Sterilization device

Abstract

To provide sterilization equipment in which sterilization liquid can be easily taken out even from a strongly sealed vial.SOLUTION: A sterilization liquid supply device for sterilization equipment comprises: a container holding unit 23 configured to hold a sterilization liquid vial 40 in such a manner that a sealing unit 45 thereof points downward; a bottom fixing unit 27 provided on the bottom side of the sterilization liquid vial held by the container holding unit; a needle 50 which has a sharp tip 52 and inside which a sterilization liquid passage 55 is provided, and on the side portion of which an opening 53 is provided; a needle holding unit 25 holding the needle in such a manner that the tip of the needle faces a sealing unit of the sterilization liquid vial held by the container holding unit; a needle moving unit 24 that makes the needle holding unit move vertically; and a control unit 18 that controls operation of the needle moving unit. The tip of the needle can be sharpened without reducing the strength of the needle since the opening of the needle exists on the side portion. Therefore, the sterilization liquid can be easily taken out from the sterilization liquid via.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a device for sterilizing medical devices (instruments used in medical procedures defined by the Pharmaceutical Affairs Law, such as surgical instruments like scissors and endoscopes, and diagnostic devices used in medical procedures).

Background Art

[0002] Viruses that are easily mutated and highly infectious, such as the novel coronavirus, and drug-resistant bacteria that are resistant to drugs such as antibiotics and alcohol have emerged and are becoming a threat to society. In order to prevent the occurrence of infectious diseases in medical institutions, sterilization treatment before shipment by medical device manufacturers and sterilization treatment during the remanufacturing process by medical device remanufacturers are important. In addition, when in a pandemic situation, medical institutions may exceptionally reuse medical devices. In that case, since there is a possibility of attachment of pathogens that cause infectious diseases to once-used medical devices, sterilization treatment is necessary.

[0003] Generally, high-pressure steam or high-temperature dry air is used for such sterilization treatment of medical devices. However, among the constituent materials of medical devices, there are materials that do not have resistance to high temperature and high pressure, resulting in deformation, corrosion, and deterioration of the instrument surface. Therefore, low-temperature sterilization treatment is required, and a method of introducing a sterilizing gas into a sealed container containing an object and performing sterilization is widely used (Patent Document 1). In a sterilization device using such a method, generally, the sterilizing gas is generated by extracting and vaporizing a liquid raw material (sterilization liquid) enclosed in a container made of plastic, metal, or glass.

[0004] Since the sterilization liquid is usually harmful to the person operating the sterilization device, it must be strictly enclosed in a container and not easily leak out when not in use. On the other hand, when taking out the sterilization liquid, it must be easily taken out and not leak at that time either.

[0005] Therefore, in most cases, containers for sterilization solutions are constructed by placing a rubber sealing sheet called a septum against the mouth of a glass or metal bottle (vial), and then securing the septum with an aluminum cap called a clin cap. To extract sterile solution from a vial, a needle with a sharp tip, an opening at its end, and a passage inside is inserted into the septum, and the sterile solution is aspirated from the vial by negative pressure. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Publication No. 2013-090908 [Overview of the project] [Problems that the invention aims to solve]

[0007] To prevent the sterile solution from leaking from the vial during storage and to protect the sterile solution from contamination by the external environment, the septum requires strong sealing performance. As efforts are made to improve the sealing performance of the septum, such as forming a surface coating or changing the material, a stronger needle is required to pierce it, but conventional needles cannot be expected to have sufficient piercing power.

[0008] This invention was made to solve the problems of the prior art, and its objective is to provide a sterilization device that can easily extract sterile solution even from vials that have been tightly sealed. [Means for solving the problem]

[0009] To solve the above problems, the sterilization solution supply device for a sterilization apparatus according to the present invention was developed. A container holder configured to hold a sterile solution vial with its sealing portion facing downwards, A bottom fixing portion is provided so as to face the bottom side of the sterile liquid vial held in the container holding portion, A needle having a sharp tip, a sterile fluid passage inside, and an opening on the side, The needle holder holds the needle such that its tip faces the sealing portion of the sterile liquid vial held in the container holder, A needle moving unit that moves the relative position of the needle holding unit with respect to the container holding unit up and down, A control unit that controls the operation of the needle moving part and It is characterized by having the following features.

[0010] The sterilization solution supply device for a sterilization apparatus according to the present invention operates as follows. First, the sterilization solution vial is held in the container holder. The sterilization solution vial is a container in which sterilization solution is sealed, and its opening is sealed by a septum. The container may be made of glass, metal, or plastic. The septum may be made of rubber, metal, or plastic. When holding the sterilization solution vial in the container holder, the sealed portion of the vial should face downwards.

[0011] Furthermore, the needle is held in the needle holder so that its tip faces the sealing portion of the sterile liquid vial held in the container holder. This needle is connected to the processing unit of the sterilization device via a tube or similar device either before or after being held in the needle holder.

