Note: Descriptions are shown in the official language in which they were submitted.
1214081;
Background
Various devices have been proposed in past years for
directing and collecting urine from female patients suffering
from urinary incontinence but, in general, such devices have
been associated with problems of leakage, wearer discomfort,
pressure sores, and even necrosis. An indication of the
ineffectiveness of such prior devices lies in their lack of
commercial success.
The problems associated with prior devices are
particularly pronounced with ambulatory patients because of
the varied and complex anatomical changes that occur in the
periurethral area during locomotion and the failure of such
devices to coapt to such changes. However, the need for an
effective device is by no means limited to ambulatory
patients. For example, non-ambulatory female patients with
spinal cord injuries are not served well by existing
devices ( indwelling catheters, intermittent catheters,
diapers, etc.) despite only minimal body movement of such
patients.
Prior patènts have disclosed female urinary collection
devices equipped with locating elements intended to be
inserted into the vagina for retaining the collection devices
in operative positions. Reference may be had to 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. Those constructions
in which the locating elements are relatively rigid clearly
fail to conform with the anatomical changes occurring during
body movement. While prior devices with flexible or deformable
vaginal locating elements may reduce tissue irritation and
increase patient comfort, problems in providing an effective
seal and avoiding lea~age along the lines or zones of con~act
have nevertheless rQmain~d.
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Other patents of interest are 4,270,539, 3,651,810,
4,198,979, and 3,194,238.
Summary
One aspect of this invention lies in the discovery
that effective sealing engagement with perimeatal tissues
may be achieved if the female incontinence device is
constructed so that the periurethral cup is compressible
but generally form-retaining and is mounted so that it may
move independently, at least to a limited exten~, with respect
to those portions of the device that make external contact
with the wearer. A further aspect lies in the recognition
that if such a molded compressible element is cup-shaped in
configuration and is operatively connected to an external
pad (which is in turn held in place by a panty or supporting
belts) by means of a tubular elastic bellows that exerts an
upward force on the cup when the device is worn without,
at the same time, interfering with limited independent
movement of the cup with respect to the pad, such a combination
will result in a device that eliminates or substantially
reduces the aforementioned problems associated with prior
devices. In another embodiment an air entry port, normally
closed by a one-way valve, allows air to enter the system
to prevent the development of relative negative pressure
within that system, and a vent is provided in the collector
to prevent expansion or deformation of the collector (normally
an expandable plastic pouch) that might otherwise result ~rom
entrapped air and the development of a relative positive
pressure.
The periurethral cup of a device embodying this
invention is molded in one piece of soft, compressikle
but generally form-retaining material havin~ a durometer
within the range o~ about 1 to 30 on the Shore A scal.e,
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the preferred range being approximately 5 to 20 on that
scale. An elastomeric material, molded so that the outer
surfaces of the cup are smooth and non-porous, has been
found particularly effective.
The periurethral cup is preferably provided with front,
rear, and lateral wall portions defining upper and lower
openings, such wall portions having a substantial wall
thickness (about 3 to 15 millimeters) and having smoothly
rounded surfaces, for making substantial surface contact
with the periurethral floor and vaginal introitus. The rear
wall portion extends upwardly beyond the upper limits of the
front and lateral portions to define a resilient, vaginally-
insertable, urine-deflecting protuberance, a feature of
importance for those patients whose urethral orifice is
located in, or immediately adjacent to, the vaginal introitus.
The urine-deflecting protuberance is capable of flexing
towards and away from the entrance opening of the cup without
causing buckling or kinking of the smoothly-rounded contact
surfaces engaging the periurethral floor and vaginal introitus
because of the`compressibility and substantial wall thickness
of the cup.
An external pad of soft, resilient and flexible material
is dimensioned for externally contacting the labia majora of
the wearer and has an opening extending therethrough.
Between that opening and the lower opening`of the periurethral
cup is a tubular elastic bellows dimensioned for exerting an
upward force on the cup, when the device is worn, to maintain
an effective seal between the rounded contact surfaces of
the cup and the surface of the periurethral floor and introitus
despite the complex anatomical changes or displacements that
occur during the dynamics of body movement. The length of
the elas~ic bellows varies within certain predetermined limi~s
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according to the distance between the periurethral floor
and the external surfaces of the labia majora for each
wearer, and a sizing instrument, patterned after the
construction of the urinary incontinence device, may be
used to establish the proper bellows length for a given
patient. Such sizing tool designed to allow endoscopic
examination if deemed necessary or desirable.
