CA2234742A1 - Condom catheter and support devices - Google Patents

Abstract

A one-piece male incontinence device comprises a condom (30) having a first sheath section (32) and a second urine collecting compartment (42) divided by a skin shield (36) which incorporates a soft thread-reinforced non-return, non-invertible valve (38). Collecting compartment has a twist-around drain valve (52) or alternatively a ball-obturator drain valve (93). First sheath section (32) has friction-increasing internal surface in the form of finely spaced-apart ribs (54). Alternatively skin shield (36) can incorporate two non-return, non-inverting reinforced valves (86 and 88) placed to eliminate urine pooling (90). Alternative design catheter (79) comprises one-piece first sheath section and second urine collecting compartment divided by an insert (36) incorporating non-return valve or valves and skin shield which is placed and imperviously sealed therein. An improved support strap (218) is used which has markings to (221) for accurate respositioning of the band (220). A garment (94) is provided for spinal injured patients for attaching thereto a condom catheter. A non-elastomeric, non-latex condom catheter (110) is provided for users who are allergic to latex products. Another embodiment has a grooved retainer ring (238) sewn into the front section (236) of a garment. An applicator ring (250) is used to spread rim (226) to facilitate fitting both condom onto penis (254) and rim (226) into groove (244) of grooved retainer ring (238).

Description

W O 97~14353 . PCTAUS96/16788 f'ONDOM CATHETER AND SUPPORT DEVICES

FTELD OF INVENTION
The present invention relates to male incontinence devices, in particular to a ribbed surface S inside the colldo~ll sheath to improve catheter adherence, an integrally made reinforced soft non-return valve to prevent urine spillage, an alternative soft non-return, non-invertible two-valve assembly c~t cign~ to prevent pooling, a more dependable means for retaining a catheter on the penis of a wearer without the use of adhesives. Also, a garment which can be used to attach a ~Lh.,t ,~ for use by spinal injured patients and an inexpensive non-elaslom~,.ic con(l-)m catheter.

BACKGROUND OF THE INVENTION
Disclosure Doc~m~nt No. 385874 dated Dec. 4, 1995, U.S patent number 5,380,312, dated Jan. 10, 1995, issued to Goulter, and I J.S patent number 5,009,649, dated April 23, 1991, issued to Goulter et al., are incorporated by reference as p~rt of the specifi~ tion of this invention 1 5 for details of construction for similar incontinence devices, which could be worn with comfort, which ~'4~n;~ the wearer to engage in most normal social and business activities, and which provided many other advantages including the avoidance of the skin~ m~ging and painful adhesives often used to keep devices in place.
The first clinical trials, at the Shepherd Center of Atlanta, Ga., proved the safety, comfort 2 0 and utility of the one piece Goulter device, while ~lefining one major we~kness The l.,se~.;h tearn concluded that this catheter was superior to the control device in that it produced less inr~ n~e of skin breakdown and was easier to apply and use. It was also conclu-iPcl that better adherence of the device should allow this product to outperform the control in many other areas as well.
The tendency of condom catheter devices to come off in use is a common problem. This 2 5 problem is at least somewhat dependent on the shape of the user's penis. As is well known, penises come in a variety of shapes and sizes. If a man's glans exceeds the penile shaft in rli~mf-tPr, a con~lom device is more likely to stay in place, whereas if the penile shaft tends to taper toward the glans, and the glans is smaller in ~ mett r than the shaf~, such a device will be less secure. This is true both for circumcised and un~ ;u-~lcised men. A more adherent condom 3 0 CaLIl~,lc~ would tend to make the wearer more socially secure. By the same token, a more secure con-lnm used for sexual purposes would be of substantial benefit in preventing both unwanted pregnancies and sexually tr~ncmitt~r~ diseases, notably AIDS.
An option to improve the security of the catheter is to increase the tension of a snug fitting sheath by using one or more elastic VELCRO bands around the sheath portion. However, a 3 ~ ~1ilemm~ arises when trying to determine how tightly the VELCRO band should been adjusted to hold the device on the penis, especially those with spinal injuries; bind the band too loosely and the ca~heter rnight slip; bind it too tightly and it might interfere with circulation.
Several other types of roll-on external catheters, such as those used with prior-art leg bags, make use of adhesives to hold the sheath in place. Adhesives, however, have several drawbacks.

WO 97/14353 .PCTIUS96/16788 They not only fail to guarantee that the sheath will remain in place, but they often cause pain and ~u.,.~l i...es iniury while being removed. As a consequence, they are extremely unpopular with users.
~.nn~ir)m catheter slippage continues to be a major concern among nursing and care-giving S staff, especi~lly those ~ttenf~ing the elderly, the spina}-injured and others likely to suffer male urinary incon~iner~çe It is equally a worry to the otherwise able-bodied incontinent, who desire to continue normal activities and work.
Another problem applies to the user of elas~ic VELCRO (hook and loop) bands. These are fitted and ad3usted by users and care-givers in a trial-and-error method to establish the proper 1 0 amount of tension needed to hold the sheath comfortably yet firmly in place. Once the band has been removed however, the position is lost and must again be sought through trial and error next time it is applied.
Further pl~bl_...s with the Goulter device, specifirPlly, related to the construction process and the use of a hard non-return valve. The hard valve had to be fitted into the completed sheath 1 5 portion of the device, requiring a scpa~t~ process which added to the cost of production. Also, if the device l~nintentionally came off the user after it had collected a quantity of urine, the ~l~,S:iU~G
of the collected urine might force the hard non-return valve casing to invert, dislodging the hard valve and causing a spill. Additionally, a hard non-return valve tends to act as a catalyst, :,u~polling the build-up of crystals from urine, possibly rending the valve ineffective and non-2 0 reusable while all other parts were still in funrtion~l condition. Yet another problem was a real ifremote danger of injury if the hard-valve device were worn during certain activities; for exarnple, if the valve were strongly imp~ct-pd by a ball or another player during contact sports, it might bruise the penis.
The drain valve also pl Gsc.l~ed problems, whether the pull-out plug or the screw-off cap 2 S were used. Men with shaky or arthritic hands or with impaired nerves might have difficulty replacing a plug or screwing a cap off and on. Some users also tended to get urine on their hands while draining the device. This last problem also affected nurses and other care-givers ~ttentlin~
inr~p~eit~tPA or aged men.
A further problem exists with prior-art incontinçnce catheters when used by certain 3 0 patients who have suffered spinal injuries. Many such patients have no feeling from the waist down, and would therefore not realize if they nnint~ ntionally fitted a cathelef too tightly, creating danger of ~limini~hed blood circulation and possibly injury to the penis.
Another cornmon problem with catheters which are attached and sealed to the penis, with or without adhesives, is that there is a tendency for some pooling to occur at the distal end of the 3 5 sheath portion, due to a quantity of urine rem~ining collected in the cavity immefli~t~ly in front of the penis glans. Since the collected urine in this area is frequently replaced with newly voided ur~ne, it is unlikely that a condom catheter could ever be designed to drain so entirely that the penis head was left perfectly dry. E~owever, it is preferred that the area be as well and thoroughly drained as possible.

