JPH0365976B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a male urine collection device and its external catheter.

A male urination device consisting of a thin elastic external catheter and a basal adhesive sealant pad to hold the catheter in place and create an effective seal to prevent urine reflux and leakage was developed in 1981.
No. 271,082, filed on June 5, 2006. The pad is formed from a compressible, deformable, water-resistant and resilient sealing material and includes a ring portion adapted to seal around the penis at or shortly after the glans penis, and a ring portion protruding from the ring portion suitable for sealing around the penis. and a pair of integral bands intended to extend inwardly (toward the center) along the axis. The band serves primarily to provide catheter retention, while the ring serves primarily as a barrier to backflow of fluid in cooperation with the retained catheter and penis.

The external catheter in said patent application is provided with a gradual sizing convolution in the neck region between the cylindrical body of the catheter and its reduced drainage tube section. Such convolutions allow for axial and radial expansion and contraction, thereby occlude the lumen that would otherwise occur or reduce the effectiveness of the seal between the pad and the catheter or the pad and the penis or both. Absorbs tensile forces that may reduce Furthermore, the convolution increases the internal capacity of the cervical region to accommodate sudden urination, thereby reducing the possibility of fluid regurgitation or dislodgement of or damage to the urination device under such circumstances.

Nevertheless, conditions arise where a surge of fluid creates a back pressure that weakens the seal between the pad and the catheter or between the pad and the penis, causing a leak. Should the neck of the catheter become dilated or distorted due to fluid pressure, the forces generated by such pressure would tend to cause the inner surface of the catheter to move laterally out of sealing contact with the annulus of the pad. do. Furthermore, apart from the possibility of leakage occurring due to fluid surges causing failure of the adhesive seal, gradual deterioration of the seal occurs due to exposure to urine over a long period of time;
Alternatively, there is always a risk that the material of the pad may tend to deteriorate due to continuous exposure to fluids, resulting in unwanted backflow or leakage.

U.S. Pat. No. 2,940,450 discloses a urinary drainage device in the form of an external catheter connected to a flexible tube leading to a suitable container, the catheter being pulled together to create a secure fit. It is held in place by a string. No. 3,835,857, an elastic adhesive tape is wrapped around the catheter in place of a drawstring, and US Pat. No. 3,863,638 uses a liner to reduce leakage and promote patient comfort. It is placed under the catheter. US Patent No. 4187851
The '999 patent discloses a method of forming such a liner in place by wrapping a double-sided adhesive band around the penile shaft prior to use of the elastic external catheter.

These devices, which have the advantage of being easy and quick to use, tend to be less effective due to backflow stagnation and prevention, while those that are more satisfactory in the latter respect are often relatively difficult to use. It is often prone to discomfort and urethral contracture in patients who have undergone this procedure. Ease of use and removal is particularly important. This is because patients who are unable to control themselves may have other disabilities that make it difficult, if not impossible, to perform complex operations. Other U.S. patent numbers reflecting the state of the art are 3364932, 3721243, 3361857, 3511241,
2891546, 4022213, 3526227, 3353538, 1423537,
1015905, 3604424, 4239044, 1490793, 3559651,
and 3405714.

A first aspect of the invention lies in the recognition of the problem of maintaining an effective adhesive seal under the conditions described above;
A second aspect recognizes that such seal degradation or rupture is prevented by providing the outer catheter with a resilient tapered inner sleeve disposed within the neck of the envelope. It is in. During use of the catheter, the sleeve is stretched into sealing engagement with the glans, thus displacing fluid posteriorly or centrally toward the adhesive seal formed between the adhesive pad, the cylindrical portion of the catheter, and the penis. provide a barrier to try to prevent Should a surge of urine in the neck of the catheter cause back pressure, such pressure would only tend to increase the effectiveness of the liquid barrier formed between the glans and the sleeve. Additionally, where the sleeve annulus is in direct contact with the adhesive pad, such back pressure increases rather than reduces the contact force between the sleeve and the adhesive pad, thereby promoting a more effective fluid-tight seal. .

