WO2004062532A1

WO2004062532A1 - Urinary flow control valve

Info

Publication number: WO2004062532A1
Application number: PCT/US2003/000719
Authority: WO
Inventors: Spencer W. Beaufore; Glenn D. Brunner
Original assignee: Opmi Funding Corp.
Priority date: 2001-07-06
Filing date: 2003-01-09
Publication date: 2004-07-29
Also published as: US7037303B2; US20030009079A1

Abstract

A flow control valve (22) such as for a catheter (10) allows discharge of urine from a bladder (12) by manual actuation. The valve (22) may be a double-duckbill valve (22) with a single slit (62) at one apex (60a) thereof. An elastomeric band (66) is positioned in a groove (68) of the valve member (22). An isolation member such as a stem (72) spaces the valve (22) from the walls (34, 36) of the valve housing (32). Crush limiting structure, such as a tube (76) or blade (82), is provided within valve member (22), or stop elements (86 or 92) are positioned external to valve member (22).

Description

URINARY FLOW CONTROL VALVE

The present application claims the filing benefit of co-pending Provisional Application U.S. Serial No. 60/303,694 filed July 6, 2001 , the disclosure of which is hereby incorporated herein by reference in its entirety.

Field -ofihe invention

The present invention relates generally to urinary flow control

valves, and, more particularly, to such valves adapted to allow discharge of

urine by manual actuation thereof.

Background of the invention Urinary control devices, such as urinary catheters, have been developed to facilitate bladder drainage in individuals who are unable to initiate or control such drainage for a variety of medical reasons. Two types of urinary catheters have been developed to assist in this need and can be considered as comprising either a continuous drainage catheter or a valved urinary catheter. Continuous drainage catheters are used when continuous αrainage of an individual's bladder into a collection bag or reserv ir is desired, such as during or after surgery or when mobility of the individual is not a primary concern. Valved urinary catheters, on the other hand, are used to retain urine within the bladder until the individual desires to void the bladder through actuation of a manual urinary flow control valve located within or external to the urethra. The urinary valves of such devices typically includes a valve housing with flexible, resilient walls that contain therewithin the actual valve member. When the housing walls are squeezed, the walls flex and cause the valve therein to deform and open for release of urine. Release of the squeezing pressure on the housing walls allows the valve to return to its original, closed state.

Valved urinary catheters are used predominantly with mobile individuals so as to provide a urinary flow control device that is not discernable by others and that is compatible with the individual's normal daily activities. However, the urinary valves used in such devices suffer from several shortcomings and drawbacks. For example, the valves may be susceptible to unintended opening and undesirable urine leakage due to movement of the individual. Additionally, current urinary valves are not believed to work reliably across the broad range of urethral pressures typically encountered by the valves during normal use. Thus, while some valves may have good closing characteristics at low pressures where urine is only beginning to build up behind the valve, those valves may leak under higher pressures as urine accumulates in the urethra. Other valves may stay closed well in the presence of high pressure, but may leak at the very low pressures encountered before there is a sufficient build-up of urine to keep the valve closed. Summary of the invention

The present invention provides manually actuatable urinary

valves which overcome the foregoing shortcomings and drawbacks. To this

end, and in accordance with the principles of the present invention, a urinary valve is provided in the form of a double-duckbill valve which

deforms to open, and restores to the closed position when released. The

double-duckbill valve is advantageously mounted within a valve housing so

as to deform when the valve housing walls are squeezed. The double-

duckbill bill comprises a pair of intersecting duckbill-like structures oriented

perpendicular to each other so as to present a cruciform shape. Each

duckbill has a pair of inclined lips or walls that extend from the base of the

valve and converge at a pair of intersecting apexes at an inlet end of the

valve. The inlet end is advantageously positioned to face upstream towards

the urine flow from the bladder.

The double duckbill valve is advantageously slit along only a

single axis, i.e, along the apex of only one of the duckbill-like structures.

