Extraction device and extraction method for extracting extractable product from medical component

Abstract

The invention provides an extraction device and an extraction method for extracting an extractable product from a medical component. The extraction apparatus comprises: a temperature control device configured to contain a fluid medium therein and heat the fluid medium to a preset temperature; a plurality of containers at least partially disposed in the fluid medium within the temperature control device, where each container is configured to contain an extraction solution; the connecting mechanism comprises an integrated center and a plurality of connecting rods, the integrated center is arranged above the temperature control equipment, the upper end of each connecting rod is detachably connected with the integrated center, and the lower end of each connecting rod is detachably connected with the medical assembly; such that the medical component is submerged in the extraction solution within a respective one of the plurality of containers; and the driver is coupled with the integrated center so as to drive the integrated center to move up and down in a reciprocating manner.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and more particularly, to an extraction device and an extraction method for extracting extractables from medical components. Background Art

[0002] Medical devices or containers are widely used in the manufacture, storage of pharmaceuticals, or patient treatment. When a medical device or container comes into contact with the surrounding environmental solution, the material components from the medical device or container may be extracted or leached into the environmental solution, affecting the safety and effectiveness of the treatment. In medical devices, filtration devices, such as filter elements, are usually used to remove particles or microorganisms from pharmaceutical products to meet the pharmaceutical requirements, and some filter elements can also be used in treatment scenarios such as hemodialysis. Since the filter element is in full contact with the environmental solution, it is necessary to evaluate the rate and total amount of the material components of the filter element being extracted or leached into the environmental solution to ensure the safety of medical supplies. Therefore, it is necessary to provide an extraction device that can efficiently and controllably extract extractables from medical devices or containers. Summary of the Invention

[0003] One object of the present application is to provide an extraction device that can effectively, controllably, and conveniently extract extractables from medical supplies.

[0004] According to one aspect of the present application, there is provided an extraction device for extracting extractables from a medical component, the extraction device comprising: a temperature control device configured to contain a fluid medium therein and heat the fluid medium to a preset temperature; a plurality of containers at least partially placed in the fluid medium within the temperature control device, wherein each container is configured to hold an extraction solution; a connection mechanism comprising an integrated center disposed above the temperature control device and a plurality of connecting rods, wherein each connecting rod is detachably connected to the integrated center at its upper end and detachably connected to a medical component at its lower end, so that the medical component is immersed in the extraction solution within a corresponding one of the plurality of containers; and a driver coupled to the integrated center to drive the integrated center to move up and down.

[0005] In some embodiments, the temperature control device comprises: a box body having an opening at the top and configured to contain the fluid medium; and a heater configured to heat the fluid medium to the preset temperature.

[0006] In some embodiments, the temperature control device further includes: a lid configured to removably cover an opening at the top of the box body, and having a plurality of slots extending to one side edge of the lid, wherein the size of each slot is set to be capable of receiving a corresponding one of the plurality of connecting rods.

[0007] In some embodiments, the box body further includes: a plurality of receiving frames disposed on the bottom surface of the box body, wherein each receiving frame is configured to receive a base of a corresponding one of the plurality of containers and restrict displacement of the container in the horizontal direction; and a positioning plate disposed above the bottom surface of the box body and having a plurality of holes, wherein each hole is configured to receive an upper portion of a corresponding one of the plurality of containers.

[0008] In some embodiments, each of the plurality of containers has a non-circular base, and the box body further includes: a fixing plate disposed above the bottom surface of the box body and having a plurality of openings, wherein each of the plurality of openings has a certain shape and size such that the base of the container can pass through the opening when the base has a passing orientation, but cannot pass through the opening when the base of the container rotates a certain angle around its longitudinal axis from the passing orientation.

[0009] In some embodiments, the distance between the fixing plate and the bottom surface of the box body is equal to the thickness of the container base or at most 1 centimeter greater than the thickness of the container base.

[0010] In some embodiments, the box body further includes: a plurality of clamps disposed on at least one side surface within the box body, wherein each clamp is configured to clamp one of the plurality of containers.

[0011] In some embodiments, the integrated hub includes at least one of the following components: a plate, a frame, or a rod.

[0012] In some embodiments, the extraction device further includes: a guiding mechanism configured to guide the up and down movement of the integrated hub.

[0013] In some embodiments, the guiding mechanism includes: a pair of guide rails vertically disposed on opposite sides of the integrated hub; and a pair of sliders connected to the integrated hub, wherein each slider of the pair of sliders is slidably connected to a corresponding one of the pair of guide rails.

[0014] In some embodiments, each of the pair of guide rails has a resilient stopper at its upper part, and the resilient stopper is capable of switching between a retracted configuration and an extended configuration, wherein when the resilient stopper is in the retracted configuration, the retracted configuration allows the slider connected to the integrated hub to move upward and pass over the resilient stopper; when the resilient stopper is in the extended configuration, the extended configuration blocks the slider connected to the integrated hub from passing over the resilient stopper.

[0015] In some embodiments, the driver includes a motor and a connecting rod, the output shaft of the motor is offset from the rotation axis of the motor, and the connecting rod has a first end pivotally coupled to the output shaft of the motor and a second end detachably coupled to the integrated hub.

[0016] In some embodiments, the driver includes a motor and a connecting rod, the output shaft of the motor is offset from the rotation axis of the motor, and the connecting rod has a first end pivotally coupled to the output shaft of the motor and a second end detachably coupled to the slider.

[0017] In some embodiments, the driver includes a motor and a cam, the cam is coupled to the rotation axis of the motor, and the cam is detachably coupled to the integrated hub.

[0018] In some embodiments, the driver includes a cylinder, the cylinder has a piston, and the piston is detachably coupled to the integrated hub.

[0019] In some embodiments, each of the plurality of containers has a lid, the lid is configured to removably cover the top opening of the container, and the lid has a central opening, wherein the size and shape of the central opening are configured to allow at least a portion of one of the plurality of connecting rods to move up and down therein.

[0020] In some embodiments, each of the plurality of connecting rods has a blocking portion near the top end of the connecting rod, and the blocking portion is configured to block the portion of the connecting rod above the blocking portion from passing through the central opening of the lid.

