JP7539197B1 - Artificial bladder device - Google Patents

Abstract

[Problem] To provide an artificial bladder device that has resistance to deformation such as twisting or bending of the pouch, while being able to secure a drain passage for waste flowing down to a drain valve by a curved drain wire even if the first wall surface and the second wall surface try to come into close contact with each other. [Solution] A curved drain wire 5 is housed in a cavity 2c formed between a first wall surface 2a and a second wall surface 2b of a pouch 2, and the drain wire 5 has a pair of straight ends 5b connected to both sides of the curved shape, which are respectively attached to a drain valve 4, and the curved ends 5a are extended to the vicinity of a backflow prevention area P. [Selected Figure] Figure 1

Description

The present invention relates to an artificial bladder device.

Figure 6 is a front view of an artificial bladder device equipped with a vinyl bag (pouch) for collecting excrement (urine), and Figure 7 is a side view of the artificial bladder device. The artificial bladder device 50 is formed by overlapping two films and welding the periphery to form a pouch 51. The internal space surrounded by the first wall surface 51a and the second wall surface 51b of the pouch 51 becomes a cavity 51c in which urine can be accumulated. Generally, the upper part of the pouch 51 is a backflow prevention area P in which a backflow prevention means is installed. In Figures 6 and 7, the backflow prevention area P is colored and the boundary line Q is shown by a dashed line. Urine flows from the urostomy side to the discharge valve 52 side by multiple sheets or the like welded to the wall surface, and flow in the opposite direction is prevented, preventing infection.

A base plate 53 with a urostomy connection port 53a is provided on the upper part of the pouch 51. The base plate 53 is adhered to the abdominal wall around the urostomy to hold the pouch 51. A discharge valve 52 is provided on the lower part of the pouch 51, and the base plate 53 and the discharge valve 52 are welded or adhered to the pouch wall surface to form a cavity 51c throughout the pouch 51. Urine is discharged intermittently in small amounts from the urostomy (urinary stoma) through the urostomy connection port 53a and accumulated in the cavity 51c formed within the pouch 51.
In addition, at night, for example, a urobag can be attached to a bedside frame and connected via a drainage valve and extension tube, increasing the amount of urine collected by approximately ten times and enabling collection for a long period of time.

The artificial bladder device 50 is used in an upright position during the day, but at night when sleeping, it is used in a supine position with an expansion bag connected. In other words, the artificial bladder device 50 has two states depending on the user's body position: an upright mode and a supine mode with a urobag connected, and the operation is significantly different between the two modes.
First, in the standing mode, the pouch 51 is in a nearly vertical position, the drain valve 52 is closed, and the collected urine is accumulated in the cavity 51c of the pouch 51. The accumulated urine is subjected to a downward force by gravity, and is discharged to the outside by opening the drain valve 52. The usage time varies depending on the capacity of the pouch 51 and the physical condition, and is about 1 to 4 hours.

On the other hand, in the supine mode, the pouch 51 is almost horizontal, and the discharge valve 52 is open and connected to the urobag via an extension tube (not shown). The pouch 51 is empty, and urine that is discharged little by little intermittently from the urostomy falls naturally almost horizontally into the discharge valve 52. Therefore, both walls of the pouch 51 are in contact and the urine moves through a small gap. Also, the pouch 51 is pulled and twisted or bent depending on the body position, and is always used in a complexly deformed state; if the twisting deformation is large, the gap through which the urine passes is closed and the urine is trapped inside the pouch 51 and does not reach the discharge valve 52.

The rotational force of the pouch 51 is applied from the outside via the extension tube. The urobag itself may rotate during installation or urine testing, and the rotational force is transmitted to the pouch 51 via the extension tube, causing the pouch 51 to be used in a twisted and deformed state. If the deformation is large, the gap through which urine passes closes, causing the urine to accumulate in the pouch 51 and not reach the drain valve 52 (see Figure 8). If this closed state continues for a long time and the user turns over and assumes a prone position, body pressure is applied to the accumulated urine, even if a backflow prevention means is provided, and urine may flow back from the urostomy to the kidneys or leak from the panel 53 that is attached to the abdominal wall around the urostomy. Therefore, various methods have been devised to prevent deformation such as twisting or bending of the pouch 51.