The external pad may, if desired, be provided with
a soft absorbent liner for directly contacting the labia
majora of the patient. Flexible tubing extends from the
outlet of the external pad to a leg bag or other suitable
collection device. The external pad is preferably held in
place by the wearer's undergarment (panty), but other
supporting means in the form of straps or belts may be used.
Other features, advantages, and objects of the
invention will become apparent from the drawings and
specification.
Drawings
Figure 1 is a perspective view of a female urinary
incontinence dèvice embodying the invention.
Figure 2 is a vertical longitudinal sectional view
of the device.
Figure 3 is an enlarged cross sectional view taken
along line 3-3 of Figure 2.
Figure 4 is a saggital sectional view illustrating
the device as it is worn.
Figure 5 is a saggital sectional view similar to
Figure 4 but illustrating the relative displacements of
the external pad and periurethral cup during weaxer movement~
Figure 6 is a lateral sectional view of the device
as it is worn.
Figure 7 is a side elevational view, shown partly
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in section, of a sizing tool adapted to be used as part of
the present invention.
Figure 8 is a fragmentary side view, taken partly in
section, showing a modified device with ports or vents for
preventing collapse of the bellows and conduit while at
the same time allowing gas to escape from the pouch.
Figure 9 is an enlarged horizontal cross sectional
view of the pouch's vent and filter, with certain elements
of the pouch and associated coupling omitted for clarity
of illustration.
Figure 10 is an enlarged vertical sectional view of
certain portions of the device depicted in Figure 8.
Figure 11 is a horizontal sectional view taken along
line ll-I1 of Figure 10.
Figure 12 is a still further enlarged sectional view
of the inlet port and valve member taken along line 12-12
o~ Figure 11.
Figure 13 is a sectional view of the umbrella valve
member showing details of construction thereof.
Figure 14`is an enlarged sectional view taken along
line 14-14 of Figure 11.
Figure 15 is a perspective view of a fluid-deflecting
element.
Figure 16 is an exploded perspective view of the valve
member, fluid detector, and the portion of the device
providing the valve passage or port.
Detailed Description
of Preferred Embodiment
Referring to the embodiment shown in Figures 1-6,
the primary components of the female urinary incontinence
device 10 are periurethral cup 11, external pad 12 f and
tubular elastic bellows 13. A flexible tube 1~ carries
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urine to a suitable collector or receptacle 15. For an
ambulatory patient, collector 15 would ordinarily take the
form of a leg bag. It is to be understood, however, that
other types of collectors might be provided to suit the
needs and physical condition of the user. Ordinarily,
flexible tube 14 would include a suitable detachable
coupling 16. The coupling illustrated in Figure 2 is
similar to that shown and described in U.S. patent 4,280,498,
but other types of couplings may be provided.
The periurethral cup 11 is molded in one piece from
a soft, compressible, but generally form-retaining material.
A molded elastomeric silicone matexial having a smooth,
substantially non-porous outer surface has been found
particularly effective, but other molded compressible
materials, such as elastomeric foam materials, might be
used. Regardless of the material selected, it is believed
critical that such material should have a durometer within
the range of about 1 to 30 on the Shore A scale, preferably
within the range of 5 to 20. Particularly effective results
have been obtained with a material having a durometer of
approximately 10.
It is also important that the side wall of the
periurethral cup have substantial thickness and that the
uppermost surfaces of the cup be smoothly curved or rounded
as shown most clearly in Figures 2 and 3. More specifically,
as depicted in the drawings, the cup has upper and lower
openings 17 and 18, respectively. The integral side wall 19
is composed of front, rear, and lateral wall portions l9a,
19b, and l9c, respectively. In the region bordering top
opening 17, each of those wall portions should have a
thickness d (Figure 3) within the range of about 3 to 15
millimeters. The result is a cup which, as brought out
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hereinafter, has upp~r surfaces making substantial contact
with the periurethral ~loor and vaginal introitus and which,
although soft and compressible, tends to be shape-retentive
in use notwithstanding the upward force exerted by elastic
bellows 13.