[0021] In some embodiments, the extraction device further includes: a controller, the controller is coupled to the temperature control device and / or the driver, wherein the controller is configured to receive signals from the temperature control device and / or the driver, or send instructions to the temperature control device and / or the driver.

[0022] In some embodiments, the controller further includes a timer for generating a termination signal, and the controller sends a termination operation instruction to the temperature control device and / or the driver in response to the termination signal.

[0023] According to another aspect of the present application, there is provided an extraction method for extracting extractable substances from a medical component, the extraction method including: providing the extraction device according to any one of claims 1 to 19; adding a fluid medium to the temperature control device; adding an extraction solution to the container; connecting the lower end of the connecting rod to a corresponding medical component; immersing the medical component in the extraction solution of the corresponding container; immersing at least a part of the container in the fluid medium of the temperature control device; connecting the upper end of the connecting rod to the integrated center; coupling the integrated center to the driver; and controlling the driver to drive the integrated center to move up and down.

[0024] The above is an overview of the present application, and there may be simplifications, generalizations, and omissions of details. Those skilled in the art should recognize that this part is only illustrative and not intended to limit the scope of the present application in any way. This overview section is neither intended to identify the key features or essential features of the claimed subject matter nor intended to be used as an aid in determining the scope of the claimed subject matter. Brief Description of the Drawings

[0025] Through the following detailed description in conjunction with the accompanying drawings and the appended claims, those skilled in the art will more fully and clearly understand the above and other features of the content of the present application. It can be understood that these drawings and detailed descriptions only depict several exemplary embodiments of the content of the present application and should not be considered as limiting the scope of the content of the present application. The same reference numerals in multiple drawings represent the same or similar components. By referring to the drawings, the content of the present application will be more clearly and detailedly described.

[0026] Figure 1A and Figure 1B respectively show a perspective structural view and a top view of an extraction device for extracting extractable substances from a medical component according to an embodiment of the present application;

[0027] Figure 1C is Figure 1B a cross-sectional view of the extraction device shown along the H-H direction;

[0028] Figure 2 is Figure 1C a top view of the lid of the temperature control device in the extraction device shown;

[0029] Figure 3A is Figure 1ASchematic perspective view of the extraction device shown after omitting the driver protection structure;

[0030] Figure 3B For Figure 3A Partial enlarged view of the X region in;

[0031] Figure 4A Is Figure 1C Cross-sectional view of the container, connecting rod and medical component of the extraction device shown;

[0032] Figure 4B Is Figure 4A Partial enlarged view of the Y region in;

[0033] Figure 5 Is Figure 1C Top view of the receiving frame of the container base and the housing of the temperature control device of the extraction device shown;

[0034] Figure 6 Is Figure 1C Top view of the positioning plate of the housing of the temperature control device shown;

[0035] Figure 7 Is a cross-sectional view of an extraction device according to another embodiment of the present application;

[0036] Figure 8 Is Figure 7 Top view of the container base of the extraction device shown and the fixing plate of the housing of the temperature control device;

[0037] Figure 9A And Figure 9B Are respectively schematic perspective views of the recoverable barrier in the retracted configuration and the extended configuration according to still another embodiment of the present application. Detailed Description of the Specific Embodiment

[0038] The following detailed description of the exemplary embodiments of the present application refers to the accompanying drawings that form a part of the description. The drawings illustrate specific exemplary embodiments in which the present application can be practiced. The detailed description including the drawings describes these embodiments in sufficient detail to enable those skilled in the art to practice the present application. Those skilled in the art can further utilize other embodiments of the present application and make logical, mechanical, etc. changes without departing from the spirit or scope of the present application. Therefore, the reader of the following detailed description should not interpret the description in a restrictive manner, and the scope of the embodiments of the present application is only defined by the appended claims.

[0039] In this application, unless otherwise clearly stated, the use of a singular term shall also include the plural meaning. In this application, unless otherwise specified, the use of "or" means "and / or". In addition, the use of the term "comprising" and other forms such as "including" and "containing" is not restrictive. In addition, unless otherwise clearly stated, terms such as "element" or "component" cover elements and components including a single unit, as well as elements and components including more than one subunit. In addition, the section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described.

[0040] As used herein, spatially relative terms, such as "below", "beneath", "under", "lower side", "above", "over", "upper", "upper side", "left", "right", "horizontal", "vertical", "edge", "longitudinal", "lateral", etc., may be used herein to facilitate the description of the relationship of one element or feature to another element or feature as shown in the drawings. In addition to the directions depicted in the figures, spatially relative terms are intended to encompass different orientations of the device during use or operation. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatially related descriptors used herein may be interpreted accordingly. It should be understood that when an element is referred to as "connected to" or "coupled to" another element, it may be directly connected to or coupled to the other element, or there may be intervening elements. In this application, unless otherwise specified, the numerical ranges mentioned include their end values and consider the conventional tolerances in the art, such as tolerances of ±0.1 mm, ±0.2 mm, ±0.3 mm, ±0.4 mm, ±0.5 mm, etc.

[0041] Figures 1A to 1C Fig. 7 shows a schematic structural view of an extraction device 100 for extracting extractables from a medical component according to an embodiment of the present application, where Figure 1A Fig. 8 is a perspective structural view of the extraction device 100, Figure 1B Fig. 9 is a top view of the extraction device 100, Figure 1C Fig. 10 is a cross-sectional view of the extraction device 100 along Figure 1B the H-H direction in Fig. 10. The extraction device 100 can be used to extract extractables from a medical component for subsequent extractable / leachable testing, so as to verify the effectiveness and safety of the medical component. In order to effectively extract extractables from a medical component, it is necessary to immerse the medical component in an extraction solution at a certain temperature and fully exchange substances with the extraction solution to complete the extraction of extractables.

[0042] Please refer to Figures 1A to 1C, the extraction device 100 includes a temperature control device 101 for containing a fluid medium. When using the extraction device 100 to extract extractables from the medical component 111, the temperature control device 101 can heat the fluid medium therein to a required preset temperature according to the material characteristics of the medical component 111 and / or relevant standard requirements, etc.

