A circulating device for preparing an extract liquid for leachable detection of an infusion device
Patent Information
- Application Number
- CN202522106300.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-29
- Publication Date
- 2026-09-04
- Estimated Expiration
- 2035-09-29
AI Technical Summary
[0005]本实用新型的目的在于提供一种用于输液器具可沥滤物检测制备提取液的循环装置,以解决上述背景技术中提出的现有的静态浸泡法和简单单次流动提取法,死腔、接口等区域接触不均,疏水性可沥滤物提取不充分以及提取液难以真实反映临床使用条件下的可沥滤物溶出情况的问题
[0009] The beneficial effect of adopting the above-mentioned further solution is that the semiconductor cooling chip inside the temperature control box cavity abuts against the bottom of the solution box, which can quickly reduce the temperature of the extract in the solution box, meet the requirements of low temperature cycle detection, and the semiconductor cooling chip has high temperature control accuracy, ensuring that the temperature of the extract is stable within the set range.
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Figure CN224719744U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device testing technology, specifically a circulation device for preparing extracts for detecting leached substances in infusion sets. Background Technology
[0002] Infusion sets, as medical devices that come into direct contact with medications and human blood / tissues during clinical treatment, may contain leachable substances such as plasticizers (e.g., phthalates), antioxidants, monomer residues (e.g., vinyl chloride), and degradation products. These substances may enter the human body during the infusion process, potentially causing safety risks such as allergic reactions and toxicity. Therefore, accurate testing of leachable substances in infusion sets, based on domestic and international pharmacopoeias (USP, EP, ChP) and the ISO 10993 series of standards, is a crucial step in ensuring safe clinical use.
[0003] Based on the above, the inventors have discovered the following problems: Currently, the mainstream methods for preparing extracts for leachable material detection are static immersion and simple single-flow extraction. Static immersion relies solely on solvent diffusion to dissolve leachable materials, which cannot simulate the fluid flow state and shear force during actual infusion, resulting in uneven contact in dead space, interfaces, and other areas, and insufficient extraction of hydrophobic leachable materials. In single-flow extraction, the solvent only flows through the infusion device once in one direction, which cannot guarantee sufficient contact with all surfaces inside the device. Furthermore, it lacks stable control over flow rate and temperature, making it difficult for the extract to truly reflect the dissolution of leachable materials under clinical use conditions, which can easily lead to missed detections or misjudgments.
[0004] Therefore, in view of this, we have studied and improved the existing structure and its shortcomings, and provided a circulation device for preparing extracts for detecting leached substances in infusion devices, in order to achieve a more practical purpose. Utility Model Content
[0005] The purpose of this invention is to provide a circulating device for preparing extracts for detecting leachable substances in infusion devices, in order to solve the problems mentioned in the background art, such as uneven contact in dead space, interface and other areas, insufficient extraction of hydrophobic leachable substances, and difficulty in the extracts reflecting the dissolution of leachable substances under clinical use conditions.
[0006] In view of the above problems, the technical solution proposed by this utility model is as follows:
[0007] A circulation device for preparing extracts for detecting leachable matter in infusion sets includes a main body, a circulation mechanism, and a connecting mechanism. The main body includes a shell with several mounting slots. A peristaltic pump is fixedly mounted on the bottom side of each mounting slot, and a slot is mounted on the other side of the bottom of each mounting slot. A mounting plate is interference-fitted into the interior of each slot. The circulation mechanism includes several temperature control boxes, the bottom of which is connected to the bottom of each of the mounting slots. A solution box is movably inserted inside each temperature control box, and an outlet pipe and an inlet pipe are respectively mounted on one side of each solution box. The connecting mechanism includes several first connectors and second connectors. One end of each of the first connectors is connected to one end of the outlet pipe and the input end of the peristaltic pump, and one end of each of the second connectors is connected to one end of the inlet pipe and the output end of the peristaltic pump.
[0008] Furthermore, the temperature control box has a cavity at its bottom, and a semiconductor cooling chip is embedded at the top of the cavity, with the top of the semiconductor cooling chip abutting against the bottom of the solution box.