[0012] After these preparatory steps are completed, the control unit moves the container holder and the needle holder relative to each other, bringing them closer together. This brings the tip of the needle closer to the sealing portion of the sterile liquid vial held by the needle holder and into contact with the septum of the sealing portion. Then, as they are brought even closer together, the tip of the needle pierces the septum, and the opening on the side of the needle enters the interior of the sterile liquid vial. At this point, the bottom fixing portion restricts the movement of the bottom of the sterile liquid vial, at least while the opening on the side of the needle enters the interior of the sterile liquid vial. Therefore, even with a septum that has strong sealing performance, the sterile liquid vial can be pierced through the septum and enter the interior of the sterile liquid vial without being pushed up and moved by the needle.

[0013] The control unit stops the relative movement of the container holder and the needle holder when the opening on the side of the needle reaches a predetermined position within the sterile liquid vial. This predetermined position is preferably directly above the septum. Such a position can be determined by pre-determining the positional relationship between the container holder and the needle holder, the positional relationship between the needle holder and the needle it holds, and the positional relationship between the container holder and the septum of the sterile liquid vial it holds. Since the sterile liquid vial is held with its seal facing downwards, the opening on the side of the needle is already submerged in the sterile liquid at this point. It is preferable to reduce the pressure inside the tube connected to the needle to prevent leakage of sterile liquid when the opening on the side of the needle passes through the septum.

[0014] The control unit stops the relative movement between the container holder and the needle holder, and then reduces the pressure inside the tube connected to the needle (if the pressure is already reduced, it reduces the pressure even more strongly for suction), thereby drawing the sterile liquid from the sterile liquid vial through the opening on the side of the needle and the internal sterile liquid passage, and supplying it to the liquid vaporization section of the sterilizer. The liquid vaporization section then vaporizes the liquid and transfers the sterilization gas from the vaporization section to the sterilization chamber. [Effects of the Invention]

[0015] In the sterile solution supply device for sterilization equipment according to the present invention, since the needle opening is located on the side, the tip of the needle can be made sharp without reducing its strength. Therefore, even sterile solution vials that have been tightly sealed can be easily dispensed from them.

[0016] Furthermore, by controlling the needle's movement using a control mechanism and setting the position of the side opening, which is the liquid suction part, to an appropriate position within the sterile liquid vial, i.e., directly above the septum, the sterile liquid in the vial can be aspirated completely, leaving no residue. This reduces the risk of the operator being exposed to the sterile liquid and becoming ill, and furthermore... 、Disposal of the sterilizing liquid vial after use also brings benefits and enables waste disposal that does not impose a burden on the environment.

Brief Description of the Drawings

[0017] [Figure 1] Schematic configuration diagram of a sterilizing device using a sterilizing liquid supply device according to an embodiment of the present invention. [Figure 2] Cross-sectional view (a) and bottom view (b) of a sterilizing liquid vial compatible with the sterilizing liquid supply unit according to the embodiment. [Figure 3] Side view (a) and cross-sectional view (b) of a needle compatible with the sterilizing liquid supply unit. [Figure 4] Side view (a) of the sterilizing liquid supply unit before needle movement and side view (b) after needle movement. [Figure 5] Flowchart for explaining the operation of the sterilizing device.

Modes for Carrying Out the Invention

[0018] Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.

[0019] <1. Sterilizing Device> Figure 1 is a schematic diagram of a sterilization apparatus using a sterilization solution supply device according to this embodiment. The sterilization apparatus 10 consists of a processing unit 11 consisting of a sealable container for containing the object to be processed 19, a sterilization solution supply unit 20 for taking the sterilization solution, which is the raw material for the sterilization gas used in the processing unit 11, from a sterilization solution vial, a vaporization unit 12 for vaporizing the sterilization solution taken from the sterilization solution vial, a suction pump 13 for sucking gas from inside the processing unit 11, a pressure gauge (P) 14 for detecting the pressure inside the processing unit 11, a flow path 16 from the sterilization solution supply unit 20 to the vaporization unit 12, a flow path 17 from the vaporization unit 12 to the processing unit 11, a flow controller (FC) 15 for adjusting the flow rate of the sterilization gas passing through the flow path 17, and a control unit 18 for integrally controlling the operation of each of these parts. Here, the present invention is implemented in the sterilization solution supply unit 20. The suction pump 13 is connected to a gas processing unit (not shown), and the sterilization gas after processing is detoxified in the gas processing unit before being discharged to the outside. In addition, an ultraviolet irradiation device that has a virus inactivation and sterilization effect may be provided in the gas processing unit.

