Disposable Male Urinary Incontinence Device

Abstract

Male incontinence device comprising the combination of a funnel element and a thin rubber sheath element adapted for application to the male member to transmit voiding of urine by the patient with connector means for preventing leakage between said elements. An additional resilient element is provided for retaining the sheath upon the male member.

Description

BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION:

This invention relates to a disposable incontinence device and, more particularly, to a device for transmitting urine voided by an incontinent male patient by a combination of sheath and funnel elements, together with an adjustable resilient retaining element for securing the apparatus upon the male member.

2. DESCRIPTION OF THE PRIOR ART:

Examples of prior art devices are disclosed in the following U.S. Pat., Nos. 947,725; 2,379,346; 2,389,831; 2,610,630; 2,789,560; 3,032,038; 3,138,160; 3,298,370; 3,339,551 and 3,364,932. Although the prior art discloses a funnel element and an elastic sheath in combination, it is to be noted that when voiding takes place and urine inevitably backs up into the elastic sheath, leakage can occur at the outer end of said elastic sheath thereby rendering the apparatus ineffectual. Also the application of an elastic strip applied to retain the elastic sheath near the outer end of the male member is extremely uncomfortable for the patient and is highly impracticable in actual use. Furthermore, such an elastic strip is physiologically dangerous because of venous constriction as a result of a tourniquet effect.

SUMMARY OF THE INVENTION

The present invention obviates the foregoing disadvantages of the prior art by providing a combination of a funnel and elastic sheath where the molded plastic funnel element is telescopically inserted into the end of the elastic sheath and thereafter the exit end of the funnel and the outer end of the elastic sheath are both clamped together so that no leakage can possibly occur therebetween. Furthermore, the sheath is retained upon the male organ adjacent the pubis by a soft, resilient cuff element that is adjustably mounted around the sheath to secure the latter comfortably at the base portion of the penis. The cuff element is fairly broad and distributes pressure unequally over a large surface area and at the base of the penis where venous pressure can be more safely tolerated. By this arrangement, the patient is not subjected to the discomfitures that would be incurred with the prior art devices. A dry state is maintained in any position of the male organ as long as the urine receptacle is located below the level of the pubis.

Further objects and advantages of the invention will be described in the drawings and specification hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation of the present invention, partly in section and partly in dotted outline, showing the application of the device upon the male member of a patient and the attachment of the apparatus by way of flexible tubing to a reservoir bottle;

FIG. 2 is an exploded view of some of the components of the apparatus shown in FIG. 1, some parts being shown in elevation and others in vertical cross-section;

FIG. 3 is a view taken on line 3--3 of FIG. 1;

FIG. 4 is a view taken on line 4--4 of FIG. 1;

FIG. 5 is an enlarged fragmentary central vertical section of a portion of the apparatus shown in FIG. 1;

FIG. 6 is an enlarged fragmentary view of a portion of FIG. 4 indicating the position of a component of the apparatus prior to its being secured;

FIG. 7 is a plan view of the securing element of the apparatus;

FIG. 8 is a reverse view of the securing element shown in FIG. 7;

FIG. 9 is a view taken on line 9--9 of FIG. 8;

FIG. 10 is a view taken on line 10--10 of FIG. 8;

FIG. 11 is a side view of the securing element shown in FIGS. 7-10 after the latter has been placed in its securing position;

FIG. 12 is a bottom view of the securing element shown in FIGS. 1, 5 and 11;

FIG. 13 is a side view, partially in section and partially in elevation, illustrating another embodiment of the invention comprising an open wall funnel to permit the collapse of the sheath;

FIG. 14 is a reverse perspective view of the open wall funnel portion of the apparatus shown in FIG. 13, with the heath illustrated in dotted outline and partially rolled;

FIG. 15 is an internal end view of the apparatus shown in FIG. 14; and

FIG. 16 is a view taken on line 16--16 of FIG. 13, showing the sealing action of portions of the sheath collapsed against each other through the opening walls of the funnel.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in detail, the present invention comprises an assembly of components, namely, a funnel element 21, a thin rubber sheath or condom 22, a flexible tube 23, and a connector element 24.

