JPH0464704B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an auxiliary bladder device,
An auxiliary bladder device capable of maintaining natural urination by filling and contracting the bladder even when a catheter is indwelling, without the loss of bladder function that inevitably occurs when a conventional urinary catheter is indwelled in the body The purpose of this is to maintain or restore bladder function, and the other purpose is to maintain or restore bladder function.
One object of the present invention is to provide a safe and inexpensive automatic intermittent nonurinary device useful for preventing cystitis, pyelonephritis, etc. caused by urinary tract infections from the outside world.

Patients with spinal cord injury, cerebral hemorrhage, encephalomalacia, or post-surgery patients, as well as bedridden elderly people, are often accompanied by symptoms such as difficulty in urination and urinary incontinence. In such cases, urinary catheters are widely used to ensure a smooth urinary tract, promote maintenance or improvement of renal function, or prevent urine leakage. However,
In the conventional continuous urinary catheterization method, which involves the long-term indwelling of a urinary catheter in the body, the bladder is always in a contracted state, and the normal urinary function due to repeated filling and contraction, which is inherent in living organisms, is completely lost. In other words, in the urinary mechanism of a normal person, urine accumulates in the bladder and the bladder wall stretches as it fills, stimulating the unique receptors that are naturally present in the bladder wall. , after reaching the brainstem and cerebral micturition center, the stimulus then descends from the cerebrum to the spinal cord, causing bladder wall contraction, pelvic floor muscle group relaxation,
The mechanism is relaxation of the urethral sphincter and urination. In contrast, in the conventional continuous catheterization method for patients with indwelling catheters, the most basic process of the micturition mechanism, which is stimulation of receptors due to bladder filling due to bladder wall stretching, is missing, so the subsequent micturition mechanism is completely stopped. be. In other words, it is no exaggeration to say that it has lost almost 100% of its function as a bladder; it has become nothing more than a passageway for urine or a storage area for residual urine. The following three points have been pointed out as medical or physiological problems caused in such cases. One of these is that with conventional continuous catheterization in patients with catheters, especially in the supine position, a small amount of urine accumulates at the back of the bladder as it becomes a dead space, and this residual urine is an ideal place for bacteria to enter through the catheter tube. Since it acts as a culture medium, it is a breeding ground for cystitis, nephritis, and even pyelonephritis. The second is Foley Chip Necrosis.
tip necrosis), commonly known as
The tip of the indwelling balloon catheter constantly presses on the contracted bladder wall, resulting in ulcers and even necrosis due to poor blood circulation in that area, which becomes an ideal entry point for bacteria and risks causing bladder ulcers. The point is that it is expensive. And 3
First, bladder function completely stops when the catheter is indwelled, and the longer the catheter is left in place, the slower the recovery of bladder function after the catheter is removed. For example, in patients with urinary retention due to neurogenic bladder after spinal cord injury, cerebrovascular disorder, or pelvic surgery, bladder training is started in the subacute phase when the abnormality of urinary function has stabilized, but an indwelling catheter is continued. It has been pointed out in the past that this is difficult with the materials used.

Conventionally, as a measure to solve the above-mentioned problems associated with long-term indwelling of a urinary catheter, a urinary control system (U.S. Pat. No. 3,503,401) in which a siphon tube is maintained at the discharge end of a urinary catheter and a bladder training device (Japanese Patent Application Laid-open No. No. 133997 (Sho 51-133997) has been proposed. These devices appear to be useful in solving the above-mentioned problems because the bladder repeatedly fills and contracts alternately even when a urinary catheter is indwelling. However, despite the clarity of the siphon principle and the simplicity of the device, these devices still have various technical problems that must be solved before they can be used in clinical practice.

