U.S. patent number 3,699,964 [Application Number 05/101,976] was granted by the patent office on 1972-10-24 for closed urinary drainage and irrigation system.
This patent grant is currently assigned to C.R. Bard Inc.. Invention is credited to Richard E. Ericson.
United States Patent |
3,699,964 |
Ericson |
October 24, 1972 |
CLOSED URINARY DRAINAGE AND IRRIGATION SYSTEM
Abstract
A closed system, disposable, urinary drainage and irrigation
system having the following improvements: 1. a flexible drainage
tube of increased internal diameter, which is larger than the
maximum internal diameter at which a continuous column of urine
will form in the tube when urine flows therethrough by gravity from
the bladder, to thereby prevent microorganisms from ascending the
tube to the bladder; 2. a circumferential slit extending part way
around the circumference of the drainage tube located over the
shank of the catheter adapter to provide a unique type irrigation
valve for alternately irrigating the bladder and draining the
bladder through the drainage tube into a drainage bag in which the
urine is collected without disconnecting and reconnecting the
drainage tube from the catheter adapter shaft and without the
necessity of clamping off the drainage tube between the valve and
the bag; 3. a one way ball valve and housing therefor at the end of
the drainage tube located within the drainage bag to prevent reflux
while permitting free flow of urine through the drainage tube into
the bag; 4. a protective cap over the end of the draw off tube for
drawing urine from the drainage bag, such cap being effective to
protect the end of the draw off tube from contact with contaminated
objects; and 5. a disposable, plastic syringe in which the sterile
irrigating fluid is prepackaged and which is particularly adapted
to be used with the aforesaid irrigation valve to permit irrigation
without leakage.
Inventors: |
Ericson; Richard E. (Keene,
NH) |
Assignee: |
C.R. Bard Inc. (Murray Hill,
NJ)
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Family
ID: |
25666470 |
Appl.
No.: |
05/101,976 |
Filed: |
December 28, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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793403 |
Jan 23, 1969 |
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Foreign Application Priority Data
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Jul 2, 1970 [CA] |
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087040 |
Jul 3, 1970 [GB] |
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32,372/70 |
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Current U.S.
Class: |
604/33; 128/912;
604/323; 604/326; D24/118; 604/37; 604/325 |
Current CPC
Class: |
A61M
39/02 (20130101); A61F 5/44 (20130101); Y10S
128/912 (20130101) |
Current International
Class: |
A61F
5/44 (20060101); A61M 39/02 (20060101); A61f
005/44 () |
Field of
Search: |
;128/214,227,275-278,294-295 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Argyle" Catalogue, A.S. Aloe Co. rec'd 1960.
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Primary Examiner: Rosenbaum; Charles F.
Parent Case Text
CROSS REFERENCES TO RELATED APPLICATIONS
This application is a continuation-in-part of my co-pending
application Ser. No. 793,403 filed Jan. 23, 1969 now abandoned.
Claims
I claim:
1. In a system for draining and irrigating a body cavity, tubing
for transporting fluids from said body cavity, said tubing having
an entry in the side thereof and comprising a distal portion
extending in one direction from said entry and a proximal portion
extending in an opposite direction from said entry, closure means
for said entry, said closure means being movable to alternately
expose said entry for irrigation and close said entry for said
transporting of said fluids, said entry being positioned so that
when it is exposed, the tip of an irrigating source may be inserted
thereinto to force fluid from the irrigating means through said
proximal portion to said body cavity without leakage while at the
same time cutting off communication between said distal and
proximal portions, said entry comprising a circumferential slit in
said tubing extending around part of the circumference thereof, the
unslit part of said circumference comprising a hinge about which
the slit ends of said tubing can be swung away from each other so
that said tip can be inserted in the slit end adjacent said
proximal portion in a liquid tight manner whereby communication is
cut off between said slit ends, said closure means normally holding
said slit ends against said swinging movement and in a manner to
permit flow of fluid through said slit portion of said tubing
without leakage.
2. In a system for transporting fluids in the medical and surgical
fields, tubing having a slit extending peripherally around a
substantial part of the periphery thereof, the slit ends being
movable away from each other to expose the interior of said tubing
and means for normally preventing said slit ends from substantial
movement away from each other but operable to permit said
movement.
3. In a system for transporting fluids in the medical and surgical
fields, tubing having a slit extending peripherally around a
substantial part of the periphery thereof and means for normally
preventing said slit ends from substantial movement away from each
other but operable to provide for said movement, the unslit portion
of said circumference forming a flexible and resilient hinge about
which the slit ends of said tubing can be swung away from and
toward each other, said preventing means comprising a protective
member normally located over said slit portion of said tubing to
hold said slit ends against said swinging movement and movable
along said tubing to expose said slit for said swinging
movement.
4. In a system for transporting fluids in the medical and surgical
fields, a tubing having a slit extending circumferentially around a
substantial part of the circumference thereof, the unslit portion
of said circumference forming a flexible and resilient hinge about
which the slit ends of said tubing can be swung away from and
toward each other, a relatively rigid tubular member, at least an
end portion of which fits snugly within said slit portion of said
tubing with the slit located at a distance from the end of said
member so that the slit end of said tubing extending beyond said
end of said member can be swung about said hinge off said end of
said member to expose said end, and a protective sleeve fitted over
said slit portion of said tubing and slidable along the outside of
said tubing to expose the slit for said swinging motion.
5. In a system according to claim 4, said slit extending
circumferentially at an angle of less than 90.degree. to the
longitudinal center line of said tubing.
6. A system according to claim 5, said angle being about
45.degree..
7. In a system according to claim 4, said tubular member having
means for holding said sleeve over said slit against accidental
sliding movement which will expose said slit.
8. In a system according to claim 7, said holding means comprising
an annular skirt extending from the periphery of said member to
form an annular recess for snugly receiving an end of said sleeve
to hold it over said slit.
9. In a system according to claim 4, said system being a urinary
drainage and irrigation system, said tube being a urinary drainage
tube, said member being the shank of a catheter adapter.
10. A system according to claim 9, said end of said shank when
exposed by said swinging movement being adapted to receive the tip
of an irrigation source in a substantially fluid-tight manner to
provide communication between said irrigation source and said
adapter and cut off communication between said adapter and the
distal portion of said tube beyond said slit.
11. A system according to claim 10, said tubing being attached to a
urinary drainage bag.
12. A system according to claim 11, said system being a closed
system, said bag being a disposable, flexible and collapsible
plastic bag to which said drainage tube is sealed.
13. A system according to claim 10, including said irrigating
source, said irrigating source being a syringe having an externally
tapered tip which is dimensioned to engage said exposed end of said
shank when inserted therein to form a seal therewith during
irrigation.
14. A system according to claim 13, said syringe comprising a
bottle made of a flexible, resilient and autoclavable plastic in
which sterilized irrigating fluid is prepackaged, said tapered tip
comprising a neck extending from the top of said bottle, said
bottle having a cap adapted to be normally secured over said tip in
sealing relationship therewith to seal said bottle.
15. A system according to claim 4, said system being a urinary
drainage system, said tube being a urinary drainage tube, the
inside diameter of said tube being greater than the maximum
diameter at which a continuous column of said fluid will form in
said tube.
16. A system according to claim 15, said inside diameter being
greater than nine thirty-seconds inch.
17. A system according to claim 4, said system being a urinary
drainage system and said tube being a urinary drainage tube, an end
of said drainage tube extending into a drainage bag, said end of
said drainage tube being provided with a one way ball valve
comprising an elongated housing, one end of which is secured to
said end of said drainage tube and has a valve seat and the other
end of which is provided with a stop, said housing having an
opening therein, a ball in said housing adapted to roll
longitudinally therein between a close position, in which it
engages said valve seat to close communication between the bag and
tube and to which it moves in response to commencement of fluid
flow from said bag into said housing, and an open position in which
it engages said stop at said other end of said housing to permit
flow of fluid from said tubing into said housing through said valve
seat and thence through said opening into said bag and to which it
is moved in response to flow of fluid from said tube to said valve
seat.
18. A system according to claim 17, the free cross-sectional areas
of said opening and said valve seat being greater than the maximum
cross-sectional area of said tube at which a continuous column of
said fluid will form in said tube during flow of said fluid through
said tube.
19. A system according to claim 4, said system being a urinary
drainage system, said tube being a urinary drainage tube, an end of
said drainage tubing extending into a drainage bag, said bag having
draw-off-tubing means for drawing fluid from said bag, the free end
of said draw-off-tubing means having a protective cap secured
thereto, said protective cap having a housing which extends around
and beyond the end of said draw-off-tubing means and which has an
internal diameter greater than the outer diameter of said
draw-off-tubing means, whereby the inner surface of said housing is
radially and outwardly spaced from the outer surface of said end of
said draw-off-tubing means to thereby prevent said end of said
draw-off-tubing means from coming into contact with contaminated
objects.
20. A system according to claim 19, said end of said
draw-off-tubing means being adapted to be snugly but slidably
received in an end of a relatively rigid stabilizing tube extending
along the top portion of said bag with the end of said stabilizer
tube being received in an annular recess between said end of said
draw-off-tubing means and said housing.
21. A system according to claim 12, the inside diameter of said
drainage tube being greater than the maximum diameter at which a
continuous column of said fluid will form in said tube, an end of
said drainage tube extending into said drainage bag, said end of
said drainage tube being provided with a one way ball valve
comprising an elongated housing, one end of which is secured to
said end of said drainage tube and has a valve seat and the other
end of which is provided with a stop, said housing having a
longitudinal slot therein, a ball in said housing adapted to roll
longitudinally therein between a closed position, in which it
engages said valve seat to close communication between the bag and
tube and to which it moves in response to commencement of fluid
flow from said bag into said housing, and an open position in which
it engages said stop at said other end of said housing to permit
flow of fluid from said tube into said housing through said valve
seat and thence through said slot into said bag and to which it is
moved in response to flow of fluid from said tube to said valve
seat, the free cross-sectional areas of said slot and said valve
seat being at least as large as the inside cross-sectional area of
said drainage tubing.