[0043] In Figures 1A to 1C the embodiment, the temperature control device 101 includes a box body 102 with an opening at the top, and the box body 102 is used to accommodate the fluid medium. A water outlet 123 can be provided at a position near the bottom of the side wall of the box body 102, and the water outlet 123 is used to discharge the fluid medium in the box body 102 from the box body 102. In this embodiment, the fluid medium includes water, and at this time the temperature control device 101 is a water bath device. In other embodiments, the fluid medium can also be oil, and the temperature control device 101 is an oil bath device. However, the present application is not limited to the above examples, and other fluids with appropriate specific heat capacities can also be used as the fluid medium in the temperature control device 101.

[0044] Furthermore, the temperature control device 101 further includes a heater (not shown) for heating the fluid medium contained in the temperature control device 101 to the preset temperature. In this embodiment, as Figure 1C shown, the bottom of the box body 102 has a chamber 106, and the chamber 106 can be formed between the bottom surface 107 and the bottom outer wall 108 of the box body 102. The heater can be placed in the chamber 106, and the bottom surface 107 of the box body 102 is provided with through holes, so that the fluid medium can flow into the chamber 106 through the through holes in the bottom surface 107, exchange heat with the heater, and be heated to a predetermined temperature. In other embodiments, the heater can also be placed at other positions of the temperature control device 101, such as on the inner surface of the side wall of the box body 102.

[0045] In this embodiment, the temperature control device 101 further includes a box cover 103. Please combine Figures 1A to 1C and refer to Figure 2 , where Figure 2 is the top view of the box cover 103. The box cover 103 is configured to detachably at least partially cover the opening at the top of the box body 102 to reduce the heat dissipated from the opening at the top of the box body 102, thereby providing a better heat preservation effect and improving the temperature control ability of the temperature control device 101.

[0046] Specifically, the lid 103 may include two separable parts 103a and 103b, each part having a plurality of slots 104 extending towards the other part to one side edge, wherein the size of each slot 104 (i.e., the width of the slot) is set to be able to receive a corresponding connecting rod 122. The lid 103 may also have a handle 105 to facilitate the operator to move the lid 103 to open or close the opening at the top of the box body 102. In some embodiments, the lid 103 may also be a single component, on which there are a plurality of slots extending to one side edge thereof to receive the corresponding connecting rods.

[0047] Please continue to refer to Figure 1C , the extraction device 100 further includes a plurality of containers 110, wherein each container 110 is used to hold an extraction solution. During the extraction process, at least a part of the container 110 is immersed in the fluid medium inside the temperature control device 101, so that the temperature control device 101 can controllably heat and keep warm the extraction solution in the container 110 through the fluid medium.

[0048] During the process of using the extraction device 100 to extract the extract in the medical component 111, each container 110 can be used to hold a corresponding medical component 111, and the medical component 111 is immersed in the extraction solution in the container 110. In this embodiment, the medical component 111 is a cylindrical filter element, and correspondingly, the container 110 is also a cylindrical tube. For example, the container 110 can be a graduated cylinder. It can be understood that the size of the container 110 should be larger than the size of the filter element 111 to accommodate the filter element 111. For example, the ratio of the diameter of the filter element 111 to the diameter of the container 110 is 7:8, and the ratio of the length of the filter element 111 to the height of the container 110 is 1:2.

[0049] It can be understood that the technical solution of the present application is not limited to the above-mentioned types of medical components, the shapes and sizes of the containers. In other embodiments, the medical component can be other medical devices other than the filter element, such as medical fluid pipelines, medical fluid bags, etc., and the shapes and sizes of the containers can also be adjusted correspondingly. In addition, an extraction device can be configured with a plurality of containers having different shapes and sizes, and those skilled in the art can select a suitable container from the above-mentioned containers with various shapes and sizes according to the specific characteristics of the medical component to be tested for the extraction operation of the extractable substance.

[0050] Furthermore, the extraction device 100 further includes a connection mechanism 120. As Figure 1A shown, the connection mechanism 120 includes an integrated center 121 disposed above the temperature control device 101 and a plurality of connecting rods 122 connected to the integrated center 121. As Figure 1CAs shown, the upper end of each connecting rod 122 is detachably connected to the integrated center 121, and the lower end of each connecting rod 122 is detachably connected to a medical component 111. When using the extraction device 100 to extract the extractable substances in the medical component 111, the integrated center 121 can simultaneously connect and suspend multiple connecting rods 122, and then suspend multiple medical components 111. Each medical component 111 is immersed in the extraction solution in a corresponding container 110, so as to be able to process multiple medical components 111 simultaneously.

[0051] Furthermore, the extraction device 100 further includes a driver 130. The driver 130 is coupled to the integrated center 121 to drive the integrated center 121 to reciprocate up and down. When using the extraction device 100 to extract the extractable substances in the medical component 111, the integrated center 121 moves up and down, so as to drive the medical component 111 to move up and down in the extraction solution in the corresponding container 110 through each connecting rod 122, enabling the medical component 111 to fully perform mass exchange with the extraction solution and accelerating the dissolution of the extractable substances.

[0052] During the process of using the extraction device 100 to extract the extractable substances in the medical component 111, first, multiple containers 110 of the extraction device 100 can be simultaneously placed in the fluid medium inside the temperature control device 101, so as to be able to simultaneously control the temperature of the extraction solution in multiple containers 110. The integrated center 121 can suspend multiple corresponding medical components 111 through multiple connecting rods 122. Therefore, when the driver 130 drives the integrated center 121 to move up and down, it can drive multiple medical components 111 to move up and down simultaneously. Thus, through the extraction device 100, on the basis of meeting the standard requirements for the extraction of extractable substances, the extraction of extractable substances from multiple groups of medical components 111 can be carried out simultaneously, improving the efficiency of the extraction operation. In this embodiment, the number of connecting rods 122 and containers 110 included in the extraction device 100 is 6, arranged in two columns, and at most 6 medical components can be extracted simultaneously. In other embodiments, the number and layout of the connecting rods 122 and containers 110 of the extraction device 100 can be changed according to specific requirements, such as setting 2, 3, 4, 5 or more connecting rods 122 and containers 110.

