JPH09322936A - Catheter for peritoneal dialysis and dialytic liquid container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent a bacteria or a virus from invading the abdominal cavity by providing a filtering part composed of a semipermeable membrance at a position closer to the side of the abdominal cavity than a connector to be detached when exchanging dialytic liquid in the injection dedicated duct of a catheter for peritoneal dialysis. SOLUTION: An injection dedicated catheter 1a and a discharge dedicated catheter 1b are inserted into the abdominal cavity 2 and, at a catheter exit 3, a semipermeable membrance 4a is fitted so as not to make the bacteria and virus permeable. Then, when the dialytic liquid is injected from a dialytic liquid bag 5 into the injection dedicated catheter 1a, the bacteria can not touch the surface of the peritoneum even when it invades. Since it is not preferable to insert the catheter by opening holes at two positions on the belly while using two catheters, the injection dedicated catheter 1a and the discharge dedicated catheter 1b are actually separated outside a body and inside the abdominal cavity 2, integrated at the section (a subcutaneous fat layer 13) between a peritoneum sewing cuff 11 and a skin sewing cuff 12 and constituted as double pipe catheters having two hollow ducts in one catheter.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter used for peritoneal dialysis for the treatment of renal failure disease, which is used for injecting and discharging a dialysate into and out of the abdominal cavity of a patient, and an improved structure of a dialysis instrument connected to the catheter. More specifically, the present invention relates to a catheter in which a filtering section made of a semipermeable membrane is provided in a catheter dedicated flow path. The present invention also relates to a dialysate container for injecting dialysate by a manual liquid feed pump joined to the catheter.

[0002]

2. Description of the Related Art Peritoneal dialysis is one of the effective treatments for patients with renal failure. In the peritoneal dialysis method, as shown in FIG. 15, one catheter 1 is placed in the abdominal cavity of a renal failure patient, and a dialysate is infused through the dialysate bag 5 into the abdominal cavity and stored for a certain period of time. , The operation of discharging the catheter to the outside of the body is repeated several times a day.
In the commonly used peritoneal dialysis method, no components such as valves, pumps, filters, etc. that hinder or promote fluid flow are incorporated in the tube of the catheter.

This peritoneal dialysis method does not require an expensive machine and can purify blood through a biological membrane called the peritoneum.
It has the advantage that it is physiologically superior to dialysis using an artificial membrane and enables the social activity of the patient, but on the other hand, since dialysate is frequently taken in and out from the outside of the body, the risk of infection is high.

For example, continuous portable peritoneal dialysis (commonly called CAP
In D), the caregiver such as the patient himself or his / her family performs the operation of injecting / draining the dialysate several times a day. This operation procedure is taught by doctors and nurses when hospitalized because the patient undergoes catheter placement surgery in the abdominal cavity.
Start at home, but due to distraction, lack of hygiene, etc.
Operation mistakes are caused and peritonitis frequently occurs due to infection with pathogenic bacteria, and dialysis cannot be continued due to a decrease in peritoneal dialysis capacity.

This infection rarely occurs via a tunnel from the catheter outlet on the abdominal wall, but in most cases, when the pathogenic bacterium disconnects the connector at the outlet end of the catheter, it touches the fingertip or the instrument and enters the abdominal cavity together with the dialysate. Invades and develops on the surface of the peritoneum to form bacterial colonies (bacterial colonies) and develop peritonitis.

[0006] Conventionally, when removing a connector, in order to prevent contamination by pathogenic bacteria, UV irradiation, heating or a sponge impregnated with a disinfectant solution is used for wiping, and the connector is detached and connected with a tool so that it is not touched by fingers. The method of doing is adopted. However, even with these methods, the incidence of peritonitis is reported to be 5 to 6 months / time on average in North America, about 14 months / time in the best performing countries, and 25 months / time in the best performing hospitals. It is difficult to reach 100 months / time.

Even in the case of an exemplary patient who has never had peritonitis, when the connector is disconnected several times a day, the window of the room is closed to stop the movement of air, and the pet and family are taken out of the room. Disinfect your fingers and operate with tension. At home, even if such an environment can be maintained patient-oriented, if you go out or work at a place where there are many people, such as a factory or office, there is a risk of infection, and you also feel uncomfortable with others, causing a psychological burden. Is very large. For this reason, it has been reported in many cases that patients with a serious personality fall out of their fatigue. Therefore, development of a peritoneal dialysis method with less risk of infection has been desired.