Briefly, the device comprises an outer catheter or jacket having a cylindrical body portion, a tapered neck leading therefrom, and a reduced drainage tube portion of the type disclosed in the above-identified U.S. patent application. in combination with a resilient skin barrier adhesive pad, the disclosures of which are hereby incorporated by reference. Located within the envelope and forming a durable portion thereof is a tubular interior of soft elastic material having a distal end disposed within the neck and a proximal end that joins the main body portion of the envelope. It's a sleeve. Since the sleeve is tapered at the distal end, an annular space is provided between the distal end of the sleeve and the inner surface of the neck of the jacket. A fluid-tight seal is formed between the sleeve and the glans, and any increase in pressure in the annular space around the sleeve only tends to bring the sleeve into tighter sealing engagement with the glans. When the catheter is worn such that the proximal portion of the sleeve engages the ring portion of the adhesive pad, an increase in fluid pressure around the sleeve results in an increased adhesive seal between the sleeve and the pad. This result has the advantages of adhesive deposits in terms of patient comfort and convenience, as opposed to conventional devices requiring belts, pullers, and the like, while also providing a high degree of resistance to fluid backflow and leakage. External catheter with safety features of

The catheter is formed in a dipping process that includes a preliminary step in which a preformed tubular member is stretched through a dipping formation to ultimately become an inner sleeve. In its unstretched and unstressed state, the tubular member has a distal end that is tapered and terminates in a reduced distal opening. After stretching the tubular member over the mold, the distal end of the member is treated to prevent liquid latex from adhering thereto. Thereafter, the molded part is immersed into a latex bath and the latex coating is then cured to create the outer shell, or at least the portion of the outer shell surrounding the inner sleeve. When the catheter is removed from the molding, the sleeve returns to its original, tension-free state, thereby creating an annular space between the outer end of the sleeve and the inner surface of the neck of the jacket.

Other features, objects and advantages of the invention will become more apparent from the drawings and description.

Referring to the drawings, numeral 10 generally indicates an external catheter formed from soft, highly elastic natural or synthetic rubber. Natural latex is preferred, but other elastomers with similar properties may be used. The catheter includes an elongate outer jacket 11 and an inner sleeve 12, the two of which are integrated or permanently joined in a manner described below.

Referring to FIG. 1, the jacket 11 includes an elongated cylindrical section 13, a reduced drain section 14, and a tapered neck section 15 disposed therebetween. The wall thickness of the cylindrical portion 13 is substantially smaller than the wall thickness of the neck and drain portions. For example, the cylindrical part
They have wall thicknesses in the general range of 0.0152 cm (0.006 inch) to 0.0254 cm (0.010 inch) and are generally too thin or weak to hold their cylindrical shape without support. In contrast, the wall thickness of the drain and neck walls is 0.127 cm (0.050 in.) or greater, and such portions retain their indicated shape in the absence of distorting forces and Thick enough to spring back to the illustrated shape when the contorting force is removed.

At the anterior axis or distal end, the neck 15 is provided with a circular taper leading to a reduced opening 16 . Drain section 14, which merges with tapered neck 15, includes a plurality of convolutions or annular extensions 17 and 18.
Two such convolutions of progressive dimensions are depicted, the purpose of which is to allow for greater extensibility, bending, and twisting of the drain tube section when the device is in use. , and to reduce the chances of lumen defects or obstructions occurring. Also, since the interior of the drain section is expanded with such convolutions, the convolution increases the fluid capacity of the section and also provides a reservoir to accommodate surges of fluid when the device is in use. .

The inner sleeve 12 has a distal end 12a disposed within the neck of the jacket and a proximal end 1 within the cylindrical body of the jacket.
2b. This relationship is most clearly depicted in the generalized enlarged view of FIG. 5, where the mesial end has approximately the same cross-sectional dimensions as the cylindrical body and merges smoothly with that cross-section; One end 12
a is shown tapering forward and inwardly, terminating in a reduced distal opening 19.
The aperture 19 is conveniently located behind (i.e. centrally relative to) the aperture 16 at the distal end of the neck 15. The latter arrangement also places an annular space 20 between the outer surface of the distal end of the sleeve and the inner surface of the neck 15. The wall thickness of the sleeve 12 may vary, but in order to ensure compliance, adequate sealing, and wearer comfort, such wall thickness is similar to that of the relatively thin cylindrical body portion 13 of the outer jacket. (i.e. from 0.00762 cm to 0.0127 cm). Both the cylindrical body part 13 and the inner sleeve 12 should therefore be like thin, weak, and highly stretchable membranes, in contrast to the shape-retaining drain and neck parts 14, 15. .

In FIGS. 1 and 5, outer jacket 11 and inner sleeve 12 are shown to fit smoothly together. Although the mantle and sleeve are in fact permanently integrated and formed of essentially the same material, they are designed for ease of manufacture and to achieve the desired posterior placement of the sleeve within the neck of the mantle. , are actually formed separately. FIG. 6 illustrates what is considered a preferred construction, in which the sleeve 12 is actually a continuation of the cylindrical body of the jacket. The neck portion 15 is permanently connected to the body portion 13 at 22. Such a structure is the 7th to 1st
It is made according to the steps depicted in Figure 1.

