Note: Descriptions are shown in the official language in which they were submitted.
~~~a~~s
FLUSHABLE MIDSTREAM
URINE COLLECTOR
BACKGROUND AND SUMMARY
Conventional urine sample collectors generally take the
form of a simple cup which includes a closable lid. Typically,
the patient voids into the cup, closes the lid, and then returns
it to a nurse who must wear gloves to pick up, label, and place
the cup in a plastic zip-lock bag for transport to a laboratory
for analysis. The sample container must then be disposed of
through a certified medical waste disposal company which follows
stringent and expensive disposal standards. Handling of the
sample container must be carefully conducted throughout the
entire process since diseases such as AIDS or hepatitis can be
transmitted by improper handling of urine specimens.
Conventional sample cups also present problems with
respect to the sample being contaminated by the initial portion
of the urine stream. The importance of collecting a "midstream"
sample for urine analysis is well known. A particularly
advantageous device for collecting a midstream sample is
disclosed in my Patent No. 4,557,274. Briefly, the device
includes a tubular body through which a patient voids and a cup
member is positioned in the flow passage of the tubular body
which by-passes the initial and terminal portions of the urine
stream but collects a midstream sample. The sample can then be
simply transferred from the cup member to a conventional air-
evacuated collection tube or conventional syringe. While this
device presents an effective way of collecting a midstream urine
sample, there still exists a need in the industry for a device
which overcomes the complexity and cost of handling and disposal
of urine sample collection devices.
An important aspect of this invention therefore lies in
providing an uncomplicated low-cost midstream urine collector
which is adapted for one time use and which is discardable in a
common toilet bowl and waste water system without obstructing or
2~70~3G
damaging the water discharge lines. More specifically, the
collector automatically by-passes the contaminated initial
portion of the stream and then collects a sterile or at least
relatively uncontaminated midstream sample which is quickly and
easily transferred to a sterile collection tube. The collector
is primarily composed of a water-soluble material which gives the
device its structural integrity and, when the device is discarded
in the water of a toilet bowl, it readily dissolves or disperses
so that it may be flushed through the water discharge lines of a
waste water system without obstructing or damaging the system.
Protective layers of water-insoluble material line or coat the
majority of the surfaces of the device which are exposed to urine
when a patient voids into the device. However, the protective
layers are thin and relatively weak so that they will break-up or
disperse once the primary water-soluble components of the
collector dissolve. Such a construction is low-cost in design
and is suitable for manufacturing and marketing as a disposable
item for one-time use and subsequent disposal in a flush toilet.
In brief, the flushable midstream urine collector
includes a tubular body which defines a flow passage and a cup
member which is disposed in the flow passage. Cover means are
provided for effectively sealing the mouth of the cup member in a
first operative state so that the initial portion of the urine
stream is deflected and for exposing the mouth of the cup member
in a second operative state so that the mouth of the cup member
is exposed to receive an uncontaminated subsequent midstream
portion. The tubular body and cup member are composed of primary
layers of water-soluble material which provide the structural
components of the device and which will dissolve or disperse when
disposed in the water of a toilet bowl. Thin protective, but
relatively weak, layers of water-insoluble material line the
inner surfaces of the tubular body and cup member to prevent
premature dissolution of the primary layers when a patient voids
into the collector. When the device is disposed in the water of
a toilet bowl, the primary layers of the tubular body and cup
-3-
21~093~
member dissolve or disperse so that the device loses its
structural integrity and the relatively weak protective layers
collapse and disperse so that the entire collector is readily
flushable. The primary layers of the tubular body and the cup
member may be composed of a relatively rigid water-soluble
polymer such as polyvinyl alcohol. The protective layers of
water-soluble material may be composed of wax, polyvinyliodine,
or other thin water-insoluble materials which are relatively weak
and which will break-up or disperse upon dissolution of the
primary layers.
The inner surface of the sup member is provided with a
protective layer of water-insoluble material to contain the
midstream sample. However, the outer water-soluble surface of
the cup member must be left exposed to the flow passage;
otherwise, if both the inner and outer surfaces of the cup member
were protected by water-insoluble material, the cup member would
not dissolve or disperse when disposed in the water of a toilet
bowl. Accordingly, urine passing through the passage will
contact the water-soluble outer surface of the cup member.