The effect is to have a single duckbill valve with structure perpendicular

thereto that is "hollow" like a duckbill valve, but is unslit. The unslit lips

thus form a pair of wedge-shaped supports integral with but perpendicular

to the slit lips to stiffen the lips or walls of the slit lips to thereby improve

the fluid seal. The fluid seal is further improved by an elastomeric band that

is retained within a groove formed around the exterior of the valve and

positioned slightly inwardly of the juncture of the duckbill walls with the

valve base. The band at least partially overlies the converging walls of the

intersecting double duckbills near their juncture with the valve base. The

elastomeric band pre-loads or biases the valve (along with any fluid pressure

at the inlet end of the valve) to a normally closed position. The double-duckbill valve design of the present invention

advantageously provides a reliable closure or seal at both high and low

urethral pressures, as well as across the range of pressures normal

encountered therebetween.

Typical of prior manually actuated urinary valves is that they

are coupled directly to the valve housing so that squeezing the valve

housing wall would cause the valve therewithin to deform and open. One

disadvantage of such a design is that movement of the user could translate

to inadvertent opening of the valve. To this end, and in accordance with

another aspect of the present invention, a urinary valve, such as but not

necessarily the double-duckbill valve of the present invention, is positioned

within the valve housing, but in spaced relationship from the flexible walls

of the valve housing so that the valve is not necessarily actuated merely by

some flexing of the housing walls, but by flexing of the housing walls

sufficiently to reach and then impact or bear against the valve to thereby

deform same. The result is to isolate the valve from the housing walls.

The urinary valve may be isolated from the valve housing walls

by a member that holds the valve away from the housing walls while

tending to resist transfer of forces to the valve from the housing wall.

Advantageously, the isolating member is flexible so as to resist transferring

such forces. In one embodiment, the isolating member is a stem extending

from the valve housing wall and connected to the urinary valve. Where the

double-duckbill valve is used, the stem may be tubular and attached to the

valve base to allow urine to flow through the stem to the valve while supporting the valve in non-contact relationship within the valve housing so

that a clearance is established between the walls of the valve housing and

the valve. The isolation member mechanically isolates the valve from forces

applied to the valve housing and/or to any discharge tube extending

therefrom during normal movement that are not intended to open the valve.

The isolation member also provides a flexible support for the valve within

the valve housing such that minor distortions of the valve housing do not

accidently actuate the valve to an open position.

In accordance with yet another aspect of the present

invention, several "crush limiting" components are provided to form positive

stops as a user pinches the valve housing and actuates the valve to an open

position. These components limit overactuation of the valve and stop valve

deflectiøn at an optimal opening distance to prevent restricted fluid flow.

By virtue of the foregoing, there are thus provided manually

actuatable urinary valve structures which overcome drawbacks and

shortcomings previously encountered with manually actuatable urinary valves.

These and other objects and advantages of the present invention shall be

made apparent from the accompanying drawings and the description thereof.

Brief Description of the Drawings

The accompanying drawings, which are incorporated in and

constitute a part of this specification, illustrate embodiments of the

invention and, together with a general description of the invention given

above, and the detailed description of the embodiments given below, serve

to explain the principles of the invention. Fig. 1 is a cross-sectional view of a urinary catheter in

operational position for draining a bladder and having a urinary flow control

valve in accordance with the principles of the present invention;

Fig. 2 is an enlarged side elevational view, partially in cross-

section, of the urinary flow control valve of Fig. 1 ;

Fig. 3 is an enlarged front elevational view of the valve

illustrated in Fig. 2 in an unactuated state with an inlet orifice of the valve

in a closed position;

Fig. 4 is a view similar to Fig. 3 illustrating the valve in an

actuated state with the inlet orifice of the valve in an open position to

permit drainage of urine through the urinary catheter of Fig. 1 ;

Fig. 5 is an enlarged partial perspective view of the urinary

flow control valve of Fig. 1 illustrating an elastomeric band disposed about

the valve to urge the inlet orifice to the closed position;

Fig. 6 is an enlarged partial cross-sectional view illustrating an

alternative embodiment of the urinary flow control valve of Fig. 1 with a

first crush limiting structure in accordance with further principles of the

present invention;

Fig. 6A is an enlarged front elevational view of the valve of

Fig. 6 in a closed position;

Fig. 6B is a view similar to Fig. 6A illustrating the valve of Fig.