Funnel element 21 may be made of a rubber or plastic material such as polyethylene or any other suitable material which is rigid or semi-rigid. The outer surface of funnel 21 may be provided with radially extending, integrally formed ribs or ridges 26 to prevent deformation of the shape of said funnel and to prevent or minimize rotation of the sheath in relation to said funnel. Also, the plastic funnel maintains a constant reservoir in the distal sheath and this is important where voiding is not normal and there is constant leakage or dribbling of urine.

At the wider end of funnel 21 there is an outwardly extending circumferential rim 27. The smaller end of funnel 21 terminates in an integrally formed tubular nozzle 28 which, intermediate its ends, has on the outer surface thereof an integrally formed, outwardly extending circumferential ridge 29. The interior surface of funnel 21 may be coated with Teflon to facilitate evacuation of urine therethrough.

Connector element 24, which may be made of a stiff but somewhat resilient plastic, rubber, or other suitable material, is tubular in shape and has an internal annular recess 31 intermediate its ends with which ridge 29 of nozzle 21 interfits with a snap action.

Drain tube 23 which is corrugated to provide flexibility has an integrally formed inlet nozzle 32 which coacts by force fit with the interior of one end of connector 24 whereby said two components are separably secured tgether. The funnel, in conjunction with the corrugated drain tube connector element, prevents acute angulation and twisting of the sheath outlet with changes in the position of the drain tube or position of the male member in relation to the drain tube. Obstruction by kinking or twisting occurs with devices utilizing button-type connectors.

Rubber sheath 22, which may comprise the well known thin rubber or latex prphylactic or condom is a tubular element which is available commercially in a rolled condition, a greater portion of which comprises rolled portion 33 to form a receiving end of said element. In FIG. 2, sheath 22 is shown partially unrolled. The other end of sheath 22 terminates in an axially extending integrally, formed, closed end receptacle tip 34 of considerably narrower diameter, said tip being insertable into the interior of connector 24 at least beyond annular recess 31.

In order to assemble the apparatus and to apply it upon the male member or penis of the patient, nozzle 28 of funnel 21 is inserted telescopically into the closed end tip 34 of the rolled rubber sheath 22. Nozzle 28, with tip 34 stretched over it, is then pressed into the interior of a connector 24 until circumferential ridge 29 snaps into and engages annular recess 31 of said connector. Thus, a leak-tight juncture is achieved between the nozzle and the sheath and obviates the use of cement or other bonding that would otherwise be required.

Thereafter, a pencil shaped perforator having a plurality of longitudinal cutting edges, not shown, is extended through the interior of funnel 21 and through nozzle 28 to perforate that portion of tip 34 which is stretched over the exit end of nozzle 28. It is advantageous to make sure that the perforation is not merely one that is obtained by piercing with a pin or an extremely sharp object, but is rather pierced by a thick and blunt instrument which will ensure that the opening made in tip 34 will be substantially equal to the interior diameter of nozzle 28.

Thereafter, the foreskin of the penis, if present, is then drawn down over the head into the normal position, the end of the penis is inserted into and nested in funnel 21, after which rolled portion 33 of sheath 22 is rolled onto the shaft of the penis until the proximal rim is adjacent the pubis.

In order to secure the unrolled sheath 22 firmly in position, there is provided a cuff generally designated 41, as shown in various views in FIGS. 4 - 12, said cuff comprising an elongated base or backing element 42 made of a flexible material such as sheet plastic or plastic coated or impregnated woven fabric. Backing 42 has an integral tab extension 43 to one surface of which is bonded or otherwise attached a Velcro fastening surface 44 comprising evenly distributed multitudinous tiny projecting hook-like plastic elements. Applied upon the opposite surface at the other end of backing 42 is a felt strip 45 which, when said backing is rolled into a tubular form, enables Velcro fastener to engage said felt strip to retain said backing in that tubular form as shown in FIGS. 4 and 6.

Mounted upon backing 42 on the same side as the Velcro fastener 44 is an elongated soft plastic sponge or foam strip 46, said strip 46 being somewhat wider than backing 42, as will be explained hereinafter. The upper and lower edges 47 and 48, respectively, may be beveled in the areas where they extend from the respective upper and lower edges of backing 42. As shown in FIG. 7, the left end of foam strip 46 protrudes a short distance beyond the edge of backing 42 to form an extension 46a.

