50 to about 90; a tensile stress, at 100% of elongation, between about 300 and 1,000 psi; and a tensile stress, at 300% elongation, between about 800 and 3,000 psi.
  • thermoplastic polyurethane species for manufacturing the condom include those set out at column 2, line 55 to column 3, line 10 of the Dyke patent, with polyether- or polyester- based urethane elastomers said to be preferred.
  • a film of the polyurethane material e.g., in the form of a 6-inch square, is heated to a temperature high enough to soften the polymer but low enough to avoid chemical degradation, preferably in a clamping frame, and at a temperature of about 400-500"F
  • the heated film then is brought into contact with a preformed mandril to cause the film to assume the shape of the mandril, preferably with application of a vacuum to the system in order to bring about uniformity in wall thickness (column 3, lines 47-50 of the patent).
  • an extruded film of Pellethane ® X5036-80AA polyurethane (The Upjohn Company, Kalamazoo, Michigan) is clamped on a clamping frame and heated at 460°F for 180-200 seconds, following which vacuum is drawn on the film and the mandril moved downward into the film. Vacuum is shut off as the mandril moves into the film, then is applied at the base of the mandril after it has moved down into the film completely, such vacuum causing the film to pull down tightly and assume the shape of the mandril.
  • the vacuum is released, excess material at the base is cut off, and the film is partly rolled up onto itself for a distance of about 3 inches, on the 10-inch mandril, and then is dusted with powder and rolled up until it is removeable from the mandril.
  • a heat cured polyurethane prepolymer solvent solution is employed into which a mold is dipped and withdrawn for heat curing on the mold.
  • the polyurethane prepolymer which is employed in the dipping medium is a prepolymer which is the reaction product of a polyisocyanate with at least one long chain polyol.
  • the polyol is amorphous at room temperature, has an average molecular weight of from about 500 to about 5,000, a hydroxy number of from 225 to about 22.4, and a NCO/OH ratio of from about 0.95:1 to about 1.1:1.
  • the European application states at page 7, line 18, that the condom mold may be dipped into and withdrawn from the polyurethane solution at a rate of about 16 to about 90 centimeters per minute; lines 25-27 at the same page of this application indicate that the dwell time of the condom form in the polyurethane pre- polymer solution is on the order of from about 20 to about 70 seconds.
  • the polyurethane film deposited on the dipped form is air dried and then cured at elevated temperature, e.g., be- tween about 130°C and about 175°C, for about 20 to about 40 minutes, as disclosed at page 7, lines 33-35 of the application.
  • the polyurethanes employed in the process of the European patent application are segmented block copolymers constituted by alternating sequences of hard rigid seg ⁇ ments and soft, flexible segments, in which the hard segment and the degree of crosslinking are balanced within the ranges of approximately 14-25 percent hard segment and approximately 5,000-30,000 molecular weight per cross link.
  • the application states that the polyurethane polymers employed in the disclosed process provide a Shore A durometer hardness of about 35 to 60.
  • Page 10, lines 19-22 of the application state that representative poly ⁇ urethane polymers comprise from about 13% to about 23% isocyanate, from about 70% to about 84% long chain diol, and from about 0.75% to about 6% of a crosslinker.
  • a further disadvantage of the process of this European application is that the polyurethane prepolymer is utilized in solvent solution. Methylene chloride is disclosed as particularly convenient in such usage.
  • the patent application discloses at page 15, lines 35-38 that the resin solution is maintained at a temperature between about 15° and about 25°C to control viscosity and help prevent evaporation of the volatile solvent. Accordingly, the resin solution and the condom forms must be maintained at a low temperature to minimize loss of volatile solvent from the dip coating system.
  • the present invention relates to a novel condom com- prising a tubular main sheath portion, closed at a distal end and open at a proximal end thereof.
  • Such condom be for example be formed of a thermo ⁇ plastic elastomeric material or a suitable polymeric non- elastomeric material, and may advantageously be made by a process including blown film formation of the tubular main sheath portion.
  • the present invention relates to a condom comprising a blown film tubular main sheath portion formed of a polyurethane material, e.g., a polyester-based polyurethane, having a specific gravity of from about 1.15 to about 1.25, a Shore A hardness of from about 80 to 95, a break tensile stress of from about 4500 to about 6,000 psi, a tensile stress at 50% elongation of from about 720 to about 2400 psi, an ultimate elongation of from about 450% to about 600%, a flexural modulus of from about 4,000 to about 37,000 psi, and a tear strength of from about 500 to about 1,000 pli.