[0053] Secondly, since the temperature control device 101 can heat the extraction solution in the container 110 through the fluid medium and maintain it at a preset temperature, and the upward and downward movements of the medical component 111 are controlled by the driver 130, the temperature of the extraction solution and the distance of the upward / downward movement of the medical component 111 are both stable and controllable during the extraction process. In summary, the extraction device 100 increases the stability, efficiency and convenience of the extraction process.

[0054] Please refer to Figure 3A and3B , in some embodiments, the extraction device 100 further includes a guiding mechanism 150 for guiding the up and down movement of the integration hub 121, wherein, Figure 3A is Figure 1A consistent with the view direction of, and Figure 3A the protective structure outside the driver in Figure 1C is omitted to clearly show the structure of the driver; Figure 3B is Figure 3A a partial enlarged view of the X region in

[0055] As Figure 3A and 3B shown, the guiding mechanism 150 includes a pair of vertically extending guide rails 151 disposed on opposite sides of the integration hub 121 and a pair of sliders 152 coupled to the integration hub 121. Each slider 152 is slidably sleeved on a corresponding guide rail 151. The driver includes a motor 156 and a connecting rod 157. The connecting rod 157 has a first end 157a pivotally coupled to the output shaft 153 of the motor 156 and a second end 157b detachably coupled to the slider 152. Wherein, the output shaft 153 of the motor 156 is offset from the rotation axis 154 of the motor 156.

[0056] In Figure 3A and 3B the shown embodiments, the motor 156 includes a rotating disk 155 connected to the rotation axis 154 of the motor 156. The rotation axis 154 passes through the center of the rotating disk 155 and can drive the rotating disk 155 to rotate. The output shaft 153 of the motor 156 is disposed on the rotating disk 155 and offset from the center of the rotating disk 155 (i.e., the rotation axis 154 of the motor 156). The first end 157a of the connecting rod 157 is pivotally coupled to the output shaft 153. The slider 152 further has a pin connecting rod 158 fixed to its surface. The second end 157b of the connecting rod 157 is pivotally and detachably coupled to the slider 152 through the pin connecting rod 158, so that the motor 156 can drive the slider 152 to move up and down along the guide rail 151 through the connecting rod 157.

[0057] In Figure 3A and 3BIn the illustrated embodiment, the integrated hub 121 is composed of two layers of plates (e.g., stainless steel plates). The two layers of plates are respectively provided with openings near the positions of their opposite side edges. The sliders 152 of the guiding mechanism 150 pass through the openings and are respectively fixedly connected to the two layers of plates. Each guide rail 151 passes through the central hole of a corresponding slider 152. When the motor 156 drives the slider 152 to move up and down along the guide rail 151, the integrated hub 121 can move up or down along the guide rails 151 on its two sides under the drive of the slider 152. In some embodiments, balls are provided on the surface of the slider 152 that slidably engages with the guide rail 151 to reduce the frictional force between it and the guide rail 151.

[0058] During the extraction process, when the motor 156 starts to operate, the output shaft 153 rotates around the rotation shaft 154, causing the connecting rod 157 to pivot relative to the output shaft 153 and drive the slider 152 to reciprocate up and down along the guide rail 151. Since the slider 152 is coupled to the integrated hub 121, the slider 152 further drives the integrated hub 121 to reciprocate up and down. Thus, the drive and the guiding mechanism 150 convert the rotational motion of the motor 156 into the reciprocating up and down movement of the slider 152, so as to stably and controllably drive the medical component 111 suspended on the integrated hub 121 to reciprocate up and down in the extraction solution, so as to fully contact the extraction solution for mass exchange.

[0059] The above combines the attached Figure 3A and 3B describes the configurations and settings of the drive, the connection mechanism, and the guiding mechanism of the extraction device in some embodiments of the present application. However, the present application is not limited thereto. In other embodiments, the configurations and settings of the above drive, connection mechanism, and guiding mechanism can also be changed without departing from the scope of the present application.

[0060] For example, in the above embodiment, the number of drives is 1 and is provided on one side of the integrated hub 121. In some other embodiments, the number of drives can also be 2, which are respectively provided on the opposite sides of the integrated hub 121 to drive the integrated hub 121 from both sides. In still other embodiments, the number of drives can also be more than two and can be set at other positions according to the specific structures of the integrated hub and the temperature control device, such as on the top of the temperature control device, etc.

[0061] In the above embodiments, the integration center 121 includes two plates arranged in parallel at intervals. In some other embodiments, the integration center 121 may further include at least one or a combination of a plate, a frame, or a rod, and a plurality of connecting rods 122 are detachably connected to the integration center 121. Each of the plate, the frame, and the rod may be an integral structure or jointly composed of several discrete parts, and the quantity and positions of the plate, the frame, and the rod included in the integration center 121 may be determined according to the specific quantity of the medical component 111 used in the extraction process and the specific design of the extraction device 100.

[0062] In another embodiment, the coupling manner of the second end 157b of the connecting rod 157 in the extraction device with the integration center 121 may be different from Figure 3A and 3B the examples in. Specifically, the second end 157b of the connecting rod 157 is not directly coupled to the slider 152, but is directly or coupled to the integration center 121 through a pin connecting rod, and the integration center 121 is slidably coupled to the guide rail 151 through the slider 152. When the motor 156 operates, it directly drives the integration center 121 to move up and down along the guide rail 151 through the connecting rod 157.

[0063] In another embodiment, the driver does not have a connecting rod, but includes a cam power-connected to the rotating shaft 154 of the motor 156, and the cam is detachably coupled to the integration center 121. For example, the edge of the cam may abut against the bottom surface of the integration center 121. When the motor 156 drives the cam to rotate, the edge of the cam always abuts against and supports the bottom surface of the integration center 121, but the distance between the abutting point and the rotating shaft 154 of the motor 156 changes as the cam rotates, thereby driving the integration center 121 to move up and down along the guide rail 151. Alternatively, a cam groove may be provided on the surface of the cam, and the integration center 121 is pivotally and detachably coupled to a slider that slides in the cam groove, and the integration center 121 is driven to move up and down by the movement of the slider in the cam groove.

