GB2278279A - Method and appliance for applying a male incontinence device - Google Patents

Abstract

A method of fitting a condom-like incontinence device 20 to a penis involves placing the device within a rigid applicator 10, reducing the pressure within the applicator to a level below atmospheric to expand the device within the applicator and hold it expanded, placing an adhesive means on the inner surface of the device, equalising the reduced pressure to allow the device to contract under its own elasticity onto the penis of the wearer, and removing the applicator. The pressure reduction may be achieved by a suction pump SP or bellows. <IMAGE>

Description

ìv!ETu.uD AND APPLIANCE FOR COPING WITH ifLALE INCONTINENCE This invention relates to a method and apparatus for coping with maie incontinence.

Over a considerable period, efforts have been made to provide devices and appliances which are aimed at ameliorating the unhappy and embarrassing consequences of incontinence in male persons. This problem is particularty acute in males of advanced years.

In 1953, in ü.S. Patent No. 2,789,500, Weimer disclosed an incontinence protector which included a hollow rigid cup which was intended to be placed over the tip of a penis, there being a rolled up condom-ike sheath placed over the cup in such a manner that it could be unrolled over the penis in a direction towards the wearer's body. The cup had an outlet spigot for connection to a tube to drain away any urine.

In 1967, in U.S. Patent No. 3,336,926, Gresham disclosed a male urinary drain with applicator. A receptacie, sheath, retainer and drain are made integral with each other and may be moulded. They may be made of soft natural rubber or latex. These parts are combined with an applicator which is of generally U-shaped configuration providing a pair of tong arms diverging outwardly from each other. The tongs are manipulated within the receptacle and sheath. The sheath is opened using the tongs and the penis can then be inserted in an open end of the sheath.

U.K. Patent No. i,05i210 and ü.S. Patent No. 3,398,745 Tjerneld et ai, both disclose a device for tapping urine and similar purposes.

These patents were published in 1968. In this arrangement, a condom-like sheath, with its open end rolled up in conventional manner, is joined to a drainage tube and an annular cushion of elastic and resilient material is located in the base of the condom.

In 1980, a patent application of the present inventor was published under ü.K. patent application No. 2,048,680 showing an arrangement of non-return valve within a sheath-like condom incontinence device.

An earlier disposable male urinary incontinence device was disclosed by Lee, in U.S. Patent No. 3,742,953, this device aiso involving a thin rubber sheath element within which a rigid funnei is inserted.

U.S. Patent 3,835,857 of Rogers discloses a device intended to minimize the back-up of urine around the peis. urine receptacle Is connected through a flexible tube to a sheath which is placed over and secured to the penis of the user. Adhesive tape is wound around the outside of the sheath to maintain it on the penis.

In U.S. Patent 3,916,902, (counterpart U.K. patent i,521,064) Lineberger disclosed a condom-like sheath for use as a male incontinence device, this being provided with means for inflating a cuff portion of the sheath. Llneberger says that the inflation results in the cuff being securely attached to the penis. Application of the roiled up condom-iike sheath to the penis is aiso disclosed in Hauser ü.â. Patent 4,187,851, this arrangement aiso having a liner pad of adhesive which is wound around the penis to provide an attaching means.

A widely commerciaiised male urine collection device is disclosed in U.K. Patent No. 2,106,784 of Mentor CorporatIon, this device including a sheath which is a flexible latex member rolied outwardly upon itself, suitable for being fitted around a flaccid penis. Adhesive is inciuded between successive rolls of the sheath which, when the device Is fitted, adheres the sheath to the penis. gleans for collection of the urine is aiso provided.

Schneider in ü.R. Patent No. 2,099,706 and ü.S. Patent o.

