Note: Descriptions are shown in the official language in which they were submitted.
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SELF CONTAINED URINARY CATHETER ASSEMBLY
I. TECHNICAL FIELD
This invention relates generally to catheters and more
particularly to intermittent catheter assemblies
incorporated in a dual purpose sterile receptacle.
II. BACKGROUND ART
Self contained urinary catheter assemblies are
currently available. These self contained catheters are
available with the catheter itself stowed in a flexible bag
to remain in a sterile field. An introducer is mounted on
the bag to permit the catheter to be extended from the bag
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during use and retracted into the bag again after use.
While the catheter is not extended, the introducer is
covered by a sealing cover. Since the discharge end of the
catheter always remains in the bag, the bag is sized to
serve as a urine receptacle when the catheter is inserted
through the urethra and into the bladder. These catheter
assemblies typically are intermittently used only when the
bladder needs to be drained and are removed after each use
for disposal. The catheter/introducer assembly is the
subject of Patent No. 4,652,259, dated March 24, 1987,
issued to Alexander G. B. O'Neil.
One of the problems with these prior art self
contained catheter assemblies is that it is difficult to
obtain an uncontaminated sample from the bag for testing as
is frequently required in the environment in which the
assembly is used. Another problem is that it is sometimes
difficult to grip the catheter through the bag and the
introducer to manipulate the catheter as it is being
inserted in or removed from the urethra.
III. DISCLOSURE OF INVENTION
These and other problems and disadvantages associated
with the prior art are overcome by the invention disclosed
herein by providing a self contained urinary catheter
assembly which provides a simple method of obtaining an
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uncontaminated urine sample for testing. The invention
further provides means for gripping the catheter through
the receptacle so that manipulation of the catheter with respect to the
receptacle during use is facilitated.
The apparatus of the invention includes a flexible
receptacle defining a closed chamber with a catheter
carried in the closed chamber and mounting means on the
flexible receptacle defining a catheter opening
therethrough into said closed chamber through which said
projecting end of the catheter can extend for insertion
into the bladder through the urethra. The catheter has
arresting means on one end thereof to prevent inadvertent
removal of the catheter from the receptacle but which is
constructed to release the catheter from the receptacle
when a sufficient force is exerted on the catheter so that
uncontaminated samples can be poured from the receptacle.
The mounting means is provided with a guide flange
projecting into the chamber in the receptacle and in
registration with said catheter opening. The guide flange
has an arcuate cross-sectional shape conforming generally
to a portion of the cross-sectional shape of the catheter
tube so that the projecting end of the catheter can be laid
in the guide flange to align the catheter with the catheter
opening through the mounting means. Further, gripping
means to positively engage the catheter when it is pressed
against the gripping means permits the catheter to be
selectively fixed with respect to the mounting means while
the catheter and receptacle are being manipulated.
These and other features and advantages of the
invention will become more clearly understood upon
consideration of the following description description of
the best mode for carrying out the invention and
accompanying drawings wherein like characters of reference
designate corresponding parts throughout the several views
and in which:
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IV. BRIEF DESCRIPTION OF DM INGS
Fig. 1 is a perspective view of a self contained
urinary catheter assembly embodying the invention;
Fig. 2 is an enlarged exploded view shown in quarter
section of the introducer subassembly;
Fig. 3 is an enlarged axial cross-sectional view of
the introducer portion of the assembly installed with the
protective cover in place and the catheter in its stowed
position;
Fig. 4 is an end view of the introducer assembly
showing the guide means;
Fig. 5 is an enlarged side view of the discharge end
portion of the catheter showing the weakened section
therein;
Fig. 6 is an enlarged cross-se --tional view taken along
line 6-6 in Fig. 5;
Fig. 7 is a view similar to Fig. 6 showing a second
embodiment of the weakened section in the catheter;
Fig. 8 is a view similar to Fig. 6 showing a third
embodiment of the weakened section in the catheter;
Fig. 9 is an enlarged side view, partly in cross-
section, of the discharge end portion of the catheter
showing an alternate release means; and
Figs. 10 and 11 illustrate the invention being used to
obtain an uncontaminated urine sample for testing.
These figures and the following detailed description
of the best mode for carrying out the invention disclose
specific embodiments of the invention, however, it is to be
understood that the inventive concept is not limited
thereto since it may be embodied in other forms.
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V. BEST MODE FOR CARRYING OUT THE INVENTION Referring to Fig. 1, it will be
seen that the self
contained urinary catheter assembly 10 includes a flexible receptacle 11 which
carries a catheter 12 therein. An
introducer assembly 14 maintains the catheter 12 in a
sterile field as it is stowed in the receptacle 11 and also
serves to isolate the catheter as it is inserted in the
urethra to minimize urethra and bladder infectiori induced
by the use of the catheter.
The receptacle 11 serves to stow the catheter 12 in a
sterile environment until it is used. It then serves as a
fluid reservoir into which the bladder is drained and
finally serves to again stow the catheter 12 until the
.assembly 10 can be discarded.