22. A system according to claim 21, said bag having draw-off-tubing
means for drawing fluid from said bag, the free end of said
draw-off-tubing means having a protective cap secured thereto, said
protective cap having a housing which extends around and beyond the
end of said draw-off-tubing means and which has an internal
diameter greater than the outer diameter of said draw-off-tubing
means, whereby the inner surface of said housing is radially and
outwardly spaced from the outer surface of said end of said
draw-off-tubing means to thereby prevent said end of said
draw-off-tubing means from coming into contact with contaminated
objects.
23. A system according to claim 22, said end of said
draw-off-tubing means being adapted to be snugly but slidably
received in an end of a relatively rigid stabilizing tube extending
along the top portion of said bag with the end of said stabilizer
tube being snugly received in an annular recess between said end of
said draw-off-tubing means and said housing.
24. In a system for draining fluids from a body cavity including a
drainage tube for transporting said fluids, the improvement
comprising increasing the internal diameter of said tube to a size
at which said fluid flows freely through said tube without forming
a continuous column of said fluid in said tube, said system being a
urinary drainage system and said tube being a urinary drainage
tube, an end of which is provided with a catheter adapter, said
body fluid being urinary fluid and said tube having an internal
diameter greater than the maximum internal diameter at which a
continuous column of said urinary fluid will form in said tube
during flow of said urinary fluid through said tube and from said
catheter adapter by gravity, said drainage tube being of a flexible
plastic, the other end of said drainage tube extending into a
closed system plastic drainage bag, said other end of said tube
being provided with a one way check valve comprising a housing one
end of which is attached to said other end of said drainage tube
and has a valve seat and the other end of which is provided with a
stop, said housing having an opening and a ball located therein
adapted to roll freely between a closed position at said one end of
said housing, in which it engages said valve seat to seal the tube
from the bag, and an open position at said other end of the housing
in which it engages said stop and in which fluid can flow from said
tube into said housing through said valve seat and thence through
said opening into the bag, said ball being responsive to the
commencement of flow of fluid from said bag into said housing to
roll to said closed position to shut off said flow and being
responsive to said flow of fluid in said tube to said valve seat to
roll to said open position to thereby provide for free flow of
fluid from said tube into said bag.
25. A system according to claim 24, the cross-sectional areas of
said housing opening and the valve opening defined by said valve
seat and the housing being at least as great as the cross-sectional
area of said drainage tube.
26. A system according to claim 25, the diameter of said ball being
substantially smaller than the inner diameter of said housing.
27. In a urinary drainage system having a drainage tubing with an
end extending within a drainage bag, a one way ball valve located
at said end of said tubing to permit free flow of fluid from the
tubing into the bag but to prevent any substantial reflux flow from
the bag back through the tubing, said valve comprising a hollow
housing, one end portion of which is secured to said end of said
tubing and has a valve seat and the other end portion of which is
provided with a stop, said housing having an opening therein, a
ball in said housing adapted to roll therein between a close
position in which it engages said valve seat to close communication
between the bag and tubing and to which it moves in response to
commencement of fluid flow from said bag into said housing, and an
open position in which it engages said stop to permit free flow of
fluid from said tubing into said housing and through said opening
into said bag and to which it is moved in response to fluid flow
from said tubing to said valve seat, the diameter of said ball
being substantially smaller than the internal diameter of said
housing so as not to interfere with flow of fluid through said
housing and opening, said ball having a specific gravity
substantially greater than said fluid and being substantially inert
to said fluid.
28. In a urinary drainage system according to claim 27, said one
end portion of said housing extending into a reduced diameter
portion to which said tubing is secured, said opening comprising an
elongated slot extending longitudinally of said housing.
29. In a urinary drainage system according to claim 28, said valve
seat being formed by the intersection of said reduced diameter
portion and said housing.
30. A bag according to claim 27, having longitudinal internal ribs
for guiding said rolling movement of said ball and for reducing
friction between said ball and housing.
31. A bag according to claim 27, having a plurality of said
openings, each opening comprising a slot which is elongated and
which extends longitudinally of said housing, said stop comprising
a closed end of said housing, said housing being of plastic and
said ball being a stainless steel ball.
32. In a urinary drainage system having drainage tubing for
transport of fluid, a bag for collection of said fluid from said
drainage tubing and draw-off-tubing means for removing fluid from
said bag, the free end of said draw-off-tubing means having a
protective cap secured thereto, said protective cap comprising a
housing which extends around and beyond said end of said
draw-off-tubing means and which has an internal diameter
substantially greater than the outer diameter of said
draw-off-tubing means, whereby the internal walls of said housing
are spaced radially and outwardly from the external wall of said
end of said draw-off-tubing means received in said housing, whereby
said end of said draw-off tubing means is protected by said cap
from contamination by contact with contaminated objects.
33. In a system according to claim 32, said bag being flexible and
having a tubular member which is more rigid than said bag, which is
affixed to said bag and an end of which is adapted to snugly but
removably receive said end of said draw-off-tubing means, the
external diameter of said draw-off-tubing means cooperating with
the internal diameter of said end of said tubular member so that
when said end of said draw-off-tubing means is received in said end
of said tubular member, said end of said tubular member is snugly
received between the outer surface of said end of said
draw-off-tubing means and the inner surface of said housing.
34. In a system according to claim 33, said housing having a
reduced diameter end portion adapted to snugly receive said
draw-off-tubing means with said end thereof extending into said
enlarged housing.
35. In a system according to claim 33, the external wall of said
end of said draw-off-tubing means being tapered to provide a snug
sealing fit with the internal surface of said end of said tubular
member.
36. In a system according to claim 33, said bag being a disposable
plastic urinary drainage bag, said tubular member being a
relatively rigid tube located laterally along the upper portion of
said bag to stabilize the bag.
37. In a system according to claim 32, said draw-off-tubing means
comprising a main flexible portion extending from and sealed to
said bag and a tip portion, which is integral with said cap but
separate from said main portion, said tip portion comprising said
end of said draw-off-tubing means which is spaced radially inwardly
from the inner surface of said housing.
38. In a system according to claim 32, said draw-off-tubing means
being a soft plastic tube and said cap being a plastic cap, which
has a greater rigidity than said draw-off-tubing means, said
housing having an end portion of reduced internal diameter for
snugly receiving the end of said main portion.
39. A system according to claim 32, said urinary drainage tubing
being larger in internal diameter than said draw-off-tubing
means.
40. A system according to claim 32, said urinary drainage tube
having an internal diameter greater than the maximum diameter at
which a continuous column of fluid will form in said drainage
tubing.
41. A system according to claim 32, an end of said drainage tube
being located in said bag, said end of said drainage tube having a
one way ball valve attached thereto comprising a housing at one end
of which is formed a valve seat and at the other end of which is
formed a stop and a ball located in said housing and adapted to
roll between a close position at said one end of said ball housing
in which it engages said valve seat to seal the drainage tube from
the bag and an open position at the other end of the ball housing
in which it engages said stop and in which fluid can flow freely
from the drainage tube into the housing and thence into the bag.
Description
These improvements are particularly applicable to the closed
urinary drainage and irrigation system disclosed and shown in my
copending U.S. patent application Ser. No. 669,183, filed Sept. 20,
1967, now U.S. Pat. No. 3,478,743, Nov. 18, 1969.
SUMMARY OF THE INVENTION
The invention relates to the aforesaid improvements in drainage and
irrigation systems, all designed to reduce the danger of retrograde
infection of the urinary tract and bladder and some of which are
also designed to facilitate alternating irrigation and drainage
without leakage and with minimum chance of contamination.
A serious problem in urinary drainage, which involves draining the
urine from the bladder into a urine collection bag or other
container through a catheter and drainage tube attached by an
adapter to the catheter, is the ascent of microorganisms from the
bag up the drainage tube to the urethra and bladder. It has been
discovered that one reason for this is because the urine often
forms a continuous liquid column in the drainage tube up which the
microorganisms can ascend to the catheter by swimming up the column
or by being carried up the column by air bubbles.
Accordingly, a primary object of the present invention is the
solution of this problem by eliminating the aforesaid ascent of the
microorganisms.
This is achieved in accordance with the present invention by
enlarging the internal diameter of the drainage tube, to a diameter
which is greater than the maximum diameter at which a continuous
column of urine can be formed during urine flow in the tube by
gravity from the catheter.
Furthermore, by eliminating the formation of a continuous column of
urine in the drainage tube, the gravity flow of the urine can be
readily observed through the transparent or translucent plastic
tube to better observe patient output.
Also, the formation of a continuous column of liquid in the
drainage tubing presents problems in making accurate periodic urine
output determinations with conventional drainage tubing, because it
is impossible to determine at any time that a measurement is taken
how much of the urine is being held up in the drainage tube. The
enlarged internal diameter drainage tubing of the present invention
eliminates this disadvantage.
The inside diameter of standard drainage tubing is between six
thirty-seconds inch and nine thirty-seconds inch. The internal
diameter of the drainage tube of the present invention is
substantially greater than nine thirty-seconds inch and is
preferably between eleven thirty-seconds inch and twelve
thirty-seconds inch, the most preferred dimension being eleven
thirty-seconds inch.
This aspect of the invention is based upon the recognition that if
the internal diameter of the tubing is increased sufficiently, a
point will be reached at which the formation of a liquid meniscus,
which involves a surface tension phenomenon, is eliminated. Such a
meniscus is formed by molecules of the liquid forming a bridge
between the drainage tube walls. It is this meniscus which results
in the formation of a continuous urine column in standard drainage
tubing. If the opposite walls of the tubing are sufficiently far
apart, cannot be formed at the normal flow rate of the urine by
gravity through the catheter and adapter a meniscus cannot be
formed. Accordingly, a continuous urine column cannot be
formed.