FIG. 7 shows an immersion molding section 23 having a support shaft 24.
, the support shaft being mounted on any suitable reciprocating mechanism (not shown) for immersing the molded part into a suitable bath of liquid latex. Prior to any dipping operations, the open-ended latex tubular member 25 is stretched over the cylindrical portion of the forming section (FIG. 8). Such snapping and stretching operations occur almost immediately starting with the tubular member 25 in a fully rolled state. The rolled annular portion is then simply snapped upwardly onto the lower end of the molding section 23 such that the reduction opening 19 at the lower end of the annular member receives and stretches the lower end of the cylindrical portion of the molding section. The annulus is then unwound. Opening 1 at the lower end
Other than the arrangement at 9, the annular member 25 is generally similar to a conventional latex condom.

While some stretching of the upper part of the tubular member 25 necessarily occurs as the member is fitted over the molding 23, greater stretching occurs in the lower part of the member, since in its relaxed state this The lower part is the opening 19 (Fig. 7).
This is because it has a circular taper that leads to. Sleeve distal end 12 of the finished catheter (Figure 8)
What ends up at a is the elongated bottom of the annular member. The upper part, which undergoes only minimal stretching, becomes the cylindrical part 13 of the jacket.

The molded section 23 with the elastic tubing member stretched thereon is then subjected to successive immersion stages creating the final catheter neck and drain section. In Figure 9 it is shown that the molded part is first dipped to level x-x with a solution or suspension of a suitable mold release agent which prevents the latex solution from adhering to the treated surface. ing. John's-Mansveillet in New York, New York
Corporation (Johns-Mans-ville)
Snow Floss (Snow Floss) by Snow Corporation
An alcoholic suspension of diatomaceous earth sold under the name Floss has been found to be particularly effective, but other mold release agents with similar properties may be used. Thereafter, the molded part is immersed in an aqueous slurry of calcium nitrate or other suitable activator, which allows the thickening of the latex layer to be formed by a dipping process and diatomaceous earth, all known in the art. be done. The level y-y at which the molded part is immersed in the activator slurry is below the level xx-x of the mold release agent treatment (Figure 10).

After removal of the mold from the activator slurry, the coating is allowed to air dry within a short period of time (from 1 to 3 minutes), and then the mold is slowly lowered into the latex bath, as shown in FIG. level z-z placed above the level xx-x. The mold should be maintained in the bath for a period of time ranging from about 4 to 5 minutes, after which the mold is removed and immersed in a condensing agent solution of calcium nitrate in alcohol. Sometimes it is served. After exposure to the condensing agent, one or more additional dips into the latex solution may be performed to achieve the desired wall thickness. The mold or mandrel with the dip coating thereon is then heated to approximately 57°C for 40 minutes to cure the latex.
(135〓) Placed in a dekama. The molded part and the nearly completed catheter held thereon are introduced into a water bath maintained at about 71°C (160°C) for a period of 30 minutes or more to strain out impurities. After the straining step, the catheter is stripped from the mold or mandrel, treated with talc to prevent the latex from sticking to itself, and dried. The catheter is completed by cutting the tip to form an opening at the distal end of the waste tube section. The final result is a catheter generally as depicted in FIGS. 1 and 5, where the layers are formed or combined in the manner specifically illustrated in FIG. 6.

Effective bonding between the two layers of latex is enhanced by the use of a solvent or adhesive applied to the annular zone of tubular member 25 between lines xx and y-y. However, an effective bond sufficient to permanently unite the two layers is formed by attaching the annular member 2 on the molding 23 (FIG. 8).
5 and before the step of immersing the molding in the mold release agent (FIG. 9), this can be easily accomplished by immersing the tubular member in a bath of the above-mentioned condensing agent. I understand. The flocculant coating should be air dried for a short period of time (approximately 1 minute) prior to the soaking stage of FIG.

In addition, the external catheter shown in FIGS. 1 and 5 is
To produce a structure with the particular layer arrangement shown in FIG. 12, the method steps depicted in FIGS. 13-17 are followed. In that embodiment, the inner sleeve 12 is formed from a preformed tubular member 125 stretched over a molded section or mandrel 23, from which the cylindrical section 13, neck section 15 and drain section 14 are formed by a dipping process, thus Integrated with a tubular sleeve. The procedure steps 7-11 are similar to those of steps 7 to 11, except that the tubular member 125 is relatively short and the cylindrical portion 13 of the jacket is formed during the dipping step rather than being provided as an extension of a preformed tubular member. It is similar to that described in connection with the figure.

