JPS6148382B2 - - Google Patents

Description

[Detailed Description of the Invention] () Background of the Invention (-1) Technical Field The present invention relates to treatments such as infusions and blood transfusions in which a medicinal solution in a container is continuously injected into the body by the action of gravity over a long period of time, or The present invention relates to a liquid transport device used in treatments such as peritoneal dialysis, which continuously injects a medicinal solution in a container into the body by the action of gravity and discharges the same medicinal solution out of the body by the action of gravity over a long period of time after a certain period of time has elapsed.

(-2) Prior art In continuous treatments such as peritoneal dialysis, infusions, and blood transfusions, it is a technology to completely prevent microorganisms such as bacteria and viruses from entering the tube when connecting tubes to tubes or connecting tubes to containers. This is considered to be a major issue. Particularly in treatments such as peritoneal dialysis, where the peritoneal cavity has no ability to protect against bacteria, it is an absolute technical challenge to reliably prevent microorganisms from entering the peritoneal cavity from within the tube. Compared to dialysis using an artificial kidney, the latest treatment method using peritoneal dialysis does not require large-scale equipment or equipment, and the treatment cost is significantly lower.Also, the causes of peritoneal adhesions have been largely elucidated, and adhesions do not occur. The continuous mobile peritoneal dialysis method (so-called CAPD therapy), which allows patients to work while continuing treatment, was invented and put into practical use. It has been frequently reviewed and is attracting attention. The reliability of this dialysis method in terms of life safety is determined by whether it can reliably prevent microorganisms such as bacteria and viruses from entering the tube, and whether it can avoid the occurrence of peritonitis due to the proliferation of microorganisms within the peritoneum. It is currently believed that it cannot be carried out continuously over a long period of time.

As a specific example, a conventional continuous mobile peritoneal dialysis method will be described with reference to FIG. Indwelling type catheter 2 surgically placed in the abdominal cavity 1 of patient M
is implanted, the connector 3 is attached to the main outer end of this indwelling type catheter 2, and this connector 3
The connector 5 attached to one end of the transportation tube 7 is connected to the connector 5. To inject the dialysate into the peritoneal cavity 1, the container 6 containing the dialysate is inserted into the peritoneal cavity 1.
The piercing needle 11 attached to the tip of the transportation tube 7 is pierced through the outlet of the hanging container 6 at a predetermined height higher than the clamp 10 attached halfway.
This is done by relaxing the After injecting the dialysate into the abdominal cavity 1, the patient can walk or work by closing the clamp 10, appropriately rolling the transport tube 7, and attaching the container 6 to the waist. To withdraw the dialysate from the peritoneal cavity 1 after a predetermined period of time has elapsed, extend the transport tube 7, place the container 6 on the floor, etc., and tighten the clamp 1.
Just relax 0. Then, by pulling out the piercing needle 11 from the container 6, making the container 6 disposable, setting the next new container 6 at a high place, and piercing the new container 6 with the piercing needle 11, the second and subsequent dialysis can be performed. .

However, in order to prevent microorganisms from entering the peritoneal cavity 1 from inside the tube when connecting the connectors 3 and 5 and the puncture needle 11 to the outlet of the container 6 during the first and second dialysis, currently iodine-based Sterilization procedures include instant immersion in a disinfectant solution and thorough cleaning of the tip of the puncture needle with disinfectant. The disinfectant used enters the body in very small amounts when injected and acts as a harmful substance, so it is not possible to increase the concentration to a level that can completely sterilize, so an extremely low concentration liquid with weak sterilizing power is used. There is.

Therefore, conventional sterilization procedures cannot be said to be sterile from a microbiological point of view, and in fact, infections from the connectors and puncture needles can occur after dialysis begins.
It occurs after about 2 months and is often reported to be accompanied by peritonitis, so although continuous mobile peritoneal dialysis is an effective treatment method as mentioned above, continuous long-term implementation is not recommended. He is said to be in a difficult condition.