W O97/14353 , PCT~US96/16788 A further problem is that some people are allergic to latex and there is no device resembling the Goulter device which is made of a non-allergenic material.
G.D. Johnson in patent U.S patent number 4,971,071, dated Nov. 20, 1990 discloses an electrically conductive condom having a permanently RttRche~l retRining strap for securing about 5 the person. The problem with this method is that it cannot be detached from the contlom itself ~ when quickly removing and refitting a new condom is required, and also requires the user to undress to reattach another condom.
P.E. Hogin in patent U.S patent number 4,354,494, dated Oct. 19, 1982 teaches anintegrally forrned strap for retRining a condom in place by stretching it around the user's S~ lu~
1 0 The problem with this method are many: firstly, the increasing weight of RccumlllRting urine in a one-piece urinary incontinence catheter using this method would exert a pull on the s~,luLu~l, and quickly become unbearably uncomfortable; second, a thin strap as shown in the patent drawing would cut into the scrotum and add to the discomfort of the user, especially one who needs to wear it continuously; thirdly, this device was only intt n(~ for brief use, during coitus for 1 5 contr~ceptive purposes.

OBJECTS AND ADVANTAGES
Accordingly, one object and advantage of the present invention is to provide a one-piece, conclnm-like, adhesive-free male urinsry incontin~ncc device which is less likely to slip off than 2 0 prior art devices.
Another object and advantage is to provide a one-piece male urinary device with a soft non-return valve which can be made integrally with the device during m~n~lfRctllre and which does not require a separate additional part to be inserted during a separate process; also, a valve which will not invert and spill urine if the device should come off unexpectedly. Also, to provide a non-2 5 return valve which is less ~u~u- Live of crystal build-up, and one which will not tend to create injury if forced into sudden, hard contact with the penis, as could happen during contact sports. A
further object and advantage of the present invention is to provide means to drain away urine which tends to pool in the cavity adiacent the penis glans in prior art external condom cRtl~.-ter~
Still another object and advantage of the present invention is to provide an in~onl ;..~ .-re 3 0 device having a drain valve which is neither a pull-out plug nor a screw-off cap but one which can be operated with ease by care-givers or by users whose hands are imperfectly steady, with far less likelihood of getting urine on their fingers. This is especially important as some ~iiceRces may be trRn~mit~eA through urine.
Another object and advantage of the present invention is to provide a urine incon~in,on~e 3 5 external condom catheter device which may be attR~hed to a simple h_rness, ga~ nl or brace to be worn by the user, which would retain the catheter in place without need for a hook-and-loop band as a ret~ining means. Such an apparatus would be especially suitable for spinal injury patients as well as others who have difficulty keeping an exterior urine collecting device securely in place due to the shape or size of the penis or to the user's over~veight. A still further object and WO 97/14353 .PCT/US96/16788 advantage is to provide a one-piece male incon~inence device which can in particular be made more inexpensively from non-elastomeric plastics such as vinyl or similar non-elastic yet very pliable material which is less likely than latex to cause allergic reactions.
Yet another object and advantage of the present invention is to provide a more positive means to prevent the catheter from slipping off the penis. Optimally, the atf~f~hm~n~ could be fitted and/or removed easily and quickly while still holding securely regardless of the shape, size and condition of the penis. This means should be simple and inexpensive to make.A still further object and advantage is to provide a means to retain catheters used by incapacitated and spinal injured patients and which cannot be readily pulled off by the senile or 1 0 ~ mf~nt~
A further object and advantage is to provide a VEI~CRO hook and loop band that can be readily adjusted to a previously established and desired tension, without the need for repeated guesswork.

BRIEF DESCRIPTION OF DRAWINGS
Fig 1 is a perspective view of the first embodiment of a condom catheter of the present invention.
Fig 2 is a perspective view of a condom catheter showing the open end of the condom sheath portion with part cut away to expose finely spaced internal ribbing and a second cut-away exposing the thread-reinforced, non-return, non-invertible soft valve.
2 0 Fig 3 is a perspective sectioned view taken along the line 3-3 of Fig 2.
Fig 4 is a cut-away view of the open end of the condom sheath portion showing an Alt~rn~ive relief structure, and also a cut-away exposing the non-return valve.
Fig S shows three alternative relief structures within the condom sheath.
Fig 6 is a sectional view of the non-return valve shown in Fig 4.
2 ~ Fig 7 is an enlarged end sectional view taken along the line 7-7 of Fig 2.
Fig 8 is the valve of Fig 7 when pressure is applied in the direction of arrows "K."
Fig 9 is a perspective view of a prior-art screw-around on/off valve.
Fig 10 is a top perspective view of a non-pooling, two-valve assembly fitted to the skin shield inside a single piece catheter, which also has a ball-obturator drain valve (~licclosed in patent no.
3 0 5,009,649) fltted to the urine collecting compartment.
Fig 11 is a sectional side view taken along the line 1 1-11 of Fig 10.
Fig 12 is a cross sectional view taken along the line 12-12 of Fig 10.
Fig 13 is a p~ e-;Live view of a single piece catheter into which a non-return, non-invertible valve is inserted and sealed inside the catheter 3 5 Fig 14 is a perspective view of mandrel and removable double-edged blade used for m~n~ rtnring a non-return, non-invertible valve and skin shield.
F-g 1~ is a section~l view taken along line 15-15 of Fig 14.
Fig 16 is a sectional view taken along the line 16-16 of Fig 14.

