GB2099706A - A male urinary collection system and external catheter therefor - Google Patents

Abstract

An external catheter (10), for a male urinary incontinence collection system is in the form of a tubular sheath (11) of thin elastic material having a cylindrical body section (13) a tapered neck section (15), and a reduced drainage tube section (14) projecting from the neck. Within the sheath, is a tubular inner sleeve (12) of soft elastic material having a distal portion (12a) within the neck and a proximal portion (12b) merging with the sheath's cylindrical body. The sleeve tapers distally to define an annular space, and terminates in a reduced distal opening. The sheath is produced by a dipping process that includes stretching a pre-formed tube (which ultimately forms the inner sleeve) over a dipping form, followed by successive dipping steps part of the tube being treated to prevent bonding of latex and part left untreated. <IMAGE>

Description

SPECIFICATION A male urinary collection system and external catheter therefor In co-pending co-owned patent application Serial No. 271,082, filed June 5, 1981,there is disclosed a male urinary drainage device composed of a thin resilient external catheter and an underlying adhesive sealant pad for holding the catheter in place and for producing an effective seal to prevent urine backup and leakage. The pad is formed of compressible, deformable, waterresistant, and elastic sealant material and includes a ring portion, adapted to seal about the penis at or directly behind the glans thereof, and a pair of integral strap portions projecting from the ring portion and intended to extend inwardly (proximally) along the penile shaft.The strap portions function primarily to provide catheter retention, whereas the ring portion coacts with the retained catheter and with the penis to serve primarily as a barrier against fluid backup.

The external catheter of the co-pending application is provided with convolutions of graduated size in the neck region between the catheter's cylindrical body portion and its reduced drainage tube portion. Such convolutions permit axial as well as radial expansion and contraction and thereby absorb tensioning forces that might otherwise occlude the lumen or reduce effectiveness of the seal between the pad and catheter, or pad and penis, or both. In addition, the convolutions increase the internal capacity of the neck region to accommodate sudden discharges of urine, thereby reducing the possibilities of fluid backup, or disengagement of or damage to the drainage device under such circumstances.

Conditions may nevertheless arise where a surge of fluid may create a back pressure that may weaken the seal between the pad and catheter, or between the pad and the penis, resulting in leakage. Should the neck portion of the catheter become enlarged or distorted because of fluid pressure, the forces generated by such pressure will tend to urge the inner surfaces of the catheter laterally out of sealing contact with the annular portion of the pad. Furthermore, apart from the possibility of leakage arising because of surges of fluid causing a failure of the adhesive seal, there is always the risk that gradual deterioration of that seal will occur because of exposure to urine over an extended period, or that the material of the pad will tend to deteriorate because of continuous exposure to fluid, resulting in undesirable back flow and leakage.

U.S. patent 2,940,450 discloses a drainage device in the form of an external catheter connected to a flexible tube leading to a suitable receptacle, the catheter being held in place by drawstrings which may be tied together to produce a secure fit. In U.S. patent 3,835,857, elastic adhesive tape is wrapped about the catheter in place of drawstrings, and in U.S. patent 3,863,638 a liner is disposed beneath the catheter to reduce leakage and promote patient comfort. U.S. patent 4,187,851 discloses a method of forming such a liner in place by wrapping the penile shaft with a double-faced adhesive strip prior to application of the elastic external catheter.

Those devices that have the advantage of being easily and quickly applied tend to be less effective in terms of retention and prevention of fluid backup, whereas those that are more satisfactory in the latter respects are often relatively difficult to apply and more likely to cause patient discomfort and urethral constriction. Ease of application and removal are particularly important because an incontinent patient may have other disabilities that make complicated manipulations difficult if not impossible to perform. Other U.S. patents reflecting the state of the art are 3,364,932, 3,721,243; 3,361,857, 3,511,241,2,891,546, 4,022,213, 3,526,227, 3,353,538, 1,423,537, 1,015,905, 3,604,424, 4,239,044, 1,490,793, 3,559,651, and 3,405,714.

