DE3331633A1 - DEVICE FOR USE WITH URINE INCONTINENCE OF WOMEN - Google Patents

Description

This application is a continuation of co-pending U.S. Patent Application No. 417,140, filed Sep. 13. 1982 _{7 by} the same owner.

Various devices have been proposed in the past few years to collect urine from female patients direct and catch those suffering from urinary incontinence, but generally occurred with these facilities as problems of leakage, wearer discomfort, tenderness, and even necrosis. An indication The ineffectiveness of such prior art devices lies in their lack of commerciality Success.

The problems encountered with the prior art devices are particularly common with outpatients Patients

stressed because of the variable and complex anatomical changes that occur in the periurethral area
occur during locomotion, and because of the failure of such facilities to adapt to such changes. However, that is a requirement for one

effective facility is by no means limited to outpatients. For example, non-ambulatory Patientiennen is spinal cord injury by the present devices do not come to meet ^ ¹ (used or remaining catheter, intermittent catheters, diapers and the like.), In spite of only minimal body movement such patients.

Older patents have urine collection devices for women

disclosed which were equipped with locating elements designed to be inserted into the vagina in order to keep the containment devices in place
To hold positions. Reference is made here
U.S. Patents 2,483,079, 2,490,969, 3,116,734,
3,528,423, 3,512,185, 3,776,235, 3,611,155 and

4,246,901. These arrangements, in which the locating elements are relatively rigid, clearly fail to conform to the anatomical changes which take place during body movement. While prior devices with flexible or deformable vaginal locators can reduce tissue irritation and increase patient comfort, the problems in achieving an effective seal are none the less
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and while preventing the leakage, left along lines or areas of contact.

Other documents of interest in this connection are US Patents 4,270,539, 3,651,810,
35

4,198,979 and 3,194,238.

One aspect of this invention lies in the recognition that effective sealing engagement with tissues around an entrance can then be achieved, when the device for use in female urinary incontinence is constructed so that the periurethral Shell compressible but generally retains its shape and is appropriate so as to be at least to a limited extent with respect to those parts of the Device can move independently, which produce the external contact with the carrier. Another point of view lies in the knowledge that when such a molded, compressible element is cup-shaped in the training and operationally with an outer soft pad (which in turn held in place by means of underpants or straps) by means of a tubular, elastic bellows is connected, which exerts an upward force on the shell when the device is worn without, however, at the same time in

interfering with the limited, independent movement of the shell with respect to the soft pad, then such a combination results in a device which obviates or substantially eliminates the problems noted above reduced, which together with the earlier

directions have occurred. An air intake port, which is normally closed by a check valve, allows air to enter the system to generate a relative negative pressure within

to prevent this system and it is an Ent-30

Ventilation provided in the sump to prevent expansion or deformation of the sump (the usually an expandable plastic bag), which otherwise result from the entrapped air and the creation of a relative, progressive pressure could.

- / fr ■

■ * - The periurethral shell of the body which this

Invention embodied is molded in one piece of soft, compressible, but generally shape-retaining material having a durometer hardness in the range of about 1 to 30 Shore A, the preferred range being about 5 to 20 in the Shore A measuring range. An elastomeric material shaped so that the outer surfaces of the shell are smooth and non-porous has been found to be particularly effective.
10

The periurethral shell is provided with anterior, posterior and lateral wall sections that limit upper and lower openings, such wall sections having a considerable wall thickness (about 8 to 15 mm) and have smoothly rounded surfaces in order to essentially make surface contact with the periurethral floor and the vaginal entrance. The rear wall part extends upwards over the upper limits of the front part and the side

Parts out to form a resilient, vaginal insertable, urine-repellent protrusion - an essential feature for those patients whose urethral opening is in or immediately next to the Vaginal entrance is arranged. The urine-repellent

The projection is able to move towards the entrance opening of the

To deform the shell back and forth without bulging or kinking the smooth, rounded contact surfaces to cause engaging the periurethral floor and the vaginal entrance, 30th

because of the compressibility and the considerable wall thickness of the shell.

An outer, soft pad made of soft, resilient material and flexible material is to the outer loading 35

touch with the wearer's large labia.

directs and has a through opening. Between this opening and the lower opening of the periurethral shell is a tubular, resilient bellows which is sized to exert an upward force on the shell when the device is worn to provide an effective seal between the rounded mating surfaces of the shell and the surfaces of the periurethral floor and input to maintain regardless of the complicated, ana- ¹ ^ tomical changes or displacements, which occur during the dynamics of body movement. The length of the elastic bellows changes within certain previously known limits according to the distance between the periurethral floor and the outer surfaces of the

large labia for each wearer, and a fitting instrument that corresponds to the model of the facility Designed for urinary incontinence, can be used to have the proper bellows length for to produce a given patient. One such

Adjusting tool is designed to be endoscopic Investigation enabled if deemed necessary or desirable.

