Medical instrument extraction anti-expansion device
By setting up an exhaust valve and a gas collection container on the leaching container, the volatile gas is automatically collected, and the problem of Teflon bag expansion is solved, and an efficient leaching process is achieved, saving manpower and material costs is avoided, and solvent leakage and experimental failures are avoided.
Patent Information
- Application Number
- CN202420746483.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-11
- Publication Date
- 2025-08-19
- Estimated Expiration
- 2034-04-11
AI Technical Summary
In the prior art, when medical devices are leaching with non-polar solvents, the expansion of Teflon bags leads to frequent manual opening and deflation balance, which is inefficient and easily leads to solvent leakage and waste of costs.
A medical device leaching and anti-expansion device is designed. By setting an exhaust valve and a gas collection container on the leaching container, volatile gas is automatically collected to prevent the leaching bag from swelling and solvent leakage, and reduce manual operation.
It improves the efficiency of leaching experiments, saves manpower and material costs, and avoids unnecessary cost waste and solvent leakage risks.
Smart Images
Figure CN223244112U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical device extraction, in particular to a medical device extraction anti-expansion device. Background Art
[0002] During the use of medical devices, processing aids in the materials may migrate out, causing adverse reactions and harm to the human body. Therefore, ISO 10993-1:2018 and GB / T 16998.1-2022 explicitly require medical device companies to conduct biocompatibility assessments of materials and devices during the R&D and material selection process. Regulatory agencies also encourage manufacturers to design appropriate extractables and leachables studies based on material information to assess potential risks. The collection and identification of material information, as well as extractables and leachables studies, have become priority steps in biological evaluation.
[0003] According to the requirements of GB / T 16886.12-2023 and GB / T 16886.18-2022, when designing extractable studies for implantable medical devices, devices are generally extracted at 50°C using solvents ranging from non-polar to polar. In testing facilities, extraction containers are typically inert glass containers or Teflon extraction bags. Larger orthopedic devices are typically extracted in Teflon extraction bags. When extracting with a non-polar solvent (typically n-hexane), after adding the sample and n-hexane, the Teflon bag is sealed at both ends with sealing clips and placed in a 50°C constant temperature shaker for extraction. The highly volatile n-hexane evaporates rapidly under the high temperature and shaking conditions, causing the Teflon bag to expand, necessitating timely opening and degassing. Manual operations are required several times daily, with a typical extraction cycle lasting 72 hours, and multiple cycles required for a single experiment. This results in significant daily labor and is time-consuming, labor-intensive, and inefficient. Once the experimenters forget to operate, it will lead to solvent leakage caused by flatulence, experimental failure and extended experimental cycle, especially when samples are scarce and costly, which will cause huge cost waste. Utility Model Content
[0004] In order to solve the problems existing in the prior art, at least one embodiment of the present invention provides a medical device immersion and anti-expansion device, which does not require manual opening, deflation and balancing, saving a lot of manpower and material costs, greatly improving the efficiency of the experiment, and avoiding unnecessary cost waste.
[0005] An embodiment of the present utility model proposes a medical device leaching and anti-expansion device, which includes an leaching container, a first vent pipe, an exhaust valve, a second vent pipe and a gas collection container. One end of the first vent pipe is connected to the leaching container, and the other end of the first vent pipe is connected to the input end of the exhaust valve; one end of the second vent pipe is connected to the output end of the exhaust valve, and the other end of the second vent pipe is connected to the gas collection container.
[0006] In some embodiments, the present invention provides a medical device leaching anti-expansion device, wherein the first vent pipe is vertically arranged on the top of the leaching container.
[0007] In some embodiments, the present invention provides a medical device immersion and anti-expansion device, wherein the first ventilation tube is a Teflon hard tube.
[0008] In some embodiments, a medical device leaching and anti-expansion device provided by the present invention also includes a three-way valve, a third ventilation tube and a fourth ventilation tube, and the gas collection container includes a first gas collection container and a second gas collection container; the other end of the second ventilation tube is connected to the input end of the three-way valve, and the output end of the three-way valve is respectively connected to one end of the third ventilation tube and one end of the fourth ventilation tube, the other end of the third ventilation tube is connected to the first gas collection container, and the other end of the fourth ventilation tube is connected to the second gas collection container.
[0009] In some embodiments, the present invention provides a medical device immersion and anti-expansion device, wherein the third ventilation tube and the fourth ventilation tube are hoses.
[0010] In some embodiments, the present invention provides a medical device leaching and anti-expansion device, wherein the first gas collection container and the second gas collection container are air bags respectively.
[0011] In some embodiments, the present invention provides a medical device immersion and anti-expansion device, wherein the second ventilation tube is a hose.
[0012] In some embodiments, the present invention provides a medical device leaching and anti-expansion device, wherein the leaching container is a Teflon leaching bag, and the Teflon leaching bag is provided with a sealing clamp.
[0013] In some embodiments, the present invention provides a medical device immersion and expansion prevention device, wherein a detachable Teflon sealing cover is installed at the other end of the first ventilation tube.