However, it is believed that the contact between the urine and
primary layer occurs only randomly and that the fluid does not
directly contact the primary layer for a sufficient amount of
time to compromise the structural integrity of the cup member.
For example, a patient will typically void into the collector for
a period of approximately 30-60 seconds whereas the primary layer
requires generally at least 2 minutes of direct and constant
exposure to fluid, preferably 2-5 minutes, in order to completely
dissolve or disperse.
The collector may also include urine-deflection means
positioned around the mouth of the cup member for deflecting
urine passing through the passage away from the outer surface of
the cup member to minimize contact between the urine and the
unprotected water-soluble outer surface of the cup member. The
construction of the urine-deflection means differs depending upon
-4-
' '
the type of cover means which is disposed over the upwardly-
directed mouth of the cup member.
In one embodiment, the cover means include a water-
soluble membrane which extends over the mouth of the cup member
and which is capable of disintegrating within a few seconds upon
direct exposure to a stream of urine. Attachment means are
provided for securing the water-soluble membrane over the mouth
of the cup member, and the attachment means may take the form of
an annular collar. The collar may also form the urine-deflection
means by being secured to the cup member so that it projects
outward from the cup member and beyond its outer surface to
deflect urine passing through the passage away from the cup
member's exposed outer surface. The collar may also include an
upper surface which extends downwardly along an inclined plane
away from the cup member to direct urine flowing through the
passage away from the outer surface of the cup member.
In another embodiment, the cover means include a cover
plate which is formed of a primary layer of water-soluble
material which will dissolve or disperse when disposed in the
water of a toilet bowl and a thin protective, but relatively
weak, layer of water-insoluble material. The cover plate is
supported in a first position upon the cup member so that it
covers the mouth of the cup member and the protective water-
insoluble layer is exposed to the passageway for protecting the
primary water-soluble layer from fluids flowing through the
passage. The cover plate is supported upon the cup member for
movement between a first position in which it covers the mouth
of, and deflects urine away from, the cup member, and a second
position in which it is displaced from the mouth to allow a
midstream sample to enter the cup. The cover may be urged into
the second position by a spring, gravity, or other suitable
means. Preferably, when the cover plate is in its second
position, the water-soluble primary layer of the cover plate is
exposed to fluids passing through the passage to initiate
dissolution of the cover plate while the sample is being
-5-
217Q~~~
collected. In this embodiment, the urine-deflection means for
protecting the outer surface of the cup member may take the form
of the cover plate which includes a peripheral portion which
projects outward beyond the outer surface of the cup member for
shielding the outer surface of the cup member when the cover
plate is in the first position. While the urine-deflection means
will be displaced or inoperative when the cover plate is in the
second position, it is believed that providing such a urine-
deflection means, although only for a short interval, is
advantageous since it protects the exposed outer surface of the
cup member from the initial surge of the urine stream.
The tubular member includes a support means for
supporting a collection tube for removal of the urine sample and
evacuation passage means are provided between the cup member and
the support means. The collection tube may take the form of an
air-evacuated collection tube having a pierceable stopper that is
slidably supported by the support means adjacent to a hollow
spike communicating with the evacuation passage means. After the
patient has finished voiding, the collector is simply placed upon
an unyielding support surface and the evacuator tube is urged
axially to cause piercing of the stopper and the flow of at least
a portion of the midstream sample into the sterile tube. The
support means is composed entirely of a water-soluble material so
that it will dissolve or disperse when disposed in the water of a
toilet bowl. Likewise, the evacuation passage means are
primarily composed of a water-soluble material except for a thin
protective layer of water-insoluble material which lines the
interior passage which extends in communication between the cup
member and support means. The hollow spike may be composed of a
water-insoluble material such as a rigid plastic or metal.
However, the spike is preferably constructed to have a relatively
short length of approximately 0.5 to 1.5 inches, preferably about
1 inch, so that it may be flushed in a common flush toilet
without obstructing the water discharge lines. Once a nurse has
extracted a urine sample from the collector with a collection
-6-
CA 02170936 2001-07-25
tube, the collector is discarded in the water of a toilet bowl.