In particular, an open-ended latex tubular member 125 having a tapered lower end with a reduced opening 19.
is stretched over the molding section 23 into the position depicted in FIG. The molded part is immersed in a condensate bath and, after an air drying interval of about 1 minute, immersed into a solution or suspension of mold release coating material to the level xx represented in FIG. . Then the molding part is poured into the activator bath of calcium nitrate solution at level y.
-y (FIG. 16) and, after an air drying period of about 2 minutes, successively into a bath of latex and flocculant. The forming section or mandrel 23 (17th
The latex immersion stage is essentially the same as described above, except that it is lowered to a level w-w near the top of the cylindrical body in FIG. The straining, stripping and trimming steps are the same as described above.

In both methods, the tubular member 25 or 125
It should be noted that the tapered portion of is pre-formed and stretched over the mold. In both instances, when the soaking process is completed and the catheter is peeled from the mold, the stretched inner sleeve 12 does not contract, thereby causing the Make an arrangement. In particular, the loose end of the sleeve retracts axially and centrally to create an axial space between the sleeve opening 19 and the jacket opening 16, and the annular space 20 (the fifth
(Fig.) is retracted inward to form.

The catheter is rolled before use and is sold in the rolled state depicted in FIG. Annular roll 27
It can be seen that it consists of a double thickness formed by both the cylindrical body portion 13 of the jacket and the substantial length of the sleeve 12. The reduced opening 19 at the distal end of the sleeve is thus completely exposed at the mouth of the rolled catheter, as is the material of the sleeve immediately surrounding it.

When using an external catheter, the patient should
Adhesive pad 30 is applied to penis 31 as generally illustrated in the figure. The particular pad shown in the drawings is that disclosed in US Pat. No. 2,710,082, which is particularly suitable, although other types of adhesive pads may be used. The pad is, for example, a helical wrap of adhesive material as disclosed in U.S. Pat. No. 4,187,851 and other prior art. The particular pad shown in FIG.
0a has a smooth annular surface for sealing contact with the catheter, thereby preventing backflow and leakage of fluid, while a rearwardly extending (towards the center) band 30b adheres the jacket in place. This is because it primarily acts as a retaining element for retention, thereby preventing rupture of the fluid-tight seal in the annular zone.

The pad may be formed from any suitable elastic material that is not only deformable but also compressible and at least somewhat elastically recoverable. To obtain these properties, the sealant pad may be formed from a composition comprised primarily of elastomeric materials such as synthetic or natural rubber. One such material is described in US Pat. No. 2,570,182 and is comprised of a mixture of nitro rubber and polyvinyl chloride. This type of material is sold under the name Ensolite by Uniroyal Inc. The use of said material in a seat arrangement for a male urinary device is described in US Pat. No. 4,187,851. Another such material is composed primarily of polyisobutylene. This material is used in artificial stoma rings and blankets for the gastrointestinal tract and is sold under the name Crixiline by Danal Laboratories Inc. of St. Louis, Missouri. Other suitable materials include pending U.S. Patent Application No. 185003, filed September 8, 1980, for "Protective Seal Compositions in Molding for Surgical Drainage Openings," which has a common assignee with the present application. A gel of a hydrocolloid, such as Karaya or carboxymethyl cellulose, and a polyhydroxy alcohol, such as glycerin or propylene glycol, preferably containing a few percent of fumed silica, as described in can be formulated from mixtures. Also, to further enhance the desired properties of such compositions for use in the present invention, polyacrylamide resins may be incorporated in relatively small proportions and cross-linked by gamma irradiation. In this regard, reference may be made to US Pat. No. 4,115,339 and US Pat. No. 4,258,715.

The catheter is unwound over the penis in the manner shown in FIGS. 3 and 4. In particular, the rolled catheter is placed in the exposed opening of the sleeve 12 in contact with the glans 33 and then the catheter is unwound to allow comfortable contact with the glans by pulling back the sleeve. The proximal end of the sleeve and the cylindrical body of the jacket contact the contact pads as illustrated in FIG. The distal end 12a of the sleeve will also come into contact with the adhesive pad 30 depending on how closely the pad is placed relative to the glans crown 32.