One aspect of this invention lies in the recognition of the problem of maintaining effective adhesive seals under the conditions described above; a second aspect lies in recognizing that the degradation or rupture of such seals may be prevented by providing the external catheter with an elastic tapered internal sleeve disposed within the neck portion of the outer sheath. In use of the catheter, the sleeve is stretched into sealing engagement with the glans to provide a barrier that tends to prevent liquid from migrating rearwardly or proximally towards the adhesive seals formed between the adhesive pad, the cylindrical portion of the catheter, and the penis.

Should a surge of urine within the neck portion of the catheter cause back pressure, such pressure only tends to increase the effectiveness of the liquid barrier formed between the glans and sleeve. Furthermore, where an annular portion of the sleeve is in direct contact with the adhesive pad, such back pressure increases rather than diminishes the force of contact between the sleeve and adhesive pad and thereby promotes an even more effective liquid-tight adhesive seal.

In brief, the system includes a resilient skinprotecting adhesive pad of the type disclosed in aforementioned co-pending application, the disclosure of which is incorporated herein by reference, in combination with an external catheter or sheath having a cylindrical body section, a tapered neck section leading therefrom, and a reduced drainage tube section. Within the sheath, and forming a permanent part thereof, is a tubular inner sleeve of soft elastic material having a distal end portion disposed within the neck section and a proximal end portion merging with the sheath's body section. Because the sleeve tapers distally, an annular space is provided between the distal portion of the sleeve and the inner surface of the sheath's neck section.A fluidtight seal is formed between the sleeve and the glans, and any increase in pressure within the annular space about the sleeve only tends to urge the sleeve into tighter sealing engagement with the glans. When the catheter is worn so that the proximal portion of the sleeve engages the ring portion of the adhesive pad, increases in fluid pressure about the sleeve may also result in enhancement of the adhesive seal between the sleeve and pad. The result is an external catheter which has the advantages of adhesive attachment in terms of patient comfort and convenience, in contrast to prior devices requiring belts, harnesses, and the like, and which at the same time provides a high degree of security against fluid backup and leakage.

The catheter is formed in a dipping process that includes the preliminary step of stretching a preformed tubular member, ultimately to become the inner sleeve, over a dipping form. In its unstretched or untensioned state, the tubular member has a distal end portion that tapers and terminates in a reduced distal opening. After stretching the tubular member upon the form, the distal end portion of that member is treated to prevent liquid latex from bonding thereto.

Thereafter, the form is dipped into a latex bath and the latex coating is then cured to produce the outer sheath, or at least that portion of the outer sheath surrounding the inner sleeve. When the catheter is stripped from the form, the sleeve returns to its original untensioned state, thereby creating an annular space between the outer distal portion of the sleeve and the inner surface of the sheath's neck section.

The invention will now be described, by way of example, with reference to the accompanying diagrammatic drawings, in which: Figure 1 is a side elevational view, shown partly in section, of an external catheter embodying the present invention, the sheath of the catheter being depicted in unfolded or unrolled condition; Figure 2 is a view similar to Figure 1 but showing the sheath in rolled condition as it would appear prior to application; Figures 3 and 4 illustrate the steps of placing the catheter over a penis upon which an adhesive and protective sealing pad has been fitted; Figure 5 is an enlarged fragmentary generalized sectional view of a catheter showing the relationship between the outer sleeve and sheath;; Figure 6 is a fragmentary sectional view illustrating the relationship between sheath and sleeve in one embodiment of the catheter, and Figures 7-11 1 illustrate the sequence of steps for forming a catheter having such a relationship of elements; and Figure 12 is a fragmentary sectional view depicting a second embodiment, and Figures 13-1 7 show the method steps for forming a catheter having the relationship of elements represented by the second embodiment.

Referring to the drawings, the numeral 10 generally designates an external catheter formed of soft, highly elastic, natural or synthetic rubber.

Natural latex is preferred but other elastomers having similar properties may be used. The catheter includes an elongate outer sheath 11 and an inner sleeve 12, the two being integrated or permanently joined in the manner hereinafter described.

Referring to Figure 1 , the sheath 11 includes an elongate cylindrical section 13, a reduced drainage tube section 14, and a tapered neck section 15 disposed therebetween. The wall thickness of the cylindrical section 13 is substantially less than that of the neck and drainage tube sections 14, 1 5. For example, the cylindrical section 13 may have a wall thickness within the general range of .006 to .010 inches (0.1524 to 0.2540 mm) and, in general, is too thin or limp to retain a cylindrical configuration without support.In contrast, the wall thicknesses of the drainage tube and neck sections 14, 1 5 may be .050 inches (1.27 mm) or more and is generally great enough so that such sections will retain the configurations shown in the absence of distorting forces and will spring back into the illustrated shapes when distorting forces are removed.