After a sufficient interval has elapsed so that the primary
layers of the tubular body and cup member, as well as the support
means and evacuation passage means, dissolve and disperse, the
toilet can then be flushed for permanent disposal of the
collector.
Other features, aspects, and advantages of the
invention will become apparent from the specification and
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a flushable midstream
urine collector embodying the present invention.
FIG. 2 is an exploded fragmentary perspective view
illustrating a portion of the cup member and one embodiment of
the cover means.
FIG. 3 is a fragmentary vertical sectional view
illustrating the construction of the water-soluble and water-
insoluble layers of the device and depicting operation of the
device at the beginning of a sample-collecting procedure.
FIG. 4 is a sectional view similar to FIG. 3 but
illustrating the device after the cover member has started to
disintegrate and a midstream sample has begun to enter the cup
member.
FIG. 5 is a sectional view similar to FIGS. 3 and 4 but
illustrating the further step of transferring_the midstream
sample from the cup member to an evacuated collection tube.
FIG. 6 is a fragmentary vertical sectional view of a
midstream collector constituting another embodiment of the
invention.
FIG. 7 is a fragmentary vertical sectional view
illustrating another embodiment of the invention.
FIG. 8 is a fragmentary vertical sectional view
illustrating the embodiment shown in FIG. 7 with the cover plate
in a second position.
CA 02170936 2001-07-25
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to the drawings, the numeral 10 generally
designates a flushable midstream urine collector which includes a
tubular body 11 having an upper inlet 12, a lower outlet 13, and
a flow passage 14 extending therebetween. The body is funnel-
shaped, the lower section lla of the body being generally
cylindrical and the upper section llb being frusto-conical in
configuration. The lower section 11a is provided with a
plurality of outwardly projecting legs 15 so that the collector
may be placed in an upstanding position upon a tabletop or other
support surface. A particularly advantageous construction of a
midstream urine collector, although non-flushable, is disclosed
in my U.S. 4,557,274 patent.
The tubular body 11 includes inner and outer surfaces
16 and 17 and inner surface 16 defines flow passage 14. The
tubular body is composed of a primary outer layer 18 of a water-
soluble polymeric material which will dissolve or disperse when
disposed in the water of a toilet bowl and a thin inner
protective layer 19 of a water-insoluble material which lines
inner surface 16 of the body and prevents urine flowing through
the passage from contacting the water-soluble primary layer of
the body. Outer layer 18 forms the structural component of the
tubular body and may be formed from water-soluble polymers which
are capable of being formed into rigid or semi-rigid articles.
One particularly suitable water-soluble material is polyvinyl
alcohol which is commercially available in pelletized form and
which may be injection molded at low temperatures to form the
tubular body. However, it will. be understood that other water-
soluble polymeric materials may be effective, such as
polyethylene oxide or carboxymethyl cellulose. In any event, it
is believed preferable if the water-soluble material requires at
least about 2 minutes of direct exposure to a fluid in order to
significantly dissolve or disperse. Preferably, the water-
soluble material is constructed so that it will dissolve or
_g_
217~93~
disperse in a period of about 2-5 minutes after it is discarded
in the water of a toilet bowl. However, water-soluble materials
which may require up to a period of about 10 minutes to dissolve
are still believed to be suitable as leaving the collector in the
toilet bowl for such a time period is usually not inconvenient in
a typical situation in which a patient is providing a urine
sample.
Unlike the primary layer of the tubular body, the inner
protective layer 19 is relatively thin and weak and serves
primarily as a protective coating to prevent direct exposure of
the primary layer to fluids flowing through the passage of the
tubular body. The inner protective layer lacks sufficient
strength to maintain its structural integrity when the primary
layer of the tubular body dissolves or disperses and will readily
collapse and disperse upon dissolution of the primary layer. The
protective layer may be formed from water-insoluble polymeric
materials such as polyvinyl chloride or polyvinyliodine, or other
suitable water-insoluble materials known in the art. One
particularly suitable water-insoluble material is wax which may
be easily applied by spray coating a thin layer of wax onto the
inner surface of the tubular body.