The receptacle 11 has a thin tubular side wall 15
which is seamed from a single sheet of transparent plastic
material. The top end of the side wall 15 is partly closed
by a pair of angled top seams 16 that angle upwardly and
inwardly in a general chevron shape. An access opening 1$
is left between the upper inner ends of the seams 16 to
mount the introducer assembly 14 therein. A bottom seam 19
closes the opposite end of the side wall 15 to form a
closed chamber 20 in the receptacle 11.
The catheter 12 includes a catheter tube 21 with an
enlarged arresting member 22 at the drainage end of the
catheter tube 21. The drainage tube 21 has a conventional
drainage passage along the length thereof which is closed
off at the rounded tip in the projecting end 24 of the tube
21 with inlet openings 25 as is conventional. The drainage
end 26 of the tube 21 is connected to the enlarged
arresting member 22. The arresting member 22 is
illustrated in Figs. 1-8 as a conventional syringe
connection.
To permit the catheter 12 to be released from the
receptacle 11, a release means is provided in the catheter
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tube 21 to permit the arresting member 22 to be removed and
allow the tube 21 to be withdrawn from the receptacle 11
and introducer assembly 14. Figs. 5-8 illustrate the
release means as a weakened section 28 in the catheter side
wall 29 adjacent the arresting member-_22 which causes the
side wall 29 to break when a force above a prescribed
threshold level pulls the arresting member and the catheter
tube apart. The threshold level of force is selected to be
substantially above that to which the side wall 29 of the
catheter 12 is subjected while the assembly 10 is in normal
use but personnel can pull on the catheter tube 21 with
enough force to cause the side wall 29 to separate at the
weakened section 28. It has been found that leaving about
25-40% of the catheter side wall 29 uncut performs
satisfactorily.
Figs. 5 and 6 illustrate the weakened section 28 being
formed with a single cut 30 in the catheter side wall 29.
For sake of clarity, the single cut weakened section has
been designated as 28SC. The uncut portion 31 of the side
wall 29 complies with the criteria set forth above. When
the technician pulls on the catheter side wall 29 lying
outside the receptacle 11, the uncut portion 31 is broken
to release the arresting member 22 from the catheter tube
21 thereby allowing it to pass out of the introducer
assembly 14 as will become more apparent.
Fig. 7 illustrates a second embodiment of the weakened
section 28 which has been designated 280C. The section 28DC
has been formed by making two cuts 34 in opposition to each
other in the side wall leaving two opposed uncut sections
35 therebetween conforming to the parameters set forth
above. The section 28DC operates similarly to that
associated with the single cut.
Fig. 8 illustrates yet another embodiment of the
weakened section which has been designated 28PC. The
section 28Pc is formed by making a peripherally extending
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cut 38 around the periphery of the catheter side wall 29 to
leave a continuous uncut section 39 adjacent the drainage
passage through the catheter tube 21. The uncut section 39
is sized to conform to the parameters set forth above.
From the above, it will be seen that pulling on the
catheter tube 21 projecting out of the introducer assembly
14 will cause a separating force across the weakened
section 28 in the tube 21 thereby causing it to separate
and release the enlarged arresting member 22 from the end
of the catheter tube 21. This allows the catheter tube 21
to pass out through the introducer assembly 14 while ,the
arresting member 22 drops within the close chamber 20 in
the receptacle 11.
The introducer assembly 14 includes generally a
mounting member 40 adapted to be mounted in the opening 18
in the flexible receptacle 11 and disposed within the
chamber 20 in the receptacle 11. The urethra penetrating
protective member 41 engages the mounting member 40 to lock
the receptacle 11 around,the mounting member 40 while at
the same time providing a penetrating isolation cover to
penetrate the distal end of the urethra during use. A
stowing cover 42 is removably mounted over the projecting
portion of the urethra penetrating protective member 41 to
cover it when it is not in use. The urethra penetrating
protective member 41 is used in accordance with the
teachings of U.S. Patent No. 4,652,259, which description
which may be referred to for further details.
The mounting member 40 comprises generally a
cylindrical bag support section 45 which fits through the
opening 18 between the top seams 16 in the receptacle and
which defines a catheter passage 46 therethrough sized to
just receive the catheter tube 21. The outside surface of
the support section 45 is provided with a locking bulge 48
that helps hold the urethra penetrating protective member
41 in place as will become more apparent. The base of the
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support section 45 is provided with a stop flange section
49 which projects outwardly therefrom and serves to arrest
the movement of the mounting member 40 out of the interior
of the chamber 20 in the receptacle 11. The flange section
49 is provided with a pair of angled orienting extensions
50 which engage the interior of the receptacle 11 along the
top seam 16 to properly orient the mounting member 40 with
respect to the receptacle 11 and provide additional support
to prevent the mounting member 40 from being pulled out of
the receptacle 11.