At its forward or distal end, the neck section 1 5 is provided with a rounded taper leading to a reduced opening 16. The drainage tube section 14, that merges with the tapered neck section 15, is provided with a plurality of convolutions or annular enlargements 17 and 18. Two such convolutions of graduated size are depicted, their purpose being to permit greater stretchability, bending, and twisting of the drainage tube section 14 when the device is in use, and to do so with less chance that kinking or obstruction of the lumen might occur. Also, since the interior of the drainage tube section 14 is enlarged at such convolutions, the convolutions 17. 18 increase the fluid capacity of that section 14 and provide a reservoir for accommodating surges of fluid when the device is in use.

The inner sleeve 12 has a distal end portion 12a disposed within the neck section 1 5 of the sheath and a proximal end portion 12b within the sheath's cylindrical body section 13. The relationship is depicted most clearly in the generalized and enlarged view of Figure 5 where it will be seen that the proximal end portion 12b has about the same cross-sectional dimensions as the cylindrical body section 13 and merges smoothly with that section, while the distal portion 12a tapers forwardly and inwardly, terminating in a reduced distal opening 19. The opening 19 is spaced well behind (i.e., proximal to) the opening 1 6 at the distal end of the neck section 1 5. The setback also results in the provision of an annular space 20 between the outer surface of the sleeve's distal end portion 12a and the inner surface of neck section 15. The wall thickness of the sleeve 12 may be varied but, to ensure conformability, good sealing properties, and wearer comfort, such thickness should approximate that of the relatively thin cylindrical body section 13 of the sheath, i.e. .003 to .005 inches (0.0762 to 0.127 mm). Thus, both the cylindrical body section 13 and the inner sleeve 12 should appear as thin, limp, highly stretchable membranes, in contrast to the drainage tube and neck sections 14, 1 5 with their shape-retaining properties.

In Figures 1 and 5 the sheath 11 and inner sleeve 12 are shown as merging smoothly with one another. Although the sheath 11 and sleeve 12 are indeed permanently integrated, and are formed of essentially the same material, they are actually formed separately to facilitate production and to achieve the desired setback of the sleeve 12 within the neck section 13 of the sheath 11.

Figure 6 illustrates what is believed to be a preferred construction wherein the sleeve 12 is actually a continuation of the cylindrical body section 13 of the sheath. The neck section 1 5 is permanently joined to the body section 13 at 22.

Such a construction may be made in accordance with the steps depicted in Figures 7-11.

Figure 7 shows a dipping form 23 having a support shaft 24 that may be mounted upon any suitable reciprocable mechanism (not shown) for dipping the form 23 into a suitable bath of liquid latex. Prior to any dipping operations, an openended latex tubular member 25 is stretched upon the cylindrical portion of the form 23 (Figure 8).

Such a fitting and stretching operation may be most readily performed starting with the tubular member 25 in fully rolled condition. The rolled annulus is then simply slipped upwardly onto the lower end of the form 23, is advanced until the reduced opening 19 at the member's lower end is stretched to receive the lower end of the cylindrical portion of the form, and the annulus is then unrolled. Except for the provision of the opening 19 at its lower end, the tubular member 25 is generally similar to a conventional latex condom.

While some stretching of the upper portion of member 25 necessarily occurs as that member is fitted upon the form 23, the greater stretching occurs at the lower portion of that member because in its relaxed state such lower portion is provided with a rounded taper leading to the opening 19 (Figure 7). It is the stretched lower portion of the tubular member 25 that will ultimately become the distal portion 12a of the sleeve 12 of the finished catheter (Figure 8). The upper portion, subjected to only minimal stretching, is to become the cylindrical section 13 of the sheath 11.