() Purpose of the Invention The present invention was devised after intensive research in view of the above-mentioned points.It can be heated with a flame such as an alcohol lamp, and chemical changes such as rust generation and surface changes due to heating do not substantially occur. First, it has been improved to include a pair of connectors that can be connected and disconnected once sufficient heating has been carried out, which requires repeated connection and disconnection over a long period of time.
It is also effective for peritoneal dialysis, which has no ability to protect against bacteria, and is especially effective for continuous mobile peritoneal dialysis, in which patients update their dialysis treatment at home or at work without the help of a doctor, and for other infusion treatments. The object of the present invention is to provide a liquid transport device that can highly reliably prevent infection from the tube's continuation site in a wide range of treatment methods including blood transfusion therapy and blood transfusion therapy.

According to the invention, this purpose is achieved by providing a container containing a medicinal solution;
a flexible transport tube that is connected to the container and has a passage therein that can communicate with the inside of the container; and a short tubular tube that is connected to the other end of the transport tube and has a liquid passage inside that communicates with the passage. 1 connector, a rupture member that is provided to close the passage and can open the passage when broken, and a rupture member that can be connected to and disconnected from the other end of the first connector, and has a liquid passage of the first connector inside. The catheter tube is made up of a short tubular second connector having a communicating flow path, and a flexible catheter tube connected to the other end of the second connector and having an internal flow path communicating with the flow path. The first connector and the second connector are composed of a pair of male and female connectors, and at least each connecting end is made of a heat-resistant and corrosion-resistant material, and the connecting mating surface of the male connector is connected to the female connector. The connecting and fitting surfaces are made of a material with a smaller thermal expansion than the connecting and fitting surfaces, and the connecting and fitting surfaces are formed in a size that provides a shrink-fit dimension difference that allows connection and dissociation due to the difference in thermal expansion. This is accomplished by a liquid transport device.

In the liquid conveying device, each of the connecting and fitting surfaces of the first connector and the second connector is made of a heat-resistant and corrosion-resistant material, and the male connector is made of a material with a smaller thermal expansion than the female connector. It is sufficient that connection and disassembly can be performed by shrink fitting, and it is not necessary that the connection ends including the connection fitting surfaces be made of the same material. At least each connecting end of both connectors must be made of a heat and corrosion resistant material since it is heated by the flame. It is preferable that both connectors be made of the same material in order to simplify manufacturing.

Furthermore, the device of the present invention provides an extremely effective means for forming the connecting and fitting surfaces of both connectors into a size that provides a shrink-fit dimension difference that allows for connection and disconnection due to a difference in thermal expansion. Preferably, the male part is made of ceramics and the female part is made of stainless steel, titanium, or nickel or chrome-plated brass, a heat-resistant and corrosion-resistant metal, or a heat-resistant and corrosion-resistant plastic material. Preferably, the ceramic is made of zirconia oxide, silicon nitride, alumina, steatite, forsterite, or the like. In addition, the device of the present invention tapers the connecting mating surfaces of both connectors as an effective means of easily obtaining a shrink-fitting dimension difference with sufficient wear resistance and simultaneously achieving liquid-tight fitting. Even better is an embodiment with a cylindrical fit.

In addition, the device of the present invention preferably has a heat-resistant sealing member on the connecting and fitting surface that connects both connectors in a liquid-tight manner in order to achieve a more reliable liquid-tight connection between the two connectors. .

Furthermore, in the device of the present invention, a cylindrical support made of a heat insulating material is provided near the tube side of each connector in order to enable each connector to be held more stably with bare hands when connecting and disconnecting the connectors. It is preferable to adopt an embodiment in which the

In addition, in the device of the present invention, the container is made of transparent or translucent flexible plastic and is formed so that it can be rolled up and folded, in order to facilitate continuous mobile peritoneal dialysis in which the container is portable. It is better to make it an embodiment.

() Specific Description of the Present Invention (-1) Configuration A preferred embodiment of the liquid transport device of the present invention will be described in connection with the continuous mobile peritoneal dialysis method shown in FIG.