4,581,026 discioses a system including an adhesive attachment for hoiding an external catheter in place. The catheter takes the form of a tubular sheath of thin elastic material having a cylindrical body section, a tapered neck section extending from the body section, and a reduced drainage tube section projecting from the neck section. Within the sheath, and constituting a unitary part thereof, is a tubular inner sieeve of soft eiastic material having a distai end portion disposed within the neck section and a proximal end portion merging with the sheath's cylindrical body sectIon. The sleeve tapers distally to define an annular space thereabout, and terminates in a reduced distil opening located at an intermediate point within the neck section. The sheath may be produced by a dipping process that includes the preliminary step of stretching a pre-formed tubular member (which ultimately forms the inner sleeve) over a dipping form, followed by successive dipping steps. A variant on the Schneider arrangement is shown by Riedei and Doerschner in U.S. Patent 4,589,874. according to this variation, a collar is provided for facilitating proper fitting of a catheter upon a patient.

A rolled up portion of the sheath is supported by the collar prior to application of the catheter to the penis. After application of the sheath, the collar is simply removed.

An incontinence device in which a condom-like catheter is mouided to form accordion-like pleats running circumferentially is shown in U.S.

Patent No. 4,713,060 of Komis. These accordion pleats provide a mechanism whereby the catheter can be telescopically folded or compacted along its tubular axis, and then expanded to its functioning state. A leg bag is suggested by Somas which enhances the gravitational flow of urine. The collection receptacle is attached to the polyethylene drainage tubing and then compressed with its valvular member in an open position. The vaivular member is then closed with the collection receptacle still in a compressed state. This manner of attachment creates a negative pressure mechanism that directs the flow of urine downwards.

Other incontinence appliances are shown in the following patents: U.S. Patent 4,769,099 Therriault et al U.S. Patent 4,892,527 Zivay U.S. Patent 4,997,427 Bowen U.S. Patent 5,147,341 Starke et ai U.S. Patent 5,176,666 Rochester Medical Corporation international Patent Application (PUT) 090j110 Dacomed Corporation.

One disadvantage, which to the present inventors knowledge has not yet been satisfactorily addressed despite the numerous prior proposals, oniy a few of which are mentioned above, is that in the prior art designs o incontinence device or applicance virtually all require a nurse or medical auxiliary to handle the penis of the person who is to wear the device or appliance. It has long been known that most nurses and medical auxiiiaries dislike or avoid handling the penis, particuiarly in the cases of elderly males. It is one of the aims of the present invention to provide a method and appliance which enables an incontinence appliance to be effectIvely applied substantially without any need to handle the penis of the wearer.

According to one aspect of the present invention, there is provided a male incontInence appliance comprising: a substantially rigid applicator and an incontinence device, the applicator being of tubular form open-ended at one end, the other end being substantially closed but for first and second orifices; the incontinence device being of condom iike form and located substantiaily within the applicator and of a stretchable nature with an orifice at its free end; means for providing a pressure below atmospheric pressure in the space between the device and the applicator whereby the device is held close to or in contact with the applicator; and an adhesive means provided on at least part of the inner surface of the device.

According to another aspect of the invention, there is provided a method or fitting an incontinence device to the penis of a male person, the device being elastically extensible and of condom-like form, comprsislng the steps of:- placing the device within a rigid applicator, expanding the device within applicator and holding it expanded, placing an adhesive means on at least part of the inner surface of the device, allowing the device to contract under its own elasticity onto the penis of the wearer, and removing the applicator.

In this specification the term "adhesive means" is intended to include a double-sided adhesive piaster one of whose sides is stuck to the inner surface of the incontinence device (i.e. stuck to the inner surface of the sheath) and the other of whose sides adheres to the skin of the penis when the device collapses. The term !'adhesive means2' is aiso intended to include a spray-applied adhesive which is put onto at least part of the inner surface of the device, and which, when the device collapses, adheres to the exterior of the penis. Other adhesive configurations and methods or application may occur to a man skilled in the art. The adhesive preferably is apt vied over at least 5 of the interior surface of the condom-lie device.

In the mose preferred embodiment of the invention, the product comprising the applicator, the device and the adhesive means may be contained for transport and marketing purposes, and to keep the product ciean and sterile, in a known vacuum-seaied package of conventional design.