[0020] <2. Sterilized solution vial> Figure 2 shows a sterile liquid vial that fits the sterile liquid supply unit 20 according to this embodiment. As shown in Figure 2(a), this sterile liquid vial 40 contains a predetermined amount of sterile liquid 42 inside an aluminum body 41, and its opening 44 is sealed by an aluminum septum 45 fixed with an aluminum clin cap 46. The body 41 may also be made of a metal other than aluminum, or glass or plastic. As shown in Figure 2(b), a two-dimensional code 47 for identifying the individual sterile liquid vial 40 is fixed to the bottom 43 of the body 41. This two-dimensional code 47 is linked to information such as the manufacturing date, type of liquid content, volume, and manufacturing plant of this individual sterile liquid vial 40. This information can be retrieved by reading the two-dimensional code 47 with a predetermined reader and accessing a predetermined database via the internet or the like for verification.

[0021] <3. Needle> Figure 3 shows a needle that fits the sterilization solution supply unit 20 according to this embodiment. As shown in Figure 3(a), this needle 50 has a body 51 with a diameter of 6 mm, the tip 52 of which is sharply processed, and an opening 53 is provided on the side of the body 51 (i.e., the part before it tapers towards the tip 52). As shown in Figure 3(b), a passage 55 is provided inside the body 51, and the opening 53 on the side connects this internal passage 55 to the outside. A recess 54 is provided at a predetermined position below the body 51, which is used for positioning when fixing this needle 50 to the needle holding unit 25 described later.

[0022] <4. Sterile liquid supply section> Figure 4 shows the sterilization liquid supply unit 20 of this embodiment. The sterilization liquid supply unit 20 is provided with a container holding unit 23, a needle holding unit 25, a bottom fixing unit 27, etc. on a base 21. The container holding unit 23 is fixed to the middle of a support column 22 erected on the base 21. The container holding unit 23 is structured to hold the sterilization liquid vial 40 with its sealing portion facing downwards. The needle holding unit 25 is fixed to a needle moving unit 24 erected on the base 21. The needle moving unit 24 is driven by a motor 26 and moves the needle holding unit 25 up and down. The needle holding unit 25 is provided with a protrusion (not shown) that engages with a recess 54 of the needle 50, thereby ensuring that the position of the needle 50 held by the needle holding unit 25 is always constant. The bottom fixing unit 27 is provided on the upper part of the support column 22 so as to be able to move up and down via a connecting unit 28. The vertical movement of the bottom fixing part 27 may be performed by a motor or manually. Alternatively, the bottom fixing part 27 may rotate instead of moving vertically. In any case, it is sufficient that it retracts to a position that does not interfere with setting the sterile liquid vial 40 into the container holding part 23.

[0023] An observation opening 29 is provided in the bottom fixing portion 27, and above it is a code reading portion 49 for reading the two-dimensional code 47 provided on the bottom 43 of the sterile liquid vial 40.

[0024] One end of the suction tube 30 is connected to the needle holding section 25, and the other end of the suction tube 30 is connected to the suction side of the sterile liquid suction section 31. A flow path 16, which is connected to the vaporization section 12, is connected to the discharge side of the sterile liquid suction section 31.

[0025] <5. Operation of the control unit> The control unit 18 is connected to the vaporization unit 12, pressure gauge 14, flow controller 15, suction pump 13, etc. of the sterilization device 10, as well as to the aforementioned parts of the sterilization liquid supply unit 20, and controls their operation. The operation of the control unit 18 when the sterilization device 10 performs sterilization of the object to be processed 19 will be explained below using the flowchart in Figure 5.

[0026] First, when the user instructs the start of operation, a display unit (not shown) on the control unit 18 displays a message requesting confirmation that the door (not shown) of the processing unit 11 has been closed, the sterile liquid vial 40 has been set in the container holding unit 23, and the needle 50 has been set in the needle holding unit 25 (step S1). Setting the sterile liquid vial 40 in the container holding unit 23 also includes setting the bottom fixing unit 27 in the predetermined position. After confirming that the user has performed these steps, the following operations begin when the user touches the start button displayed on the display unit. Alternatively, instead of asking the user to confirm the setting of the sterile liquid vial 40, etc., sensors may be provided in each part (door of the processing unit 11, container holding unit 23, needle holding unit 25, bottom fixing unit 27) to confirm the setting of each part.

[0027] When operation begins, the control unit 18 first reads the two-dimensional code 47 fixed to the bottom 43 of the set sterile solution vial 40 using the code reading unit 49, and obtains individual information of the sterile solution vial 40 by accessing a predetermined server (step S2). Based on the obtained individual information, it determines whether the set sterile solution vial 40 is suitable for the sterilization process currently to be performed. If it is determined to be unsuitable, it displays this fact on the display unit and does not perform the subsequent sterilization operation (step S3).

[0028] If it is determined that the set sterile solution vial 40 is appropriate, the subsequent sterilization operation is performed. Also, based on the acquired individual information, the operating parameters of each part, such as the vaporization conditions in the vaporization unit 12, are set to corresponding values ​​in the subsequent sterilization operation (step S3).