The rear wall portion l9b curves upwardly beyond the
upper limits o~ the front and lateral wall portions to define
a resilient, vaginally-insertable, urine-deflecting extension
or protuberance 20. The essential purpose of the protuberance
is to serve as a urine deflector for that portion of the
female population, estimated at between 15 to 20%, whose
urethral orifice is located within, or immediately adjacent
to, the vaginal introitus. Any functions the protuberance
performs in locating and retaining the cup in position are
of secondary significance. As described more fully hereinafter,
the wide-smoothly rounded contact surfaces of the compressible
cup, in combination with the gentle upward force exerted by
elastic bellows 13, serve primarily to maintain the cup in
its operative position.
As shown in Figures 1-3, the rounded upper surfaces 20a
of protuberance 20 merge smoothly and-gradually with the
upper surfaces lla of the remaining side and front wall
portions of the cup. Specifically, the upper front surfaces
of the protuberance 20 merge with the upper surfaces of the
side walls along a curved line represented in Figure 2 as
having a substantial radius r. That radius would normally
fall within the range of about 5 to 12 millimeters. Of
particular significance is the fact that even when the
protuberance is urged forwardly, as indicated by broken lines
in Figure 2, no buckling or kinking of the wall occurs at
radius r because of the compressibility of the material from
which the cup i~ forme~. Consequently, an e~fective seal
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between the curved upper surfaces of the cup (including the
protuberance) and the contact surfaces of the patient tends
to be maintained during normal body movement.
External pad 12 may be formed of the same soft,
compressible material as periurethral cup 11 and, in any
event, should be formed of a resilient, flexible polymeric
material. The pad is generally oval in outline, substantially
larger than cup 11, and has a passage or opening 21 extending
therethrough (Figure 2). As shown in the drawings, the
external pad has an upper surface 12a that is pre~erably
concave or dish-shaped and, if desired, the upper surface may
support an annular absorbent liner 22 (Figure 2) formed of
non-woven cotton fibers or other suitable absorbent material.
Along its lower or external surface 12b, pad 12 may be
provided with attachment means 23 in the form of fabric
having nylon hooks or loops of the type commercially available
under the Velcro* designation. If such retaining means is
used, then the patient would also wear a panty having a
brushed nylon crotch panel for engaging and interlocking with
attachment means 23, thereby helping to maintain the external
pad 12 against the outer surfaces of ~he labia majora.
Bellows 13 may be formed of any suitable elastomeric
material and, in an uncompressed or extended state, assumes
the appearance depicted in Figures 1-3. The number of
corrugations or convolutions 13a of the bellows for any
given urinary collection appliance will depend on the
distance between the labia majora and the periurethral floor
of the wearer to be fitted with the device so that, when worn,
the corrugations will be compressed or axially reduced as
indicated in Figures 4 and 6. Ordinarily, for adult wearers,
the number of corrugations will range between 2 (Figure ~)
to 6, and the undeormed length o ~h~ ~orrugated por~ion
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will range from 10 to 50 millimeters, with 3 selected sizes
within those ranges meeting the requirements for over 90%
of the adult female population. The tublar bellows may be
formed of elastomers of polyurethane, silicone rubber, latex,
or any of a variety of other materials having similar
properties. A particularly effective material has been
found to be a silicone rubber marketed by Dow Cornlng,
Midland, Michigan, under the designation Q7-4840*; another,
available from the same source, is MDX4-4210*.
In the embodiment shown, the bellows 13 and cup 11 are
formed separately and the upper end of the bellows is then
secured by adhesive or by any other suitable means to the
cup about the lower opening 18; however, it is to ba
understood that, if desired, the two elements may be formed
integrally. The lower end of the bellows is connected to
flexible tube or conduit 14 at the upper end of opening 21
of the external pad by means of an upwardly-flared extension 25
of conduit 14. Extension 25 of conduit 14 may be joined to
the bellows 13, and to the wall of external pad 12, by
adhesives, heat sealing, or any other suitable means.
Figures 4-6 depict the anatomical orientation of
the urinary incontinence device 10 under normal conditions
of use. External pad 12 bears upwardly against the external
surfaces of the labia majora 30 and is held in that position
by a panty or other support means (not shown) extending
beneath the external pad and interlocked with the annular
Velcro patch 23 (if provided). The periurethral cup 11
extends upwardly between the labia minora 31, and its soft
rounded upper surfaces lla of front and side wall portions l9a
and l9c engage the periurethral floor 32 about the meatus of
the urethra 33. The urine-deflecting protuberance 20 e~tends
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upwardly a short distance into the introitus or vagina 34.