Within the flow passage 14 of body 11 is a cup member
20. The cup member includes an outer surface 20a which is
exposed to the flow passage and an inner surface 20b which
defines an interior chamber 21 positioned below an upwardly-
directed mouth 22. The cup member is preferably mounted within
the upper portion of the body's lower section 11a, and bridging
means in the form of struts 23 support the cup member within the
flow passage. The cup member is substantially smaller than the
body and, in particular, has an outer diameter smaller than the
inside diameter of body 11. Consequently, fluid entering the
inlet of the funnel-shaped body may flow downwardly through
passage 14 past cup member 20 and may be discharged through
outlet 13.
-9-
The cup member is composed of a primary layer 24 of
water-soluble material which will dissolve or disperse when
disposed in the water of a toilet bowl and the primary layer of
the cup member may have the same, or a similar, construction as
the primary layer of the tubular body. The cup member also
includes a thin protective, but relatively weak, layer 25 of
water-insoluble material which lines the inner surface 20b of the
cup member and prevents fluid collected in chamber 21 from
contacting the primary layer 24 of the cup member. Protective
layer 25 may have the same, or a similar, construction as the
protective layer which lines the inner surface of the tubular
body.
The struts 23 which support cup member 20 in the flow
passage are primarily composed of a water-soluble material except
for a thin layer 23a of water-insoluble material which faces
inlet 12 and deflects fluid entering and flowing through the
passage away from the primary water-soluble component of the
struts. It will be understood that at least a portion of the
water-soluble component of the struts should remain exposed to
the passage so that, when the collector is discarded in the water
of a toilet bowl, the water will contact and initiate dissolution
of the primary component of the struts.
It will also be noted that outer surface 20a of cup
member 20 is formed from water-soluble primary layer 24 which is
exposed to fluids flowing through the passage; otherwise, if the
outer and inner surfaces of the cup member were coated with a
water-insoluble material, the cup member would be completely
insulated and would not dissolve or disperse in the water of a
toilet bowl. Although the water-soluble outer surface of the cup
member is exposed to the fluid passage, it is believed that
fluids passing through the passage will not cause significant
disintegration or dissolution of the cup member. This is because
fluids passing through the passage only randomly contact the
outer surface of the cup member, and such contact only occurs
during the limited period of time that the patient voids into the
-10-
. ~1'~0~3G
collector, which is typically a period of about 30 to 60 seconds.
In contrast, the primary layer of the cup member, as well as the
primary layer of the tubular body, are preferably constructed of
a water-soluble material which requires at least about 2 minutes
of direct exposure to a fluid in order to significantly dissolve
or disperse. When a the collector is discarded in the water of a
toilet bowl, the water in the bowl envelopes the collector and
initiates dissolution of the exposed primary layer 18 of the
tubular body and the exposed. primary layer 20a of the cup member
so that within approximately 2-10 minutes, preferably 2-5
minutes, the primary layers of the collector lose their
structural integrity. The relatively weak protective layers then
collapse or disintegrate so that the entire collector is readily
flushable through a common flush toilet without obstructing or
otherwise damaging the discharge lines of the water disposal
system.
Cover means 26 extend over the mouth 22 of cup member
20. In the embodiment shown in FIGS. 1-5, the cover is formed
entirely, or substantially so, of a non-contaminating water-
soluble material capable of rapidly disintegrating upon direct
exposure to an aqueous fluid (urine). The cover is shown to be
dome-shaped; however, other configurations might be suitable such
as, for example, a conical configuration or a sloping planar
configuration. In any event, it is important that the
imperforate cover 26 present an upwardly-facing outer surface
capable of deflecting fluid entering the flow passage of the body
and preventing the fluid from initially entering cup member 20.
To maintain the cover in a dome condition, cup member 20 may be
provided with a framework of arched supporting struts 27. The
struts are primarily formed from a non-contaminating water-
soluble polymeric material which may be the same, or similar to,
the primary layers of the tubular body and cup member. However,
the uppermost portion or upwardly-directed surfaces 27a of the
struts which support the cover are provided with a thin
protective layer of water-insoluble material to prevent the
-11-
~~7~~3s
struts from significantly disintegrating when a patient voids
into the collector. While the unprotected surfaces of the struts
will come into random contact with the urine stream, it is
believed that the thin protective layer 27a of water-insoluble
material is sufficient to deflect the stream and prevent
prolonged direct contact between the stream and the structural
components of the struts so that only a minimal portion of the
struts may dissolve during use and flow into the cup member.