Since the distal end 12a of the sleeve is under some tension when the external catheter is properly fitted onto the wearer, most of the surface area of the glans and the area of the penile shaft and adhesive pad 30 close to the glans are Protected by a sleeve against direct fluid contact. In the unlikely event that a surge occurs in the excretion of urine, an uncontrollable occurrence that is not often associated with spinal cord injury, substantial space is available within the neck 15 and in the drain area to accommodate the surge. It is provided within the convolution section. Nevertheless,
A bulge in the envelope and an increase in back pressure occur, as shown by the dashed line in FIG. However, if such back pressure were to increase,
Such pressure forces the distal end 12a of the sleeve onto the glans 3.
3, thereby reducing the possibility of leakage. Additionally, the sleeve 12 near the adhesive pad 30
Any such back pressure applied to the sleeve will increase the contact force between the sleeve and pad and will further reduce the possibility of leakage. In terms of results,
Should a sudden surge of fluid associated with an increase in back pressure occur, the external catheter 10, when used in combination with a suitable adhesive seal pad, is very effective in avoiding leakage problems. .

The external catheter also acts to protect the adhesive seal between pad 30, catheter 10 and penis 31 against exposure to fluids under normal conditions of use, thereby preventing leakage during relatively long periods of wear. It will be clear that this is a combination that is likely to provide greater security to the wearer. Minimizing deterioration of the pad and its seal, and greater pleasure resulting from reduced continued exposure of the glans and shaft to urine reflux, are important advantages of this configuration.

A currently preferred composition for use in preparing sealant pad 30 is comprised of a mixture of hydrocolloid, polyhydroxyalcohol, fumed silica, and polyacrylamide. The general formula for this type of composition is set out below.

General Formula Ingredients Weight Component Bidrocolloid 15-25 Polyhydroxy alcohol 50-70 Humid silica 1-3 Polyacrylamide resin 5-20 In the above formula, the hydrocolloid is gum Karaya or other natural hydrocolloids such as gelatin, pectin, etc. or synthetic rubbers such as carboxymethyl cellulose or hydroxyethyl cellulose, or mixtures thereof. The polyhydroxy alcohol is preferably glycerin,
or a mixture of glycerin and propene glycol, although other polyhydroxy alcohols may be used. An example of a suitable humidified silica is Cab-O-Sil from Cabot Corporation of Boston, Mass.
It is a product. The polyacrylamide resin may be Hercules Incorporated and Reten resins, as described in US Pat. No. 4,115,339 and US Pat. No. 4,258,271. The cited patents also describe Gama radiation cross-linking of polyacrylamide resins, which is a desirable procedure in preparing materials for the sealant pads of the present invention. Examples of currently preferred specific formulations are: Specific Formula Ingredients Weight % Karaya Powder 15.00 Carboxymethyl Cell 5.00 Loose Sodium Polyacrylamide (Non-Ionic) 10.00 Polyvinyl Alcohol 5.00 Humid Silica 2.00 Glycerin 59.73 Propylene Glycol 3.05 Methyl Paraben (Product name of para-hydroxybenzoic acid methyl ester) 0.09 Propylparaben (trade name of para-hydroxybenzoic acid propyl ester) 0.02 Butylparaben (trade name of para-hydroxybenzoic acid butyl ester) 0.11 100.00% When combining the above ingredients The mixture can be initially prepared from liquid ingredients (glycerin, propylene glycol and parabens). The fumed silica is then dispersed into the liquid mixture, after which the other powder ingredients (Karaya, carboxymethyl cellulose, polyacrylamide and polyvinyl alcohol) are added. The completed mixture is then molded to form pads or formed into sheets for use in equipping pads. In either pad or sheet molding, the material is preferably subjected to gamma irradiation, preferably from a cobalt-60 radiation source. The radiation dose used should be sufficient to sterilize the material and achieve cross-linking of the polyacrylamide resin. For example, a radiation level of 2.5 megarads is satisfactory. The final product is then coated with a conventional medical grade vinyl pressure sensitive adhesive to increase tack.

Although embodiments of the invention have been disclosed in considerable detail above, those skilled in the art will appreciate that many of these details may be changed without departing from the spirit and scope of the invention. .