In the arrangement and method described above, the reduced pressure holds the sheath-like condom so that it is open, at least to the extent that the applicator containing the open-ended condom can be placed over the penis without the need to manipulate the penis and without any need to effect an unrolling operation on the sheath to roll it up the shaft of the penis. Instead, the reduced pressure is suddenly removed for example by breaking off or opening a port, vaive or spigot forming part of the applicator, whereupon the condom-like sheath collapses due to its own eiasticity into close, firm and reliable contact with the penis, the desired attachment being achieved through presence of the adhesive means on the inner surface of the sheath.

In an embodiment of the invention, the means for providing a pressure below atmospheric comprises an expansibie bellows whose interior is connected to the second orifice, the arrangement being such that expansion of the bellows causes a reduction in pressure in the space between the applicator and the device.

The invention will be better understood from the following descriptIon of an illustrative example thereof, this being a non-limiting example, given with reference to the accompanying Illustrative drawings, in which: Figure 1 is one exampie of rigid injection-mouided or blow mouided applicator; Figure 2 shows the applicator in diagrammatic form with a sheath like-condom inserted in the applicator and its skirt inverted around the open end of the applicator to provide a seai; Figure 3 shows a iater stage and illustrates the position of the parts after vacuum is applied to the smaller orifice; Figure a illustrates a later stage in the manufacture in which adhesive has been applied to the outer surface of the folded over portion of the sheath-like condom, following which a release layer such as siiicone paper is placed over this adhesive so covering the exposed surface of the folded over portion of the sheath; and Figure 5 Illustrates the final package ready for despatch to the point of sale; that is to say the appliance illustrated in Figure 5 is contained within a conventional vacuum package, this being done firstly for ease and convenience of handling and transport, secondly for preservatIon of cleanliness and steriiity, and thirdly as an extra protection against failure of the vacuum or reduced pressure which would result in premature collapse of the elastic sheath-like condom.

Figures 1-5 diagrammaticaliy illustrate stages in the manufacture of one for of incontinence appliance according to the invention.

Referring firstly to Figure 1, the applicator 10 is tubular and may be a rigid Injection moulding or a biow mouided device. It couid be made of PET, or polypropylene, or high density polypropylene, or any other suitable plastics material which is relatively thin and iight, yet sufficiently rigid to withstand the reiatively small forces applied thereto. The applicator has an open end i2, a smaii opening 14 in te other end, and a spigot or tube 16 to facilitate the generation of a reduced pressure within the applicator in the space between the applicator and the condom-iike sheath 20. The applicator 10 is preferably mainly a circuiar tube, and has a diameter chosen to be somewhat iarger, usually about i0-25 iarger than, the maximium crosssectional dimension across the penis of the person who is to use the appliance. in practice, only a few different sizes of applicator need be stocked.

Referring now to Figure 2, this shows an incontinence device which is a condom-like sheath 23 inserted inside the container with one end stretched as seen at 22 and with the other end 24 which is open, extending through the hole or opening i4. Heat seal jaws are illustrated at 30 and these are iocated in association with a pipe 32 attached to the applicator 10 whIch pipe is connected to a suction pump or equivalent device for evacuating air and thus obtaining a reduced pressure in the space between the condom 20 and the applicator iO. suction pump is shown at SP and is connected to the pipe 32. The open end 2s in use is connected to a drain tube and serves as the exit route for urine.

Turning now to Figure 3, this iliustrates the situation when the suction pump has partly-evacuated the interior of the applicator iO and the condom 20 has consequently been expanded to come into contact with the interior wall of the applicator 10, due to the reduction of pressure achieved in the space which is denoted 38 in Figure 2. At this time, the heat sealing jaws 30 are actuated so ciosing off the spigot 16 as seen at 36 in Figure 4. The pipe 32 can then be removed. The next stage in the manufacture, as seen in Figure 4, involves placing adhesive over the exposed cylindrical collar-like surface of the folded over end of the condom 20, and then covering this adhesive with a suitable release layer.

