A biological valve centrifugal fixing tool

Abstract

This application relates to the technical field of bioprosthetic valve drying treatment, and in particular to a bioprosthetic valve centrifuge fixing fixture for mounting on a centrifuge support. It includes a placement tube for placing the bioprosthetic valve, a fixing cap detachably connected to the opening of the placement tube, and a fixing device for fixing the placement tube to the support. The fixing device is connected to the fixing cap. A filter screen is installed inside the placement tube, dividing the interior of the placement tube into a placement area for placing the bioprosthetic valve and a collection area for collecting the liquid filtered from the bioprosthetic valve. This application has the ability to stably fix the bioprosthetic valve in the centrifuge, achieving the effect of drying the valve using an existing centrifuge and reducing the probability of the valve adhering to the inner wall of the container.

Description

Technical Field

[0001] This application relates to the technical field of biological valve drying treatment, and in particular to a biological valve centrifugal fixation fixture. Background Technology

[0002] A bioprosthetic valve is an artificial valve used in heart valve replacement or repair surgery. It is usually made of porcine heart valves or bovine pericardial tissue and has good biocompatibility and hemodynamic properties. It is an important medical device for treating heart valve diseases.

[0003] The traditional process for bioprosthetic valves currently on the market involves preservation in glutaraldehyde solution followed by gamma irradiation sterilization. Gamma irradiation can directly penetrate the liquid packaging to sterilize the valves without dehydration. However, glutaraldehyde decomposes rapidly at temperatures above 10°C, leading to cross-linking failure and a decrease in the valve's mechanical strength. Therefore, bioprosthetic valves manufactured using this traditional process require cold chain storage and transportation throughout the entire process, resulting in high logistics costs. Furthermore, gamma irradiation may accelerate tissue degradation, affecting the long-term durability of bioprosthetic valves, limiting their shelf life to 2-3 years. Additionally, the refrigerated storage requirement makes these bioprosthetic valves unsuitable for regions with limited medical resources (lacking stable cold chain conditions). Therefore, dry valves have been developed, whose main process involves first dehydrating the valves and then sterilizing them with ethylene oxide (EO). Dry valves can meet the needs of special regions due to their room temperature storage (25°C). At the same time, because dry valves are sterilized with ethylene oxide (EO), they reduce collagen cross-linking damage caused by radiation, improve the long-term durability of the valves, and extend the shelf life to more than 5 years.

[0004] Centrifuges, as general-purpose equipment that uses centrifugal force to separate mixtures, work on the principle of achieving density stratification or solid-liquid separation through centrifugal acceleration generated by high-speed rotation. However, centrifuges are mainly suitable for dehydrating relatively stable objects such as hard, blocky, or granular materials. Due to their soft structure, biological valves cannot be stably placed on a centrifuge. If biological valves are placed directly on a centrifuge for dehydration, they will suffer mechanical damage. At the same time, when the centrifuge is controlling the liquid on the surface of the valve to be thrown off and separated from the valve by centrifugal force, the valve is also prone to floating or adhering to the inner wall of the container, making it impossible for the liquid on the valve to be effectively removed by centrifugal force. Utility Model Content

[0005] In order to stabilize and fix the biological valve in the centrifuge and to dry the valve using the existing centrifuge, thereby reducing the probability of the valve adhering to the inner wall of the container, this application provides a biological valve centrifugation fixing fixture.

[0006] The biological valve centrifugal fixation fixture provided in this application adopts the following technical solution: A bioprosthetic valve centrifuge fixture for mounting on a centrifuge support includes a placement tube for placing the bioprosthetic valve, a fixing cap detachably connected to the opening of the placement tube, and a fixing device for fixing the placement tube to the support. The fixing device is connected to the fixing cap. A filter screen is installed inside the placement tube, dividing the interior of the placement tube into a placement area for placing the bioprosthetic valve and a collection area for collecting the liquid filtered from the bioprosthetic valve.

