Extraction device for extracting extractable products from medical components

Abstract

The present application provides an extraction device 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 for extracting extractables from medical components. Background Art

[0002] Medical devices or containers are widely used in the manufacture and storage of medicines, or in the treatment of patients. When a medical device or container is in 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, filtering devices, such as filter elements, are often used to remove particles or microorganisms from pharmaceutical products to meet pharmaceutical needs, 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, attention should be paid to evaluating the rate and total amount of 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. Utility Model Content

[0003] One of the purposes of the present application is to provide an extraction device that can be used to 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, the temperature control device being configured to contain a fluid medium therein and to heat the fluid medium to a preset temperature; a plurality of containers, the plurality of containers being at least partially placed in the fluid medium within the temperature control device, wherein each container is configured to contain an extraction solution; a connecting mechanism, the connecting mechanism comprising 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 the medical component at its lower end so that the medical component is immersed in the extraction solution within a corresponding container among the plurality of containers; and a driver, the driver being coupled to the integrated hub to drive the integrated hub to move up and down.

[0005] In some embodiments, the temperature control device comprises: a box 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 also includes: a box cover, which is used to removably cover the opening at the top of the box body and has a plurality of grooves extending to a side edge of the box cover, wherein the size of each groove is set to be able to receive a corresponding connecting rod among the plurality of connecting rods.

[0007] In some embodiments, the box body also includes: a plurality of receiving frames, which are arranged on the bottom surface of the box body, wherein each receiving frame is configured to receive the base of a corresponding container among the multiple containers and limit the displacement of the container in the horizontal direction; and a positioning plate, which is arranged above the bottom surface of the box body and has a plurality of holes, wherein each hole is configured to receive the upper part of a corresponding container among the multiple containers.

[0008] In some embodiments, each of the multiple containers has a non-circular base, and the box body further includes: a fixing plate, which is arranged above the bottom surface of the box body and has a plurality of openings, wherein each of the multiple openings has a certain shape and size, and the shape and size enable the base of the container to pass through the opening when it has a pass orientation, but cannot pass through the opening when the base of the container is rotated a certain angle around its longitudinal axis from the pass 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 is at most 1 cm 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 of the box body, wherein each clamp is configured to clamp one container among the plurality of containers.

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

[0012] In some embodiments, the extraction device further comprises: 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 arranged on opposite sides of the integrated hub; and a pair of sliders connected to the integrated hub, each slider in the pair of sliders being slidably connected to a corresponding one of the pair of guide rails.

[0014] In some embodiments, each guide rail in the pair of guide rails has a recoverable barrier on its upper portion, and the recoverable barrier is capable of switching between a retracted structure and an extended structure, wherein, when the recoverable barrier is in the retracted structure, the retracted structure allows a slider connected to the integrated hub to move upward and pass over the recoverable barrier; and when the recoverable barrier is in the extended structure, the extended structure blocks the slider connected to the integrated hub from passing over the recoverable barrier.

[0015] In some embodiments, the driver includes a motor and a connecting rod, wherein 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, wherein an output shaft of the motor is offset from a 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 a rotating shaft of the motor, and the cam is detachably coupled to the integrated hub.

[0018] In some embodiments, the actuator includes a cylinder having a piston that is removably coupled to the integrated hub.

[0019] In some embodiments, each of the plurality of containers has a lid configured to removably cover a 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 connecting rod 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 close to a top end of the connecting rod, and the blocking portion is configured to block a portion of the connecting rod located above the blocking portion from passing through the central opening of the cover.

[0021] In some embodiments, the extraction device also includes: a controller, which 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 comprises a timer, wherein the timer is configured to generate 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] The above is an overview of the present application, which may be simplified, summarized, and omitted in detail. Those skilled in the art should recognize that this section is only illustrative and is not intended to limit the scope of the present application in any way. This summary section is neither intended to determine the key features or essential features of the claimed subject matter, nor is it intended to be used as an auxiliary means to determine the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Through the detailed description made below in conjunction with the accompanying drawings and the attached 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 is 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 figure numbers in multiple drawings represent the same or similar parts. By referring to the drawings, the content of the present application will be more clearly and detailed.

[0025] Figure 1A and Figure 1B A three-dimensional structural schematic diagram and a top view of an extraction device for extracting extractables from a medical component according to an embodiment of the present application are respectively shown;

[0026] Figure 1C for Figure 1B A cross-sectional view of the extraction device along the HH direction is shown;

[0027] Figure 2 yes Figure 1C A top view of a box cover of a temperature control device in the extraction device is shown;

[0028] Figure 3A yes Figure 1A The illustrated three-dimensional schematic diagram of the extraction device after omitting the driver protection structure;

[0029] Figure 3B for Figure 3A A local enlarged view of the X region in FIG.