[0029] First, the suction pump 13 is driven to expel the air from the processing unit 11 and reduce the pressure to a predetermined level. When expelling the air from the processing unit 11, if there is a possibility that viruses or pathogens may be expelled along with the air from the object to be processed 19 before sterilization, it is preferable to expel the air while irradiating it with ultraviolet light, which has a virus inactivation and sterilization effect. Next, the needle moving part 24 is raised to a predetermined position. As a result, the tip 52 of the needle 50 pierces the septum 45 of the sterile liquid vial 40, and the opening 53 of the needle 50 stops just above the septum 45 (step S4). Here, while the needle 50 is piercing the septum 45, the bottom fixing part 27 holds down the bottom of the sterile liquid vial 40, so the needle 50 can pierce the septum 45. Also, because the opening of the needle 50 is located on the side, it can reliably pierce even sterile liquid vials 40 that are strongly sealed with a thick septum or the like. Furthermore, reducing the pressure inside the tube while the needle 50 penetrates the septum 45 prevents the sterile solution from leaking out.

[0030] In this state, the control unit 18 operates the sterile liquid suction unit 31 to draw the sterile liquid 42 from the sterile liquid vial 40 through the opening 53 on the side wall of the needle 50 and send it to the vaporization unit 12 at a predetermined flow rate (step S5). As described above, since the opening 53 of the needle 50 is located just above the septum 45, the sterile liquid 42 from the sterile liquid vial 40 can be drawn up completely without waste.

[0031] In the vaporization unit 12, the sterilization solution 42 is vaporized, and the vaporized sterilization gas is sent to the processing unit 11 via the flow controller 15. In this way, the object to be processed 19 is exposed to the sterilization gas for a predetermined time, thereby sterilizing the object to be processed 19 (step S6).

[0032] Once the predetermined sterilization process is complete, the control unit 18 performs a termination process (step S7). Specifically, the needle movement unit 24 is lowered by a predetermined amount, and the needle 50 is withdrawn from the sterilization solution vial 40. At this time, the operation of the sterilization solution suction unit 31 is continued. After a predetermined time has elapsed, the sterilization solution in the needle 50 has completely vaporized, all the vaporized sterilization gas has been supplied to the processing unit 11, and all the sterilization gas in the processing unit 11 has been discharged by the suction pump 13. After this time has elapsed, the operation of the vaporization unit 12 is stopped, and the flow controller 15 is shut off. Then, operation information such as the amount of sterilization solution used in this sterilization process is sent to the server and added to the individual information of the sterilization solution vial 40. With this, the termination process is completed, and the sterilization of the object to be processed 19 is finished.

[0033] In the above embodiment, the relative position between the container holder 23 and the needle holder 25 is moved up and down by moving the needle holder 25 up and down. However, the container holder 23 may be moved up and down instead of the needle holder 25, or together with the needle holder 25. [Explanation of symbols]

[0034] 10...Sterilizer 11… Processing Section 12...Vaporization section 13…Suction pump 14…Pressure gauge (P) 15…Flow Controller (FC) 16, 17…flow channels 18…Control Unit 19...Objects to be processed 20...Sterilizing liquid supply section 21... Bass 22...post 23...Container holding part 24... Needle movement section 25... Needle holder 26…motor 27…Bottom fixing part 28...Connection part 29… Observation opening 30... Suction tube 31...Sterile liquid suction part 40…Sterilized liquid vial 41...Main unit 42...Sterilizing liquid 43...bottom 44…Opening 45... Septum 46...Clean Cap 47... 2D code 49... Code reading unit 50... Needle 51...Main unit 52…Tip 53…Aperture 54…recess 55…Passageway

Claims

1. A container holder configured to hold a sterile solution vial with its sealing portion facing downwards, A bottom fixing portion is provided so as to face the bottom side of the sterile liquid vial held in the container holding portion, A needle having a sharp tip, a sterile fluid passage inside, and an opening on the side, The needle holder holds the needle such that its tip faces the sealing portion of the sterile liquid vial held in the container holder, A needle moving unit that moves the relative position of the needle holding unit with respect to the container holding unit up and down, A control unit that controls the operation of the needle moving part and A sterile solution supply device for a sterilization apparatus, characterized by being equipped with the following features.

2. The sterile liquid supply device for a sterilization apparatus according to claim 1, wherein the bottom fixing portion is provided with a sensor that reads an identification symbol for identifying the sterile liquid vial, which is written on the bottom of the sterile liquid vial.

3. A sterile liquid vial used in a sterile liquid supply device for a sterilization apparatus according to claim 2, wherein an identification symbol for identifying the sterile liquid vial is inscribed on the bottom of the sterile liquid vial.

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