[0007] By adopting the above technical solution, the biological valve is placed in the placement tube and then fixed to the centrifuge bracket by the fixing device. This can achieve stable fixation of the biological valve on the centrifuge, allowing the valve to be dried using the existing centrifuge, reducing the probability of the valve adhering to the inner wall of the container. At the same time, the collection area can filter and collect the liquid on the valve.

[0008] Optionally, a drain pipe communicating with the collection area is fixedly connected to one side of the placement tube, and a drain plug cap is detachably connected to the drain pipe.

[0009] By adopting the above technical solution, the drain pipe is connected to the collection area, which facilitates the discharge of liquid collected in the collection area; the drain plug can be detachably connected to the drain pipe, which can close the drain pipe when drainage is not required to prevent liquid leakage.

[0010] Optionally, the bottom of the placement tube is inclined, and the height of the bottom surface inside the placement tube gradually decreases from the side away from the drain pipe to the side closer to the drain pipe.

[0011] By adopting the above technical solution, the bottom of the placement tube is tilted so that the height of the inner bottom surface gradually decreases from the side away from the drain pipe to the side closer to the drain pipe, which facilitates the flow of liquid filtered by the bio-valve to the drain pipe and makes it easier to discharge the liquid.

[0012] Optionally, the fixing device includes a fixing ring sleeved on the fixing cap, and a positioning groove is provided on the outer wall of the fixing cap for the fixing ring to be inserted.

[0013] By adopting the above technical solution, a placement tube is used to place the bioprosthetic valve. The fixing cap is detachably connected to the placement tube to seal the placement tube. The fixing device connects the fixing cap to the centrifuge bracket. The filter screen inside the placement tube divides the placement area and the collection area, which can stably fix the bioprosthetic valve in the centrifuge and realize liquid collection. The fixing ring of the fixing device is fitted on the fixing cap and embedded in the positioning groove, which can accurately position the fixing ring on the fixing cap and ensure the connection stability between the fixing device and the fixing cap, thereby ensuring the overall installation stability of the bioprosthetic valve centrifuge fixing fixture on the centrifuge bracket.

[0014] Optionally, the fixing device further includes a fixing strip fixed to the outer wall of the fixing ring and a fixing component for fixing the fixing strip to the position on the centrifuge bracket.

[0015] By adopting the above technical solution, a fixing strip is fixed to the outer wall of the fixing ring. With the help of the fixing components, the fixing strip can be fixed to the centrifuge bracket, so that the biological valve centrifuge fixing fixture is stably installed on the centrifuge bracket. This allows the biological valve to be dehydrated and dried by centrifugation, reducing the probability of the biological valve adhering to the inner wall of the container and avoiding mechanical damage to the valve. At the same time, the biological valve stably fixed on the centrifuge can be processed using a dry valve process, which can achieve room temperature storage, meet the needs of special areas, reduce collagen cross-linking damage caused by radiation, improve the long-term durability of the valve, and extend its shelf life.

[0016] Optionally, mounting grooves are provided on opposite sides of the fixing strip. The fixing component includes an L-shaped buckle that is slidably connected in the mounting groove and a force spring that is fixed between the side wall of the mounting groove and the buckle. The centrifuge bracket has a slot for the buckle to be inserted. Under the elastic force of the force spring, the buckle is locked on one side of the slot to prevent the buckle from sliding out of the slot.

[0017] By adopting the above technical solution, the fixing strip on the fixing ring has an installation groove, and an L-shaped buckle is connected to the force-applying spring in the installation groove. The centrifuge bracket has a slot, and the buckle is locked on one side of the slot under the elastic force of the force-applying spring, which can stably fix the fixing strip on the centrifuge bracket, thereby stabilizing the position of the bioprosthetic valve centrifugation fixing fixture on the centrifuge, avoiding damage to the bioprosthetic valve caused by the change of the fixture position during centrifugation, and realizing the drying treatment of the bioprosthetic valve using the centrifuge.

[0018] Optionally, a telescopic rod for guiding the sliding of the buckle is fixedly connected between the buckle and the side wall of the mounting groove.