However, like the cover itself, the struts are formed of a non-
contaminating water-soluble polymeric material which will not
effect the sample that is collected.
Attaching means are provided for securing the cover
over the mouth of the cup member. The attachment means may take
the form of a circumferential beaded portion 28 provided on the
cover so that the cover may be locked into place upon the cup
member by a resilient collar 29 disposed about the cover, between
the bead 28 and the annular flange or rim 30 about the mouth of
the cup member, in the manner depicted most clearly in FIG. 3.
Collar 29 is preferably composed primarily of a water-soluble
material which may be the same as or similar to the primary
layers of the tubular body and cup member. However, collar 29
includes a thin protective layer 29a of water-insoluble material
on its uppermost surfaces which face inlet 12 of the tubular body
for preventing the primary water-soluble component of collar 29
from prematurely dissolving when a patient voids into the device.
Operation of the cover means between a first operable
state in which it seals the mouth of the cup member and deflects
the initial portion of urine stream and a second operative state
is which it exposes the mouth of the cup member for collection of
a subsequent midstream sample will now be described. As stated,
cover 26 consists essentially of a thin membrane formed of water-
soluble polymeric material, and such material should not
contaminate the fluid that contacts and dissolves it. The term
"non-contaminating" is used here to mean any material that when
dissolved in a fluid sample will not have any significant effect
-12-
CA 02170936 2001-07-25
on the results of tests that may subsequently be performed on
that sample. A particularly effective material for such purposes
has been found to be a polyvinyl alcohol film of the type
marketed by Polymer Films, Inc., Rockville, Connecticut, under
the trade-mark PVOH 17-35-1; however, other water-soluble non-
contaminating polymeric materials might be used such as, for
example, methyl cellulose and derivatives thereof. The thickness
of the film or membrane may be varied depending on the material
used but, in any event, the composition and thickness of the
membrane should be such that disintegration of the cover
commences within a period of about 2 to 15 seconds when the cover
is directly exposed to a stream of urine. Preferably, such
disintegration should commence within about 3 to 8 seconds.
Consequently, when a patient voids into the sterile tubular
collector, the initial contaminated portion of the stream
(contaminated by the labia in the female and the foreskin and
distal urethra in the male) is deflected by the cover and
bypasses cup member 20. Such deflected bypassing flow is
represented by arrows 31 in FIG. 3. After a few seconds, the
membrane cover 26 begins to disintegrate, allowing a midstream
portion of the flow to enter the cup member (FIG. 4). Complete
bypassing of the cup member again occurs after that member has
become completely filled with the relatively uncontaminated
midstream portion of the flow of urine. Once urination is
completed, the midstream portion remains collected in the cup
member, with the beginning and terminal portions of the stream
having been passed through the funnel-shaped body and into the
toilet bowl.
Means are provided for extracting a sample from the cup
member and transferring such sample to a sterile collection tube.
More specifically, support means 32 are provided as part of the
tubular body 11 and an evacuation passage means 33 defines an
interior passage 34 which extends in communication between the
support means and the cup member. The support means and
evacuation passage means are formed almost entirely, or
-13-
CA 02170936 2001-07-25
substantially so, of a water-soluble material which will dissolve
or disperse when disposed in the water of a toilet bowl.
Preferably, the support means and evacuation passage means are
formed from the same material as the primary layers of the
tubular body and cup member. As mentioned, pelletized water-
soluble polymers such as polyvinyl alcohol may be injection
molded at low temperatures to form the unitary device.
