Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/4404—Details or parts
  • A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/451—Genital or anal receptacles
  • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member

Definitions

• the present invention relates to male incontinence devices, in particular to a ribbed surface inside the condom sheath to improve catheter adherence, an integrally made reinforced soft non ⁇ return valve to prevent urine spillage, an altemative soft non-return, non-invertible two-valve assembly designed 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 catheter for use by spinal injured patients and an inexpensive non-elastomeric condom catheter.
• condom catheter devices to come off in use is a common problem. This 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 diameter, a condom 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 diameter than the shaft, such a device will be less secure. This is true both for circumcised and uncircumcised men. A more adherent condom catheter would tend to make the wearer more socially secure. By the same token, a more secure condom used for sexual purposes would be of substantial benefit in preventing both unwanted pregnancies and sexually transmitted 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 po ⁇ ion.
• a dilemma 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 catheter might slip; bind it too tightly and it might interfere with circulation.
• Adhesives have several drawbacks. They not only fail to guarantee that the sheath will remain in place, but they often cause pain and sometimes injury while being removed. As a consequence, they are extremely unpopular with users.
• Condom catheter slippage continues to be a major concern among nursing and care-giving staff, especially those attending the elderly, the spinal-injured and others likely to suffer male urinary incontinence. It is equally a worry to the otherwise able-bodied incontinent, who desire to continue normal activities and work.
• the drain valve also presented problems, whether the pull-out plug or the screw-off cap 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 attending incapacitated or aged men.
• 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.
• one object and advantage of the present invention is to provide a one-piece, condom-like, adhesive-free male urinary incontinence device which is less likely to slip off than prior an 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 manufacture 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- return valve which is less supportive 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 adjacent the penis glans in prior an extemal condom catheters.
• Still another object and advantage of the present invention is to provide an incontinence 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 diseases may be transmitted through urine.
• Another object and advantage of the present invention is to provide a urine incontinence extemal condom catheter device which may be attached to a simple harness, garment 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 retaining 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 overweight.
• a still further object and advantage is to provide a one-piece male incontinence 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.
• the attachment 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 demented.
• a further object and advantage is to provide a VELCRO hook and loop band that can be readily adjusted to a previously established and desired tension, without the need for repeated guesswork.
• 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 intemal ribbing and a second cut-away exposing the thread-reinforced, non-retu , non-invertible soft valve.
• 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 po ⁇ ion showing an altemative relief structure, and also a cut-away exposing the non-retu valve.
• Fig 5 shows three altemative relief structures within the condom sheath.
• Fig 6 is a sectional view of the non-retum valve shown in Fig 4.
• 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-a ⁇ 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 (disclosed in patent no. 5,009,649) fitted to the urine collecting compa ⁇ ment.
• a ball-obturator drain valve (disclosed in patent no. 5,009,649) fitted to the urine collecting compa ⁇ ment.
• Fig 11 is a sectional side view taken along the line 11-11 of Fig 10.
• Fig 12 is a cross sectional view taken along the line 12-12 of Fig 10.
• Fig 13 is a perspective view of a single piece catheter into which a non-retum, non-invertible valve is inse ⁇ ed and sealed inside the catheter.
• Fig 14 is a perspective view of mandrel and removable double-edged blade used for manufacturing a non-retum, non-invertible valve and skin shield.
• Fig 15 is a sectional view taken along line 15-15 of Fig 14.
• Fig 16 is a sectional view taken along the line 16-16 of Fig 14.
• Fig 17 is a perspective view of the mandrel shown in Fig 14 with double-edged blade inse ⁇ ed, then dipped into liquid latex and fine thread wound around the blade.
• Fig 18 is a perspective view of a garment which can be used by a spinal-injured person for anchoring a catheter of the present invention.
• Fig 19 is a perspective view of a male urinary incontinence extemal catheter constructed from a non-elastomeric 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.
• Fig 22 is a sectional view taken along line 22-22 of Fig 19.
• Fig 23 is a side view of a casing supporting the prior an duck-bill non-retum valve of Fig 19.
• Fig 24 is a perspective view of a penis fitted with a prior an condom catheter.
• Fig 25 is a perspective view of another embodiment showing a combination of a suppo ⁇ strap and an improved elastic VELCRO band.