In the perfusion device (cycler) used in the peritoneal perfusion method, as shown in FIG. 16, two catheters 1 are used.
There is an example of continuous injection / exhaustion into the abdominal cavity through a and 1b, and an example of incorporating a sterile filter 8 in the device to sterilize the dialysate can be seen. No example has been reported in which the filter is connected to the flow channel of the catheter inside.

[0009]

As a result of studying this point, the inventor of the present invention tried to prevent the passage of bacteria and viruses by providing a filter in the flow path of the catheter. When a filter with small holes is attached, there is no major problem when injecting dialysate,
When discharging, the filter part will be clogged and discharging will not be performed smoothly. Therefore, by using a catheter that is separated into a dedicated flow channel for injection and a dedicated flow channel for discharge, by providing a hollow fiber-shaped or balloon-shaped filtration unit made of a semipermeable membrane that blocks passage of bacteria and viruses in the dedicated flow channel for injection. ,
It has been found that bacteria and viruses can be prevented from entering the abdominal cavity.

However, by providing such a filter, the liquid injection speed is reduced and the liquid injection time is lengthened, and by separating the catheter into a dedicated flow channel for injection and a dedicated flow channel for discharge, a dedicated flow channel for discharge is provided. Problems such as backflow in the road newly occur, and infection cannot be prevented by the filter unless these problems are solved. Therefore, we examined these points and found a solution.

Further, in the present invention, a manual pump is attached between the dialysate container and the catheter, and dialysis is promoted by operating this pump to form a dialysis circuit which allows the patient to circulate the solution by a simple operation. In addition, the dialysate container can be pre-connected to a manual delivery pump that has a connector that is joined to the inlet of the catheter's injection channel, and it can be packed and sterilized as a set pack. It was found that peritoneal dialysis can be carried out safely, because there are few.

[0012]

DISCLOSURE OF THE INVENTION The present invention provides an abdominal cavity from a connector to be removed when exchanging the dialysate in the injection-only channel of the peritoneal dialysis catheter having a channel for injecting the dialysate and a channel for injecting the dialysate, which are left in the abdominal cavity of the human body. It is a catheter having a filtering part made of a semipermeable membrane at a side position, for example, an intraperitoneal outlet of an infusion channel.

Further, the present invention is a dialysate container which is pre-joined with a manual liquid feed pump having a connector joined to the inlet of the catheter for exclusive use of injection and which is packaged and sterilized.

[0014]

BEST MODE FOR CARRYING OUT THE INVENTION As described above, pathogenic bacteria invade most of the cases inflow with the dialysate at the time of infusion. Therefore, according to the present invention, the catheter is used as a dialysate-injecting flow path and a discharge-use flow path. Separation into individual tubes, and a hollow fiber-shaped or balloon-shaped semipermeable membrane filtering section is provided in the dialysate-only channel.

As the catheter to be left in the abdominal cavity of the present invention, a catheter separated into a dialysate injecting channel and an exhausting channel is used. In the conventional single-tube catheter, injection and discharge are performed in the same tube. Therefore, it is not preferable to attach a filter because clogging occurs at the time of discharge.

Since the infection mainly occurs by touching the connector with the hand when exchanging the dialysate, it is necessary to attach the filtering part to the abdominal cavity side of the connector which is removed when exchanging the dialysate for exclusive use with the injection channel. Specifically, it is preferably provided at the intraperitoneal outlet of the injection-only channel.

FIG. 1 is a simplest view for helping understanding of the structure, and an abdominal cavity is provided with an exclusive catheter 1a for injecting dialysate from a dialysate bag 5 and an exclusive catheter 1b for draining waste fluid into a waste fluid bag 6. Then, the semipermeable membrane 4a, which is impermeable to bacteria and viruses, is attached to the intraperitoneal opening 3 of the injection catheter. When dialysate is injected into this catheter from the dialysate bag, even if bacteria enter, it cannot contact the peritoneal surface.

However, since it is not preferable to use two catheters as shown in FIG. 1 to open two holes in the abdomen to pass the catheter through, a catheter for injection 1a is used outside the body and inside the abdominal cavity as shown in FIG. The catheter 1b for exclusive use of discharge is separated, and is integrated in the portion (subcutaneous fat layer 13) between the peritoneal suture cuff 11 and the dermis suture cuff 12 in the abdominal cavity,
The structure of a double-tube catheter having two hollow channels in one catheter and having a circular or elliptical double cavity (double lumen) as shown in 14 is preferable.