[0030] Figure 4A yes Figure 1C A cross-sectional view of the container, connecting rod and medical component of the extraction device is shown;

[0031] Figure 4B yes Figure 4A A partial enlarged view of the middle Y region;

[0032] Figure 5 yes Figure 1C A top view of the container base of the extraction device and the receiving frame of the housing of the temperature control device is shown;

[0033] Figure 6 yes Figure 1C A top view of a positioning plate of a housing of a temperature control device is shown;

[0034] Figure 7 is a cross-sectional view of an extraction device according to another embodiment of the present application;

[0035] Figure 8 yes Figure 7 A top view of the container base of the extraction device and the fixing plate of the temperature control device box is shown;

[0036] Fig. 9A and Fig. 9B They are schematic three-dimensional structural diagrams of a recoverable barrier in another embodiment of the present application when it is in a retracted structure and an extended structure respectively. DETAILED DESCRIPTION

[0037] The following detailed description of exemplary embodiments of the present application refers to the accompanying drawings that form a part of the description. The accompanying drawings show specific exemplary embodiments in which the present application can be practiced. The detailed description, including the accompanying drawings, describes these embodiments in sufficient detail to enable those skilled in the art to practice the present application. Those skilled in the art may 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, readers of the following detailed description should not interpret the description in a restrictive manner, and only limit the scope of the embodiments of the present application with the appended claims.

[0038] In this application, unless otherwise expressly stated, the use of singular words shall also include the plural meaning. In this application, unless otherwise stated, the use of "or" means "and / or". In addition, the use of the term "including" and other forms of expression such as "including" and "containing" are not restrictive. In addition, unless otherwise expressly stated, terms such as "element" or "component" cover elements and components including one 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 interpreted as limiting the subject matter described.

[0039] As used herein, spatially relative terms, such as "lower", "below", "below", "lower side", "upper", "above", "above", "upper side", "left side", "right side", "horizontal", "vertical", "edge", "longitudinal", "lateral", etc., may be used herein to facilitate describing the relationship between one element or feature and another element or feature as shown in the accompanying drawings. In addition to the directions depicted in the figures, spatially relative terms are intended to cover different directions of the device in use or operation. The device can be oriented in other ways (rotated 90 degrees or in other directions), and the spatially related descriptors used herein can also be interpreted accordingly. It should be understood that when an element is referred to as "connected to" or "coupled to" another element, it can be directly connected to or coupled to another element, or there can be an intermediate element. In this application, unless otherwise specified, the numerical ranges mentioned include their end values ​​and take into account the conventional tolerances in the art, such as tolerances of ±0.1mm, ±0.2mm, ±0.3mm, ±0.4mm, ±0.5mm, etc.

[0040] Figures 1A to 1C FIG. 1 shows a schematic structural diagram of an extraction device 100 for extracting extractables from a medical component according to an embodiment of the present application, wherein Figure 1A is a schematic diagram of the three-dimensional structure of the extraction device 100, Figure 1B is a top view of the extraction device 100, Figure 1C For the extraction device 100 Figure 1B The extraction device 100 can be used to extract extractables from a medical component for subsequent extractable / leachable testing, thereby verifying the effectiveness and safety of the medical component. In order to effectively extract extractables from a medical component, the medical component needs to be immersed in an extraction solution at a certain temperature and fully exchange substances with the extraction solution to complete the extraction of the extractables.

[0041] Please refer to Figures 1A to 1C The extraction device 100 includes a temperature control device 101, which is used to contain a fluid medium. When the extraction device 100 is used to extract extractables from the medical component 111, the temperature control device 101 can heat the fluid medium therein to a desired preset temperature according to the material properties of the medical component 111 and / or relevant standard requirements.

[0042] exist Figures 1A to 1CIn the embodiment, the temperature control device 101 includes a box 102, the top of the box 102 has an opening, and the box 102 is used to accommodate a fluid medium. A water outlet 123 may be provided at a position close to the bottom of the side wall of the box 102, and the water outlet 123 is used to discharge the fluid medium in the box 102 from the box 102. In the present embodiment, the fluid medium includes water, and 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 the fluid medium in the temperature control device 101 can also use other fluids with suitable specific heat capacity.

[0043] Furthermore, the temperature control device 101 further includes a heater (not shown), which is used to heat the fluid medium contained in the temperature control device 101 to a preset temperature. Figure 1C As shown, the bottom of the box 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 102. The heater can be placed in the chamber 106, and the bottom surface 107 of the box 102 is provided with a through hole, so that the fluid medium can flow into the chamber 106 through the through hole of the bottom surface 107, and heat exchange with the heater is performed to be heated to a predetermined temperature. In other embodiments, the heater can also be placed in other positions of the temperature control device 101, such as on the inner surface of the side wall of the box 102.

