JP5899776B2 - Portable sterilizer. - Google Patents

Description

  The present invention relates to a portable sterilizer.

As a method of sterilizing medical instruments used in medical treatment, there is a method of sterilizing using hydrogen peroxide gas. If the object to be sterilized is, for example, scissors, the surface may be sterilized. However, if the object to be sterilized is an endoscope or an injection needle, the object to be sterilized has a complex-shaped lumen, so the lumen is also sterilized. There is a need to.
The following techniques are disclosed as techniques for enhancing the sterilization effect of the inner hole portion having a constant internal volume.
Prior art document 1 discloses a technique in which a disinfectant is allowed to flow from a chamber through an inner hole into a drive star.
The following techniques are disclosed as techniques for sterilizing the internal cavity of an endoscope.

  In Prior Literature 2, in order to sufficiently sterilize the internal cavity of the endoscope with the sterilization gas in the sterilization chamber, an air pump capable of sucking the sterilization gas in the sterilization chamber and supplying it to the endoscope is provided in the sterilization chamber. The technique provided in is disclosed.

JP 2001-204799 A Japanese Patent Laid-Open No. 2003-339639

  In cases where a medical instrument such as an endoscope is used in a surgical procedure and then sterilized to cleanly sterilize the internal cavity of the endoscope, a cleanly sterilized medical instrument is not used immediately after processing. After being sterilized by a sterilizer, the operation is generally such that the product is stored under strict management while maintaining the sterilized state for a certain period of time in preparation for the next operation. That is, in order to maintain a high sterilization state, a medical instrument such as a sterilized endoscope is not touched at a time other than immediately before or immediately after an operation.

In the medical field, even when the medical device is not directly touched, such as immediately before or immediately after surgery, or when the medical device is stored and stored in a sterilization storage bag during the sterilization process There is a demand to remotely operate a process that enhances the sterilization effect of the lumen.
In the prior art, there is a problem in that it is impossible to instruct a sterilization process that enhances the sterilization effect from a remote location where the medical instrument cannot be touched directly.

The present invention is to provide a mechanism which can be performed automatically in accordance with the medical device, even if that can not be touched directly, the state change during sterilization the sterilization treatment for increasing the sterilizing effect on the lumen With the goal.

The present invention is a portable sterilization apparatus that can be taken out from a sterilization chamber, wherein a coupling part that couples with a sterilized object having a lumen, a sterilization gas in the sterilization chamber is sucked, and the inner part is coupled from the coupling part with the sterilized object. a pump for discharging the sucked sterilizing gas into the cavity, of the sterilization chamber portion environment in which the object to be sterilized is placed, a detecting means for detecting a state change during sterilization, according to the state change in the detected Control means for activating the pump discharge so that the pump discharges the sterilizing gas into the lumen.
The present invention is a portable sterilization apparatus that can be taken out from a sterilization chamber, wherein a coupling part that couples with a sterilized object having a lumen, a sterilization gas in the sterilization chamber is sucked, and the inner part is coupled from the coupling part with the sterilized object. a pump for discharging the sucked sterilizing gas into the cavity, in response to said status change during sterilization of the sterilization chamber unit environment object to be sterilized is placed, a switch for starting the discharge of physically the pump And control means for activating the pump discharge so that the pump discharges the sterilizing gas into the lumen when pressed.
Further, the control means stops the discharge of the activated pump in response to the state change when the sterilization process is not in progress.
The portable sterilization apparatus can be housed in a sterilization container or a sterilization bag.
Further, the control means activates the discharge of the pump when the internal environment of the sterilization chamber changes to the first state during the sterilization process.
Further, the control means may be configured such that, when the environment inside the sterilization chamber changes from the first state to the second state during the sterilization process, the pump that has been started in response to the state change. Discharging is stopped.
In addition, the state change during the sterilization process of the environment inside the sterilization chamber is a temperature change or a pressure change.

The present invention, to provide a mechanism for the medical device, even if that can not be touched directly, can be performed automatically in accordance with the sterilization process to enhance the sterilizing effect on the lumen to a state change during sterilization Is possible.

It is a figure which shows the hardware constitutions of a portable sterilizer. It is a figure which shows one example of the condition which uses a portable sterilizer. It is a figure which shows the hardware constitutions of a sterilizer. It is a figure which shows the flowchart of a sterilization method. It is a figure which shows the time change of the pressure in the sterilization room | chamber interior during a sterilization process.