6 in an open position;

Fig. 7 is an enlarged partial cross-:sectional view illustrating a

further alternative embodiment of the urinary flow control valve of Fig. 1 with a second crush limiting structure in accordance with further principles

of the present invention;

Fig. 7A is an enlarged front elevational view of the valve of

Fig. 7 in a closed position;

Fig. 7B is a view similar to Fig. 7A illustrating the valve of Fig.

7 in an open position;

Fig. 8 is an enlarged partial cross-sectional view illustrating a

still further alternative embodiment of the urinary flow control valve of Fig.

1 with a third crush limiting structure in accordance with further principles

of the present invention;

Fig. 8A is an enlarged front elevational view of the valve of

Fig. 8 in a closed position;

Fig. 8B is a view similar to Fig. 8A illustrating the valve of Fig.

8 in an open position; and

Fig. 9 is a view similar to Fig.5 showing a yet further

alternative embodiment of urinary flow control valve in accordance with the

principles of the present invention.

Detailed Description of the Drawings

With reference to Fig. 1 there is shown a urinary catheter 1 0

for purposes of describing an embodiment of urinary flow control valve 22

in accordance with the principles of the present invention. Catheter 1 0 is

shown by way of example and not limitation. To this end, catheter 1 0 is

shown in operational position for controlling flow of urine from a bladder 1 2

by manual manipulation of valve 22 as will be hereinafter described. Urinary catheter 1 0 has an elongated catheter shaft 1 4 that is adapted to

be inserted through a patient's urethra (such as at 1 5) so as to provide a

urine discharge passageway 1 6 extending from a pair of opposite inlets 1 8

(one shown) located within the bladder 12 at the distal end 19 of the

catheter 1 0 and communicating via valve 22 to a urine discharge outlet 20

located outside the urethra at the proximal end 21 of the catheter 1 0.

Urinary catheter 1 0 is formed, such as by injection molding, extrusion or

transfer molding processes, from silicone, such as 40 or 50 durometer

liquid silicone rubber, supplied by GE-Bayer Silicones of Waterford, New

York under the name Baysilone LSR 4040 and LSR 4050.

Further referring to Fig. 1 , an inflatable balloon 24 is provided

on the catheter shaft 14 for seating and sealing the urinary catheter 1 0 in

the bladder 1 2 as is well known in the art. An inflation lumen or

passageway 26 is provided in the wall of the catheter shaft 14 that fluidly

communicates with the balloon 24 mounted on the catheter shaft 14 and a

microvalve 28 mounted within a microvalve extension arm 30 of the urinary

catheter 1 0. A needle (not shown) or other device is inserted through the

microvalve 28 to inflate the balloon 24 with fluid as shown in Fig. 1 to seat

and seal the catheter 10 in the bladder 1 2.

In the embodiment of the invention shown herein, the valve 22

is supported within a spherical valve housing 32 connected to the catheter

shaft 1 4 at proximal end 21 thereof. The valve housing 32 includes a pair

of hemispherical bodies or walls 34 and 36 that are joined along abutting

outer annular edges 38 and 40 (Fig. 6), respectively, to form the spherical valve housing 32. Hemispherical body or wall 34 is integral with the

catheter shaft 14 and includes a groove 42 (Fig. 6) formed in the annular

edge 38. The valve 22 is held with the hemispherical body 36 having an

annular rib 44 (Fig. 6) formed on the annular edge 40 that is received in the

groove 42. A urinary discharge tube 46 is integral with the hemispherical

body 36 and defines the urine discharge outlet 20 at a remote end of the

urinary catheter 1 0. In use, urine flows from the bladder 1 2 through the

catheter shaft 14, through the valve 22 and out through the discharge tube

46 upon manual actuation of the valve 22 as will be described in detail

below.

