JPH0657253B2 - Connector disconnection method and auxiliary device thereof - Google Patents

Description

TECHNICAL FIELD The present invention relates to a connector connection / disconnection method and an auxiliary device thereof. More specifically, the present invention relates to, for example, CAPD (Continuous Ambulatory Peritoneal Di
alysis: In continuous mobile peritoneal dialysis), when connecting the tube communicating with the indwelling catheter to the tube communicating with the dialysate bag at the connector provided at each tip, the sterility is maintained and the sterilization effect is more reliable. The present invention also relates to a connector connection / disconnection method and an auxiliary device for the same, which facilitates operation.

(Prior Art) When it is necessary to join one container or system and another container or system to transfer fluid aseptically, for example, to a catheter placed in the body by a surgical procedure. In the case of continuous mobile peritoneal dialysis (CAPD), etc., in which the operation of flowing the dialysate into the body by joining the tubes communicating with the container containing the dialysate into the communicating tube has to be repeated, it has been sterilized in advance. A method of aseptically connecting each container or system is needed.

In particular, in the case of the CAPD method and the like described above, a sterile connection / disconnection method that does not require equipment such as a large-scale sterile room is desired in order to enable home treatment and the like.

As such an aseptic connection / disconnection method, a flame sterilization method has been mainly used conventionally. The flame sterilization method uses an alcohol lamp etc. to keep both connector parts in the flame.
The connector part is sterilized by flame heat to dissociate and connect in an aseptic state. However, in this flame sterilization method, since both connector parts are exposed to high temperature, glucose contained in the dialysate composition, for example,
Carmelation occurs at the connector part or its vicinity, making it difficult to inject and discharge dialysate, and it is easy to cause individual differences in the operation due to the large number of operation procedures. Furthermore, for example, the flow of air by an air conditioner or the like. If you perform the operation in a room with a fire, the flame will shake, it will not be possible to heat the connector part sufficiently, and it will be difficult to maintain sterilization or sterility. The problem remains that it is easily affected by the surrounding environment such as wind, which causes an operation error. As a method for aseptic connection and dissociation other than the flame sterilization method, an ultraviolet irradiation method, a method filed by Daepon Co. (hereinafter referred to as DuPont method), a povidone-iodine method, etc. have been proposed. However, the ultraviolet irradiation method is a method of connecting both connector parts and then irradiating ultraviolet rays, but it requires a long irradiation time, and the apparatus is expensive, which imposes an economic burden on the patient. Further, the Japanese method is a method of cutting and welding a tube by using high temperature as disclosed in JP-A-57-49,468 and the like, but since it is exposed to a high temperature, it is dialyzed similarly to the above-mentioned flame sterilization method. Glucose contained in the liquid composition may turn into carmela, which may make it difficult to inject and discharge the dialysate. Further, in the povidone-iodine method, preparation of the sterilizing agent is complicated, and there is a risk of contaminating the connector part by immersing it in the sterilizing agent. Thus, none of the conventional aseptic dissociation methods can be said to be sufficiently satisfactory, and in particular, when insufficient sterilization or poor connection occurs from the above aspects, the bacterial cells in the system are Invasion occurred, and in the case of CAPD, there was a risk of peritonitis due to this.

(Problems to be Solved by the Invention) Accordingly, an object of the present invention is to provide a novel method for disconnecting and connecting a connector and an auxiliary device therefor. The present invention can also be used, for example, in a dialysate solution exchange operation in CAPD therapy, and makes it more reliable to maintain sterility in the system and sterilize the connector part, and to make the connection / disconnection operation easier. An object of the present invention is to provide a method for disconnecting and connecting a connector and an auxiliary device for the method. The present invention further provides a connector connection / disconnection method and an auxiliary device therefor, which can provide a stable aseptic effect with easy operation without being affected by uncertain factors such as individual differences of operators and surrounding environments. The purpose is to do.

(Means for Solving the Problems) The above-mentioned objects are a tube communicating with an indwelling catheter used for continuously movable peritoneal dialysis that can be connected and disconnected to each other within an infrared effective irradiation region of an infrared irradiation device equipped with an infrared radiator. The connector provided at the tip of the tube and the connector provided at the tip of the tube communicating with the dialysate bag are arranged, and while maintaining a substantially sterile condition in the infrared flux irradiated from the infrared irradiation device, This is achieved by a method for disconnecting and connecting a connector, which comprises disconnecting and connecting two connectors.

