A vascular tissue disaggregation device and system

Abstract

The utility model provides a kind of vascular tissue decomposition circulating device, including reactor bin, and the reactor cover being set to the top of reactor bin;Support mounting device is set in reactor bin, one end of support mounting device is connected to reactor cover, the other end of support mounting device is used to place vascular tissue stent;Reactor bin is opened with water inlet and water outlet, and filter screen is set in water inlet and water outlet, and the water inlet height of water inlet is same with the height that support mounting device places vascular tissue stent, water inlet and water outlet are respectively used to pipeline external connection to the water outlet and water inlet of peristaltic pump circulating device;The side of reactor bin is provided with temperature control device.The utility model is through the structural design of decomposition circulating device, using matching enzyme decomposition liquid, carries out circulating cleaning to vascular tissue, realizes the quick decomposition of vascular tissue, and also can avoid influence or destroy the degradable material on vascular stent surface.

Description

Technical Field

[0001] This utility model belongs to the field of vascular tissue decomposition technology, and relates to a vascular tissue decomposition and circulation device and system. Background Technology

[0002] Currently, after implantation in animal experiments, biodegradable or partially biodegradable vascular stents containing biodegradable materials such as polylactic acid (PLA) require investigation into the in vivo degradation behavior of the biodegradable polymer in the stent. Testing methods for degradation behavior typically include observing the surface morphology of the biodegradable material after degradation or measuring changes in mass before and after degradation.

[0003] However, after vascular stents are implanted in animals, endothelialization occurs on the device surface, where they adhere to the vascular tissue. To improve the utilization rate of vascular stents, it is necessary to fully separate the stent surface from the vascular tissue, and the separation process must not affect or damage the biodegradable materials on the stent surface.

[0004] Most existing technologies use mechanical dissection to remove vascular tissue from the surface of vascular stents, such as using tweezers, scissors, scalpels, etc., to separate the vascular tissue from the implant. This can easily lead to incomplete dissection and damage the biodegradable material on the surface of the vascular stent.

[0005] Existing technologies, such as CN114930430A, disclose a method of treating with potassium hydroxide solution under atmospheric pressure. This method can remove vascular tissue from vascular stents, but biodegradable polymers can also react with the potassium hydroxide solution, leading to corrosion and damage.

[0006] Therefore, there is an urgent need to design a device and system for the decomposition and circulation of vascular tissue to overcome the shortcomings of existing technologies and meet the needs of practical applications. Utility Model Content

[0007] To address the shortcomings of existing technologies, the purpose of this invention is to provide a vascular tissue decomposition and circulation device and system. In this invention, through the structural design of the decomposition and circulation device, a matching enzyme decomposition solution is used to circulate and clean vascular tissue, thereby achieving rapid decomposition of vascular tissue while avoiding impact or damage to the biodegradable materials on the surface of the vascular stent. The structure is simple, highly operable, and suitable for widespread use.

[0008] To achieve this objective, the present invention adopts the following technical solution:

[0009] In a first aspect, this utility model provides a vascular tissue decomposition and circulation device, which includes a reaction vessel, a support mounting device, a temperature control device, and a peristaltic pump circulation device.

[0010] The reactor includes a reactor chamber and a reactor cover disposed on top of the reactor chamber;

[0011] The stent mounting device is installed inside the reaction vessel chamber. One end of the stent mounting device is connected to the reaction vessel cover, and the other end of the stent mounting device is used to place a vascular tissue stent, and the vascular tissue stent does not contact the inner wall of the reaction vessel chamber.

[0012] The reaction vessel chamber is provided with an inlet and an outlet. Both the inlet and the outlet are equipped with filters. The water inlet height is the same as the height at which the vascular tissue support is placed in the support mounting device. The inlet and the outlet are respectively used to connect the pipeline to the outlet and inlet of the peristaltic pump circulation device.

[0013] The temperature control device is installed on one side of the reaction vessel chamber, and the temperature control device is used to control the temperature of the liquid in the reaction vessel chamber.

[0014] In this invention, through the structural design of the decomposition and circulation device, a matching enzyme decomposition solution is used to circulate and clean the vascular tissue, thereby achieving rapid decomposition of the vascular tissue while avoiding affecting or damaging the biodegradable material on the surface of the vascular stent. The structure is simple, highly operable, and suitable for widespread use.

[0015] As a preferred technical solution of this utility model, the bracket installation device is a traction bracket installation device or a round rod bracket installation device.