A silicone anchoring collar 48 (Fig. 1 ) is provided around the

catheter shaft 14 outwardly of the balloon 24 and frictionally engages the

outer surface of the catheter shaft 1 4 to hold the walls of the balloon 24 in

sealing contact with bladder orifice and neck as shown in Fig. 1 . Rounded

serrations 50 are provided along the outside of the catheter shaft 1 4 and

register with serrations 52 on the inside face of the collar 48. The

serrations 50 and 52 serve to hold the collar 48 in place which, in turn,

holds the balloon seal in place to prevent leakage around the catheter shaft

14. In the female, the collar 48 presses against the body 54 around the

opening to the urethra. The design, structure and operation of the

components of catheter 10, with the exception of valve 22 and/or its

relationship to valve housing 32, may be conventional such as are shown in

U.S. Patent Nos. 4,968,294; 5,306,226; and .5, 800, 339, all assigned to the assignee hereof and the disclosures of which, in their entireties, are

incorporated as if set out fully herein.

In accordance with one aspect of the present invention, the

valve 22 comprises a double-duckbill valve in fluid communication with the

urine discharge passageway 1 6. The double-duckbill valve 22 has a pair of

duckbill-like structures 56a and 56b (see Figs. 3 and 5) oriented

perpendicular to each other so as to present a cruciform shape. Each

duckbill-like structure 56a and 56b (Fig. 5) has a pair of inclined lips or

walls 58a and 58b, respectively, that converge at a pair of intersecting

apexes 60a and 60b, respectively, at an inlet end of the valve 22. The inlet

end of the valve 22 faces upstream toward the urine flow from the bladder

1 2.

The double-duckbill valve 22 is advantageously slit along only

a single axis, i.e, along the apex 60a of duckbill-like structure 56a to form a

single slit 62. The duckbill-like structure 56b is unslit. The slit 62 defines

an inlet orifice to the valve 22 that is operable to control urine flow through

the urinary catheter 1 0 from the bladder 1 2. The unslit duckbill-like

structure 56b defines a pair of wedge-shaped hollow supports 64 (Fig. 5)

that are each integral with but perpendicular to one of the converging walls

58a of the slit duckbill-like structure 56a. The wedge-shaped supports 64

stiffen the lips or walls 58a of the slit duckbill-like structure 56a to resist

opening of the slit 62 and thereby improve the fluid seal.

As shown in Fig. 5, the fluid seal. may be further improved by

an elastomeric band 66 that is retained within a groove 68 (Fig. 6) formed around the exterior of the valve 22 and positioned slightly inwardly of the

juncture of the duckbill walls 58a and 58b with a base 70 of the valve 22.

The band 66 at least partially overlies the converging walls 58a and 58b of

the intersecting duckbill-like structures 56a and 56b near their juncture with

the valve base 70. The elastomeric band 66 pre-loads or biases the valve

22 (along with any fluid pressure at the inlet end of the valve 22) to a

normally closed position as shown in Fig. 5. The elastomere band 66 is

formed from silicone, such as 60 durometer silicone rubber, supplied by

Wacker Silicones Corporation of Adrian, Michigan. In an alternative

embodiment, the groove 68 is dispensed with and an annular shoulder (not

shown) is provided around the exterior of the valve 22 so as to position the

band 66 slightly inwardly of the juncture of the duckbill walls 58a and 58b

with the^'base 70 of the valve 22 when the band 66 is positioned around

the valve 22 and placed in abutting relationship with the annular shoulder

(not shown). Alternatively, the band 66 is positioned around the valve 22

and bonded to the valve 22 through adhesive or other suitable methods of

bonding so as to be positioned slightly inwardly of the juncture of the

duckbill walls 58a and 58b with the base 70 of the valve 22 without the

use of the groove 68 or the annular shoulder (not shown).