As shown in FIG. 10, the end of foam strip 46 adjacent Velcro fastener 44 has a recessed ledge 49 which, when said backing and foam strips are rolled into tubular form around sheath 22, the extension 46a of foam strip 46 beyond the left end of backing 42 (FIG. 7) nests into said ledge 49 to permit the formation of a smooth, tubular assembly as shown in FIGS. 4 and 6. The resiliency of the soft, plastic foam permits the ready accommodation of this interfitting juncture whereby a substantially smooth tubular interior surface is formed thereby preventing tenting of the rubber sheath and of the enclosed flaccid skin of the penis with resulting pinching and skin irritation.

In some embodiments, the upper edges of both backing 42 and foam strip 46 may be provided with a concave contour 50 intermediate the ends thereof for conformation to the male anatomy. Furthermore, the surface of foam strip 46 may be marked with an index arrow pointer 51 located at the apex of the contoured area (FIG. 8) to guide the patient in the proper application of the cuff which is located with the base portion of the penis centered over said arrow pointing toward the body of the patient. This ensures that the concave edge of the cuff will be in a position adjacent the symphysis.

With the proximal rim 52 of the rubber sheath now adjacent the pubis, cuff 41 is applied circumferentially around the sheath-enclosed base of the penis with the ends of the cuff extending upwardly and then mating the ends of the foam strip 46 together in ledge 49. Thereafter, the Velcro strip 44 is urged against felt strip 45 to which it adheres firmly. Cuff 41 can readily be removed by manually pulling at Velcro tab 43 which causes the Velcro hooks to become released from felt strip 45. After cuff 41 is in position, then the proximal circumferential rim 52 of sheath 22 is brought over the edge of cuff 41 as shown in FIGS. 5 and 12, whereby the position of sheath 22 in relation to cuff 41 is further secured. In some embodiments, strip 46 is provided with a circumferential bead 53 with which elastic rim 52 cooperates to enhance the position stability of sheath 22. When the circumferential rim 52 of sheath 22 is brought over the edge of cuff 41, a smooth anatomically countoured cushion is produced which adds to the comfort of the device and prevents skin irritation due to pressure especially at the peno-scrotal angle.

OPERATION

When voiding occurs, the rubber sheath 22 fills suddenly with urine. Sheath 22 expands elastically but is secured in position by cuff 41. The elastic force of sheat 22 is exerted to cause the outflow of the urine from the sheath through funnel 21, connector 24, and through drainage tube 23. The flow of urine through drainage tube 23 creates a siphonage effect and a negative intra-sheath pressure which completely empties the sheath after voiding. The widened portion of funnel 21 prevents this negative pressure from being exerted directly onto the penile meatus and to the distal male organ which would otherwise be painful. The drain tube 23 is corrugated to give maximum flexibility and longitudinal expansibility thereby resulting in minimal tension on the sheath and preventing kinking at the outlet end. The corrugations on drain tube 23 render the latter somewhat expansible and contractable to the extent that any tension or twisting applied to any portion of said tube is not appreciably transmitted to the assembly of sheath 22 and funnel 21 or to the male member. Drain tube 23 is connected by means of a connector tube 56 to a suitable reservoir bottle 57 having a suitable air vent valve 58 to ensure proper function of the siphonage principle.

It will be noted that ribs 26 of funnel 21 also perform the function of frictionally preventing twisting and undue rotational displacement of elastic sheath 22 relative to said funnel, before or during the process of voiding.

In one embodiment, cuff 41 may be as much as about 1 inch to 2 inches wide, whereby the pressure thereof is distributed over a comparatively wide area thereby ensuring the comfort of the patient and preventing a tourniquet. The cuff provides for maximum contact with the skin of the enclosed male member thereby decreasing the circumferential pressure necessary to maintain the position of the rubber sheath. The anatomically contoured cuff also allows the device to be used where the shaft of the penis is short by virtue of its being gripped by the narrow lower edge while still maintaining maximum cuff diameter and to provide for maximum skin contact laterally and superiorly to maintain the appliance in position without excessive circumferential pressure. The skin pressure is distributed unequally circumferentially of the penis in contrast to the undesirable equal and higher pressure induced by a band-type restraint.