For example, the first problem with the urine control system of U.S. Pat. The fundamental problem is that the possibility of retrograde bacterial infection from the outside world is extremely large. In other words, in this system, in the process of returning from negative pressure to normal pressure immediately after the siphon flow, the backflow from the outside world toward the bladder is temporary, but much stronger than in continuous catheterization using an ordinary indwelling catheter. However, at this time, the bacteria attached to the dust floating in the air forms bubbles, or the urine contaminated with them travels backwards through the drainage tube and reaches the bladder. There is. Bacteria that reach the bladder begin to multiply exponentially depending on the number of bacteria, so it goes without saying that it is desirable that the number of bacteria is as small as possible. In other words, although this system has been devised to dilute bacteria that have entered the bladder and expel them as much as possible, it is not fully satisfactory in terms of perspective and ingenuity to prevent bacteria from entering from the outside world as much as possible. This is actually the main reason why it cannot be used clinically in terms of its effectiveness in preventing urinary tract infections. This point can also be considered in the same way regarding the invasion of bacteria from the air tube.
The second problem with this system is that the part that forms the siphon tube is very thin and has a particularly long tube, so it is difficult to drain the liquid after the siphon flows, and many short liquid columns are created inside the siphon tube. It consists in remaining and being confined. In other words, in such a case, the subsequent siphon cycle will not work normally; for example, if negative pressure is trapped between two short liquid columns, the next siphon flow will work before the bladder is filled. Undesirable.

On the other hand, the basic problem with the bladder training device disclosed in JP-A-51-133997 is that its urination cycle is significantly longer than that of a normal person. The reason why intermittent urinary catheterization is superior to continuous urinary catheterization in terms of infection prevention effect is that even if bacteria invade the bladder, the bacteria can completely proliferate without leaving any residual urine. However, if the urination cycle is long and urine is stored in the bladder for a long time, bacteria will increase exponentially. Furthermore, the risk of complications such as severe ascending pyelonephritis becomes a serious problem. This is common knowledge among medical professionals involved in urology today; for example, see Nishiura: Modern Medicine, December issue, p. 22 (1979).
As stated in According to the studies of the present inventors, urine needs to be excreted preferably within 3 hours, and at the latest within 5 hours. However, in this bladder training device, as is clear from the specification, especially from FIGS. 1 and 2, the volume of the pressure chamber provided below the bladder position is much larger than the volume of the bladder. It is described that the lower end of the inverted U-shaped siphon tube provided therein is inserted deep into the pressure chamber. (In the bladder training device of JP-A No. 51-133997, there are no specific numerical values listed for the dimensions other than the inner diameter of the siphon tube, and their relative sizes and positional relationships are as shown in the drawing. ) The amount of fluid discharged by one siphon flow, in other words, the amount of fluid that must be filled before the next siphon flow occurs, is the inverse of the bladder capacity (V ₁ ) and the pressure chamber. It is approximately equal to the sum of the volumes (V ₂ ) above the lower end of the U-shaped siphon tube, and therefore, the larger V ₂ is, the more the urination cycle deviates from the body's natural urination cycle, causing the problem that the time between micturition becomes longer. . From this point of view, it is desirable that the insertion depth of the siphon pipe into the pressure chamber be as shallow as possible. Therefore, if the depth of insertion of the siphon tube in Figures 1 and 2 of this bladder training device is made shallower, this does not necessarily solve the problem; in that case, the catheter Since the pressure drop of the flow is large due to the small inner diameter, the drainage portion of the pressure chamber above the lower end of the siphon pipe is emptied first before the bladder is emptied, and the siphon flow stops there. That is, this problem is
Since V ₁ , V ₂ , the inner diameter of the catheter, and the inner diameter of the siphon tube are closely related to each other, ventilation adjustment is performed by sealing the pressure chamber with a filter having ventilation resistance, as described later in the present invention. This problem could only be solved by installing a pipe. In this regard, in the bladder training device described above, the tube corresponding to the ventilation adjustment tube of the present invention is simply connected to the urine collection container or the air-containing bag, and air can freely flow between the tubes, which eliminates the above-mentioned problem. A solution is essentially impossible. As detailed above, the aforementioned Unexamined Japanese Patent Publication No. 51-
Although the bladder training device of No. 133997 is useful as a short-term bladder training device, it is difficult to put into practical use because it has a poor infection prevention effect and infection becomes fixed when used for a long period of time.

The present inventors have taken into account the problems of the prior art described in detail above, and have developed a method that completely prevents bacterial infection from the outside world even during long-term catheterization, and maintains and restores bladder function. The present invention was arrived at as a result of intensive research to provide an auxiliary bladder device useful for achieving this goal.

That is, in the present invention, the discharge end of the urinary catheter 2 placed in the bladder is connected to the concentric siphon tube 10.
The uppermost end of the inner pipe 11 of the concentric siphon pipe and the lowermost end of the outer pipe 12 of the concentric siphon pipe are directly connected to the pressure adjustment chamber 3 containing the or connecting pipe 4. The pressure adjustment chamber 3
and a urine storage chamber 5 provided below the pressure adjustment chamber 3.
are connected to each other by the inner tube 11 of the concentric siphon tube, and the pressure adjustment chamber 3 has a vent sealed with a ventilation resistant filter 15 at a position higher than the highest position of the concentric siphon tube 10. 14 is an auxiliary bladder device.