[0064] In yet another embodiment, the driver of the extraction device includes a cylinder, the cylinder has a piston rod that can contract relative to the cylinder block, and the piston rod can be detachably coupled to the integration center 121 through a connecting rod, thereby driving the integration center 121 to move up and down.

[0065] Please refer to Figure 1C 、 Figure 4A and 4B , Figure 4A are Figure 1C cross-sectional views of the container, the connecting rod, and the medical component of the extraction device shown, Figure 4B are Figure 4AA partial enlarged view of the Y region in []. A plurality of connecting rods 122 are detachably suspended on the integrated center 121. Among them, the upper end 122a of each connecting rod 122 is detachably connected to the integrated center 121, and the lower end 122b of each connecting rod 122 is detachably connected to a medical component 111. The entire medical component 111 and the portion of the connecting rod 122 near the lower end 122b are immersed in the extraction solution in a corresponding container 110. Specifically, the connecting rod 122 includes an upper end fixing member provided at its upper end 122a, and the upper end fixing member is used to fix the connecting rod 122 to the integrated center 121. Among them, the upper end fixing member may include a threaded connector, a buckle or other detachable locking structures. The connecting rod 122 further includes a lower end fixing member provided at its lower end 122b, and the lower end fixing member is used to fix the medical component 111 to the connecting rod 122, and the lower end fixing member may include a buckle structure.

[0066] Further, each container 110 has a lid 160, and the lid 160 is used to removably and at least partially cover the top opening of the container 110 to reduce the volatilization of the extraction solution in the container 110. The lid 160 has a central opening, and the size and shape of the central opening are configured to allow at least a part of a corresponding connecting rod among the plurality of connecting rods to move up and down therein. In some examples, each connecting rod includes a cylindrical rod body with a uniform diameter, and the rod body is configured to be able to pass through the central opening of the lid 160. Additionally, each connecting rod may include one or two head ends, and the diameter of the head end is larger than the diameter of the rod body; after the rod body is inserted into the central opening of the lid 160, the head end can be installed at one or both ends of the rod body. In still other embodiments, a sealing film may further be used to wrap the top of the lid 160 and the container 110 that are joined to each other to prevent the extraction solution from volatilizing between the lid 160 and the container 110.

[0067] In addition, each connecting rod 122 has a blocking portion 161 near the top end of the connecting rod 122. The size of the blocking portion 161 is larger than the diameter of the central opening of the lid 160, and is used to block the portion of the connecting rod 122 above the blocking portion 161 from passing through the central opening of the lid 160. When the connecting rod 122 is detached from the integrated center 121, the connecting rod 122 and the medical component 111 fall under the action of gravity, and the presence of the blocking portion 161 limits the falling distance of the connecting rod 122. In the illustrated embodiment, the blocking portion 161 is constructed as a cylinder, but the blocking portion 161 may also be constructed in other suitable shapes, such as in the form of a crossbar intersecting the connecting rod body, a triangular prism, a quadrangular prism, etc.

[0068] The position of the blocking portion 161 can be appropriately set according to the length of the portion of the connecting rod 122 located below the blocking portion 161, the length of the medical component 111, and the height of the container 110, so that when the blocking portion 161 contacts the lid 160, the lower end of the medical component 111 still has a certain distance from the bottom of the container 110, to avoid the situation where the lower end of the medical component 111 touches the bottom of the container 110 and causes the container 110 to rupture. In some embodiments, the position of the blocking portion 161 on the connecting rod 122 can be adjusted to flexibly adapt to the sizes of different medical components and containers.

[0069] In some embodiments, with reference to Figure 1C and Figure 5 , the housing 102 of the temperature control device 101 further includes a plurality of receiving frames 141 provided on the bottom surface 107 of the housing 102, where Figure 5 is a top view of the receiving frame 141, the base 110b of the container 110, and the bottom surface 107 of the housing 102. Each receiving frame 141 is configured to receive the base 110b of a corresponding container 110, and the receiving frame 141 is used to limit the displacement of the container 110 in the horizontal direction.

[0070] In Figure 5 example, the base 110b of the container 110 is circular (shown by a dotted circle in the figure), and the projected pattern of the receiving frame 141 on the bottom surface 107 of the housing 102 is square, and its four side walls are all perpendicular to the bottom surface 107 of the housing 102. The size of the receiving frame 141 is set such that when the circular base 110b of the container 110 is placed into the receiving frame 141, the respective side walls of the receiving frame 141 abut against the circular base 110b, thereby restricting the degree of freedom of movement of the base 110b of the container 110 in the direction parallel to the bottom surface 107 of the housing 102 (horizontal direction). In other embodiments, the receiving frame 141 can also be other shapes suitable for accommodating and restricting the horizontal displacement of the base 110b of the container 110.

[0071] In some embodiments, with reference to Figure 1C and Figure 6 , the housing 102 further includes a positioning plate 142 provided at a certain distance above the bottom surface 107 of the housing 102, where Figure 6 is a top view of the positioning plate 142. In the illustrated embodiment, the positioning plate 142 has a plurality of holes 142a therein. The shape of each hole 142a corresponds to the shape of the top of the container 110, so that the tops of the respective containers 110 can pass through the corresponding holes 142a of the positioning plate 142. The positioning plate 142 is detachably fixed within the housing 102 at a position higher than the bottom surface 107 by fixing members located on the inner wall of the housing 102.

[0072] In Figure 1C In the illustrated embodiment, since the receiving frame 141 provided on the bottom surface 107 and the corresponding holes 142a of the positioning plate 142 provided above the bottom surface 107 are substantially aligned in the vertical direction, the degree of freedom of movement of the container 110 can be restricted, so that the upper part of the container 110 cannot move horizontally within the box body 102 or rotate relative to the bottom surface 107.

[0073] In other embodiments, the container has a non-circular base, and the box body may correspondingly include a fixing plate provided at a certain distance above the bottom surface of the box body, and the fixing plate has a plurality of openings, each opening having a certain shape and size, and the shape and size enable the base of the container to pass through the opening when the base of the container has a passing orientation, but cannot pass through the opening when the base of the container rotates a certain angle around its longitudinal axis from the passing orientation. The following refers to Figure 7 and Figure 8 to take a container with a pentagonal base as an example to illustrate the structure of the above fixing plate in detail.

