AU665095B2 - External male catheter and applicator - Google Patents

Description

P/00/01 1 ReguLation 3.2

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

I C 4 tt TO BE COMPLETED BY APPLICANT Name of Applicant HOLLISTER INCORPORATED Actual Inventors: Michael Metz; Joseph J. Lantolf; Susan C. Gorski r L t Address for Service: CALLINAN LAWRIE, 278 High Street, Kew, 3101, Victoria, Australia Invention Title: "EXT 5 ERNAL MALE CATHETER AND APPLICATOR" The following statement is a full description of this invention, including the best method of performing it known to us:o S S. S 0 •5 Ct r •r o o o ooe *oi

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EXTERNAL MALE CATHETER AND APPLICATOR Background The use of external catheters for male urinary drainage systems is well known, as disclosed in U.S. patents 4,378,018, 4,187,851, 3,863,638 and 3,835,857.

Essentially, such a system comprises an elastic sheath adapted to fit over the user's penis, the sheath having an outlet at its distal end connected to a tube leading to a suitable collection receptacle. The sheath includes a cylindrical body portion that fits over the penile shaft, a tapered neck portion that functions as a surge chamber near the distal end of the sheath, and a reduced drainage tube portion that extends beyond the neck portion. In a preferred construction, the sheath also includes an inner sleeve portion for sealingly (but non-adhesively) engaging the head or glans of the penis.

External catheters also quite commonly have an annular layer of pressure-sensitive adhesive on the inner surfaces of their cylindrical portions to retain the sheaths in place. Whether adhesive-coated or not, such catheters are usually marketed in rolled form with instructions that the sheaths be unrolled during application in essentially the same manner as a prophylactic condom.

Experience has revealed that such an application procedure is more difficult than it sounds. Orienting and unrolling a sheath with respect to a flaccid (and possibly 4r 4t

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-2retracted) penis is difficult even for a patient that retains manual dexterity and is capable of applying such a product to himself; it is obviously more difficult for a nurse or other attendant who lacks the tactile feedback that would assist a patient in carrying out the procedure on himself. The problems are compounded by the fact that a nurse undertaking such a procedure would normally wear 4 o surgical gloves and, should such gloves happen to contact the adhesive of the catheter as it is being unrolled, the gloves and catheter may adhere strongly to each other.

Experience indicates that problems of applying such a catheter tend to be reduced if a nurse holds the penis in one hand and directs it into the opening of the rolled catheter held in the other, and then, immediately after commencing the unrolling operation, externally grips the sheath-covered glens and stretches or extends the penis as the unrolling operation is continued. It is believed, however, that nurses sometimes fail to perform such procedures completely, or with sufficient patience and care, because they are concerned about possible discomfort or injury to the patient, or are rushing to perform other healthcare duties, or simply because they find themselves uncomfortable making such direct and extended contact with the limp penis of an incontinent patient. Often the result is that such an external catheter is improperly or incompletely applied, causing discomfort and resulting in leakage of urine when the drainage sylstem is in use.

-3- Summary of the Invention This invention is concerned broadly with a combination of an external male catheter and a tubular applicator which encloses a portion of a substantially non-stretchable friction-reducing sleeve for facilitating application of the catheter to the penis. While finger contact with the penis may be made at an initial stage in the application procedure to insure that the penis and the applicator are properly oriented with respect to each other, even such limited contact is seldom necessary. Later, during the 44*44* actual application of the elastic sheath to the penis, both hands are in contact not with the penis but with the applicator (and possibly with a portion of the sheath carried by it), one hand being used to grip and pull the outlet section of the catheter that partially projects Ir I through the open rear end of the applicator tube and the other hand being used to direct the applicator tube, maintaining its entrance opening in close proximity to the penis and, if desired, urging the cylindrical body portion of the sheath towards that entrance opening.

The invention is particularly effective when used with an external catheter that has an inner sleeve for sealingly engaging the head or glans of the penis. It is also desirable if the catheter sheath is of the adhesive-coated type, since the combination of this invention allows such a catheter to be applied to a patient with little or no risk -12 Wjagwmi 4, -4that the pressure-sensitive adhesive coating of the sheath will be contacted by the user's fingers.

Briefly, the combination takes the form of an applicator tube supporting an external male urinary catheter with the distal portion of the catheter (which includes its tapered neck section and its outlet section) disposed partially within and partially extending out of the tube while its cylindrical body section is everted and extending externally about the tube. A flexible, tubular.

and lonjitudinally non-stretchable, friction-reducing sleeve is interposed between the inner and outer surfaces of the tube and the catheter to reduce static and sliding a,**r friction. The pulling force exerted on the outlet section of the catheter causes the portion of the catheter external to the rigid applicator tube to be reverted and pulled into and through the tube and, at the same time, causes the cylindrical body portion of the catheter to assume its c..o final reverted position about the penile shaft.