Consequently, all of the substantial components of the collector
are formed from a water-soluble polymer which will dissolve or
disperse in the water of a toilet bowl and the remainder of the
device is formed from thin protective, but relatively weak,
layers of water-insoluble material which lack sufficient strength
to maintain their structural integrity upon dissolution of the
primary components of the collector. Interior passage 34
includes a thin protective layer 34a of water-insoluble material
so that collected fluid will not prematurely initiate dissolution
of the evacuation passage means. A tubular spike 35 projects
upwardly and outwardly from the wall on the lower body section
11a and its lumen constitutes an extension of the evacuation
passage means 33. As shown most clearly in FIGS. 3 and 5, the
spike is provided with a pointed upper end 36 spaced slightly
below the stopper 37 of a conventional air-evacuated collection
tube 38. The spike may be formed from a rigid plastic or metal
and will typically be constructed of a water-insoluble material.
Preferably, the spike has a length of approximately 0.5 to 1.5
inches, preferably about 1 inch, so that the tubular spike may be
flushed with the device in a common flush toilet without
obstructing the water discharge lines.
The collection tube may be of the same type commonly
used with double-pointed needles for the collection of blood
samples, such as, for example, the collection tubes sold under
the "Vacutainer" trade-mark by Becton, Dickinson & Company,
Rutherford, New Jersey. The collection tube 38 is snugly but
slidably supported within the support means 32 that extends
alongside body 11. Normally, the tube 38 is supported above the
-14-
2~.7~9~G
tip of spike 35 as shown in FIG. 3. After a midstream sample has
been collected within cup 20, the collection tube 38 is urged
axially downward in the direction represented by arrow 39 in FIG.
to cause the tip 36 of spike 35 to pierce the membrane of
stopper 37. Since the tube 38 is supplied in evacuated
condition, piercing of the membrane causes liquid to flow from
cup 20 into the collection tube (FIG. 5). The stopper 37 is
self-sealing, which is well known in the art; hence, upon removal
of the collection tube from the collector 10, stopper 37
automatically shields and protects the collection sample from
contamination. In this manner, the device automatically extracts
the relatively uncontaminated midstream portion, allowing the
initial and terminal portions of the stream to pass through the
device and into the toilet. Following urination, the collector
is simply placed upon a stable support surface, and the
patient, nurse or other person urges the air-evacuated collection
tube 38 axially downward to cause the collection sample to be
transferred from the cup member to the tube. Thereafter, the
device may be discarded in the water of a toilet bowl so that the
primary layers of the tubular body and the cup member, as well as
the support means and the evacuation passage means, dissolve or
disperse and the protective inner layers sufficiently
disintegrate so that the entire collector, including the short
tubular spike, may be safely flushed through the water discharge
lines of a waste water treatment system.
The embodiment of FIGS. 6-8 is substantially the same
in structure and operation as the embodiment of FIGS. 1-5 except
for the cup 20' and the cover means 26'. Cup 20' is similar to
cup 20 and includes a primary layer 24' of water-soluble material
which will dissolve or disperse when disposed in the water of a
toilet bowl and an inner protective layer 25' of water-insoluble
material which lines the interior of cup 20' and prevents fluids
contained therein from initiating dissolution of primary layer
24'. Primary layer 24' and protective layer 25' may have the
same, or a similar composition, as the primary and protective
-15-
210936
layers 24 and 25, respectively, of cup 20. It will be noted that
primary layer 24' of water-soluble material is left exposed to
the passage just like the primary layer 24 of cup 20.
Cover means 26' includes a cover plate 100 which is
composed of a first primary layer 101 of water-soluble material
which will dissolve or disperse when disposed in the water of a
toilet bowl and a thin protective layer 102 of water-insoluble
material. The cover plate extends over the mouth 103 of the cup
20' so that the water-insoluble protective layer 102 is exposed
to the flow passage, and the cover plate normally prevents fluid
falling downwardly through the passage from entering the cup.
Means are provided for urging cover plate 100 into a second
position displaced from the mouth of the cup member to collect
the midstream sample.