As another structure, as shown in FIG.
The catheter consists of a concentric cylinder and the outer tube is dedicated to injection 1
a, the inner tube is a discharge-only passage 1b, and a connector in which a loop-shaped hollow fiber 4 made of a semipermeable membrane is connected inside the peritoneal cavity of the injection-only passage is an outer tube and a male female spiral grooved connector 19;
Can also be used. Two tubes 1a and 1a 'are connected to the injection pump on the outside of the body of the dedicated injection path 1a, respectively. If necessary, a clamp 20 is attached to the flow path to open and close the flow of the liquid. You can also.

The semipermeable membrane attached to the outlet of the dialysate injection passage of the catheter is for preventing passage of bacteria and viruses. The maximum pore size of this semipermeable membrane is bacteria (100-
Considering the sizes of 5,000 nanometers) and viruses (8 to 250 nanometers), the size is preferably 5 nanometers or less for safety.

As such a semipermeable membrane, those commercially available for industrial use for producing sterile water can be used.
These are mainly formed into a hollow fiber shape, and a membrane having a high water permeation rate can be used. For example, ultrafiltration membrane (UF membrane)
Many types of membranes are commercially available.

The filtration part comprising a semipermeable membrane in the present invention may be in the form of hollow fibers or balloons, and various forms can be selected according to the application. For example, the balloon-like semipermeable membrane (4
In addition to a), as shown in FIG. 4, the outlet of the flow channel dedicated to injection is closed with a semipermeable membrane sheet (4b), the tip of the hollow fiber is closed, and the injected dialysate has pores of the hollow fiber. Examples thereof include a type (4c) of exuding and diffusing into the abdominal cavity, and a type (4d) in which a plurality of hollow fiber tips are connected to form a loop (4d).

The selection criteria for the shape of these semipermeable membranes are the sheet diameter semipermeable membranes (4b), 10 if the required area is about 1 cm ² depending on the pore diameter, porosity, and film thickness of the membrane satisfying the desired liquid permeation rate.
cm ² degree if the balloon-like semi-permeable membrane (4a), a few hundred cm ² or more if a hollow fiber semipermeable membrane (4c) or loop hollow fiber semipermeable membrane (4d), the number of hollow fibers, the inner diameter, and length, calculated Design above. The inner diameter of the catheter is also defined by the outer diameter, the number, and the packing density of the hollow fibers. Note that a loop (4d) is more preferable than a tail (4c) of a horse with a closed hollow fiber tip because the sharp tip does not stimulate the peritoneum. The length of the hollow fibers is not uniform, and mixing the long and short fibers serves the purpose of uniformly diffusing the dialysate into the abdominal cavity.

By providing such a filtration unit, the invasion of bacteria into the abdominal cavity can be prevented, but the bacteria may survive in the flow path dedicated to injection. Therefore, as shown in FIG.
Is added to the inside of this flow channel and is placed in the abdominal cavity to sterilize the bacteria, thereby suppressing the growth of bacteria. Silver fine particles are suitable as a long-acting antibacterial agent.

Further, in order to reduce the progress of precipitation in such a stored liquid in the abdominal cavity, the surface of the semipermeable membrane is covered with an anticoagulant (not shown). As the anticoagulant, heparin, urokinase, dextran and the like are used.

For the purpose of preventing infection, the position where the filtering portion is provided may be a position other than the outlet as long as it is located on the abdominal cavity side of the connector that is removed when exchanging the dialysate in the dedicated injection channel. For example, as shown in FIG. 5, a porous filter 23 having a semipermeable membrane may be provided outside the body between the connector 22a and the next connector 22b on the abdominal cavity side. In addition, the filtering section at this position also has an effect of preventing clogging of the dialysis membrane in the event that dust or foreign matter is mixed in the dedicated injection channel. In addition, this filter provided outside the body should be replaced regularly at the hospital.

The probability that bacteria will invade the discharge-exclusive flow path is low, and, as described above, if a filtration section with a semipermeable membrane is provided here, there is a risk of clogging due to suspended fine particles precipitated in the discharge liquid. Therefore, the filtration part is not normally attached. If this happens, there is a risk of infection due to the backflow of the drainage fluid that has flowed out of the body in the discharge-only flow path. Therefore, it is preferable to attach the check valve 24 to the discharge-only channel as shown in FIG.