[0019] By adopting the above technical solution, the telescopic rod guides the sliding of the buckle, ensuring that the buckle is accurately embedded in the slot to fix the tooling on the centrifuge bracket.

[0020] Optionally, two mounting slots are spaced apart along the length of the fixing strip, and each mounting slot is slidably connected with a buckle, with the L-shaped openings of the two buckles facing away from each other.

[0021] By adopting the above technical solution, the position of the fixing strip on the centrifuge support can be further stabilized, reducing the risk of displacement or shaking of the fixing strip due to centrifugal force. This makes the bioprosthetic valve more stable during centrifugal dehydration, reduces mechanical damage, and effectively improves the dehydration effect and stability of the bioprosthetic valve.

[0022] Optionally, there are two fixing strips, which are located on opposite sides of the fixing ring. There are two sets of fixing components, each set of which is used to fix each fixing strip to the centrifuge bracket.

[0023] By adopting the above technical solution, the fixing strip can be fixed on the centrifuge bracket, further improving the fixation stability of the biological valve centrifuge fixing fixture on the centrifuge.

[0024] Optionally, the fixing cap is threadedly connected to the placement pipe.

[0025] By adopting the above technical solution, the fixation cap can be detachably connected to the opening of the placement tube, which makes it easy to put the bioprosthetic valve into the placement tube. The threaded connection is also secure, which can prevent the fixation cap from loosening during centrifugation.

[0026] In summary, this application includes at least one of the following beneficial technical effects: 1. To achieve stable fixation of the biological valve in the centrifuge, the valve can be dried using existing centrifuges, resulting in lower costs; 2. Reduce the probability of the bioprosthetic valve floating or adhering to the inner wall of the container during centrifugation, so that the liquid on the valve can be effectively removed by centrifugal force; 3. It facilitates the use of ethylene oxide (EO) sterilization after dehydration of biological valves, meeting the requirements for dry valve storage at room temperature, reducing logistics costs, and extending the shelf life of valves. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the overall structure of this application.

[0028] Figure 2 This is a schematic diagram created to show the tooling mounted on the support structure after the centrifuge has been hidden in this application.

[0029] Figure 3 This is a front sectional view of the biological valve centrifugal fixation fixture of this application.

[0030] Figure 4 This is a cross-sectional schematic diagram to illustrate the structure of the fixing device in this application.

[0031] Explanation of reference numerals in the attached drawings: 1. Centrifuge; 11. Support; 111. Slot; 2. Placement tube; 21. Placement area; 22. Collection area; 23. Drain pipe; 24. Drain plug; 25. Filter screen; 3. Fixing cap; 31. Positioning groove; 4. Fixing device; 41. Fixing ring; 42. Fixing strip; 421. Mounting groove; 43. Fixing component; 431. Buckle; 4311. First plate; 4312. Second plate; 432. Force spring; 433. Telescopic rod. Detailed Implementation

[0032] The following is in conjunction with the appendix Figure 1-4 This application will be described in further detail.

[0033] This application discloses a biological valve centrifugation fixation fixture for mounting on the support 11 of a centrifuge 1.

[0034] Example 1 Reference Figure 1 and Figure 2 The bioprosthetic valve centrifugation fixation fixture includes a placement tube 2 for placing the bioprosthetic valve, a fixation cap 3, and a fixation device 4. The fixation device 4 is connected to the fixation cap 3 and is used to fix the fixation cap 3 to the support 11 of the centrifuge 1. The fixation cap 3 is detachably connected to the opening of the placement tube 2, which can realize the closing and opening of the placement tube 2, facilitating the insertion and removal of the bioprosthetic valve.

[0035] Reference Figure 2 and Figure 3 The placement tube 2 is equipped with a filter screen 25, which divides the interior of the placement tube 2 into a placement area 21 above the filter screen 25 for placing the bioprosthetic valve and a collection area 22 below the filter screen 25 for collecting the liquid on the bioprosthetic valve. When the centrifuge 1 is operating, the liquid filtered from the bioprosthetic valve is separated from and collected, preventing the liquid from re-contacting the bioprosthetic valve. This effectively dehydrates the bioprosthetic valve and reduces the probability of the valve adhering to the inner wall of the container. Simultaneously, the fixing device 4 stabilizes the entire fixture on the centrifuge 1 support 11, the fixing cap 3 ensures the relative stability of the bioprosthetic valve inside the placement tube 2, and the filter screen 25 effectively achieves liquid-solid separation.