Another embodiment of the invention is shown in FIGS. 13-16 wherein the funnel element, generally designated 61, comprises an outlet tube 62 having an annular rib 63 which is comparable to respective elements 28 and 29 of funnel 21 as shown in FIG. 2.

Integrally formed or otherwise connected to one end of outlet tube 62 are the inner ends of a plurality of curved radially spaced apart ribs 64, the outer ends of said ribs terminating in a common, integrally formed ring element 65 and said ribs 64 defining a plurality of apertures 66. In a manner similar to that shown in FIG. 2, a flexible sheath 67 made of rubber or the like, is rolled over the outside of wall-less funnel 61 with outlet 62 being telescopically inserted into sheath receptacle tip 68. Outlet 62 is inserted into a tubular connector 24 as shown in FIG. 2 after which the end of the receptacle tip 68 of sheath 67 is pierced in order to permit exit flow of fluid through outlet 62 in the same manner as described hereinbefore.

Thereafter, the head of the penis is inserted only partially into the cage formed by ribs 64 as shown in FIG. 13, after which sheath 67 is retracted along the shaft of the penis as shown in FIGS. 1 and 5.

In this embodiment, protection is afforded for the head of the penis, the foreskin and the penile meatus against excessive negative intrasheath pressure generated where voiding is vigorous or voluminous. By omitting the walls of the funnel between the radially spaced ribs 64, the surrounding segmentary portions 69 of sheath 67 collapses and enters circumferentially into the cage formed by said ribs, following the exit of urine. This action is permitted by the great elasticity of sheath 67 whereby said segmentary portions 69 of the sheath that enter into the cage become urged against the end portion of the penis as well as against the sheath portions 68 themselves as shown in FIGS. 13 and 16 to form an effective liquid-tight seal between the end of the penis and outlet tube 62, thereby abruptly halting further generation of intrasheath pressure and, at the same time, cushioning the distal male member against funnel outlet 62. Thus, when outlet 62 is blocked, further increase in negative siphonage pressure is prevented while, at the same time, the entry of the foreskin or portions of the urethral meatus into said outlet and consequent irritation are also prevented.

Although funnel element 61 (FIG. 14) is shown as being formed of radial ribs 64 and a circular ring 65, it is understood that similar open wall funnels may be substituted wherein apertures or openings 66 in the walls of the funnel element are of different shapes and sizes but are sufficiently large to permit the stretching of segments 69 of sheath 67 into and through said apertures so that said segments are urged against each other as shown in FIGS. 13 and 14. The sizes and shapes of apertures 66 will be determined by empirical means to cause the apparatus to perform efficiently and comfortably.

The incontinence appliance described and claimed herein has been used on a good number of patients who would otherwise have been relegated to indwelling catheter drainage of the bladder with inevitable urinary tract infection and bladder calculi resulting therefrom.

In some embodiments, suitable suspension tabs may be connected to cuff 41 for securing the latter to a suspensory means having an adjustable elastic waistband in order to prevent accidental dislodgement of the device herein from the patient.

Although the present invention has been described with reference to particular embodiments and examples, it will be apparent to those skilled in the art that variations and modifications can be substituted therefor without departing from the principles and true spirit of the invention.

Claims

I claim:

1. A male incontinence device comprising a funnel element made of semi-rigid or rigid material adapted to receive and encase the end portion of the male member, an elongated sheath of thin elastic material, said funnel element being telescopically inserted into the end portion of said sheath, an exit nozzle integrally formed on the outer end of said funnel, said exit nozzle being surrounded by the outer end portion of said sheath, a connector element, locking means on said nozzle, locking means on said connector element, both of said locking means cooperating to secure said connector to said nozzle with the portion of said sheath surrounding said nozzle being clamped between both said locking means to form a liquid-tight seal, the remainder of said sheath extending over the remainder of the male member, and a plurality of radially spaced apart, elongated ridges on the outer surface of said funnel member, said ridges cooperating with the surrounding portion of said sheath to prevent the latter from becoming displaced rotationally in relation to the surface of said funnel member.