[0014] In some embodiments, the medical device extraction and anti-expansion device provided by the present invention further includes a secondary container and a shock box, the extraction container is arranged in the secondary container, and the secondary container is arranged in the shock box.
[0015] It can be seen that the medical device leaching anti-expansion device of the embodiment of the present invention is provided with an exhaust valve on the leaching bag, which can be opened when the volatilized gas reaches a certain pressure during leaching, and is collected by the air bag to reduce the pressure in the leaching bag, thereby preventing the leaching bag from expanding and the leaching solvent from leaking. There is no need for manual unsealing and deflation balance, which saves a lot of manpower and material costs, greatly improves the efficiency of the experiment, and avoids unnecessary cost waste. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.
[0017] Figure 1 Shown is a structural schematic diagram of a medical device leaching and anti-expansion device in an embodiment of the present utility model.
[0018] The reference numerals in the accompanying drawings are as follows:
[0019] Extraction container 1, sealing clamp 11, first ventilation pipe 2, exhaust valve 3, second ventilation pipe 4, gas collection container 5, first gas collection container 51, second gas collection container 52, three-way valve 6, third ventilation pipe 7, fourth ventilation pipe 8, secondary container 9, shock box 10. Specific implementation plan
[0020] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.
[0021] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. In this document, the terms "comprise", "include" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a..." does not exclude the presence of other identical elements in the process, method, article or device that includes the element.
[0022] The inventors of this solution have found that in the prior art, when a non-polar solvent (typically n-hexane) is used for extraction, after adding the sample and n-hexane to the Teflon bag, the two ends are sealed with sealing clips and placed in a 50°C constant temperature shock box for extraction. The highly volatile n-hexane evaporates rapidly under high temperature and shock conditions, causing the Teflon bag to expand, and it is necessary to manually open the bag in time to release the air for balance. Manual operation is required several times a day, and generally one extraction cycle lasts 72 hours. An experiment requires multiple cycles, which leads to a huge amount of manual effort every day during the extraction process, and the operation is time-consuming, labor-intensive, and inefficient. Once the experimenter forgets to operate, it will lead to solvent leakage caused by flatulence, experimental failure, and extended experimental period, which will cause a huge waste of cost, especially when samples are scarce and costly. This embodiment provides the following solution:
[0023] like Figure 1 As shown, this embodiment provides a medical device leaching and anti-expansion device, including an leaching container 1, a first vent pipe 2, an exhaust valve 3, a second vent pipe 4 and a gas collection container 5, one end of the first vent pipe 2 is connected to the leaching container 1, and the other end of the first vent pipe 2 is connected to the input end of the exhaust valve 3; one end of the second vent pipe 4 is connected to the output end of the exhaust valve 3, and the other end of the second vent pipe 4 is connected to the gas collection container.
[0024] It should be noted that when the medical device is placed in the extraction container 1 for extraction, as the extraction proceeds, the non-polar solvent in the extraction container 1 evaporates, causing the pressure in the extraction container 1 to increase. When the gas generated in the extraction container 1 reaches a certain pressure, the exhaust valve 3 opens under pressure, and the gas enters the gas collection container 5 through the first vent pipe 2 and the second vent pipe 4, so that the gas is collected by the gas collection container 5, causing the pressure in the extraction container 1 to drop, preventing the extraction container 1 from leaking, saving a lot of manpower and material costs, greatly improving the efficiency of the experiment, and avoiding unnecessary cost waste.
[0025] Specifically, the exhaust valve 3 can be model YM5 or WJ01P. The extraction container 1 is a Teflon extraction bag equipped with a sealing clamp 11, which is used to seal the entire bag. The first vent tube 2 is a thin, rigid Teflon tube with a diameter of approximately 4 mm. It is vertically mounted on the top of the extraction container 1, allowing gases to be collected more easily through the tube. A removable Teflon sealing cap is installed on the other end of the first vent tube 2. When the extraction container 1 is not in use, the Teflon sealing cap is installed on the first vent tube 2 for sealed storage.
[0026] The device also includes a three-way valve 6, a third vent pipe 7, a fourth vent pipe 8, a secondary container 9 and an oscillation box 10. The three-way valve 6 is made of acrylonitrile butadiene styrene (ABS). The extraction container 1 is arranged in the secondary container 9, and the secondary container 9 is arranged in the oscillation box 10. The third vent pipe 7 and the fourth vent pipe 8 are relatively thick, with a diameter of about 7 mm. The gas collection container includes 5 a first gas collection container 51 and a second gas collection container 52. The other end of the second vent pipe 4 is connected to the input end of the three-way valve 6, and the output end of the three-way valve 6 is respectively connected to one end of the third vent pipe 7 and one end of the fourth vent pipe 8. The other end of the third vent pipe 7 is connected to the first gas collection container 51, and the other end of the fourth vent pipe 8 is connected to the second gas collection container 52. The second vent pipe 4, the third vent pipe 7 and the fourth vent pipe 8 are respectively connected to hoses made of polyvinyl chloride (PVC). The first gas collection container 51 and the second gas collection container 52 are respectively air bags, with different volumes, such as 600 ml or 800 ml, and are made of polyvinyl chloride (PVC).