• 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 suppo ⁇ strap and undergarment's waistband.
• 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.
• Fig 29 is a perspective view of a grooved retainer for attaching to a garment.
• Fig 30 is a perspective view of an improved applicator ring.
• Rg 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.
• 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 undergarment.
• Fig 35 is a perspective view of the catheter of Fig 34, showing the applicator ring removed, and graspable ring securely dislodged off the applicator and into the circular groove of the retainer.
• Fig 1 shows a male urinary incontinence condom device 30 according to the invention. It can be made of an elastomeric material such as latex, silicon or polyisoprene or any other suitable material.
• the device consists of two main pans.
• the first pan comprises an inner condom sheath 32, which has a graspable rim 34 at its open proximal end and a skin shield 36 incorporating a soft non-invertible, non-retum valve 38 at its distal or closed end 40;
• the second pan is a urine- collecting compa ⁇ ment 42 having an open end 44 which is imperviously sealed at 46 to cylindrical po ⁇ ion 48 of inner condom sheath 32, and a closed distal end 50 which incorporates a prior an twist-around drain valve 52.
• Inner condom sheath 32 can be made in several sizes to accommodate the needs of users.
• interior ribs 54 are about .5 mm (.020") deep and are incorporated around the inside of the sheath starting near the open end; these are spaced at about .5 mm (.020”) apan, creating fine grooves in between.
• the width of the ribbed portion is approximately matched to the size of the device, such that about 28 mm of ribs are foimed in a device measuring 28 mm in diameter, while approximately 31 mm width of ribs are molded into a 31 mm diameter device.
• a lesser or greater number of ribs per centimeter or inch can be used; i.e., the ribs can be 1 mm deep and 1 mm apan; however, it is preferred that the ribs be very closely spaced, as shown in Fig 2. Also the length of the ribbed area can be increased or decreased.
• 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).
• 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 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 angles besides those shown at 58 in Fig 3 can be designed; also different depths and spacings can be used to obtain different degrees of catheter adherence.
• a fine screw thread (not shown) can be machined into the mandrel in lieu of a series of separate grooves shown at 54 (Fig 2).
• Fig 4 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.
• Other altemative 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 v back to back' as shown at 62, (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 vi ⁇ ually infinite.
• Fig 1,2,4 and 6 show a non-return valve 38, which allows urine from skin shield inner compartment 36 to pass without restriction into urine collecting compartment 42.
• This valve is formed 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). 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, pa ⁇ ly-open slit 72 remains between flaps 68 (Fig 7.)
• the soft non-retu valve as described above is preferred to a hard non-retum valve in a condom catheter for the reason described in Background of the Invention above.
• the valve must also retain its original flexibility so that it will close even when low pressure is applied from the collecting compartment, thus preventing voided urine from returning from the urine collecting compartment to the penis glans behind the skin shield.
• Making a non-retum valve, also "non-invertible" has been achieved by reinforcing the latex in the valve itself with fine polyester or other suitable thread which is imbedded into the latex during manufacture. This is described below.
• a double-edged, double convex blade 74 (Fig 10 and 13) is removably inse ⁇ ed into a corresponding cavity 81 (Fig 10 and 12) in the lower end of mandrel 76.
• 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-retum valve. Fu ⁇ her heat curing and dipping is done until the latex is about 1 mm (.040") thick.
• valve 38 is cut to about 9mm (.375") long, as shown at arrows C-C. (Fig 11).
• the resulting non-retum valve cannot inve ⁇ simply because the reinforcing threads prevent slit 72 (Figs 4, 6-8) of the valve from opening sufficiently to allow the remainder of the valve to pass through it to the opposite side of the skin shield.
• valve 38 can be made non-invertible by using a latex mbber to which certain chemicals have been added which make the rubber harder and less elastic.
• such valve is not as flexible, nor as responsive in operation when subjected to very low hydraulic back pressure from the urine in the collection compa ⁇ ment as a valve reinforced with thread only.
• Fig 14 shows a one-piece catheter 79 into which mandrel 76, together with completed skin shield 36 and non-return, non-invertible valve 38 are inse ⁇ ed in the direction of arrows "J" and hermetically sealed in the position shown by broken line 82.
• Condom sheath portion 77 is stretched open in the direction of arrows "L” to facilitate entry of mandrel 76 into catheter 79 when fitting skin shield 35 and its non-retum valve 38.