The outer, soft pad can, if desired, with

a soft, absorbent coating for immediate / contact with the patient's labia majora be provided. A flexible hose extends from the outlet of the outer soft pad to one Leg bag or other suitable collection device. The outer, soft pad is preferred held in place by the wearer's underwear (panties), but other holding devices can also be used be used in the form of straps or belts.

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

In the drawings is:

Fig. 1 is a perspective view of the invention

embodying device for use in urinary incontinence in women,

Fig. 2 is a view of a vertical longitudinal section of the device,

3 is a view of an enlarged cross-section,

made along line 3-3 of FIG

became,

Fig. 4 is a view of a vertical section, wherein the device is shown how it is worn,

FIG. 5 shows the view of a sagittal section similar to FIG. 4, but with the relative displacements between the outer, soft on-25

position and the periurethral shell during

the movement of the wearer are shown,

6 is a side sectional view of the device when it is being worn;

Fig. 7 is a view of a partially cut side view of a fitting tool which can be used as part of the present invention,

J J J Ί ö 3

Fig. 8 is a partially sectioned, partial side view a modified facility, with openings or vents to prevent the coincidence to prevent the bellows and conduit while allowing gas to escape from the bag,

9 is a view of an enlarged, horizontal cross-section through the vent and the Filter of the bag, with certain elements of the bag and the associated couplings are omitted for the sake of clarity,

10 is an enlarged view of a vertical section

certain sections of the facility / which is shown in Fig. 8,

Fig. 11 is a view of a horizontal section ,,

taken along line 11-11 in FIG became,

12 shows the view of a further, enlarged “j-. Section of the inlet opening and the valve

part, namely along line 12-12 in Fig. 11,

Fig ο 13 the view of a section of the umbrella valve QQ part ^. being details of his on

buildings are shown,

14 is a view of an enlarged section taken along line 14-14 in Fig. 11,

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15 is a perspective view of a fluid rejection element _t and

16 shows an exploded perspective view of the valve part, the fluid-rejecting element

direction and that part of the device that the valve passage or the valve opening provides.

There now follows a detailed description of preferred exemplary embodiments.

Reference is now made to the exemplary embodiment, shown in Figures 1 to 6; the main component

ten of the device 10 for use in urinary incontinence of women are a periurethral shell 11, one outer, soft pad 12 and an elastic, tubular bellows 13. A flexible tube 14 conveys urine to a suitable collecting or receiving container 15.

For an outpatient, the collection container 15 usually takes the form of a leg bag, such as such as the pouch disclosed in commonly assigned U.S. Patent Application No. 273,363, filed June 15, 1981

is revealed.
25th

It is pointed out, however, that other types of collecting containers can also be provided in order to to meet the needs and physical condition of the user. Usually it wears flexibly 30th

Ie tube 14 a suitable, removable coupling 16. The The coupling shown in Figure 2 is similar to that shown and described in U.S. Patent 4,280,498 but also other types of coupling are provided.

The periurethral shell 11 is made in one piece soft, compressible, but generally form-retaining

Shaped material. A molded, elastomeric silicone material with a smooth, essentially non-porous outer surface has been found to be particularly effective, but other, compressible materials, such as elastomeric foam materials, can also be used. Regardless of the material selected, it is considered critical that such a material should have a durometer hardness in the range from about 1 to 30 Shore A, preferably in the range from 5 to 20 Shore A. Particularly effective results were achieved with a material that has a durometer hardness of about 10 Shore A.

It is also essential that the side wall of the peri-

urethral shell is of considerable thickness and that the uppermost surfaces of the shell are smoothly curved or rounded, as shown most clearly in Figs. In detail, as in the drawings shown, the shell an upper and a lower one

Opening 17 or 18. The one-piece side wall 19 is composed of a front wall part, rear wall part and side wall parts 19a, 19b and 19c, respectively. In that Area adjacent to the upper opening 17 should each of these wall parts has a thickness d (Fig. 3) in the area

from about 3 to 15 mm. The result is one

Shell, which, as set out below, has upper surfaces that are in appreciable contact with the periurethral floor and the vaginal entrance and which, although soft and compressible, 30th

seeks to retain its shape in use, regardless of the upward facing Force exerted by the elastic bellows 13.

The rear wall part 19b is up over the

. JIl.

the upper limits of the front and side wall parts are curved to create a resilient, to form a urine-repellent extension or protrusion 20 insertable into the vagina. The essential one The purpose of the projection is to act as a urine repellent for that part of the female population, which is estimated to be around 15 to 20% and its urethral exit within the vaginal entrance or is arranged immediately next to this. All the functions that the head start in arranging and holding the shell in its location are of secondary importance. As described in more detail below, the wide and gently rounded contact surfaces of the compressible shell serve in

action with the gentle upward force exerted by the elastic bellows 13 is mainly used to hold the bowl in its operative position.