The device of the present invention includes a container 12 containing a drug solution, and a flexible transport tube 1 connected to the container 12.
3, a first connector 14 connected to the other end of the transport tube 13, and a first connector 14 connected to the other end of the transport tube 13.
a breakable member 15 housed therein, a second connector 16 that can be freely connected to and disconnected from the other end of the first connector 14, and the second connector 16;
A flexible catheter connected to the other end
Consists of 17 tubes. The container 12 is made of plastic, and is preferably made of a flexible, transparent or biologically safe material that does not easily cause chemical reactions with the drug solution, in order to provide portability and to allow observation of the amount of drug solution in the container. It is preferably formed into a flat bag made of translucent plastic that can be rolled up and folded. The transport tube 13 is made of silicone rubber or flexible transparent or semitransparent plastic such as vinyl chloride, polyethylene, or ethylene vinyl acetate, and has a passage 18 communicating with the inside of the container 12 inside. It has a large-diameter breakable member storage chamber 18a that accommodates the breakable member 15.
The first connector 14 is made of a heat-resistant and corrosion-resistant metal such as stainless steel, titanium, nickel, or chrome-plated brass, or a heat-resistant and corrosion-resistant plastic material, and is formed into a short tube shape having a liquid passage 19 communicating with the passage 18 inside. A female tapered surface is formed on the inner surface of the connecting end 14a that connects with the second connector 16 and has a larger diameter toward the end surface. The breaking member 1
For example, the outer surface of 5 has a large diameter portion 15a and a small diameter portion 15b.
The liquid hole 15c is open from the end face of the large diameter part to the middle of the small diameter part, and the large diameter part 15a is made of hard plastic and has a breakable thin part at the root of the small diameter part 15b and the large diameter part. is accommodated in the breakable member storage chamber 18a so as to be in close contact with the entire circumference with adhesive, thereby closing the passage 18. The breaking member 1
5 is not closer to the container 12 side but the first connector 14
It is convenient for handling if it is installed near the side. The second connector 16 is made of ceramics and is formed into a short tube shape having a flow path 20 communicating with the liquid path 19 of the first connector 14 inside. A male tapered surface with a smaller diameter on the opposite side is formed and rubbed against the female tapered surface of the first connector 14, correcting the machining error of the taper and achieving a good all-around close contact. Therefore, the connecting and fitting surfaces of the first connector 14 and the second connector 16 are connected and fitted due to the difference in thermal expansion, since the male connector is made of a material with a lower coefficient of thermal expansion than the female connector and is tapered fitted. This means that they are formed to a size that provides a shrink-fitting dimension difference that allows for disassociation.
At least one of the first connector 14 and the second connector 16 has a sealing member such as an O-ring for liquid-tightly connecting the two connectors. The catheter tube 17 is one or both of an indwelling type catheter 17a and an extension tube 17b connected to the catheter, and is made of silicone rubber or a flexible transparent or translucent plastic such as vinyl chloride, polyethylene, or ethylene vinyl acetate. and the second connector 16 inside
It has a flow path 21 that communicates with. When the catheter tube 17 includes an extension tube 17b, a third connector 22 configured similarly to the first connector 14 is connected to the catheter side connection end of the extension tube 17b, and a third connector 22 configured similarly to the first connector 14 is connected to the extension tube side connection of the catheter 17a. A fourth connector configured similarly to the second connector 16 at the end
Connector 23 is connected. Reference numeral 24 denotes a clamp, which is attached to the extension tube 17b and is adjustable so as to crush the tube and close the flow path 21. Note that a pair of male and female connectors is used not only in a liquid transport device but also as a tube connection device in treatments using tubes such as infusions, blood transfusions, and dialysis.