[Brief explanation of drawings]

FIG. 1 is a partially cutaway side view of an external catheter embodying the invention, with the catheter jacket depicted in an unwrapped or unrolled state, and FIG. 2 before use. Figures 1, 3 and 4 similar to Figure 1 showing the jacket in a rolled up state;
FIG. 5 is a generalized partial enlarged cross-sectional view of the catheter showing the relationship between the outer sleeve and the jacket; FIG. ,
FIG. 6 is a partial cross-sectional view illustrating the relationship between the jacket and sleeve in a first embodiment of the catheter, and FIGS. 7-11 illustrate the sequence of steps in forming a catheter having such a relationship of components. diagram,
Figure 12 is a partial sectional view depicting the second embodiment;
3-17 illustrate the steps for forming a catheter having the relationship of components represented by the second embodiment. 10...catheter, 11... jacket, 12...
Sleeve, 12a...Distal end, 12b...Mesial end, 13...Cylindrical body part, 14...Drain pipe part, 1
5... Neck, 17, 18... Rotating part, 19... Opening, 20... Annular space, 23... Molded part (mandrel), 25... Tubular member, 30... Adhesive pad,
30a...Ring part, 30b...Band part.

Claims (1)

[Scope of Claims] 1. A tubular jacket made of a soft elastic material having a cylindrical main body with a thin wall, a drain pipe having a smaller diameter, and a drain tube disposed between the two. a tapered neck portion, the tapered neck portion and drain tube portion having a wall thickness that is substantially greater than a wall thickness of the cylindrical body portion;
The tubular jacket has a neck spaced axially and radially from the neck while the cylindrical body of the jacket is secured to the penile shaft by adhesive means. In an external catheter for a male urinary device adapted to be attached as such, said outer sheath 11, 11' includes an inner sleeve 12, 12' of soft elastic material, said inner sleeve 12, 12' has a proximal end which is permanently integral with said cylindrical body part 13, 13' and tapers towards a distal end 12a within said neck part 15, 15';
It also has a narrow opening 19 inside.
The opening 19 extends radially and axially from the neck 15, 15' and the distal opening 16 of the neck 15, 15' in such a way that the mantle 11, 11' When placed on top of
The inner sleeve 12, 12' elastically and sealingly covers the glans and covers the cylindrical body portion 1.
3, 13' and the penile shaft, in which case the outer surface of the inner sleeve 12, 12' is spaced such that it is maintained in place by said adhesive means effective between said inner sleeve 12, 12'; the neck 15;
15', an annular space 20 is formed around the glans, and the annular space 20 serves for temporary accumulation of a large amount of urine produced. external catheter. 2. The external catheter for a male urinary device according to claim 1, wherein the drain tube portion includes a plurality of annular convolutions adjacent to the distal end of the neck. 3. An external catheter for a male urinary device according to claim 2, wherein the convoluted portion is progressive in size increasing towards the neck. 4. An external catheter for a male urinary device according to claim 1, wherein the distal end of the inner sleeve includes a circular taper extending from the proximal end to the narrow opening. 5. An external catheter for a male urinary device according to claim 1, wherein the internal sleeve has a wall thickness that is substantially less than the wall thickness of the neck and drainage tube sections. 6. The male according to claim 1, wherein the cylindrical body portion and the inner sleeve are integrally formed, and the neck portion is hermetically secured to the cylindrical body around the inner sleeve. External catheter for urinary drainage device. 7. The body and neck of the jacket are integrally formed, and the inner sleeve has a proximal end hermetically secured within the cylindrical body. An external catheter for a male urinary device according to item 1. 8. Claim 1, wherein the adhesive means is adhesive and is provided for adhering the cylindrical body portion of the outer sheath to the wearer's penis shaft behind the glans. An external catheter for a male urinary device according to any one of items 7 to 8. 9. The external catheter for a male urinary device according to claim 8, wherein the adhesive means is provided on the inner surface of the cylindrical body portion of the jacket. 10. The adhesive means comprises a pad made of an elastic, compressible, deformable and water-resistant material, the pad having adhesive inner and outer surfaces. , thereby causing the pad to extend around the penis shaft into adhesive sealing engagement with the penis shaft, and
9. An external catheter for a resilient urinary drainage device as claimed in claim 8, the outer surface of which is in adhesive sealing engagement with the inner surface of the cylindrical body portion of the jacket. 11. Claim 1, wherein said part includes a ring portion mounted in adhesive engagement with said cylindrical body portion and an inner surface portion of said inner sleeve to form a fluid-tight seal therebetween.
An external catheter for a male urinary device according to item 0. 12 said pad protruding from said ring portion and having at least one integral dimension extending in a central direction along the penile shaft for adhesively sealing engagement with both the penile shaft and said cylindrical body; 11. An external catheter for a male urinary device according to claim 10, including a band.