• Fig 15 shows a one-piece urinary incontinence condom catheter 84 fitted with pool draining means.
• the means comprises having two non-retum, non-inve ⁇ ible 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 perspective 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 vertically near 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 sectional view taken along line 16-16 of Fig 15, showing a pool of urine 90 between penis glans 92 and skin shield 36.
• the following system is designed to drain the pool of urine into the collecting compa ⁇ ment, leaving the glans as dry as it is possible under these circumstances.
• An incontinence sufferer may be voiding urine almost continuously, or frequently, or occasional, or just sometimes, so it is unlikely that the penis glans will ever become completely dry in such an environment.
• the system of draining the pool of urine is similar to that used to empty a can of liquid (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 ve ⁇ ical valve 88 (which is always slightly open unless under pressure) is provided for air from within urine collecting compa ⁇ ment 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, the pool of urine will not flow so freely through lower valve 86 even though it is pa ⁇ ly open. With the small upper ve ⁇ ical 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.
• FIG 15 also shows a ball-obturator valve 94 which is disclosed in patent no. 5,009,649 and which can be used on any of the catheters which are constructed from elastomeric materials.
• the advantage of this valve over other drain valves is that it is a soft valve generally and it can be rnanufactured integrally with the urine collection compartment requiring only the inserting of a plastic ball 95 and a compression spring 96 to complete the valve.
• 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 compa ⁇ ment. This action will push the ball away from its seat, thereby allowing urine to flow.
• the nozzle can be made integrally with the collecting compartment and provided with an extended nozzle 99, so as to prevent urine coming into contact with the user's hand when operating the valve.
• the nozzle can be connected to an extension tube (not shown) using prior an tube connectors, and then to a bedside bag, or even to a leg bag.
• Fig 9 shows a prior art twist-around drain valve 52, which can be attached and imperviously sealed to any of the condom catheter embodiments in this application.
• the catheter is made of latex and/or elastomeric material, it is preferred that the material be made more substantial where the valve is to be inse ⁇ ed and sealed.
• the valve be adhesively attached and imperviously sealed to the catheter material and in addition is bound around the outside with suitable thread cord and/or tape.
• Fig 18 shows a harness or garment 94 comprising a central bib po ⁇ ion 96, suppo ⁇ ed at its upper end by an elastic waist band 98 and at its lower end by leg straps 100.
• a circular hole 102 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 catheter is fitted onto the user, rings 106 can be attached onto hooks 104, thereby retaining the catheter in place. Rings 106 can be of the split-link type clamped around graspable rim 34.
• other means can be adapted to anchor the incontinence catheter to the garment, such as VELCRO hook and loop strips (not shown), one pan attached to the catheter and the other to the garment.
• Fig 19 shows a one piece male urinary incontinence catheter 110 comprising a condom sheath 112 and a urine collecting compartment 114, according to a fourth embodiment of the invention.
• This embodiment is made of non-elastomeric material such as vinyl, having such desirable properties as softness, pliability, water-resistance, puncture-resistance, non-allergic and conformity to both the wearer's body and his clothing. It can also be made of any similarly tough pliable material, which preferably can be instant heat-cut/welded using prior-a ⁇ methods around a suitable pattem, as shown in Fig 20.
• Fig 20 and 21 show a suitable pattem 116 comprising two layers 117 and 119 of plastic material such as vinyl, which are instant heat-cut/welded along edges 118 and 120. Edge 124 and 122 are cut but not welded, and provide an open proximal and distal end. Open proximal end 124 (Fig 19) is fitted intemally with a deformable plastic sleeve 126, such as foam plastic or the like, (Fig 19 and 22) having a slightly larger internal diameter than the size of the penis for which it is intended to fit.
• a deformable plastic sleeve 126 such as foam plastic or the like
• Narrow portion 130 (Fig 19 and 20) of catheter pattem 116 provides a cylindrical aperture for fitting and imperviously sealing and binding thereto a prior art non-retum valve 132, shown in
• Fig 19 shows non-return valve 132 imperviously sealed inside na ⁇ ow portion 130 and externally bound in place.