Mounted on and depending below the stop flange section
49 is a catheter gripping guide 51. The guide 51 is used
to guide the tip of the catheter 12 into the catheter
opening in the section 45. It is also used to assist in
gripping the catheter tube 21 to fix the catheter 12 with
respect to the mounting member 40 to facilitate the using
of the catheter 12 and to facilitate its extension from and
retraction into the chamber 20 in the receptacle 11. The
gripping guide 51 includes a flange 52 projecting below the
flange section 50 with an inside radius of curvature
corresponding generally to the outside radius of the
catheter tube 21. The arcuate flange 52 has a semi-
circular cross sectional shape so that one side of the
flange is open and provides an elongate recess into which
the projecting end 24 of the catheter 12 can be placed.
The flange 52 is oriented in registration with the catheter
passage 46 so that the projecting end 24 of the tube 21
will be guided into the passage 46. To facilitate gripping
the catheter 12 located inside the receptacle 11, a
plurality of grippers 54 are provided on the gripping guide
51 and project inwardly thereof. The grippers 54 are
designed to engage the outside surface of the catheter tube
21 as it is pressed thereagainst to help fix the catheter
tube 21 with respect to the flange 52 and thus the mounting
member 40.
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The urethra penetrating protective member 41 is made =
out of a soft material such as silicone or latex rubber.
The urethra penetrating protective member 41 includes a
cylindrical base 55 which defines a mounting counterbore 56
in one end thereof sized to fit over the cylindrical
section 45 of the mounting member 40 and be frictionally
retained thereon to hold the receptacle onto the mounting
member 40. The cylindrical base 55 is also provided with
catheter passage 58 corresponding in size to the catheter
passage 46 in the mounting member 40 so that the catheter
tube 21 can also pass through the catheter passage 58.
,. .
That end of the cylindrical base 55 opposite the
counterbore 56 mounts a penetrating cover 59 which projects
out from the mounting member 40 when the protective member
41 is in place. The projecting end of the penetrating
cover 59 is cross cut as indicated at 60 so that the
penetrating cover 59 can extend beyond the periurethral
area in the urethra so as to bypass the area with the high
bacterial count during use. As explained in Patent No.
4,652,259, this allows the projecting end 24 of the
catheter tube 21 to pass beyond the periurethral area and
thus reduce the. bacterial infection associated with the use
of the catheter. An annular holding flange 61 is provided
around the base of the penetrating cover 59 at the
cylindrical base 55 which purpose is to arrest the movement
into the urethra and to hold the stowing cover 42 in place
as will become more apparent.
The, stowing cover 42 comprises generally an annular
mounting flange 62 which has a diameter large enough to
extend over the annular holding flange 61 on the protective
member 41 and is provided with an inwardly directed annular
lip 64 which extends under the holding flange 61 to hold
the stowing cover 42 in place over the end of the
protective member 41. An enclosure dome 65 is provided on
the mounting flange 62 which projects out and over the
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projecting end of the penetrating cover 59 to enclose it.
Thus, when the stowing cover 42 is in place, a sterile
field is defined completely around the catheter 12 and the
penetrating cover 59 on the urethra penetrating member 41
to provide a sterile field to which the patient is exposed.
As best seen in Fig. 1, the self contained urinary
catheter assembly 10 comes assembled with the stowing cover
42 in place on the introducer assembly 14 and with the
catheter 12 stowed in the chamber 20 on the flexible
receptacle 11. The user removes the stowing cover 42 and
uses the assembly 10 in conventional manner to drain the
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user's bladder. After using the assembly 10, the catheter
12 can again be stowed in the chamber 20 and the stowing
cover 42 replaced on the introducer assembly 14 to again
close the chamber 20. The user can then dispose of the
entire unit.
Where it is desirable to take an uncontaminated sample
of the urine drained, the technician extends the catheter
tube 21 and pulls on the catheter tube externally of the
introducer assembly 14 so as to pull the enlarged arresting
member 22 up against the bottom of the mounting member 40
as seen in Fig. 10. By continuing to pull on the catheter
tube 21, the catheter tube 21 breaks at the weakened
section 28 to release the catheter tube 21 from the
passages 46 and 58 in the introducer assembly 14. The
technician then removes the urethra penetrating protective
member 41 from the mounting member 40 as seen in Fig. 10.
The technician can then simply pour a urine sample for
testing out through the mounting member 40 as seen in Fig.
11. Since this sample is not exposed to any external
contamination, the sample obtained is an uncontaminated
sample for testing.
The release means described above is directed to
weakened section 28 being formed in the catheter tube 21.
It will be understood that different type release means
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could be used. For instance, making an enlarged section
122 in the drainage end 126 of the catheter 112 seen in
Fig. 9 will allow the enlarged section 122 to stop the
catheter tube 121 from being pulled out of the *mounting
member 40 during normal usage. The enlarged member 122 is
made out of a material and sized such that, when the
threshold force is exceeded, the arresting member 122 will
collapse and allow the end of the catheter 112 to pass out
through the passage 46 in the mounting member 40.