In the illustrations given in Figures 7 and 8, the
urging means takes the form of a spring element 104 which has one
end secured to the disk-shaped cover plate 100 and its opposite
end joined to cup 20'. The spring element exerts a force on the
cover plate tending to pivot that plate from the first or closed
position shown in FIG. 7 to the second or open position depicted
in FIG. 8. However, the action of the spring is resisted by a
water-soluble second cover portion 105 of the cover means which
is secured to both the cup and plate 100 and holds the plate in
its closed position. Cover portion 105 is formed of a film of
polyvinyl alcohol or any other non-contaminating water-soluble
polymeric material capable of dissolving within a period of about
2-15 seconds (preferably about 3-8 seconds) upon direct exposure
to urine flowing downwardly through tubular body 11. When the
water-soluble cover portion 105 dissolves, the spring element
exerts a force on the cover plate which pivots it to the second
position shown in Figure 8 which exposes the mouth of the cup
member to fluids passing through the passage. When the cover
plate 100 is in the second position, the primary water-soluble
layer 101 of the cover plate is exposed to fluid passing through
-16-
21'~093~
the tubular body and that fluid may initiate partial dissolution
of that member prior to disposal in the water of a toilet bowl.
In the embodiment shown in FIG. 6, the disk-shaped
cover plate is shifted from its first (closed) position to its
second (open) position by means of gravity. More specifically,
the cover plate 100 is normally held in position by the
connecting portion 105, thereby sealing the mouth of cup 20' as
depicted by the broken lines in FIG. 6. The connecting portion
105 is composed of the same material as a water-soluble non-
contaminating cover portion as the previous embodiments (for
example, polyvinyl alcohol), with the result that urine entering
the body of the collector will initially be deflected by the
sloping cover portion and then, as connecting portion 105
disintegrates, cover plate 100 will slide away from the mouth of
the cup 20', dropping into the lowered position shown in FIG. 6.
The relatively uncontaminated midstream portion of the flow of
urine may then enter the cup member, and the collected sample may
be transferred to an evacuated collection tube 38 in the same
manner described in connection with the prior embodiments. Since
gravity is primarily responsible for shifting the cover plate 100
into its second position, the mouth of the cup member 20' must
extend along a sloping plane having a sufficient incline to cause
the cover plate to slide out of position when the connecting
portion 105 is dissolved. In general, the angle of inclination
should be at least 30° measured from the horizontal, with angles
in the range of 45° to 60° being preferred. When the cover plate
100 is in the lowered or second position, the water-soluble
component (layer 101) of the plate is exposed to fluids passing
through the device which will initiate some dissolution of the
cover plate prior to disposal of the device in the toilet bowl.
In such a construction, an annular ring 23' may be provided
instead of stretch 23 for mounting cup member 20' within the
tubular body. Like struts 23, ring 23' is preferably formed from
a water-soluble material but includes a thin protective layer
23a' of water-insoluble material disposed upon its uppermost
-17-
. 21~0.~36
surface and facing inlet 12 for protecting the ring from
prematurely dissolving.
It has been noted that the outer surface 20a of the cup
member is formed from the water-soluble primary layer but is left
exposed to fluid passing through flow passage 14. While it is
believed that fluid flowing through the passage only randomly
contacts the outer surface for a limited period of time, it may
be desirable in some applications to provide means for protecting
the outer surface from at least the initial surge of the urine
stream. Urine deflection means may therefore be provided around
the mouth of the cup member for deflecting urine passing through
the passage away from the exposed outer surface of the cup
member.
In the embodiment illustrated in FIGS. 1-5, the urine
deflection means may take the form of collar 29 which projects
outward from cup member 20 and beyond the cup member's outer
surface 20a so that fluid passing through the passage will
impinge upon the collar and be directed outward away from the
outer surface of the cup member as most clearly illustrated in
FIG. 4 by arrow 40. Collar 29 may include a sloped surface 29b
which forms the upper-most part of the collar and which extends
along an inclined plane away from the cup member for directing
fluids flowing through the passage in an outward direction away
from the exposed outer surface of the cup member.
In the embodiments illustrated in FIGS. 6-8, the urine
deflection means may take the form of the cover plate 100 which
includes a peripheral portion 106 which extends outward from the
cup member and beyond the cup member's outer surface for
shielding the exposed outer surface of the cup member, which is
positioned below and inward from the peripheral portion of the
cover plate, from fluids flowing through the passage. While it
will be understood that the cover plate is displaced from the
mouth of the cup member in the second position, the peripheral
portion of the cover plate is still advantageous since it
deflects urine away from the outer surface of the cup member
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while in the first position and protects the outer surface of the
cup member from the initial surge of the urine stream.
While in the foregoing I 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.
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