  • a polyurethane material e.g., a polyester-based polyurethane
  • the present invention relates to a condom comprising a blown film tubular main sheath portion formed of a multiblock rubber-based co- polymer material, e.g., a multiblock rubber-based co- polymer material having a Shore A hardness from about 25 to about 100, a tensile strength of from about 500 to about 4500, a 300% modulus of from about 120 to about 1,000 psi, and an ultimate elongation of from about 200 to about 1400%.
  • a multiblock rubber-based co- polymer material e.g., a multiblock rubber-based co- polymer material having a Shore A hardness from about 25 to about 100, a tensile strength of from about 500 to about 4500, a 300% modulus of from about 120 to about 1,000 psi, and an ultimate elongation of from about 200 to about 1400%.
  • the present invention relates to a method of making a condom, comprising the steps of:
  • the blow forming step in the method described in the preceding paragraph may comprise blow extrusion forming, or alternatively blow molding, of the tubular film article.
  • Figure 1 is a partial sectional, elevational view of an illustrative condom according to one embodiment of the present invention.
  • Figure 2 is a partial sectional, elevational view of an illustrative condom according to another embodiment of the present invention.
  • the condom article of the present invention is of a general type having a tubular main sheath portion, closed at a distal end and open at a proximal end thereof.
  • a condom 10 comprising a tubular main sheath portion 12.
  • the condom has an open proximal end 14, which as shown, may be circumferentially bounded by retaining ring 16.
  • the condom is closed at its distal end 18.
  • Figure 2 shows a condom of generally corresponding construction, wherein all elements analogous to those of the Figure 1 condom are identified by corresponding reference numerals to which 100 has been added.
  • the Figure 2 condom differs from that shown in Figure 1, however, by the addition of a distal tip reservoir 122 at the distal end 118 of the condom, for retention of ejaculate during use of the condom.
  • the condom articles of the invention may be of generally cylindrical shape, as in the illustrative embodiments of Figures 1 and 2 described hereinabove. Alternatively, it may be suitable in some instances to utilize the condom of the present invention in the form of a baggy-type penile enclosure which is wrapped about the penis for use, and retained in relatively looser configu- ration on the penis than are the condom articles shown in Figures 1 and 2, which are of a type closely overfitting the penis, and rolled or pulled onto the penis for use.
  • the specific structure of the condom article of the present invention may be widely varied, depending on the mode of application intended, and the specific materials of construction employed.
  • the materials useful for forming the condom articles of the present invention may variously include thermo ⁇ plastic materials such as elastomeric thermoplastic materials, as well as non-elastomeric materials such as olefinic homopolymers and copolymers, e.g., ultra-low density polyethylene.
  • thermo ⁇ plastic materials such as elastomeric thermoplastic materials
  • non-elastomeric materials such as olefinic homopolymers and copolymers, e.g., ultra-low density polyethylene.
  • elastomeric in reference to thermoplastic materials useful for forming condom articles in accordance with the present invention, means a material which subsequent to elongation thereof under an applied tensional force, regains at least a significant portion of its original dimensional characteristics when the applied tensional force is released.
  • Pebax ® multiblock rubber-based copolymers, particuarly those in which the rubber block component is based on butadiene, isoprene, or ethylene/ butylene, such as the multiblock rubber-based copolymers commercially available from Shell Chemical Company (Houston, Texas) under the trademark Kraton ® ; ethylene-octene copolymers such as those commercially avaiable from The Dow Chemical Company (Midland, Michigan) under the trademark ATTANE ; as well as any other suitable homopolymers and copolymers, and mixtures, alloys, and composites thereof.
  • Pebax ® multiblock rubber-based copolymers, particuarly those in which the rubber block component is based on butadiene, isoprene, or ethylene/ butylene, such as the multiblock rubber-based copolymers commercially available from Shell Chemical Company (Houston, Texas) under the trademark Kraton ® ; ethylene-octene copoly
  • polyester-based poly ⁇ urethanes, and multiblock rubber-based copolymers are most particularly preferred.
  • the composition of multiblock rubber-based copolymers employed as materials of construction for the condom articles of the present invention may be varied widely, it being understood that the non-rubber repeating units of the copolymer may be derived from any suitable monomer(s), as for example, (meth)acrylate esters, such as methyl methacrylate, cyclohexylmethacrylate, etc.; vinyl arylenes, such as styrene; etc.