W O 97/~43~3 . PCTrUS96/16788 Fig 17 is a perspective view of the mandrel shown in Fig 14 with double-edged blade inserted, then dipped into liquid latex and fine thread wound around the blade.
Fig 18 is a pc;~ e~;~ive view of a garment which can be used by a spinal-injured person for ~nrh~ring a catheter of the present invention.
5 Fig 19 is a perspective view of a male urinary incontinence external catheter constructed from a non-el, ~," 'e~ ;C material.
Fig 20 is a top view of two sheets of vinyl which are cut/welded to a pattern for fabrication of the ~ catheter shown in Fig 19.
Fig 21 is a sectional view taken along the line 21-21 of Fig 20, shown welded at its edges.
1 0 Fig 22 is a sechon~l view taken along line 22-22 of Fig 19.
Fig 23 is a side view of a casing supporting the prior art duck-bill non-return valve of Fig 19.
Fig 24 is a perspective view of a penis fitted with a p~rior art condom catheter.
Fig 25 is a perspective view of another embodiment showing a combination of a support strap and an improved elastic VELCRO band.
1 5 Fig 26 is a perspective view of the support strap and VELCRO band attached to a penis.
Fig 27 is an enlarged sectional view taken along line 27-27 of Fig 26, illustrating snap buttons fitted to the support strap and undergarment's w:~icth:lnfl Fig 28 is a perspective view of another embodiment, comprising a retainer having a circular groove, which is attached to a garment to be worn by a user.
2 0 Fig 29 is a perspective view of a grooved retainer for attaching to a garment.
Fig 3~) is a ~l ~eclive view of an improved applicator ring.
Fig 31 is a perspective view of a catheter ready to be stretched onto an applicator ring.
Fig 32 is a perspective view of the catheter of Fig 29 stretched around and over the end of an applicator ring.
2 5 Fig 33 is a perspective view of a garment including the grooved retainer encircling a penis, ready to receive a catheter with the use of an applicator ring.
Fig 34 is a perspective view of the catheter shown in Fig 33, fitted as far as it will go onto a penis and in a position ready for dislodging graspable ring of the catheter into the grooved retainer on the unde~me.-t.
3 0 Fig 35 is a perspective view of the catheter of Fig 34, showing the applicator ring removed, and ~r~ble ring securely dislodged off the applicator and into the circular groove of the retainer.

DETAILED DESC~IPTION--Fig 1 Fig 1 shows a male urinary incontinence condom device 30 according to the invention. It 3 5 can be made of an elastomeric material such as latex, silicon or polyisoprene or any other suitab~e m~t~-ri~l The device consists of two main parts. The first part comprises an inner condom sheath 32~ which has a graspa~le rim 34 at its open proxim~l end and a skin shield 36 incorporating a soft non-invertible, non-return valve 38 at its distal or closed end 40; the second part is a urine-cf ll~-cting colnpal~l..ent 42 having an open end 44 which is imperviously sealed at 46 to -W O 97tl4353 .PCTAJS96/16788 cylindrical portion 4,'3 of inner condorn sheath 32, and a closed distal end 5(i which incorporates a prior art twist-around drain valve 52.

INNER CONDOM SHEATH--Figs 2-8 Inner condom sheath 32 can be made in several sizes to accomrnodate the needs of users.
Most adult penises range from 20 mm (.83") diameter to 40 mm (1.66"), the vast majority m~ lring between 23 mm (.875") and 32 (1.25"). Since a snug fit is preferred in keeping the device securely in place, as well as in preventing urine leaks, it is desirable to make the c~ t~ - ~ in several si~s. Each size is design~ted in mm and/or inches according to the di~m~t~or of the range 1 0 of penises they are intencled to accom m~ te.

MEANS FOR ADHERING CATE~ETER ONTO PENIS
In extended e~ cnts and tests ~ have found that a series of very fine circular grooves and raised relief ribs 54 (Fig 2 ;md 3) incised into the inside of the catheter at the proximal end 1 5 have a positive effect in holding the device onto the penis. This effect can be further enh~n~ ~l by adding some :ltlflition~l pressure by the use of an elastic hook and loop band 56 (Fig 1).
When used for incontinence catheters, interior ribs 54 are about .5 mm (.020") deep and are inco.~ula~d around the inside of the sheath starting near the open end; these are spaced at about .5 mm (.020") apart, creating fine grooves in between. The width of the ribbed portion is 2 0 appro~cim~tely matched to the size of the device, such that about 28 mm of ribs are formed in a device m~ ring 28 mm in diameter, while approximately 31 mm width of ribs are molded into a 31 rnm r~ ot~ . device. A lesser or greater number of ribs per centim~ter or inch can be used;
i.e., the ribs can be I mm deep and I mm apart; however, it is LJl~r~ d that the ribs be very closely spaced, as shown in Fig 2. Also the length of the ribbed area can be increased or de~ a~i.
The shape of the ribbing can add additional adherence; i,e., ribs that lean inwardly, as shown at 58 (Fig 3), tend to be more adhering on a penis than ribs that would resemble the rounded shape of a screw thread (not shown). To obtain a lean-in type rib 58 (Fig 3), a series of look-alike grooves are machined around the proximal end of the mandrels (also called formers) to 3 0 create the desired rib shape. The ribs in the catheters are produced integrally with the sheath when the mandrel is dipped into liquid latex and thereafter cured. Various other groove shapes and ang}es besides those shown at 58 in Fig 3 can be designed; also different depths and sp~cing~ can be used to obtain different degrees of catheter adherence.
Alternatively, a fine screw thread (not shown) can be m~chinef1 into the mandrel in lieu of 3 5 a series of separate grooves shown at 54 (Fig 2). Another design is shown in Fig 4, in which rows of circular grooves are combined to produce a pattern of waving lines 60 in raised relief.
Qther alternative designs besides the ribs shown in Fig 2 can be used in relief to form gripping means; these would include circles of arcs placed 'face to face' and 'back to back' as shown at 62, wO 97/14353 . PCT/US96/16788 (Fig 5) or circles of small, closely spaced-apart protruding mounds 64, or circles of "S" shaped protrusions 66. The possible variety of such patterns is virtually infinite.