[0044] In this embodiment, the temperature control device 101 further includes a box cover 103. Figures 1A to 1C And refer to Figure 2 ,in Figure 2 103 is a top view of the box cover 103. The box cover 103 is configured to detachably cover at least partially the opening at the top of the box body 102 to reduce the heat radiated 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.

[0045] Specifically, the box cover 103 may include two separable parts 103a and 103b, each part having a plurality of grooves 104 extending to one side edge toward the other part, wherein the size of each groove 104 (i.e., the width of the groove) is set to be able to receive a corresponding connecting rod 122. The box cover 103 may also have a handle 105 to facilitate the operator to move the box cover 103 to open or close the opening at the top of the box body 102. In some embodiments, the box cover 103 may also be a single component, which is provided with a plurality of grooves extending to one side edge thereof to receive the corresponding connecting rods.

[0046] Please continue to refer to Figure 1CThe 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 portion 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 the extraction solution in the container 110 warm through the fluid medium.

[0047] In the process of extracting the extract in the medical component 111 using the extraction device 100, each container 110 can be used to accommodate a corresponding medical component 111, and the medical component 111 is immersed in the extraction solution in the container 110. In the present embodiment, the medical component 111 is a cylindrical filter element, and accordingly, the container 110 is also a cylindrical cylinder. For example, the container 110 can be a measuring 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.

[0048] It is understood that the technical solution of the present application is not limited to the above-mentioned types of medical components, shapes and sizes of containers. In other embodiments, the medical components may be other medical devices other than filter elements, such as medical fluid pipelines, medical fluid bags, etc., and the shape and size of the container may be adjusted accordingly. In addition, an extraction device may be configured with multiple containers of different shapes and sizes, and those skilled in the art may select a suitable container from the above-mentioned containers of various shapes and sizes according to the specific characteristics of the medical component to be tested, and perform an extraction operation of the extractables.

[0049] Furthermore, the extraction device 100 also includes a connecting mechanism 120. Figure 1A As shown, the connection mechanism 120 includes an integrated hub 121 disposed above the temperature control device 101 and a plurality of connection rods 122 connected to the integrated hub 121. Figure 1C As shown, the upper end of each connecting rod 122 is detachably connected to the integrated hub 121, and the lower end of each connecting rod 122 is detachably connected to a medical component 111. When the extractables in the medical component 111 are extracted using the extraction device 100, the integrated hub 121 can simultaneously connect and suspend multiple connecting rods 122, and then suspend multiple medical components 111, each medical component 111 is immersed in an extraction solution in a corresponding container 110, so that multiple medical components 111 can be processed simultaneously.

[0050] Furthermore, the extraction device 100 further includes a driver 130. The driver 130 is coupled to the integrated hub 121 to drive the integrated hub 121 to reciprocate up and down. When the extraction device 100 is used to extract the extractables in the medical component 111, the integrated hub 121 moves up and down, thereby driving the medical component 111 to move up and down in the extraction solution in the corresponding container 110 through each connecting rod 122, so that the medical component 111 and the extraction solution can fully exchange substances, thereby accelerating the dissolution of the extractables.

[0051] In the process of using the extraction device 100 to extract the extractables in the medical component 111, first, the multiple containers 110 of the extraction device 100 can be placed in the fluid medium inside the temperature control device 101 at the same time, so that the temperature of the extraction solution in the multiple containers 110 can be controlled at the same time. The integrated hub 121 can suspend multiple corresponding medical components 111 through multiple connecting rods 122. Therefore, when the driver 130 drives the integrated hub 121 to move up and down, it can drive multiple medical components 111 to move up and down at the same time. Therefore, through the extraction device 100, on the basis of meeting the standard requirements for extractable extraction, extractables of multiple groups of medical components 111 can be extracted simultaneously, thereby 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 rows, and up to 6 medical components can be extracted at the same time. In other embodiments, the number and layout of the connecting rods 122 and the containers 110 of the extraction device 100 may be changed according to specific needs, for example, 2, 3, 4, 5 or more connecting rods 122 and containers 110 may be provided.

[0052] Secondly, since the temperature control device 101 can heat the extraction solution in the container 110 and maintain it at a preset temperature through the fluid medium, 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 upward / downward movement distance of the medical component 111 during the extraction process are stable and controllable. In summary, the extraction device 100 increases the stability, efficiency and convenience of the extraction process.

[0053] Please refer to Figure 3A and 3B In some embodiments, the extraction device 100 further includes a guide mechanism 150 for guiding the integrated hub 121 to move up and down, wherein: Figure 3A and Figure 1A The viewing direction is consistent, and Figure 3A Omitted Figure 1C The protective structure outside the drive in the figure clearly shows the structure of the drive; Figure 3B for Figure 3A A local enlarged view of the X region in FIG.