The present invention also shows a method for disconnecting and connecting a connector in which the infrared radiator is a ceramic heater. The present invention also shows a method of connecting and disconnecting the connector, wherein the infrared ray bundle contains a large amount of far infrared rays.
The present invention further provides a connector connection in which one of the two connectors and the other connector are arranged in a state of being connected to each other, and after dissociation, another connector prepared separately is connected to one connector. It shows a dissociation method.

The above-mentioned various objects are an infrared irradiation mechanism provided with an infrared radiator, and a tube connected to a connector and a dialysate bag provided at the tip of a tube connected to an indwelling catheter used for continuously movable peritoneal dialysis that can be connected to each other. And a connector gripping mechanism capable of gripping a plurality of connectors provided at the tip of each of the connectors and disposing each connector within the infrared effective irradiation area of the infrared irradiation mechanism. It

The present invention also arranges a heat wire connected to an external power source on the outer peripheral surface of a ceramic cylindrical body having a notch in the axial direction, and fills a heat insulating material around the heat wire to form a ceramic cylindrical body. A connector characterized by having an infrared irradiation mechanism surrounding the outer peripheral surface and further enclosing the heat insulating material with a metal plate, and a set of connector gripping mechanisms roughly positioned on the axis of the ceramic cylindrical body. 2 shows a connection dissociation assisting device. The present invention further relates to a connector including a support body for moving the connector gripping mechanism from a first position which is generally located on the axis of the ceramic cylindrical body to a second position which is located outside the ceramic cylindrical body. It shows a connection dissociation auxiliary device. The present invention also shows a device for assisting connection / disconnection of a connector in which the infrared radiator is a ceramic heater. In the present invention, the ceramic constituting the ceramic heater contains a ceramic selected from the group consisting of zirconia, titania, alumina, and silicic acid as a main component. It shows a connection / disconnection assistance device for a connector. The present invention further provides a ceramic zircon _(ZrO 2 · _SiO 2), sphene _{(CaO · TiO 2 · SiO 2} ), cordierite _{(2MgO · 2Al 2 O 3 ·} 5SiO 2), β- Supodjumen _(Li 2 O · Al ₂ O ₃ · 3SiO ₂ ) and aluminum titanate, which is a main component selected from the group consisting of aluminum titanate.

(Operation) The present invention communicates with an indwelling catheter used for continuously movable peritoneal dialysis that can be connected and disconnected to and from each other in an infrared effective irradiation region of an infrared irradiation device provided with an infrared radiator, particularly an infrared radiator made of a ceramics heater. A connector provided at the tip of the tube and a connector provided at the tip of the tube communicating with the dialysate bag are arranged, and each connector is attached / detached in the infrared flux irradiated from the infrared irradiation device. It is a feature of the connector dissociation method. In this way, when the connection part is detached under the irradiation of infrared rays, each connector resonates and absorbs this infrared ray and heats it from the inside, so that not only the surface but also the inside is extremely well and in a short time. Although the detailed mechanism of action is not clear, radiant heating by infrared rays works well against bacteria even at low temperature and for a short time compared to conduction heating by flames, etc. Is certainly done. Further, the infrared irradiation guarantees a stable aseptic connection / disconnection operation because it is not affected by the surrounding environment such as wind and has little influence on the operator.

Further, the connector disconnection assisting device of the present invention is an infrared irradiation mechanism provided with an infrared radiator such as a ceramics heater, and a distal end of a tube communicating with an indwelling catheter used for continuously movable peritoneal dialysis that can be disconnected and connected to each other. And a connector gripping mechanism for gripping the connector provided at the tip of a tube communicating with the dialysate bag and enabling each connector to be placed in the infrared effective irradiation area of the infrared irradiation mechanism. Since it is a feature, when it is used in the connector dissociation method as described above, by controlling the surface temperature of the ceramic heater, infrared rays of a wavelength corresponding to the absorption wavelength of the connection part that is the heating object are generated. It is possible to ensure that each connector is placed within this effective irradiation area. Because it is shall, in which may perform stable aseptically connected dissociation operation.

(Example) Hereinafter, the present invention will be described more specifically based on an embodiment.

FIG. 1 is a partial cross-sectional side view showing an embodiment of a connector disconnection assisting device of the present invention, and FIG. 2 is a front view of the same embodiment. As shown in FIGS. 1 and 2, in the connector connection / disconnection assistance device of this embodiment, the infrared irradiation mechanism 1 has an outer diameter of 70 mm, a length of 60 mm, and a wall thickness of 10 mm, and is cut in the axial direction by 45 °. A plurality of nickel-chromium-based or nickel-based heating wires 4 connected to an external power source (not shown) are arranged on the outer peripheral surface 3 of the ceramic cylindrical body 2 having a notch, and around the heating wires 4. , The outer peripheral surface 3 of the ceramic cylindrical body 2 filled with glass wool as the heat insulating material 5.
Is surrounded by a heat insulating material 5, and the heat insulating material 5 is further covered with an aluminum plate 6. The cross section of the ceramic cylindrical body 2 is protected by a heat insulating material 7 such as silicone.

In the connector dissociation assisting device of the present invention,
The infrared radiator of the infrared irradiation mechanism is preferably a radiator that emits infrared rays that resonate with the absorption band of the material forming the connection part, for example, at the tip of the tube communicating with the indwelling catheter used for CAPD. Since the provided connector and the connector provided at the tip of the tube communicating with the dialysate bag are mainly made of ceramics and have absorption in a relatively far infrared region in many cases, a far infrared radiator is preferable. In order to obtain such a far-infrared radiator, the ceramics forming the ceramics heater is composed mainly of one selected from the group consisting of zirconia, titania, alumina, and silicic acid, and more specifically. , Zircon (ZrO ₂ · SiO ₂ ), Sphene (CaO · T
iO ₂ · SiO ₂ ), cordierite (2MgO · 2A)
l ₂ O ₃ .5SiO ₂ ), β-spodumene (Li ₂
O.Al ₂ O ₃ .3SiO ₂ ) and sodium titanate are preferably used as a main component. In addition, in this embodiment,
The ceramics heater is formed as a tubular body having a cutout portion, but its shape is not limited at all, and in addition to this, for example, a combination of a plurality of plate-shaped ceramics can be taken into any shape.

In this embodiment, an aluminum plate is used as a metal plate that covers the outer peripheral surface of the ceramic cylindrical body 2. The aluminum plate has a high infrared reflectance and the infrared rays are transmitted to the outside of the infrared irradiation mechanism. It is effective in preventing leakage. However, the metal plate is not limited to the aluminum plate, and various types such as a copper plate and a steel plate can be used.

Further, in the connector connection / disconnection assisting device of the present embodiment, since electricity is used as the heat source of the ceramic heater of the infrared irradiation mechanism 1, irradiation control can be carried out very easily. That is, since the energy emitted from the ceramic heater is determined by the temperature of the heater surface, the surface temperature of the heater can be changed by arbitrarily changing the voltage and current applied to the heater, and this will match the absorption wavelength of the material forming the connector. Further, the heating efficiency can be increased by generating an arbitrary wavelength.

In order to arrange the connectors in the infrared effective irradiation area of the infrared irradiation mechanism 1 having the above-described configuration, in the present embodiment, the left and right independent tiltable columns 8a, which are tilted to the front,
It has connector holders 10a and 10b mounted on pedestals 9a and 9b supported by 8b, respectively.
The connector holders 10a and 10b are attached so as to be freely movable in the axial direction on the mounts 9a and 9b, respectively. Then, the connector holder 10
a and 10b are, as shown in FIG.
By making 8b stand upright with respect to the support base 11, the first cylindrical body 8b is positioned substantially on the axis of the cylindrical ceramic body 2.
It is possible to be placed in the second position B located outside the ceramic cylindrical body 2 by being placed in the position A and having the retractable columns 8a, 8b tilted to the front.

Next, using the connector dissociation assisting device of the present embodiment, taking as an example the case of connecting the tube communicating with the indwelling catheter in CAPD with the tube communicating with the dialysate bag at the connector provided at each tip, The method for disconnecting and connecting the connector of the present invention will be specifically described. The connectors joined together in this case are as shown in FIG. In other words, the male type cocter 12 provided at the distal end of the tube communicating with the indwelling catheter is made of ceramics so as to exhibit stable performance for a long period of time without being changed with time even after performing aseptic joining operations a plurality of times. On the other hand, since the female connector 13 provided at the tip of the tube communicating with the dialysate bag is disposable, it is made of phenol resin, epoxy resin, urea resin, polyimide, polyamide, polycarbonate, etc. Although it may be made of synthetic resin, it is preferably made of ceramics. Further, an O-ring 14 is provided at the fitting portion of the female connector 13 to maintain liquid tightness after connection with the male joint portion 12 and to invade bacterial cells from the external environment and circulate inside. Prevent leakage of dialysate.

Such an aseptic drop connection dissociation operation of both connectors 12, 13 is usually started in a state where both connectors 12, 13 are connected. First, the heating wire 4 of the connector dissociation auxiliary device of the present embodiment is energized to bring the inner peripheral surface of the ceramic cylindrical body 2 to a predetermined temperature. Next, both retractable columns 8a, 8
b to the front, the connector holders 10a and 10b are placed in the second position B, and both connectors 12 in the connected state,
13 are respectively held by the connector holders 10a and 10b, and then the retractable stanchions 8a and 8b are returned to the original positions so that the connector holders 10a and 10b are placed in the first position A, and the both held connectors 12 and 13 are infrared rays. Keep within the effective irradiation area. After a lapse of a predetermined time, the connector holder 1 holding the female connector 13 on the dialysate bag side
0a is slid outward on the pedestal 9a to disconnect the connection, and then only the foldable support column 8a supporting the connector holder 10a is laid down on the front side to be in the second position B, and the female mold is disassembled. The connector 13 is replaced with the female connector 13 of the new dialysate bag, and the retractable stanchions 8a are returned again to place the connector holder 10a holding the new female connector 13 in the first position A. After holding both connectors 10a and 10b under infrared irradiation for a predetermined time, the connector holder 10a holding the female connector 13 is slid toward the center side on the mount 9a to fit the female connector 13 and the male connector 12 together. Combine and join. After that, both the retractable columns 8a and 8b are tilted to the front, the two connector holders 10a and 10b are placed in the second position B, the two connectors 12 and 13 connected from the two connector holders 10a and 10b are removed, and further screwed or the like. The joining operation is completed by reinforcing with.

When the connection dissociation assisting device of the connector of the present embodiment is used to actually perform the connection dissociation operation as described above, Candida albicans [Saccharomyces cerevisiae] and Rhodospirillum [Rhodospirillum] rubra]
Yeast of each connector die at the surface temperature of each connector at 60 ° C for 10 minutes, and the Penicillium cytolinum [Pencillium
The molds of citrinum] and Cladsporium cladosporioides die at the surface temperature of each connector of 60 ° C for 10 minutes,
Also, molds from Aspergillus niger and Staphylococcus aureus [Staphy
lococcus aureus], Escherichia coli [Esherichia
coli] and Pseudomonas aeruginosa [Pseudo
monas aeruginosa] bacteria were killed at the surface temperature of each connector of 80 ° C. for 10 minutes.

[Advantages of the Invention] As described above, the connector connection / disconnection method of the present invention is used for continuously movable peritoneal dialysis capable of connection / disconnection with each other within the infrared effective irradiation region of an infrared irradiation device equipped with an infrared radiator. The connector provided at the tip of the tube communicating with the indwelling catheter and the connector provided at the tip of the tube communicating with the dialysate bag are arranged, and are substantially aseptic in the infrared flux irradiated from the infrared irradiation device. Since it is characterized in that the connection and disconnection of the two connectors are performed while maintaining the state, the connector can be detached while reliably and efficiently performing sterilization or maintaining the sterilization state by using infrared rays. And the ambient environment such as wind and individual differences of those who operate as in the flame sterilization method using direct fire as a heat source It does not depend on uncertain factors such as, and does not require expensive equipment such as the ultraviolet irradiation method. Furthermore, for example, even when the system to be connected contains a dialysate, the composition of the dialysate is There is no possibility of caramelizing glucose, which is one of them, to make it difficult to inject and discharge the dialysate, and, of course, no special disinfectant is required as in the Popillon iodine method, so that there is a risk of contamination by the disinfectant. Therefore, it is an extremely excellent connection and dissociation method, and is particularly preferably used in aseptic exchange of the dialysate bag used for CAPD and enables home treatment of CAPD.

Further, in the connector connection / disconnection method of the present invention, if the infrared radiator is a ceramic heater and the infrared flux contains a large amount of far infrared rays, better sterilization or maintenance of aseptic condition will be ensured.

The present invention also provides an infrared irradiation mechanism equipped with an infrared radiator and a tube connected to a connector and a dialysate bag provided at the distal end of a tube connected to an indwelling catheter used for continuously movable peritoneal dialysis that can be connected to each other. And a connector gripping mechanism capable of gripping a plurality of connectors provided at the tip of the connector and arranging each connector within the infrared effective irradiation area of the infrared irradiation mechanism. Therefore, it is preferably used when carrying out the method of connecting and disconnecting the connector of the present invention which exhibits the above-mentioned excellent effects, and makes the aseptic joining operation by infrared rays more reliable and easy, and also economically inexpensive. Is.

Further, in the connector disconnection assisting device of the present invention, the infrared radiator is a ceramics heater, and the ceramics constituting the ceramics heater is mainly composed of one selected from the group consisting of zirconia, titania, alumina, and silicic acid. , More specifically, when the main component is selected from the group consisting of zircon, sphene, cordierite, β-spodumene and aluminum titanate, the ceramic heater has a more desirable wavelength range. Aseptic connection and disconnection operations become more reliable because they can be irradiated with infrared rays. Further, the connector disconnection assisting device of the present invention is arranged such that a heating wire to be connected to an external power source is arranged on the outer peripheral surface of a ceramic cylindrical body having a notch in the axial direction, and a heat insulating material is provided around the heating wire. And an infrared irradiation mechanism that encloses the outer peripheral surface of the ceramic cylindrical body and further coats the heat insulating material with a metal plate, and a pair of connector gripping mechanisms that are approximately positioned on the axis of the ceramic cylindrical body. If it is configured to have a simpler and more compact structure, it becomes a device that exhibits stable performance, and by changing the voltage and current of infrared rays of any wavelength to use electricity as a heat source. It becomes possible to irradiate easily. Further, the connector disconnection assisting device is provided with a support body for moving the connector gripping mechanism from a first position, which is substantially located on the axis of the ceramic cylindrical body, to a second position, which is located outside the ceramic cylindrical body. If so, the connector replacement operation can be performed more easily.

[Brief description of drawings]

FIG. 1 is a partially sectional side view showing an embodiment of a connector disconnection assisting device of the present invention, FIG. 2 is a front view of the same embodiment, and FIG. 3 is a view of the connector of the present invention. It is a half cross-sectional view which shows an example of the joining part joined in the connection dissociation method. 1 ... Infrared irradiation mechanism, 2 ... Ceramic cylindrical body, 4 ... Heat source, 5, 7 ... Thermal insulation material, 6 ... Aluminum plate, 8a, 8b ... Retractable column, 9a, 9b ... Stand , 10a, 10b ... Connector holder, 12 ... Male connector, 13 ... Female connector, A ... First position, B ... Second position.

Claims (10)

[Claims] 1. A connector and a dialysis provided at the distal end of a tube communicating with a storage catheter used for continuously movable peritoneal dialysis, which can be connected and disconnected from each other within an infrared effective irradiation region of an infrared irradiation device equipped with an infrared radiator. A connector provided at the tip of a tube communicating with the liquid bag is arranged so that connection and disconnection of the two connectors can be performed while maintaining a substantially sterile condition in the infrared ray bundle irradiated by the infrared ray irradiation device. A characteristic method for disconnecting the connector connection. 2. The method for connecting and disconnecting a connector according to claim 1, wherein the infrared radiator is a ceramic heater. 3. The method for connecting and disconnecting a connector according to claim 1, wherein the infrared ray bundle contains a large amount of far infrared rays. 4. One of the two connectors and the other connector are arranged in a state of being connected to each other,
The connector connection dissociation method according to any one of claims 1 to 3, wherein another connector prepared separately is connected to one connector after dissociation. 5. An infrared radiation mechanism having an infrared radiator,
A connector provided at the tip of a tube that communicates with an indwelling catheter used for continuously movable peritoneal dialysis that can be connected and disconnected and a connector provided at the tip of a tube that communicates with a dialysate bag are grasped and each connector is A connector disconnection assisting device, comprising: a gripping mechanism that can be placed within an infrared effective irradiation area of the infrared irradiation mechanism. 6. A ceramic cylindrical body having a notch in the axial direction, a heating wire connected to an external power source is arranged on the outer peripheral surface of the cylindrical ceramic, and a heat insulating material is filled around the heating wire. Patents characterized by having an infrared irradiation mechanism surrounding the outer peripheral surface and further covering the heat insulating material with a metal plate, and a pair of connector gripping mechanisms roughly positioned on the axis of the ceramic cylindrical body. The connection / disconnection assistance device for a connector according to claim 5. 7. A support body for moving the connector gripping mechanism from a first position, which is generally located on the axis of the ceramic cylindrical body, to a second position, which is located outside the ceramic cylindrical body. The connection / disconnection assistance device for a connector according to claim 6. 8. The connection / disconnection assistance device for a connector according to claim 5, wherein the infrared radiator is a ceramics heater. 9. The ceramic according to claim 5, wherein the ceramics constituting the ceramics heater has a main component selected from the group consisting of zirconia, titania, alumina, and silicic acid. A device for assisting connection and disconnection of a connector according to item 1. 10. The ceramic is zircon (ZrO ₂ .S).
iO ₂ ), sphene (CaO ・ TiO ₂・ Si
O _2), cordierite _{(2MgO · 2Al 2 O 3 ·} 5
SiO ₂ ), β-spodumene (Li ₂ O.Al ₂ O
The connector connection / disconnection assisting device according to claim 4 or 5, wherein the main component is selected from the group consisting of ₃ · 3SiO ₂ ) and aluminum titanate.