In accordance with another aspect of the present invention, a

urinary flow control valve, such as double-duckbill valve 22, is positioned in

spaced relationship from the flexible walls of the valve housing 32 through

an isolation member such as a flexible tubular stem 72 extending from the

hemispherical body 36 and connected to the valve base 70. The tubular stem 72 supports the valve 22 in non-contact relationship within the valve

housing 32 so that a clearance is established between the spherical walls of

the valve housing 32 and the valve 22. The tubular stem 72 has a

sufficiently thin wall, for example a wall thickness of about 0.020 in., to

mechanically isolate the valve 22 from forces applied to either the valve

housing 32 or the discharge tube 46 during normal movement that are not

intended to open the valve 22. The tubular stem 72 also provides a flexible

support for the valve 22 within the valve housing 32 such that minor

distortions of the valve housing 32 do not accidently actuate the valve 22

to an open position as described in detail below. The tubular stem 72 is

coupled between the double-duckbill valve 22 and the discharge outlet 20

of the discharge tube 46 so as to allow urine to flow through the stem 72

to the discharge outlet 20. Alternative isolation members may be utilized as

will be apparent to those skilled in the art. By way of example, and not

limitation, the isolation member could be a different thin, flexible member

such as a diaphragm or wall (not shown) extending between a wall 34 or

36 of the valve housing 32 and the urinary control flow valve (which could

be a valve as shown, for example in the aforementioned patents, or double-

duckbill valve 22 by way of example, or other valve structure as will be

readily apparent to those ordinarily skilled in the art) which diaphragm or

wall, like isolation stem 72, resists transfer of forces from walls 34, 36 to

valve 22.

When a crushing force is applied to the walls 34 and/or 36 of

valve housing 32 along the axis of the slit 62 of duckbill-like structure 56a , i.e., the user squeezes the valve housing 32 with fingers at opposite finger

pads 74 (Fig. 3), the cruciform structure of the double-duckbill valve 22 is

deformed sufficiently to compress the valve 22 along the axis of the slit 62

such that the lips or walls 58a come apart and open the valve 22 for the

flow of urine as shown in Fig. 4 (i.e., through passageway 1 6, into valve

housing 32, through valve 22, and out through stem 72 and outlet 20).

The valve 22 is actuated only when the wall 36, for example, of the valve

housing 32 deforms sufficiently to move into position to impact and bear

against valve 22 to thereby apply a sufficient crushing force to the double-

duckbill valve 22 to open the slit 62. After the crushing force is removed,

the natural tendency of the walls 58a is to close back up to close the slit

62. The perpendicular wedge-shaped supports 64 and the elastomeric band

66 helpfassure closure, and also retain the walls 58a in a closed position to

seal the slit 62 when there is only low fluid pressure, such as when urine

first begins to collect up around the OD of the valve 22. Alternatively,

valve 22 may be formed integrally with wall 36 so as not to be isolated

therefrom by stem 72, for example, such that squeezing pressure on

housing 32 may cause valve 22 to deform without having to move into

contact with valve 22 as that contact is inherent in the integral attachment

(not shown). However, the isolation of valve 22 is considered

advantageous to reduce the likelihood that valve 22 will be unintentionally

opened due to typical movement of valve housing 32 as the patient moves

about during normal activities. The valve 22 is oriented in the valve housing 32 so that fluid

flows in only one direction upon external actuation of the valve housing 32,

thereby permitting fluid flow from the inlet end of the valve 22 at the

apexes 60a and 60b of the cruciform toward the outlet end of the valve 22

at the connection of the tubular stem 72 with the valve base 70.

Otherwise, the valve 22 is designed to remain closed in the presence of

fluid pressure at the inlet end of the valve 22.