[0074] Figure 7 FIG. shows a schematic cross-sectional view of an embodiment of an extraction device having a fixing plate 243, Figure 8 which is Figure 7 a top view of the fixing plate 243 in Figure 7 and Figure 8 and the base 210b of the container 210. In the embodiment shown in

[0075] When the base 210b of the container 210 is in a certain orientation (for example, Figure 8 the orientation shown by the solid pentagon in Figure 7 ), the base 210b of the container 210 can just pass through the opening 243a in the fixing plate 243 and enter the space between the fixing plate 243 and the bottom surface 107 of the box body 102. In this application, this orientation of the container 210 is referred to as the "passing orientation". When the base 210b of the container 210 passes through the opening 243a, if the base 210b of the container 210 is rotated a certain angle around its longitudinal axis ( Figure 7 the vertical direction in Figure 8The orientation shown by the dashed pentagon. At this time, the base 210b of the container 210 and the pattern of the opening 243a are offset from each other, so that the base 210b of the container 210 is blocked by the fixing plate 243, and the base 210b of the container 210 cannot pass through the fixing plate 243. This application refers to this orientation of the container 210 as the "blocking orientation". Thus, the degree of freedom of movement of the container 210 in the direction perpendicular to the bottom surface 107 of the box body 102 (vertical direction) can be simply restricted by the fixing plate 243.

[0076] In this embodiment, the distance between the fixing plate 243 and the bottom surface 107 of the box body 102 should be restricted within a certain range. On the one hand, if the distance between the fixing plate 243 and the bottom surface 107 of the box body 102 is too large, due to the buoyancy of the fluid medium on the container 210, the base 210b of the container 210 is more likely to move up and down in the space between the fixing plate 243 and the bottom surface 107. And since the upper diameter of the container 210 is smaller than the diameter of the base 210b, the upper part of the container 210 is more likely to deflect to a certain extent relative to the base 210b, thus causing an obstacle to the up and down movement of the connecting rod in the container 210 and even resulting in damage to the container 210. On the other hand, if the distance between the fixing plate 243 and the bottom surface 107 of the box body 102 is too small, the base 210b of the container 210 cannot be received in the space between the fixing plate 243 and the bottom surface 107, and the container 210 cannot be rotated from the passing orientation to the blocking orientation. Preferably, the distance between the fixing plate 243 and the bottom surface 107 of the box body 102 is equal to the thickness of the base 210b of the container 210, or at most 1 centimeter larger than the thickness of the base 210b of the container 210. For example, the distance between the fixing plate 243 and the bottom surface 107 of the box body 102 is 1 millimeter, 3 millimeters, 5 millimeters, 7 millimeters or 9 millimeters larger than the thickness of the base 210b of the container 210, etc.

[0077] The above combination Figures 1A to 1C 、 Figure 5 and Figure 6 、as well as Figure 7 and Figure 8, different embodiments of the fixing component for restricting the displacement of the container in the extraction device of the present application have been described, but the present invention is not limited thereto. For example, in another embodiment, the box body may further include a plurality of clamps located on at least one side surface inside the box body, where each clamp is configured to hold a container. The clamp is fixed to the inner wall surface of the box body through a fixing member. When the clamp holds the corresponding container, it can simultaneously restrict the displacement of the container in the direction parallel to the bottom surface of the box body (horizontal direction) and the direction perpendicular to the bottom surface of the box body (vertical direction), and has a good limiting effect. In still other embodiments, the box body may include one or more of the above-mentioned positioning plate 142, fixing plate 243, receiving frame 141 or clamps, so as to restrict the displacement of the container in the horizontal direction parallel to the bottom surface of the box body and / or the vertical direction perpendicular to the bottom surface of the box body.

[0078] In another embodiment provided by the present application, as Figure 9A and Figure 9B shown, the upper part of each vertical guide rail 151 of the extraction device has a resilient stopper 310, and the resilient stopper 310 can be in Figure 9A the retracted configuration shown in Figure 9B and the extended configuration shown in Figure 9A and Figure 9B convert between them. For the convenience of understanding hereinafter,

[0079] Specifically, as Figure 9A shown, when the resilient stopper 310 is in the retracted configuration, the resilient stopper 310 is located inside the guide rail 151, so that the slider 152 coupled to the integrated center 121 can move upward and cross the resilient stopper 310. Then, as Figure 9B shown, when the integrated center 121 passes through the resilient stopper 310, the resilient stopper 310 extends and protrudes beyond the outer peripheral surface of the guide rail 151. At this time, the resilient stopper 310 is in its extended configuration, blocking the slider 152 coupled to the integrated center 121 from crossing the resilient stopper 310, thereby fixing the integrated center 121 at the corresponding height (above the resilient stopper 310) of the guide rail 151.

[0080] Although not shown in Figure 9BAs shown in the figure, it can be understood that at this time, the connecting rod 122 and the medical component 111 are suspended on the integrated center 121, while the container 110 remains inside the box body 102. Thus, the extraction solution in the container 110 can be obtained and the container 110 can be cleaned without disassembling the connecting rod 122, making the operation more convenient. Specifically, in this embodiment, the recoverable blocker 310 includes a button, and the operator can press the button to retract it into the guide rail 151 (retraction structure) or extend it beyond the outer peripheral surface of the guide rail 151 (extension structure).

[0081] The extraction device 100 may further include a controller. The controller is coupled to the temperature control device 101. The controller can receive a signal indicating the current temperature of the fluid medium from the temperature control device 101 and, optionally based on this signal, send an instruction to the temperature control device 101 to adjust the operating state of the heater of the temperature control device 101, thereby controlling the temperature of the extraction solution in the container 110 within the required range.

[0082] In addition, the controller may also be coupled to the driver 130. The controller can receive a signal indicating the current operating state of the driver 130 from the driver 130 and, optionally based on this signal, send an instruction to the driver 130 to adjust the rotational speed of the motor 156 in the driver 130, thereby controlling the frequency of the upward or downward movement of the medical component 111 within the required range, so as to be able to stably, controllably and more conveniently set the extraction conditions to meet the requirements of the extraction standard.