As shown in Figs. 1 to 3, the rounded top surfaces 20a of the protrusion 20 go smoothly and gradually into the top surfaces 11a of the remaining side edge portion and the front edge portion

the shell over. In particular, the top upper 25 go

surfaces of the projection 20 in the upper surfaces of the side walls along a curved line, which in FIG. 2 has a considerable radius r. This Radius usually falls in the range of about

5 to 12 mm. Of special importance is the fact that 30

that even if the protrusion is pushed forward as shown by dashed lines in FIG denotes, no bulging or buckling of the wall takes place at radius r, because of the compressibility the material from which the shell is formed. Accordingly, an effective seal seeks

- between the curved upper surfaces of the shell (including the protrusion) and the patient's contact surfaces thereafter, during normal body movement excited to be received. 5

An outer, soft pad 12 can be formed from the same, soft, compressible material as the periurethral shell 11, but in any case should be formed from a resilient, flexible polymer material ¹ ^. The soft pad is generally oval in outline, substantially larger than the shell 11 and has a passage or opening 21 which extends continuously (Fig. 2). As shown in the drawings, the outer cover has a top surface 12a which is preferably concave or plate-shaped and, if desired, the top surface can support an annular, absorbent layer 22 (FIG. 2) made of nonwoven cotton fibers or a other suitable absorbent material

is formed. Along the lower or outer surface 12b can the support 12 with an attachment device 23 be provided in the form of a fabric having nylon hooks or loops of the type that are in Commercially available under the name "Velcro" are available.

If such a retainer is used, then the patient would also wear panties that a gusset made of brush-like nylon for engaging the attachment 23 and

to get caught up with this, which contributed 30

becomes ,, the outer support 12 against the outer surfaces to hold the labia majora.

The bellows 13 can be made from any suitable elastomeric material

Material to be shaped and takes in a non-35

the appearance when pressed or stretched out,

which is shown in Figs. The number of corrugations or corrugations 13a of the bellows for any given Urine collection facility depends on the distance between the labia and the wearer's periurethral floor, to which the device is to be adapted so that when worn the ribs are compressed or axially can be reduced as shown in Figs. Usually these are for adult carriers Number of ribs in the range between 2 (Fig. 2) to 6 and the undeformed length of the ribbed section ranges from 10 to 50 mm, with three selected sizes within those ranges which meet the requirements of over 90% of the adult female population. The tubular bellows can be made from 15th

Elastomers can be formed such as polyurethane, silicone rubber, latex, or any of a variety of other materials that exhibit similar properties. As a particularly effective material has a silicone rubber _on proven, which is sold by Dow Corning, Midland, Michigan, under the name "Q7-4840"; another material available from the same source is MDX4-4210.

ο, - In the embodiment shown are the bellows 13 and the shell 11 molded separately, and the upper The end of the bellows is then round on the shell by an adhesive or some other suitable measure attached around the lower opening 18; however, it should be noted that, if desired, the two Elements can also be molded in one piece. The lower end of the bellows is connected to a flexible tube or a line 14 at the upper end of the opening 21 of the outer, soft pad by means of an upwardly widened Extension 25 of the line 14 connected. The extension 25 of the line 14 can on the bellows 13 and on

ν * -

the wall of the outer, soft support 12 by adhesives, heat gluing or welding or other suitable Measures to be attached.

■ ° The Fig. 4 to 6 form the anatomical alignment of the Device 10 for use in urinary incontinence from, under normal conditions of use. The outer soft pad 12 lies up against the outer surfaces of the labia majora 3 0 and is in this position by a pair of panties or some other holding device (not shown) held, which extends below the outer, soft support and with the circular ring-shaped Velcro patch 23 (if provided) is caught. The periurethral shell 11 extends

up between the labia majora 31, and hers soft, rounded, upper surfaces 11a of the front and side wall parts 19a and 19c into the periurethral floor 32 around the passage of the urethra 33. The urine-repellent projection 20

extends upward a small distance into the entrance of the vagina 34. The gently rounded ones upper surfaces 20a and 11a of the periurethral shell therefore provide resilient sealing contact with the periurethral ones located on the urethra

Surfaces even in the minority of cases in which the patient's urethra is directed backwards is curved and opens directly into the entrance (as shown in dashed line 35 in FIG. 4

is). The broad, gently rounded, upper upper 30

surfaces of the shell produce significant surface contact with the wearer and reduce the Possibility of local concentration of forces to a high degree, which can lead to discomfort and pressure

Necrosis. The thickness of the wall of the shell 35

provides a dimensionally stable structure despite the soft and compressible material from which the shell is formed

vr . ^ -

is. Should there be limited deformation of the shell in use (such as by dashed Lines indicated in Fig. 2), then such a deformation can be due to the compressibility of the material the shell can be added without bulging or buckling effects that lead to leakage and without the relative movement between the body tissues and the shell surfaces that May cause irritation and discomfort.