[0036] Specifically, placement tube 2 is the component used to place the bioprosthetic valve. The material of placement tube 2 can be medical-grade plastic, such as polypropylene, which has good chemical stability and biocompatibility and will not adversely affect the bioprosthetic valve; it can also be made of stainless steel, which has high strength and durability. Placement tube 2 is usually cylindrical in shape, which facilitates processing and installation and ensures good stability during high-speed rotation of centrifuge 1. A drain tube 23, communicating with collection area 22, is fixedly connected to one side of placement tube 2. The function of drain tube 23 is to drain the liquid from collection area 22. Drain tube 23 can be made of the same material as placement tube 2, and its diameter is moderate to ensure smooth liquid drainage. A drain plug 24 is detachably connected to drain tube 23. Drain plug 24 can be made of rubber and is connected to drain tube 23 by interference fit to effectively prevent liquid leakage. The drain plug 24 can also be made of plastic, with internal threads machined on the outer wall of the drain plug 24 and external threads machined on the outer wall of the drain pipe 23. By connecting the drain plug 24 to the drain pipe 23 by threads, the drain plug 24 can be installed and removed, which makes it easy to remove and also increases the firmness of the drain plug 24 installation.

[0037] The bottom of the placement tube 2 is inclined, and the height of the bottom surface inside the placement tube 2 gradually decreases from the side away from the drain pipe 23 to the side closer to the drain pipe 23. This design is conducive to the liquid flowing to the drain pipe 23 under the action of gravity, making it easier to discharge the liquid.

[0038] The filter screen 25 installed inside the placement tube 2 can be made of metal, such as stainless steel, which has high strength and corrosion resistance; or it can be made of polymer material, such as polyester, which has good filtration effect. The pore size of the filter screen 25 needs to be selected according to the characteristics of the bioprosthetic valve and the dehydration requirements. The filter screen 25 is fixed inside the placement tube 2 by welding or snap-fitting to ensure that it will not shift during the operation of the centrifuge 1.

[0039] The fixing cap 3 is used to seal the opening of the placement tube 2. The fixing cap 3 is threaded to the placement tube 2. Specifically, the fixing cap 3 has an internal thread machined on its inner wall and an external thread machined on the outer wall of the opening end of the placement tube 2. The fixing cap 3 can be installed and removed by screwing it onto the placement tube 2. The operation is very simple and convenient.

[0040] Reference Figure 3 and Figure 4The fixing device 4 includes a fixing ring 41, a fixing strip 42, and a fixing assembly 43. The fixing ring 41 is sleeved on the fixing cap 3, and a positioning groove 31 is formed on the outer wall of the fixing cap 3 for the fixing ring 41 to be inserted. By inserting the fixing ring 41 into the positioning groove 31, the position of the fixing ring 41 on the fixing cap 3 can be fixed. The positioning groove 31 is annular in shape, and its width and depth are adapted to the fixing ring 41 to ensure that the fixing ring 41 is accurately inserted, thus playing a role in positioning and fixing.

[0041] The fixing strip 42 is typically long and narrow, with its length designed according to the dimensions of the centrifuge bracket 11 and the installation requirements. Mounting slots 421 are provided on opposite sides of the fixing strip 42, with two slots 421 spaced apart along the length of the fixing strip 42.

[0042] The fixing assembly 43 includes an L-shaped buckle 431 slidably connected within each mounting slot 421, a force-applying spring 432 fixed between the side wall of the mounting slot 421 and the buckle 431, and a telescopic rod 433 fixed between the side wall of the mounting slot 421 and the buckle 431 for guiding the sliding of the buckle 431. The buckle 431 can be made of metal, such as carbon steel, which has high hardness and wear resistance. The L-shaped openings of the two buckles 431 on the same fixing strip 42 are arranged opposite to each other, and a slot 111 for inserting the buckle 431 is provided on the bracket 11 of the centrifuge 1.