[0027] It should be noted that the gas generated in the extraction container 1 passes through the first vent pipe 2 and the second vent pipe 4, and then enters the first gas collection container 51 and the second gas collection container 52 through the third vent pipe 7 and the fourth vent pipe 8. The second vent pipe 4 is passed through the bottom gap of the shock box 10 to the outside of the box, that is, a part of the second vent pipe 4, the first gas collection container 51, the second gas collection container 52, the three-way valve 6, the third vent pipe 7 and the fourth vent pipe 8 are all outside the shock box 10.
[0028] In a specific implementation, a sample medical device (e.g., a femoral stem) is placed into a Teflon extraction bag through the side opening, a non-polar solvent for extraction (e.g., n-hexane) is added according to the ratio in GB / T 16886.12-2023, the bag is sealed as a whole with a sealing clamp 11, and placed in a secondary container 9. The Teflon sealing cap is removed, the exhaust valve 3 is installed on the first vent pipe 2, and the secondary container 9 is placed in a shock box 10 with a constant temperature of 50°C. When the gas generated in the extraction container 1 reaches a certain pressure, the exhaust valve 3 is opened under pressure, and the gas generated in the extraction container 1 passes through the first vent pipe 2 and the second vent pipe 4, and then enters the first gas collection container 51 and the second gas collection container 52 through the third vent pipe 7 and the fourth vent pipe 8 respectively.
[0029] In summary, the embodiments of the present invention provide a medical device leaching anti-expansion device, in which an exhaust valve is provided on the leaching bag, which can be opened when the volatilized gas reaches a certain pressure during leaching, and is collected by the air bag to reduce the pressure in the leaching bag, thereby preventing the leaching bag from expanding and the leaching solvent from leaking. There is no need for manual unsealing and deflation balance, which saves a lot of manpower and material costs, greatly improves the efficiency of the experiment, and avoids unnecessary cost waste.
[0030] The above content is only a specific embodiment of the present application, and the protection scope of the present application is not limited thereto. Those skilled in the art may make changes or substitutions within the technical scope disclosed in the present application, and these changes or substitutions should all be within the protection scope of the present application.
[0031] Those skilled in the art will understand that although some embodiments described herein include certain features included in other embodiments but not other features, the combination of features from different embodiments is meant to be within the scope of the present invention and to form different embodiments.
[0032] Although the embodiments of the present invention have been described with reference to the accompanying drawings, those skilled in the art may make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations shall fall within the scope defined by the appended claims.
Claims
1. A medical device leaching and anti-expansion device, comprising a leaching container (1), characterized in that: It also includes a first vent pipe (2), an exhaust valve (3), a second vent pipe (4) and a gas collection container (5), wherein one end of the first vent pipe (2) is connected to the extraction container (1), and the other end of the first vent pipe (2) is connected to the input end of the exhaust valve (3); one end of the second vent pipe (4) is connected to the output end of the exhaust valve (3), and the other end of the second vent pipe (4) is connected to the gas collection container.
2. The medical device anti-expansion device according to claim 1, characterized in that: The first ventilation pipe (2) is vertically arranged on the top of the extraction container (1).
3. The medical device anti-expansion device according to claim 2, characterized in that: The first ventilation pipe (2) is a Teflon hard pipe.
4. The medical device anti-expansion device according to claim 1, characterized in that: It also includes a three-way valve (6), a third ventilation pipe (7) and a fourth ventilation pipe (8), and the gas collection container includes (5) a first gas collection container (51) and a second gas collection container (52); the other end of the second ventilation pipe (4) is connected to the input end of the three-way valve (6), and the output end of the three-way valve (6) is respectively connected to one end of the third ventilation pipe (7) and one end of the fourth ventilation pipe (8), the other end of the third ventilation pipe (7) is connected to the first gas collection container (51), and the other end of the fourth ventilation pipe (8) is connected to the second gas collection container (52).
5. The medical device anti-expansion device according to claim 4, characterized in that: The third ventilation pipe (7) and the fourth ventilation pipe (8) are respectively hoses.
6. The medical device anti-expansion device according to claim 4, characterized in that: The first gas collection container (51) and the second gas collection container (52) are respectively air bags.
7. The medical device anti-expansion device according to claim 1, characterized in that: The second vent pipe (4) is a hose.
8. The medical device anti-expansion device according to claim 1, characterized in that: The extraction container (1) is a Teflon extraction bag, and the Teflon extraction bag is provided with a sealing clamp (11).
9. The medical device anti-expansion device according to claim 1, characterized in that: The other end of the first ventilation pipe (2) is provided with a detachable Teflon sealing cover.
10. The medical device anti-expansion device according to claim 1, characterized in that: It also includes a secondary container (9) and an oscillation box (10), wherein the extraction container (1) is arranged in the secondary container (9), and the secondary container (9) is arranged in the oscillation box (10).