The gently-rounded upper surfaces 20a and lla of the peri-
urethral cup therefore make resilient sealing contact with
the periurethral meatal surfaces even in the minority of
cases where the patient's urethra curves rearwardl~ and
communicates directly with the introitus (as represented
in broken lines 35 in Figure 4). The wide smoothly-rounded
upper surfaces of the cup make substantial surface contact
with the wearer and greatly reduce the possibility of
localizing of forces that might result in discomfort and
pressure necrosis. The thickness of the cup's walls yield
a form-retaining construction despite the softness and
compressibility of the material from which the cup is
formed. Should limited deformation of the cup occur in
use (as indicated, for example, by broken lines in Figure 2),
such deformation can be accommodated by the compressibility
of the material of the cup without accompanying buckling
or kinking actions that might result in leakage, and
without relative movement between body tissues and the cup
surfaces that might produce irritation and discomfort.
It is to be emphasized that the form-retentive cup
is urged upwardly into sealing contact with the periurethral
floor and introitus because of the expansive force exerted
by elastomeric bellows 13. When the urinary incontinence
device is properly worn, the bellows is in a partially
compressed state as shown most clearly in Figures 4 and 6.
External pad 12 is immobilized against labia ma~ora 30
and functions as a base against which the expansive force
of the bellows is applied in a downward direction. The
upward force exerted by cup 11 against the periurethral
surfaces is therefore relatively con~tant in magnitude
and direction.
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The bellows not only exexts a constant gentle upward
force on the cup, to maintain the cup in the position
illustrated, but also is capable of twisting, bending,
and deflecting to accommodate changes in position of
external pad 12 and internal cup 11 resulting from the
dynamics of body movement. Figure S illustrates what is
believed to be a typical condition where, because of wearer
movement, the cup 11 and pad 12 have become laterally
disposed but, nevertheless, the expansive force exerted
by bellows 13 coupled with the substantial contact surfaces
between the form-retentive but compressible cup and the
periurethral surfaces still maintain the cup in sealing
contact with the wearer.
Figure 7 illustrates a si~ing instrument 40 that may be
conveniently used for establishing the bellows length required
for properly fitting a wearer with urinary collection device
10. Periurethral cup 111 is of substantially the same size
and shape as cup 11 previously described, the essential
difference being that cup 111 is secured or formed at the upper
end of a stiff calibrated tube 41 rather than extending from
a resilient bellows 13. The external pad 112 may be similar
to previously-described pad 12, being formed of a resilient
elastomeric material (Dow Corning Q7-4840* has been found
particularly effective) and having essentially the same
dimensions. The primary difference is that instead of being
secured to bellows 13 and flexible tube 14, external pad 112
may be provided with a sleeve 42 that slidably receives rigid
calibrated tube 41. The external pad 112 may therefore be
slid along the length of tube 41, and its position
established by reference to calibration lines 43 and
numerical indicia 44.
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The sizing instrument 40 may be disposable and is used
by a doctor or other medically-trained personnel by inserting
periurethral cup 111 into the position assumed by cup 11 in
Figure 4, and then sliding the external pad 112 axially along
the indexed tube 41 until the pad bears against the labia
majora 30 in the same manner shown in Figure 4 for pad 12.
If inspection is deemed necessary or desirable to establish
that the periurethral cup 111 is properly seated against
the periurethral floor and vaginal introitus, or if inspection
is required for any other reason, the doctor may insert the
stem of a conventional endoscope through the passage 4~ of
tube 41, so that the objective of the endoscope extends into
the open cup 112. Once it is determined that both the
periurethral cup 111 and the external pad 112 are properly
positioned, the sizing instrument is removed and the
determination of bellows length for the collection device 10
to be used by the patient is made from scale 43-44.
The following example details the preparation of a
soft, compressible material, and the construction of a
periurethral cup formed of such material, found to be
particularly effective for use in practicing the invention:
Ten 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, type Q7-4840* from Dow
Corning, Midland, Michigan, were mixed with 1.7 parts by
weight of type 360 Dow Corning silicone fluid having a
viscosity of about 350 centipoises, and then degassed and
injected into molds for the periurethral cup 11, the
external pad 12, and bellows 13. Curing was achieved by
heating to a temperature of 200-400 F. for an interval
of up to about 6 minutes. The silicone rubber of the inal
parts was homogeneous, smooth and clear (semi-txanspa.rent), `
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with a durometer of approximately 10 Shore A.
