Note: Descriptions are shown in the official language in which they were submitted.
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COL~APSIBLE CA~l~l~
Field of the Invention
The present invention relates to a surgical device and
method for draining or feeding a biological system and in
particular a collapsible indwelling catheter is provided ~or
draining or aspirating the urinary bladder.
Backqround of the Invention
A urinary bladder tube is used on patients who are unable
to urinate. There are many causes of the inability to urinate.
Frequently, surgery or other invasive procedures produce such an
effect. Generally, the origin o~ such a condition differs with
age and gender. For example, the inability to urinate in men is
commonly caused by a blockage of the urethra passageway by an
enlargening prostate. In females, the condition may occur after
delivery of a baby. And, in small children, a congenita:l
abnormality obstructing the bladder neck or urethra can produce
the condition.
After major surgery, it is advantageous to continuously
drain the bladder. Continuous drainage of the bladder is also
preferred where medical conditions dictate the necessity of
monitoring a patient's urine output. It is well known that close
measurement of urine output provides a direct correlation to
kidney ~unctions and careful monitoring allows one to identi~y
and prevent kidney failure.
It is important to drain the bladder by an indwelli~g
catheter after prostate or bladder surgery. An indwelling Foley
type catheter is usually the catheter of choice. U.S. Patent
5,300,022 to Klapper et al and incorporated herein, shows an
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improvement over the Foley catheter by providing a second lumen
for continuous delivery of a sterile irrigating solution directly
into the bladder, and preventing any mixture with the main
drainage lumen, thus avoiding any reintroduction of harmful
bacteria into the bladder during irrigation.
U.S. Patent No 4,701,162 issued to Rosenberg and
incorporated herein, shows a Foley catheter with two lumens, one
for drainage and one for inflation of the balloon. Having
separate lumens for drainage and inflation i8 common in the prior
art. U.S. Patent No. 5,098,379, which i8 incorporated herein by
reference, discloses a Foley catheter having a balloon portion
and a lubricated resilient sleeve. U.S. Patent No. 5,269,770,
which is incorporated herein by reference, shows a dual lumen
system and balloon Foley catheter for releasing a bactericidal
agent. Similarly, U.S. Patent No. 5,269,755 which is
incorporated therein by reference, shows a Foley urinary catheter
with a dual membrane delivery system that allows bactericidal
agents to diffuse into the urinary tract.
One thing is clear in the prior art of Foley urinary
catheters: none of them teach a collapsible device.
An indwelling catheter drains the bladder and diverts the
urine from the wound. Moreover, the bladder can be either
continuously irrigated with a three way Foley catheter or hand
irrigated at discrete moments when desired. In the three way
catheter, one port used is connected to a large fluid reservoir
and the other port is used for drainage of the returned fluld.
The speed of irrigation can be controlled by different mechanisms
or different pumps.
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In certain patients the bladder must be drained for many
years, as in patients with spinal cord lesions. If the bladder
is not drained, the pressure inside it will build up and obstruct
the kidneys. Continuous kidney obstruction could end in reL ~l
failure and death in only a few weeks. Furthermore, the catheter
is used to clear blockages and constrictions of the urinary
tract.
Therefore, the use of indwelling catheter is very important
and could be life saving.
However, there are many serious draw backs to the stiff
indwelling catheter. First, it is painful and certain patients
cannot tolerate the catheter. Second, a stiff hollow indwelling
catheter invites micro-organisms to invade the bladder end
kidneys which may cause a serious infection. Third, for patients
who are unable to tolerate the stiff catheter, a hole in the
bladder must be created to drain the bladder directly through the
anterior abdominal wall. This is a serious procedure and exposes
the patient to unnecessary risks of other complications.
Thus, it would be ideal if a Foley catheter was stiff enough
to be introduced, but collapsed after insertion. The urethra is
naturally in a state of collapse at rest. The present invention
will mimic the urethra~s physiological status. The pain c;r
discomfort from an indwelling catheter will be reduced. In
addition, the incidence of bladder or kidney infection is
minimized.
Summary of the Invention
The present invention relates to a catheter for insertion
into a patient which is aimed at reducing the discomfiture
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experienced with conventional indwelling catheters. The catheter
of the invention comprises a pair of substan~ially collapsible
elongated elastomeric telescoping tubes which are joined together
and have an opening at a proximal and have at least one openiIlg
for fluid drainage into the inner tube. The tubes are joined
together and closed at the distal end. A valve means is provided
about the proximal end to permit fluid entrance between the tubes
so as to stiffen the catheter for insertion into the patient and
to remove the ~luid so as to cause the catheter to collapse.
Advantageously, the tubes are joined or bonded together so
as to be reinforced at the proximal end, the distal end and about
the drainage opening. Preferably, a balloon means is provided
near the distal end to maintain the catheter within the patiell
after its collapse. A small hollow tube connects the balloon to
a valve system located near the open proximal end.
Advantageously, the tubes are joined or bonded at dif~erent
points along their length. The bonding or joining of the tubes
and their reinforcement at the openings or at the distal end can
be by use of adhesives, fusion bonding of the tubes alone or with
a fusible polymeric material. In the device, the tubes are thin
enough to keep them in a state of collapse at rest. The
collapsible tubes are open at one end, that is, the proximal elld
to permit access into the inner tube. The open end preferably
has a valve means which allows passage of fluid into and out of
the tube.
There are one or more holes, at the distal end of the
catheter, which is the end that connects to the bladder. A
circular hollow tube or a thickener portion can be used to
_
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reinforce the open end of the catheter tube, which is the end
that can be connected to a calibrated urine bag. The
reinforcement prevents collapse of the open end and facilitates
the insertion of the tube for connection to a urine bag.