For example, one idea is to provide a reinforcing member on the pouch wall to prevent twisting. To prevent twisting, a long, thin, flat reinforcing member is provided extending toward the side of the pouch. This is intended to allow the wall to cancel the rotational moment in the discharge axis direction (see Patent Document 1; JP 2018-507067 A). Another idea is to provide a hollow discharge tube in the pouch to ensure a discharge path when the wall is closed (see Patent Document 2; JP 3681717 A).

JP 2018-507067 A Patent No. 3681717

In Patent Document 1, a reinforcing member is added to the pouch to cancel the rotation moment at the pouch wall. The pouch wall is required to be easy to wear and flexible, so it is made of a thin film of about 80 μm, which is not durable enough and there is a risk that the wall will break and the collected urine will leak all at once, which is a hygiene problem.
Since the reinforcing member extends laterally perpendicular to the longitudinal direction of the pouch, if the reinforcing member is large or thick, it may feel like a foreign object to the user. Furthermore, if an external force is applied to the reinforcing member, it may pierce the body, which poses a safety problem.

In Patent Document 2, a hollow drainage tube is provided from the opening of the pouch to the bottom of the pouch, ensuring a drainage path for excrement even when the pouch walls are in close contact with each other. However, it does not have the function to prevent the pouch from twisting or bending, and the drainage tube must be fixed to the upper and lower ends of the pouch, making installation cumbersome, and there is a risk that the upper end of the tube will break the pouch wall due to deformation of the pouch. In addition, secretions mixed with urine and impurities dissolved in chemicals applied to the face plate are likely to clog the inside of the tube and the drainage path.

The object of the present invention is to provide an artificial bladder device that has resistance to deformation such as twisting or bending of the pouch, and that can ensure a drain passage for waste flowing down to the drain valve by using a curved drain wire even if the first wall surface and the second wall surface try to come into close contact.

In order to solve the above-mentioned problems, the present invention has the following configuration.
An artificial bladder device having a pouch for storing waste excreted from an artificial bladder, the pouch being formed by overlapping two thin films forming a first wall surface and a second wall surface and welding or bonding the periphery of the two thin films to form a cavity capable of storing the collected waste inside without leakage, a face plate provided at the upper part of the pouch and having a urostomy connection port, and a drain valve provided at the lower part of the pouch for discharging the waste collected in the pouch, the device being characterized in that a curved drain wire is housed in the cavity formed between the first wall surface and the second wall surface, and the drain wire has a pair of straight ends connected to both sides of the curved shape, which are respectively attached to the drain valve, and the curved ends are extended to the vicinity of a backflow prevention area.
According to the above configuration, a curved drain wire is housed in the cavity, a pair of straight ends connected to both sides of the curved shape of the drain wire are respectively attached to the drain valve, and the curved ends are extended to the vicinity of the backflow prevention area. Therefore, while providing resistance to deformation such as twisting or bending of the pouch, the curved drain wire can ensure a drainage passage for waste (urine) flowing down to the drain valve even if the first wall surface and the second wall surface try to come into close contact with each other.

The drain wire is preferably made of a flexible polymer wire.
This prevents accidents such as the pouch being torn by a broken drain wire tip or the user being injured, ensuring safety.

It is preferable that the pair of straight portions of the drain wire are parallel to a central axis of the drain valve and are assembled such that a valve opening of the drain valve is located between the straight ends of the drain wire.
In this way, since the valve opening of the drain valve is positioned between the pair of straight end portions, an increase in the resistance to urine discharge caused by the drain wire can be suppressed, impurities mixed in the urine are easily discharged, and the pouch does not become clogged.