[0009] The beneficial effect of adopting the above-mentioned further solution is that the semiconductor cooling chip inside the temperature control box cavity abuts against the bottom of the solution box, which can quickly reduce the temperature of the extract in the solution box, meet the requirements of low temperature cycle detection, and the semiconductor cooling chip has high temperature control accuracy, ensuring that the temperature of the extract is stable within the set range.
[0010] Furthermore, the bottom of the semiconductor cooling chip is provided with heat dissipation fins, and several heat dissipation fans are inserted into the bottom side of the temperature control box, with one end of each heat dissipation fan communicating with the cavity.
[0011] The beneficial effects of adopting the above-mentioned further solution are that the heat dissipation fins at the bottom of the thermoelectric cooler increase the heat dissipation area, the cooling fan accelerates the air circulation in the cavity, and removes the heat generated by the thermoelectric cooler in time, so as to avoid the cooling effect being affected by overheating and ensure the continuous and stable low temperature control.
[0012] Furthermore, an electric heating sleeve is provided around the inner wall of the temperature control box, and the inner side of the electric heating sleeve abuts against the outer side of the solution box.
[0013] The beneficial effect of adopting the above-mentioned further solution is that the electric heating jacket inside the temperature control box abuts against the outside of the solution box, which can quickly raise the temperature of the extract. Combined with the semiconductor cooling chip, the temperature of the extract can be adjusted in both directions, adapting to the detection needs of leached substances under different temperature conditions and improving the applicability of the device.
[0014] Furthermore, a drain port is provided on one side of the upper end of the solution box, and a plug is threaded to one end of the drain port. A temperature sensor is inserted into the other side of the upper end of the solution box, and a handle is installed at the center of the upper end of the solution box.
[0015] The advantages of adopting the above-mentioned further solution are that the drain port of the solution box matches the plug cap, making it convenient to drain or pour the extract; the handle makes it easy to pick up and put down the solution box; the temperature sensor monitors the temperature of the extract in real time, ensuring that the temperature meets the detection standards and improving the reliability of the detection data.
[0016] Furthermore, a plurality of elastic buckles are installed on one side of the mounting plate, and an infusion set is wound around the plurality of elastic buckles.
[0017] The beneficial effect of adopting the above-mentioned further solution is that the elastic buckle on the mounting plate can firmly fix the infusion set, prevent the infusion set from shifting or falling off during circulation, ensure that the infusion set is in full contact with the extract, and guarantee the extraction effect of the leaching material.
[0018] Furthermore, a plug tube is installed at the center of one end of both the first connector and the second connector, and a locking clamp is installed on the outer side of the end of both the first connector and the second connector near the plug tube. A locking head is threaded to one end of both the first connector and the second connector, and the inner sidewall of the locking head abuts against the outer side of the locking clamp.
[0019] The beneficial effects of adopting the above-mentioned further solution are that the insertion pipes of the first connector and the second connector facilitate the connection of the pipeline, and rotating the locking head can squeeze the locking clamp to shrink, so that the insertion pipe fits tightly with the connecting pipe or infusion set, enhances the pipeline sealing, and prevents the extraction liquid from leaking and affecting the detection.
[0020] Furthermore, the connecting mechanism also includes a connecting tube, the two ends of which are respectively connected to the insertion tubes in two adjacent first connecting heads, and the two ends of the infusion set are respectively connected to the insertion tubes in two adjacent second connecting heads.
[0021] The beneficial effect of adopting the above-mentioned further solution is that the connecting tube connects to the adjacent first connector to realize the circulation of the extract between the solution box and the peristaltic pump; the infusion set connects to the adjacent second connector to ensure that the extract flows through the infusion set to complete the extraction of leached substances, thus constructing a complete circulation pipeline and ensuring the continuity of the testing process.