• a screw-around drain valve 128 is imperviously sealed in ape ⁇ ure 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 outside with tape or cord of any suitable type. It is recommended that VELCRO hook and loop bands (discussed later) be used to close condom sheath 112, along with deformable plastic sleeve 126, snugly onto the penis.
• garment 94 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-a ⁇ adhesive strips.
• the urine collecting compartment will be non-extensible under pressure of continually voided urine, and such pressure could tend to push the catheter off the penis unless the compartment is timely emptied. This could be a real problem for users, especially for spinal injured patients.
• a prior-a ⁇ , pressure-sensitive electrical switch 134 is imperviously sealed into edge 120 (Fig 19 and 20).
• Switch 134 comprises two pans, a small sealed elastomeric chamber 138 positioned inside urine collection compa ⁇ ment 114, and extemal connector pins 136 on the outside of the compartment. Pins 136 can be attached by leads 140 to a belt-mounted "buzzer' (not shown) worn by the user.
• pressure sensitive switch 134 becomes switched 'on' thereby completing an electrical circuit and sounding the buzzer and alerting the user to drain the compa ⁇ ment.
• Fig 24 shows a one-piece male urinary incontinence condom 210 of U.S. patent 5,380,312 which has been incorporated by reference, fitted onto a flaccid penis, 212.
• a condom catheter was usually retained in place by a prior-a ⁇ elastic VELCRO band 214.
• the weight of voided urine which collects in the collection compartment 216 of condom 210 is supported by the extended pouch 217 of a modified undergarment shown in Fig 26 in this application and also in Fig 27 of U.S patent number 5,009,649.
• this embodiment was not always successful in keeping the Goulter condom catheter on tapering penises, the purpose of the present invention is to hold the device in place more securely.
• Suppo ⁇ strap 218 (best seen in Rg 25), which is combined with VELCRO band 220, preferably by sewing or otherwise securing strap 218 and band 220 together, as shown at 222 (Fig 25).
• Suppo ⁇ strap 218 has sufficient length to be attached to the waistband 230 (Fig 26) of a modified undergarment 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 indicating marks 221, permanently imprinted or otherwise made on loop section 223. Marks 221 are spaced about 5 mm (.187") apan. A single cooperating mark 225 is made on hook section 227,. such that when the user is fitted VELCRO band 220, mark 225 will align with, or near, one of the six marks 221, thus providing a visual read-out of where hook section mark co ⁇ esponds relative to one of the loop section marks.
• the patented pouch-enlarged undergarment shown in Fig 26 of this application and in Fig 27 of U.S patent number 5,009,649 may be used with this, and other, embodiments of the present invention, and that snaps or similar adjustable anchoring means be attached to the waistband of said garment, to secure the suppo ⁇ strap.
• the use of such a garment suppo ⁇ s the device both from below, by pouch 217, and above, by suppo ⁇ strap 218.
• suppo ⁇ strap 218 In order to conveniently and securely attach suppo ⁇ strap 218 to modified undergarment's waistband 230, suppo ⁇ strap 218 (Fig 25-27) is fitted with multiple male-pan snaps, or press studs, 224, while one or two female-pan snaps or press studs 224' are sewn to waistband 230 of the under garment, such that while VELCRO band 220 is attached to a catheter at its lower end, the upper end is anchored to waistband 230 by the snaps, thereby positively securing condom 210 to penis 212 and preventing it from slipping off the penis.
• Fig 27 shows a sectional view taken along broken line 27-27 of Fig 26, showing portion of the user's body 232, po ⁇ ion of undergarment and its waistband 230 fitted with female-pan snaps 225, and po ⁇ ion of support strap 218 fitted with male-pan snaps 224'.
• Multiple fitting of male pan snaps along the upper end of strap 218 allows for the adjustment of the length of strap 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.
• 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 the remote danger that die strap and the band may become separated; therefore, a positive attachment of strap and band (i.e., by sewing) is prefe ⁇ ed.
• the weight of urine is supported both from beneath, by the undergarment pouch, and from above, by the tethered support strap and waistband. Together, they promote retention of the catheter irrespective of the penis' shape.
• the present invention is so well supported that users have no sensation of wearing the device until the bulk of voided urine increases sufficiently to act as a reminder to drain the compartment. Draining, in turn, can be done by simply unzipping the trouser fly, pulling the end of the device out through the fly of the undergarment, and opening the release valve, making it possible for the wearer to use any convenient toilet or urinal.