Several "crush limiting" components may be provided to form

positive stops as a user pinches the valve housing 32 and actuates the

valve 22 to the open position. These components are intended to limit

overactuation of the valve 22 which may result in restricted fluid flow, such

as through catheter 10, and stop valve deflection at an optimal opening

distance^".- In accordance with one aspect of the present invention as shown

in Figs. 6, 6A and 6B, a rigid or semi-rigid shell or tube 76 is suspended

within the valve 22 through an annular flexible flange 78. The tube 76 has

an outer diameter (OD) that is less than an inner diameter (ID) of the valve

22, and the OD dimension of the tube 76 is selected to stop valve

deflection at an optimal opening position of the slit 62. Valve deflection

stops when a wall 80 of the valve 22 engages the tube 76 as shown Fig.

6B.

According to another aspect of the present invention, as

shown in Figs. 7, 7A and 7B, a rigid or semi-rigid blade 82 is suspended

within the valve 22 and oriented parallel to the axis of the slit 62. The

width of the blade 82 is selected to stop valve deflection at the optimal opening of the slit 62 whereat the wall 80 of valve 22 engages lateral

edges 84 of the blade 82 as shown in Fig. 7B.

Alternatively, as shown in Figs. 8, 8A and 8B, a pair of rigid or

semi-rigid stop elements 86 are positioned external to the valve 22 and

supported or suspended in place by flexible fingers 88 such the stop

elements 86 limit valve deflection perpendicular to the slit 62 to the optimal

opening distance while flexing outwardly to allow the valve 22 to open. In

one embodiment of the present invention, the stop elements 86 comprise a

pair of rectangular plates suspended on opposite sides of the slit 62,

although other structural shapes of the stop elements 86 are possible as

well. Each stop element 86 has a width selected to stop valve deflection at

the optimal opening position of the slit 62 whereat the ID of valve housing

32 engages lateral edges 90 of the stop elements 86 as shown in Fig. 8B.

in accordance with yet another aspect of the present

invention, as shown in Fig. 9, stop elements 92 in the form of rigid or semi¬

rigid wedge-shaped supports are provided that are each integral with but

perpendicular to respective ones of the converging walls 58a of the slit

duckbill-like structure 56a. The solid wedge-shaped supports 92 provide a

limit to the opening of the valve 22, while also limiting the crushing of valve

housing 32 during actuation, so as to provide the optimal opening position

of the slit 62. Inserts of metal or other materials (not shown) may be

molded within the supports 92 to control the outward flexing extent of the

supports 92 to obtain the optimal opening position of the slit 62. While valve 22 is shown with catheter 1 0, it will be

appreciated that urinary flow control valve 22 and isolating a valve from the

valve housing both provide various advantages and benefits, either singly or

in combination, by which to reduce the likelihood of inadvertent opening of

the valve during normal activities, the ability to remain closed under a range

of normally encountered urethral pressures, and also the avoidance of

overactuation which may result in restricted urine flow.

In use, the urinary flow control valve 22 is associated with a

urethra 1 5, such as by being inserted into urethra 1 5, or by being fluidically

coupled to the urethra such as by a fluid passageway, which may be a

urinary catheter 10. When it is appropriate to empty the patient of urine,

the patient simply squeezes wall 36, for example, of housing 32 until valve

22 opens, while avoiding overactuation if crush limiting structure is

provided, such that urine flows out of discharge outlet 20. The patient

then releases the valve housing 32 which allows valve 22 to reclose and

begin the process of allowing urine to again collect up behind the valve 22,

but without concern from inadvertent leakage.

By virtue of the foregoing, there are thus provided urinary flow

control valves which overcome drawbacks and disadvantages associated

with prior urinary flow control valves.