It must be emphasized that the shape-retaining shell after pressed up in. sealing contact with the periurethral floor and entrance because of the expansive force exerted by the elastomeric bellows 13

will. If the device is properly worn for use with urinary incontinence then it is located the bellows is in a partially compressed condition, as shown most clearly in Figs is. The outer, soft pad 12 is unaffected

movably against the labia majora 3 0 and acts as a base against which the expansive force of the Bellows attacks in a downward direction. The from the shell 11 upwards against the periurethral surfaces The force exerted is therefore relatively constant in size and direction.

Not only does the bellows exert a constant, gentle, upward force on the shell, around the shell

_ori in the position shown, but is also able to twist, bend and deform to accommodate changes in the position of the outer, soft pad 12 and inner shell 11 resulting from the dynamics of body movement . Fig. 5

_gi - represents what is believed to be a typical state in which, as a result of the movement of the wearer, the shell

11 and the soft pad 12 have been moved laterally, yet the expansive force exerted by the bellows 13 coupled with the substantial contact areas between the form-retaining, but compressible

Shell and the periurethral surfaces hold nothing the less the shell is still in tight contact with the wearer.

Fig. 7 illustrates a fitting tool 40 that is convenient to use can be used to determine the length of bellows required to provide a urine collection device for a wearer 10 adapt. The periurethral shell 111 is substantially the same size and size Form auf. wie the shell 11, which has already been described before the main difference, however, is that the shell 111 is at the top of a stiff, calibrated tube 41 is attached and formed, instead of being made from a resilient bellows 13

2Q stretch. The outer soft pad 112 can be similar the previously described, soft pad 12 and made of a resilient, elastomeric Material (Dow Corning Q7-4840 has been found to be particularly effective) and essentially have the same dimensions. The main difference is that instead of fastening The outer, soft support 112 is provided with a sleeve 42 on a bellows 13 and a flexible tube 14 The outer support 112 can be, which slidably receives the rigid, calibrated tube 41 therefore shifted along the length of the pipe 41. . and their location can be determined by referring to Calibration lines 43 and identification numbers 44 can be determined. '

The fitting instrument 40 can be disposable and is made by a doctor or other medically trained person

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sonally used by the periurethral shell 111 is introduced into that position that of the shell 11 in Fig. 4 is taken that one then the outer Support 112 in the axial direction of the one provided with a scale The tube 41 moves until the pad rests against the labia majora 30 in the same way, as shown in FIG. 4 for the support 12. If an investigation is necessary or desired

is considered to determine that the periurethra-10

Ie shell 111 properly against the periurethral Floor and vaginal entrance is adjacent, or when an examination is required for any other reason then the doctor can use the shaft of a conventional one

Insert the endoscope through the channel 45 of the tube 41, Io

so that the objective of the endoscope extends into the open shell 112. Once determined is that both the periurethral shell 111 and the outer overlay 112 are properly positioned then the fitting instrument is removed and the length of the bellows for the collecting device 10 is determined, which is to be used by the patient is made on the scale 43-44.

₂ j- The following example details the manufacture of a soft, compressible material and the construction of a periurethral shell molded from such a material, this example being found to be "particularly effective for use in practicing the invention: 10 parts by weight of a first component and 7 parts by weight of a second component of a two-part silicone rubber addition polymerization system of the type Q7-4840 from Dow Corning, Midland, Michigan, were mixed with 1.7 parts by weight of a silicone fluid of the type 36 0 Dow Corning, _s having a viscosity of about 350 cP (Centipoises) and

r?

then degassed and placed in molds for the periurethral shell 11, the outer, soft pad 12 and the bellows 13 are injected. The curing was done by heating to a

Temperature from 93 to 205 ⁰ C for a period of to b

reached to 6 min. The silicone rubber .. the final one Parts were homogeneous, smooth and clear (semi-transparent), with a durometer hardness of about 10 Shore A.

The parts can also be made from an elastomer foam as follows: 4 parts by weight of a silicone foam base, type Q7-4 290 from Dow Corning, Midland, Michigan, with a viscosity within the range of 1000 to 6000 cP, and 2.5 parts by weight of the EIa-

, R stomeren "Silastic 382" from the same manufacturer with Io

Viscosity in the range from 35,000 to 65,000 cP, and 0.045 part of a silicone foam catalyst were mixed intimately of the type Q7-429 0 were then added and thoroughly mixed in for about 30 s. You have the mixture

Allow 2Q to degas for about 30 s and then stir vigorously. The degassing and stirring operations were repeated twice, and then the mixture became directly in molds for the periurethral shell 11 and the outer, soft pad 12 is cast. The bowl and overlay were made from their respective Mold cavities after a cure period of about 12 minutes away. In order to facilitate removal, the cavities of the molds were previously made with a suitable Mold release agent (HEM 41220) coated.

The small cell size of the foam parts was promoted by the degassing processes and the vigorous stirring activity. The final parts had smooth, substantially non-porous outer surfaces or surfaces Skin and a durometer hardness of about 10 Shore A.