In a three way injection system, an extra hollow tube can
be added at the proximal end of the catheter and connected to a
reservoir for irrigation. This tube does not need to be
reinforced.
A method is also provided for irrigating and aspirating the
urinary tract using a device as the present invention describes
herein.
Obiect of the Invention
Accordingly, it is the general object of this invention to
provide a collapsible catheter that mimics the urethra in every
respect, thus overcoming the disadvantages of the prior art.
It is a further object of the invention to provide a
catheter and method of aspirating the bladder a~ter surgery whic~
can be used with less discomfiture to the patient.
It is a further object of this invention to provide a
catheter and method of irrigating the bladder for certain
urological conditions.
It is a further object of this invention to provide a
catheter that advantageously can be at least partially stiffened
or flaccid when desired, thus minimizing the incidence of
infection and reducing the pain or discomfort the patient
experiences during the period that the catheter is le t
indwelling.
It is a further object of this invention to provide a
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collapsible catheter that advantageously can be stiff or flaccid
when desired, thus minimizing the incidence of infection and
reducing the pain or discomfort the patient experiences during
the period when the tube is left indwelling.
Brief Description of the Drawinqs ~,
Figure 1 is a perspective view of the collapsible catheter
of the invention.
Figure 2 is a cross-section of the collapsible catheter of
Figure 1 taken along line 2-2.
Description of the Preferred Embodiments
Although specific terms are used in the following
description for the sake of clarity, these terms are intended to
refer only to the particular structure of the invention selected
for illustration in the drawings and are not intended to define
or limit the scope of the invention.
As shown in Figure 1, the catheter 10 of the invention lS
formed by a ~irst collapsible hollow tube 13 which is within a
second collapsible hollow tube 12. The tubes 12,13 are joined
or bonded together so as to have an openinq 11 at the proximal
end of the catheter 10. The tubes 12,13 are further joined or
bonded at the distal end 17 and at various points 21 along the
length.
The outside circumference of the outer tube 12 is slightly
larger than the outside circumference of tube 13, generallyr
about 0.33 mm larger. The outside diameter of tube 12 is
generally about 1.6 to 10 mm and the length of the tube 12 can
vary between about 13 to 17 inches (8387.08 to 10967.72 mm).
There are one or more reinforced openings or holes 16,
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preferably two or three, located at the distal end of catheter
10 which is the end that connects into the bladder. The holes
16 are advantageously six to eight millimeters in diameter. The
distal tip 17 is preferably thickened to aid in insertion into
the bladder.
The open end 11 of the catheter 10 is the end that can be
connected to a calibrated urine bag. This end 11 can be
thickened or rein~orced with a circular hollow tube or a valve
to prevent collapse of the open end and facilitate the connection
of the catheter 10 to a urine bag (not shown).
To prevent the catheter 10 from slipping out of the urinary
bladder an inflatable balloon 15 can be provided near the distal
end as shown in Figure 1. The balloon 15 may be inflated through
the hollow tube or channel 19 which runs along wall of the
catheter 10 to a valve system 14. The tube 19 can be on the
outside wall or between the tubes 12,13.
In a three way irrigation system an extra hollow tube may
be added to the catheter 10. This tube may be connected to a
reservoir of fluid for irrigation.
The collapsible tubes 12,13 may be made from medically
approved silicone rubber, latex rubber or any other suitable
medically approved elastomer. The distal end 17 is preferably
thickened about 1 to 2 cm so as to provide sufficient stiffness
to prevent collapse during drainage. The proximal end which has
the opening 11 preferably has a thickness of about 2-3 cm ~n
length to prevent collapse.
The valve systems 14 and 20 may be one, two or three ways.
The balloon member 15 is attached to the periphery of the
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catheter 10. The balloon 15 is at least partially inflated to
prevent the catheter 10 from slipping out of the urinary bladder.
The balloon 15 is attached to the outside of the catheter 10 and
is connected to a small hollow tube 19 of the valve system 20
located near the proximal end. The balloon can be filled witr;
air or fluid through use of a syringe. The balloon can be fully
or partially inflated to support the sides of the tube.
As shown in Figure 2, the bonded points 21 are spaced so
that the space 22 between the tubes 12,13 is continuous along the
length whereby fluid which is inserted through the valve 14 will
pressurize and completely stiffen the catheter 10 for insertion
into a patient. The degree of collapse can be controlled by
removal of fluid from between the space 21.
The present invention will mimic the physiological sta~us
of the urethra in every respect. In the event of a three way
urethral catheter, the fluid will distend the hollow non-
reinforced tube when the fluid is turned on. If the fluid is
turned off, the infusion or irrigating hollow tube will collapse.
In certain difficult cases, the balloon is injected through
the valve 14 with fluid from a syringe until the catheter 10 is
stiff enough to be threaded into the bladder. The balloon 15 of
the catheter is then further inflated with fluid to prevent the
catheter from slipping out of the bladder. The balloon 15 car.
then be deflated in the manner just described.
In the method for draining the urinary bladder, the catheter
is stiffened by inserting fluid between the tubes 12,13, i.e.
spaces 22, with a syringe through valve system 14. The stiffened
urethral catheter is well lubricated and passed urethrally into
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the bladder. Once the urethral catheter is in position, as noted
by the return of urine, the balloon 15 at the distal end of the
catheter is inflated. After the catheter 10 is secured in the
urinary bladder, the fluid from between the tubes 12,13, i.e. in
spaces 22, is withdrawn through valve 14 which collapses the
indwelling catheter except for the balloon 15.
Although the invention has been described with a certain
degree of particularity, it is understood that the present
disclosure has been made only by way of example and that numerous
changes in the details of construction and the combination and
arrangement of parts may be resorted to without departing fl-om
the spirit and scope of the invention.