The parts may also be fabricated from an elastomeric
foam as follows: Four parts by weight of a silicone foam
base, type QU-4290* from Dow Corning, Midland, Michigan
having a viscosity within the range of 1,000 to 6,000
centipoises, and 2.5 parts by weight of Silastic 382
elastomer from the same source, having a viscosity within
the range of 35,000 to 65,000 cp, were mixed thoroughly
and 0.045 part of a silicone foam catalyst, type Q7-4290*,
was then added and mixed thoroughly for approximately 30
seconds. The mixture was allowed to degas for approximately
30 seconds and then stirred vigorously. The degasing and
stirring procedures were repeated twice, and the mixture
was then immediately poured into molds for the periurethral
cup 11 and the external pad 12. The cup and pad were
removed from their respective mold cavities from a curing
interval of approximately 12 minutes. To facilitate
removal, the cavities of the molds were pre-coated with a
suitable mold release agent (HEM 41220*). The small cell
size of the foàm parts were promoted by the degasing
procedures and the vigorous stirring action. The final
parts had smooth, substantially non-porous outer surfaces
of skins and a durometer of approximately 10 Shore A.
The embodiment depicted in Figures 8-16 i9 essentially
the same as the embodiment of Figures 1-6 except for air
porting and gas venting means. The device includes an
external pad 212 for contacting the labia majora of the
wearer, a periurethral cup 211 having upper and lower
openings 217 and 218, respectively, and a tubular elastic
bellows 213 extending between the lower opening of the
cup and the opening of the external pad for urging the
cup into engagement with the periurethral floor and
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vaginal introitus when the pad is held against the labia
majora. The cup has an integral side wall 219 composed of
front, rear, and lateral wall portions 219a, 219b, and ~19c,
respectively. In the region bordering top opening 217,
each of those wall portions has smoothly rounded surfaces
and has a substantial thickness within the range of about 3
to 15 millimeters. The rear wall portion 219b curves
upwardly beyond the upper limits of the front and lateral
wall portions to define the resilient, vaginally-insertable,
urine-deflecting extension or protuberance 2~0. All of the
characteristics, compositions, dimensions, and functions
of the cup, bellows, and pad of this embodiment are
essentially the same as those described in connection with
the first embodiment of Figures 1-6.
Whether bellows 213 and cup 211 are formed separately
(and then joined by adhesive or-any other suitable means,
as shown and previously described) or integrally, the upper
end of the bellows 213 communicates directly with the
periurethral cup 211 at lower opening 218. The lower end of
the bellows is connected to the upper end of a flexible
conduit or tube 214 by an extension 225 of that conduit.
As shown most clearly in Figures 8 and 10, the interfacial
conduit extension 225 has a wall 225a that flares upwardly
and outwardly to match the larger diameter of the bellows.
However, one portion 225b of that wall extends generally
horizontally, that is, in a plane normal to the axis of
the bellows in an undeformed state. One or more air
entry ports 250 extend vertically (i.e., axially) through
wall portion 225b; in the form shown, a pair of such ports
are provided, each having an arcuate configuration when
viewed in transverse section or plan (Figure 11). Valve
means 251, which may take ~he ~orm of an umbrella valve
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havin~ à conical canopy portion 252 and stem portion 253
is positioned to allow entry of ambient air while at the
same time blocking the escape of fluids tgases and liquids)
from the bellows 213 and upper end of the conduit 214. As
shown most clearly in Figures 12-14, the elongated stem 253
o~ the valve member 251 is adapted to extend downwardly
through an opening 254 in wall portion 225b, such opening
being centered between arcuate ports 250. An intermediate
enlargement 253a of the stem serves to limit upward movement
of the stem with respect to wall portion 225b; downward
movement is prevented by an upper enlargement 253b of the
stem shrouded by the conical canopy portion 252.
The umbrella valve member 251 is composed of a soft,
easily-deformable and readily-recoverable elastic material
such as, for example, silicone rubber. Figure 13 depicts
the valve member in an untensioned or undeformed state, but
it will be noted from Figure 14 that when the valve member is
secured to apertured wall 225b of the interfacial conduit
extension 225 the valve member is in a pre-tensioned or
pre-loaded condition with canopy portion 252 having a
distinctive downward and outward curvature and with the
peripheral edge of the canopy portion held in normal
sealing engagement with the upper surface of wall 225b.