The embodiment shown in FIGS. 8 to 16

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is essentially the same as the embodiment of Figs. 1-6 except for devices for air admission and gas discharge. the

Device includes an outer, soft pad 212 for δ

Contact with the wearer's labia majora, a periurethral shell 211 with an upper and lower Opening 217 or 218 and a tubular, elastic Bellows 213, which is located between the lower opening of the shell and the opening of the outer, soft support extends to push the shell into engagement with the periurethral floor and the vaginal entrance, when the pad is held against the labia majora. The shell has a one-piece side wall

219, consisting of the front, rear and 15th

lateral wall parts 219a, 219b and 219c, respectively. In that area that is against the upper one Adjacent opening 217, each of these wall parts has smoothly rounded surfaces and has a considerable Thickness within the range of about 3 to 15 mm.

The rear wall portion 219b is upward beyond the upper limits of the front and side Wall parts curved outwards around the resilient, flexible urine-repellent that can be inserted into the vagina

_Of - extension or protrusion 220 to form. All of the properties, compositions, dimensions and functions of the shell, bellows and soft pad of this embodiment are essentially the same as those used in connection with the

₃ Q first embodiment of FIGS. 1 to 6 are described.

Whether the bellows 213 and the shell 211 are formed separately (and then joined together by glue or some other suitable means as shown and previously described) or are made in one piece,

in each case the upper end of the bellows 213 is directly in communication with the periurethral shell 211 at the lower opening 218. The lower end of the bellows is to the top of a flexible conduit or pipe 214 through an extension 225 of this Line connected. As shown most clearly in Figures 8 and 10, the interface forming the conduit extension 225 has a wall 225a which is flared upwards and outwards to the larger diameter of the bellows to fit. A portion 225b of this wall, however, extends generally horizontally, i.e., in a plane perpendicular to the axis of the bellows in the undeformed state. One or more air inlets 250 extend vertically (i.e. axially) through the

Wall part, 225b; in the form shown there is a pair of such Openings are provided each having an arcuate configuration when in cross-section or in plan inclined (Fig. 11). Valve means 251 which take the form of an umbrella or poppet valve

can, has a conical roof portion 252 and a shaft portion 253 and is arranged such that it allows the entry of ambient air while at the same time the escape of fluids (gases and liquids) from the bellows 213 and the upper end

de line 214 is blocked. As shown most clearly in Figures 12-14, the elongated shaft is 253 of the valve part 251 is set up to extend downward through an opening 254 in the wall part 225b,

such an opening centrally between the arch-30

shaped openings 250 is arranged. A middle one Enlargement 253a of the shaft serves to limit the upward movement of the shaft with respect to the wall part 225b; the downward movement is through

prevents an upper enlargement 253b of the shaft, 35

which is covered by the conical roof section 252.

2ϋ

. Ά.

The poppet valve part 251 is made of a soft, easily deformable and easily recoverable elastic Material made, such as SiIi-

cone. 13 forms the valve part in a non-5

strained or undeformed state, but it will 14 it is noted that when the valve member on the apertured wall 225b of the Interface forming line extension 225 attached is, this valve part is in a pretensioned or preloaded state, wherein the roof section 252 has a clearly downward and outward curvature and wherein the peripheral edge of the Roof section in normal sealing engagement with the

upper surface of the wall 225b is held. Because of be-15

With its deformability and regardless of the preload, the roof section 252 of the valve part is able to flexible upward movement to allow air to enter the system even if a there is only a small pressure difference (for example

12.7 mm HO). This flexible, upward deformation is indicated by dashed lines in FIG. On the other hand, the pressure within the system should be the same or exceed the ambient pressure, then that seals

2j- highly flexible roof 252 effective against the top surface of the wall part 225b and blocks the escape of fluids at least in that area of pressure differences which occurs during normal use of the facility. As shown in Fig. 10, the

QQ outer, soft support 212 an inlet channel 255, which is in communication with the opening 250 'in the wall part 225b. Channel 255 extends from an entrance 256 at the lower end of the support up through the wall.

The purpose of the openings 250 and the valve part 251 is

333-633

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it to ensure the superior sealing effect between the periurethral shell and the periurethral floor and the vaginal entrance is not the correct one Urine flow through line 214 to one

Bag or a collecting device 257 interferes. Without the inlet openings, a column of liquid would pass through the line 214 flows downward, creating a relative negative pressure which might even be sufficient to close the bellows 213 and / or the conduit 214 compressing or sucking together that defines the seat of the periurethral shell 211 could interfere and possibly lead to leakage or could lead to discomfort for the wearer. Since the openings 250 and the check valve 251 the Air is allowed in at the top of the line, the pressure is equalized and such problems are encountered avoided here.

Although the poppet valve shown in the drawings - "_ arrangement has been found to be highly effective, other types of air inlet valves can also be used. Further, if a poppet valve is used, it can be used in conjunction with a diverter 258 to be or not. The purpose of the deflector 2g is to simply prevent the possibility that then a leak occurs when the roof 252 of the valve member 251 is hit by a stream of urine which flows rapidly through bellows 213 and enters conduit 214. If the possibilities of that leakage by urine caused when it hits the valve part and deforms it, is estimated to be so low become negligible or inconsistent, then deflector 258 can be omitted will.