Further advantages are achieved by making the plastic drainage tube
highly flexible. To achieve this, the plastic is made softer and
thicker (greater wall thickness) than in conventional drainage
tubes. A preferred plastic is a highly plasticized
polyvinylchloride, e.g., plasticized with a phthalate plasticizer.
Preferably, the plastic has a softness falling within the
Durometer-Shore A range, a preferred softness being between 60 and
70 Durometer-Shore A, and the thickness of the wall of the drainage
tube is substantially greater than 0.040 inch, for example 0.055
inch. The thickness of the wall of standard drainage tubes is
between 0.030 inch and 0.040 inch.
This increased softness and increased wall thickness of the
drainage tube permits it to take sharp bends without occlusions,
which are apt to prevent drainage or to cause the formation of a
continuous column of urine even with the larger internal diameter
drainage tubing.
Another problem with closed drainage and irrigation systems is that
in order to connect the irrigation source with the in-dwelling
catheter to alternately introduce irrigation liquid into the
bladder, it is necessary to disconnect the end of the drainage
tube, i.e., the catheter adapter, from the in-dwelling catheter.
Upon disconnection of the drainage tube from the catheter, it is
difficult for the nurse or doctor to continue to hold it while
irrigating. Consequently, it is usually placed upon the bed or upon
a table and, in many cases, becomes contaminated. Furthermore, it
is apt to fall on the floor to further increase the chances of
contamination. Also, in disconnecting and reconnecting the drainage
tube with the in-dwelling catheter, the fingers are very apt to
come in contact with the end of the drainage tube or with the open
end of the catheter funnel with resulting contamination. When it is
remembered that during irrigation, this disconnection and
reconnection is repeated alternately a number of times, it will be
realized that the chances of contamination are extremely great.
In an attempt to overcome these very serious disadvantages of the
aforesaid conventional disconnect-reconnect arrangement, in my
aforesaid copending application, I propose a catheter with a branch
having a valve in it, which normally closes the branch during
drainage but which can be forced open by inserting the tip of an
irrigation syringe or of an irrigation adapter connected to an
irrigation bottle by tubing. Although this avoids many of the
disadvantages of a disconnect-reconnect arrangement, it has further
disadvantages as follows:
1. in order for the insertion of the tip of the syringe or adapter
to open the branch valve while, at the same time, forming a seal
with the branch to prevent leakage, a specially designed tip must
be used. Accordingly, this construction cannot be used with the
many different commercially available tip designs, which is
essential as a practical matter;
2. when the irrigation tip is inserted into the branch to open the
valve, it tends to push contaminants, which accumulate at the
valve, into the catheter and eventually into the urethra and
bladder with danger of infection; upon repeated irrigations, the
build up of contaminants on the inside and the outside of the valve
increases with consequent increased chance of infection, due to the
lack of any self cleaning of these areas; furthermore, with such a
construction, there are undercut pockets and recesses in which
contaminants can easily collect; this is a disadvantage with any
kind of valved irrigation branch;
3. the cross-sectional area of the portal entry is restricted by
the valve construction so that blood clots and debris from the
bladder and urethra are apt to plug the valve; even if they do not
plug the valve, they are a source of contamination and interfere
with good and proper irrigation;
4. the branch and valve contained therein add to the bulk,
unbalance and instability of the catheter and drainage tube
assembly and are apt to dig into the patient when he rolls over,
all of which add to the discomfort of the patient;
5. with a valved branch or side arm, the drainage tube must be shut
off during irrigation to prevent the irrigating fluid from flowing
through the drainage tube into the drainage bag; this must be done
by clamping the drainage tube; however, most hospitals will not
approve of clamping the drainage tube in this manner because of the
danger that the nurse might forget to unclamp the tube after the
irrigation step is terminated and drainage is commenced; although
this can be avoided by the use of complex one-way check valves,
these are so complicated they are impractical;
6. it is not possible to take a urine specimen directly from the
catheter without disconnecting the drainage tube from the
catheter.
Accordingly, it is another object of the present invention to
provide a combined drainage and irrigating system in which the
aforesaid disadvantages of a connect-disconnect arrangement and a
valved branch are avoided.
This is achieved in accordance with the invention by providing a
normally closed entry in the side of the drainage tube into which
the syringe tip or irrigation adapter can be inserted to thereby
provide communication between the irrigation source and the
catheter while shutting off communication between the catheter and
the drainage bag without disconnecting the drainage tube from the
catheter. It is achieved in accordance with a preferred embodiment
of the invention by providing a circumferential slit extending part
way around the circumference of the drainage tube located over the
shank of the catheter adapter with the unslit portion of such
circumference acting as a flexible hinge about which the slit end
of the tube can be flexed off the open end of the adapter shaft to
expose it for irrigation by inserting into it the externally
tapered tip of an irrigation syringe or an externally tapered
irrigation adapter connected to a source of irrigating fluid. A
sleeve is provided over the slit portion of the drainage tube to
prevent accidental opening of the slit and also to protect against
contamination of the slit.
The catheter adapter is preferably made of a material, preferably
plastic, which has greater resilience and flexibility and is less
brittle than conventional plastic catheter adapters so that when
the externally tapered irrigation syringe tip or externally tapered
irrigation adapter is inserted into the open end of the adapter
shank and into engagement with such open end an excellent seal is
formed between such open end and the tip or irrigation adapter
without danger of cracking the catheter adapter with most tips and
adapters of conventional design.
After irrigation, it is necessary only to flex the slit end of the
drainage tubing about the aforesaid flexible hinge and back over
the open end of the catheter adapter shaft followed by sliding the
protective sleeve in place over the slit portion of the tube.
During irrigation, the slit end of the tube which has been removed
from over the catheter adapter shank is held in place by the hinge
portion to thereby reduce the danger of contamination thereof, as
compared to the aforesaid connect-disconnect arrangement.
With this kind of an arrangement the dangers of touching either the
slit end of the sleeve which is flexed off the catheter adapter
shank or the open end of the catheter adapter shank are greatly
reduced.
Furthermore, this arrangement provides a self cleaning effect, as
compared to a valved irrigation branch, in that any contaminants
which might accumulate on the aforesaid slit end of the tube or at
the aforesaid open end of the catheter adapter shank during
irrigation will be washed down the enlarged drainage tube into the
drainage bag after the slit end of the tube has been again flexed
back onto the catheter adapter shank and drainage is commenced.
Because when the irrigation tip or adapter is introduced into the
exposed end of the catheter adapter shank the drainage tube is cut
off from communication with either the source of irrigating fluid
or the catheter, it is not necessary to clamp the drainage tube
during irrigation, as is true with the use of a valved irrigation
branch.
Furthermore, this slit tube arrangement is ultra simple,
inexpensive, fool-proof and avoids the necessity of a bulky and
uncomfortable valved irrigation branch.
Another problem which presents itself with these types of drainage
systems is the danger of reflux of urine from the collection bag
back through the drainage tube to the urethra. In the past it has
been attempted to avoid this by applying to the end of the drainage
tube which extends into the drainage bag a flutter valve made up of
two flat pieces of flexible material, which are normally collapsed
against each other to prevent flow of fluid into the tube but which
are forced apart by the flow of urine from the catheter through the
tube into the bag. Although this flutter type valve is effective to
prevent reflux, the pressure necessary to open it is usually such
that it sometimes tends to support a column of urine.
Accordingly, it is yet another object of the present invention to
provide an improved valve arrangement at the end of the drainage
tube within the drainage bag which does not have the aforesaid
characteristic of a flutter valve.
This is achieved by means of a ball valve made up of (a) a housing,
one end of which is secured to the end of the drainage tube and has
a valve seat and the other end of which is provided with a stop and
(b) a ball which is adapted to roll freely within the housing to a
closed position against the valve seat and to an open position
against the stop. The ball is instantaneously moved to the closed
position at the commencement of any flow from the bag into the
housing to instantaneously seat on the valve seat and thereby
prevent reflux of urine into the drainage tube. Furthermore, the
ball is instantaneously responsive to any tilting of the bag to
close the valve seat. On the other hand, it is highly responsive to
even a very slight flow of urine in the drainage tube to the valve
seat to instantaneously roll to its open position against the
aforesaid stop to allow free flow of the urine through the housing
into the bag without any build up of a urine column in the drainage
tube.
By making the minimum open cross-sectional flow area into, through
and out of the housing greater than the maximum cross-sectional
area of the drainage tubing at which a continuous column of urine
is formed in the tubing, this insures against the build up of such
a column due to restriction of urine flow.
Since the housing is made of a plastic which is substantially more
rigid than the bag, it effectively prevents the bag panels from
sticking together at the exit end of the drainage tube to thereby
impede the flow of urine from the drainage tube into the bag, which
may also be a cause of build up of a continuous liquid column in
the drainage tube.
Furthermore, the housing prevents the inner surfaces of the bag
panels, if contaminated, from coming in contact with the end of the
enlarged drainage tube.
Preferably, a plurality of slots are provided in the housing for
flow between the housing and bag and they are elongated and extend
in the longitudinal direction of the housing. In this way, free
flow is insured. Furthermore, the ball must be of a material which
has a greater specific gravity than the urine and which is
resistant to attack by urine, a preferred material being stainless
steel. This is to prevent the ball from floating in urine inside
the housing and from corroding.
Another problem which, in some instances, has presented itself with
the closed drainage system disclosed in my aforesaid copending
patent application is the contamination of the end of the draw-off
tubing for drawing urine out of the bag. Such draw-off tubing, as
well as the draw-off tubing of conventional urinary drainage
systems, is apt to become contaminated by contact with the fingers
or with contaminated objects in the room.
Accordingly, it is yet another object of the present invention to
overcome this problem.