INTEGRAL, NON-RETURN, NON-INVERTIBLE VALVE--Figs 1,2,4,6-8.
Fig 1,2,4 and 6 show a non-return valve 38, which allows urine from skin shield inner Cu~ al Ll~lent 36 to pass without restriction into urine collecting c~ palllllent 42. This valve is forrned around a double-edged, double-convex blade (described and illustrated in detail in Figs 10-14,) which protrudes from the lower end of the mandrel which produces skin shield 36, during the dipping process. It consists of two flaps 68 (Fig 4), best seen in enlarged sectional view (Fig 6).
1 0 The two flaps are joined at their edges 70 (Fig 7). Due to the double-convex cross sectional shape of the double-edged blade a permanent, partly-open slit 72 remains between flaps 68 (Fig 7.) In use, when hydraulic or pneumatic pressure is applied to the exterior surfaces of flaps 68 in the direction of arrows "K" (Figs 8), as would exist if the user continued to urinate into the device and not timely empty the urine from the collection ~;olll~3~LIllent. This pressure will exert a 1 5 hydraulic ~UlG~>Ul'G in the direction of arrows "K" and flaps 68 will imm~ tely ciose together forrning a seal as shown in Fig 8. The seal is effective in preventing voided urine from flowing back through slit 72 to the opposite side of the skin shield.

NON-RETURN, NON-INVERTIBLE, VALVE CONSTRUCTION
2 0 The soft non-return valve as described above is preferred to a hard non-return valve in a c~nrlom catheter for the reason described in Background of the Invention above. However, it is also n.ocec~ry to make the soft valve, non-invertible in order to prevent urine spillage should the catheter inadvertently come off the penis. At the same time, the valve must also retain its original flexibility so that it will close even when low ~ UlG iS applied from the collt-cting col~
2 5 thus preventing voided urine from returning from the urine collecting cl~ulpal ullent to the penis glans behind the skin shield. Making a non-return valve, also "non-invertible" has been achieved by lGinrul~;illg the latex in the valve itself with fine polyester or other suitable thread which is imher1rl~d into the latex during manufacture. This is described below.
A double-edged, double convex blade 74 (Fig 10 and 13) is removably inserted into a 3 0 cc,.. ~ ,onding cavity 81 (Fig 10 and 12) in the lower end of mandrel 76. After dipping into liquid latex and curing, about seven to ten turns of fine polyester thread 78 (Fig 11) is then wound around latex-covered blade 74 starting at base 80 and spiraling toward the distal end of the blade for about 15 mm (.5") The mandrel and blade are then dipped again in latex which seals-in the polyester thread, and reinforces the non-return valve. Further heat curing and dipping is done 3 5 until the latex is about 1 mm (.040") thick. After curing blade 74 is withdrawn and valve 38 is cut to about 9mm (.375") long, as shown at arrows C-C. (Fig 11). The resulting non-return valve calmot invert simply because the reinforcing threads prevent slit 72 (Figs 4, 6-8) of the valve from opening sufficiently to allow the rçm~i ndt r of the valve to pass through it to the opposite side of the skin shield.

WO 97/14353 PCT~U~96/16788 Alternatively, valve 38 can be made non-invertible by using a latex rubber to which certain çh.omi~alc have been added which make the rubber harder and less elastic. However such valve is not as flexible, nor as responsive in operation when subjected to very low hydraulic back plcs~u from the urine in the collection compartment as a valve reinforced with thread only.
s ONE-PIECE CATHETER WITH NON-RETURN VALVE INSERTED THEREIN.
Fig 14 shows a one-piece catheter 79 into which mandrel 76, together with complet~d skin shield 36 and non-return, non-invertible valve 38 are inserted in the direction of arrows "J" and herm.-tic~lly sealed in the position shown by broken line 82. Condom sheath portion 77 is 1 0 ~ Lehcd open in the direction of arrows "L" to facilitate entry of mandrel 76 into catheter 79 when fitting skin shield 35 and its non-return valve 38.

POOL DRAINING TECHNOLOGY EMBODIMENT FOR MALE EXTERNAL
CA-l ~lk l l;~S
1 5 Fig 15 shows a one-piece urinary incontinence condom catheter 84 fitted with pool draining means. The means comprises having two non-return, non-invertible soft valves 86 and 88 being positioned, one above the other on skin shield 36 (Figs 15,16,and 17). Fig 15 is a top ~ .c.;li~re view of condom catheter 84, having a cut-away section 85 exposing one wide valve 86 positioned transversely across the lower side of skin shield 36, and one small valve 88 positioned 2 0 vertically ne~r the top side. Fig 17 shows an end view taken along the line 17-17 of Fig 15, which clearly shows transverse valve 86 positioned at the lower portion of skin shield 36 and horizontal valve 88 positioned at the top portion of the shield. Fig 16 is a side section~l view taken along line 16-16 of Fig 15, showing a pool of urine 90 between penis glans 92 and skin shield 36.

When the user is urinating, pressure from the bladder forces the urine to flow through the non-return valve into the urine collecting compartment. However, when urinating stops, a small quantity of urine may remain between the glans and the skin shield. This is known as pooling.
The following system is designed to drain the pool of urine into the collecting 3 0 cu"~ enl, leaving the glans as dry as it is possible under these ci;cumst~nces An incontinenre ,.lrrc.c. may be voiding urine almost continuously, or frequently, or occasional, or just s~ s so it is unlikely that the penis glans will ever become completely dry in such an en~ t.
The system of draining the pool of urine is similar to that used to empty a can of liquid 3 5 (soup) by puncturing two holes in either side of the lid, one allows air to enter the can, while the other allows the liquid to drain out until the can is empty.
A small upper vertical valve 88 (which is always slightly open unless under ~l~S ~WG) iS
provided for air from within urine collecting compartment 85, to bleed into the top of the pocket above the pool of urine and replace the voiding urine which flows out the lower valve. Without it, WO 97/143~3 . PCT~US96/16788 the pool of urine will not flow so freely through lower valve 86 even though il is partly open.
With the small upper vertical valve present, however, air will bleed through this valve thereby allowing urine to flow outward through the lower valve until pool of urine 92 has drained away.
It will be realized that should the catheter inadvertently come off after collecting a quantity 5 of urine, both valves will fully close. because a hydraulic pressure will then exist against the valves, due to the el~ctom~ric n1aterial in the catheter, thereby preventing any spilling of voided urine.
-BALL-OBTURATOR VALVE.
1 0 Fig 15 also shows a ball-obturator valve 94 which is disclosed in patent no. 5,0Q9,649 and which can be used on any of the catheters which are constructed from elastomeric m~teri5,1~. The advantage of this valve over other drain valves is that it is a soft valve generally and it can be m:~n-lf7~ctured integrally with the urine collection colnp~L~nent requiring only the inserting of a plastic ball 95 and a cu~ lGs~ion spring 96 to complete the valve.
1 5 The ball obturator valve requires only to be squeezed by the thumb and forefinger of one hand in the direction of arrows "P" to drain urine from the collecting colnp~llllellt. This action will push the ball away from its seat, thereby allowing urine to flow. It can be made integrally with the collecting comy~ llllent and provided with an e~cten(~ed nozzle 99, so as to prevent urine coming into contact with the user's hand when operating the valve. The nozzle can be cor n~ctP~ to 2 0 an extension tube (not shown) using prior art tube connectors, and then to a bedside bag, or even to a leg bag.