Referring to FIG.
FIG. 1 is a diagram showing a hardware configuration of the portable sterilization apparatus of the present invention.

  100 is a pump. A small air pump. The pump sucks the gas (sterilization gas) in the sterilization chamber 11 and discharges it from the coupling portion 140 with the article to be sterilized 500 to the lumen 510.

Reference numeral 110 denotes detection means, which can detect the state (pressure or temperature) of the installed environment. The operating principle of detecting the pressure is that the portable sterilization device is placed in the sterilization chamber, and when the sterilization chamber reaches a predetermined pressure (vacuum level), the atmospheric pressure gas (air) inside the detection means (cylinder) expands and the piston Is pressed to turn on (activate) the switch as the control means 120. That is, the detection here is not electrically detected like a sensor, but is described as detection including physical operation. Of course, a detection means for performing electrical detection may be provided, and the control means 120 may be electrically controlled by the detection.
Reference numeral 120 denotes a control means (switch). The discharge of gas by the pump can be controlled according to the state detected by the detection means 110.

  When the control unit 120 detects that the environmental state (pressure) is the first pressure (10,000 Pascals or less, in this embodiment, for example, 9500 Pascals) when it is stopped, Can be activated. In this embodiment, as the first pressure, 9500 Pascal is used as the first pressure threshold, but the present invention is not limited to this threshold.

Here, the environmental state preferably indicates the internal pressure of the sterilization chamber 11, but if the detection means detects the temperature, the pump can be remotely connected in accordance with the change in the internal temperature of the sterilization chamber 11. It may be activated and there is no problem if combined with changes in internal pressure and temperature during sterilization.
This allows the pump to be remotely activated during processing of the sterilizer, which is the case when the medical instrument cannot be touched directly.
Furthermore, the pump can be started according to the process by setting an arbitrary condition in the state of the environment.

  When the control unit 120 detects that the environmental state (pressure) is the second pressure (10000 Pascals or higher, in this embodiment, for example, 10500 Pascals) after the startup, the discharged gas is started. Can be stopped. In the present embodiment, 10500 Pascal is used as the second pressure threshold as the first pressure, but the present invention is not limited to this threshold.

  In other cases, when the portable sterilization apparatus 300 is outside the sterilization chamber (when not being sterilized) or stored in a storage, for example, the environmental condition (pressure) is atmospheric pressure, It means that it is always stopped.

During the sterilization process, the environmental state preferably indicates the internal pressure of the sterilization chamber 11, but if the detection means detects the temperature, a pump is used in accordance with a change in the internal temperature of the sterilization chamber 11. May be stopped remotely, and there is no problem if combined with changes in internal pressure and temperature during sterilization.
This allows the pump to be stopped remotely during processing of the sterilizer, where it is not possible to touch the medical instrument directly.
Furthermore, the pump can be stopped according to the process by setting an arbitrary condition in the state of the environment.
130 is an inlet. Inhale the environmental gas (sterile gas) installed from the inlet.
Reference numeral 140 denotes a coupling portion, which is a connection portion that couples to the sterilized object 500. Drain the environmental gas (sterilization gas) installed from the joint.

Reference numeral 150 denotes a battery (dry battery). When the control means 120 is turned on (started up), the pump is driven by supplying electric power to the pump. When the control means 120 is turned off (started up), the pump is stopped by not supplying power to the pump. The battery may be a small battery.
160a is a tube. A flexible scissor, for example, a Teflon (registered trademark) tube. The sterilized gas discharged from the pump 100 passes.
Reference numeral 160b denotes a tube. A flexible scissor, for example, a Teflon (registered trademark) tube. The sterilized gas discharged from the pump 100 passes.
300 is a portable sterilizer. It can be taken out from the sterilization chamber 11.

  Reference numeral 200 denotes an indicator storage box. It is a cylindrical shape (a small space that can be sealed) having an inner diameter of about 10 mm and a length of about 30 mm. If the indicator is stored in advance here, it is possible to confirm whether the object to be sterilized has been sterilized from the sterilizing gas passing through the indicator due to the change of the indicator.

210 is an indicator. In order to confirm whether the article to be sterilized has been sterilized, the biological indicator is generally a biological method using actual bacteria, or the chemical indicator is a method that reacts chemically like litmus paper. Is used.
Reference numeral 500 denotes an article to be sterilized, preferably an endoscope (long medical device). There is a lumen inside the endoscope.
Reference numeral 510 denotes a lumen.
FIG. 2 will be described.
FIG. 2 is a view showing an example when the portable sterilization apparatus 300 and the article to be sterilized 500 are accommodated in a sterilization container (or sterilization storage bag).