A specific embodiment of the present invention will be explained in detail below with reference to the drawings. In FIG. 1, 1 is a bladder, 2 is a urinary catheter placed in the bladder, 3 is a pressure adjustment chamber, 4 is a tube connecting the discharge end of the urinary catheter and the pressure adjustment chamber, 5 is a connecting tube. A urine storage chamber provided below the pressure adjustment chamber; 6 a vent provided in the urine storage chamber; 7 a sterilization filter provided in the vent; 8 a drain provided below the urine storage chamber; Exit, 9 is the stopper,
10 is a concentric shaft type siphon tube built into the pressure adjustment chamber; 11 is an inner pipe of the concentric shaft type siphon tube; 12
13 is an outer tube of the concentric siphon tube; 13 is a bacterial retrograde prevention device provided at the entrance of the urine storage chamber; 14 is a vent provided at a position higher than the highest position of the concentric siphon tube; 15 is a ventilation resistant filter that seals the ventilation openings.

The structural features of the auxiliary bladder device of the present invention are that, because it uses a concentric siphon tube 10, it has a compact external shape that is easier to handle than a device that uses an inverted U-shaped siphon tube. In addition, a vent hole 14 having a ventilation resistant filter 15 is provided at a position higher than the highest position of the concentric siphon tube 10 built into the pressure adjustment chamber 3. Generally, the inner diameter of the urinary catheter 2 that is indwelled in the urethra is as small as 2 to 3 mm, and because it is long, there is a large pressure drop when urine flows through it.
Because the fluid supply rate (Q ₁ ) cannot keep up with the drainage rate (Q ₂ ) of the pressure adjustment chamber 3 by the siphon tube 10, the pressure adjustment chamber 3 is drained before the bladder 1 is completely emptied. It has a tendency to empty first, but
In the device of the present invention, by providing the ventilation port 14 with ventilation resistance, it is possible to reduce the siphon flow rate and maintain the negative pressure generated in the system due to the siphon flow for a long time. the result,
For the first time, it became possible to bring Q ₁ as close as possible to Q ₂ . This means that the excluded volume V ₂ in the pressure adjustment chamber, that is, the volume between the lowermost end of the outer pipe 12 of the concentric siphon pipe and the uppermost end of the inner pipe 11 of the concentric siphon pipe, is reduced to the necessary minimum. As a result, it has become possible for the first time to shorten the urination cycle, that is, to bring it as close as possible to the natural urination cycle of the living body. In other words,
The first advantage of providing an airflow-resistant filter in the present invention is that the urination cycle is shortened, so that even if bacteria enter the bladder from inside or outside the catheter, the bacteria can be expelled before they multiply in large quantities. The reason is that it has become possible. Second, this airflow-resistant filter can also be expected to play a role as a sterilization filter, making it possible to prevent contamination by bacteria from the outside world caused by the negative pressure generated in the system after siphon flow. That's true. Thirdly, because the negative pressure generated in the system as a result of siphon flow is maintained over a long period of time, the difference in height, which is the main driving force when flowing from the bladder into the pressure adjustment chamber, is small. In other words, it has become possible to significantly downsize the device.

As the ventilation resistance filter 15, one having an air flow rate of 10 to 20,000 ml/min is preferably used.
If the air flow rate is less than 10 ml/min, the siphon flow will not work effectively, so the air flow rate should be 10 ml/min or more, or even 50 ml/min.
ml/min or more, especially 100 ml/min or more is preferably used; on the other hand, if it exceeds 20,000 ml/min, the siphon flow becomes too fast and the pressure adjustment chamber is emptied before the bladder is emptied. Therefore, those with a flow rate of 20,000 ml/min or less, further 10,000 ml/min or less, further 5,000 ml/min or less, particularly 1,000 ml/min or less are preferably used. The air flow rate in this case refers to the value when particle-free air at 20°C is filtered at a pressure of 0.07Kg/cm ² (1PSI). Various types of airflow-resistant filter 13 can be manufactured by controlling the pore size, porosity, and area, but from the viewpoint of preventing bacteria from entering the system as much as possible, one with a pore size of 1 μm or less is preferable. The material and shape of the air permeability filter 15 are not particularly limited, but generally include porous membrane filters made of regenerated cellulose, nitrocellulose, cellulose acetate, polyvinylidene fluoride, polytetrafluoroethylene, etc., sponges, and nonwoven fabrics. Alternatively, a cotton plug or the like is preferably used.