Since an adhesive-coated catheter is not supported in rolled condition upon the applicator tube, at least in the sense that inner and outer surfaces of the sheath are in direct concentric contact with each other, the outer surface of the sheath does not require a release coating of the type disclosed in prior patents such as Re. 33,206 and 4,581,026. A silicone release coating is typically applied to the outer surface of a conventional catheter while the

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i 5 m 0*00*0 0* *0 I I release agent is in a dissolved state, and the solvents that have been commonly used in the past may present environmental concerns. Those concerns are eliminated by the combination of this invention because no such release coating is required.

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

Drawings Figure 1 is a longitudinal cross sectional view of a catheter and applicator combination constituting a preferred embodiment of this invention.

Figure 2 is a longitudinal sectional view showing a first stage in the application of a catheter sheath.

Figure 3 illustrates an intermediate stage.

Figure 4 depicts a final stage with the sheath fully applied.

Detailed Description of Preferred Embodiment Referring to the drawings, the numeral 10 generally designates the combination of an external male catheter 11 and an applicator 12. The catheter may be an adaptation of a conventional external catheter of the type disclosed, for example, in U.S. patents 4,378,018 (Fig. 7) and 4,187,851 (Fig. however, a catheter having the features disclosed in co-owned patent 4,581,026 is believed particularly desirable because of its inner sleeve construction and the 6 presence of an internal band or zone of pressure-sensitive adhesive.

Catheter 11 is formed of soft, highly elastic, natural or synthetic rubber. Natural latex is preferred but other elastomers having similar properties, such as silicone rubber, may be used. The catheter comprises a sheath having an elongated cylindrical section lla, a reduced outlet section llb, and a tapered neck section llc disposed therebetween. The wall thickness of the cylindrical section Ila is substantially less than that of the neck and 948.

.outlet sections. For example the cylindrical section may have a wall thickness within the genieral range of 0.006 to 0.010 inches and, in general, is too thin or limp to retain it a cylindrical configuration without support. In contrast, the wall thicknesses of the outlet and neck sections may be 0.050 inches or more and are generally great enough so that such sections will retain the configurations shown in the ::ti 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 llc is provided with a rounded taper leading to a reduced opening 13. The outlet section llb that merges with the tapered neck section llc is provided with a plurality of convolutions or annular enlargements 14. Two such convolutions of graduated size are depicted, their purpose being to permit greater stretchability, bending, and 7 -E -7twisting of the outlet section 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 outle4 section is enlarged at such convolutions, convolutions increase the fluid capacity of that section and, along with the neck section, provide a reservoir for accommodating surges of fluid when the catheter is in use.

An inner sleeve section 15 has a proximal end portion 15a that merges smoothly with the distal end of the sheath's cylindrical body section lla and an elongated distal end portion 15b disposed within the sheath's neck section llc. The distal portion 15b tapers forwardly and Sinwardly, terminating in a reduced distal opening 16 that is spaced well jehind proximal to) opening 13. The setback also results in the provision of an annular and axially-elongated expansion space 17 between the outer St surface of the sleeve's distal end portion 15b and the inner surface of neck section lic. The wall thickness of the sleeve may be varied but, to insure conformability, good sealing properties, and wearer comfort, such thickness should approximate that cf the relatively thin cylindrical body section lla. Thus, both the cylindrical body section lla and the inner sloeve 15 should appear as thin, limp, highly stretchable membranes, in contrast to the outlet and neck sections i1b and lic with their shape-retaining properties.

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In the preferred embodiment disclosed herein, the catheter or sheath 11 is also provided with an internal (once the catheter is reverted) adhesive coating or band 18. The adhesive zone is located within the cylindrical section 11a of the sheath behind inner sleeve 15. While the adhesive coating might conceivably extend the full length of the cylindrical section lla, it is believed preferable to provide the adhesive zone in the form of a narrow but continuous band located within the distal portion of the sheath's cylindrical section Ila. The adhesive oating may be composed of any suitable medical-grade pressure-sensitive adhesive of a type well known in the art; a hypoallergenic acrylic adhesive is believed to be particularly effective.

Applicator 12 comprises two components: a relatively rigid applicator tube 20 and a flexible, tubular friction-reducing sleeve 21. Tube 20 is generally cylindrical in shape and is open at both its proximal and distal ends 20a and 20b, respectively. The edges of the tube at the proximal end 20a are rounded (when viewed in longitudinal section) and, if desired, the edges at the opposite end may be similarly formed. Tube 20 may be composed of any of a wide variety of generally stiff materials, a relatively rigid polyolefin such as polypropylene or high-density polyethylene being found particularly effective. Other polymeric materials having similar properties may also be used.