Reference numeral 400 denotes a container to be sterilized (sterilization container). A sterilization gas by sterilization treatment can be introduced into the container to be sterilized by a semi-permeable filtration unit (not shown), and the box can prevent entry of contaminants even outside the sterilization apparatus.
This is an example of a case where the medical device cannot be directly touched.
<Usage example>
(1) As shown in FIG. 2, the portable sterilization apparatus 300 combined with the object to be sterilized 500 is stored in the object to be sterilized container 400.
(2) As shown in FIG. 3, the container 400 to be sterilized is installed in the sterilization chamber 11 (chamber) of the hydrogen peroxide gas sterilizer 700.
(3) The container 400 to be sterilized is sterilized by the hydrogen peroxide gas sterilizer 700.
(4) The container 400 to be sterilized is taken out from the sterilization chamber 11 of the hydrogen peroxide gas sterilizer 700.
(5) The to-be-sterilized object storage container 400 is stored in a storage.

  Since the portable sterilization apparatus 300 is stored in the storage, the portable sterilization apparatus 300 is in the sterilization object storage container 400 for a long time until the next use, and the pump 100 once activated cannot be stopped. If the pump 100 that has been started is still activated, there is no power to activate the pump 100.

That is, when the medical instrument cannot be directly touched, it cannot be operated with a simple ON / OFF switch after the sterilization process, so that the pump 100 is stopped according to a change in the state of the environment. There is an effect that it can be controlled.
FIG. 3 will be described.
FIG. 3 is a diagram showing a hardware configuration of a sterilization apparatus including a chamber that is a sterilization chamber in which the portable sterilization apparatus of the present invention is placed.
FIG. 3 is a cross-sectional view of the sterilizer as viewed from the side.
Reference numeral 400 denotes a container to be sterilized, which is stored in a sterilization chamber and sterilized.

Reference numeral 11 denotes a sterilization chamber (chamber), which is a casing having a volume of 76 liters capable of sterilizing medical instruments. The pressure in the sterilization chamber can be maintained from atmospheric pressure to vacuum pressure.
The temperature inside the sterilization chamber is maintained at 50 ° C. during the sterilization process.
Reference numeral 12 denotes a door of the sterilization chamber, which is a door through which the article to be sterilized 500 and the container to be sterilized 400 containing the article to be sterilized are put in and out.
Reference numeral 21 denotes a vacuum pump, which can set the pressure inside the sterilization chamber to a vacuum pressure.
Reference numeral 40 denotes a vaporization valve, which can open and close the conduction between the vaporization chamber and the sterilization chamber 11.
A vaporization chamber 30 vaporizes the hydrogen peroxide solution supplied from the hydrogen peroxide solution supply device.
Reference numeral 22 denotes an air release valve, which can open and close the connection between the sterilization chamber and the outside air (atmosphere).
In addition, the gas supplied to the sterilization chamber 11 may not be air | atmosphere, and air may be sufficient as it.
A hydrogen peroxide solution supply device 50 supplies a hydrogen peroxide liquid to the vaporizing chamber.
The concentration of the hydrogen peroxide solution supplied by the hydrogen peroxide solution supply device is between 59 wt% and 98 wt%.
Reference numeral 60 denotes a pressure sensor, which measures the pressure inside the sterilization chamber 11.
<First embodiment>
FIG. 4 will be described.
FIG. 4 is an example of a sterilization method (sterilization process step) for sterilizing the lumen of an object to be sterilized by the sterilization apparatus of the present embodiment.
In step S101, the inside of the sterilization chamber is maintained at a vacuum pressure by closing the atmosphere release valve and operating the vacuum pump (preliminary vacuum process).

  In step S102, it is determined whether or not step S103 has been executed a predetermined number of times (about four times) (determination step). That is, it is determined how many times the process has been repeated from step S103 to step S106. If it has been repeated a predetermined number of times, the process proceeds to the ventilation step of step S107.

  In step S103, the vacuum pump is stopped and the vaporization valve is opened, so that the hydrogen peroxide vapor prepared in advance in the vaporization chamber is supplied into the sterilization chamber, and the hydrogen peroxide vapor diffuses into the sterilization chamber (excessive). Hydrogen oxide diffusion process). The diffusion time is a predetermined time set in advance (between 60 seconds and 480 seconds). During the diffusion time, the pressure in the sterilization chamber increases, and when the predetermined time is reached, P1 (the first pressure) 1 pressure). In step S103, the air release valve remains closed. Steps 301 to 302 in FIG. 5 correspond to step S103.