If the check valve fails, the check valve is connected to the outlet of the discharge-exclusive flow path outside the body by a removable connector 22 for easy replacement. After exiting the outlet, the outlet is sealed with a cap 34 (FIG. 13).

In the conventional method, the dialysate can be injected by suspending the dialysate bag above the patient's head and injecting it at a drop. However, in the present invention, in order to prevent infection, a flow path dedicated for injection is used. Since the semipermeable membrane is provided inside, a manual liquid delivery pump 26 as shown in FIGS. 7 and 8 is provided in case the conventional natural free fall method may lengthen the liquid injection time due to the resistance of the semipermeable membrane. Can be connected and used. The structure of the pump is, for example, a ball 27 made of an elastic material having a prototype restoring force as shown in FIG. 9, for example, thick rubber, provided with check valves at the inlet and the outlet, and slowly squeezed or loosened by hand to deliver the liquid. As another example, as shown in FIG. 10, a structure in which a soft balloon (not shown) is sandwiched between two hard plates and a spring 28 provides a prototype restoring force between the upper and lower sides thereof may be used. .

Since the above-mentioned manual pump may be contaminated when it is removed after use, stored and reused next time, as shown in FIG. A connector that can be connected to the passage entrance is provided, and the set pack 25 is set as a set with a dialysate bag, sterilized by high-pressure steam or the like, and after each use, discarded together with an empty bag.

When the liquid is drained, the flow path does not have a filter or a semipermeable membrane, so the natural drop method is considered to be sufficient, but similarly, the liquid can be drained through a manual liquid feed pump.

A connector is used to connect the outlet for exclusive use of discharge / outlet valve / check valve / drainage bag and the dialysate bag / manual pump / porous filter / external inlet for exclusive use of flow passage.

Connector 22 for connecting the dialysate circuit
11 has a cylindrical shape in which the spiral type screw groove of the male type 29 female type 30 is cut as shown in FIG.
Is retracted deeper than the tip 32a of the concentric cylindrical guard cover 32 on the inside, and can be prevented from touching a finger or an object. Further, the female screw tip 30a is designed so as not to come into contact with the tip 31a of the male guard cover 31 which is easily contaminated. The sealing surface is sealed with a packing ring 33. The connector of this structure is injection,
Although it can be used for any of the discharge circuits, if the flow of the liquid is always changed from the female screw to the male screw (from left to right in FIG. 11), the risk of contamination due to the attaching / detaching operation is small.

After completion of the liquid injection, as shown in FIG. 12, the male connector connected to the external inlet of the injection channel and the female connector of the check valve outlet connected to the external outlet of the discharge channel are joined together. As a connector 22, a circuit is formed so that daily life can be carried out. Alternatively, as shown in FIG. 13, the caps 34 may be respectively tightened at the above two places.

While the dialysate is stored in the abdominal cavity, the nitrogen metabolites and the like exuded from the body through the peritoneum into the abdominal fluid have a high concentration near the peritoneum and a low concentration gradient with the distance. Therefore, when the liquid is occasionally circulated and flowed, the concentration in the vicinity of the peritoneum becomes uniform and decreases, so that dialysis is accelerated. For this purpose, without manually removing the manual liquid delivery pump as shown in FIG. 14, the pump is stored in a closed circulation circuit and stored in the patient's abdomen or the inner pocket of the pants, and is slowly grasped or loosened by hand. Liquid can be circulated by operation. This operation can be done while going out without being noticed by others.

The device of the present invention was originally devised for portable continuous peritoneal dialysis. However, even when performing night dialysis using an automatic perfusion device (cycler), the connector of the cycler is used as the connector of the present invention. Can be used by connecting with a connectable adapter.

[0037]

By using the catheter of the present invention for peritoneal dialysis, infection of pathogenic bacteria can be almost completely prevented, peritoneal dialysis ability can be maintained, and the onset of peritonitis due to infection can be suppressed. In addition, the psychological burden on patients and caregivers is greatly reduced, and the place for dialysate replacement can be widely selected, such as at work, out, travel, or in a car near the ceiling. In addition, the patient can easily operate by installing the manual liquid feeding pump, the concentration gradient is eliminated, and the dialysis is efficiently performed.