As shown in Fig. 12 and 14 to 16, the decrease

steering device 258 is in the form of a plate 259 having a pair of spaced apart, downwardly extending Has leg 260. The cover plate 259 extends over the roof 252 of the valve part 251 and is held in place by upstanding tenons © tier approaches 261, which are integral with the Transition forming line extension 225 formed and received within channels or holes 262 are, which are in the legs 260 of the Abweiseinrich-

device are formed. The reject device can by

Frictional action can be held in place by means of the lugs and, as shown, the free ends of the lugs should be flattened and laterally enlarged in order to avoid the deflection device in the operating la-15

ge to lock. The parts can also constantly go through suitable means glued or welded together.

In order to prevent the air entering the system through the openings 250 from inflating the bag 257, is a wall 257a of the bag is provided with a venting device 270 at its upper end. Any suitable Means for venting the air from the top of the bag can be used when doing this at the same time blocks the escape of liquid. In the illustrated embodiment, the venting device takes indicates the shape of perforations 271 formed in the wall 257a, the area of such Perforations of a thermoplastic, microporous

OQ sen strip 272 is deposited, which is capable. Allow gases to escape from the bag while blocking the passage of urine. The stripe or patch 272 is circumferentially on the Viand the bag by means of a hot glue point 273 or

gg by any other suitable sealing device

glued to form a seal. While various types of hydro-

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phobic, microporous materials used to manufacture the Vent or pad 272 have been used to have effective results of a 3μm filter material that is placed under the 5

The term "Versapor" is sold by Gelrnan Corporation, Ann Arbor, Michigan.

The lower or distal end of the flexible conduit 214

is represented by a 10 as shown with the bag 257

detachable coupling 280 of the type shown and described in commonly assigned U.S. Patent 4,280,498 is. It is also referred to on the pending US patent application No. 273,363, filed June 15, 1981 for a

Approach referred to in order to ensure an effective, fluid flow-15

Establish a tight seal between the conduit and the bag while allowing limited pivoting action between the conduit and the bag. Since any of a variety couplings and connections between the line and bag can be provided, all of which are within the knowledge of a skilled person who is familiar with urine collection devices, a more detailed discussion of this is not required ^ten such assemblies supported "

While the above embodiments of the invention have been disclosed in great detail for the purpose of illustration, it is pointed out that those skilled in the art OQ can change many of these details without changing the main idea and to depart from the scope of the invention.

Claims (43)