2. A male incontinence device comprising a funnel element made of semi-rigid or rigid material adapted to receive and encase the end portion of the male member, an elongated sheath of thin elastic material, said funnel element being telescopically inserted into the end portion of said sheath, an exit nozzle integrally formed on the outer end of said funnel, said exit nozzle being surrounded by the outer end portion of said sheath, a connector element, locking means on said nozzle, locking means on said connector element, both of said locking means cooperating to secure said connector to said nozzle with the portion of said sheath surrounding said nozzle being clamped between both said locking means to form a liquid-tight seal, the remainder of said sheath extending over the remainder of the male member, an element for securing a portion of said sheath to the base portion of the male organ, said securing element comprising an outer strip of non-elastic material, an inner strip of soft resilient foam material bonded to said first mentioned strip, said combination of strips being encircled around said sheath and the base portion of the male member for securing said sheath to said male member and means for adjusting the length of said combination of strips for accommodation to the size of the male member and the comfort of the patient, and an outwardly extending circumferential bead formed on said first mentioned strip, said bead being engaged by the rim of the open end of said sheath which is rolled over when the latter is retracted over the edge of said combination of strips when said securing element is fixed in place.

3. A male incontinence device comprising a funnel element made of semi-rigid or rigid material adapted to receive and encase the end portion of the male member, an elongated sheath of thin elastic material, said funnel element being telescopically inserted into the end portion of said sheath, an exit nozzle integrally formed on the outer end of said funnel, said exit nozzle being surrounded by the outer end portion of said sheath, a connector element, locking means on said nozzle, locking means on said connector element, both of said locking means cooperating to secure said connector to said nozzle with the portion of said sheath surrounding said nozzle being clamped between both said locking means to form a liquid-tight seal, the remainder of said sheath extending over the remainder of the male member, an element for securing a portion of said sheath to the base portion of the male organ, said securing element comprising an outer strip of non-elastic material, an inner strip of soft resilient foam material bonded to said first mentioned strip, said combination of strips being encircled around said sheath and the base portion of the male member for securing said sheath to said male member and means for adjusting the length of said combination of strips for accommodation to the size of the male member and the comfort of the patient, and a recess in one end of said soft resilient strip which accommodates an end portion of the other end of said soft resilient material to provide a substantially smooth interior surface for said securing element.

4. A male incontinence device comprising a funnel element made of semi-rigid or rigid material adapted to receive and encase the end portion of the male member, an elongated sheath of thin elastic material, said funnel element being telescopically inserted into the end portion of said sheath, an exit nozzle integrally formed on the outer end of said funnel, said exit nozzle being surrounded by the outer end portion of said sheath, a connector element, locking means on said nozzle, locking means on said connector element, both of said locking means cooperating to secure said connector to said nozzle with the portion of said sheath surrounding said nozzle being clamped between both said locking means to form a liquid-tight seal, the remainder of said sheath extending over the remainder of the male member, an element for securing a portion of said sheath to the base portion of the male organ, said securing element comprising an outer strip of non-elastic material, an inner strip of soft resilient foam material bonded to said first mentioned strip, said combination of strips being encircled around said sheath and the base portion of the male member for securing said sheath to said male member and means for adjusting the length of said combination of strips for accommodation to the size of the male member and the comfort of the patient, and a concave recess intermediate the ends of said securing element for adaptation of the latter adjacent the symphysis when encircling the base portion of the male organ.

5. Device according to claim 4 and further comprising an index mark on the surface of the resilient foam material near said concave recess for indicating the optimum position of the male organ prior to encircling the same with said securing element.

6. A male incontinence device comprising a funnel element made of semi-rigid or rigid material adapted to receive and encase the end portion of the male member, an elongated sheath of thin elastic material, said funnel element being telescopically inserted into the end portion of said sheath, an exit nozzle integrally formed on the outer end of said funnel, said exit nozzle being surrounded by the outer end portion of said sheath, a connector element, locking means on said nozzle, locking means on said connector element, both of said locking means cooperating to secure said connector to said nozzle with the portion of said sheath surrounding said nozzle being clamped between both said locking means to form a liquid-tight seal, the remainder of said sheath extending over the remainder of the male member, and a plurality of apertures in the walls of said funnel element, said apertures being of sufficient size to permit the stretching of segments of said sheath through said apertures and into contact with each other under the siphonage action of the outflow of fluid through said exit nozzle to form an effective seal and to provide protection for the end of the male member.

7. Device according to claim 6 wherein said funnel comprises a plurality of radially spaced apart ribs forming said apertures, said ribs being joined at their outer end by a connecting ring.