  • the non-rubber blocks in the multiblock rubber-based copolymer preferably are derived from monomer(s) which are non-elastomeric in character, so that "soft" rubber blocks and "hard” non-elastomeric blocks are - provided in the multblock copolymer.
  • Such hard blocks may suitably be derived from monomers having a glass transition temperature (T_) of at least about 50°C, with styrene being generally preferred.
  • T_ glass transition temperature
  • the rubber block of such multiblock copolymers may be formed of repeating units derived from synthetic rubbers such as butadiene, isoprene, ethylene/butylene, etc., with butadiene and ethylene/butylene elastomeric blocks generally being preferred.
  • the most preferred multiblock rubber-based copolymers are those having an A-B-A structure comprising polystyrene endblocks and an elastomeric midblock.
  • Illustrative multiblock butadiene-based copolymers which may be usefully employed in the broad practice of the present invention include those variously described in U.S. Patent Nos. 3,297,793; 3,595,942; 3,402,159; 3,842,029; and 3,694,523, the disclosures of which hereby are incorporated by reference herein.
  • Various multiblock butadiene-styrene copolymers may be usefully employed to form the condom of the present invention, such as the aforementioned triblock ethylene-butadiene-styrene copolymers commercially available under the trademark Kraton from Shell Chemical Company (Houston, Texas) and small block butadiene-styrene copolymers commercialized by Firestone Synthetic Rubber & Latex Company (Akron, Ohio) under the trademark Stereon ® .
  • the copolymer material preferably is characterized by the following physical properties: a Shore A hardness of from about 25 to about 100; a tensile strength of from about 500 to about 4500; a 300% modulus of from about 120 to about 1,000 psi; and an ultimate elongation of from about 200 to about 1400%.
  • processing conditions and apparatus may be varied widely in blow forming the tubular main sheath portions of condoms in accordance with the present invention, depending on the specific thermoplastic material employed in the blow forming operation, the volumetric space requirements of the process system, the method and apparatus employed for closure of the distal end of the tubular main sheath portion to form the finished condom structure, etc.
  • the choice of specific processing conditions, materials, and the like may readily be determined for a given product application without undue experimentation, by those skilled in the art.
  • the temperatures over a three-zone extruder may illustratively range from about - 300° to about 380° Fahrenheit for a polyester-based polyurethane material or a multiblock butadiene-based styrene copolymer, while the temperature range in the same extruder for an ultra low density ethylene-octene copolymer or a polyether block amide may range from about 400° to about 450°F; associated therewith are blow pressures which may range from 1 to 12 ounces per square inch of blown film, depending on the specific material employed crevice, ethylene-octene copolymer or a polyether block amide.
  • the resulting tubular article has two open ends, and one of such open ends is sealingly closed to form the final condom article.
  • the end closure operation may be carried out in any suitable manner, and preferably is automated so as to accommodate high speed manufacture of the condom article in high volume.
  • the tubular body formed by blow extrusion may concurrently be sealed and severed at regular intervals along its length, to accommodate continuous processing.
  • the closure of the blow extruded tubular main sheath portion preferably is carried out by heat sealing, as is advantageous from the standpoint of thermoplastic materials being employed to form the condom.
  • the specific method of closure will depend largely on the specific material of construction employed for the tubular sheath portion of the condom, as well as its thickness.
  • the wall thickness of the condom article may vary widely, but preferably is on the order of from about 0.05 to about 0.25 millimeter.
  • thermal impulse heat sealing is highly preferred, since it can initiate the sealing process at low temperature, with the material to be sealed thereafter quickly rising to the desired high sealing temperature, and then quickly returning to ambient temperature.
  • rapid sealing of a localized region is effected, in a manner which prevents nearby regions of the film being sealed from experiencing substantial tempera ⁇ ture changes, such as might otherwise result in undesir ⁇ able change of material properties in the.vicinity of the seal.
  • This consideration is particularly important in thinner films, e.g., with material thicknesses on the order of 0.05 millimeter, or lower, up to approximately 0.1 millimeter.