Claims .17 Device for use with urinary incontinence from Women, characterized by the following characteristics: - An outer, soft pad (12; 212) made of flexible, resilient material for externally contacting the greater labia (30) of a wearer, the Support has a through opening (21), - An around the urethra or periurethral shell ( 11-211) f which is formed from soft, compressible material and has an upper opening (17; 217) which is delimited by smoothly rounded contact surfaces which are designed to with the engage the periurethral floor and vaginal entrance of a wearer - the compressible material has a durometer hardness ranging from about 1 to 30 Shore A to _t - The support also has a lower opening (18; 218), and - A tubular, elastic bellows (13; 213), the extends between the lower opening of the shell and the opening of the support to engage the shell to press with the periurethral floor and the vaginal entrance when the support against the large one Labia is pressed. 2. Device according to claim 1, characterized in that a holding device (23) is provided to the Support (12; 212) in contact with the labia majora 15 (3 0) to hold a wearer. 3. Device according to one of claims 1 or 2, characterized in that the shell (11; 211) has a front, rear and side wall parts (19a-c; A \ j - 219a-c) that have upper surfaces that merge smoothly and have a rounded cross-sectional contour to broad, gently curved ones Contact surfaces for sealing engagement with the period urethral floor and the vaginal entrance of a wearer to manufacture. 4. Device according to claim 3, characterized in that the rear wall part (19b; 219b) extends upwards QQ over the front and the side wall parts (19a, c; 219a, c) extends to a resilient, to form urine-repellent projection (20; 220) which can be inserted into the vagina. 5. Device according to claim 4, characterized in that the urine-repellent projection (20; 220) is able is to and from the upper opening (17; 217) way to deform flexibly without bulging or kinking of the contact surfaces of the shell (11; 211) on the Transition of the side and rear wall parts (19c, 5 b; 219c, b) because of the compressibility and the considerable wall thickness of the shell. 6. Device according to one of claims 3 to 5, characterized characterized in that the wall parts (19a-c; 219a-b) of periurethral shell (11; 211) next to the upper opening (17; 217) a thickness in the range from about 3 to 15 mm exhibit. 7. Device according to claim 6, characterized in that that the material of the shell (11; 211) has a durometer hardness in the range from about 5 to 20 Shore A. 8. Device according to claim 7, characterized in that the material of the shell (11; 211) has a durometer hardness of about 10. 9. Device according to one of claims 1 to 8, characterized in that-the material of the shell (11; 211) Silicone rubber is. 10. Device according to one of claims 1 to 8, characterized in that the material of the shell (11; 211) is an elastomer foam. 11. Device according to one of claims 1 to 10, characterized in that the support (12; 212) has a soft, absorbent, removable coating (22) for engaging the labia majora (30) of a Has wearer. 12. Device for use in urinary incontinence by women, characterized by the following characteristics: - An outer, soft support (12; 212) made of flexible, resilient material, with a concave upper Surface for touching the labia majora (3 0) from the outside, and with a through opening (21), - A periurethral shell (11; 211) which is formed from soft, compressible material and a front, having rear as well as side wall sections (19a-c; 219a-c), with upper surfaces that are smooth merge into each other and have a rounded cross-section skon door to wide, curved contact surfaces for engaging the periurethral floor and to form the vaginal entrance, - The rear wall section (19b; 219b) extends to above and over the front and side wall sections (19a, c; 219a, c) to create a resilient, urine-repellent protrusion that can be inserted into the vagina (20) to form - the compressible material of the periurethral shell has a durometer hardness in the range of about 1 to 30 Shore A, - the projection is in the position to an upper opening (17; 217) to away flexible toward and. deform without bulging or buckling of the contact surfaces of the shell at the transition between the lateral and rear wall sections (19c, b; 219c, b) cause,
30th - the shell also has a lower opening (18; 218) on and - A tubular, elastic bellows (13; 213), the between the lower opening of the shell and the Opening of the support extends to the tray in A-35 grip with the periurethral floor and the vaginal input to press when the pad against the lower Labia is supported. 13. Device according to claim 12, characterized in that that the material of the shell (11, 211) has a durometer hardness in the range from about 5 to 20 Shore A. 14. Device according to claim 13, characterized in that the material of the shell (11; 21 meter hardness of about 10 Shore A. net that the material of the shell (11; 211) has a Duro- 15. Device according to one of claims 12 to 14, characterized in that the material of the shell (11; 211) is silicone rubber. 16. Device according to one of claims 12 to 14, characterized in that the material of the shell (11; 211) is elastomeric foam.
20th 17. Device according to claim 16, characterized in that that the elastomer foam of the shell (11; 211) has an essentially non-porous outer skin. 18. Device according to one of claims 12 to 17, characterized in that the wall parts (19a-c; 219a-c) of the periurethral shell (11; 211) has a thickness in the range from about 3 to 15 mm. 19. Device according to one of claims 12 to 18, characterized in that holding devices (23) are provided are to the outer support (12; 212) in their facility hold against the labia majora (30). 20. Device according to claim 19, characterized net, that the holding means comprises a releasable and panties, can be brought together into locking engagement means (23) attached to the panties and the underside of the support (12; 212) to secure are provided to support panties and ° against relative movement. 21. Device according to one of claims 12 to 20, characterized in that a flexible tube (14) with one end on the outer support (12; 212) on its * -0 opening (21) is attached, and that a receiving device or a container (257) is provided which is in communication with the opposite end of the tube. 22. Device according to one of claims 12 to 21, characterized in that the concave surface of the outer support (12; 212) an annular coating (22) made of soft, absorbent material for engagement with the labia majora (30). 23. Device according to one of claims 12 to 22, characterized in that the elastic bellows (13; 213) has two to six grooves and an undeformed length of 10 to 50 mm. 24. Adjustment tool for the facility for use for urinary incontinence of claims 1 to 23, characterized by the following features: - a second, periurethral shell (111), which is placed in the we-30 essentially identical to the first-mentioned periurethral Shell (11; 211) is, - a relatively stiff, elongated part (41) attached to the second shell and protruding downward therefrom,
■ · - The part has calibration marks (43, 44) along its outer surface on, - a second, outer, soft pad (112) similar to the first mentioned, outer pad (12; 212) which is "slidable for movement up and down longitudinally