The form 23 with the elastic tubular member 25 stretched thereon is then subjected to successive steps to produce the neck section 15 and drainage tube section 14 of the final catheter 10. Figure 9 indicates that the form 23 is first lowered to a level x-x in a solution or suspension of a suitable release agent that will prevent latex solution from adhering to the portion of the outer surface of the member 25 treated thereby. An alcohol suspension of diatomaceous earth marketed under the designation Snow Floss by Johns-Mansville Corporation, New York, New York, has been found particularly effective, but other release agents having similar properties may be used.Thereafter, the form 23 is lowered into an aqueous slurry of calcium nitrate or other suitable activator capable of causing a thickening of the latex layer to be subsequently formed by a dipping process, all as well known in the art, and diatomaceous earth. It will be observed that the level y-y to which the form 23 is lowered into the activator slurry is spaced below the level x-x of the release agent treatment (Figure 10).

After removal of the form from the activator slurry, the coating is allowed to air dry for a short interval (1 to 3 minutes), and the form is then slowly dipped into a latex bath to a level z-z spaced above x-x as indicated in Figure 11. The form should remain within the bath for an interval within the range of about 4 to 5 minutes; thereafter, the form is removed, dipped in and out of a coagulant solution of calcium nitrate in alcohol. One or more additional dippings into the latex solution, followed by exposure to coagulant, may be undertaken to develop the desired wall thickness. Thereafter, the form or mandrel with the dip coating thereon is placed in an oven at approximately 1 35OF (57.20C) for 40 minutes to cure the latex.The form and nearly completed catheter retained thereon are introduced into a water bath maintained at approximately 1 600F (71.1 OC) for an interval of 30 minutes or more to leach impurities therefrom. Following the leaching step, the catheter is stripped from the form or mandrel, treated with talc to prevent the latex from sticking to itself, and dried. The catheter is completed by cutting away the tip to form the opening at the distal end of the drainage tube section. The end result is a catheter as generally depicted in Figures 1 and 5 but in which the layers are formed or joined in the manner specifically illustrated in Figure 6.

Effective bonding between the two layers of latex may be enhanced by the use of solvents or adhesives applied to the annular zone of the tubular member 25 between lines x-x and y-y.

It has been found, however, that an effective bond sufficient to permanently integrate the two layers may be simply achieved by dipping the tubular member 25 into a bath of the coagulant described above following the step of fitting the member 25 upon mandrel 23 (Figure 8) and before the step of dipping the form into the release agent (Figure 9).

The coagulant coating should be air dried for a short interval (approximately one minute) prior to the dipping step of Figure 9.

The external catheter of Figures 1 and 5 may also be made in accordance with the method steps depicted in Figures 13-1 7 to produce a construction having the particular arrangement of layers shown in Figure 12. In that embodiment, the inner sleeve 12 is formed from the pre-formed tubular member 125 stretched upon the form or mandrel 23, and the cylindrical section 13, neck section 15, and drainage tube section 14 are then formed by a dipping process and are thus integrated with the tubular sleeve 12. The procedural steps are similar to those described in connection with Figures 7-11 1 except that the tubular member 125 is relatively short and the cylindrical section 1 3 of the sheath 11 is formed during the dipping process rather than being provided as an extension of the pre-formed tubular member.

Specifically, the open-ended latex tubular member 125, having a tapered lower end with a reduced opening 19, is stretched over the form 23 into the position depicted in Figure 14. The form 23 is dipped into a coagulant bath and, following an air-drying interval of approximately one minute, is then dipped into a solution or suspension of the release coating material to a level x-x represented in Figure 15. The form 23 is then dipped into the activator bath of calcium nitrate solution to level y-y (Figure 16) and, after an airdrying period of approximately 2 minutes, is successively dipped into latex and coagulant baths.The latex-dipping steps are essentially the same as previously described except that the form 23 is lowered into the latex and coagulant baths to a level w-w near the upper end of the cylindrical body of the form or mandrel 23 (Figure 17). The leaching, stripping, and trimming steps are the same as previously described.

It is to be noted that in both methods the tapered portion of the tubular member 25 or 125 is pre-formed and stretched upon the mandrel. In both instances, when the dipping processes are completed and the catheters are stripped from the mandrels, the stretched inner sleeves 12 are free to contract and thereby produce the setback depicted in Figures 1, 5, 6, and 12. Specifically, the released distal portions of the sleeves retract axially and proximally to produce the axial spacing between sleeve opening 19 and sheath opening 16, and also retract inwardly to form the annular spacing 20 (Figure 5).