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The length of applicator tube 20 is substantially less than that of elastic sheath 11. The outside diameter of the applicator tube should be slightly greater than the maximum inside diameter of the sheath, particularly the cylindrical body section lla thereof, in an unstretched state. It will be observed that the length of the applicator tube is preferably greater than the length of the sheath's cylindrical body section lla so that when the cylindrical body section is externally supported upon the smooth outer surface of the applicator tube 20, an annular portion 20c of the tube's outer surface adjacent distal end is exposed and may be gripped between the fingers during use of the device as depicted in Figures 2-4. The length of outlet section llb should also be sufficient to extend outward from distal end 20b a sufficient distance to enable a person to easily grasp the outlet section and apply the catheter.

The tubular sleeve 21 has an inside diameter (when supported in cylindrical configuration) slightly greater than the outside diameter of rigid applicator tube 20 and *has a length sufficient to extend along the cylindrical body section of the catheter and at least partially surround the neck section llc. In the embodiment illustrated, the sleeve is composed of an open mesh of flexible, interconnected polymeric fibers or filaments.

Two sets of such fibers 22 and 23 intersect to provide a Il

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i' 10 multiplicity of mesh openings 24 with the parallel fibers of each set extending in directions that are not perpendicular to, and preferably not parallel with, the longitudinal axes of the applicator tube and sleeve. As a result, the sleeve may slide smoothly over the rounded edges at the entrance or proximal end 20a of tube without a ratcheting action that might otherwise occur if jj the fibers of either set extended in a plane normal to the axis of the tube. The-smooth fibers of the drawsleeve may be formed of any material that is substantially non-stretchable in response to forces of a magnitude that would be expected to arise during use of the product and that has a relatively low coefficient of friction with respect to the material of the applicator tube. A nylon I I (polyamide) mesh is believed suitable, and particularly effective results have been obtained utilizing a mesh formed of a polyolefin such as polypropylene or rpolyethylene. In particular, the frictional resistance between the sleeve 21 and the smooth surfaces of applicator tube 20 should be substantially less than the frictional resistance between the sleeve and the material of catheter sheath 11. Figure 1 depicts the preferred catheter/applicator combination in a form in which it would be made available to users. The catheter sheath 11 has its neck and outlet sections extending axially within applicator tube 20. The 11 neck section 11c extends outwardly through the entrance opening at the tube's first or proximal end 20a and is reverted so that the cylindrical section lic is disposed about the outside of the tube. The sheath does not, however, make direct contact with the tube. Instead, sleeve 21 has a first portion 21a disposed within tube between the neck and outlet sections of the sheath and the inner surface of tube 20. A reverted second portion 21b S extends through the opening at the tube's proximal end and is interposed between the smooth outer surface of the tube 20 and the cylindrical section of the elastic sheath 11. As shown, the second portion 21b is substantially shorter than applicator tube 20. If the second portion of the sheath is provided with a band of pressure-sensitive adhesive 18, the adhesive is preferably covered by a 1 release strip of siliconized paper or other material represented by phantom lines 26 in Figure 1. The release t strip would be peeled away by a user to expose the pressure-sensitive adhesive band before commencing the procedure of applying the sheath to a patient.

If the catheter sheath 11 is provided with an inner sleeve 15 as described and shown, then it has been found advantageous to mount the sheath upon tube 20 (with sleeve 21 interposed therebetween) so that the proximal end portion 15a of the sleeve is also everted and is disposed about the outside of tube 20 adjacent the opening at the iI pll 12 tube's proximal end 20a (Figure The effect is to stretch or enlarge the proximal end of the sleeve and to reduce the length of that portion of the sleeve disposed within tube 20. Because the distal end portion 15b is thereby positioned at the entrance of the support tube it is exposed in a manner that facilitates fitting the catheter upon a patient as described hereinafter.

Referring to Figure 2, outlet section lb is gripped

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and pulled by one hand in the directions indicated by oel,4 arrows 30 while tube 20 is supported and advanced by the other hand in the directions represented by arrows 31. As 4 4 mentioned, the applicator tube may be indirectly supported and advanced by gripping the assembly as represented by dashed arrows 32 and, in that event, forward movement of the fingers towards the proximal end 20a of the tube also r.r contributes to and promotes sliding action between the tube on one hand and the sleeve 21 and catheter 11 on the tc other. In any event, a primary force causing the drawsleeve and catheter to revert and unroll about the penis is the pulling force applied to outlet section lIlb and exerted in the direction of arrows Figure 3 illustrates a further stage in the procedure of applying the catheter to a patient, the adhesive band 18 rolling about the rounded proximal edges of tube 20 for contact with the shaft of penis P. In Figure 4, application of the catheter is complete, and all that i ftaz- 13 remains is for the applicator tube 20 and sleeve 21 to be drawn away from the ensheathed penis in the direction represented by arrows 33.