[0054] like Figure 3A and 3B As shown, the guide mechanism 150 includes a pair of vertically extending guide rails 151 disposed on opposite sides of the integrated hub 121 and a pair of sliders 152 coupled to the integrated hub 121, each slider 152 being slidably mounted on a corresponding guide rail 151. The driver includes a motor 156 and a connecting rod 157, wherein the connecting rod 157 has a first end 157a pivotally coupled to an output shaft 153 of the motor 156 and a second end 157b detachably coupled to the slider 152. The output shaft 153 of the motor 156 deviates from the rotation axis 154 of the motor 156.

[0055] exist Figure 3A and 3B In the illustrated embodiment, the motor 156 includes a rotating disk 155 connected to a rotating shaft 154 of the motor 156, and the rotating shaft 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 deviates from the center of the rotating disk 155 (i.e., the rotating shaft 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 also has a pin connecting rod 158 fixed to its surface, and 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.

[0056] exist Figure 3A and 3B In the illustrated embodiment, the integrated hub 121 is composed of two layers of plates (e.g., stainless steel plates). The two layers of plates have openings near their opposite edges, and the sliders 152 of the guide mechanism 150 pass through the openings and are fixedly connected to the two layers of plates, respectively. Each guide rail 151 passes through the center 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 both sides thereof driven by the slider 152. In some embodiments, the surface of the slider 152 that is slidably engaged with the guide rail 151 is provided with a ball bearing to reduce the friction between it and the guide rail 151.

[0057] During the extraction process, when the motor 156 starts to operate, the output shaft 153 rotates around the rotation axis 154, so that the connecting rod 157 pivots relative to the output shaft 153 and drives the slider 152 to move up and down reciprocatingly 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 move up and down reciprocatingly. Thus, the driver and guide mechanism 150 converts the rotational motion of the motor 156 into the reciprocating up and down movement of the slider 152, so that the medical component 111 suspended on the integrated hub 121 can be stably and controllably driven to move up and down reciprocatingly in the extraction solution, so as to fully contact with the extraction solution for substance exchange.

[0058] The above combined with Figure 3A and 3B The configuration and setting of the driver, connecting mechanism and guiding mechanism of the extraction device in some embodiments of the present application are described. However, the present application is not limited thereto. In other embodiments, the configuration and setting of the driver, connecting mechanism and guiding mechanism may also be changed without departing from the scope of the present application.

[0059] For example, in the above embodiment, the number of drivers is 1, and it is disposed on one side of the integrated hub 121. In some other embodiments, the number of drivers may also be 2, and they are disposed on opposite sides of the integrated hub 121, so as to drive the integrated hub 121 from both sides. In some other embodiments, the number of drivers may also be more than two, and they may be disposed in other positions according to the specific structure of the integrated hub and the temperature control device, such as on the top of the temperature control device.

[0060] In the above embodiments, the integrated hub 121 includes two parallel and spaced plates. In some other embodiments, the integrated hub 121 may also include a combination of at least one or more of a plate, a frame or a rod, and a plurality of connecting rods 122 may be detachably connected to the integrated hub 121. Each of the plates, frames, and rods may be an integral structure, or may be composed of several separate parts. The number and position of the plates, frames, and rods included in the integrated hub 121 may be determined according to the specific number of medical components 111 used in the extraction process and the specific design of the extraction device 100.

[0061] In another embodiment, the second end 157b of the connecting rod 157 in the extraction device can be coupled to the integrated hub 121 in the same manner as Figure 3A and 3BSpecifically, the second end 157b of the connecting rod 157 is not directly coupled to the slider 152, but is directly or through a pin connecting rod coupled to the integrated hub 121, and the integrated hub 121 is slidably coupled to the guide rail 151 through the slider 152. When the motor 156 is working, the connecting rod 157 directly drives the integrated hub 121 to move up and down along the guide rail 151.

[0062] In another embodiment, the driver does not have a connecting rod, but includes a cam that is dynamically connected to the rotating shaft 154 of the motor 156, wherein the cam is detachably coupled to the integrated hub 121. For example, the edge of the cam may abut against the bottom surface of the integrated hub 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 integrated hub 121, but the distance between the abutment point and the rotating shaft 154 of the motor 156 changes with the rotation of the cam, thereby driving the integrated hub 121 to move up and down along the guide rail 151. Alternatively, a cam groove may be provided on the cam surface, and the integrated hub 121 may be pivotally and detachably coupled to a slider that slides in the cam groove, and the integrated hub 121 is driven to move up and down by the movement of the slider in the cam groove.

[0063] In another embodiment, the driver of the extraction device includes a cylinder having a piston rod that can be retracted relative to the cylinder body. The piston rod can be detachably coupled to the integrated hub 121 through a connecting rod, thereby driving the integrated hub 121 to move up and down.