While the present invention has been illustrated by a

description of various embodiments and while these embodiments have

been described in considerable detail, it is not the intention of the applicants

to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those

skilled in the art. For example, while the urinary valve 22 and housing 32

are shown herein as being external to urethra 1 5, depending upon the

relative size of the urethra and valve housing, the valve(s) of the present

invention could also be used within the urethra, provided the valve can be

activated manually such as by palpation of the body surrounding the

urethra. Moreover, while the urinary valves of the present invention are

shown at the terminal end of a urethral catheter, the valves could be used

along a length of catheter, without a catheter extending into the bladder

such as with a shorter artificial passageway 1 6 extending into the urethra

but not all the way to the bladder, and/or with no such passageway at all,

depending upon the placement of the valve. Additionally, while the

isolation^' member and crush limiting structure are shown herein in

connection with a urinary flow control valve, the concepts may be

applicable to other flow control valves. The invention in its broader aspects

is therefore not limited to the specific details, representative apparatus and

method, and illustrative example shown and described. Accordingly,

departures may be made from such details without departing from the spirit

or scope of applicants' general inventive concept.

Having described the invention, what is claimed is:

Claims

1 . A urinary flow control valve comprising:

a double-duckbill valve adapted to fluidly communicate with a

urine discharge passageway and having an inlet orifice operable to control

urine flow therethrough;

said inlet orifice comprising a single slit.

2. The urinary flow control valve of claim 1 , the double-duckbill

valve having:

a first duckbill structure terminating at a first apex; and

a second duckbill structure oriented perpendicular to said first

duckbill structure and terminating at a second apex;

said first and second apexes defining said inlet orifice;

said slit being formed in only one of said first and second

apexes.

3. The urinary flow control valve of claim 2 further comprising an

elastomeric band disposed about said double-duckbill valve and operable to

urge said inlet orifice to a closed position.

4. The urinary flow control valve of claim 1 further comprising an

elastomeric band disposed about said double-duckbill valve and operable to

urge said inlet orifice to a closed position.

5. The urinary flow control valve of claim 1 further comprising:

a valve housing defined by at least one wall; and

an isolating member extending from said wall to said double-

duckbill valve, said double-duckbill valve being supported in said valve

housing in spaced relationship with said wall by said isolating member.

6. The urinary flow control valve of claim 5, said isolation

member being a stem.

7. The urinary flow control valve of claim 6, said stem being

flexible.

8. The urinary flow control valve of claim 5, said isolation

member being a tubular stem.

9. The urinary flow control valve of claim 8, said tubular stem

being coupled with said double-duckbill valve so as to allow urine to flow

through said stem.

1 0. The urinary flow control valve of claim 9, said valve housing

having a discharge outlet, the tubular stem being coupled between said

discharge outlet and said double-duckbill valve.

1 1 . The urinary flow control valve of claim 8, said tubular stem

being flexible.

1 2. The urinary flow control valve of claim 1 further comprising:

a valve housing containing said double-duckbill valve;

said valve housing having a discharge outlet operatively

coupled with said double-duckbill valve.

1 3. The urinary flow control valve of claim 1 further comprising a

crush limiting member associated with said double-duckbill valve.

1 4. The urinary flow control valve of claim 1 3, said crush limiting

member including a tube member disposed within said double-duckbill

valve.

1 5. The urinary flow control valve of claim 1 3, said crush limiting

member including a blade member disposed within said double-duckbill

valve.

1 6. The urinary flow control valve of claim 1 3, said crush limiting

member including a stop member disposed external to said double-duckbill

valve.

1 7. A flow control valve comprising:

a valve member having a normally closed inlet orifice;

a separate elastomeric band disposed about said valve member

and operable to urge said inlet orifice to a closed position.

1 8. The flow control valve of claim 1 7 wherein said valve member

has a groove associate therewith, the elastomeric band being situated in

said groove.

1 9. The flow control valve of claim 1 7 wherein said valve member

has a base and at least a pair of lips extending from said base at respective

junctures of said lips with said base, band being positioned inwardly of said

juncturel of said lips with said base.