[0022] Compared with the prior art, the beneficial effects of this utility model are as follows: The circulating device for preparing extracts for the detection of leachable substances in infusion sets provides installation space for the peristaltic pump and temperature control box through the installation groove of the main body shell. The mounting plate and the slot are interference-fitted, and the user can remove the mounting plate, fix the infusion set, and then insert it into the slot, which can improve the installation efficiency. The temperature control box of the circulating mechanism can adjust the temperature of the extract in the solution box. The outlet pipe and the inlet pipe work with the peristaltic pump to realize the circulation of the extract. The first connector and the second connector of the connecting mechanism connect the infusion set and the connecting pipe, which can facilitate quick installation by the user and ensure the pipeline is sealed. The whole device realizes the circulation and temperature control of the extract for the detection of leachable substances in infusion sets, improving the detection accuracy and efficiency. Attached Figure Description
[0023] Figure 1 This is a three-dimensional structural diagram of a circulating device for preparing extracts for detecting leachable substances in infusion sets, as disclosed in an embodiment of this utility model. Figure 1 ;
[0024] Figure 2 This is a three-dimensional structural diagram of a circulating device for preparing extracts for detecting leachable substances in infusion sets, as disclosed in an embodiment of this utility model. Figure 2 ;
[0025] Figure 3 This is a three-dimensional structural diagram of a circulating device for preparing extracts for detecting leachable substances in infusion sets, as disclosed in an embodiment of this utility model. Figure 3 ;
[0026] Figure 4 This is a cross-sectional schematic diagram of a circulation device for preparing extracts for detecting leachable matter in infusion devices, as disclosed in an embodiment of this utility model.
[0027] Figure 5 This is a cross-sectional schematic diagram of a circulating device for preparing extracts for detecting leachable substances in infusion devices, as disclosed in an embodiment of this utility model.
[0028] In the diagram: 1. Main body; 101. Shell; 103. Mounting plate; 104. Elastic buckle; 105. Slot; 106. Infusion set; 107. Peristaltic pump; 108. Mounting groove; 2. Circulation mechanism; 201. Temperature control box; 202. Solution box; 203. Cooling fan; 204. Plug; 205. Drain port; 206. Handle; 207. Temperature sensor; 208. Electric heating jacket; 209. Semiconductor cooling chip; 210. Cavity; 211. Inlet pipe; 212. Outlet pipe; 3. Connecting mechanism; 301. First connector; 302. Second connector; 303. Connecting pipe; 304. Insert pipe; 305. Locking clamp; 306. Locking head. Detailed Implementation
[0029] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.
[0030] Please see Figure 1 - Figure 5This utility model provides a technical solution: a circulation device for preparing extracts for detecting leachable substances in infusion sets, comprising a main body 1, a circulation mechanism 2, and a connecting mechanism 3. The main body 1 includes a housing 101, on which a plurality of mounting grooves 108 are provided. A peristaltic pump 107 is fixedly mounted on the bottom side of each mounting groove 108, and a slot 105 is mounted on the other side of the bottom end of each mounting groove 108. A mounting plate 103 is interference-fitted into the interior of each slot 105. The circulation mechanism 2 includes a plurality of temperature control boxes 201. The bottom end of each is connected to the bottom end of a plurality of mounting slots 108. A solution box 202 is movably inserted inside the temperature control box 201. An outlet pipe 212 and an inlet pipe 211 are respectively installed on one side of the solution box 202. The connection mechanism 3 includes a plurality of first connectors 301 and second connectors 302. One end of the plurality of first connectors 301 is connected to one end of the outlet pipe 212 and the input end of the peristaltic pump 107, respectively. One end of the plurality of second connectors 302 is connected to one end of the inlet pipe 211 and the output end of the peristaltic pump 107, respectively.
[0031] As an embodiment of this utility model, the temperature control box 201 is further provided with a cavity 210 at the bottom. A semiconductor cooling chip 209 is embedded in the top of the cavity 210. The top of the semiconductor cooling chip 209 abuts against the bottom of the solution box 202. The semiconductor cooling chip 209 in the cavity 210 of the temperature control box 201 abuts against the bottom of the solution box 202, which can quickly reduce the temperature of the extract in the solution box 202 to meet the requirements of low temperature cycle detection. Moreover, the semiconductor cooling chip 209 has high temperature control accuracy, ensuring that the temperature of the extract is stable within the set range.
[0032] As an embodiment of this utility model, the semiconductor cooling chip 209 is further provided with heat dissipation fins at its bottom end, and several cooling fans 203 are inserted into the bottom side of the temperature control box 201. One end of the cooling fan 203 is connected to the cavity 210. The heat dissipation fins at the bottom end of the semiconductor cooling chip 209 increase the heat dissipation area, and the cooling fan 203 accelerates the air circulation in the cavity 210, so as to remove the heat generated by the semiconductor cooling chip 209 in time, avoid it from affecting the cooling effect due to overheating, and ensure the continuous and stable low temperature control.