  In step S104, a gas (atmosphere) is supplied from the outside of the sterilization chamber by opening the air release valve, and hydrogen peroxide vapor is introduced into the lumen of the object to be sterilized. The introduction time is a predetermined time set in advance (between 5 seconds and 10 seconds). During the introduction time, the pressure in the sterilization chamber rises rapidly, and P2 (a predetermined pressure at a predetermined time) The second pressure) is reached. In step S104, the vacuum pump remains stopped. Steps 302 to 303 in FIG. 5 correspond to step S104.

  Here, it is important that the hydrogen peroxide vapor is introduced into the deep part of the lumen and the hydrogen peroxide vapor introduced into the deep part of the lumen is once condensed in a liquid (hydrogen peroxide condensing step). In order to condense into a liquid, it is necessary to rapidly increase the pressure in the sterilization chamber to atmospheric pressure in a short time.

This rapid increase means that the pressure in the sterilization chamber, which was 1500 Pascals with a volume of 76 liters, is a short time of 5 seconds to 10 seconds at a predetermined pressure increase rate that reaches atmospheric pressure (P2). It is to supply the atmosphere abruptly.
In addition, the vaporization valve is closed to prepare hydrogen peroxide vapor in the vaporization chamber.
In step S105, it is determined whether the atmospheric pressure (P2), which is a predetermined pressure, has been reached by a pressure sensor that measures the pressure inside the sterilization chamber.

  In step S106, when the atmospheric pressure (P2) is reached, the air release valve is closed and the vacuum pump is operated to exhaust the inside of the sterilization chamber, which is atmospheric pressure. In the initial process of exhausting the interior of the sterilization chamber, as the pressure in the interior of the sterilization chamber decreases (decompression), hydrogen peroxide is condensed in the lumen of the object to be sterilized in step S104 to sterilize the lumen of the object to be sterilized This liquid is vaporized again (vaporized) in the lumen of the object to be sterilized (hydrogen peroxide vaporization step).

  In this embodiment, the instant at which the hydrogen peroxide liquid once condensed in the lumen of the object to be sterilized at atmospheric pressure by the introduced gas is vaporized again into hydrogen peroxide vapor by decompression has the highest sterilization effect. The hydrogen peroxide liquid once condensed in the deep part of the lumen in step S104 is not allowed to remain for a certain period of time due to the high sterilization effect. Since the hydrogen liquid does not need to remain for a certain period, the vacuum process of step S106 can be started immediately.

  In other words, hydrogen peroxide vapor or liquid is left in the lumen of the object to be sterilized for a certain period of time, so that the sterilization effect is not enhanced. By executing using pressure change, a high sterilization effect can be obtained instantaneously.

  That is, according to the present embodiment, it is not necessary to increase the sterilization effect by leaving a vapor or liquid of hydrogen peroxide in the lumen of the object to be sterilized for a certain period of time in the deep portion of the lumen. There is an effect that the vacuum process can be started.

  The vacuum time including the initial process is a predetermined time set in advance. During the vacuum time, the pressure in the sterilization chamber gradually decreases, and reaches a vacuum pressure P0 when the predetermined time is reached. Steps 303 to 304 in FIG. 5 correspond to step S106 (vacuum process).

By operating the vacuum pump, the inside of the sterilization chamber, which is at atmospheric pressure, is exhausted. The hydrogen peroxide solution that has been condensed into a liquid in step S104 and the surface of the object to be sterilized in the sterilization chamber, the hydrogen peroxide solution that has sterilized the lumen of the object to be sterilized, and vaporized again in step S106 The hydrogen peroxide vapor sterilized on the surface of the object to be sterilized in the sterilization chamber and the hydrogen peroxide vapor sterilized in the lumen of the object to be sterilized can be removed (recovered).
In step S107, the inside of the sterilization chamber is ventilated (ventilation process).
The sterilization process ends.
FIG. 5 will be described.
FIG. 5 is a diagram showing the time change <first example> of the pressure in the sterilization chamber during the sterilization process for sterilizing the lumen of the object to be sterilized by the sterilization apparatus of the present embodiment.