20. The flow control valve of claim 1 7 further comprising:

a valve housing containing said valve member;

an isolation member extending between said valve housing and

said valve member whereby to support said valve member in spaced

relationship to said valve housing.

21 . The flow control valve of claim 20, said isolation member

being a stem.

22. The flow control valve of claim 21 , said stem being flexible.

23. The flow control valve of claim 20, said isolation member

being a tubular stem.

24. The flow control valve of claim 23, said tubular stem being

coupled with said valve member so as to allow fluid to flow through said

stem.

25. The flow control valve of claim 23, said tubular stem being

flexible.

26. The flow control valve of claim 1 7 further comprising a crush

limiting member associated with said valve member.

27. The flow control valve of claim 26, said crush limiting member

including a tube member disposed within said valve member.

28. The flow control valve of claim 26, said crush limiting member

including a blade member disposed within said valve member.

29. The flow control valve of claim 26, said crush limiting member

including a stop member disposed external to said valve member.

30. The flow control valve of claim 1 7, said inlet orifice being

defined by a single slit.

31 . The flow control valve of claim 1 7, said valve member being a

double-duckbill valve.

32. A flow control valve comprising:

a valve member having a normally closed inlet orifice;

a valve housing containing said valve member;

an isolation member extending between said valve housing and

said valve member whereby to support said valve member in spaced

relationship to said valve housing.

33. The flow control valve of claim 32, said isolation member

being a stem.

34. The flow control valve of claim 33, said stem being flexible.

35. The flow control valve of claim 32, said isolation member

being a tubular stem.

36. The flow control valve of claim 35, said tubular stem being

coupled with said valve member so as to allow fluid to flow through said

stem.

37. The flow control valve of claim 35, said tubular stem being

flexible.

38. The flow control valve of claim 32 further comprising a crush

limiting member associated with said valve member.

39. The flow control valve of claim 38, said crush limiting member

including a tube member disposed within said valve member.

40. The flow control valve of claim 38, said crush limiting member

including a blade member disposed within said valve member.

41 . The flow control valve of claim 38, said crush limiting member

including a stop member disposed external to said valve member.

42. The flow control valve of claim 32, said inlet orifice being

defined by a single slit.

43. The flow control valve of claim 32, said valve member being a

double-duckbill valve.

44. A flow control valve comprising:

a valve member having a normally closed inlet orifice;

a crush limiting member associated with said valve member.

45. The flow control valve of claim 44, said crush limiting member

including a tube member disposed within said valve member.

46. The flow control valve of claim 44, said crush limiting member

including a blade member disposed within said valve member.

47. The flow control valve of claim 44, said crush limiting member

including a stop member disposed external to said valve member.

48. The flow control valve of claim 44, said inlet orifice being

defined by a single slit.

49. The flow control valve of claim 44, said valve member being a

double-duckbill valve.

50. A urinary catheter comprising:

a urine discharge passageway;

a urinary flow control valve associated with said urine

discharge passageway;

said urinary flow control valve being a double-duckbill valve;

said double-duckbill valve having an inlet orifice operable to

control urine flow therethrough.

51 . The urinary catheter of claim 50, said inlet orifice comprising a

single slit.

52. The urinary catheter of claim 51 , said double-duckbill valve

having:^

a first duckbill structure terminating at a first apex; and

a second duckbill structure oriented perpendicular to said first

duckbill structure and terminating at a second apex;

said first and second apexes defining said inlet orifice;

said slit being formed in only one of said first and second

apexes.

53. The urinary catheter of claim 50 further comprising an

elastomeric band disposed about said double-duckbill valve and operable to

urge said inlet orifice to a closed position.

54. The urinary flow control valve of claim 50 further comprising:

a valve housing defined by at least one wall; and

an isolating member extending from said wall to said double-

duckbill valve, said double-duckbill valve being supported in said valve

housing in spaced relationship with said wall by said isolating member.

55. The urinary catheter of claim 50, further comprising a crush

limiting member associated with said double-duckbill valve.