[0016] As a preferred technical solution of this utility model, the traction stent installation device includes a connecting buckle, a traction wire, and a stent receiving assembly; one end of the connecting buckle is connected to the reactor lid, the other end of the connecting buckle is connected to the traction wire, and the end of the traction wire away from the connecting buckle is connected to the stent receiving assembly; the stent receiving assembly includes a mesh frame and a central rod, a connecting buckle is provided inside the mesh frame, an opening is provided on one side of the mesh frame, the central rod is provided inside the opening, and the interior of the central rod is used to place a vascular tissue stent and is fixed by the connecting buckle; a connector is provided on the side of the mesh frame facing the traction wire, and the connector is used to connect the traction wire.

[0017] As a preferred technical solution of this utility model, an opening and closing component is provided at the opening, which is used to open and insert the center rod.

[0018] And / or, the central rod is a hollow porous structure.

[0019] As a preferred technical solution of this utility model, the round rod support installation device includes a round rod and a limiting member; one end of the round rod is snapped to the reactor cover, and the other end of the round rod is connected to the limiting member; the outer wall of the round rod is used to fit a vascular tissue support, and the height of the vascular tissue support is limited by the limiting member; the limiting member is a protruding structure, the protruding structure is disposed at the inner bottom of the reactor chamber, and the end of the protruding structure away from the inner bottom of the reactor chamber is connected to the round rod.

[0020] As a preferred technical solution of this utility model, the temperature control device is provided at the bottom of the reaction vessel chamber.

[0021] Alternatively, the interior of the reactor chamber is divided into a reaction chamber and a heating chamber. The reaction chamber is located on one side of the heating chamber. The reaction chamber is equipped with the support mounting device and the water outlet. The temperature control device is located on the top of the heating chamber, and the water inlet is located on the side of the heating chamber away from the reaction chamber.

[0022] As a preferred technical solution of this utility model, the reaction chamber and the heating chamber are separated by a partition plate; the partition plate is provided with an inclined liquid channel, the inlet of the inclined liquid channel is located near the inner top of the heating chamber, and the height of the outlet of the inclined liquid channel is greater than the height of the vascular tissue scaffold placed by the scaffold mounting device.

[0023] Alternatively, small holes are evenly distributed on the barrier plate, which are used for the liquid in the heating chamber to flow into the reaction chamber.

[0024] As a preferred technical solution of this utility model, the filter screen is an ultrafiltration membrane module.

[0025] Optionally, the molecular weight cutoff of the ultrafiltration membrane module is 20 to 50 kDa, such as 20 kDa, 25 kDa, 30 kDa, 35 kDa, 40 kDa, 45 kDa, 50 kDa, etc., but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0026] Secondly, this utility model provides a vascular tissue decomposition and circulation device system, which includes an automatic control device and at least one set of decomposition and circulation devices.

[0027] The automated control device is used to control the decomposition operation of the decomposition cycle device.

[0028] Each set of decomposition and circulation devices includes three vascular tissue decomposition and circulation devices connected in series, which are respectively referred to as the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device, and the third vascular tissue decomposition and circulation device.

[0029] The outlet pipe of the first vascular tissue decomposition and circulation device is connected to the inlet of the second vascular tissue decomposition and circulation device, and the outlet pipe of the second vascular tissue decomposition and circulation device is connected to the inlet of the third vascular tissue decomposition and circulation device.

[0030] The inlet of the first vascular tissue decomposition and circulation device is the main inlet, and the outlet of the third vascular tissue decomposition and circulation device is the main outlet.

[0031] The filter screen is provided at the inlet and outlet of the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device and the third vascular tissue decomposition and circulation device.

[0032] The first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device, and the third vascular tissue decomposition and circulation device all adopt the vascular tissue decomposition and circulation device described in the first aspect.

[0033] As a preferred technical solution of this utility model, the automated control device includes automated equipment and a conveying device; the automated equipment is connected to the conveying device by wired or wireless means; the conveying device is connected to the top of the reaction vessel lid of the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device and the third vascular tissue decomposition and circulation device by snap-fit.

[0034] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0035] In this invention, through the structural design of the decomposition and circulation device, a matching enzyme decomposition solution is used to circulate and clean the vascular tissue, thereby achieving rapid decomposition of the vascular tissue while avoiding affecting or damaging the biodegradable material on the surface of the vascular stent. The structure is simple, highly operable, and suitable for widespread use. Attached Figure Description

[0036] Figure 1 A schematic diagram of the vascular tissue decomposition and circulation device provided in a specific embodiment of this utility model;

[0037] Figure 2 A schematic diagram of the reaction vessel lid in a vascular tissue decomposition and circulation device provided for a specific embodiment of this utility model;

[0038] Figure 3A schematic diagram of the traction support mounting device used in a specific embodiment of the vascular tissue decomposition and circulation device provided by this utility model;

[0039] Figure 4 A schematic diagram of the structure of the vascular tissue decomposition and circulation device with the mesh frame facing the water outlet direction, provided in a specific embodiment of the present invention.