of the part is attached, and - by positioning the second periurethral
Shell of the instrument (40) against the periurethral floor and the vaginal entrance and then by moving the second outer support until it is in contact with the labia majora (30), the distance between the second shell and the second support, as indicated by the calibration mark on Part is designated, used to determine the correct length of the tubular, elastic bellows (13; 213) for a pa- To determine clients in which the instrument (40) or the device (10) is used. 25. Instrument according to claim 24, characterized in that that the elongate part (41) is tubular, a Endoscope shaft through the part and into the shell (111) introduced for cystoscopic observation of a patient when the instrument (40) is in place. 26. Device for use in the case of urinary incontinence in women, characterized by the following features: - An outer, soft pad (212) made of flexible, resilient material for external contact with the greater labia (30) of a wearer, with the 30th Support has a through opening, - A periurethral shell (211) made of soft, compressible Material is shaped and has an upper opening (217), which by smoothly rounded contact surfaces is limited to engaging with the periurethral floor and the vaginal entrance one Bearer are set up, - the compressible material has a durometer hardness in the range from about 1 to 30 Shore A, - the shell also has a lower opening (218), - a tubular, elastic bellows (213), which extends between the lower opening of the shell and the opening of the support to engage the shell to press with the periurethral floor and the vaginal entrance when the support is in contact with the large ones Labia is held, - a conduit means (214) extending into the opening the support extends and is attached to and connected to the lower end of the bellows, - The conduit device comprises a wall (225), with a through opening (250), and - A one-way valve device (251) is the opening assigned to allow air to enter the duct device while simultaneously allowing air to escape of fluids from this is prevented. 20th 27. Device according to claim 26, characterized by the following features: - A urine collection bag (257) is connected to the line device (214), - the bag is provided with a wall which is provided with a gas vent (270) through it, and means for preventing liquids from escaping from the bag through the vent. 28. Device according to one of claims 26 or 27, characterized in that a holding device (23) is provided to rest against the support (212) to hold the labia majora (30) of a wearer. 29. Device according to one of claims 26 to 28, characterized in that the shell (211) has a front, has rear and side wall parts (219a-c), with upper surfaces that merge smoothly and have a rounded cross-sectional contour, around wide, gently curved contact surfaces for sealing engagement with the periurethral floor and the Provide a vaginal entrance of a wearer. 30. A device according to claim 29, characterized gekennzeich- ¹ ^ net, that the rear wall part extends (219b) upwardly over the front and lateral wall portions (219a, c) addition, resilient spring at one, can be inserted into the vagina, urinary repellent Projection (220) to build.
15th 31. The device according to claim 30, characterized in that the urine-repellent device (220) in the It is able to be deformed flexibly towards the upper opening (217) and from this path without bulging or Buckling of the contact surfaces of the shell (211) at the transition between the side and rear wall parts (219c, b) because of the compressibility and the considerable wall thickness of the shell. 32. Device according to one of claims 29 to 31, characterized in that the wall parts (219a-c) periurethral shell (21i) a thickness close to the upper Have opening (217) ranging from about 3 to 15 mm.
30th 33. Device according to claim 32, characterized in that the material of the shell (211) has a durometer hardness in the range from about 5 to 20 Shore A. 34. Device according to claim 33, characterized net that the material of the shell (211) has a durometer hardness of about 10. 35. Device according to one of claims 26 to 34, characterized in that the material of the shell (211) is an elastomer foam. 36. Device for use in the case of urinary incontinence in women, characterized by the following features: - An outer, soft pad (212) made of flexible, resilient compliant material with a concave top surface for external contact with the labia majora (30), as well as with a through opening, - a periurethral shell (211) made of soft, compressible material is shaped to pass over a front, rear and side wall portion (219a-c), the upper surfaces smoothly into each other and have a rounded cross-sectional contour to wide, curved contact surfaces prepare for engagement with the ^w periurethral floor and vaginal opening, - the rear wall part (219b) extends upwards to over the front and the side wall parts (219a, c) to create a resilient, in to form the vagina-insertable urine-repellent projection (220), - The compressible material of the periurethral shell has a durometer hardness in the range from about 1 to 30 Shore A on, - The protrusion is able to move towards the upper opening to be flexibly deformed back and forth without bulging or buckling of the contact surface the shell at the transition between the lateral and the rear wall part, 35 - The shell also has a lower opening (218) , ■ - a tubular, elastic bellows (213) extends between the lower opening of the shell and the Opening the pad to engage the tray with to press the periurethral floor and the vaginal entrance when the support is against the great pubic supports lips, - A conduit means (214) extends into the opening of the supports and is at the lower end of the Bellows added and is related to it, - The line device comprises a wall (225) a through opening (250), and - A one-way valve device (251) is connected to the wall to allow the ambient air to to enter the conduit facility while simultaneously allowing fluids to escape therefrom is prevented. 37. Device according to claim 36, characterized by the following features: - A urine collection bag (257) is with the line in-20 direction (214) connected, - the bag is connected to a wall (257a) which has a through-going gas vent (270), and - a device for blocking the escape of Liquids from the pouch while there are gases ge-25 is equipped to pass through the vent. 38. Device according to one of claims 36 or 37, characterized in that the material of the shell (211) a durometer hardness in the range of about 5 to 20 Shore A. 39. Device according to claim 38, characterized in that the material of the shell (211) is a durometer GPR hardness of about 10 Shore A. 40. Device according to claim 38 or 39, characterized / that the material of the shell (211) is silicone rubber is. 41. Device according to claim 38 or 39, characterized in that that the material of the shell (211) is an elastomer foam. 42. Device according to claim 41, characterized in that the elastomer foam of the shell (211) has an im has substantial non-porous outer skin. 43. Device according to one of claims 36 to 42, characterized in that the wall parts (219a7c) of the 15th periurethral shell (211) a thickness in the range of about 3 to 15 mm.