It is desirable that the cavity side end of the drain valve facing the cavity is provided with fitting holes into which a pair of straight ends of the drain wire are each fitted, and that each fitting hole is provided with a locking mechanism that allows the straight ends to be inserted but not pulled out.
This simplifies the assembly of the drain wire to the pouch and also prevents the drain wire from coming off the discharge valve when the pouch is deformed, improving the reliability of the device.

One end of an extension tube may be connected to the discharge valve, and the other end of the extension tube may be connected to a urobag.
As a result, even if an additional urobag is added to the pouch, the drain wire prevents the pouch from closing, allowing the patient to sleep peacefully without worrying about overflow, improving their quality of life (QOL).

The rational arrangement of the curved drain wire within the cavity provides a strong resistance to twisting and deformation of the pouch while ensuring a passage for the discharge of excrement. In addition, the drain wire is highly safe, with a shape and material that is less likely to cause injury.
This proposal can provide an artificial bladder device at low cost due to its simple structure. In addition, when adding a urobag to the pouch, the drain wire prevents the pouch from closing, allowing patients to sleep without worrying about overflow.

FIG. 1 is a front view of an embodiment of an artificial bladder device according to the present invention. FIG. 1 is a side view of an embodiment of an artificial bladder device according to the present invention. FIG. 2 is a front cross-sectional view of the vicinity of the discharge valve and drain wire of an embodiment of the artificial bladder device according to the present invention. FIG. 2 is a cross-sectional view taken along line AA' around the exhaust valve and the drain wire of an embodiment of the artificial bladder device according to the present invention. This is an example of an artificial bladder device system in which a urobag is connected to a pouch. FIG. 1 is a front view of an embodiment of a typical artificial bladder device. FIG. 1 is a side view of an embodiment of a typical artificial bladder device. FIG. 1 is a photograph of a pouch in a twisted closed state.

An example of an artificial bladder device will be described below with reference to Figs.
First, an overview of the artificial bladder device 1 will be described. Fig. 1 is a front view of the artificial bladder device 1. Fig. 2 is a side view of the artificial bladder device 1. The waste (urine) collection bag pouch (hereinafter simply referred to as "pouch") 2 is formed by overlapping two films. The pouch 2 has a first wall surface 2a and a second wall surface 2b that are welded or bonded around their peripheries to form a cavity 2c capable of storing urine inside. The first wall surface 2a and the second wall surface 2b are made of a polymer film such as polyethylene having a film thickness of about 80 μm. A urine storage capacity of about 0.2 liters is often adopted for the cavity 2c.

In Figures 1 and 2, the upper part of the pouch 2 is a backflow prevention area P where a backflow prevention means is installed. Specifically, in the backflow prevention area P, multiple sheets etc. are welded to the first wall surface 2a and the second wall surface 2b, and urine flows only from the urostomy connection port 3a side to the discharge valve 4 side, preventing reverse flow. In Figures 1 and 2, the backflow prevention area P is colored and the boundary line Q is shown by a dashed line. The area below the boundary line Q does not affect backflow prevention, and urine accumulates and is discharged from the discharge valve 4.

A base plate 3 having a urostomy connection port 3a is provided on the upper part of the pouch 2. The base plate 3 is adhered to the abdominal wall around the urostomy to hold the pouch 2. The base plate 3 may have a two-piece structure. A hook for a fastening belt may be provided on the base plate 3. A nonwoven fabric surface may be provided on the abdominal wall side of the pouch 2.
A drain valve 4 is provided at the bottom of the pouch 2, and the base plate 3 and the drain valve 4 are welded or bonded to the first wall surface 2a and the second wall surface 2b to form a cavity 2c within the pouch 2. A curved (e.g., inverted U-shaped) drain wire 5 is provided within the cavity 2c. Urine is intermittently discharged in small amounts from the urostomy connection port 3a and accumulated in the cavity 2c.