  • the sealing method may be com- bined with, or otherwise effect, severing of the film into discrete tubular segments for the desired product articles.
  • an ultrasonic sealing assembly comprising an ultrasonic horn having associated therewith a blade element as an integral part of the horn structure, which in combination with a mating anvil effects concurrent or substantially con ⁇ temporaneous severing of the tubular film into discrete sequential tubular segments and ultrasonic bonding of distal ends thereof to form condom articles.
  • the condom articles of the present invention may be formed in various configurations, including tubular cylindrical-type configurations, as well as "baggy"-type configurations, the choice of a specific configuration depending on the particular materials of
  • IJQ construction and the intended packaging, storage, and use -environments of the condom.
  • a reinforcing ring is provided at the periphery of the open-
  • the purpose of such reinforcing ring is to provide a manually grippable region for application and removal of the condom to the penis for use, as well as to provide a structure facili ⁇ tating rolling of the condom when the condom is to be
  • the reinforcement ring is an elastic and resilient element, to assist in the retention of the condom on the penis of a wearer and to prevent the leakage of seminal fluids from the condom during and subsequent to
  • the sheath material at the open proximal end of the condom may be rolled onto itself, and then tacked in place employing, e.g., a thermal weld or an elastomeric adhesive.
  • the sheath material at the open proximal end of the condom may be rolled onto a ring of a different material from that employed to form the sheath portion of the condom, or it may be rolled onto a ring of the same material, followed by securement of the rolled length of condom to the ring structure.
  • Still another approach is to roll the open end of the condom onto a narrow section of a second piece of the tubular film material, of the same material of construction as the main sheath portion of the condom. It will be appreciated that all such rolling techniques must be carefully controlled during the manufacturing process, to avoid excessive wrinkling of the sheath material at the proximal end, such as otherwise may cause distortion of or undesired reduction in the diametral extent of the proximal opening of the condom.
  • a still further approach to forming a reinforced proximal opening for the condom article is simply to fold the open end material back onto the exterior surface of the sheath portion, in the vicinity of the proximal open ⁇ ing.
  • an untacked single fold approximately 0.25 inch wide may be employed.
  • condom articles of the present invention are suitably produced by blow forming, i.e., blow molding or blow extrusion forming.
  • an extruded parison tube of heated thermoplastic is introduced between respective halves of an open split mold, and then expanded against the sides of the closed mold via fluid pressure, typically a volume of interiorly provided air. The mold then is opened and the tubular part ejected.
  • This method is generally economical for and amenable to high volume manufacturing of one piece hollow articles, which may vary considerably in complexity of shape. Blow molding generally requires close attention to and control of processing conditions to obtain highly uniform wall thicknesses in the molded article.
  • Blow extrusion forming typically involves feeding of a thermoplastic or thermosettable molding compound from a hopper to a screw and barrel, where the molding compound is heated to a plastic state and then urged forwardly, typically by a rotating screw, through a nozzle of a selected cross-sectional configuration.
  • An air bubble is introduced into the interior of the tubular extruded film, and the pressure of such air bubble is employed to control the diametral and film thickness characteristics of the tubular extrudate.
  • An illustrative blow molding apparatus which may be usefully employed to produce condom articles of the pre ⁇ sent invention is a Esta blow-molding machine, HS 361 or HS 451, commercially available from Staehle Maschinenbau GmbH, Leinfelden-Echterdingen, Federal Republic of Germany.
  • thermosetting materials of construction for the condom article
  • thermoplastic materials most pre- ferably thermoplastic elastomeric materials, although, as indicated, non-elastomeric polymeric materials such as ultra-low density polyethylene or other non-elastomeric homopolymeric or copolymeric films may be advantageously utilized.
  • thermoplastic materials are employed to form the tubular main sheath portion of the condom article, and blow extrusion forming is employed, heat sealing methods of closing the distal end of the tubular article to form the condom of the invention are preferred, although any other suitable closure techniques appropriate to the specific materials of construction employed may advan ⁇ tageously be used.