  The pressure of P0 is a pressure after the atmosphere release valve and the vaporization valve are closed and the inside of the sterilization chamber is evacuated by a vacuum pump, and is between 20 Pascals and 100 Pascals and is a vacuum pressure.

The pressure of P1 is a pressure after the vapor of hydrogen peroxide is diffused into the sterilization chamber, and is between 1000 Pascals and 4000 Pascals (preferably 1500 Pascals).
The pressure of P2 is the pressure after supplying gas (atmosphere) to the inside of the sterilization chamber and the vapor of hydrogen peroxide condenses in the lumen, and is atmospheric pressure.
301 is a pressure (P0) before starting the hydrogen peroxide diffusion process of step S103.
302 is a pressure (P1) when the hydrogen peroxide diffusion process of step S103 is completed.
302 is the pressure (P1) before starting the hydrogen peroxide condensing process of step S104.
303 is a pressure (atmospheric pressure) when the hydrogen peroxide condensing process of step S104 is completed.
Reference numeral 303 denotes a pressure (atmospheric pressure) before starting the hydrogen peroxide vaporization process in step S106.
304 is a pressure (P0) when the vacuum process of step S106 is completed.
305 is a pressure (P0) before starting the ventilation process of step S107.

300 Portable sterilizer 500 Object to be sterilized (endoscope)
400 Container to be sterilized 700 Sterilizer (low temperature gas sterilizer)

Claims (9)

A portable sterilizer that can be taken out of a sterilization room,
A coupling part for coupling with an object to be sterilized with a lumen;
A pump for discharging the sterile chamber of the sterilizing gas by suction, sterile gas the suction into the lumen from the coupling portion with the object to be sterilized,
A detecting means for detecting a state change during the sterilization process of the environment inside the sterilization room where the article to be sterilized is installed;
Control means for activating the discharge of the pump so that the pump discharges the sterilizing gas into the lumen according to the detected state change;
A portable sterilization apparatus comprising: A portable sterilizer that can be taken out of a sterilization room,
A coupling part for coupling with an object to be sterilized with a lumen;
A pump for discharging the sterile chamber of the sterilizing gas by suction, sterile gas the suction into the lumen from the coupling portion with the object to be sterilized,
In response to a change in state during the sterilization process in the sterilization room environment where the object to be sterilized is installed, the pump physically pushes the pump to discharge the sterilization gas. Control means for activating the pump discharge to discharge into the cavity;
A portable sterilization apparatus comprising:   3. The portable sterilization apparatus according to claim 1, wherein the control unit stops discharging of the activated pump according to the state change when the sterilization process is not in progress.   The portable sterilizer according to any one of claims 1 to 3, wherein the portable sterilizer can be accommodated in a sterilization container or a sterilization bag.   5. The pump according to claim 1, wherein the control unit activates the discharge of the pump when the environment inside the sterilization chamber changes to the first state during the sterilization process. 6. The portable sterilizer according to claim 1.   The control means, during the sterilization process, when the state inside the sterilization chamber changes from the first state to the second state, discharges the pump that has been started in response to the state change. The portable sterilizer according to claim 5, wherein the portable sterilizer is stopped.   The portable sterilization apparatus according to any one of claims 1 to 6, wherein the state change during the sterilization treatment of the environment inside the sterilization chamber is a temperature change or a pressure change. Mochidase from the sterilization chamber, and a coupling portion for coupling the object to be sterilized with the lumen to aspirate sterile gas in the sterilization chamber, for discharging the sucked sterilizing gas into the lumen from the coupling portion with the object to be sterilized A sterilization method using a portable sterilizer equipped with a pump,
A detecting step of detecting a state change during the sterilization process of the environment inside the sterilization room where the object to be sterilized is installed;
A control step in which the control means of the portable sterilization apparatus starts the discharge of the pump so that the pump discharges the sterilization gas into the lumen according to the detected state change;
A sterilization method comprising: Mochidase from the sterilization chamber, and a coupling portion for coupling the object to be sterilized with the lumen to aspirate sterile gas in the sterilization chamber, for discharging the sucked sterilizing gas into the lumen from the coupling portion with the object to be sterilized A sterilization method using a portable sterilizer equipped with a pump,
The control means of the portable sterilizer presses a switch that physically activates discharge of the pump in response to a state change during the sterilization process of the environment inside the sterilization chamber where the article to be sterilized is installed, A sterilization method comprising a control step of activating discharge of the pump so that the pump discharges the sterilizing gas into the lumen.

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