(-2) Action This will be explained in the context of continuous mobile peritoneal dialysis shown in Figure 2. In addition, each component shall be sterilized beforehand. To perform the first injection of a drug into the abdominal cavity, the indwelling type catheter 17a is implanted in the abdominal cavity, and the fourth connector 23 at the outer end of the indwelling type catheter 17a and the extension tube 17b are connected.
The third connectors 22 at one end are heated together with the flame of an alcohol lamp, etc., and then fitted together, and then the two connectors are pressed together in the fitted state and left to naturally cool for a short period of time, thereby achieving a shrink-fit connection. Next, the container 12 is hung at a predetermined height and the first connector 14 at the tip of the transport tube 13 and the second connector 1 at the other end of the extension tube 17b are connected.
6 are heated with flame in the same manner as above, then fitted together, cooled naturally, and connected by shrink fitting. The shrink-fit connection between the connectors is sufficient because the connection fitting surface of the female connector is a tapered cylindrical surface fitting made of a material with higher thermal expansion than the connection fitting surface of the male connector, and is heated strongly. The connectors will not come apart on their own unless a considerable external force is applied to the heated connectors, and since the connectors are fitted with tapered cylindrical surfaces, the connectors will not fit together in a liquid-tight manner. This ensures that the After the connectors have been connected, the breakable member 15 is broken from the base of its small diameter portion 15b to open the passage 18, and the container 12 is opened.
The drug solution inside is injected into the abdominal cavity by the action of gravity, and when the injection is finished, the extension tube 17b is pinched and crushed with the clamp 24 to close the flow path 21, thereby completing the first drug solution injection operation. If the container 12 is rolled up, the transport tube 13, the extension tube 17b, and the indwelling catheter 17a are bundled together and tied around the waist or the like, walking or working is possible. To renew dialysis for the second and subsequent times, the patient can remove the container 12 from his or her waist, stretch it out flat, place it on the floor, etc., and loosen the clamp 24. Then, the dialysis waste fluid in the peritoneal cavity is collected into the container 12 by gravity. And container 12
Since the transport tube 13 is disposable, the clamp 24 is squeezed and the joint between the first connector 14 and the second connector 16 is reheated with a flame of an alcohol lamp or the like to disconnect the connectors. The first connector 14 is actually connected to the abdominal tube with both hands.
This is done by heating the second connector 16 with a flame from an alcohol lamp or the like and applying a slight disassociation force to both connectors. The female connector is heated more strongly than the male connector, and the disconnection of the connectors from each other is easily achieved due to the difference in thermal expansion, as in the case of connection. 1st connector 14 and 2nd connector
After disconnecting the connector 16, use one hand to heat the second connector 16 with the flame of an alcohol lamp, heat the new spare first connector with the flame, and then heat the second connector 16 with the flame.
The connector 16 and the first connector may be fitted together and the shrink-fit connection may be achieved by natural cooling.

Since the connection and disconnection operations of the first connector and the second connector are performed on or near the lower edge, they can be performed while maintaining sterile conditions not only on the surface of the connector but also in the atmosphere. It is possible to more completely prevent bacteria from entering the connector.

However, heating is required to connect and disconnect the connectors, and since a liquid-tight fit is achieved using a tapered cylindrical surface fitting and a sealing member such as an O-ring, microorganisms such as bacteria and viruses from the connector part are prevented. Furthermore, since the connector is made of heat-resistant and corrosion-resistant material, chemical changes such as rust and surface changes do not occur even when heated, thereby completely eliminating the occurrence of peritonitis.

() Modification of the present invention (-1) First modification FIG. 3 shows a modification in which the breaking member is provided near the container. The container 12 and the transport tube 13 are connected via a flexible transport cylinder 25 having a diameter one larger than that of the transport tube 13.
A breaking member 15 is accommodated in the space inside the breaking member 1.
By breaking 5, the inside of the container 12 and the passage 18
are starting to communicate.

(-2) Second Modified Example FIG. 4 shows a modified example that includes a breaking member with a different breaking function from that of the above embodiment. The tube 13 is joined by a flexible extension tube 26 having a diameter one size larger than that of the tube 13, and the breakable member 15 housed in the extension tube 26 has a puncture needle 15d. needle 15
The passage 18 before and after the breaking member 15 is opened by piercing the thin film 27 blocking the upstream side of the passage at d and returning.

(-3) Third modification Figure 5 shows a modification of the connector.
The connecting end 14a of the female connector is made of heat-resistant and corrosion-resistant stainless steel, titanium, nickel, or brass coated with chrome plating, and the threaded portion is firmly screwed into the base 14b made of heat-resistant and corrosion-resistant plastic by applying adhesive. The connecting end 16a of the male connector is made of ceramics with a thermal expansion close to 0, and the base 16b is made of heat-resistant and corrosion-resistant plastic.
They are tightly screwed together by applying adhesive. A heat-resistant sealing member 28 such as an O-ring is provided between the connecting and fitting surfaces.

(-4) Fourth Modification Figure 6 shows a modification in which both connectors can be stably held with bare hands and can be heated while being held with bare hands. The tube 13 is forcibly fitted onto the first connector 14, and a cylindrical support 29 made of a heat insulating material such as silicone rubber or cork is also forcibly fitted onto the outer surface of the connecting end of the tube 13. Connector 16 with catheter
The tube 17 is forcibly fitted, and a support 2 is also provided on the outer surface of the connecting end of the catheter tube 17.
9 is forcibly fitted.

