Collapsible catheter

A collapsible catheter is provided for irrigation or aspiration of the urinary bladder with fluid. The catheter consists of a collapsible hollow elastomeric tube which is open at the proximal end. The distal end portion has at least one stiffened aperture. A plurality of channels are provided along the length of the tube which contain removable wires or rods which stiffen the tube for insertion into the bladder. A balloon means is provided to hold the catheter in place.

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 for draining or aspirating the urinary bladder. 
BACKGROUND 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 of 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 congenital 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 functions and careful monitoring allows one to 
identify and prevent kidney failure. 
It is important to drain the bladder by an indwelling catheter after 
prostate or bladder surgery. An indwelling Foley type catheter is usually 
the catheter of choice. U.S. Pat. No. 5,300,022 to Klapper et al and 
incorporated herein, shows an 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. Pat. 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 is 
common in the prior art. U.S. Pat. No. 5,098,379, which is incorporated 
herein by reference, discloses a Foley catheter having a balloon portion 
and a lubricated resilient sleeve. U.S. Pat. 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. Pat. 
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 
fluid. The speed of irrigation can be controlled by different mechanisms 
or different pumps. 
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 renal 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 and 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 or 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 experienced with conventional 
indwelling catheters. The catheter of the invention comprises a 
substantially collapsible elongated elastomeric tube which is open at a 
proximal end and has at least one opening at the distal end. A valve means 
is provided at the proximal end of the tube. The tube is provided with a 
plurality of horizontal channels containing removable wire or rod means 
for stiffening the tube when inserting into the patient. 
Advantageously, the means for stiffening or collapsing the tube includes a 
balloon means. The balloon means may be within the tube or along its 
periphery. Preferably, a small hollow tube connects the balloon to a valve 
system located near the open proximal end. 
In accordance with one embodiment of the present invention, there is 
provided a device and method for draining and aspirating the urinary 
system using a collapsible hollow elastomeric catheter tube. In the 
device, the tube is thin enough to keep it in a state of collapse at rest. 
The collapsible tube is open at one end, that is, the proximal end, has at 
least one aperture at the distal end or at the other end, and a rigid tip. 
The open end has a valve which allows passage of fluid into and out of the 
tube. 
There are one or more holes, at the distal end of the tube, which is the 
end that connects to the bladder. A circular hollow tube or a thickener 
portion can be used to reinforce the open end of the catheter tube, which 
is the end that connects 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. 
OBJECT 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 after surgery which 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 ufological 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 left indwelling. 
It is a further object of this invention to provide a 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.

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. 
FIGS. 1-3 show the collapsible catheter of the invention with the removable 
stiffening means. The collapsible hollow elastomeric catheter 10 comprises 
a tube 12 which is approximately ten to twenty-five millimeters, 
preferably about 10 to 15 mm in diameter, thirty to thirty-five 
centimeters in length, and one tenth of a millimeter in thickness. The 
tube 12 must be thin enough to keep it in a collapsed state at all times, 
for example, about a tenth of a millimeter in thickness. There are one or 
more reinforced openings or holes 14, preferably two or three, located at 
the distal end of tube 12 which is the end that connects into the bladder. 
The holes 14 are advantageously six to eight millimeters in diameter. The 
distal tip is preferably thickened to aid in insertion into the bladder. 
The open end 20 of the tube 12 is the end that can be connected to a 
calibrated urine bag. This end 20 can be thickened or reinforced with a 
circular hollow tube or a valve to prevent collapse of the open end and 
facilitate the connection of the tube 12 to a urine bag. 
Around the periphery of the tube 12 are a plurality of parallel channels 18 
which house removable rods or wires 19 which provide stiffness to the 
catheter 10 during insertion into the patient. The rods or wires 19 may be 
metallic, plastic or fiberglass. The channels 18 may be formed within the 
wall of the tube 12 or on the inner 16 or outer portion of the wall. 
To prevent the tube 12 from slipping out of the urinary bladder an 
inflatable balloon 15 can be provided near the distal end as shown in 
FIGS. 1 and 3. The balloon 15 may be inflated through the hollow tube or 
channel 11 which runs along wall 16 to a valve system 17. 
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 tube 12 may be made from silicone rubber, latex rubber or 
any other suitable medically approved elastomer. The distal end is 
preferably thickened about 1 to 2 cm so as to provide sufficient stiffness 
to prevent collapse during drainage. The proximal end preferably has a 
thickness to prevent collapse of about 2-3 cm in length. 
The valve system 17 may be one, two or three ways. The balloon member 15 is 
attached to the periphery of the 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 11 of the valve system 17 
located near the proximal end. The balloon can be filled with air or 
fluid. When inflated, the balloon can fully or partially support the sides 
of the tube. 
The present invention will mimic the physiological status 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 then injected with fluid until 
the catheter is stiff enough to be threaded into the bladder. The balloon 
of the catheter is then further inflated with fluid to prevent the 
catheter from slipping out of the bladder. The balloon can then be 
deflated in the manner just described. 
In the method for draining the urinary bladder, the catheter is stiffened 
by placement of the wires or rods within their channels. The stiffened 
urethral catheter is well lubricated and passed urethrally into the 
bladder. Once the urethral catheter is in position, as noted by the return 
of urine, the balloon at the distal end of the catheter is inflated. After 
the catheter is secured in the urinary bladder, the fluid in the 
stiffening wires or rods are withdrawn, which collapses the indwelling 
catheter. 
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 from the spirit and scope of the invention.