Figure 3 shows a front cross-sectional view of the drain valve 4 and the drain wire 5. Figure 4 shows a cross-sectional view of the drain valve 4 and the drain wire 5 shown in Figure 3 along the arrow A-A'. The drain valve 4 is welded to the first wall 2a and the second wall 2b. The drain wire 5 is a round thin wire that is inverted U-shaped overall and is placed in the cavity 2c of the pouch 2. The inverted U-shaped end (curved end) 5a of the drain wire 5 is extended to the vicinity of the backflow prevention area P, and is long enough not to enter the backflow prevention area P, so that it does not affect the backflow prevention function. As shown in Figure 4, the drain wire 5 prevents the first wall 2a and the second wall 2b from coming into close contact even if the pouch 2 is twisted, and ensures a small gap through which urine can pass. This ensures a drain path even if the pouch 2 is severely deformed, and when a urobag (described later) is connected, urine continues to be discharged, preventing overflow.

The drain wire 5 is preferably made of a flexible polymer wire so that it exerts resistance to suppress deformation of the pouch 2, such as twisting or bending, and so that the drain wire 5 itself will not break due to twisting. If the drain wire 5 breaks, there is a risk of damage to the pouch 2 or injury. In order to improve the strength of the drain wire 5, the shape of the inverted U-shaped end 5a may be annular. A ladder frame-shaped or truss-shaped connecting member may be provided on the straight portion leading to the inverted U-shaped end 5a.

3, the pair of straight portions of the drain wire 5 are parallel to the central axis of the drain valve 4, and are assembled so that the valve opening 4a of the drain valve 4 is located between the straight ends 5b of the drain wire 5. In this case, it is desirable to arrange the straight ends 5b so that the distance between them is maximum.
The inverted U-shaped end 5a of the drain wire 5 has a curved shape and therefore has resistance to rotational moment. Therefore, when the pouch 2 is twisted, the inverted U-shaped end 5a comes into contact with the first wall surface 2a and/or the second wall surface 2b, and a repulsive force that resists twisting is generated in the drain wire 5. In addition, since the valve opening 4a of the drain valve 4 is disposed between the pair of straight ends 5b, it is possible to suppress an increase in the drain resistance of urine caused by the drain wire 5, and impurities mixed in urine are easily discharged, preventing the pouch 2 from clogging.

The drain valve 4 has a cavity-side end facing the cavity 2c, and is provided with fitting holes 4b into which the pair of straight ends 5b of the drain wire 5 are fitted. Each fitting hole 4b is provided with a retaining mechanism that allows the straight ends 5b to be inserted but not pulled out. Specifically, a retaining protrusion 6 is provided on the inner wall surface of the fitting hole 4b, and the tip of the retaining protrusion 6 is tapered obliquely downward toward the bottom of the hole. In addition, a wedge-shaped recessed groove 5c is provided on the outer circumferential surface of the pair of straight ends 5b. When the straight ends 5b of the drain wire 5 are inserted into the fitting hole 4b until the tip of the retaining protrusion 6 hits the bottom of the hole, the straight ends 5b are deformed to push outward the tip side of the retaining protrusion 6 and are fitted in, and the deformed retaining protrusion 6 fits into the recessed groove 5c, making it impossible to pull out the straight ends 5b.
This simplifies the assembly of the drain wire 5 to the pouch 2 and also prevents the drain wire 5 from coming off the discharge valve 4 when the pouch 2 is deformed, improving the reliability of the device.

The artificial bladder device 1 has two modes: when the user is in an upright position (when no expansion bag is used) and when the user is in a lying position (when an expansion bag is used). In the upright mode, the discharge valve 4 is closed and urine is stored in the pouch 2. In the lying mode, the expansion bag is connected to the pouch 2, the discharge valve 4 is opened, one end of the extension tube 7 is connected to the discharge port 4c, and the other end of the extension tube 7 is connected to the expansion bag.

There are two types of expansion bags. The leg bag is attached to the leg and is designed to accommodate longer periods of activity during the day, with a capacity two to three times that of the pouch. On the other hand, the urobag 8 is attached to the side frame of the bed and has about ten times the capacity of the pouch, as it is used in a recumbent position during sleep. The following explanation will mainly use the urobag 8.