PRIOR-ART TWIST-AROUND DRAIN VALVE--Fig 9.
Fig 9 shows a prior art twist-around drain valve 52, which can be attached and 2 ~i imperviously sealed to any of the condom catheter embodiments in this application. When the c~hct~,i is made of latex and/or elastomeric material, it is preferred that the material be rnade more s~ .t;~l where the valve is to be inserted and sealed. When made of non-el~ctnmtonc m~t~ri~l it is p~crcll~d that the valve be adhesively ~t~:lrlleA and imperviously sealed to the Cd~ L~;~ m~tori~
and in addition is bound around the outside with suitable thread cord and/or tape.
ALTERNATIVE MEANS FOR ATTACHING THE CATHETER TO THE WEARER--Fig 18.
Fig 18 shows a harness or garment 94 comprising a central bib portion 96, ~U~ Cd at its upper end by an elastic waist band 98 and at its lower end by leg straps 10Q. A circular hole 102 3 5 is provided through which the penis is placed when fitting the brace onto the wearer. Several hooks 104 are positioned in a circular manner around hole 102, in garment 94, such that when the c~theter is fitted onto the user, rings 106 can be attached onto hooks 104, thereby ret~ining the catheter in place. Rings 106 can be of the split-link type clamped around graspable rim 34.

WO 97/14353 ~PCT/U~96/16788 Alternatively, other means can be adapted to anchor the incontinence catheter to the g;~ ont, such as VELCRO hook and loop strips (not shown), one part attached to the catheter and the other to the garment.

5 DESCR~PTION OF NON-ELASTOMERIC CATHETER--Figs 19-24 Fig 19 shows a one piece male urinary incontinence catheter 110 comprising a condom sheath 112 and a urine collecting Cvl,lpd~ ent 1 14, according to a fourth embodiment of the invention. This embo~iim~nt is made of non-el~ctomçric materia} such as vinyl, having such desirable properties as softness, pliability, water-reci~t~nce. puncture-resistance, non-allergic and 1 0 ~-o~rv~ ty to both the wearer's body and his clothing. It can also be made of any simi}arly tough pliable material, which preferably can be instant heat-cut/welded using prior-art m~ thnrl5 around a suitable pattern, as shown in Fig 20.
Fig 20 and 21 show a suitable pattern 116 ~-ol~ h~g two layers 117 and 119 of plastic m~t~l such as vinyl, which are instant heat-cu~/welded along edges 118 and 120. Edge 124 and 1 5 122 are cut but not welded, and provide an open proximal and distal end. Open proximal end 124 (Fig 19) is fitted internally with a def ~ hle plastic sleeve 126, such as foam plastic or the like, (~;ig 19 and 22) having a slightly larger internal rli~3meter than the size of the penis for which it is int~nd~ to fit.
Narrow portion 130 (Fig 19 and 20) of catheter pattern 116 provides a cylin-lrir ~1 a~.tu-t 2 0 for fitting and imperviously sealing and binding thereto a prior art non-return valve 132, shown in Fig 23. Fig 19 shows non-return valve 132 imperviously sealed inside narrow portion 13() and ~ms-lly bound in place.
A screw-around drain valve 128 is imperviously sealed in aperture 121 of catheter 110 for the user to drain urine into a men's urinal in a natural manner. It is also securely bound on the 2 5 outside with tape or cord of any suitable type. It is leco-llmel1ded that VELCRO hook and loop bands (discussed later) be used to close condom sheath 112, along with deformable p}astic sleeve 126, snugly onto the penis.
In the event that a user is a spinal patient with impaired feeling below the waist line and who is also allergic to latex materials, and needs to use a catheter made of vinyl, g~ nt 94 (Fig 3 0 18) can be used in conjunction with the vinyl catheter to removably attach it to the user. The catheter can be attached to the garment rings as shown in Fig 18, or by the use of VELCRO hook and loop strips, or by prior-art adhesive strips.
Since a non-elastomeric material is used in this embodiment of my condom catheter, the urine collecting COIll~ Llllent will be non-extensible under pressure of continually voided urine, 3 5 and such pressure could tend to push the catheter off the penis unless the CO~ h lmeQt iS timely emptied. This could be a real problem for users. especially for spinal injured patients.
_ This problem is overcome herewith by using a sound producing buzzer which sounds when the urine collecting compartment becull,es full and needs to be drained, and is described in the following paragraph.

W O 97/14353 . PCT~US96/16788 A prior-art, pl~,~..ul~-sensihve eleetrical switch 134 is imperviously sealed into edge 120 (Fig 19 and 20). Switch 134 comprises two parts, a small sealed elastomeric chamber 138 positioned inside urine collection CC,~ ~klle,1t 1 l4, and extemal connector pins 136 on the outside of the coll~ lent. Pins 136 can be attached by leads 140 to a belt-mounted 'buzzr' (not shown) worn by the user. When pressure inside compartment 114 rises due to continued ~ urination, l-rc;,.ule sensitive switch 134 becomes switched 'on' thereby completing an elc~ ical circuit and sounding the buzzer and alerting the user to drain the C~ u~LIllellt.

