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1. (WO2007001526) MALE EXTERNAL CATHETER AND METHOD OF MAKING SAME
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MALE EXTERNAL CATHETER AND METHOD OF MAKING SAME

Background of the Invention
[0001] Male external urinary catheters are commonly manufactured by dip processing or blow molding. Examples of dip processing are set forth in U.S. Patents 5,376,085 (silicone rubber), 5,407,715 (triblock copolymers), 4,475,910 (latex), 4,846,909 (latex) and International Publication WO
96/29962 (polyurethane). A combination of injection molding, pull extrusion and blow molding is disclosed in U.S. Patent 5,554,141 (styrehe-based block copolymers). Regardless of the method used, the catheters produced by such processes characteristically have the common feature of inner surface contours that mimic or match the contours of the outer surfaces.
[0002] Typically, a male external catheter has a generally cylindrical body section or sheath that fits about a wearer's penis and may include a bulbous enlargement at it distal end for extending over the glands, a drain tube section of reduced diameter adapted to be connected to drainage tubing leading to a leg bag or some other urine-receiving receptacle, and a tapered or generally frusto-conical neck section interposed between and connecting the body and drain tube sections. The tapered neck section is frequently provided with a series of annular corrugations or convolutions to permit greater stretchability, bending and twisting of the neck section when the device is in use and to do so with less chance that kinking or obstruction of the lumen might occur. While the corrugations are effective in achieving those objectives, they also result in a construction in which the inner surface of the neck portion, which mimics the corrugations of the outer surface, has the disadvantage of collecting and retaining small amounts of urine within its annular channels or grooves.
[0003] The fact that inner and outer surfaces of conventional male external catheters are parallel to each other or follow the same contours also has other disadvantages. Such catheters commonly have smooth-walled drain tube sections that must be pushed over stepped connectors to attach the catheters to urine collection bags. Smooth-walled tubes can be difficult to push onto such connectors but, heretofore, it has not been considered feasible to provide such a drain tube section with a contoured outer surface that facilitates gripping and advancing the section onto a connector while at the same time providing such section with a smooth cylindrical inner surface.
Summary of the Invention
[0004] This invention is concerned with a male external catheter and the method for its manufacture, in which the catheter is formed in whole or in part from a suitable injection-moldable plastic material and in which the contours of its inner and outer surfaces are selectively and substantially different. Thus, the outer surface of the funnel-shaped neck section may have a series of concentric corrugations, as described above, while the inner surface of that same section may be smoothly tapered, thereby enhancing flow and eliminating or reducing the possibilities that urine might coHect and be retained in the neck section. Similarly, the outer surface of the drain tube section might be provided with one or more recesses and or projections to facilitate manual gripping of the drainage tube section when it is to be joined to a connector. Other substantial differences in the contours and textures of the inner and outer surfaces may be provided to facilitate application and use of the catheter.
[0005] An important aspect of this invention lies in providing a male external catheter that is formed entirely by injection molding and composed of one or more injection-moldable polymeric materials. In its method of manufacture, a mandrel having an outer surface that defines the inside surface of such a catheter is positioned within a multiple-section mold having an inner surface defining the contours of the catheter's outer surface. One or more molten plastic materials, usually but not necessarily thermoplastic elastomeric materials, are then injected into the cavity of the mold and, after cooling, the mold's outer sections are separated. The catheter may be retained on the mandrel for further processing or, if desired, it may be removed and repositioned on a working mandrel.
[0006] The production method has the advantages of providing a male external catheter having sections formed of different but compatible injection-moldable plastic materials. For example, the catheter may have a drainage tube section formed of a relatively rigid or stiff thermoplastic material (which may or may not be elastomeric) while the remaining sections may be formed of a compatible thermoplastic having the desired properties of softness and elasticity (i.e.,stretchability and recoverability). Further, the sections may be formed in different colors, textures and/or degrees of transparency and gas (vapor) permeability. Such a catheter, having sections formed of different but compatible injection-moldable plastics, may be made using known over-molding or multi-shot injection molding techniques.
[0007] A further advantage of using injection molding, and
particularly multi-shot molding or over-molding techniques, is that the catheter may be formed with materials of different composition along its inner and outer surfaces. For example, the outer layer may include additives to promote release whereas the inner layer may have additives to provide or at least promote adhesion, or enhance skin care, or supply therapeutic and/or antibacterial agents to the skin.
[0008] Other features, objects and advantages of the invention will become apparent from the drawings and specification.

Brief Description of the Drawings
[0009] FIG. 1 is a longitudinal side view of a male external catheter embodying this invention, a portion of the catheter being cut away to reveal the cross sectional contours of the product.
[0010] FIG. 2 is an enlarged perspective view of the neck and connected drain tube sections of the catheter, again with a portion of the catheter removed to reveal the differences between the contours of the catheters inner and outer surfaces.
[0011] FIG. 3 is a perspective view of the catheter in completed and rolled condition.
[0012] FIG. 4 is a fragmentary perspective view of a second embodiment showing an annular bead formed at the proximal end of the catheter.