This is achieved by providing a protective cap over and around the
end of the draw-off tubing. The cap comprises a housing into which
the end of the draw-off tubing extends but which extends axially
beyond such end of the draw-off tubing with the inner surface of
the housing around the end of the draw-off tubing being
substantially larger in radius than the outer surface of the end of
the draw-off tubing, whereby the inner surface of the housing is
spaced radially and outwardly from the outer surface of the end of
the draw-off tubing located within the housing. In this way, the
housing at all times protects the end of the draw-off tubing to
prevent it from becoming contaminated.
Furthermore, when this cap is used with the closed drainage system
disclosed in my aforesaid copending application, which has a
relatively rigid stabilizing tube extending along the top of the
bag, it has the further advantage that when the end of the draw-off
tubing is inserted into an open end of the stabilizing tube when
the tubing is not being used, as described in the aforesaid such
end of the stabilizing tube is received within the housing between
the housing wall and the end of the draw-off tubing to provide a
seal between the stabilizing tube and the draw-off tubing.
Preferably, the protective cap is provided with an integral
internal hollow tubular section, which is an extension of and
functionally forms the end portion of the draw-off tubing and it is
this end portion which is located within the housing and is spaced
radially and inwardly from the housing wall, as aforesaid.
Preferably, the external surface of the aforesaid tubular section
is tapered to facilitate insertion thereof into the end of the
stabilizing tube and to provide a tight sealing fit between such
section and the stabilizing tube. The protective cap insures
against the clamp on the draw-off tubing accidentally sliding off
the end thereof.
Conventionally, irrigation with an irrigation syringe is carried
out with the use of the irrigating syringe, a basin and a bottle
containing the irrigating fluid. The irrigating fluid is poured
into the basin and is aspirated into the bulb or piston type
syringe followed by irrigation of the patient. This technique has
the serious disadvantages that it is time consuming, it involves a
number of manipulations and it is subject to a number of errors. In
pouring the irrigating fluid from the bottle into the basin and in
aspirating it from the basin into the syringe, there are multiple
opportunities for contamination.
Accordingly, it is yet another object of the invention to provide
an irrigating syringe and technique which will avoid these
disadvantages.
This is achieved in accordance with the present invention by
providing a prepackaged, plastic irrigating syringe, containing the
sterile irrigating fluid, such as a saline solution, prepackaged
and sealed therein. Thus, the syringe functions not only as a bulb
type syringe but also as a package for the irrigating fluid. This
syringe is made of a heat resistant, compressible, flexible,
transparent or translucent, resilient, plastic material having a
low rate of moisture vapor transmission, which is highly resistant
to autoclaving conditions, particularly, heat and hot steam, and
which has a reduced neck extending axially from an end thereof into
an externally tapered elongated syringe tip. The tip has a cap
removably secured thereover and therearound with a sealing surface
of the cap urged against a complimentary sealing surface of the tip
to seal the syringe. After the cap has been removed and the tip has
been inserted into the exposed open end of the catheter shank, as
aforesaid, the fluid can be forced out of the bottle by squeezing
and compressing the side walls, aspiration into and out of the
bladder being achieved by alternate and repetitive compression and
release.
Preferably, the bottle is made of a copolymer of a major proportion
of propylene and a minor proportion of ethylene and is of a size
which will fit in the palm of the hand with the preferred maximum
and minimum wall thickness, exclusive of the tip, being 0.035 inch
and 0.020 inch, respectively.
The use of this prepackaged syringe reduces to a minimum the danger
of contamination and the number of procedural steps required for
irrigation. Also, the syringe is disposable so that once it is
emptied, it is discarded with no danger of contamination due to
repeated use.
Preferably, the bottle-syringe has a relatively flat or equivalent
bottom so that it can be placed upright on a supporting surface
without danger of spillage or tip contamination. Preferably, it is
in the form of a cylinder with the tip extending from one end of
the cylinder.
Further advantages and features of the invention will be apparent
from the following description and accompanying drawings describing
and showing preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
In the drawings:
FIG. 1 is a view in elevation of a closed urinary drainage and
irrigation system embodying the improvements of the invention and
showing the draw-off tubing in full lines when urine is not being
drawn from the drainage bag (this is the normal position of the
draw-off tubing) and in broken lines during draw off;
FIG. 2 is a section taken along the line 2--2 of FIG. 1;
FIG. 3 is a section taken along the line 3--3 of FIG. 1;
FIG. 4 is an enlarged view in perspective with portions cut away of
the catheter adapter and the end portion of the urinary drainage
tube secured thereto of the system of FIG. 1, showing the
irrigation slit for alternate irrigation and drainage and with the
protective sleeve located over the irrigation slit to protect the
slit and to prevent it from being opened;
FIG. 5 is a non-sectional view like FIG. 4 but with the protective
sleeve slid back on the drainage tube to expose the irrigation
slit;
FIG. 5A is a view like FIG. 5 in which the irrigation slit lies in
a plane at an angle of about 45.degree. to the longitudinal center
line of the drainage tube rather than in a plane 90.degree. to such
center line as in FIG. 5.
FIG. 6 is a view in perspective of the irrigation arrangement of
FIGS. 4 and 5 with the protective sleeve slid off from the slit in
the drainage tube to expose it and with the slit end of the
drainage tube swung off from the open end of the catheter adapter
shank to expose such open end for taking a sample of urine and/or
for irrigation;
FIG. 6A is a view corresponding to FIG. 6 of the embodiment of FIG.
5A;
FIG. 6B is a side view of the embodiment of FIG. 5A;
FIG. 7 is a view like FIG. 6 showing the tip of an irrigation
syringe inserted into the open end of the exposed catheter adapter
shank end during irrigation;
FIG. 8 is a view taken along the line 8--8 of FIG. 7;
FIG. 8A is a reduced view of the irrigation arrangement of FIG. 7
with the open end of the catheter adapter shank exposed for
irrigation but showing irrigation from a bottle of irrigating fluid
through an irrigating tube and tapered adapter rather than from a
syringe;
FIG. 9 is a section taken along the line 9--9 of FIG. 4;
FIG. 10 is a section taken along the line 10--10 of FIG. 9;
FIG. 11 is a view like FIG. 9 showing a different construction for
holding the protective sleeve in place over the slit drainage
tube;
FIG. 12 is an enlarged view in perspective of the end of the
drainage tube of FIG. 1 which extends into the drainage bag and
with a part of the bag panel cut away to expose the ball valve
located at such end of the drainage tube;
FIG. 13 is a section taken along the line 13--13 of FIG. 12;
FIG. 14 is a section taken along the line 14--14 of FIG. 13;
FIG. 15 is a view in perspective of the free end of the draw-off
tube of FIG. 1 together with a portion of the corner of the
drainage bag and showing the protective cap over such end of the
draw-off tube and the draw-off tube removed from the stabilizing
tube extending along the top of the drainage bag;
FIG. 16 is a view in elevation and partially in section of the part
of the closed drainage system shown in FIG. 15;
FIG. 17 is a section taken along the line 17--17 of FIG. 16;
FIG. 18 is a view partially in section of the prepackaged
irrigation syringe shown in FIGS. 7 and 8;
FIG. 19 is a view in perspective of another kind of irrigating
entry associated with the catheter adapter and showing the closure
therefor in solid lines in open position and in broken lines in
closed position;
FIG. 20 is a view like FIG. 19 with the closure open and with the
tip of the irrigating syringe of FIGS. 7 and 8 inserted in the
irrigating entry for irrigation;
FIG. 21 is a longitudinal view in cross-section of the embodiment
shown in FIG. 20, with the closure shown in full lines in the open
position and in broken lines in closed position;
FIG. 22 is a view taken along the section line 22--22 in FIG. 21
with the irrigating syringe removed;
FIG. 23 is a sectional view in elevation of another kind of
irrigating entry in the catheter adapter utilizing a flap valve
shown in its normal position during drainage; and
FIG. 24 is a view like FIG. 23 during irrigation with the
protective cap removed and with the tip of the syringe introduced
into the irrigating entry to shut off communication between the
catheter and the drainage tube.
DETAILED DESCRIPTION
With reference to the figures, the numeral 2 represents a closed
urinary drainage and irrigation system comprising a sealed, plastic
urinary drainage bag 4, a urinary drainage tube 6, an end of which
extends into the interior of bag 4 and the opposite end of which is
provided with a catheter adapter 8, and a draw-off tube 10
extending from the bottom of the bag 4 and having a clamp 11.
The urinary drainage bag 4 is of generally the same construction as
that disclosed in my copending patent application Ser. No. 669,183
now U.S. Pat. No. 3,748,743. It comprises a pair of thin, flat,
flexible, plastic, e.g., polyvinylchloride, sheet panels 12 and 14
arranged back-to-back against each other and heat sealed together
along their margins at 16 to form a flat, collapsible bag having an
upper edge 18, a lower edge 20 and two side edges 22 and 24.
Preferably, the front panel 12 is transparent or translucent
whereas the rear panel 14 is opaque and white, and the inside
surface of each of the panels is embossed with a medium taffeta
finish to thereby make the surface rough to reduce the tendency of
the panels to adhere against each other. A pair of heat seal lines
26 and 28, extending along but spaced from the upper edge 18 of the
bag, separate the bag into a main urine collection chamber 30 and
an upper marginal pocket 32 extending along the top of the bag from
side-to-side. The pocket 32 is open at its ends 34 and 36, the side
edges 22 and 24 not being sealed in these areas.
Located slightly above the seal line 28 are a plurality of
horizontally spaced, horizontal slits 38 heat sealed along their
edges and extending through both panels of the bag for receiving a
flexible plastic hanging strap 40 for hanging the bag to a bed rail
or the like during use, all as described in the aforesaid copending
application.