[0083] In Figure 1A In the illustrated embodiment, the extraction device 100 may further include a user operation interface 170 coupled to the controller. The user operation interface 170 is disposed on the outer surface of the temperature control device 101. The operator can input an instruction to the controller by operating the user operation interface 170 to preset the extraction temperature that the temperature control device 101 needs to reach and / or the extraction rotational speed that the motor 156 needs to reach. Specifically, the user operation interface 170 may include an input part and a display part. The input part includes keys, knobs, etc.; the display part includes a display screen or indicating scales, etc., for displaying the current / preset heating temperature of the temperature control device 101 and the current / preset rotational speed of the motor 156.

[0084] In other embodiments, when one of the temperature control device 101 or the driver 130 is an adjustable device, the controller may also be coupled only to this adjustable device.

[0085] In yet another embodiment, the controller further includes a timer for generating a termination signal. The timer is used to record the running time of the temperature control device 101 and / or the driver 130. When the running time reaches a preset time, the timer generates a termination signal, and the controller sends a termination signal to the heater in the temperature control device 101 and / or the motor 156 of the driver 130 in response to the termination signal to terminate the operation of the heater and / or the motor 156.

[0086] After the extraction process using the extraction device 100 is completed, the integrated hub 121, the connecting rod 122, the container 110, and the medical component 111 can be separated from each other, the extraction solution for extracting the medical component 111 can be obtained from the container 110, and the connecting rod 122 and the container 110 can be cleaned.

[0087] The present application further provides an extraction method for extracting extractable substances from the medical component 111. The following will use Figures 1A - 1C and Figures 2 - 6 the extraction device 100 shown as an example to illustrate how to perform extraction operations using the extraction device 100.

[0088] First, provide the extraction device 100, and add a fluid medium to the temperature control device 101 of the extraction device 100.

[0089] Next, add an extraction solution to the container 110, and connect the lower end of the connecting rod 122 to a corresponding medical component 111. For the container 110 provided with a lid 160, before connecting the lower end of the connecting rod 122 to the medical component 111, it is also necessary to first pass the lower end of the connecting rod 122 in the corresponding container 110 through the central opening of the lid 160.

[0090] Then, immerse the medical component 111 and a part of the connecting rod 122 (the lower end part of the connecting rod 122) in the extraction solution of the corresponding container 110, and then immerse at least a part of the container 110 in the fluid medium in the box body 102 of the temperature control device 101. Specifically, place the base 110b of the container 110 in the corresponding receiving frame 141, then pass the top of the container 110 through the hole 142a of the positioning plate 142, and fixedly engage the positioning plate 142 to the inner wall surface near the top of the box body 102. In addition, when the temperature control device 101 includes a box cover 103, the box cover 103 is also installed on the top of the box body 102, and the connecting rod 122 passes through the slot 104 on the box cover 103.

[0091] Next, the upper ends of the respective connecting rods 122 are connected to the integrated center 121, and the integrated center 121 is coupled to the driver 130. Specifically, the coupling of the integrated center 121 to the driver 130 is achieved by connecting the second end 157b of the connecting rod 157 pivotally connected to the output shaft 153 of the motor 156 of the driver 130 to the pin connecting rod 158 fixedly coupled to the slider 152.

[0092] Thereafter, the driver 130 is controlled to drive the integrated center 121 to move up and down. During the extraction operation, the operator can input instructions to the controller through the user operation interface 170 coupled to the controller to set the extraction temperature that the temperature control device 101 needs to reach and / or the extraction rotation speed that the motor 156 needs to reach. Then, the controller can send instructions to the temperature control device 101 and / or the driver 130 based on the received instructions, control the temperature control device 101 to heat the fluid medium to a preset temperature, and / or the driver 130 to drive the integrated center 121 to move up and down at a certain frequency.

[0093] Although the above takes Figures 1A - 1C and Figures 2 - 6 the illustrated embodiment as an example to introduce the process of performing the extraction operation using the extraction device of the present application, any specific extraction device detailed in the present application can implement the extraction operation, and only the foregoing steps need to be slightly adjusted according to the specific configuration differences of the device. For example, for the extraction device having the Figures 7 - 8 illustrated fixing plate 243, the step of placing the container into the temperature control device is correspondingly changed to first make the container in the passing orientation so that its base smoothly enters the corresponding opening 243a of the fixing plate 243, and then make the container rotate to the blocking orientation, thereby fixing the position of the container, which will not be elaborated here. Additionally, for the extraction device having the Figure 9A and 9B illustrated recoverable blocker 310 provided on the upper part of the guide rail 151, after the extraction operation, the integrated center 121 can be fixed at a position above the recoverable blocker 310 on the upper part of the guide rail 151 by operating the recoverable blocker 310, so that the extraction solution in the container 110 can be obtained without disassembling the connecting rod 122, which will not be elaborated here either.

[0094] For different medical components, the operating parameters specifically adopted by the extraction device can be appropriately changed. For example, the preset temperature that the temperature control device 101 can heat the fluid medium to is 30 °C to 90 °C (for example, 40 °C, 60 °C, 80 °C, etc.); the rotational speed of the motor 156 is 20 rpm to 100 rpm (for example, 30 rpm, 50 rpm, 70 rpm, 90 rpm, etc.). Additionally, the amplitude range of the up and down movement of the medical component 111 can be 10 mm to 20 mm (for example, 12 mm, 15 mm, 18 mm, etc.).

[0095] In the embodiment described above, the filter element is taken as a specific example of the medical component 111, and the filter element is generally cylindrical in shape. However, those skilled in the art can foresee that the extraction method and extraction device of the present application are also applicable to other types of medical components (such as medical container bottles, medical packaging bags, etc.), and only need to correspondingly adjust the specific configurations of the container and the connecting rod according to the specific type of the medical component, and the present application will not elaborate on this anymore.

[0096] The discussion herein includes many illustrative drawings that show various example parts or components of an extraction device for extracting extractables from a medical component. For the sake of clarity, these figures do not show all aspects of each example component. Any example component and / or method provided herein can share any or all features with any or all other components and / or methods provided herein.