[0013] FIG. 5 is a sectional longitudinal view depicting the mandrel and the outer mold sections for injection molding the catheter.
[0014] FIG. 6 is an enlarged view of the mandrel and mold elements for forming the final-shaped neck section and contoured drain tube section of the catheter.
[0015] F)G. 7 is a fragmentary longitudinal sectional view of a further embodiment of the invention.
[0016] FIG. 8 is a sectional view of a catheter formed by overmolding or multi-shot injection molding with different materials used for the drainage tube section, on one hand, and the sheath and neck sections on the other.
[0017] FIG. 9 is a perspective view, partly broken away to reveal longitudinal sectional contours, of a male external catheter constituting a further embodiment of this invention.
Detailed Description of Preferred Embodiments
[0018] Referring to FIGS. 1 and 2 of the drawings, the numeral (10) generally designates a male external catheter injection molded in whole or in part from one or more injection-moldable plastic materials and having an elongated cylindrical body section (11) a drain tube section (12), and a tapered funnel or neck section (13) interposed between and joining the body and drain tube sections. If desired, the body section may have a bulbous portion (11a) at its distal end, such portion serving both as a glans-receiving chamber for enhancing wearer comfort and as an expandable surge chamber for temporarily accommodating surges of fluid that may occur at the commencement of urination.
[0019] In the illustration given, the sections of the external catheter are integrally formed, but as explained hereinafter, certain sections such as the drainage tube section may be injection molded as a separate component and joined to the remainder of the catheter through overmolding or multi-shot injection molding.
[0020] A distinguishing feature of the external catheter is that its tapered neck section (15) has inner and outer surfaces of substantially different contours. Specifically, the outer surface (13a) is corrugated or convoluted with a longitudinal series of concentric ridges (14) and grooves (15) that diminish in circumferential dimensions towards the distal end of the catheter. The main purpose of the convolutes is to allow flexing of the neck section of the catheter without kinking and occluding its lumen. While the use of such convolutes is known in the prior art, it is believed novel and unobvious that the inner surface (13b) of this same neck section is smooth and free of corrugations. Thus, while the neck section shares the kink-resisting attributes of prior constructions, it does so without providing internal grooves or recesses that might entrap and retain small amounts of urine. The smooth internal surface (13b) of the neck section promotes fluid flow and avoids the potential problem of retaining urine close to the penis when the product is worn.
[0021] The external convolutes are shown in the drawings as being smoothly rounded, but it is to be understood that any of a variety of different profiles may be selected for such external corrugations. For example, each of the corrugations of the series may be V-shaped jn outline or, alternatively, have sharply-squared edges. Further, while the neck section will generally have a multiplicity of such corrugations or convolutes, the number is not critical and may vary widely depending on the construction and design of the catheter.
[0022] As shown most clearly in FIGS. 1 and 2, the drain tube section (12) may also have an outer surface (12a) of substantially different contour than its inside surface (12b). Ideally, the inside surface is cylindrical and merges smoothly with the inner surface of the tapered neck section (13). In prior external catheters, the outer surfaces are also generally cylindrical in shape and, since such drain tube sections must usually be pushed onto stepped connectors for attaching the catheters to tubing leading to urine collection bags, the smoothness of the outer surfaces may make prior drain tube sections difficult to grip and push over such connectors. In contrast, the outer surface (12a) of this drain tube section has one or more annular indentations or recesses (16) and/or one or more annular projections (16a) to provide user-friendly gripping means to facilitate tube attachment. Further, the outer surface of the drain tube section may be textured to further reduce the possibility that the drain tube section might unintentionally slip between the fingers during an attaching operation.
[0023] The inner surface of the generally cylindrical body portion (11 ) may be provided with an annular band or layer (17) of a suitable pressure-sensitive non-allergenic adhesive. Such an adhesive layer may be formed as part of the molding operation, as by overmolding the material of the catheter over an adhesive layer or by introducing the adhesive in the first step of a multi-shot injection molding operation. To enhance adhesion of the adhesive to the catheter, as well as to promote user comfort, the inner surface of the body section may also be textured. Since the catheter is intended to be rolled up in one of the final steps of its manufacture (see FIG. 3), the catheter's outer surface, or at least the outer surface of the cylindrical body section (11) must be coated or otherwise provided with a suitable release material. Silicone rubber has been commonly used in the past to prevent adhesive from adhering to the outer surface of a rolled-up catheter, but any suitable release agent in the form of a layer, coating, or film capable of preventing such adherence may be used. Again, the outer surface of the body section may be textured to promote adhesion between the release material and the body section's outer surface.
[0024] FIG. 4 shows that the outer surface (11 a) of the cylindrical body section (11 ) may also depart from the contour of inner surface (11 b).
Specifically, an annular bead (18) may be provided at the catheter's proximal end. The provision of such a bead facilitates rolling of the sheath at the time of manufacture and when the catheter is to be removed from a patient.
[0025] The substantial differences in contour between the inner and outer surfaces of the external catheter are achieved because the catheter is injection molded in its entirety. Any suitable injection-moldable materials or combinations of materials that are preferably soft and flexible may be used. While thermoplastic resins are believed particularly suitable, including thermoplastic elastomers, the injection-moldable material(s) may also include silicones and thermoformable rubbers and vulcanites.