Figure 5 shows an example of a system of an artificial bladder device 1 in which a urobag is connected to a pouch 2. The urobag 8 is a large urine collection bag, and is connected to the discharge valve 4 of the pouch 2 by a transparent extension tube 7 with a diameter of about 10 mm and a length of more than 1 m. A check valve 8a is provided upstream of the urobag 8, and a discharge valve 8b is provided downstream. The urobag 8 is transparent, and the outer circumference of the cavity 8c is marked with a volume scale. Since the volume of the urobag 8 is about 2.5 liters, which is about 10 times that of the pouch 2, the usage time is extended to more than 24 hours. Therefore, the urobag 8 can be used for a long time, and it is safe to sleep. The urobag 8 may have a built-in measuring cup for measuring the amount of urine in hospitals, etc.

The urobag 8 used during sleep is attached to the side frame 9a of the bed 9, and the cavity 8c of the urobag 8 must be positioned sufficiently lower than the upper surface of the mattress 10 to enable urine to be discharged. The urobag 8 is connected to the pouch 2 before sleep, and the next morning it is detached from the pouch 2 and the urine accumulated in the urobag 8 is discarded. For hygienic reasons, the extension tube 7 and the urobag 8 must be washed with water and stored during the day. The user X can lie on the mattress 10 in a supine position or in a lateral position (not shown) facing the urobag 8.
As a result, when an additional urobag 8 is installed, the drain wire 5 can prevent the pouch from closing, allowing the patient to sleep peacefully without worrying about overflow, improving the quality of life (QOL).

As explained above, even if the pouch 2 is deformed by twisting or bending, the curved (e.g., inverted U-shape) drain wire 5 provided in the cavity 2c ensures a passage for urine to be discharged to the discharge valve 4. Therefore, by connecting the urobag 8 to the pouch 2, it becomes possible to use it for about 10 times longer than using only the pouch 2, realizing a life in which one can sleep peacefully without worrying about overflow. Operability and fit are the same as conventional devices, and costs are kept to a minimum. The artificial bladder device needs to be replaced every 4 to 5 days, and one person uses about 90 devices per year, so cost is very important to the user.

1 Artificial bladder device 2 Pouch 2a First wall 2b Second wall 2c Cavity 3 Face plate 3a Urostomy connection port 4 Discharge valve 4a Valve opening 4b Fitting hole 4c Discharge port 5 Drain wire 5a Inverted U-shaped end 5b Straight end 5c Groove P Backflow prevention area Q Boundary 6 Anti-pullout protrusion 7 Extension tube 8 Urobag 8a Check valve 8b Discharge valve 8c Cavity 9 Bed 9a Side frame 10 Mattress X User

Claims (5)

An artificial bladder device having a pouch for storing waste discharged from the artificial bladder,
A pouch in which two thin films constituting a first wall and a second wall are overlapped and the periphery of the two films is welded or bonded to form a cavity inside which collected excrement can be accumulated without leakage;
A base plate provided at the top of the pouch and having a urostomy connection port;
a discharge valve provided at a lower portion of the pouch for discharging the excrement collected in the pouch;
An artificial bladder device characterized in that a curved drain wire is housed in the cavity formed between the first wall surface and the second wall surface, and a pair of straight ends of the drain wire connected to both sides of the curved shape are respectively attached to the discharge valve, and the curved ends are extended to the vicinity of the panel. The artificial bladder device according to claim 1, wherein the drain wire is made of a flexible polymer wire. The artificial bladder device according to claim 1 or 2, wherein the pair of straight portions of the drain wire are parallel to the central axis of the drain valve, and are assembled so that the valve opening of the drain valve is positioned between the straight ends of the drain wire. The artificial bladder device according to claim 1 or 2, wherein the drain valve has a cavity-side end facing the cavity, and a pair of straight ends of the drain wire are fitted into the fitting holes, and each fitting hole is provided with a mechanism for preventing the straight ends from being pulled out while allowing them to be inserted. An artificial bladder device according to claim 1 or 2, in which one end of an extension tube is connected to the discharge valve, and the other end of the extension tube is connected to a urobag.