[0033] As an embodiment of this utility model, the inner wall of the temperature control box 201 is further provided with an electric heating sleeve 208, the inner side of the electric heating sleeve 208 abutting against the outer side of the solution box 202. The electric heating sleeve 208 on the inner side of the temperature control box 201 abutting against the outer side of the solution box 202 can quickly raise the temperature of the extract. In conjunction with the semiconductor cooling chip 209, the temperature of the extract can be adjusted in both directions to adapt to the detection requirements of leached substances under different temperature conditions and improve the applicability of the device.
[0034] As an embodiment of this utility model, a drain port 205 is further provided on one side of the upper end of the solution box 202. A plug cap 204 is threadedly connected to one end of the drain port 205. A temperature sensor 207 is inserted into the other side of the upper end of the solution box 202. A handle 206 is installed at the center of the upper end of the solution box 202. The drain port 205 of the solution box 202 cooperates with the plug cap 204 to facilitate the discharge or pouring of the extract. The handle 206 facilitates the handling of the solution box 202. The temperature sensor 207 monitors the temperature of the extract in real time to ensure that the temperature meets the detection standard and improves the reliability of the detection data.
[0035] As an embodiment of this utility model, a plurality of elastic buckles 104 are installed on one side of the mounting plate 103, and an infusion set 106 is wound around the plurality of elastic buckles 104. The elastic buckles 104 on the mounting plate 103 can firmly fix the infusion set 106, prevent the infusion set 106 from shifting or falling off during circulation, ensure that the infusion set 106 is in full contact with the extractant, and ensure the extraction effect of the leaching material.
[0036] As an embodiment of this utility model, further, a insertion tube 304 is installed at the center of one end of the first connector 301 and the second connector 302. A locking clamp 305 is installed on the outer side of the end of the first connector 301 and the second connector 302 near the insertion tube 304. A locking head 306 is threadedly connected to one end of the first connector 301 and the second connector 302. The inner sidewall of the locking head 306 abuts against the outer side of the locking clamp 305. The insertion tubes 304 of the first connector 301 and the second connector 302 are convenient for connecting the pipeline. Rotating the locking head 306 can squeeze the locking clamp 305 to shrink, so that the insertion tube 304 is tightly fitted with the connecting tube 303 or the infusion set 106, which enhances the pipeline sealing and prevents the extraction liquid from leaking and affecting the detection.
[0037] As an embodiment of this utility model, the connecting mechanism 3 further includes a connecting pipe 303. The two ends of the connecting pipe 303 are respectively connected to the insertion pipes 304 in the two adjacent first connectors 301. The two ends of the infusion set 106 are respectively connected to the insertion pipes 304 in the two adjacent second connectors 302. The connecting pipe 303 is connected to the adjacent first connectors 301 to realize the circulation of the extract between the solution box 202 and the peristaltic pump 107. The infusion set 106 is connected to the adjacent second connectors 302 to ensure that the extract flows through the infusion set 106 to complete the extraction of leached substances. The whole system forms a complete circulation pipeline to ensure the continuity of the detection process.
[0038] Specifically, the working principle of this circulating device for preparing extracts for detecting leached substances in infusion sets is as follows: First, remove the mounting plate 103, secure the infusion set 106 around the elastic buckle 104, and then insert the mounting plate 103 into the slot 105. Next, remove the solution box 202 via the handle 206, pour the extract into the drain port 205, and tighten the cap 204. Insert the solution box 202 into the temperature control box 201, ensuring that the semiconductor cooling chip 209 and the electric heating jacket 208 abut against the bottom and outer side of the solution box 202, respectively. Then, connect the connecting tube 303 to the insertion tube 304 of the adjacent first connector 301, connect both ends of the infusion set 106 to the insertion tube 304 of the adjacent second connector 302, and rotate the locking head 306 to compress the lock. The clamp 305 contracts to seal the pipeline; according to the testing requirements, the temperature of the extract is raised by the electric heating jacket 208 or lowered by the semiconductor cooling chip 209, and the temperature sensor 207 monitors the temperature in real time; the peristaltic pump 107 is started, and the extract enters the peristaltic pump 107 from the solution box 202 through the outlet pipe 212, the first connector 301, and the connecting pipe 303, and then is delivered by the peristaltic pump 107 to the infusion set 106 through the second connector 302, and finally flows back to the solution box 202 through another second connector 302 and the inlet pipe 211 to form a cycle, completing the extraction of leachable substances from the infusion device. Multiple solution boxes 202, together with the peristaltic pump 107, allow users to test multiple samples simultaneously at different temperatures and infusion rates, improving testing efficiency.