While the applicator tube 20 and sleeve 21 of this invention may be used with a catheter that lacks inner sleeve 15, particularly effective results are achieved with a catheter having such a sleeve. The reason is that the stretched distal portion 15b of the sleeve may be brought into direct contact with the end of the penis in the first step of applying the sheath (Figure 1) and then, as the sheath is reverted and applied, sleeve 15 is pulled and stretched tightly over the glans to form a non-adhesive liquid-tight seal (Figures 3 and That seal is then o •maintained, with the inner sleeve 15 in stretched condition, because of the adhesive contact between band 18 and the penile shaft in an area well behind the glans. In cases where the inner sleeve 15 is omitted, it may be cconsidered necessary or desirable to commence the reverting action without first bringing the sheath into direct contact with the glans because such contact with the relatively thick tapered neck section lc of the catheter sheath may be undesirable in terms of patient comfort and the elimination of space that would otherwise function as a surge chamber.

h While in the foregoing an embodiment of he invention has been disclosed in considerable detail for- purposes of 14 illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.

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Claims (6)

1. An external catheter and applicator combination, said catheter comprising a sheath of thin, stretchable, elastic material having a generally cylindrical section merging at one end with a tapered neck section terminating in an outlet section of reduced diameter; said applicator including a relatively rigid tube having inner and outer surfaces and having oppositely-facing first and second end openings; said tube having a length substantially less than that of said sheath and having an outside diameter slightly greater than the maximum inside diameter of said sheath in o.VO.: an unstretched state; said applicator also including a flexible, tubular, relatively non-stretchable friction-reducing sleeve of greater length than said tube; said sheath having its neck section extending axially within said applicator tube and at least a portion of its S*S*c-ahy~ outlet section extending through si secon end of said applicator tube; said sheath extending outwardly through said first end opening and being reverted so that said cylindrical section is disposed about said tube; said sleeve having a first portion disposed within the said tube between said neck section of said sheath and said inner surface of said tube and having a reverted second portion extending through said fVrst end opening and interposed between said outer surface of said tube and said cylindrical section of said sheath; the frictional Sresistance between said sleeve and said tube being LCj 4/7- 2 16 substantially less than the frictional resistance between said sleeve and said sheath; whereby, said sheath may be applied to a patient by positioning said tube's first end opening at the glans of the penis and then pulling said outlet section end of said sheath away from said tube to extract said sheath from the interior of said tube and simultaneously evert and advance the sheath's cylindrical section onto the penile shaft.

2. The combination of Claim 1 in which said tube is cylindrical.

3. The combination of Claim 1 in which said tube is ror longer than said cylindrical section of said sheath. *4

4. The combination of Claims 1, 2 or 3 in which said .5 0 cylindrical section of said sheath extending about said applicator tube has an outwardly facing surface; at least a r portion of said outwardly facing surface having a pressure-sensitive adhesive coating thereon. r, The combination of Claims 1, 2 or 3 in which said sheath also includes an inner sleeve section disposed within said neck section and exposed at said first end opening of said tube.

6. The combination of Claim 1 in which said tube has an exposed outer surface portion adjacent said second opening for gripping and directing said tube in one hand as said outlet tube of said sheath is gripped and pulled by the other hand. of said mesh drawsleeve comprise two sets of spaced parallel filaments with the filaments of e set extending in directions that are not parall with a plane normal to the axis of said applic tube.

14. The c ination of Claims 8 or 15 in which said fila s are composed of a polyolef in. *0409 04 DATED this 2nd day of HOLLISTER INCORPORATED By their Patent Attorneys: CALLINAN LAWRIE July, 1993. I- T 0 Abstract The combination of an external male catheter and an applicator to facilitate properly fitting the catheter on a patient, as well as the method for doing so, are disclosed. The catheter is preferably of the well-known external type and the applicator takes the form of a relatively rigid open-ended tube and a flexible tubular sleeve formed of substantially non-stretchable material that slides easily against the surfaces of the tube. The sleeve includes a first portion disposed within the applicator tube and surrounding the neck portion of the catheter therein and a second portion interposed between the outer surface of the tube and the cylindrical body of the catheter. A user applies the catheter by gripping and pulling the outlet end of the catheter to extract the catheter from one end of the applicator tube while the interior surfaces of the catheter sheath at the opposite end of the applicator tube are in contact with the penis. i-l Fr