[Brief description of drawings]

FIG. 1 is an example of a peritoneal dialysis catheter of the present invention.

FIG. 2 is another example of the peritoneal dialysis catheter of the present invention.

FIG. 3 is another example of the catheter for peritoneal dialysis of the present invention.

FIG. 4 is an example of the shape of a filtration unit provided at an intraperitoneal outlet of a dedicated injection channel.

FIG. 5 is an example of the shape of a filtering unit provided outside the body of a flow channel dedicated to injection.

FIG. 6 is a view of a discharge-only flow path provided with a check valve.

FIG. 7 is a catheter in which a manual liquid feeding pump is attached to a channel dedicated to injection.

FIG. 8 is a catheter in which a dialysate bag is attached to a flow path dedicated to injection via a manual liquid feed pump.

FIG. 9 is an example of the shape of a manual liquid feeding pump.

FIG. 10 is another example of the shape of the manual liquid feeding pump.

FIG. 11 is an example of a structure of a connector of a catheter.

FIG. 12 is a view showing a connected state of the catheter after the injection is completed.

FIG. 13 is a view showing a connection state in which the catheter is sealed with a cap after the injection.

FIG. 14 is a diagram showing a circuit in which a catheter is connected to a manual liquid feeding pump.

FIG. 15 is a diagram showing a conventional peritoneal dialysis method.

FIG. 16 is a perfusion device used in a conventional peritoneal perfusion method.

[Explanation of symbols]

 1 catheter 1a catheter for exclusive use of injection 1b catheter for exclusive use of discharge 2 peritoneal cavity 3 catheter outlet 4 semipermeable membrane 5 dialysate bag 6 waste solution bag 7 dialysate tank 8 sterile filter 9 injection pump 10 drainage pump 11 peritoneal suture cuff 12 dermis suture cuff 13 Subcutaneous fat layer 14 Catheter cross-section 15 Fascia 16 Muscle layer 17 Peritoneum 18 Epidermis 19 Connector 20 Clamp 21 Antibacterial agent 22 Connector 23 Porous filter 24 Check valve 25 Dialysate set pack 26 Manual pump 27 Rubber ball 28 Spring 29 Male spiral screw 30 Female spiral screw 31 Outer guard cover 32 Inner guard cover 33 Packing ring 34 Cap

Claims (9)

[Claims] 1. A semipermeable membrane at a position on the abdominal cavity side of a connector to be removed when exchanging a dialysate in a dedicated flow passage for injection of a peritoneal dialysis catheter having a dedicated flow passage for injecting dialysate and a flow passage for exclusive discharge, which are left in the abdominal cavity of a human body. A peritoneal dialysis catheter having a membrane-made filter. 2. The catheter according to claim 1, further comprising a filtering portion at the intraperitoneal outlet of the injection-only channel. 3. The catheter according to claim 1, which contains an antibacterial agent in a flow path dedicated to injection in the abdominal cavity. 4. A check valve is provided in at least one of the injection-use flow path and the discharge-use flow path of the catheter.
The catheter according to any one of 3 above. 5. The catheter is completely integrated between at least the subcutaneous cuff and the peritoneal cuff, and the front and rear portions thereof.
5. The catheter according to claim 1, wherein the catheter has two hollow channels dedicated to infusion and ejection, and two tubes are separated from each other in an extracorporeal portion and an intraperitoneal portion. catheter. 6. A connector comprising a concentric circular cylinder, an inner tube serving as a discharge passage, and a connector having a loop-shaped hollow fiber made of a semipermeable membrane connected to an intermediate portion between the inner tube and the outer tube, and an outer tube and a male female. The catheter according to any one of claims 1 to 4, which is connected by a spiral grooved connector. 7. The catheter according to any one of claims 1 to 6, wherein a pump for manually feeding liquid is connected to the inlet of the injection-only channel of the catheter. 8. A structure comprising a male and female cylindrical portion with a spiral groove cut and having a structure surrounded by a double concentric circular cylinder longer than the tip of the cylindrical portion.
A connector for connecting the catheter according to any one of 7 to the dialysate delivery circuit. 9. A dialysate container which is pre-joined, packaged and sterilized with a manual liquid feed pump having a connector joined to the inlet port of the catheter for injection according to any one of claims 1 to 7.