• Fig 28 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 bottom of section 236 to the waistband at the side.
• Circular annular grooved retainer 238 (Fig 29), hereafter called 'retainer,' can be made in two sizes, one larger in inner diameter than the thickness of most penises at the base and another of smaller diameter.
• Such retainers of whichever size, can be made of any suitable material, such as plastic, polyurethane, laminated wood, metal, fiber-glass, or any other skin-compatible suitable substance.
• the retainer has an outward facing circular groove 244, which protrudes forward of a mounting flange 246.
• Range 246 is provided with multiple holes 248 for sewing flange 246 to frontal section 236 (Fig 28).
• Frontal section 236 is preferably made of soft thick fabric, which acts as a protecting buffer between retainer 238 and the user's body.
• waistband 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 widi a grooved retainer, which is tapered, thus providing a large end 252 and a small end 253. Individual ends can be 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
• Rg 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 applicator against front section 236 of the garment.
• graspable ring 226 is rolled off the end of die applicator ring and into groove 244 of the retainer in the direction of arrows "K”.
• Rg 35 shows the catheter fitted onto penis 254, its graspable ring 226 securely locked and seated in annular groove 244.
• the catheter is anchored securely to the garment and therefore cannot slip off the penis.
• the pressure applied between the sheath portion of the catheter and the penile shaft by the improved VELCRO band can be reapplied in the exact position to prevents the leakage of urine.
• mark 225 on the hook portion (Fig 35) is aligned widi the third mark 221 on the loop portion 227 of the band.
• mark 225 on the hook portion (Fig 35) is aligned widi the third mark 221 on the loop portion 227 of the band.
• an elastic VELCRO band 256 attached around the sheadi portion as shown in Fig 35, tightened just sufficiendy to effect a liquid tight seal.
• Modified undergarment with enlarged pouch shown in Fig 26 of this application and more clearly in U.S patent number 5,009,649, herein inco ⁇ orated by reference is used in conjunction with the garment shown in Fig 35 of this embodiment and helps provide adequate support for the accumulation of urine collected in the condom catheter. This arrangement is suitable both for able- bodied users and bedridden patients.
• the present invention has many advantages over prior art male incontinence devices.
• the non-disabled user enjoys freedom to engage in a normal life-style, including social and athletic activities such as working, swimming, aerobics, driving, running, skiing, dancing, or riding horses or motorcycles, without having to worry about d e catiieter coming off unexpectedly.
• He can dress in standard street clotiring, knowing that his incontinence is imperceptible to all, even when he stands side by side with other men at a urinal. Patients and staff in hospitals can rest assured diat the catheter will not come off until and unless purposely released from the retainer devices.
• die relief are virtually limidess, and the depth may also vary, as may the extension of die relief structure inside the length of the sheath portion.
• other forms of garments can be designed to attached the suppo ⁇ strap; an anchoring patch can be adhesively attached to die bare skin of a user for attaching a suppo ⁇ strap; or a waistband alone can be used to attach the suppo ⁇ strap.
• the shape, width, length, or position of the non-retum valve can be changed, or even the number of turns of thread, or type of thread material used.
• the size, shape and manner of attaching the twist-around drain valve are also variable. It is also possible to change the size, position or angle of die wide horizontal and small vertical valves, or even the type of valves used to reduce pooling of urine.
• harness or braces can be envisioned for spinal injury patients to wear, and to which the catheter can be attached.
• Other attachment means can be provided for connecting the catheter to the braces, aside from the present rings and hooks; for example, hook and loop tabs fitted to the catheter and the bib portion, and or adhesive strips.

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• 1996
  • 1996-10-18 JP JP9516066A patent/JPH11513597A/ja active Pending
  • 1996-10-18 AU AU74584/96A patent/AU7458496A/en not_active Abandoned
  • 1996-10-18 WO PCT/US1996/016788 patent/WO1997014353A1/en not_active Application Discontinuation
  • 1996-10-18 EP EP96936739A patent/EP0855873A4/en not_active Withdrawn
  • 1996-10-18 KR KR1019980702858A patent/KR19990066937A/ko not_active Application Discontinuation
  • 1996-10-18 CA CA002234742A patent/CA2234742A1/en not_active Abandoned

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