[0097] Various embodiments have been described herein with reference to the drawings. However, it is obvious that various modifications and changes can be made to them, and additional embodiments can be implemented without departing from the broader scope of the invention as set forth in the appended claims. In addition, by considering the specification and the practice of one or more embodiments of the invention disclosed herein, other embodiments will be apparent to those skilled in the art. Therefore, the present application and the embodiments herein are intended to be considered only as exemplary, and the true scope and spirit of the invention are indicated by the list of appended exemplary claims.

Claims

1. An extraction device for extracting extractables from a medical component, characterized in that, The extraction device includes: a temperature control device configured to contain a fluid medium therein and heat the fluid medium to a preset temperature; a plurality of containers, at least a part of the plurality of containers being placed in the fluid medium within the temperature control device, wherein each container is configured to contain an extraction solution; a connection mechanism including an integrated hub disposed above the temperature control device and a plurality of connecting rods, wherein each connecting rod is detachably connected to the integrated hub at its upper end and detachably connected to a medical component at its lower end, so that the medical component is immersed in the extraction solution within a corresponding one of the plurality of containers; and a driver coupled to the integrated hub to drive the integrated hub to move up and down.

2. The extraction device according to claim 1, wherein The temperature control device includes: a box body having an opening at the top thereof and configured to accommodate the fluid medium; and a heater configured to heat the fluid medium to the preset temperature.

3. The extraction device according to claim 2, characterized in that, The temperature control device further includes: a box cover for removably covering the opening at the top of the box body and having a plurality of slots extending to one side edge of the box cover, wherein the size of each slot is set to be able to receive a corresponding one of the plurality of connecting rods.

4. The extraction device according to claim 2 or 3, characterized in that, The box body further includes: a plurality of receiving frames disposed on the bottom surface of the box body, wherein each receiving frame is configured to receive the base of a corresponding one of the plurality of containers and restrict the displacement of the container in the horizontal direction; and a positioning plate disposed above the bottom surface of the box body and having a plurality of holes, wherein each hole is configured to receive the upper part of a corresponding one of the plurality of containers.

5. The extraction device according to claim 2 or 3, characterized in that, Each of the plurality of containers has a non-circular base, and the box body further includes: a fixing plate disposed above the bottom surface of the box body and having a plurality of openings, wherein each of the plurality of openings has a certain shape and size such that the base of the container can pass through the opening when the base of the container has a passing orientation, but cannot pass through the opening when the base of the container rotates a certain angle about its longitudinal axis from the passing orientation.

6. The extraction device according to claim 5, characterized in that, The distance between the fixing plate and the bottom surface of the box body is equal to the thickness of the container base or at most 1 centimeter greater than the thickness of the container base.

7. The extraction device according to claim 2 or 3, characterized in that, The box body further includes: a plurality of clamps disposed on at least one side surface within the box body, wherein each clamp is configured to clamp one of the plurality of containers.

8. The extraction device according to any one of claims 1 to 7, characterized in that, The integrated hub includes at least one of the following components: a plate, a frame, or a rod.

9. The extraction device according to any one of claims 1 to 8, characterized in that, The extraction device further includes: a guiding mechanism configured to guide the up and down movement of the integrated hub.

10. The extraction device according to claim 9, characterized in that, The guiding mechanism includes: a pair of guide rails vertically disposed on opposite sides of the integrated hub; and A pair of sliders, the pair of sliders being connected to the integrated hub, and each slider of the pair of sliders being slidably connected to a corresponding one of the pair of guide rails.

11. The extraction device according to claim 10, wherein Each of the pair of guide rails has a resilient blocker at its upper portion, and the resilient blocker is capable of switching between a retracted configuration and an extended configuration, wherein when the resilient blocker is in the retracted configuration, the retracted configuration allows the slider connected to the integrated hub to move upward and over the resilient blocker; when the resilient blocker is in the extended configuration, the extended configuration blocks the slider connected to the integrated hub from passing over the resilient blocker.

12. The extraction device according to any one of claims 1 to 11, characterized in that, The driver includes a motor and a connecting rod, the output shaft of the motor being offset from the rotational axis of the motor, and the connecting rod having a first end pivotally coupled to the output shaft of the motor and a second end removably coupled to the integrated hub.

13. The extraction device according to claim 10, characterized in that, The driver includes a motor and a connecting rod, the output shaft of the motor being offset from the rotational axis of the motor, and the connecting rod having a first end pivotally coupled to the output shaft of the motor and a second end removably coupled to the slider.

14. The extraction device according to any one of claims 1 to 11, characterized in that The driver includes a motor and a cam, the cam being coupled to the rotational axis of the motor, and the cam being removably coupled to the integrated hub.

15. The extraction device according to any one of claims 1 to 11, characterized in that, The driver includes a cylinder having a piston, the piston being removably coupled to the integrated hub.

16. The extraction device according to any one of claims 1 to 15, characterized in that Each of the plurality of containers has a lid configured to removably cover the top opening of the container, and the lid has a central opening, wherein the size and shape of the central opening are configured to allow at least a portion of a corresponding one of the plurality of connecting rods to move up and down therein.

17. The extraction device according to claim 16, wherein Each of the plurality of connecting rods has a blocking portion near the top end of the connecting rod, and the blocking portion is configured to block the portion of the connecting rod above the blocking portion from passing through the central opening of the lid.

18. The extraction device according to any one of claims 1 to 17, characterized in that The extraction device further includes: A controller coupled to the temperature control device and / or the driver, wherein the controller is configured to receive signals from the temperature control device and / or the driver or send instructions to the temperature control device and / or the driver.

19. The extraction device according to claim 18, characterized in that, The controller further includes a timer for generating a termination signal, and the controller sends a termination operation instruction to the temperature control device and / or the driver in response to the termination signal.

20. An extraction method for extracting extractables from a medical component, characterized in that, The method includes: Providing the extraction device according to any one of claims 1 to 19; Adding a fluid medium to the temperature control device; Adding an extraction solution to the container; Connecting the lower end of the connecting rod to a corresponding medical component; Immersing the medical component in the extraction solution of the corresponding container; Immersing at least a portion of the container in the fluid medium of the temperature control device; Connecting the upper end of the connecting rod to the integrated hub; Coupling the integrated hub to the driver; and Controlling the driver to drive the integrated hub to move up and down.

Images