1 0 Fig 24 shows a one-piece male urinary incontinence condom 210 of U.S. patent 5,380,312 which has been incorporated by i~ ,nce, fitted onto a flaccid penis, 212. Previously, a con~i-)m eatheter was usually retained in place by a prior-art e}astic VELCRO band 214. The weight of voided urine whieh colleets in the collection co~p~L~ent 216 of condom 210 is .u~ l~d by the ext~n~le~l pouch 217 of a modified undergarment shown in Fig 26 in this applieation and also in 1 5 Fig 27 of U.S patent number 5,0Q9,649. However, since this embodiment was not always succe~.~rul in keeping the Goulter condom catheter on tapering penises, the purpose of the present invention is to hold the device in place more securely.
The present invention achieves this by the use of a support strap 218 (best seen in Fig 25), which is combined with VELCRO band 220, preferably by sewing or otherwise securing strap 2 0 218 and band 220 together, as shown at 222 (Fig 25). Support strap 218 has s--ffi-~ient length to be ~stqrhel1 to the wqicth~nd 230 (Fig 26) of a modified under~mel1t by any suitable means, such as snaps or press studs or the like.
VELCRO band 220 (Fig 25 and 26) also shows a plurality of six inrliç~qting marks 221, pçrmqnently imprinted or otherwise made on loop section 223. Marks 221 are spaced about 5 2 5 rnm (.187") apart. A single cooperating mark 225 is made on hook section 227,. such that when the user is fitted VELCRO band 2Z0, mark 225 will align with, or near, one of the six marks 221, thus providing a visual read-out of where hook section mark corresponds relative to one of the loop section marks. Once the user has decided on the degree of tension and pressure most eomfortable for himcelf, he can quickly achieve exactly the same fit each time he reuses the band 3 0 in the future. If he feels it n~eccq-, y to change the adj--ctment, he can note the change and use that as a future guide. The proper setting can be recorded by a care-giver as well, and also explained or directed to o~Lher care-givers; this would be especially useful in a nursing home setting, above all, where in~p~qc;~ l, helpless, senile or spinal-injured patients are treated.
The patented pouch-enlarged undelg~ulllel2t shown in Fig 26 of this application and in Fig 3 5 27 of U.S patent number 5,0Q9,649 may be used with this, and other, embo~limp-ntc of the present invention, and that snaps or similar adjustable anchoring means be ~t~q~hçd to the w~ictbqn~ of said g~rrnPnt~ to secure the support strap. The use of such a garment supports the device both from below, by pouch 217, and above, by support strap 218.

W O 97/14353 PCT~US96/16788 In order to conveniently and securely attach support strap 2l8lo modified underg~ en~'s w~icth~n-l 230, support strap 218 (Fig 25-27) is fitted with multiple male-part snaps, or press studs, 224, while one or two female-part snaps or press studs 224' are sewn to w~ictk~n~ 23() of the under garment, such that while VELCRO band 220 is attached to a catheter at its lower end, S the upper end is anchored to w~istband 230 by the snaps, thereby positively securing condom 210 to penis 212 and preventing it from slipping off the penis.
It will also be realized that retention will no longer depend so heavily on pressure exerted by the VELCRO band. The band need only be sufficiently snug to forrn a seal and so that it will not slip back over the graspable ring 226, which is made integrally with the catheter during 1 0 m~nuf~r~tl-re.
Fig 27 shows a sectional view taken along broken line 27-27 of Fig 26, showing portion of the user's body 232, portion of undergarment and its waistband 230 fitted with female-part snaps 225, and portion of support strap 218 fitted with male-part snaps 224'. Multiple fitting of male part snaps along the upper end of strap 218 allows for the adi~lctment of the length of strap I ~ 218 according to the height and body build of the user, so as to obtain the best length of strap in order to support catheter 210.
Alternatively, snaps can be replaced with buttons and button holes, hooks and eyes, VELC~O hook-and-loop portions; the support strap can even be secured to the w~i~th~nA with a safety pin.
2 0 Support strap 218 can be made of any suitable non-elastic flexible fabric; it can also be made entirely or in part of elastomeric material, such as elastic bands or even latex strips. Testing has shown that fabric, elastic and combination support straps achieve similarly satisfactory results.
Support straps can also be attached to an elastic VELCRO band around a penis by a tab of hook-side VELCRO which can be sewn to the lower end of the strap. This method, however, carries 2 5 the remote danger that the strap and the band may become separated; therefore, a positive atL~cl~ e.lt of strap and band (i.e., by sewing) is preferred.
In use, the weight of urine, as it accumulates in collecting co---yal L~"ent 216 of catheter 210, is supported both from beneath, by the undergarrnent pouch, and from above, by the tethered support strap and w~i~rh~nrl Together, they promote retention of the catheter irrespective of the 3 0 penis' shape. Rather than pulling down on the wearer's penis, like most co;:siom c~thet~rs ,.ltly available do~ the present invention is so well supported that users have no sen~ on of wearing the device until the buL~ of voided urine increases sufficiently to act as a rerninder to drain ~e cu~ ~Ln~ellt. Draining, in turn, can be done by simply unzipping the trouser fly, pulling the end of the device out through the fly of the undc~ ment, and opening the release valve, making it 3 5 possible for the wearer to use any convenient toilet or urinal.

A~URTHER EMBQDIMENT--FI(~ 28-35 Fig 2B shows a simple garment comprising a frontal section 236 incorporating a circular grooved retainer 238, an elastic waistband 240 at the top, and two leg straps 242 leading from the 4~53 . PCT~US96/16788 bottom of section 236 to the w~i~th:~nc~ at the side. Circular annular ~rooved retainer 238 (Fig 29), hc.~;~Le~ called 'retainer,' can be made in two si~s, one larger in inner ~ m~oter than the thirl~nP~c of most penises at the base and another of smaller di:~meter.
Such retainers of whichever size, can be made of any suitable material, such as plastic, S polyurethane, I,.min~tef~ wood, metal, fiber-glass, or any other skin-compatihle suitable sl-hst~nre The retainer has an outward facing circular groove 244, which protrudes forward of a n~ ,g flange 246. Flange 246 is provided with multiple holes 248 for sewing flange 246 to fronsal section 236 ~Fig 28). F;ontal section 236 is preferably made of soft thick fabric, which acts as a l~ling buffer between retainer 238 and the user's body.
1 0 Preferably, w~ t'r ~nd 240 is made of wide elastic material in various waist sizes to suit individual users. It can also be made adjustable in size by known methods for individual users.
Leg straps 242 can be made either of fabric or elastic material.
Fig 30 shows an improved applicator ring 250, for use in conjunction with a grooved retainer, which is tapered, thus providing a large end 252 and a small end 253. Individual ends 1 5 can 'oe used effectively when fitting large and small size catheters onto penises and retainers.
Fig 31 shows a catheter being fitted onto large size end 252 of an applicator ring, while Fig 32 shows the graspable ring 226 of the catheter securely placed over large end 252, ready for fitting the catheter onto penis 254 as shown in Fig 33.
Fig 34 shows the catheter fitted as far as it will go onto penis 254 and large end 252 of 2 0 ~rplis~tnr against front section 236 of the garment. In this position, graspable ring 226 is rolled off the end of the applicator ring and into groove 244 of the retainer in the direction of arrows "K".
Fig 35 shows the c~ el~,. fitted onto penis 254, its graspable ring ~"6 securely locked and seated in annular groove 244. In this position, the c~hete~ is anchored securely to the ~ and l}lc..,~,~ cannot slip off the penis. The pressure applied between the sheath portion of the catheter 2 5 and the penile shaft by the improved VELCRO band can be reapplied in the exact position to t~. the leakage of urine. It will be seen that mark 225 on the hook portion (Fig 35) is aligned with the third mark 221 on the loop portion 227 of the band. Even too-large a catheter can be sealed against leakage by adding an elastic VELCRO band 256 attached around the sheath portion as shown in Fig 35, tightened just s~lffici.Dntly to effect a liquid tight seal.3 0 ~Ic~lifiç~l undclgallllellt with enlarged pouch shown in Fig 26 of this application and more clearly in U.S patent number 5,009,649, herein incorporated by reference, is used in conjunction with the g~ shown in Fig 35 of this embodimen~ and helps provide adequate support for the arCum~ tiQn of urine cQllectl A in the condom catheter. This arrangement is suitable both for able-bodied users and bedridden patients.
SUMMARY, RAMIFICATION, and SCOPE.
Thus, the reader will see that the present invention has many advantages over prior art male incontin-onre devices. The non-disabled user enjoys freedom to engage in a normal life-style, inr~ln-ling social and athletic activities such as working, swimming, aerobics, driving, running, .