Snugly but removably received in the pocket 32 above slits 38 (the
end portion 27 of line 26 and the branch 29 of line 28 form
restrictions in the pocket) is a cylindrical, elongated,
stabilizing tube 42 made of plastic, e.g., polystyrene, and open at
both ends 44 and 46. The plastic of tube 42, and hence tube 42, are
relatively rigid compared to the plastic bag 2. The length of the
plastic, stabilizing tube 42 is about the same as the overall width
of the bag proper from side to side. However, the unsealed edge 34
of the pocket 32 terminates short of the corresponding main side
edge 22 of the bag, as shown, so that the stabilizing tube 42
protrudes beyond the edge 34 of the pocket, as shown, for receiving
a protective cap 48 secured to the free end of the draw off tube
10, as shown. The fit between the stabilizing tube 42 and the
restrictions 27 and 29 of the pocket 32 is a snug one to insure
against the tube 42 accidentally sliding out of an open end of the
pocket 32.
The lower edge 20 of the bag bows downwardly as shown, the lowest
area 21 lying near the middle of the lower edge 20 directly below
the middle slit 38.
Located in the stabilizing tube 42, opposite the end which receives
the protective cap 48 of the draw-off tube 10 is a filter 50, e.g.,
a wad of cotton, for filtering out microorganisms from any air
which might enter the urine collection chamber 30 through the
stabilizing tube 42 and the draw-off tube 10, the free end of which
is removably received in the end 46 of the stabilizing tube 42 in
an air-tight manner to provide communication therebetween, as will
be described more fully hereinafter.
Although the open-ended stabilizing tube 42, and draw-off tube 10
provide communication between the atmosphere and the fluid chamber
30 through the filter 50 for gas sterilization of the system and
for over-flow from the bag 2, nevertheless, the wad 50 prevents the
entry of microorganisms into the system, all as described in my
aforesaid copending patent application.
The hanging strap 40 is of a highly flexible, plastic, e.g., linear
polyethylene and has the same shape and the same fastening button
41 for removably and adjustably fastening the ends together as the
corresponding hanging strap described in the aforesaid pending
patent application.
The relatively rigid stabilizing tube 42 stabilizes the bag so that
it can be hung by the single strap 40 without sagging or wrinkling
due to the unbalanced weight of the bag. Furthermore, it provides
support for strap suspension by the strap 40 and the end 46 thereof
provides a protective and convenient receptacle for the free end of
the draw-off tube 10. Also the draw-off tube, when located within
the end 46 of the stabilizing tube 42, as shown in FIG. 1, provides
a route for gas sterilizing the system and for overflow in the
event that the bag becomes too full and before the bladder becomes
distended in the event that the bag is not emptied when it should
be, all as described in my copending patent application.
The end portion of the soft, flexible, transparent or translucent
plastic, e.g., polyvinylchloride, drainage tube 6 extends through
the upper left side edge 24 of the bag at the thickened seal area
52 into the fluid chamber 30 in an air-right manner, as shown.
Actually, the edge portions of the panels 12 and 14 at the seal
area 52 are hermetically sealed around the periphery of and to a
short plastic receptor tube (not shown) through which the drainage
tube 6 extends and in which it is hermetically sealed. The end
portion 64 of the drainage tube 6 which is located within the
drainage bag 4 is provided at its end with a ball valve
construction 66, shown in detail in FIGS. 12 to 14 and which will
be described more fully hereinafter. The other end of drainage tube
6 is fitted tightly around the shank 54 (FIGS. 4 and 5) of the
catheter adapter 8 in an air-tight manner and is provided with an
irrigation entry arrangement 56 to be described in detail
hereinafter.
The catheter adapter is covered by a conventional, removable,
flexible, plastic (polyethylene) adapter cap (not shown) which
snaps over the shoulder 57 in an air-tight manner but which is
removed when the system is to be used so that the rubber catheter
58 (Foley catheter in the drawings) can be attached thereto, as
shown in FIGS. 4 and 6-8.
The end portion of the soft, flexible, transparent or translucent,
plastic (e.g. polyvinylchloride) draw-off tube 10 extends in an
air-tight manner between the panels 12 and 14 through the lower
side edge 22 at the enlarged seal area 60 of the bag into the fluid
chamber 30. Actually, as in the case of the drainage tube 6, the
draw-off tube 10 is hermetically sealed by solvent cement within a
flexible, plastic (polyvinylchloride), transparent receptor tube
(not shown) which extends through the seal area 60 with the
adjacent edge portions of the panels 12 and 14 being hermetically
sealed by heat around and to the periphery of the receptor tube at
the seal area 60. The other end 62 (FIGS. 15-17) of draw-off tube
10 is beveled and is secured within the protective cap 48, which is
removably applied over the end 46 of the stabilizing tube 42, as
shown in FIG. 16, and which will be described more fully
hereinafter.
The improvements provided by the present invention are directed
primarily to the irrigation entry arrangement 56, to the ball valve
assembly 66, to the protective cap 48, to a drainage tube 6 of
increased internal diameter, as will be described more fully
hereinafter, and to an improved prepackaged irrigation syringe 68
(FIGS. 7, 8 and 18) in which sterile irrigation fluid is
prepackaged and which is particularly adapted for use with the
irrigation entry arrangement 56 as shown in FIGS. 7 and 8 and as
will be described more fully hereinafter. The aforesaid
improvements will now be described in detail as follows.
THE ENLARGED INSIDE DIAMETER DRAINAGE TUBE 6
The inside diameter of the drainage tube 6 leading from the
catheter adapter 8 to the drainage bag 4 is made large enough so
that urine will pass by gravity from the catheter adapter through
the tube and into the bag without forming a continuous column of
urine therein, i.e., the internal diameter and cross-sectional
area, respectively, of the drainage tube 6 are greater than the
maximum internal diameter and cross-sectional area, respectively,
at which a continuous column of urine will form in the tube 6 when
urine flows therethrough from the catheter adapter by gravity.
In conventional drainage tubes, having a standard inside diameter
between six thirty-seconds inch and nine thirty-seconds inch, the
urine flowing by gravity from the catheter adapter through the tube
into the drainage bag may form a continuous column of urine in the
tube from drainage bag to catheter, up which column microorganisms
may ascent to the catheter 58 and thence to the urethra by swimming
up the column or by being carried up the column by air bubbles.
The formation of such a continuous urine column in the drainage
tube is avoided.
This by increasing the internal diameter of the drainage tube 6
sufficiently to eliminate the formation of a liquid meniscus in the
tube which involves a surface tension phenomenon as previously
explained.
Urine has components which give it adhesive characteristics and
consequently the surface tension phenomenon is greater than with
water so that a solid column of liquid forms more easily.
It has been found that the minimum inside diameter to prevent the
formation of a urine meniscus and thereby eliminate the aforesaid
surface tension phenomenon, which causes the formation of a
continuous urine column, is a diameter substantially greater than
nine thirty-seconds inch. Therefore, the minimum inside diameter is
substantially greater than nine thirty-seconds inch and the
preferred I.D. is between eleven thirty-seconds inch and twelve
thirty-seconds inch. If the inside diameter is made too large the
tubing becomes too cumbersome.
Because a solid column of urine does not form in the enlarged tube
6, the free flowing movement of the urine through the tube can be
easily observed, which is an important advantage in observing rate
of flow of urine.
The tube 6 is preferably made highly flexible so that it can take
relatively short bends without forming occlusions or restrictions
which cause the build up of a continuous urine column. To achieve
this, it is made somewhat softer and thicker (wall thickness) than
conventional drainage tubes. The tube 6 shown in the drawings is
made of plasticized polyvinyl chloride, the plasticizer being a
phthalate ester, e.g., diisooctyl phthalate.
The thickness of the wall of the drainage tube 6 in the drawings is
0.055 inch, whereas the thickness of the wall of standard drainage
tubes is between 0.030 and 0.040 inch. The thickness of the wall of
the drainage tube of the instant invention is preferably
substantially greater than 0.040 inch.
The tubing 6 preferably has a softness falling within
Durometer-Shore A. More preferably, the softness is between 55 and
80 (Durometer-Shore A). Tubing 6 in the drawings has a
Durometer-Shore A softness of 65.
IRRIGATION ENTRY ARRANGEMENT 56
The end portion 70 (FIGS. 4-10) of the internally enlarged flexible
drainage tube 6 is fitted tightly over and around the hollow shank
54 of the catheter adapter 8 with a friction fit and has a
circumferential slit 72 which extends around a major part of, but
not entirely around, its circumference and which is located over
the shank. This slit end portion 70 of tube 6 is normally covered
by a plastic, e.g., polyethylene, protective irrigation sleeve 74
which, like adapter shank 54, is relatively rigid compared to tube
6, which is fitted snugly but slidably around such end portion 70
and which protrudes axially beyond the open end 76 of adapter shank
54 over a portion of the tube 6 located adjacent to, but not over,
such shank as shown in FIG. 4.
When the relatively rigid irrigation sleeve 74 is positioned over
the slit tube portion 70, as shown in FIG. 4, to cover and close
slit 72, the end portion 75 thereof over the shank 54 is received
with a snug friction fit within the skirt 78, which extends
integrally from the periphery of shank 54 radially outwardly and
then longitudinally along the shank 54, as shown in FIG. 4. The
friction fit between the skirt 78 and the end 75 of irrigation
sleeve 74 prevents the sleeve 74 from being accidentally moved
axially off the slit portion 70 of tube 6 to thereby accidentally
expose the slit.
The radially extending portion 79 of skirt 78 is spaced a slight
distance from the shoulder 57 of the adapter 8, as shown, in order
to provide an annular external radiused recess 81 for receiving the
end 84a of the adapter-receiving funnel 94 of rubber catheter 58,
which is stretched around the shoulder 57 to hold the catheter 58
firmly on the adapter 8, as shown in FIGS. 4 and 8. The external
corner 83 of the skirt 78 is radiused.
The circumferential slit 72 is exposed by sliding the protective
sleeve 74 axially along the tubing and off from the shank 54 so
that the end 80 thereof clears the open end 76 of such shank, as
shown in FIG. 5.
Irrigation sleeve 74 has two oppositely disposed corrugated finger
pieces 82 to aid in sliding the sleeve along tube 6 off the slit
portion 70 of the tube to expose the slit.