[0043] The fixing strip 42 can be arc-shaped as a whole, fitting against the outer wall of the support 11 of the centrifuge 1, making the fixing to the support 11 more secure.

[0044] Reference Figure 4 The buckle 431 includes a first plate 4311 slidably connected in the mounting groove 421 and a second plate 4312 vertically fixed to one end of the first plate 4311. The second plate 4312 is located on the side of the first plate 4311 away from the arc center of the fixing strip 42. During installation, the second plate 4312 is oriented towards the bracket 11 of the centrifuge 1. Then, the operator directly pinches the ends of the two first plates 4311 away from the second plate 4312, which allows the two buckles 431 to slide in the mounting groove 421 and compress the corresponding force spring 432, bringing the two buckles 431 closer together. This allows the two buckles 431 to be inserted into the slot 111. Then, the force applied to the buckle 431 is released, and the two buckles 431 move away from each other under the elastic force of the force-applying spring 432, so that the second plate 4312 is locked on the side wall of the bracket 11, preventing the second plate 4312 from sliding out of the slot 111, thereby fixing the position of the buckle 431 on the centrifuge 1 bracket 11.

[0045] The telescopic rod 433 can be located on the side of the buckle 431 facing the force-applying spring 432, or on the side of the buckle 431 away from the force-applying spring 432, as long as it can guide the buckle 431. The telescopic rod 433 is designed so that when force is applied to the buckle 431, the buckle 431 can slide as a whole within the mounting groove 421 without tilting and affecting the installation and disassembly of the buckle 431 and the centrifuge 1 bracket 11. The telescopic rod 433 can be a metal rod, with one end connected to the side wall of the mounting groove 421 and the other end connected to the buckle 431, ensuring that the buckle 431 does not shift during sliding.

[0046] This solution involves creating two mounting slots 421 on the same fixing strip 42, setting two buckles 431 to slide and connect in each mounting slot 421 respectively, and setting two sets of fixing components 43 to fix the two buckles 431 respectively, making the fixing strip 42 more secure.

[0047] Two fixing strips 42 can be provided for each placement tube 2. The two fixing strips 42 are located on opposite sides of the fixing ring 41, which can stably fix the entire fixture on the bracket 11 of the centrifuge 1.

[0048] The implementation principle of Embodiment 1 of this application is as follows: This bioprosthetic valve centrifugation fixation fixture achieves stable fixation of the bioprosthetic valve on the centrifuge 1 through the combination of placement tube 2, fixing cap 3, and fixing device 4. The fixing device 4 firmly installs the fixture on the support 11 of the centrifuge 1, the fixing cap 3 ensures the stability of the bioprosthetic valve in the placement tube 2, and the filter screen 25 effectively separates the bioprosthetic valve from the liquid. The drain tube 23 and drain plug 24 facilitate the discharge of collected liquid, and the inclined design at the bottom of the placement tube 2 further promotes liquid discharge. The synergistic effect of the fixing ring 41, fixing strip 42, and fixing assembly 43 ensures that the fixture will not loosen or shift when the centrifuge 1 rotates at high speed. Compared with existing technologies, this tooling solves the problem that bioprosthetic valves cannot be stably placed on centrifuge 1 due to their soft structure, reduces the probability of valves adhering to the inner wall of the container, effectively achieves the dehydration treatment of bioprosthetic valves, and avoids mechanical damage to the valves. It provides a reliable solution for the drying treatment of bioprosthetic valves, reduces the processing cost of bioprosthetic valves, extends the shelf life of bioprosthetic valves, and can better adapt to the medical needs of different regions.

[0049] Example 2 The difference between this embodiment and embodiment 1 lies in the shape of the placement tube 2. In this embodiment, the placement tube 2 can be shaped like an hourglass, and the filter screen 25 is set at the connection between the upper and lower parts of the hourglass.