The catheter would be rolled prior to use, and would normally be marketed in the rolled condition depicted in Figure 2. It will be observed that the annular roll 27 is of double thickness, being formed of both the cylindrical body section 13 of the sheath 11 and also a substantial length of sleeve portion 12. The reduced opening 19 at the distal end 12a of the sleeve 12, as well as the material of the sleeve 12 immediately surrounding that opening 19, are therefore fully exposed at the mouth of the rolled catheter.

In use of the external catheter 10, a patient first applies an adhesive pad 30 to the penis 31 as generally illustrated in Figure 3. The particular pad 30 shown in the drawings is the pad disclosed in the aforementioned co-pending application; however, it is to be understood that while such a pad is particularly suitable, other types of adhesive pads may be used. The pad might, for example, be a spiral wrapping of adhesive material as disclosed in U.S. patent 4,187,851 and in other prior art.

The particular pad shown in Figure 3 is preferred because the ring portion 30a disposed behind the corona 32 of glans 33 provides a smooth annular surface for sealing contact with the catheter 10, thereby preventing fluid backup and leakage, while the rearwardly (proximally) extending strap portions 30b act primarily as retaining elements for adhesively holding the sheath 11 in place, thereby preventing disruption of the fluid-tight seals in the annular zone. The pad 30 may be formed of any suitable resilient material which is not only deformable but also compressible and at least somewhat elastically recoverable. To obtain these properties, the sealant pad may be prepared from a composition composed principally of an elastomeric material such as synthetic or natural rubber.One such material is described in United States patent 2,570,182, being composed of a blend of nitro rubber and polyvinyl chloride. A material of this kind has been sold under the name "Ensolite", by Uniroyal, Inc. Its use in a sheet arrangement for a male urinary drainage device is described in United States patent 4,187,851.

Another such material is composed principally of polyisobutylene. This material has been used in ostomy rings and blankets, and has been sold under the same "Crixiline" by Danal Laboratories, Inc., St. Louis, Missouri. Other suitable materials can be formulated from gelled mixtures of hydrocolloids such as karaya or carboxymethyl cellulose and polyhydroxy alcohols such as glycerin or propylene glycol, which preferably includes a few percent of fumed silica, as described in co-pending application Serial No.

185,003, filed September 8, 1980 for "Protective Sealing Composition in Molded Form for Surgical Drainage Openings", having a common assignee with the present application. Also, to further improve the desired properties of such compositions for use in the present invention, a minor proportion of polyacrylamide resin can be incorporated, and cross-linked by gamma irradiation. See United States patents 4,115,339 and 4,258,715.

The catheter 10 is unrolled over the penis in the manner shown in Figures 3 and 4. Specifically, the rolled catheter is positioned with the exposed apertured portion of the sleeve 12 in contact with the glans 33, and the catheter 10 is then unrolled to allow the sleeve 12 to retract into snug contact with the glans. The proximal end portion 12b of the sleeve 12, and the cylindrical body section 13 of the sheath 11, contact the adhesive pad 30 as illustrated in Figure 4. The distal end portion 12a of the sleeve 12 may also be brought into contact with the adhesive pad 30 depending on how closely the pad 30 is positioned to the corona 32.

Since the distal portion 12a of the sleeve 12 is under slight tension when the external catheter is properly fitted upon the wearer, most of the surface area of the glans, and the areas of the penile shaft and the adhesive pad 30 proximal to the glans, are protected by the sleeve against direct liquid contact. Should there be a surge in the discharge or urine, an uncontrollable occurrence not infrequently associated with spinal injuries, substantial space is provided within the neck section 1 5 and the convoluted portion of the drainage tube section 14 to accommodate that surge. Ballooning of the sheath 11 and the development of back pressure may nevertheless occur, as indicated in broken lines in Figure 4.

However, should such back pressure develop, such pressure would have the effect of urging the distal end portion 1 2a of the sleeve 12 into even tighter contact with the glans 33, thereby reducing the possibility of leakage. Furthermore, any such back pressure applied to the sleeve 12 in the vicinity of the adhesive pad 30 will tend to increase the force of contact between the sleeve 12 and pad 30 and further reduce the possibility of leakage. The result is that the external catheter 10, when used in combination with a suitable adhesive sealing pad, is highly effective in avoiding problems of leakage should sudden surges of fluid, accompanied by the development of back pressure, take place.