(-5) Other variations The container may be made of non-flexible plastics, except when specifically used for continuous mobile peritoneal dialysis.

The first connector may be a male connector, and the second connector may be a female connector. In this case, ceramics may be used for the first connector, but since the first connector 14 is disposable and expensive, the first connector 14 is made of stainless steel or titanium, and the second connector, which is a female connector, is made of ceramic. It is best to use nickel or chrome plated brass.

The connection fitting surfaces of the first connector and the second connector may be cylindrical surface fitting or rectangular cylindrical surface fitting instead of tapered cylindrical surface fitting. In this case, the female connector is made of brass, and the male connector is made of ceramic, which has almost no thermal expansion, in order to ensure that the first and second connectors have a sufficient shrink-fit dimension difference due to the difference in thermal expansion. do.

A breaking member may be provided inside the container so as to communicate with the passage within the tube when the container is broken.

Figure 7 shows a connector that can be double locked to each other, with collars 31 and 3 on the male connector.
1, and a nut 32 is rotatably attached between the flanges and is adapted to be screwed into a female connector.

() Effects As explained above, in the liquid transport device of the present invention, the transport tube is connected to a container containing a drug solution so as to be able to communicate with the container, the passage inside the transport tube is closed with a breakable member, and the transport tube is further closed. In a configuration in which the first connector at the tip and the second connector at one end of the catheter tube are a pair of male and female connectors and can be connected and disconnected, at least the connecting ends of both connectors are heat and corrosion resistant. The mating surface of the male connector is made of a material with lower thermal expansion than the mating surface of the female connector, and the two mating surfaces can be connected and disconnected due to the difference in thermal expansion. This structure is formed to a size that corresponds to a shrink-fitting dimensional difference.

Therefore, the liquid transport device of the present invention connects the connecting ends of the first connector and the second connector, which are entry points for microorganisms, with a flame such as an alcohol lamp, ruptures the breakable member, and injects the medicinal liquid into the body. After injection, except in the case of continuous mobile peritoneal dialysis, the first connector is removed from the second connector by heating and disposable together with the container, and the second connector has the same connection and disconnection functions as the first connector. In the case of continuous mobile peritoneal dialysis, the container and tubes are rolled up and tied around the waist after injecting the drug solution, allowing walking and working. When renewing treatment using continuous mobile peritoneal dialysis, the container is placed on the floor, etc., the dialysis waste fluid is collected, and the first connector or the above-mentioned stopper is separated from the second connector by heating, and the container and transport tube are disposable. year,
Prepare a new spare, heat its first connector, connect it to the second connector, break the breakable member, and inject a new chemical solution.

Therefore, the liquid conveying device of the present invention can perform a shrink-fit connection by heating the connecting end of the connector, and once the shrink-fit connection is performed, there is no risk of the connector being separated by the force normally applied to the connector unless heated. When both connectors are separated for renewal of treatment, the female connector is inevitably heated more strongly than the male connector, and the two connectors can be easily separated due to the difference in thermal expansion between the mating surfaces. For this reason, the liquid transport device of the present invention can be used for dialysis treatment or infusion, because if an alcohol lamp or the like is used, the connectors can be connected extremely safely and easily so that no microorganisms such as bacteria or viruses can enter the connector. In a wide range of treatment methods, including medical treatment and blood transfusion therapy, it is possible to completely eliminate intraperitoneal infection due to bacteria that have entered through the connector, and is particularly effective in peritoneal dialysis, which has no protective ability. is extremely effective for continuous mobile peritoneal dialysis to update dialysis treatment at home or at work.

Further, in the device of the present invention, the male connector is made of ceramics, and the other female connector is made of stainless steel, titanium, or heat-resistant and corrosion-resistant metal such as nickel or chrome-plated brass, or heat-resistant and corrosion-resistant plastic. In the case of an embodiment made of a base material, the male connector's mating surface has almost no thermal expansion, so the inner diameter of the female connector's mating surface is slightly smaller than the outer diameter of the male connector's mating surface. In addition, when the second connector is a male connector made of ceramics, the function of differential thermal expansion, which is a feature of the present invention, can be achieved. The first connector is made of a heat-resistant and corrosion-resistant metal such as stainless steel, titanium, and brass coated with nickel or chrome plating, or a heat-resistant and corrosion-resistant plastic material, which is cheaper than ceramics. Since the first connector is disposable, it is economical.