Although the friction fit between skirt 78 and the end portion 75
of the sleeve is tight enough to prevent accidental sliding of the
sleeve off the slit portion 70 to expose the slit, it is not so
tight as to unduly hinder such movement of the sleeve deliberately
with the fingers from the slit covering position shown in FIG. 4 to
the slit exposing position shown in FIG. 5 and back again. Also,
although the fit between the sleeve and the end portion 70 of the
tube 6 is snug, it is not so tight as to unduly hinder the
aforesaid movement of the sleeve.
As aforesaid, the slit 72 extends around only a part of the
circumference of the end portion 70 of tubing 6. The remaining
unslit part 73 of such circumference acts as a flexible, resilient
hinge for swinging the slit end 84 of the tube 70 off the open end
76 of the adapter shank 54 to thereby expose such open end 76, as
shown in FIG. 6, for irrigating the bladder, as shown in FIGS. 7
and 8, by inserting the tapered neck 90 of the flexible and
resilient plastic irrigation syringe bottle 68, filled with sterile
irrigation fluid, into the exposed open end 76 of the shank and
squeezing the irrigating fluid into the bladder through the
catheter.
When irrigation is completed the tapered neck 90 is removed from
the open exposed end 76 of shank 54 and the slit end 84 of the tube
6 is swung about the unslit hinge portion 73 of the tube
circumference back over the open end 76 of the shank again into
abutting relation with the other opposed slit end 91 of the tube,
whereupon the protective sleeve 74 is slid axially back over the
slit end portion 70 of the tubing 6 (over the slit 72) and over the
adapter shank 54 to the position shown in FIG. 4 with the edge
portion 75 thereof snugly received within the skirt 78.
The rigid protective sleeve 74 prevents accidental swinging of the
slit end 84 off the open end 76 of the shank 54 of the adapter.
Also, it protects the slit 72 from contamination and holds the slit
ends of the tube snugly together, i.e., it prevents any parting of
such slit ends.
The length of the relatively rigid sleeve 74 is such that when it
is in the close position shown in FIG. 4, it extends away from the
catheter a sufficient distance beyond the slit 72 and the open end
76 of the shank 54 so that flexing of the tube 6 will not disturb
the slit, i.e., it isolates the slit from such flexing. The
relatively rigid adapter shank, which functions as a rigid support
for the slitted portion 70 of the tube, cooperates to so isolate
the slit.
The slit 72 is located over the shank 54 close enough to the open
end 76 of the shank to permit the slit end 84 of the tube 70 to
clear such open end 76 when such slit end is swung about hinge 73
to the irrigation position shown in FIGS. 6-8 to expose such open
end 76 for irrigation.
The outside diameter of he adapter shank 54 is larger than the
normal inside diameter of the drainage tube 6 to achieve a tight,
liquid and air-proof seal between the slit end 70 of the tube and
the adapter shank when the sleeve 74 is in the close position shown
in FIG. 4. However, the fit is not so tight that the slit end 84 of
the tube 70 cannot be easily swung over the open end 76 of the
catheter shank to the position shown in FIG. 6.
The sleeve 74 and slit end portion 70 of tube 6 are in the
positions shown in FIG. 4 during drainage. The tight fit between
the slitted tube end portion 70 and the shank 54 of the adapter and
the relatively snug fit between the irrigation sleeve 74 and the
tube portion 70, together with the fact that the slit ends of the
tube 70 are held in snugly abutting relationship on the shank 54,
insures against leakage of urine through the slit and also reduce
the danger of contamination entering the system through the slit.
The prevention of a continuous column of urine in the drainage tube
because of the increased internal size of such tubing also prevents
such leakage since the urine falls from the open end 76 of the
adapter shank 54 into the tubing 6 beyond the slit 72 and
consequently does not have an opportunity to back up between the
tube end portion 70 and the periphery of the adapter shank 54.
It is noted that the end of tubing 6 abuts against the internal
surface of the wall 79 of skirt 78. The same is true of the end 80
of sleeve 74 when it is in the close position shown in FIG. 4.
It is preferred to have the slit 72 in the end portion 70 of the
drainage tube 6 located around the relatively rigid catheter shank,
as shown, but the slit 72 can be located further down the drainage
tube 6 toward the drainage bag. In such case, it is preferred to
provide a relatively rigid inner sleeve fitted within such slitted
portion of the tube with a tight friction fit to take the place of
the adapter shank to rigidly support such slit portion with the
outer, relatively rigid protective sleeve located over such slitted
portion and the relatively rigid inner sleeve. In such case, the
inner sleeve may be of the same dimensions as the adapter shank 54
and the position of the slit relative to the ends of such inner
sleeve may be the same as the position of slit 72 relative to the
shank 54 in FIG. 4. However, the closer the slit is to the catheter
adapter the better. If such a relatively rigid inner supporting
sleeve is omitted, it is more difficult to isolate the slit from
flexing of the tube 6, it is more difficult to prevent accidental
parting of the slit ends and leakage through, and contamination of,
the slit is more apt to occur, but if the outer protective sleeve
is made long enough to effectively isolate the slit from flexing of
the tube 6 and to prevent accidental parting of the slit ends, and
if it fits snugly enough around the tubing to minimize leakage,
such inner sleeve can be eliminated.
If desired, this same slit valve principle can be used on the
catheter itself if inside and outside, relatively rigid sleeves are
used.
A small piece of larger diameter, flexible plastic
(polyvinylchloride) tubing 92 is sealed (by solvent or friction
sealing) around the drainage tubing 6 at a point spaced from the
slit 72 and from the open end 76 of shank 54, as shown in FIGS. 4
and 5, to act as a stop for the protective sleeve 74 when it is
slid axially over the drainage tubing out from over the slit to the
position shown in FIG. 5.
The catheter adapter 8 is novel in that it is made of a resin, such
as polyvinylchloride, which has a greater resilience, flexibility
and impact strength and is substantially less hard and brittle than
conventional polystyrene catheter adapters, although it is still
relatively rigid so that the shank 54 thereof provides an excellent
non-bending and non-yieldable support for the slit portion 70 of
the tube 6. Accordingly, when the tapered neck or tip 90 of the
irrigating syringe 68 is thrust firmly into the open end 76 of the
adapter shank 54, an excellent liquid-tight seal is provided
between the inner edge 93 of such open end 76 and the tapered tip
90 so that irrigation can be achieved without leakage and without
entry of contaminants into the system and without danger of
breaking the shank. This greater resilience, flexibility and
yieldability of the adapter shank insures an excellent liquid-tight
seal with tapered irrigation tips of a variety of sizes, including
all conventional sizes.
The tapered neck 90 itself is made of a linear copolymer of
ethylene and propylene so that it also has resilience and
flexibility to contribute to the liquid-tight seal between it an
the open end 76 of the shank 54 to thereby insure irrigation
without leakage.
Since the protective sleeve 74 is also made of a plastic which,
although relatively rigid, also has sufficient resilience and
flexibility (preferably the same material as the catheter shank), a
tight fit can be achieved between the end portion 75 thereof and
the skirt 78 while still permitting the sleeve to be slid out of
the skirt without difficulty.
As can be seen in FIG. 6, a urine sample can be conveniently
obtained at any time with minimum danger of contamination merely by
sliding the irrigation sleeve off the slitted portion 70 of the
drainage tube followed by swinging the slit end 84 off the open end
76 of the catheter adapter shank 54, as shown in FIG. 6, while the
catheter is in place in the urethra and bladder of the patient,
i.e., with an in-dwelling catheter.
Although in the drawings the catheter is shown secured to the
catheter adapter, the system is manufactured and shipped with a
protective cap (not shown) secured over the catheter adapter in an
air-tight manner to provide a closed system. The cap is removed
when the system is to be used and the catheter has been inserted
into the patient, followed by inserting the adapter into the
adapter receiving funnel 94 of the catheter, as shown in FIGS. 4
and 6-8.
Since both the adapter 8 and the irrigation sleeve 74 are molded,
close tolerances can be accurately achieved between the internal
annular surface of the skirt 78 and the external annular surface of
the end portion 75 of such sleeve when the sleeve is located within
the skirt in the position shown in FIG. 4, to thereby insure a good
snug fit therebetween to prevent accidental sliding movement of the
sleeve to expose the slit 72 while permitting the sleeve to be
deliberately so moved by the fingers without difficulty when so
desired.
However, such skirt can be omitted as shown in FIG. 11, in which
case the snug fit between the internal surface of the sleeve 74 and
the external surface of the slit tube portion 70 over the shank 54
is relied on to prevent accidental sliding movement of the sleeve.
Actually, in such case the external diameter of the shank and the
internal diameter of the sleeve are such as to squeeze the tube
portion 70 between them to insure the aforesaid snug fit between
sleeve and tube. However, it is difficult to control the tolerances
of plastic tubing and consequently the fit between the sleeve and
tubing over the shank may be too tight, in which case movement of
the sleeve becomes too difficult, or the fit may be too loose in
which case the sleeve is apt to be accidentally moved to expose the
slit. Accordingly, the FIGS. 4-10 embodiment with the skirt 78 is
preferred although the FIG. 11 embodiment has proved successful
also.
Irrigation can be carried out not only with the prepackaged
irrigating syringe 68 shown in FIGS. 7 and 8 but also, with
conventional irrigating syringes and, as shown in FIG. 8A, with a
conventional supply 96 of irrigating fluid in a stoppered bottle 98
having a vent tube 100 and a plastic, flexible, translucent or
transparent irrigation tube 102 with a molded, plastic, e.g.,
polyvinyl chloride, adapter 104 secured at its end, which is
relatively rigid compared to the tube 102 and which is externally
tapered so that when it is inserted into the exposed open end 76 of
the adapter shank 54, as shown in FIG. 8A, the tapered periphery
forms a liquid-tight seal with such open end by engagement with the
outer end 93 of the bore 55 in the adapter shank 54 in the same way
that the tapered neck 90 of the syringe 68 forms a seal with such
open end in FIG. 8. A clamp 106 is provided for the irrigating tube
102.