  • blow extrusion may be particularly advantageous in some instances to utilize blow extrusion to form the tubular main sheath portion of the condom, due to the ability of blow extrusion to impart biaxial orientation to the formed tubular film.
  • blow forming techniques which may be usefully employed for a given application may be widely varied, depending on the materials of construction, type of condom configuration desired, processing rates employed, etc.
  • Table I Based on initial materials selection criteria in ⁇ cluding tensile strength, elongation, hardness, and flex- ural modulus, the materials identified in Table I below were selected for testing as materials of construction for condom articles of the present invention. Set out in Table I are the generic types and commercial tradenames of the materials selected, together with their appertaining ⁇ physical property values for tensile strength, elongation, 300% modulus. Shore A hardness, specific gravity and melt temperature (where applicable) .
  • Polyester Block Amide D35 1.01 (Pebax 3533-SN-00, Atochem)
  • the blow extrusion apparatus employed in this evalu ⁇ ation was a laboratory-sized unit manufactured by C. W. Brabender Instruments, Inc., (Southhackensack, New Jersey) including a Model 3003 extruder and a Model BFW-100 take-off tower.
  • the extruder had a 0.75 inch diameter screw and a 30:1 length to diameter ratio, with three heater zones.
  • An add-on extruder die functioned as a fourth heater zone.
  • the take-off tower effected pulling and conveying of the extruded tube in a vertical direction until it was sufficiently cooled.
  • the top of the take-off tower comprised a set of rolls to collapse the contained air bubble and re-direct the tube to a final take-up roll.
  • the take-off tower also comprised controls for air pres ⁇ sure for internal tube pressurization, and controls for external tube cooling.
  • the extruder die employed for extruding thin, small diameter tubes in this initial qualitative evaluation was a C. W. Brabender 0.5 inch diameter (outer ring diameter) heated die.
  • the formed tubular film was thicker than desired.
  • the inner die was replaced by a die with a diameter of 0.48 inch, providing a gap of 0.01 inch, which produced desirable tube thicknesses, ranging from 0.0015 to 0.005 inch after blowing, depending on the specific material processed.
  • Samples 3 and 4 styrene-butadiene-styrene block copolymers
  • Sample 7 polybutylene terephthalate/polyether glycol block copolymer
  • Samples 8 and 9 polyether block amides
  • Sample 14 polyester-based polyurethane
  • an ultra-low density polyethylene material (Sample 16; ATTANE 4003 ethylene-octene copolymer, commercially available from The Dow Chemical Company, Midland, Michigan) was evaluated.
  • This polymeric material is not an elastomeric thermoplastic, however it was very easy to process via blow extrusion and produced tube samples in the desired range of diameter and thickness.
  • This ultra-low density polyethylene was not as soft as some of the other materials, such as the styrene- butadiene-styrene block copolymer of Sample 3, and did not recover from high strain extensions, but was relatively extensible.
  • Example I On the basis of the results obtained in Example I, a further blow extrusion evaluation was carried out for Samples 3, 4, 7, 8, 9, 14, and 16, using refined operating parameters.
  • Example II In contrast to the initial extrusion evaluation of Example I wherein the inner die had a diameter of 0.46 inch, the further extrusion tests employed an inner die having a diameter of 0.48 inch.
  • Samples 4 and 8 were undesirably difficult to process in low film thicknesses. Specifically, Sample 4 did not stablize in a thin blown bubble, and Sample 8 exhibited an undesirable tendency to self-adhere, even with extended cooling. The remaining five samples. Samples 3, 7, 8, 9, 14 and 16, produced extruded tube diameters and film thicknesses which were much closer to the desired values.
  • Table III provides a summary of processing conditions for the blow extrusion processing of these samples, together with the approximate thickness range, in inches, achieved for each of the blow extruded samples.
  • blow extruded tubes produced in Example II were evaluted for heat sealing capability, utilizing heat sealing as a method for forming a closed distal end- of the tube for condom usage.
  • Extruded tubes of-Samples 3, 7, 9, 14, and 16 were evaluated.
  • the impulse heat sealer is a potentially attractive means for forming enclosed distal ends on blow extruded tubes for condoms of the present invention, because it can initiate the sealing process at a low temperature, with the material to be sealed quickly rising to the desired elevated sealing temperature, and then returning quickly to ambient conditions.
  • the resulting rapid sealng in a localized region prevents surrounding material in the vicinity of the seal from experiencing undesirable temperature changes such as may deleteriously alter material properties.
  • Such localized heating character is particularly important in thin film sealing applications such as forming enclosed distal ends for blow extruded condoms of the present invention.