[0026] Styrene-type thermoplastic elastomers are believed to be especially suitable and include styrene/butadiene block copolymers (SBS),
styrene/isoprene block copolymers (SIS) and the hydrogenation products thereof, styrene/ethylene/butylene block copolymers (SEBS),
styrene/ethylene/propylene block polymers (SEPS), styrene/butadiene rubber (SBR) and styrene/butadiene/methyl methacrylate copolymers (MBS).
Various additives such as plasticizers, antioxidants, ultraviolet absorbers, light stabilizers, adhesion promoting agents, antibacterial agents, agents for skin conditioning and care, and colorants may be included in the resin
composition(s), all as well-known in the art.
[0027] FIG. 5 depicts a mold assembly (20) that may be used for injection molding the male external catheter of this invention. The mold includes a mandrel (21) that has an outer surface defining the generally smooth
(including evenly textured) inner surface of the final product. The assembly also includes separable mold sections (22) and (23) which together provide a cavity (24) that defines the contoured outer surface of the product. A plurality of inlet passages (25) extend through the mold sections to convey molten plastic material to cavity (24). Once the molten plastic has cooled within the cavity, sections (22) and (23) are separated and the mandrel (21) with the molded catheter supported thereon is advanced for further processing. This may include processing steps that are performed while the catheter remains on the mandrel or, if desired, the catheter may be removed and transferred to a working mandrel.
[0028] As already described in connection with the embodiment depicted in FIGS. 1-3, the contour of the outer surface of the drain tube section (12) may be provided with one or more recesses (16) and/or projections (16a) to facilitate gripping of the drainage tube section when it is to be coupled to a suitable connector. In the embodiment of FIG. 7, the drainage tube section (12') is provided with a plurality of recesses (16') defined by a series of stepped frusto-conical surface portions (40). The recesses (16') also facilitate the gripping of the drainage tube portion (12') when it is to be fitted upon a suitable connector. However, the illustrated construction might also be used by inserting the drainage tube section into an etøstomeric connecting tube, with the drain tube section then being internal to the connecting tube and the edges of the frusto-conical portions serving as barbs to restrain the parts from unintentional separation,
[0029] Where the drain tube section is intended to function as the male element in its assembly with a female connector, it is desirable that the drain tube section be stiffer or more rigid that the remainder of the catheter. That may be accomplished by what is known in the art as multi-shot injection molding where, in this instance, the thermoplastic material from which the drain tube section is molded is harder or has a higher elastic modulus than the elastomeric material used for injection molding the remainder of the catheter. Both materials in molten state may be injected simultaneously or sequentially into the cavity (multi-shot injection), and the thermoplastic compatibility of the two materials ensures that the final injection-molded product will have its drain tube section fully integrated with the neck and body sections of the catheter.
[0030] Alternatively, the drain tube section of the catheter may be preformed by injection molding in a prior step and then joined in a second injection molding step to the elastomeric neck and body sections. FIG. 8 shows a drain tube section (12") which is preformed of suitable thermoplastic material and placed within the cavity (24) of the mold with softer elastomeric material then being injected to form the stretchable and recoverable neck and body sections (13) and (11). The result is an integrated assembly produced by over-molding in the second injection-molding step.
[0031] The sections of the catheter may also differ in respects other than stiffness and stretchability. For example, the drain tube section may be more opaque, or of a different color, than the neck and body sections. Preferably, the neck and body sections are relatively transparent or clear, whereas transparency is less needed for the drain tube section.

[0032] FIG. 9 depicts another embodiment of an injection molded catheter embodying the invention. Both the neck section (113) and the drain tube section (112) have their outer surfaces provided with an uninterrupted series of corrugations or convolutions defined by concentric ridges (114) and grooves (115). It will also be noted that the ridges increase slightly in radial thickness, and the grooves become deeper, towards the distal tip of the catheter. If desired, the final ridge or rib may have a chamfered inner surface at (130) to facilitate fitting the drain tube section over the end of a drain tube connector. The corrugations not only enhance non-kinking flexing and bending of the tapered neck and drain tube sections but also provide a gripping surface to facilitate coupling of the catheter to a connector. As in the previous embodiments, the inner surfaces of the neck and drain tube sections are without corrugations and merge smoothly together to promote fluid flow and avoid the grooves and indentations of prior constructions that tend to collect and retain small amounts of fluid in use.

[0033] Throughout this application, the term "plastic" has been used in a broad sense to mean a material capable of being molded and then passing into a more solid state because of cooling or curing or some other treatment or condition. In most cases, a thermoplastic material is used, particularly a thermoplastic elastomer, but this invention also comprehends the use of a multi-component composition which passes from a flowable state to a stable or cured state because of a chemical reaction between such components.
[0034] While in the foregoing we have disclosed embodiments of the invention in considerable detail for purposes of illustration, it will be
understood by those skilled in the art that many of these details may be varied without the departing from the spirit and scope of the invention.