Although in FIGS. 1-5, 6 and 7-11, the circumferentially extending
irrigation slit 72 lies in a plane which is 90.degree. to the
longitudinal center axis of the irrigation tube, the
circumferential slit may lie in a plane at any other angle to the
longitudinal center axis of the irrigation tube, as shown in FIGS.
5A, 6A and 6B, in which the circumferentially extending irrigation
slit 72A lies in a plane at an angle of 45.degree. to the
longitudinal center axis of the irrigation tube. As a matter of
fact, the embodiment of FIGS. 5A, 6A and 6B is preferred since it
facilitates swinging of the slit end 84A of the tube off from and
onto the open end of adapter 54, reduces the chance of leakage and
increases the durability of the hinge portion of the irrigation
tube. Although in FIGS. 5A, 6A and 6B, the angle of the slit is
45.degree. to the longitudinal axis of the irrigation tube, it may,
as aforesaid, be at any angle to such center line which will permit
swinging of the slit end 84A of the irrigation tube off from and
onto the open end of the adapter. Furthermore, the slit may be
curvilinear as shown by the dot-dash line 72B in FIG. 6B.
Furthermore, it may have a bend in it as shown by broken line 72C
in FIG. 6B.
It is noted that the slit 72 and open end 76 of the catheter shank
form an entry in the side of the drainage tube (the catheter
adapter, as well as the catheter, may be considered part of such
tube) with a proximal (i.e., closest to the patient) portion of
such tube extending in one direction from such slit and open end
and a distal (i.e., furtherest from the patient) portion 6 of the
tubing extending in an opposite direction from such slit and open
end (this is the portion which is swung off the adapter shank). It
is also noted that when the tip 90 of the irrigation syringe 68 is
inserted into the exposed open end 76 to provide communication
between the catheter and irrigation source, communication is cut
off between such proximal and distal portions so that irrigating
fluid cannot flow into such distal portion of the drainage tube
into the drainage bag but only into the proximal portion of the
tubing and thence through the catheter. Accordingly, it is not
necessary to clamp the drainage tube during irrigation. This may be
referred to as a closed end to end irrigation system and it is
achieved without the aforesaid disadvantages of a
connect-disconnect arrangement.
Another less preferred way of achieving this is shown in FIGS. 19
to 22 in which the shank 54a of the catheter adapter 8a is extended
and is provided with an obtuse angle bend 106 of about 135.degree.
to form a proximal part 108 and a distal part 110 on either side of
the bend, the distal end of the distal part 110 having the end of
the flexible drainage tube 6 extending thereover to secure the
adapter to the drainage tube 6. Again, the adapter is really a part
of the drainage tube. The top of the distal portion 110 adjacent
the bend has a flat area 112 having an opening or entry 114
therein, which is located at the proximal end thereof and which is
axially aligned and communicates with the bore 116 in the proximal
part of the adapter. Actually, the opening 114 and its wall are
continuations of the bore 116 and its wall, i.e., the curvilinear
contour of the wall of bore 116 continues uninterrupted to the
upper edge of the opening 114, except for the intersection
therewith at 120 of the reduced diameter bore 118 of distal portion
110. Such bore 116, at its upper end, and opening 114 have a slight
taper inwardly as they extend in a proximal direction. Accordingly,
when the tapered irrigation tip 90 of the prepackaged irrigating
syringe 68 or of any conventional irrigating syringe is inserted
into the opening 114 and bore 116, as shown in FIGS. 20 and 21 to
provide irrigation, such tip fits snugly in such opening and bore
to thereby cover the end 120 of bore 118 to effectively cut off
communication between the distal portion 110 and proximal portion
108 of the drainage tubing. Accordingly, it is not necessary to
clamp the flexible drainage tube 6 distally of the opening or entry
114. The aforesaid snug fit provides a leakproof seal between the
catheter adapter or drainage tube and the tip 90.
The flat 112 is provided with a pair of marginal and longitudinal
overhangs 122 which form a way for sliding movement of a flat
sliding closure 124 between close position over the opening 114
during drainage (full line position in FIGS. 19 and 21) and open
position to expose such opening 114 for irrigation (broken line
position in FIGS. 19 and 21). The closure 124 is provided with a
finger piece 126 to aid in sliding the closure. The fit between the
closure 124 and the way 122 is snug enough to prevent accidental
movement of the closure from close position to accidentally expose
the opening during drainage.
Yet another even less preferred way of obtaining end-to-end closed
irrigation without a connect-disconnect arrangement is disclosed in
FIGS. 23 and 24. In this case, the adapter 8b has a 90.degree. bend
at 130 dividing the adapter into a proximal portion 132 having a
bore 148 and a distal portion 134 having a bore 136 of
substantially smaller diameter than bore 148 and to the free end of
which the flexible drainage tube 6 is secured, as shown. The
proximal portion 132 has a slight axial extension 137 over which is
normally located during drainage a removable cap 138. Secured
within the extension 136 is an annular sleeve 140 of a flexible,
resilient and elastic material, such as rubber, the inner end of
which is provided with a circular disk 142 of the same material and
integrally connected to the sleeve only at a small flexible hinge
area 144 but otherwise separate from the sleeve.
The normal relaxed position of the disk 142 during drainage is
shown in FIG. 23, in which position the periphery of the disk 142
engages the inner wall of the bore 148 snugly around its entire
circumference.
However, when the tapered tip 90 of the irrigating syringe 68 is
inserted into the open extension 137 (after removal of cap 138) it
forces the disk 142 to be swung around its flexible hinge 144 into
the recess 145 and over the end 146 of the bore 136 in the distal
portion 134 to thereby shut off communication between such distal
portion and the proximal portion 132, as shown in FIG. 24.
By tapering the disk 142, as shown, a snug fit is achieved between
the tip 90 and the wall of bore 148 of which the disk 142 now forms
a part to provide a seal and thereby permit irrigation without
leakage. Since the disk 142 is forced tightly against the end of
bore 136 a seal is achieved to prevent irrigating fluid from
flowing into bore 136. The open extension 137 comprises an entry in
the side of the catheter adapter 8b, which is functionally part of
the drainage tubing.
It may be seen that with all of these embodiments irrigation can be
carried out quite conveniently and simply without the aforesaid
connect-disconnect arrangement, with its attendant dangers of
contamination, and without requiring a clamp for the drainage tube
during irrigation.
The slit tube irrigation arrangement of FIGS. 4-11 is exceedingly
simple, fool-proof, inexpensive and convenient to use. It does not
become plugged by solids in the urine and reduces danger of
retrograde infection to a minimum, particularly when coupled with
the enlarged, inside diameter drainage tube and the one way ball
valve assembly 66 to be hereinafter described in greater
detail.
BALL VALVE ASSEMBLY 66
The one-way ball valve assembly 66 (FIGS. 12-14) within the bag 4
comprises a semi-rigid polyvinylchloride (the same material as the
catheter adapter 8 and irrigation sleeve 74) hollow cylindrical
ball housing 150 having at one end thereof a reduced end portion
152 around which the end of the drainage tube within the drainage
bag is cemented.
The intersection of reduced end portion 152 and the housing proper
forms an external shoulder 154, against which the end of tube 6
abuts, and an internal valve seat 156 formed by the intersection of
the internally tapered bore 158 in reduced section 152 and the
curved end portion 160 of the internal bore 168 within the enlarged
portion 170 of the housing. The other open end of the housing 170
is closed by a cap 151 of the same material as the housing and
cemented thereover. Housing portion 170 houses a stainless steel
ball 172 and is provided with three elongated, circumferentially
and equidistantly spaced longitudinal slots 174 extending to the
capped end, and three circumferentially and equidistantly spaced
internal, tapered longitudinal ribs 176 to decrease frictional
contact of the housing with the ball.
The ribs 176 extend to the capped end of the enlarged portion 170
of the housing and, as shown in FIG. 13, they are tapered inwardly
as they extend from such capped end.
The diameter of the stainless steel ball is substantially less than
the diameter of the ball housing portion 170 but is, of course,
substantially larger than the diameter of the valve seat 156. It is
also substantially larger than the width of the slots 174.
Ball 172 is adapted to roll freely within the housing 170 between a
closed position (shown in broken lines in FIG. 13), in which it
firmly engages the valve seat 156 to close communication between
the bag 4 and the drainage tube 6 and to which it moves
instantaneously in response to the commencement of even the
slightest flow of urine from the bag through slots 174 into the
housing 170 or in response to any tilting of the bag which might
cause such commencement of flow, and an open position (shown in
full lines in FIG. 13), in which it engages the flat inside wall of
cap 151 to permit free and unrestricted flow of urine from tubing 6
into housing 170 and through slots 174 into the drainage bag and to
which it is moved instantaneously in response to the slightest flow
of urine in the drainage tubing 6 to the valve seat 156.
The length and width of the slots 174 are such that at any time
there is flow of urine through the drainage tube 6 to the valve
seat so that the ball is in open position, the open cross-sectional
area of each of the slots 174 and of the seat 156 is at least as
great as the internal cross-sectional area of the enlarged drainage
tube 6. Accordingly, the entire system from catheter adapter to bag
has no passage having a cross-sectional area small enough to form a
continuous column of urine in the tube so that the ball valve
assembly 66, although effectively preventing reflux of urine from
the bag into the tube 6, cooperates with the internally enlarged
drainage tube to prevent the formation of a continuous column of
urine in the drainage tube. It also functions to do this because of
the ease with which the ball is rolled to its normal open position.
Preferably, but not necessarily, the drainage tube 6 is secured in
the edge 52 of the drainage bag so that the valve housing 66 is at
a very slight inclination to cause the ball 172 to normally occupy
its open position by gravity. This insures that the ball valve will
not normally restrict the flow of urine in the slightest.
Accordingly, no force is required to open the valve seat 156 so
that the ball does not support the build-up of any urine column in
the drainage tube, which is a disadvantage of a valve which
requires any substantial force to open it.