It is believed apparent that the external catheter also operates to protect the adhesive seals between pad 30, catheter 10, and penis 31 against exposure to liquid under normal conditions of use, thereby resulting in a combination which should be expected to give the wearer greater security against leakage for longer wearing intervals. Minimizing deterioration of the pad and its sealing properties, as well as the greater comfort arising from reduced continuous exposure of the glans and shaft to the back flow of urine, are significant advantages of this construction.

A presently preferred composition for use in preparing the sealant pads 30 comprises a mixture of hydrocolloid, polyhydroxy alcohol, fumed silica, and polyacrylamide. A general formula for this type of composition is set out below.

General Formula Ingredients Parts by Weight Hydrocolloid 1 5-25 Polyhydroxy alcohol 50-70 Fumed silica 1-3 Polyacrylamide resin 5-20 In the above formula, the hydrocolloid may be karaya gum or other natural hydrocolloid such as gelatin, pectin, etc., or a synthetic gum such as carboxymethyl cellulose or hydroxyethyl cellulose, or mixtures thereof. The polyhydroxy alcohol is preferably glycerin, or mixtures of glycerin and propylene glycol, but other polyhydroxy alcohols can be used. An example of suitable fumed silicas are the Cab-0-Sil products of Cabot Corporation, Boston, Massachusetts. The polyacrylamide resin may be a "Reten" resin of Hercules, Incorporated, as described in United States patents 4,115,339 and 4,258,271.The cited patents also describe gamma irradiation cross-linking of the polyacrylamide resins, which is a desirable procedure in preparing the material for the sealant pads of the present invention. An example of a presently preferred specific formulation is as follows: Specific Formula Ingredients Weight % Karaya powder 15.00 Sodium carboxymethyl 5.00 cellulose Polyacrylamide (non-ionic) 10.00 Polyvinyl alcohol 5.00 Fumed silica 2.00 Glycerin 59.73 Propylene glycol 3.05 Methyparaben 0.09 Propylparaben 0.02 Butylparaben 0.11 100.00% In compounding the foregoing ingredients, a mixture can first be prepared of the liquid ingredients (glycerin, propylene glycol, and the parabens).Fumed silica is then dispersed in the liquid mixture, and thereafter the other powder ingredients are added (karaya, carboxymethyl cellulose, polyacrylamide, and polyvinyl alcohol).

The completed mixture is then molded to form the pads, or formed into sheets for use in preparing the pads. Either in pad or sheet form, the material is preferably subjected to gamma irradiation, preferably from a Cobalt-60 radiation source. The amount of radiation employed should be sufficient to sterilize the material, and to achieve crosslinking of the polyacrylamide resin. For example, a radiation level of 2.5 megarads (25 kGy) is satisfactory. To increase tackiness, the final product is then coated with a conventional medical-grade vinyl acrylic pressure sensitive adhesive.

While in the foregoing, embodiments of the invention have been disclosed in considerable detail, it will be understood by those skilled in the art that many of these details may be varied without departing from the scope of the claims.

Claims (11)

1. An external catheter for a male urinary drainage system, comprising a tubular sheath formed of soft elastic material having a thinwalled cylindrical body section, a reduced drainage tube section, and a tapered neck section disposed therebetween; said neck and drainage tube sections having a wall thickness substantially greater than that of said cylindrical body section; said sheath also including a tubular inner sleeve of soft elastic material; said sleeve having a distal end portion disposed within said neck section and a proximal end portion disposed within said cylindrical body section; said distal end portion of said sleeve having an unstretched outside diameter smaller than the inside diameter of said neck section to define an annular space therebetween, and terminating in a reduced distal opening spaced axially from the distal end of said neck section; said proximal end portion of said sleeve merging with said cylindrical body section.

2. A catheter according to Claim 1, in which said drainage tube section is provided with a plurality of annular convolutions adjacent the distal end of said neck section.

3. A catheter according to Claim 2, in which said convolutions are graduated in increasing size towards said neck section.

4. A catheter according to any one of Claims 1 to 3, in which said distal end portion of said sleeve is provided with a rounded taper extending from said proximal end portion to said reduced distal opening.