  • an aluminum heating platen was constructed having a concave hemispherical cavity for sealingly forming rounded ends on the extruded tubes.
  • the extruded tubes were placed in the hemispherical concave region of the platen and pressed against a hard rubber backup strip to form the seal.
  • Table IV sets forth the heat sealing temperatures and dwell times employed for heat sealing each of the identified extruded tube samples.
  • samples of the blown extruded films were tested to compare the properties of condoms according to the present invention to those of conventional latex rubber condoms.
  • SUBSTITUTESHEET The tests conducted were determinations of ultimate tensile strength, ultimate elongation, 100% modulus, and puncture resistance.
  • the ultimate tensile strength and ultimate elongation values were measured at material breaking points.
  • the puncture resistance test simulated a fingernail and finger being pushed through a condom, and comprised a lower base unit which clamped and secured the condom film, providing a circular opening of 1 inch diameter within which the clamped film was exposed.
  • a finger simulator probe was pushed through the base unit opening and into the film using an Instron test unit which monitored the probe travel and the force applied to the probe.
  • the probe comprised a 0.5 inch diameter steel rod tapered at its end to a central wedge shape with a thickness of 0.025 inch, and rounded at its extremity to a radius of curvature of 0.25 inch.
  • the polyester-based polyurethane film (Sample 14) provided the highest tensile strength at 5193 psi.
  • the next highest tensile strength material was the ultra-low density polyethylene film (Sample 16) at 1800 psi and the conventional latex condom film (control) at 1665 psi.
  • the lowest strength material was the polyester block amide material (Sample 9) at 434 psi; this material was tested after soaking it in water for a minimum of 24 hours to reduce its stiffness.
  • the conventional latex rubber material (control) and the styrene-butadiene-styrene block copolymer (Sample 3) showed comparable elongation characteristics (1163% for the control, and 1241% for Sample 3).
  • the polyester block amide material (Sample 9) had the lowest elongation at 204%, while the remaining three materials exhibited between 800% and 1000% elongation. The lowest, and most desirable, 100% modulus value was obtained with the styrene-butadiene-styrene block copolymer material (Sample 3) at 83 psi.
  • the control had a 100% modulus value of 123 psi. The remaining materials required much higher stress levels to stretch them to twice their original length.
  • the highest 100% modulus level " was obtained for the ultra-low density polyethylene material (Sample 16) at 990 psi, and the polyester-based poly ⁇ urethane (Sample 14) was also relatively high at 772 psi
  • the materials tested fell into two general classes.
  • the ultra low density polyethylene (Sample 16), the polyester-based polyurethane (Sample 14) and the latex rubber material (control) required high loads to initiate a puncture.
  • the remaining materials (Samples 3, 7, and 9) [Note: Sample 9 was tested wet in the puncture testl , exhibited punctures at loads which were approximately one-half of the loads necessary to initiate puncture in the first-mentioned class of materials.
  • the condom of the invention comprises a tubular main sheath portion, closed at a distal end and open at a proximal end thereof.
  • the condom is formed of a thermoplastic elastomeric, or a suitable polymeric non- elastomeric, material including polyurethane and multiblock rubber-based copolymer materials, by a process including blown film formation of the tubular main sheath portion an sealing one end -of the tubular portion.
  • the invention provides an improved condom which is readily, simply and inexpensively formed. Using the process of blown film formation the condom may be mass produced. The condom thus may be used in a low cost manner to help combat the spread of sexually transmitted diseases, including AIDS and to provide a safe and reliable contraceptive means.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Mechanical Engineering (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention décrit un préservatif (10, 110) comprenant une partie gaine principale tubulaire formée par soufflage (12, 112), ainsi qu'un procédé de fabrication dudit préservatif. Des techniques de fabrication par extrusion par soufflage et par moulage par soufflage, ainsi que l'utilisation de divers matériaux de fabrication thermoplastiques, tels que des polyuréthanes, des amides blocs de polyéther, des copolymères blocs de styrène-caoutchouc-styrène, des copolymères d'éthylène-octène et des polyesthers, sont décrites.
PCT/US1989/001532 1988-05-26 1989-04-12 Preservatif et son procede de fabrication WO1989011258A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US19903088A 1988-05-26 1988-05-26
US199,030 1988-05-26