This layer is denoted 40 in Figure 4. In an alternative embodiment of the Invent Ion, instead o placing the adhesive on the external exposed collar-like surface as described above, adhesive covered by a release layer may be placed over all or part of the interior surface which is adjacent to the open end of the condom-like incontinence device, the end portion of the device then being folded over so that the adhesive still covered by release paper is trapped between the folded-over end of the condom device and the part of the condom device on the upper end portion of the penis shaft. In use, with this arrangement, the folded-over portion is unfolded, the release paper stripped off, and the condom device outer end allowed to contract onto the upper part of the penis shaft.

The final stage in preparing the appliance suitable for transport and sale is placing the appliance as shown in Figure 4 within a conventional vacuum packaging 42, and sealing this closed. Suitable seai lines are indicated at 44 and 46 in Figure 5. Vacuum packaging is used very widely for all kinds of products including foods, medicai devices, and engineering parts. It is beiieved that, since this technology is now thoroughly well known, there is no need to give a specific description of the vacuum packaging step. In use of the applicator, the vacuum package is opened, the applicator containing t ccndom e sheath In its expanded form is withdrawn from the package and placed over the penis, and the spigot i6 is broken off. This allows the ambient air to flow within the actuator resulting in the sheath collapsing onto the penis. The attachment is made more secure due to the adhesive means.

It ill be seen that there has been partIcularly disclosed and illustrated herein a method and appliance for use of male incontinents whereby secure yet comfortable attachment of a condom-iike sheath to the exterior of the penis is achieved, without the need for roiling the sheath up the shaft of the penis, and substantIally without any need for a nurse or medical auxiliary to manipuiate the penis in order to place it within the incontinence sheath. Of course, as will readily be understood, a drainage tube of any suitable form, together with a coupling of any suitable form, would in use be attached to the outlet 24 of the sheath, in order to ensure that the urine is conveyed away appropriately to a drainage bag or other receptacle.

To the best of the inventors knowledge and belief, this is the first male incontinence appliance which can be placed on the penis substantially without any handling of the penis by the nurse or medical auxiliary.

Of course one skilled in the art wiii realise that the invention is not limited to the specific details disclosed and Illustrated. For example, the applicator could be made of any suitable material and not merely of polypropylene. While the condom-'ike sheath wiii normally be of iatex rubber, other suitable materials may be usable. While the silicone paper release layer 40 is preferred, other release layers could be employed. While the provision of heat seai jaws 30, to close off the spigot lo, is currently preferred, other means of closing off the spigot lo could of course be employed.

Claims (9)

1. A male incontinence appliance comprising: a substantially rigid applicator and an incontinence device, the applicator being of tubular form open-ended at one end, the other end being closed except for first and second orifices; the incontinence device being located substantially within the applicator and of condom-like form and of a stretchable nature with an orifice at its free end; means for providing a pressure below atmospheric pressure in the space between the device and the applicator whereby the device is held close to or in contact with the applicator; and an adhesive means provided on at least part of the inner surface of the device.

2. A method of fitting an incontinence device to the penis of a male person, the device being of condom-like form, comprising the steps of:placing the device within a rigid applicator, expanding the device within the applicator and holding it expanded, placing an adhesive means on at least part of the inner surface of the device, allowing the device to contract under its own elasticity onto the penis of the wearer, and removing the applicator.

3. An appliance according to claim 1 in which the adhesive means is provided over at least 50 of the area of the interior surface of the condom-like device.

4. An appliance according to claim 1, 2 or 3 in which the means for providing a pressure below atmospheric is a suction pump.

5. An appliance according to claim 1 or 3 in which the means for providing a pressure below atmospheric comprises an expansible bellows whose interior is connected to the second orifice, the arrangement being such that expansion of the bellows causes a reduction in pressure in the space between the applicator and the device.

o. An appliance according to any of ciaims 1 and 3-5 in which the incontinence device is made of a stretchable and lIquId-Impermeable textile material.

7. A method according to claim 2 which inciudes peripherally stretching and then folding a free end portion of the device over the free end of the applicator.

8. male incontinence appliance substantially as herein described with reference to and as illustrated in the accompanying drawings.

9. Any novel combination or sub-combination of features disclosed andxor illustrated herein.