The installation position of the ventilation resistance filter 15 in the pressure adjustment chamber 3 is such that during the filling process of the bladder 1, the liquid column is at the same height not only in the gap between the inner and outer tubes of the concentric siphon tube but also in the pressure adjustment chamber 3. In order to avoid contamination with urine from the point where the concentric siphon tube 10 ascends, it is necessary that the position be higher than the highest position of the concentric shaft type siphon tube 10. In addition, when a patient coughs or sneezes, the liquid column may suddenly rise due to the instantaneous pressure fluctuations applied to the abdomen, so the height should be set to allow for some extra margin, and the sudden rise in the liquid column may cause the liquid column to rise suddenly. It is preferable to take measures such as providing a barrier inside the vent 14 to prevent this.

The inner diameter of the inner tube 11 of the concentric siphon tube is 1 to 10
mm, particularly preferably in the range of 3 to 7 mm. Further, it is preferable to set the inner diameter of the outer tube 12 so that the annular cross-sectional area between the outer wall of the inner tube 11 and the inner wall of the outer tube 12 is approximately equal to the inner diameter cross-sectional area of the inner tube 11. In this case, if it is less than 1 mm, there is a high probability that multiple short liquid columns will be trapped after siphon flow, while if it exceeds 10 mm, siphon flow tends to be difficult to work effectively. The lower end of the outer tube of the concentric siphon tube preferably has a widening structure, for example, an inverted funnel, in order to prevent the liquid column from being trapped after the siphon flow. The appropriate volume of the pressure adjustment chamber 3 is 50 to 150 ml/. The internal volume (V ₂ ) is preferably 100 ml or less. The urine output per day for an adult male is approximately 1500 ml, so if the bladder capacity (V ₁ ) is approximately 200 ml, the output volume (V ₁ + V ₂ ) with one siphon flow will be approximately 200 to 300 ml.
Urine is excreted 5 to 7 times a day, that is, once every 3 to 5 hours.

The appropriate internal volume of the urine storage chamber 5 is about 2000 ml, which corresponds to the patient's maximum urine output per day. It is preferable to have a structure having a retrograde obstruction device or drip chamber 11, a vent 6 equipped with a sterilization filter 7, and an outlet 8 for draining urine from the lower part.

As the urinary catheter 2 used in the auxiliary bladder device of the present invention, a Foley balloon catheter, which is generally widely used for long-term indwelling, is preferably used. To prevent this, double balloon catheters or irregularly shaped balloon catheters that bulge also in the prostate region are also used. In addition, by continuously injecting disinfectant dropwise using a three-way balloon catheter that also has an injection path for disinfectant for bladder cleaning, the bladder can be cleaned without the need for conventional complicated operations. can also be done automatically.

The vertical positional relationship of various components in the auxiliary bladder device of the present invention will be described in more detail. First, when the urinary catheter 2 is placed in the bladder, the height from the insertion end position to the highest reached position of the inner tube 11 of the concentric siphon tube is the height required to fill the bladder of a normal person. Since the internal pressure is approximately 100 mm in the water column, it can vary from 0 to 100 mm depending on the purpose of use.
It would be better if it could be adjusted between. In this case, if it is made higher than necessary, for example, in patients with atonic neurogenic bladder, the bladder wall may be forced to stretch excessively, which may lead to receptor destruction, which is not very preferable. Next, when the urinary catheter 2 is placed in the bladder, the difference in height from the position of the insertion end to the entrance of the pressure adjustment chamber 3 can be significantly shortened with the device of the present invention. 200mm
is suitable. Further, the height difference between the lowest end of the outer tube 12 of the concentric siphon tube in the pressure adjustment chamber 3 and the entrance of the urine storage chamber 5, which is related to the driving force during siphon flow, is preferably 100 to 300 mm.

The material constituting the auxiliary bladder device of the present invention is not particularly limited, and may be made of hard plastic that can be injection molded such as polycarbonate or acrylonitrile/styrene resin, or flexible material such as soft polyvinyl chloride. It may also be made of soft plastic.