5. A catheter according to any one of Claims 1 to 4, in which said sleeve has a wall thickness substantially thinner than that of said neck and drainage tube sections.

6. A catheter according to any one of Claims 1 to 5, in which said cylindrical body section and said sleeve are integrally formed and said neck section is sealingly secured to said cylindrical body section about said sleeve.

7. A catheter according to any one of Claims 1 to 5, in which said body and neck sections of said sheath are integrally formed and said sleeve has its proximal end portion sealingly secured to the interior of said cylindrical body section.

8. A catheter according to any one of Claims 1 to 7, in combination with a pad formed of resilient, compressible, deformable, and water-resistant material; said pad being provided with tacky adhesive inner and outer surfaces; said pad being adapted to extend about the penis with said inner surface in adhesive sealing engagement therewith and said outer surface adhesively and sealingly engaging said sheath.

9. A combination according to Claim 8, in which said pad includes a ring portion adapted to adhesively engage inner surface portions of said cylindrical body section and said sleeve to form a fluid-tight seal therewith.

10. A combination according to Claim 9, in which said pad also includes at least one integral strap portion projecting from said ring portion and dimensioned to extend proximally along a penile shaft for adhesively and sealingly engaging both said shaft and said cylindrical body section.

11. A method of making an external catheter, comprising stretching a pre-formed open-ended tubular latex member upon a cylindrical mandrel so that said member assumes a diameter larger than its unstretched diameter; then treating an annular end portion of the outer surface of said member to prevent liquid latex from bonding thereto while at the same time leaving an adjacent annular portion of said member untreated; then dipping said mandrel into a latex bath to cover said treated and untreated portions of said member; and then curing said latex and stripping the catheter so formed from said mandrel, whereby, when said catheter is stripped from said mandrel, said treated portion of said pre-formed tubular member retracts from the portion of said catheter formed by said dipping and curing steps and extending thereabout, and returns to an unstretched state.

11. A method of making an external catheter, comprising stretching a pre-formed open-ended tubular latex member upon a cylindrical mandrel so that said member assumes a diameter larger than its unstretched diameter; then treating an annular end portion of the outer surface of said member to prevent liquid latex from bonding thereto while at the same time leaving an adjacent annular portion of said member untreated; then dipping said mandrel into a latex bath to cover said treated and untreated portions of said member; and then curing said latex and stripping the catheter so formed from said mandrel, whereby, when said catheter is stripped from said mandrel, said untreated portion of said pre-formed tubular member retracts from the portion of said catheter formed by said dipping and curing steps and extending thereabout, and returns to an unstretched state.

12. A method according to Claim 11, in which said pre-formed tubular latex member has its outer surface exposed to a latex coagulant between said stretching and treating steps.

13. A method according to Claim 11 or 12, in which said pre-formed open-ended tubular latex member has one end portion provided with a rounded taper leading to a reduced end opening when said member is in unstretched condition.

14. A method according to any one of Claims 11 to 13, in which a section of said mandrel projects below said tubular member after said member has been stretched upon said mandrel, including, following said treating step and prior to said dipping, coating said section of said mandrel and a lower annular portion of said treated portion of said member with an activator capable of promoting an increased thickness of latex to form thereon during said dipping step.

15. A method according to any one of Claims 11 to 14, in which said pre-formed tubular member extends a substantial portion of the length of said mandrel; said dipping including introducing said mandrel into said latex bath to a depth substantially less than the full length of said member.

16. A method according to any one of Claims 11 to 14, in which said member is substantially shorter than the length of said mandrel; said dipping including introducing said mandrel into said latex bath a distance approximately the length of said mandrel and well above the upper limits of said member.

17. An external catheter constructed, arranged and adapted to operate substantially as herein described with reference to, and as shown in, the accompanying drawings.

18. An external catheter according to any one of Claims 1 to 7 or 17 combined with a pad, constructed, arranged and adapted to operate substantially as herein described with reference to, and as shown in, the accompanying drawings.

19. A method of making an external catheter substantially as herein described with reference to, and as shown in, the accompanying drawings.

20. An external catheter made by a method according to any one of Claims 11 to 16 or 19.

New claims or amendments to claims filed on 3 August 1982 Superseded claim:- claim 11 New or amended claims: