JPH0779837B2 - Connection member heat sterilizer - Google Patents

Description

TECHNICAL FIELD The present invention relates to a heating sterilizer for connecting members, and more particularly to CAPD.
In (Continuos Ambulatory Peritoneal Dialtsis: continuous ambulatory peritoneal dialysis method), a transfer tube that communicates with the abdominal catheter connected to the patient's body and a bag tube that communicates with the plastic bag containing the perfusate are provided at each tip. The present invention relates to a heating and sterilizing apparatus for connecting members, which can maintain a sterile condition and ensure a sterilizing effect more easily when connecting with a connected male or female member.

[Conventional technology]

Conventionally, when renal function is deteriorated, excretion of waste products (for example, urea, uric acid, creatinine, etc.), salt and other electrolytes, water, etc. occurs, and these substances are accumulated in the body. Therefore, since various pathological symptoms are exhibited, blood purification has been performed for such patients with reduced renal function using a dialysis method using an artificial kidney. However, when an artificial kidney is used, the patient has to be in bed for a long time and is restrained during that time.Therefore, in recent years, the peritoneum is used as a dialysis membrane, and a continuous ambulatory peritoneal dialysis can be performed while continuing treatment. The law is gaining attention. In this continuous ambulatory peritoneal dialysis method, the peritoneum that exists in the living body and has the property of a semipermeable membrane is used as a dialysis membrane, and a perfusate that causes a predetermined solute concentration gradient and osmotic pressure difference enters the living body. It uses a complete closure system with a plastic bag. In this continuous ambulatory peritoneal dialysis method, perfusate is infused into the abdominal cavity and kept for a long time, for example, 4 to 8 hours at all times,
During this period, the solute concentration gradient and osmotic pressure difference generated between the perfusate injected into the abdominal cavity and the blood in the capillaries distributed in the peritoneum removes solute and water from the inside of the body to purify blood. The plastic bag containing the perfusate is replaced every 4 to 8 hours. Therefore,
According to this continuous ambulatory peritoneal dialysis method, the patient can be reintegrated into society by training the patient to aseptically replace the plastic bag containing the perfusate. This plastic bag containing the perfusate is replaced by a male member at one end of the transfer tube connected to the abdominal catheter implanted in the abdominal cavity of the patient by surgery and a female member connected to the bag tube on the plastic bag side. The connection of the connecting member may be aseptically released, and the female member connected to the new plastic bag side bag tube may be aseptically connected to the transfer tube side male member.

The aseptic connection and disconnection method of such a connecting member includes the following.

Conventionally, the flame sterilization method is mainly used. In this flame sterilization method, both male and female members of a connecting member are kept in a flame by using an alcohol lamp or the like, both male and female members are sterilized by flame heat, and dissociated and connected in an aseptic state.

In the ultraviolet irradiation method, both male and female members are connected to each other, and then ultraviolet rays are irradiated for a long period of time to sterilize them.

The method disclosed in JP-A-57-49468 is to sterilize the tube by cutting and welding the tube at high temperature.

The povidone-iodine method prepares a fungicide such as iodine,
By immersing both male and female members in this bactericide, a sterile state is obtained.

Further, as a systematic implementation of connection / disconnection of connecting members by the applicant of the present invention in an aseptic state, Japanese Patent Laid-Open No.
-99254 and JP-A-63-127769 are known.

[Problems to be Solved by the Invention]

However, in the above-mentioned flame sterilization method, since both male and female members are exposed to high temperature, for example, glucose contained in the perfusate composition is caramelized in the male and female members or their vicinity and further carbonized. It is not easy to inject and drain the perfusate. Also, since there are many operation procedures, it is easy for individual differences in operation. For example, if the operation is performed in a room with an air flow by an air conditioner or the like, the flame is shaken and the male and female members cannot be sufficiently heated, and it is difficult to maintain sterilization or sterility. There were inconveniences such as being directly touched by the fingers and feeling hot, and heating the tube and the like more than necessary, and being easily affected by the surrounding environment.

The ultraviolet irradiation method requires a long irradiation time, the apparatus is expensive, and the patient is economically burdened.

Method uses high temperature, as in the flame sterilization method, glucose contained in the dialysate composition is caramelized,
Further, there is a possibility that carbonization will occur and it will become difficult to inject and discharge the perfusate.

In the povidone-iodine method, preparation of the fungicide is complicated, and
There is a risk of contaminating the male and female parts by immersing them in a germicide.

The method by the applicant of the present application can substantially eliminate the disadvantages of the above-mentioned conventional examples, but as a whole, the device becomes large-scale, and the device becomes relatively expensive. I have a tendency to end up.

Therefore, the present invention has been made in view of the above circumstances,
Can be sterilized in a short time without being affected by the surrounding environment such as liquid or wind remaining on the connecting member,
Moreover, it is an object of the invention to provide an inexpensive connecting member heat sterilizer.

[Means for Solving the Problems]

In order to solve the above problems, the connection member heat sterilization apparatus of the present invention is a connection member comprising a combination of a male member having one end connected to a liquid supply means and a female member having one end connected to another liquid supply means. Of these, a device for heating and sterilizing at least a connecting member connected to a liquid feeding means on the side to be connected to the inside of the body, wherein an inlet into which the member can be inserted, and a member continuous to the inlet and electrically connected to the member. It comprises a heating part capable of heating and a control part for controlling the operation of the heating part.The control part has a mechanism for stopping energization when the heating part rises to a predetermined temperature, and heats the member by residual heat. It is configured so that it can be sterilized.

Further, it is preferable that the heating section has an inclined section that positions the other end of the member downward from the introduction port.

[Action]

According to the connecting member heat sterilization device having the above-described configuration, the heating part is heated to a predetermined temperature, the energization is stopped, and the connecting member connected to the liquid feeding means on the side to be connected to the inside of the body is inserted from the introduction port. It is held in the heating unit, and the connecting member is heat-sterilized by the residual heat of the heating unit.

Further, when the heating portion has the inclined portion, the member can be easily inserted and does not come out.

[Embodiment] An embodiment of the present invention will be described below in detail with reference to the accompanying drawings.

FIG. 1 is a perspective view showing a connection member heat sterilization apparatus of the present invention,
FIG. 2 is a side view in which a part of the connecting member heat sterilization device is sectioned, FIG. 3 is a half cutaway view showing a state before connection of the connecting member, and FIG. 4 is a half cutaway view showing connection state of the connecting member. FIG. 5 is a schematic configuration diagram of the control unit. In the figure, reference numeral 1 denotes a connection member heat sterilization apparatus, and the connection member heat sterilization apparatus 1
Is a case 4 composed of a sterilization box 2 and a control box 3, and a connecting member 7 which is formed in a combination of a male member 5 and a female member 6 while being pierced in the sterilization box 2 of the case 4.
Introducing port 8 into which at least one of
And a heating unit 9 which is continuous with the inlet 8 and can electrically heat the male member 5 or the female member 6, a control unit 10 for controlling the operation of the heating unit 9, and a control state by the control unit 10 are displayed. And a display unit 11 for performing the operation.

The case 4 is made of a heat-resistant synthetic resin material, and the introduction port 8 is formed in the front surface of the sterilization box 2. A joint holder 12 that is tapered so that the male member 5 or the female member 6 can be easily inserted into the introduction port 8
The joint holder 12 is positioned by the positioning holder 13. Further, the display portion 11 is provided on the sloped portion of the control box 3. A power switch 14 is provided on the left side surface of the control box 3 in FIG.

The heating section 9 is mainly composed of a cylindrical ceramic heater 15 provided continuously to the introduction port 8. If the heating portion 9 has an inclined portion so that the tip of the male member 5 or the female member 6 is positioned below the inlet port 8,
The male member 5 or the female member 6 can be easily inserted. In this case, a suitable inclination is about 10 degrees. The ceramic heater 15 is attached to the heater holder 17 via a heat insulating spacer 16, and the heater holder 17 is fixed to the wall surface of the control box 3 via a heat insulating plate 18. Further, the ceramic heater 15 is covered with a heat insulating roll 19 made of silica fiber so that heat from the ceramic heater 15 is not transmitted to the outside to facilitate heat sterilization by residual heat, and further, the case 4 is overheated. The operator does not get burned. Further, a temperature sensor 20 is inserted in the ceramic heater 15, and the temperature sensor 20 is attached to a holder 21.
21 is fixed to the wall surface of the control box 3 via a heat insulating plate 22.

The control unit 10 is provided in the control box 3 of the case 4 located near the display unit 11. This control unit 10
Is a power supply unit 23, the power switch, as shown in FIG.
14, electrically connected to the ceramic heater 15, the temperature sensor 20, and the display unit 11. In addition, as the power supply unit 23, a structure that can use a household power supply,
Although preferable in terms of downsizing of the device, a battery or the like may be housed in the control box 3 and used as the power supply unit 23.
Further, as the temperature sensor 20, for example, a thermocouple or the like can be used, but it is also possible to use a ceramic heater having a sensor circuit for calculating the temperature by measuring the resistance.

The display unit 11 includes a sterilization switch 24, a red lamp 25 that lights up when the ceramic heater 15 is turned on, and turns off when the temperature reaches 700 ° C., and the temperature inside the ceramic heater 15 is decreasing, and 600 ° C. Green lamp 26 that turns on when it is above and turns off when it becomes 600 ° C or lower, and turns on when sterilization switch 24 is turned on and timer 27 built in control unit 10 turns on, and timer 27 turns on after 20 seconds have passed. A yellow lamp 28 that turns off and turns off is provided.

Next, the connecting member 7 will be described in detail with reference to FIGS. 3 and 4. The male member 5 is mainly made of ceramics, and the insertion portion 30 for the female member 6 is provided at one end and the transfer tube (not shown) at the other end. Each of which has a plug-in portion 32 of a liquid feeding means) 36, a passage 33 inside thereof, and a flange portion approximately at the center of the outer peripheral surface in the axial direction.
34 are provided. The insertion portion 30 has a tapered surface 30a.

The female member 6 is mainly made of metal and has a female member 5 at one end.
The insertion part 35 capable of accommodating and connecting the insertion part 30 is provided at the other end, and the insertion part 37 of the bag tube (liquid feeding means) 31 connected to the plastic bag 42 described later is provided, and the passage is provided therein. Has 38. A female taper surface 35a is formed on the inserted portion 35 along the taper surface 30a of the insertion portion 30 of the male member 5. Then, the annular groove 35 provided on the inner surface of the inserted portion 35
A heat- and corrosion-resistant O-ring seal member 39 is fitted in b. Therefore, as shown in FIG. 4, the male member 5 and the female member 6 are liquid-tightly connected by the tapered surfaces 30a and 35b and the seal member 39, and liquid leakage from the connecting member 7 is prevented.

Next, a case where the connecting member heat sterilization apparatus having the above-mentioned configuration is used in a continuous portable peritoneal dialysis method (CAPD method) will be described.

FIG. 6 is a schematic configuration diagram of a continuous ambulatory peritoneal dialysis method (CAPD method). In the figure, an indwelling type catheter 41 is implanted in the abdominal cavity 40 of a patient M by a surgical operation, and the male member 5 is attached to one end of a transfer tube 36 connected to the catheter 41 located inside the body. Next, the female member 6 attached to one end of the bag tube 31 is connected to the male member 5. At this time, the male member 5 is sterilized by the coupling member heat sterilizer 1. First, when the power switch 14 is turned on, energization of the ceramic heater 15 is started, the temperature of the ceramic heater 15 is raised, and the red lamp 25 is turned on.
The temperature inside the ceramic heater 15 reaches 700 ° C. in about 120 seconds, as is clear from the characteristic diagram of time-temperature inside the ceramic heater in FIG. When it reaches 700 ° C, the temperature sensor 20 detects it, the power is turned off, and the red lamp 25 goes out.
Further, the green lamp 26 is turned on. Immediately, the male member 5 of the connecting member 7 is inserted into the heating portion 9 through the hole of the joint holder 12 attached to the inlet 8, and the sterilization switch 24 is turned on. At the same time, the yellow lamp 28 lights up and the timer 27 also turns on. At this time, either the male member 5 or the female member 6 may be sterilized, but since the male member 5 is likely to heat up, the male member 5 is usually heat sterilized. In general, the female member 6 connected to the plastic bag 42 is a disposable 0 and is sterilized in advance when connecting as the connecting member 7. Therefore, only the male member 5 to be repeatedly used may be heat sterilized. . Then, the temperature of the male member 5 in the ceramic heater 15 of the heating unit 9 rises rapidly, and as shown in the temperature-time characteristic diagram of FIG. After that, the temperature rises to a maximum of about 380 ° C, after which a downward-sloping curve is gently drawn, and a state of 200 ° C or higher continues for 100 seconds or longer.

During this time, the presence state of the number of bacteria on the surface of the male member 5 is 1og No =
As is clear from the characteristic diagram of 1og No-time in Fig. 9, the state of 6 kills within 20 seconds if the number of bacteria is 10 ³ . Therefore, if the ceramic heater 15 is raised to about 700 ° C and kept sufficiently warm with a heat insulating material, the temperature inside the ceramic heater 15 is maintained at 600 ° C or higher for about 100 seconds, during which the male member 5 is heated to 200 ° C for about 10 seconds. Above, and maximum 300 ℃
The duration can be 100 seconds or more. Therefore, during this period, the bacteria on the surface of the male member 5 are completely killed in about 20 seconds, so that the male member 5 can be sufficiently sterilized by heat with residual heat.

Then, when the temperature inside the ceramic heater 15 falls below 600 ° C. during the temperature drop process, the green lamp 26 is turned off. At this time, the yellow lamp 28
Lights up when the sterilization switch 24 is turned on as described above,
At the same time, the timer 27 is started, and after 20 seconds, the yellow lamp 28 is turned off, and the heat sterilization is completed. In addition, while the yellow lamp 28 is on, that is, during heat sterilization, the green lamp must be used.
26 is on, and the condition is that the temperature inside the ceramic heater 15 is maintained at 600 ° C. or higher.

After the sterilization of the male member 5 is completed, the male member 5 is removed from the joint holder 12 and immediately fitted into the female member 6. In addition,
At this time, as is clear from FIG. 8, even if the male member 5 is detached from the joint holder 12, the male member 5 will be kept at 300 for about 10 seconds.
In order to maintain the temperature of not less than 0 ° C., even if bacteria adhere to the surface of the male member 5, it can be sterilized during the time required for connecting the connecting member 7.

Then, in order to inject the perfusate into the abdominal cavity 40, the plastic bag 42 is hung at a predetermined height higher than the abdominal cavity 40, and the plug body provided near the connecting portion between the main body of the plastic bag 42 and the bag tube 31. 43 broken and separated, bag tube
This is done by loosening the clamp 44 attached in the middle of 31. After injecting the perfusate into the abdominal cavity 40, the patient M can walk or work by closing the clamp 44, appropriately rolling the bag tube 31 and attaching the plastic bag 42 to the waist.

In order to drain the perfusate from the abdominal cavity 40 after a predetermined time, for example, 4 to 8 hours, the bag tube 31 may be extended, the plastic bag 42 may be placed on the floor or the like, and the clamp 44 may be loosened. Then, the connection of the connecting member 7 is disconnected, the plastic bag 42 to which the female member 6 is connected is made disposable, the next new plastic bag 42 is set at a high place, and the female member 6 of the new plastic bag 42 remains. If the male member 5 is connected, the second and subsequent dialysis can be performed.

Male and female members 5 of the connecting member 7 in the second and subsequent dialysis
When connecting 6 as well, the male member 5 is heat-sterilized by the above-described connecting member heat sterilization apparatus 1 in order to prevent bacteria and the like from entering the bag tube 31.

〔The invention's effect〕

As described above in detail, according to the connection member heat sterilization apparatus of the present invention, the heating portion is heated to a predetermined temperature, the current is stopped, and the connection is connected to the liquid feeding means on the side to be connected to the inside of the body. The member is put in through the inlet and held in the heating unit, and the male member or the female member is heat-sterilized by the residual heat of the heating unit. Therefore, during heat sterilization, since there is no power supply, there is no risk of electric shock from the patient via the liquid feeding means connected to the member to be sterilized. Further, the connection member can be sterilized in a short time without being affected by the surrounding environment such as liquid or wind remaining on the connection member, and the structure is simple, so that the cost can be reduced. effective.

Further, when the heating portion has the inclined portion, in addition to the above-mentioned effects, there is an effect that the member can be easily inserted and the member does not come out.

[Brief description of drawings]

The drawings show an embodiment of the present invention, FIG. 1 is a perspective view showing a connecting member heat sterilization apparatus of the present invention, FIG. 2 is a side view of a part of the connecting member heat sterilization apparatus, and FIG. FIG. 4 is a half-cut sectional view showing a state before connection of members, FIG. 4 is a half-cut sectional view showing connection state of connecting members, and FIG.
FIG. 6 is a schematic configuration diagram of a continuous ambulatory peritoneal dialysis method, FIG. 7 is a temperature-time characteristic diagram of the temperature inside the ceramic heater, and FIG. 8 is a surface temperature-time characteristic diagram of the male member inside the ceramic heater. FIG. 9 is a characteristic diagram of the number of bacteria-time on the surface of the male member in the ceramic heater. 1 ... Connection member heat sterilizer 5 ... Male member, 6 ... Female member 7 ... Connection member, 8 ... Inlet port 9 ... Heating part, 10 ... Control part 31 ... Bag tube (liquid feeding means) ) 36 …… Transfer tube (liquid transfer means)

Claims (2)

[Claims] 1. A transfer member at least on the side to be connected to the inside of a body of a connecting member comprising a combination of a male member having one end connected to a liquid supply unit and a female member having one end connected to another liquid supply unit. An apparatus for sterilizing a connecting member connected to a liquid means by heating, an inlet into which the member can be inserted, a heating unit continuous to the inlet and capable of electrically heating the member, and operation of the heating unit. And a control unit for controlling the
A connecting member heat sterilization apparatus having a mechanism for stopping energization when the heating unit rises to a predetermined temperature, and configured to heat sterilize the member with residual heat. 2. The heating and sterilizing apparatus for a connecting member according to claim 1, wherein the heating unit has an inclined portion that positions the other end of the member downward from the inlet.