Publications (1)

Publication Number Publication Date
WO1989011258A1 true WO1989011258A1 (fr) 1989-11-30

Family

ID=22735915

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1989/001532 WO1989011258A1 (fr) 1988-05-26 1989-04-12 Preservatif et son procede de fabrication

Country Status (3)

Country Link
EP (1) EP0417139A4 (fr)
AU (1) AU3542789A (fr)
WO (1) WO1989011258A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994009965A1 (fr) * 1992-10-31 1994-05-11 Smith & Nephew Plc. Article medical
EP0621126A1 (fr) * 1993-04-23 1994-10-26 Chartex International Plc Dispositif et méthode pour souder un élément de renforcement à un élément du type sachet
US5554141A (en) * 1990-05-15 1996-09-10 Colplast A/S Thermoplastic uridom and method and apparatus for the manufacturing thereof
WO2004004796A1 (fr) * 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3608268A (en) * 1967-06-07 1971-09-28 Schmith Niels Bay Method for producing thin-walled,collapsible containers or packages
US3853661A (en) * 1971-05-01 1974-12-10 Mitsubishi Petrochemical Co A method of producing plastic bags
US3880691A (en) * 1971-03-23 1975-04-29 Pannenbecker H Process for producing film and sheet materials from thermoplastic materials having hot tack by the blown film process and the film and sheet materials thereby obtained
US4576156A (en) * 1978-04-17 1986-03-18 Ortho Pharmaceutical Corporation Prophylactic device and method
US4579907A (en) * 1983-08-30 1986-04-01 J. H. Benecke Gmbh Polyvinyl chloride plastic film
US4735621A (en) * 1987-02-03 1988-04-05 Lasse Hessel Tubular protective device for protection against transfer of infectious matter during sexual intercourse