Because of its deformability, and notwithstanding the
pre-tensioning, the canopy portion 252 of the valve member
is capable of ~lexing upwardly to allow entry of air into
the system when even a small pressure differential (for
example, 0.5 inches H2O) exists. Such upward flexure is
indica~ed in broken lines in Figure 12. On the other hand,
should the pressure within the system be equal to or exceed
ambient pressure, the highly flexible canopy 252 will
eEectivel~ seal against tho upper surf~ce of wall portion 225b
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and will block exit of fluids, at least within the range
o~ pressure differentials encountered in normal use of the
device. As shown in Figure 10, the external pad 212 has an
inlet passage 255 communicating with opening 250 in wall
portion 225b. Passage 255 extends upwardly through the wall
of the pad from an entrance 256 at the pad's lower end.
The purpose of ports 250 and valve members 251 is
to insure that the superior sealing action of the
periurethral cup against the periurethral floor and vaginal
introitus will not interfere with proper flow of urine
through conduit 214 to pouch or collection device 257.
If it were not for the inlet ports, a column of liquid
flowing downwardly through conduit 214 would generate a
relative negative pressure that might even be sufficient
to collapse bellows 213 and/or conduit 214, interfere
with the fit of periurethral cup 211, and possibly result
in leakage or wearer discomfort. Since ports 250 and one-way
valve 251 permit the entry of air at the upper end of the
conduit, pressure is equalized and such problems are thereby
avoided.
While the umbrella valve construction shown in the
drawings has been found highly effective, other types of
air-inletting valves might be used. Furthermore, where
an umbrella valve is utilized, it may or may not be used
in conjunction with deflector means 253. The purpose of
the deflector is simply to prevent the possibility that
leakage might occur should canopy 252 of the valve member 251
be impacted by a stream of urine flowing rapidly through
the bellows 213 and entering conduit 214. If the possibilities
of leakage caused by urine impinging upon and deforming the
valve member are considered so slight as to be ne~ ible
or inconse~uentlal then deflector 25~ ~nay be elimin~ted.
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As shown in Figures 12 and 14-16, the deflector 258
takes the form of a plate 259 havin~ a pair of spaced
downwardly-extending legs 260. The cover plate 259 extends
over the canopy 252 of valve member 251 and is held in place
by upstanding spindles or lugs 261 that are formed integrally
with interfacial conduit extension 225 and received within
channels or holes 262 formed in the legs 260 of the deflector.
The deflector may be frictionally held in place by the lugs
and, as shown, the free ends of the lugs may be flattened and
whereby, laterally enlarged to lock the deflector in operative
position. Alternatively, the parts may be permanently bonded
or fused together by any suitable means.
To prevent air which enters the system through ports 250
from inflating pouch 257j a wall 257a of the pouch is
provided at its upper end with air venting means 270. Any
suitable means for venting air from the upper end of the
pouch while at the same time blocking the outflow of liquid
may be used. In the embodiment illustrated, the venting
means takes the form of perforations 271 formed in wall 257a
with the area of such perforations backed by a thermoplastic
microporous strip 272 capable of allowing gases to escape
from the pouch while at the same time blocking the passage
of urine. The strip or patch 272 is perimetrically sealed
to the wall of the pouch by heat sealing 273 or by any other
suitable sealing means. While various types of hydrophobic
microporous materials may be used for fabrication of the vent
or filter patch 272, effective results have been achieved
using 3-micron filter stock marketed under the designation
"Versapor*" by Gelman Corporation, Ann Arbor, Michigan.
The lower or distal end of flexible conduit 214 is
shown to be connected to pouch 257 b~ a detachable coupling 280
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of the type shown and described in co-owned U.S. patent
4,280,498. Since any of a variety of couplings and
connections between the conduit and the pouch might be
provided, all within the knowledge of someone familiar
with urine collection systems, a discussion of such structures
in further detail is believed unnecessary herein.
While in the foregoing we have disclosed embodiments
of the invention in considerable detail for purposes of
illustration, it will be understood by those skilled in
the art that many of these details may be varied without
departing from the spirit and scope of the invention.