WO 97/143S3 PCT~US96/16788 skiing, dancing, or riding horses or motorcycles, without having to worry about the catheter coming off unexpectedly. He can dress in standard street clothing, knowing that his in~vl,li.,. , is ill.p~ ,plible to all, even when he stands side by side with other men at a urinal. Patients and staff in hospitals can rest assured that the catheter will not come off until and unless purposely 5 released from the retainer devices. These advantages are accomplished by providing an int~
soft~ non-return, non-invertible valve and superior attachment, as well as embo~liment for those with allergic reaction to latex materials. Care-givers and users also will feel in~;..,ased confi-le-n~e in the use of elastic VEI CRO straps due to the plurality of in-licz~ting marks relating to tightn~sc of the band.
1 0 While the above description contains many specificities, the reader should not construe these as limit~tionc on the scope of the invention, but merely as exemplifications of preferred c.. -bo~l;.. llt~thereof.Thoseskilledintheartwillenvisionthatmanyotherpossiblev~ liQ.~care within its scope. For example, skilled artisans will readily be able to change the finen.-cs of the ribbing, and/or the shape and angles and depth of the grooves. The possible configurations of the 1 ~; relief are virtually limitT~ss) and the depth may also vary, as may the extension of the relief structure inside the length of the sheath portion. Also, other forms of g~rm~ntc can be decign~1 to ~tt~ch~l the support strap; an anchoring patch can be adhesively attached to the bare skin of a user for atfZlrhing a support strap; or a wzlic~b~nd alone can be used to attach the support strap.
The shape, width, length, or position of the non-return valve can be changed, or even the 2 0 number of turns of thread, or type of thread ~teri~l used. The size, shape and manner of ~tt~l~hing the twist-around drain valve are also variable. It is also possible to change the size, position or angle of the wide horizontal and small vertical valves, or even the type of valves used to reduce pooling of urine.
Other types of harness or braces can be envisioned for spinal injury patients to wear, and 2 5 to which the catheter can be ~tt~h--A Other atr~- hn~ent means can be provided for co~ e~ g the catheter to the braces, aside from the present rings and hooks; for example, hook and loop tabs fitted to the catL~,Lel and the bib portion, and or adhesive strips.
Accordingly, the reader is requesterl to ~l~rermine t-h-e scope of the invention by the a~-,n~ed claims and their legal equivalents, and not by the examples which have been given.

Claims (40)

I Claim:

1. A male incontinence device, comprising:
a first compartment sized to fit over the penis of a wearer, a second, urine collecting compartment, and a soft, non-invertible, non-return valve means connecting:
said first compartment to said second compartment for allowing fluid to flow from said first compartment to said second compartment and for preventing fluid from flowing from said second compartment to said first compartment.

2. The male incontinence device of claim 1 wherein said first compartment has a friction-increasing surface on at least a portion of an interior surface of said first compartment.

3. The male incontinence device of claim 2 wherein said friction-increasing surface comprises a relief pattern on said interior surface of said first compartment.

4. The male incontinence device of claim 3 wherein said relief pattern comprises a pattern of alternating circumferential ribs and grooves on said interior surface of said first compartment.

5. The male incontinence device of claim 3 wherein said relief pattern comprises a pattern of raised relief structures.

6. The male incontinence device of claim 5 wherein said raised relief structures are selected from the group consisting of mounds, arc-shaped raised relief structures, and S-shaped raised relief structures.

7. The male incontinence device of claim 1 wherein said soft, non-invertible, non-return valve means comprises a flexible, tubular member having a proximal end attached to said skin shield and a distal end extending into said second compartment and a slit-shaped lumen therebetween, whereby a pressure gradient from said first compartment to said second compartment causes said slit-shaped lumen to open, allowing fluid to flow from said first compartment to said second compartment and a pressure gradient from said second compartment to first second compartment causes said slit-shaped lumen to close, preventing fluid from flowing from said second compartment to said first second compartment.

8. The male incontinence device of claim 7 wherein said soft, non-invertible, non-return valve means further comprises a circumferential reinforcing fiber within a wall of said flexible, tubular member, whereby said flexible, tubular member is prevented from inverting due to a pressure gradient from said second compartment to said first second compartment.

9. The male incontinence device of claim 1 further comprising a drain valve means connected to said second, urine-collecting compartment for draining fluid from said second, urine-collecting compartment.

10. The male incontinence device of claim 9 wherein said drain valve means is a twist valve selectively rotatable from a closed position to an open position.

11. The male incontinence device of claim 1 wherein said first compartment and said second, urine-collecting compartment are formed with a single, continuous exterior wall surrounding an interior chamber including said first compartment and said second. urine-collecting compartment, and said skin shield is bonded within said interior chamber to separate said first compartment from said second compartment.