[0064] Please refer to Figure 1C , Figure 4A and 4B , Figure 4A yes Figure 1C A cross-sectional view of the container, the connecting rod and the medical component of the extraction device is shown, Figure 4B for Figure 4A A partial enlarged view of the Y area in FIG. A plurality of connecting rods 122 are detachably suspended on the integrated hub 121. The upper end 122a of each connecting rod 122 is detachably connected to the integrated hub 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 close to the lower end 122b are immersed in an extraction solution in a corresponding container 110. Specifically, the connecting rod 122 includes an upper end fixing member disposed at its upper end 122a, and the upper end fixing member is used to fix the connecting rod 122 to the integrated hub 121. The upper end fixing member may include a threaded connector, a buckle or other detachable locking structure. The connecting rod 122 also includes a lower end fixing member disposed 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.

[0065] Further, each container 110 has a lid 160, which is used to removably and at least partially cover the top opening of the container 110 so as to reduce the volatilization of the extraction solution in the container 110. The lid 160 has a central opening, the size and shape of which are configured to allow at least a portion of a corresponding connecting rod in 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, which is configured to be able to pass through the central opening of the lid 160. In addition, each connecting rod may include one or two head ends, the diameter of which is greater than the diameter of the rod body; after the rod body is inserted into the central opening of the lid 160, the head end may be installed at one or both ends of the rod body. In some other embodiments, the lid 160 and the top of the container 110 that are joined to each other may be further wrapped with a sealing film to prevent the extraction solution from volatilizing between the lid 160 and the container 110.

[0066] In addition, each connecting rod 122 has a blocking portion 161 near the top of the connecting rod 122. The size of the blocking portion 161 is larger than the diameter of the central opening of the cover 160, and is used to block the portion of the connecting rod 122 located above the blocking portion 161 from passing through the central opening of the cover 160. When the connecting rod 122 is removed from the integrated hub 121, the connecting rod 122 and the medical component 111 fall under the action of gravity, and the existence of the blocking portion 161 limits the falling distance of the connecting rod 122. In the illustrated embodiment, the blocking portion 161 is configured as a cylinder, but the blocking portion 161 can also be configured as other suitable shapes, such as a crossbar form that intersects the connecting rod body, a triangular prism, a quadrangular prism, etc.

[0067] 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 cover 160, the lower end of the medical component 111 is still a certain distance from the bottom of the container 110, so as to avoid the lower end of the medical component 111 touching the bottom of the container 110 and causing the container 110 to break. 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.

[0068] In some embodiments, while referring to Figure 1C and Figure 5 The housing 102 of the temperature control device 101 further includes a plurality of receiving frames 141 disposed on the bottom surface 107 of the housing 102, wherein Figure 5It is a top view of the receiving frames 141, the base 110b of the container 110 and the bottom surface 107 of the box 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.

[0069] exist Figure 5 In the example of the embodiment, the base 110b of the container 110 is circular (shown by a dotted circle in the figure), and the projection figure of the receiving frame 141 on the bottom surface 107 of the box body 102 is a square, and its four side walls are perpendicular to the bottom surface 107 of the box body 102. The size of the receiving frame 141 is set so that when the circular base 110b of the container 110 is placed in the receiving frame 141, each side wall of the receiving frame 141 abuts against the circular base 110b, thereby limiting the freedom of movement of the base 110b of the container 110 in the direction parallel to the bottom surface 107 of the box body 102 (horizontal direction). In other embodiments, the receiving frame 141 can also be other shapes suitable for accommodating and limiting the horizontal displacement of the base 110b of the container 110.

[0070] In some embodiments, while referring to Figure 1C and Figure 6 The box 102 further includes a positioning plate 142 disposed a certain distance above the bottom surface 107 of the box 102, wherein Figure 6 1 is a top view of the positioning plate 142. In the illustrated embodiment, the positioning plate 142 has a plurality of holes 142a. The shape of each hole 142a corresponds to the shape of the top of the container 110, so that the top of each container 110 can pass through the corresponding hole 142a of the positioning plate 142. The positioning plate 142 is detachably fixed to a position in the box body 102 that is a certain distance higher than the bottom surface 107 by a fixing member located on the inner wall of the box body 102.

[0071] exist Figure 1C In the illustrated embodiment, since the receiving frame 141 arranged on the bottom surface 107 and the corresponding holes 142a of the positioning plate 142 arranged above the bottom surface 107 are basically aligned in the vertical direction, the freedom of movement of the container 110 can be limited, so that the upper part of the container 110 cannot move horizontally in the box body 102 or rotate relative to the bottom surface 107.

[0072] In other embodiments, the container has a non-circular base, and the box body may accordingly include a fixing plate disposed 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, the shape and size allowing the base of the container to pass through the opening when it has a pass orientation, but not passing through the opening when the base of the container is rotated a certain angle around its longitudinal axis from the pass orientation. Figure 7 and Figure 8 , taking a container with a pentagonal base as an example, the structure of the above-mentioned fixing plate is described in detail.