Next, the operating conditions during actual use of the auxiliary bladder device of the present invention will be explained with reference to the drawings. Figure 2 shows that the bladder 1 and pressure adjustment chamber 3 are filled with urine after a certain period of time.
It is a diagram of the situation immediately before the siphon works. FIG. 3 is a diagram showing a state in which the siphon flow reaches its final stage after a certain period of time after the siphon flow has started, and the bladder 1 has already been emptied. FIG. 4 shows a situation where the siphon flow has stopped, and the above cycle will be repeated one after another.

The auxiliary bladder device of the present invention allows the bladder to repeatedly fill and contract at regular intervals by placing a urinary catheter in the bladder without using any complicated mechanical or electrical drive or control mechanism. Compared to the conventional simple indwelling catheter method, it is possible to maintain bladder function and perform recovery training, and it can also greatly reduce urinary tract infections. That is, the auxiliary bladder device of the present invention (1) is used at regular intervals (at least 5 hours,
Forced cleaning or rinsing of the bladder (preferably within 3 hours) can prevent retention of residual urine and bacterial growth that would lead to the spread of cystitis;
(2) The filling process of the bladder occurs as a result of the so-called “Foley tip necrosis” caused by the tip of the indwelling catheter constantly compressing the contracted bladder wall.
It is possible to prevent the occurrence of cystitis caused by pressure necrosis of the bladder wall, and (3) the series of filling and contracting movements of the bladder are caused by the bladder wall being constantly contracted. In addition to preventing muscle degeneration, a healthy bladder wall increases resistance to infection;
(4) As a result of the bladder filling process, which prevents constant negative pressure from acting on the bladder as seen in the case of continuous urinary catheterization using an ordinary indwelling catheter, bacteria from the outside world may enter the bladder through the inside and outside of the catheter tube. It is characterized by being able to reduce the risk of intrusion.

The auxiliary bladder device of the present invention can be used to treat spinal cord injury, cerebral hemorrhage,
In patients with encephalomalacia or post-surgery patients, bedridden elderly, etc. who exhibit symptoms of urinary difficulty or urinary incontinence,
It is effective when used. As a specific example of its use, for example, in the case of patients with spinal cord injuries, conventional continuous urinary catheterization required an indwelling catheter for one to two months, but by using the auxiliary bladder device of the present invention (automatic intermittent urination) ) It must be said that it is of great significance in terms of rehabilitation, since it is possible to restore bladder function to a state where a catheter is not required in two weeks without causing urinary tract infection. Furthermore, when the auxiliary bladder device of the present invention was used on a bedridden elderly patient with urinary incontinence, no symptoms such as cystitis or fever were observed even after 2 months, and the patient was freed from unpleasant symptoms such as diaper rash.

[Brief explanation of the drawing]

The drawings show one embodiment of the auxiliary bladder device of the present invention, and FIG. 1 is an overall view showing the overall positional relationship of the auxiliary bladder device of the present invention, and FIG. Fig. 3 is a state diagram immediately before siphon flow has occurred and the bladder has already been emptied and siphon flow has stopped, and Fig. 4 is a state diagram when siphon flow has stopped. 1 is a bladder, 2 is a urinary catheter, 3 is a pressure adjustment chamber, 4 is a connecting pipe, 5 is a urine storage chamber, 6 is a vent, 7 is a sterilization filter, 8 is an outlet, 9 is a stopper,
10 is a concentric shaft type siphon tube, 11 is an inner tube of the concentric shaft type siphon tube, 12 is an outer tube of the concentric shaft type siphon tube, 13 is a bacterial migration prevention device, 14 is a vent hole, 1
5 is a ventilation resistant filter.

Claims (1)

[Claims] 1. The discharge end of the urinary catheter 2 indwelled in the bladder is connected to the pressure adjustment chamber 3 containing the concentric siphon tube 10 by the uppermost end of the inner tube 11 of the concentric siphon tube 10 and the concentric siphon tube 10. The lowermost end of the outer pipe 12 of the siphon pipe is directly connected or connected via the connecting pipe 4, and the pressure regulating chamber 3 and the pressure regulating chamber 3 are connected directly or via the connecting pipe 4.
The urine storage chamber 5 provided further down is connected to the inner tube 11 of the concentric siphon tube, and the pressure adjustment chamber 3 has a ventilation resistor installed at a position higher than the highest position of the concentric siphon tube 10. This auxiliary bladder device is provided with a vent hole 14 sealed by a sex filter 15.