[0050] A temperature sensor is installed inside the placement tube 2 to monitor the temperature inside in real time, thus controlling the valve placement environment. An external display device is installed. The temperature sensor is wirelessly connected to a PLC controller, which can use Bluetooth, Wi-Fi, or other methods. The PLC controller connects to the display device to transmit the temperature sensor data, which is then displayed. The display device can be a monitor, a mobile phone, or a computer, allowing staff to monitor the temperature inside the placement tube 2 in real time. The PLC controller is also connected to an alarm. When the temperature sensor reading received by the PLC controller exceeds a set value, it indicates that the temperature inside the placement tube 2 is too high. In this case, staff need to take immediate action, such as storing the valve in a cold storage room, depending on the specific situation.

[0051] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. A biological valve centrifugation fixation fixture for mounting on a support (11) of a centrifuge (1), characterized in that: It includes a placement tube (2) for placing a bioprosthetic valve, a fixing cap (3) detachably connected to the opening of the placement tube (2), and a fixing device (4) for fixing the placement tube (2) to the support (11). The fixing device (4) is connected to the fixing cap (3). A filter screen (25) is installed inside the placement tube (2). The filter screen (25) divides the inside of the placement tube (2) into a placement area (21) for placing the bioprosthetic valve and a collection area (22) for collecting the fluid filtered from the bioprosthetic valve.

2. The biological valve centrifugation fixation fixture according to claim 1, characterized in that: The placement tube (2) is fixedly connected to a drain pipe (23) that communicates with the collection area (22) on one side, and a drain plug cap (24) is detachably connected to the drain pipe (23).

3. The biological valve centrifugation fixation fixture according to claim 2, characterized in that: The bottom of the placement tube (2) is inclined, and the height of the bottom surface inside the placement tube (2) gradually decreases from the side away from the drain pipe (23) to the side closer to the drain pipe (23).

4. The biological valve centrifugation fixation fixture according to claim 1, characterized in that: The fixing device (4) includes a fixing ring (41) sleeved on the fixing cap (3), and a positioning groove (31) is provided on the outer wall of the fixing cap (3) for the fixing ring (41) to be inserted.

5. The biological valve centrifugation fixation fixture according to claim 4, characterized in that: The fixing device (4) further includes a fixing strip (42) fixed to the outer wall of the fixing ring (41) and a fixing component (43) for fixing the position of the fixing strip (42) on the centrifuge (1) bracket (11).

6. The biological valve centrifugation fixation fixture according to claim 5, characterized in that: Mounting grooves (421) are provided on opposite sides of the fixing strip (42). The fixing component (43) includes a buckle (431) with an L-shaped cross section that is slidably connected in the mounting groove (421) and a force spring (432) fixed between the side wall of the mounting groove (421) and the buckle (431). A slot (111) for the buckle (431) to be inserted is provided on the bracket (11) of the centrifuge (1). Under the elastic force of the force spring (432), the buckle (431) is locked on one side of the slot (111) to prevent the buckle (431) from sliding out of the slot (111).

7. The biological valve centrifugation fixation fixture according to claim 6, characterized in that: A telescopic rod (433) for guiding the sliding of the buckle (431) is fixed between the buckle (431) and the side wall of the mounting groove (421).

8. The biological valve centrifugation fixation fixture according to claim 6, characterized in that: Two mounting slots (421) are spaced apart along the length of the fixing strip (42), and each mounting slot (421) is slidably connected with a buckle (431), with the L-shaped openings of the two buckles (431) being arranged opposite to each other.

9. The biological valve centrifugation fixation fixture according to any one of claims 5-8, characterized in that: There are two fixing strips (42), which are located on opposite sides of the fixing ring (41). There are two sets of fixing components (43), each set of which is used to fix each fixing strip (42) to the bracket (11) of the centrifuge (1).

10. The biological valve centrifugation fixation fixture according to claim 1, characterized in that: The fixing cap (3) is threadedly connected to the placement tube (2).

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