[0073] Figure 7 A schematic cross-sectional view of an embodiment of an extraction device having a fixing plate 243 is shown, Figure 8 for Figure 7 A top view of the fixing plate 243 and the base 210b of the container 210. Figure 7 and Figure 8 In the illustrated embodiment, the container 210 has a pentagonal base 210b. Accordingly, the shape of the corresponding opening 243a on the fixing plate 243 is also pentagonal, and the size of the opening 243a corresponds to the size of the base 210b of the container 210, which is equal to or slightly larger than the size of the base 210b of the container 210.

[0074] When the base 210b of the container 210 is in a certain orientation (e.g. Figure 8 When the base 210b of the container 210 passes through the opening 243a in the fixing plate 243 and enters the space between the fixing plate 243 and the bottom surface 107 of the box 102, this orientation of the container 210 is referred to as the "passing orientation" in the present application. After the base 210b of the container 210 passes through the opening 243a, if the base 210b of the container 210 is rotated around its longitudinal axis ( Figure 7 The vertical direction in the figure is rotated by a certain angle, such as 36 degrees, so as to achieve the following Figure 8 The dotted pentagon in the middle shows the orientation. At this time, the base 210b of the container 210 and the pattern of the opening 243a are staggered, 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 orientation of the container 210 is referred to as the "blocking orientation" in this application. Therefore, the 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 limited by the fixing plate 243.

[0075] In this embodiment, the distance between the fixing plate 243 and the bottom surface 107 of the box 102 should be limited to a certain range. On the one hand, if the distance between the fixing plate 243 and the bottom surface 107 of the box 102 is too large, 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 due to the buoyancy of the fluid medium on the container 210, 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, thereby hindering the up and down movement of the connecting rod in the container 210 and even causing 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 102 is too small, the base 210b of the container 210 cannot be accommodated 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 is at most 1 cm greater 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 mm, 3 mm, 5 mm, 7 mm or 9 mm greater than the thickness of the base 210b of the container 210.

[0076] Combination of the above Figures 1A to 1C , Figure 5 and Figure 6 ,as well as Figure 7 and Figure 8 , different embodiments of the fixing components for limiting the displacement of the container in the extraction device of the present application are described, but the utility model is not limited thereto. For example, in another embodiment, the box may further include a plurality of clamps located on at least one side surface in the box, wherein each clamp is configured to clamp a container. The clamp is fixed to the inner wall surface of the box by a fixing member. When the clamp clamps the corresponding container, it can simultaneously limit the displacement of the container in a direction parallel to the bottom surface of the box (horizontal direction) and a direction perpendicular to the bottom surface of the box (vertical direction), and has a good limiting effect. In some other embodiments, the box may include one or more of the above-mentioned positioning plate 142, fixing plate 243, receiving frame 141 or clamps, so as to limit the displacement of the container in a horizontal direction parallel to the bottom surface of the box and / or a vertical direction perpendicular to the bottom surface of the box.

[0077] In another embodiment provided in the present application, Fig. 9A and Fig. 9B As shown, the upper portion of each vertical guide rail 151 of the extraction device has a recoverable barrier 310, and the recoverable barrier 310 can be Fig. 9A The retracted structure shown is Fig. 9BThe following is for ease of understanding: Fig. 9A and Fig. 9B Only the three-dimensional structural diagram of the recoverable barrier 310, the guide rail 151 and the integrated hub 121 of the extraction device is shown.

[0078] Specifically, Fig. 9A As shown, when the recoverable barrier 310 is in the retracted configuration, the recoverable barrier 310 is located inside the guide rail 151, so that the slider 152 coupled to the integrated hub 121 can move upward and pass over the recoverable barrier 310. Fig. 9B As shown, after the integrated hub 121 passes through the recoverable barrier 310, the recoverable barrier 310 extends out and protrudes beyond the outer peripheral surface of the guide rail 151. At this time, the recoverable barrier 310 is in its extended structure, blocking the slider 152 coupled to the integrated hub 121 from passing over the recoverable barrier 310, thereby fixing the integrated hub 121 at a corresponding height of the guide rail 151 (above the recoverable barrier 310).

[0079] Although not in Fig. 9B , but it can be understood that at this time, the connecting rod 122 and the medical component 111 are suspended on the integrated hub 121, and the container 110 is still located in the box 102, so that the extraction solution in the container 110 can be obtained and the container 110 can be cleaned without removing the connecting rod 122, making the operation more convenient. Specifically, in this embodiment, the recoverable barrier 310 includes a button, and the operator can press the button to retract it into the guide rail 151 (retracted structure) or extend it to the outside of the outer peripheral surface of the guide rail 151 (extended structure).