In addition, when the device of the present invention is implemented in such a manner that the connecting fitting surface of the male connector and the connecting fitting surface of the female connector are fitted with tapered cylindrical surfaces, it is possible to shrink-fit the connecting fitting surfaces of both connectors. It is extremely easy to process the connectors, and simultaneously achieves highly wear-resistant shrink-fit connection and liquid-tight connection between the connectors.

Furthermore, when the device of the present invention is implemented with a heat-resistant sealing member that connects the connectors in a liquid-tight manner, a sufficiently reliable liquid-tight fitting can be achieved.

Furthermore, if the device of the present invention is implemented in which a cylindrical support made of a heat insulating material is fitted near the tube of each connector, the connector can be held stably and easily, and can be held directly with bare hands. Therefore, it becomes much easier for the patient to perform treatment operations by himself/herself.

Furthermore, if the device of the present invention is made of flexible plastic and can be easily rolled up and folded, the container can be made portable, making it suitable for continuous mobile peritoneal dialysis.

[Brief explanation of the drawing]

FIG. 1 is a usage diagram showing a continuous mobile peritoneal dialysis method using a conventional liquid transport device, and FIG. 2 shows a continuous mobile peritoneal dialysis method using a liquid transport device according to an embodiment of the present invention. It is a usage state diagram. 3 to 7 show modifications of main parts of the present invention, in which FIG. 3 is a partial front view in which a breaking member is provided near the container, and FIG. 4 is a portion provided with a breaking member having a different breaking function. An enlarged view, FIG. 5 is an enlarged sectional view of the connector, and FIG. 6 is a front view of the main part showing the part that has a cylindrical body that can be heated by holding both connectors with bare hands when both connectors are made of metal. FIG. 7 is a partially sectional front view of a main part of a double-lockable connector. 12... Container, 13... Transport tube, 14... First
Connector, 14a... Connection end, 15... Breaking member, 16... Second connector, 17... Catheter.
Tube (one or both of the indwelling type catheter 17a and the extension tube 17b), 18... passage,
19...Liquid path, 20...Flow path, 21...Flow path, 28...
Seal member, 29...cylindrical body.

Claims (1)

[Scope of Claims] 1. A container containing a drug solution, a flexible transport tube connected to the container and having a passage therein that can communicate with the inside of the container, and a flexible transport tube connected to the other end of the transport tube and having a passage inside the container. A short tubular first connector having a liquid path communicating with the passage, a breakable member provided to close the passage and capable of opening the passage when broken, and capable of being connected and disconnected from the other end of the first connector. a short tubular second connector having a flow path therein that communicates with the liquid path of the first connector;
a flexible catheter tube connected to the other end of the second connector and having a flow passage therein communicating with the flow passage, the first connector and the second connector having a pair of male and female connectors; type connector, and at least each connecting end is made of a heat-resistant and corrosion-resistant material, and furthermore, the connecting fitting surface of the male connector is made of a material having a smaller thermal expansion than the connecting fitting surface of the female connector. A liquid conveying device characterized in that the connecting and fitting surfaces are formed to have a size that provides a shrink-fitting dimension difference that allows connection and dissociation due to a difference in thermal expansion. 2 The connecting and fitting surfaces of the first connector and the second connector are such that one male connector is made of ceramics, and the other female connector is made of stainless steel, titanium, nickel, or chrome plating. 2. A liquid conveying device according to claim 1, which is made of a heat-resistant and corrosion-resistant metal such as brass or a heat-resistant and corrosion-resistant plastic material. 3. The liquid conveyance device according to claim 1 or 2, wherein the joint fitting surface of the male connector and the joint fitting surface of the female connector are tapered cylindrical fitting surfaces. 4. Claims 1, 2, or 3, wherein either the first connector or the second connector has a heat-resistant sealing member that connects the two connectors in a liquid-tight manner. The liquid conveyance device described. 5. The first connector and the second connector are fitted with a cylindrical support made of a heat insulating material on the side of each tube.
4. The liquid conveying device according to item 1, 2, 3, or 4. 6. The liquid conveying device according to claim 1, 2, 3, 4, or 5, wherein the container is made of transparent or translucent flexible plastic and can be rolled up and folded.