[0039] It should be noted that all standard parts used in this application can be purchased from the market, and can be customized according to the description and drawings. The specific connection methods of each part adopt conventional methods such as bolts, rivets, and welding that are mature in the prior art. The machinery, parts and equipment adopt conventional models in the prior art. The control method is automatic control through a controller. The control circuit of the controller can be implemented by simple programming by those skilled in the art and is common knowledge in the field. Furthermore, since this application is mainly used to protect mechanical devices, this application will not explain the control method and circuit connection in detail.
Claims
1. A circulating device for preparing extracts for detecting leachable matter in infusion sets, characterized in that, The system includes a main body (1), a circulation mechanism (2), and a connecting mechanism (3). The main body (1) includes a housing (101) with several mounting slots (108) on it. A peristaltic pump (107) is fixedly mounted on the bottom side of each mounting slot (108), and a slot (105) is installed on the other side of the bottom of each mounting slot (108). A mounting plate (103) is interference-fitted into the interior of each slot (105). The circulation mechanism (2) includes several temperature control boxes (201), and the bottom ends of the several temperature control boxes (201) are respectively connected to the several mounting slots (108). The bottom end is connected, and the temperature control box (201) is movably inserted with a solution box (202). The solution box (202) is equipped with an outlet pipe (212) and an inlet pipe (211) on one side. The connection mechanism (3) includes a plurality of first connectors (301) and second connectors (302). One end of the plurality of first connectors (301) is connected to one end of the outlet pipe (212) and the input end of the peristaltic pump (107), respectively. One end of the plurality of second connectors (302) is connected to one end of the inlet pipe (211) and the output end of the peristaltic pump (107), respectively.
2. The circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 1, characterized in that, The temperature control box (201) has a cavity (210) at its bottom. A semiconductor cooling chip (209) is embedded in the top of the cavity (210). The top of the semiconductor cooling chip (209) abuts against the bottom of the solution box (202).
3. The circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 2, characterized in that, The semiconductor cooling chip (209) is provided with heat dissipation fins at the bottom end, and several heat dissipation fans (203) are inserted into the bottom side of the temperature control box (201), with one end of the heat dissipation fan (203) communicating with the cavity (210).
4. The circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 1, characterized in that, The inner wall of the temperature control box (201) is provided with an electric heating sleeve (208), and the inner side of the electric heating sleeve (208) abuts against the outer side of the solution box (202).
5. A circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 1, characterized in that, A drain port (205) is provided on one side of the upper end of the solution box (202), and a plug cap (204) is threaded to one end of the drain port (205). A temperature sensor (207) is inserted on the other side of the upper end of the solution box (202), and a handle (206) is installed at the center of the upper end of the solution box (202).
6. A circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 1, characterized in that, A plurality of elastic buckles (104) are installed on one side of the mounting plate (103), and an infusion set (106) is wound around the plurality of elastic buckles (104).
7. A circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 6, characterized in that, A plug tube (304) is installed at the center of one end of the first connector (301) and the second connector (302). A locking clamp (305) is installed on the outer side of the end of the first connector (301) and the second connector (302) near the plug tube (304). A locking head (306) is threaded to one end of the first connector (301) and the second connector (302). The inner sidewall of the locking head (306) abuts against the outer side of the locking clamp (305).
8. A circulating device for preparing extract for detecting leachable matter in infusion devices according to claim 7, characterized in that, The connecting mechanism (3) further includes a connecting tube (303), the two ends of which are respectively connected to the insertion tubes (304) in the two adjacent first connectors (301), and the two ends of the infusion set (106) are respectively connected to the insertion tubes (304) in the two adjacent second connectors (302).