12. The male incontinence device of claim 1 wherein said first compartment is formed with an open proximal end and a closed distal end and said second, urine-collecting compartment is formed with an open proximal end and a closed distal end, and wherein said proximal end of said second, urine-collecting compartment is bonded to said distal end of said first compartment.

13. The male incontinence device of claim 1 further comprising a graspable rim on a proximal end of said first compartment.

14. The male incontinence device of claim 1 further comprising a garment to be worn by the wearer and means for attaching a proximal end of said first compartment to said garment.

15. The male incontinence device of claim 1 wherein said means for attaching comprises at least one hook attached to said garment and at least one ring attached to said proximal end of said first compartment, whereby said proximal end of said first compartment is attached to said garment by engaging said at least one ring with said at least one hook.

16. The male incontinence device of claim 1 wherein said first compartment is made of an elastomeric which conforms to the penis of the wearer.

17. The male incontinence device of claim 1 wherein said second compartment is made of an elastomeric material which expands to increase the capacity of said second compartment as it is filled with fluid.

18. A male incontinence device, comprising:
a condom catheter sized to fit over the penis of a wearer, a garment to be worn by the wearer, and means for attaching a proximal end of said condom catheter to said garment, whereby said condom catheter is secured to the wearer by attaching said proximal end of said condom catheter to said garment.

19. A condom device, comprising:
a condom sheath sized to fit over the penis of a wearer, and a friction-increasing surface on at least a portion of an interior surface of said condom sheath, whereby said condom device is secured to the wearer by friction between said friction-increasing surface and an exterior surface of the wearer's penis.

20. The condom device of claim 19 wherein said friction-increasing surface comprises a relief pattern on said interior surface of said condom sheath.

21. A device for retaining an external urinary catheter onto a penis of a wearer, said external urinary catheter having a proximal end encircling the penis of the wearer, said device comprising:
a band for encircling said proximal end of said external urinary catheter, a support strap having a first end and a second end, said first end of said support strap being attached to said band, and an attachment means for attaching said second end of said support strap to the wearer.

22. The device of claim 21, wherein said band is made of an elastic material, and wherein said band fastens about said proximal end of said external urinary catheter with a hook and loop fastener.

23. The device of claim 21, wherein said band comprises a first end portion and a second end portion and an adjustable fastening means for connecting said first end portion to said second end portion in an overlapping manner, the degree of overlapping between said first end portion and said second end portion determining the tightness of said band around said proximal end of said external urinary catheter and the penis of the wearer, and wherein said band further comprises a plurality of indicating marks for indicating the degree of overlapping between said first end portion and said second end portion and therefore the tightness of said band around said proximal end of said external urinary catheter and the penis of the wearer.

24. The device of claim 21, wherein said attachment means comprises a means for attaching said second end of said support strap to a waistband of an undergarment having an expandable pouch for supporting said external urinary catheter

25. The device of claim 21, wherein said attachment means comprises a removable attachment means selected from the group consisting of snaps, press studs, safety pins, buttons, hooks and eyes, and hook and loop fasteners.

26. The device of claim 21, further comprising an adjustment means for adjusting the length of said support strap.

27. The device of claim 21, wherein said adjustment means comprises a plurality of attachment means positioned at different positions along the length of said support strap.

28. In combination:
an external urinary catheter having a proximal end encircling the penis of the wearer;
a garment having a waistband; and a retaining device comprising:
a band for encircling said proximal end of said external urinary catheter, a support strap having a first end and a second end, said first end of said support strap being attached to said band, and an attachment means for attaching said second end of said support strap to said waistband of said garment.

29. The combination of claim 28, wherein said band is made of an elastic material and, wherein said band fastens about said proximal end of said external urinary catheter with a hook and loop fastener.

30. The combination of claim 28, wherein said garment is an undergarment having an expandable pouch for supporting said external urinary catheter

31. The combination of claim 28, wherein said attachment means comprises a removable attachment means selected from the group consisting of snaps, press studs, safety pins, buttons, hooks and eyes, and hook and loop fasteners.

32. The combination of claim 28, further comprising an adjustment means for adjusting the length of said support strap.

33. A device for retaining an external urinary catheter onto a penis of a wearer, said external urinary catheter having a proximal end encircling the penis of the wearer, said device comprising:
a garment having a front panel, and a retainer attached to said front panel of said garment, said retainer having a groove for attachment of said proximal end of said external urinary catheter.

34. The device of claim 33, wherein said retainer comprises a circular ring having an inner diameter sized to fit over the penis of the wearer and a mounting flange for attaching said circular ring to said front panel of said garment, said groove encircling an exterior surface of said circular ring.

35. In combination:
an external urinary catheter having a proximal end encircling the penis of the wearer, and a retaining device comprising:
a garment having a front panel, and a retainer ring attached to said front panel of said garment, said retainer ring having a groove for attachment of said proximal end of said external urinary catheter.

36. The combination of claim 36, wherein said retainer ring comprises a circular ring having an inner diameter sized to fit over the penis of the wearer and a mounting flange for attaching said circular ring to said front panel of said garment, said groove encircling an exterior surface of said circular ring.

37. The combination of claim 36, wherein said proximal end of said external urinary catheter has a graspable ring sized to fit within said groove of said retainer ring.

38. The combination of claim 36 further comprising an applicator ring having a tapered body having a first end and a second end, said first end having a first diameter larger than a retainer ring of a first size, said second end having a second diameter larger than a retainer ring of a second size which is different from said first size, whereby said external urinary catheter is applied to a selected retainer by passing said proximal end of said external urinary catheter through said applicator ring and stretching said proximal end over an exterior surface of an end selected from said first end and said second end corresponding with the size of the selected retainer ring, then positioning said applicator ring around said selected retainer ring and rolling said proximal end of said external urinary catheter off of said applicator ring and into said groove of said selected retainer ring.

39. The combination of claim 36 further comprising a band for encircling said external urinary catheter to seal said external urinary catheter around the penis of the wearer.

40. A method of retaining an external urinary catheter onto a penis of a wearer, comprising:
passing a proximal end of said external urinary catheter through an applicator ring and stretching said proximal end over an exterior surface of said applicator ring, positioning said applicator ring around a retainer ring attached to a front panel of a garment worn by said wearer, said retainer ring encircling the penis of the wearer, then rolling said proximal end of said external urinary catheter off of said applicator ring and into a groove on an exterior surface of said retainer ring.