A plurality of slots 174 are used and the diameter of the ball is
made considerably smaller than the inside diameter of the housing
170 in which it rolls and the slots are elongated to insure free
and unrestricted flow of liquid from the tube 6 through the housing
into the bag to thereby prevent the build-up of a liquid column in
the drainage tube. Actually, only one slot of the aforesaid size
would be enough to prevent the formation of a continuous column of
urine in the drainage tube but multiple slots provide a safety
margin and also increase the sensitivity of the ball to
commencement of refluxing into the housing through the slots. The
greater the total slot area the better.
It is noted that when the ball is in open position (full lines in
FIG. 13) it lies in front of the slots so that any slight flow
inwardly through the slots instantly moves the ball to close
position.
In the drawings, the spherical ball 172 is 0.375 inch in diameter,
the valve seat is 0.340 inch in diameter, the inside diameter of
the housing is 0.50 inch, the open length of the slots is 0.50 inch
and the width of the slots is 0.16 inch.
The ribs 176 reduce friction between the ball and housing to a
minimum to thereby insure free rolling of the ball in response to
even the slightest force.
The cap 151 functions as a stop for the ball. Any other kind of
stop will do and it is not essential that the open end of the
housing 170 be closed.
The polyvinylchloride housing 150, although relatively rigid has
sufficient resilience and flexibility so that the ball 172 forms a
good seal with the valve seat 156.
The bore 158 of reduced diameter portion 152 is tapered inwardly as
it extends toward the valve seat 156 to cause the ball to be more
easily moved away from the seat to open position by flow of urine
through the drainage tube 6 to the seat.
The ball may be made of other materials, such as plastic, as long
as it has a specific gravity substantially greater than the urine
so that it will not float and so long as it is inert to the
urine.
The molded housing 150 holds apart the flexible panels 12 and 14 of
bag to thereby insure against the panels sticking together at the
exit of the drainage tube into the bag i.e., the housing insures
that there will always be a space at the exit of the drainage tube
into which the urine can freely flow. This is another reason for
the plurality of circumferentially spaced slots, i.e., to insure
against the bag panels covering a single slot to thereby restrict
such outflow. In this respect, it is pointed out that urine is more
adhesive than water and consequently is apt to cause the bag panels
to adhere together. For the same reason the tendency of the urine
to form a meniscus in the drainage tube 6 is greater than
water.
It is noted that the outside diameter of reduced end portion 152 is
larger than the inside diameter of the flexible tube 6. As
aforesaid, the diameter of the opening defined by valve seat 156 is
eleven thirty-seconds inch like the internal diameter of the tube
6.
If desired the enlarged housing 170 may be slightly tapered
inwardly as it extends from the cap 151 to the shoulder 154.
PROTECTIVE CAP 48 FOR DRAW-OFF-TUBING 10
The semi-rigid (relatively rigid compared to the flexible plastic
draw-off-tubing 10), hollow protective cap 48 (FIGS. 15-17) is
cylindrical in shape and is made of a molded polyvinyl chloride,
having the same properties as the ball valve housing and the
catheter adapter in that it has more resilience and flexibility as
compared, for example, to polystyrene. It is made up of an enlarged
diameter hollow part 180 having an enlarged bore 191 therein and a
reduced diameter hollow part 182 having a reduced diameter bore 188
within which the beveled end portion 184 of the flexible plastic
draw-off-tubing 10 is snugly received in a liquid-tight and
air-tight manner with the corner 186 of the beveled end 62 of the
draw-off-tube 10 in engagement with the internal shoulder 186a
within the bore 188.
The enlarged portion 180 has an integral internal hollow tubular
tip 190 therein extending integrally, coaxially and longitudinally
thereinto from the end of portion 180 adjacent to reduced portion
182 but terminating a substantial distance from the opposite open
end 181 of portion 180 so that the free end of tip 190 is located
well within the portion 180, as shown in FIG. 16. The external
periphery of the tip 190 is tapered and is spaced radially inwardly
from the internal surface 191 of the enlarged portion 180.
The wall of the internal bore of the tip 190 is axially aligned
with the wall of the bore of the draw-off-tube 10 and is of the
same diameter so that when the draw-off tube 10 is located in the
cap 48, as shown in FIG. 16, the tip 190 constitutes an extension
of the draw-off-tube 10 and may be considered as a part
thereof.
The dimensions of the periphery of tip 190 and of the space 192
between such periphery and the internal surface of the portion 180
are such that when the cap 48, with the draw-off-tube 10 located
therein, is placed over the end portion 194 of the stabilizing tube
42 protruding beyond the edge 34 of the pocket 32, the tapered tip
190 is received snugly within the end 46 of the stabilizing tube
with a liquid-tight and air-tight fit and the enlarged diameter
part 180 of the cap is located around, but radially spaced from,
such end of the stabilizing tube, as shown in FIG. 16. The
resilience and flexibility of the tip 190 and stabilizing tube 42,
together with the external taper of the tip, provides an excellent
seal therebetween while at the same time permitting the cap 48 to
be easily placed over the end of the stabilizing tube during normal
use and to be easily removed therefrom to draw urine from the bag
4.
The aforementioned close fit between tip 190 and the end of the
stabilizing tube and between the draw-off-tube 10 and the internal
surface of the reduced diameter portion 182 of the cap insures
against the entry of contaminants into the system, against leakage
of sterilizing gas during sterilization and against leakage of
urine in the event that urine should overflow up the draw-off-tube
10 into the stabilizing tube.
If desired, the draw-off-tube 10 can be sealed in the cap.
The open end 181 of the cap is preferably beveled, as shown.
It may be seen that when the draw-off-tube 10 is removed from the
stabilizing tube, as shown in broken lines in FIG. 1, to draw off
urine from the bag, the protective cap 48, i.e., the enlarged
housing 180, protects the end 190 of the draw off tube 10-190 from
contamination by contact with contaminated objects, including the
fingers, while at the same time improving the seal between the
draw-off-tube and stabilizing tube when the draw-off-tube is
located in the stabilizing tube during drainage.
A less preferred way of obtaining generally the same effect is to
eliminate the tip 190, with the end portion 184 of the flexible
draw-off-tubing being inserted in the cap so that the corner 186
thereof is located in the same position as the end of tip 190 in
FIG. 16. In such case, the external surface of such draw-off-tube
within the enlarged portion 180 is spaced radially inwardly from
the internal surface of portion 180 the same distance as the
external surface of the tip 190 is spaced from such internal
surface in FIG. 16 and the end portion 184 of the draw-off-tube is
received snugly within the end of the stabilizing tube.
In such case, the space between the external surface of the
draw-off-tube within portion 180 and the inside surface of portion
180 may be such that the end of the stabilizing tube is snugly
gripped therebetween, or the end portion 184 of the draw-off-tube
10 may be tapered and of the same size as the tip 190 to thereby
cooperate with the end of the stabilizing tube in the same way.
The internal diameter of the draw-off-tube is a standard nine
thirty-seconds inch which is smaller than the inside diameter of
the drainage tube 6 although it may be of the same size or
larger.
The draw-off-tube 10 is provided with a conventional external clamp
11 which is normally open during drainage when the draw-off-tube is
in the position shown in full lines in FIG. 1.
The overflow provided by the draw-off-tube-stabilizing tube route
cooperates with the other features described above to insure
against retrograde infection.
The irrigation sleeve 74, ball valve housing 150 and cap 151 and
protective cap 48 may be colored, e.g., yellow, to designate by
color code the vital areas so far as retrograde infections is
concerned. This is done in the commercial embodiment.
Also in the commercial embodiment, the stabilizer tube is colored
blue and the transparent or translucent bag panel is provided with
graduations to indicate the amount of urine in the bag at any time.
Irrigation Bottle 68
Irrigation bottle-syringe 68 is cylindrical in shape and is made of
an autoclavable, flexible, resilient and elastic copolymer of
propylene and ethylene in which propylene constitutes the major
constituent.
It is prepackaged with sterile irrigating fluid, e.g., water or
saline solution (the syringe tip 90 and internal surface of the
bottle-syringe 68 are also sterile) and is sealed by an elongated
rigid cap 200 of polypropylene located over the syringe tip 90 and
threaded over the threaded base 202 of the tip 90 by cooperating
internal threads 205 on the cap so that the end 204 of the tip 90
is pressed tightly against the sealing disk 206 of compressible
material, e.g., rubber, to provide an air-tight and liquid-proof
seal, as described in my aforesaid copending application. A
"whiskey" seal may be used between cap and bottle at the threaded
areas to make the unit tamper-proof, as described in such copending
application.
The syringe-bottle 68 has sufficient rigidity to hold its shape but
is sufficiently flexible, resilient, yieldable and elastic to be
easily squeezed by the fingers to eject the fluid. It is elastic
enough to return to its normal shape after squeezing so that the
fluid can be easily aspirated out of and into the syringe and into
and out of the bladder to irrigate.
The syringe tip 90 is more rigid than the syringe proper and, as
aforesaid, is of such dimension that it can be inserted into the
exposed open end 76 of the catheter adapter shank 54 to a point at
which its periphery engages such open end to form an excellent
friction fit and seal during irrigation.
The optimum thickness of the wall of the syringe proper is between
0.025 and 0.030 inch. The maximum thickness is preferably about
0.035 inch and the minimum preferably about 0.020 inch.
The syringe 68 is of a size to fit within the palm of the hand and
has a flat bottom or the equivalent (e.g., centrally dished) to
permit it to be placed on a supporting surface without tipping. The
syringe is also provided with graduation marks.
The present invention is not only useful for drainage from, and
irrigation of, the bladder but can also be used for closed system
drainage from, and closed system irrigation of, other body
cavities.
It is not intended that the invention be limited to the
constructions shown and described in the accompanying drawings and
the above description but only to those constructions which are
claimed below and their equivalents.
* * * * *