[0080] The extraction device 100 may further include a controller. The controller is coupled to the temperature control device 101. The controller may receive a signal indicating the current temperature of the fluid medium from the temperature control device 101, and optionally send an instruction to the temperature control device 101 according to the signal to adjust the working state of the heater of the temperature control device 101, so as to control the temperature of the extraction solution in the container 110 within a desired range.

[0081] In addition, the controller may also be coupled to the driver 130. The controller may receive a signal indicating the current working state of the driver 130 from the driver 130, and optionally send an instruction to the driver 130 according to the signal to adjust the rotation speed of the motor 156 in the driver 130, so as to control the frequency of the upward or downward movement of the medical component 111 within a desired range, so as to stably, controllably and more conveniently set the extraction conditions to meet the requirements of the extraction standard.

[0082] exist Figure 1AIn the illustrated embodiment, the extraction device 100 may further include a user operation interface 170 coupled to the controller, and the user operation interface 170 is disposed on the outer surface of the temperature control device 101. The operator may input instructions to the controller by operating the user operation interface 170 to pre-set the extraction temperature that the temperature control device 101 needs to reach or / and the extraction speed that the motor 156 needs to reach. Specifically, the user operation interface 170 may include an input unit and a display unit, wherein the input unit includes buttons, knobs, etc.; the display unit includes a display screen or an indicator scale, etc., for displaying the current / preset heating temperature of the temperature control device 101 and the current / preset speed of the motor 156.

[0083] 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 the adjustable device.

[0084] In another embodiment, the controller further includes a timer, and the timer is used to generate a termination signal. The timer is used to record the operating time of the temperature control device 101 and / or the driver 130. When the operating 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 or / and 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.

[0085] When 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.

[0086] This application will be based on Figures 1A-1C as well as Figure 2-6 The extraction device 100 shown is taken as an example to illustrate how to use the extraction device 100 to perform an extraction operation.

[0087] First, an extraction device 100 is provided, and a fluid medium is added into a temperature control device 101 of the extraction device 100 .

[0088] Next, the extraction solution is added into the container 110, and the lower end of the connecting rod 122 is connected to a corresponding medical component 111. For the container 110 provided with a cover 160, before the lower end of the connecting rod 122 is connected to the medical component 111, the lower end of the connecting rod 122 in the corresponding container 110 needs to be passed through the central opening of the cover 160.

[0089] Then, the medical component 111 and a portion of the connecting rod 122 (the lower end portion of the connecting rod 122) are immersed in the extraction solution of the corresponding container 110, and at least a portion of the container 110 is immersed in the fluid medium in the box 102 of the temperature control device 101. Specifically, the base 110b of the container 110 is placed in the corresponding receiving frame 141, and then the top of the container 110 is passed through the hole 142a of the positioning plate 142, and the positioning plate 142 is fixedly joined to the inner wall surface of the box 102 near the top. 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 102, and the connecting rod 122 is passed through the groove 104 on the box cover 103.

[0090] Next, the upper ends of the connecting rods 122 are connected to the integrated hub 121, and the integrated hub 121 is coupled to the driver 130. Specifically, the coupling of the integrated hub 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 combined with the slider 152.

[0091] Thereafter, the driver 130 is controlled to drive the integrated hub 121 to move up and down. During the extraction operation, the operator may 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 or / and the extraction speed that the motor 156 needs to reach. Then, the controller may 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 hub 121 to move up and down at a certain frequency.

[0092] Although the above Figures 1A-1C as well as Figure 2-6 The illustrated embodiment is used as an example to introduce the process of performing an extraction operation using the extraction device of the present application, but any specific extraction device detailed in the present application can achieve the extraction operation, and only the aforementioned steps need to be slightly adjusted according to the specific configuration differences of the device. Figure 7-8 For the extraction device with the fixed plate 243 shown in FIG. 1 , the step of placing the container into the temperature control device is changed accordingly to first placing the container in the passing orientation so that its base can smoothly enter the corresponding opening 243a of the fixed plate 243, and then rotating the container to the blocking orientation, thereby directional fixing the position of the container, which will not be described in detail here. Fig. 9A and 9BAs for the extraction device with the recoverable barrier 310 arranged on the upper part of the guide rail 151 as shown, after the extraction operation, the integrated hub 121 can be fixed at a position above the recoverable barrier 310 on the upper part of the guide rail 151 by operating the recoverable barrier 310, so that the extraction solution in the container 110 can be obtained without removing the connecting rod 122, which will not be repeated here.

[0093] For different medical components, the specific operating parameters used by the extraction device can be appropriately changed. For example, the temperature control device 101 can heat the fluid medium to a preset temperature of 30 degrees Celsius to 90 degrees Celsius (for example, 40 degrees Celsius, 60 degrees Celsius, 80 degrees Celsius, etc.); the speed of the motor 156 is 20rpm to 100rpm (for example, 30rpm, 50rpm, 70rpm, 90rpm, etc.). In addition, 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.).