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3608268A (en) * 1967-06-07 1971-09-28 Schmith Niels Bay Method for producing thin-walled,collapsible containers or packages
US3880691A (en) * 1971-03-23 1975-04-29 Pannenbecker H Process for producing film and sheet materials from thermoplastic materials having hot tack by the blown film process and the film and sheet materials thereby obtained
US3853661A (en) * 1971-05-01 1974-12-10 Mitsubishi Petrochemical Co A method of producing plastic bags
US4576156A (en) * 1978-04-17 1986-03-18 Ortho Pharmaceutical Corporation Prophylactic device and method
US4579907A (en) * 1983-08-30 1986-04-01 J. H. Benecke Gmbh Polyvinyl chloride plastic film
US4735621A (en) * 1987-02-03 1988-04-05 Lasse Hessel Tubular protective device for protection against transfer of infectious matter during sexual intercourse

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0417139A4 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554141A (en) * 1990-05-15 1996-09-10 Colplast A/S Thermoplastic uridom and method and apparatus for the manufacturing thereof
WO1994009965A1 (fr) * 1992-10-31 1994-05-11 Smith & Nephew Plc. Article medical
GB2286554A (en) * 1992-10-31 1995-08-23 Smith & Nephew Medical apparatus
GB2286554B (en) * 1992-10-31 1996-07-24 Smith & Nephew Medical apparatus
AU671324B2 (en) * 1992-10-31 1996-08-22 Ansell Healthcare Products Llc Flexible elastomeric glove
US5640720A (en) * 1992-10-31 1997-06-24 Ansell Perry Inc. Medical apparatus
EP0621126A1 (fr) * 1993-04-23 1994-10-26 Chartex International Plc Dispositif et méthode pour souder un élément de renforcement à un élément du type sachet
US5603802A (en) * 1993-04-23 1997-02-18 Chartex International Plc Method and apparatus for welding bags to rings
US5695585A (en) * 1993-04-23 1997-12-09 Chartex International Plc. Method for welding bags to rings
WO2004004796A1 (fr) * 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe

Also Published As

Publication number Publication date
EP0417139A1 (fr) 1991-03-20
EP0417139A4 (en) 1991-06-12
AU3542789A (en) 1989-12-12

Similar Documents

Publication Publication Date Title
EP0444112B1 (fr) Condoms, appareil et procede de fabrication et d'utilisation
AU679441B2 (en) Bidirectionally donnable generally tubular sheath
CA1161713A (fr) Preservatif et methode de fabrication
AU671324B2 (en) Flexible elastomeric glove
US5344400A (en) Balloon catheters containing molded polyarylenesulfide material
US5335675A (en) Stress-softened elastomeric films, articles, and method and apparatus for making such films and articles
US20060029756A1 (en) Catheter balloon formed of ePTFE and a diene polymer
JPH0363908B2 (fr)
EP1436035A2 (fr) Ballonnets basse pression a usage medical et leur procede de fabrication
JPH0523787B2 (fr)
US4670313A (en) Method for parting rubber and products formed thereby, and a method of making a blood vessel
US5169464A (en) Method of making a condom by blow extrusion
US4690844A (en) Method for parting rubber and products formed thereby, and a method of making a blood vessel
WO1989004647A1 (fr) Articles prophylactiques a enrobages biocompatibles
US5199444A (en) Condom having enhanced grippability structure and annular sealing element
WO1989011258A1 (fr) Preservatif et son procede de fabrication
US5036863A (en) Condom articles, and apparatus and method for making and using the same
JPH1071207A (ja) バルーン用チューブの製法

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU DK FI JP KR NO

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE FR GB IT LU NL SE

WWE Wipo information: entry into national phase

Ref document number: 1989905829

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1989905829

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1989905829

Country of ref document: EP