[0094] In the above-described embodiment, the filter element is used as a specific example of the medical component 111, and the filter element is cylindrical as a whole. 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 (e.g., medical container bottles, medical packaging bags, etc.), and the specific configuration of the container and the connecting rod only needs to be adjusted according to the specific type of the medical component, and the present application will not elaborate on this.

[0095] The discussion herein includes a number of illustrative drawings that show various example parts or components of an extraction device for extracting extractables from a medical component. For clarity of description, these figures do not show all aspects of each example component. Any example component and / or method provided herein may share any or all features with any or all other components and / or methods provided herein.

[0096] Various embodiments have been described herein with reference to the accompanying drawings. However, it is apparent that various modifications and changes may be made thereto, and additional embodiments may be implemented without departing from the broader scope of the present invention as set forth in the appended claims. In addition, by considering the specification and the practice of one or more embodiments of the present 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 merely exemplary, and the true scope and spirit of the present invention are indicated by the list of the appended exemplary claims.

Claims

1. An extraction device for extracting extractables from a medical component, characterized in that: The extraction device 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 a fluid medium within the temperature control device, wherein each container is configured to hold an extraction solution; a connecting mechanism, the connecting mechanism comprising 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 an upper end thereof and detachably connected to a medical component at a lower end thereof, so that the medical component is immersed in an extraction solution in a corresponding one of the plurality of containers; and A driver is coupled to the integrated hub to drive the integrated hub to move up and down.

2. The extraction device according to claim 1, characterized in that The temperature control device comprises: a box having an opening at the top and configured to contain the fluid medium; and A heater is 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 also includes: The box cover is used for removably covering the opening at the top of the box body and has a plurality of grooves extending to a side edge of the box cover, wherein the size of each groove is set to be able to receive a corresponding connecting rod among the plurality of connecting rods.

4. The extraction device according to claim 3, characterized in that The box also includes: a plurality of receiving frames disposed on a bottom surface of the box, wherein each receiving frame is configured to receive a base of a corresponding container among the plurality of containers and to limit displacement of the container in a horizontal direction; and A positioning plate is disposed above the bottom surface of the box and has a plurality of holes, wherein each hole is configured to receive an upper portion of a corresponding container among the plurality of containers.

5. The extraction device according to claim 3, characterized in that: Each container of the plurality of containers has a non-circular base, and the housing further comprises: a fixing plate, the fixing plate being arranged above the bottom surface of the box body and having a plurality of openings, Wherein, each of the multiple openings has a certain shape and size, and the shape and size enable the base of the container to pass through the opening when it has a pass orientation, but cannot pass through the opening when the base of the container is rotated a certain angle around its longitudinal axis from the pass 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 is at most 1 cm greater than the thickness of the container base.

7. The extraction device according to claim 3, characterized in that: The box also includes: A plurality of clamps are disposed on at least one side surface of the box body, wherein each clamp is configured to clamp one container among 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 claim 4, characterized in that: The extraction device also includes: A guide mechanism is 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 comprises: a pair of guide rails, the pair of guide rails being vertically disposed on opposite sides of the integrated hub; and A pair of sliders are connected to the integrated hub, and each slider in the pair of sliders is slidably connected to a corresponding one of the pair of guide rails.

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

12. The extraction device according to any one of claims 1-7, 9-11, characterized in that: The driver includes a motor and a connecting rod, wherein an output shaft of the motor is offset from a 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.

13. The extraction device according to claim 10, characterized in that The driver includes a motor and a connecting rod, wherein an output shaft of the motor is offset from a 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.

14. The extraction device according to any one of claims 1-7, 9-11, characterized in that: The driver includes a motor and a cam, the cam is coupled to a rotating shaft of the motor, and the cam is detachably coupled to the integrated hub.

15. The extraction device according to any one of claims 1-7, 9-11, characterized in that: The actuator includes a cylinder having a piston that is removably coupled to the integrated hub.

16. The extraction device according to any one of claims 1-7, 9-11, 13, characterized in that: Each of the plurality of containers has a lid configured to removably cover a 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, characterized in that Each of the plurality of connecting rods has a blocking portion close to a top end of the connecting rod, and the blocking portion is configured to block a portion of the connecting rod located above the blocking portion from passing through the central opening of the cover.

18. The extraction device according to any one of claims 1-7, 9-11, 13, characterized in that: The extraction device also includes: A controller is coupled to the temperature control device and / or the driver, wherein the controller is configured to receive a signal from the temperature control device and / or the driver, or send an instruction to the temperature control device and / or the driver.

19. The extraction device according to claim 18, characterized in that The controller further comprises a timer, wherein the timer is used to generate 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.

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