[0040] Figure 5 A top view of the mesh frame in a vascular tissue decomposition and circulation device provided in a specific embodiment of this utility model;

[0041] Figure 6 A cross-sectional view of the mesh frame facing the water outlet in a vascular tissue decomposition and circulation device provided in a specific embodiment of this utility model.

[0042] Figure 7 A schematic diagram of the structure of the vascular tissue decomposition and circulation device using a round rod support mounting device, provided for a specific embodiment of the present utility model;

[0043] Figure 8 A schematic diagram of the structure of the vascular tissue decomposition and circulation device provided in a specific embodiment of the present invention, showing that the reaction vessel chamber is divided into a heating chamber and a reaction chamber;

[0044] Figure 9 A schematic diagram of the structure of a vascular tissue decomposition and circulation device system provided in a specific embodiment of the present invention;

[0045] Among them, 1-reaction vessel; 2-peristaltic pump circulation device; 3-support mounting device; 4-temperature control device;

[0046] 5-Reaction vessel chamber; 6-Reaction vessel cover;

[0047] 7-Connecting buckle; 8-Center rod; 9-Wire mesh frame; 10-Connector; 11-Opening and closing part; 12-Traction line;

[0048] 13-Outlet; 14-Inlet; 15-Filter screen;

[0049] 16-Round rod; 17-Limiting component;

[0050] 18-Reaction chamber; 19-Heating chamber; 20-Slanted liquid channel; 21-Baffle plate;

[0051] 22-Automated equipment; 23-Transfer device; 24-First vascular tissue decomposition and circulation device; 25-Second vascular tissue decomposition and circulation device; 26-Third vascular tissue decomposition and circulation device; 27-Snap fastener; 28-Main water inlet; 29-Main water outlet. Detailed Implementation

[0052] It should be understood that in the description of this utility model, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used solely for the convenience of describing this utility model and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0053] It should be noted that, in the description of this utility model, unless otherwise explicitly specified and limited, the terms "set," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0054] The technical solution of this utility model will be further described below with reference to the accompanying drawings and specific embodiments.

[0055] In one specific embodiment, the present invention provides a device for decomposing and circulating vascular tissue, such as... Figure 1 As shown, the vascular tissue decomposition and circulation device includes a reaction vessel 1, a support mounting device 3, a temperature control device 4, and a peristaltic pump circulation device 2. The reaction vessel 1 includes a reaction vessel chamber 5 and a reaction vessel cover 6 located on top of the reaction vessel chamber 5. The support mounting device 3 is located inside the reaction vessel chamber 5, with one end connected to the reaction vessel cover 6 and the other end used to place the vascular tissue support, which does not contact the inner wall of the reaction vessel chamber 5. The reaction vessel chamber 5 has an inlet 14 and an outlet 13, both of which are equipped with filters 15. The water inlet height of the inlet 14 is the same as the height at which the support mounting device 3 places the vascular tissue support. The inlet 14 and outlet 13 are respectively used to connect pipelines to the outlet and inlet of the peristaltic pump circulation device 2. A temperature control device 4 is located on one side of the reaction vessel chamber 5 to control the temperature of the liquid inside the reaction vessel chamber 5.

[0056] The structure of the reactor lid 6 is as follows: Figure 2As shown.

[0057] In this utility model, the reaction vessel 1 includes a reaction vessel chamber 5 and a reaction vessel cover 6. The reaction vessel chamber 5 and the reaction vessel cover 6 are connected in a detachable manner. The detachable connection can also be a bolt connection or a snap-fit ​​connection. The design of the reaction vessel cover 6, which can be opened, is conducive to adding cleaning fluid and inserting vascular tissue. The reaction vessel chamber 5 and the reaction vessel cover 6 can be made of stainless steel, which has good corrosion resistance and mechanical strength. They can also be made of carbon steel or other alloy materials. The shape of the reaction vessel chamber 5 is usually a vertical cylindrical shape, which provides uniform pressure and is easy to clean. Those skilled in the art can make adaptive adjustments to the material, shape or connection relationship according to the actual situation.

[0058] In this invention, the filter screen 15 at the water inlet 14 can block impurities in the pump tube from contaminating the blood vessel tissue, and the filter screen 15 at the water outlet 13 can allow the decomposed blood vessel tissue to flow into the pump tube, achieving the purpose of thorough cleaning. The connection method between the filter screen 15 and the water inlet 14 and the water outlet 13 is not specifically limited here. It can be a detachable connection to facilitate the replacement of the filter screen 15. Those skilled in the art can also make adaptive adjustments according to the actual situation.

[0059] The temperature control device 4 of this utility model can include three parts: a heater, a temperature monitor, and a temperature control system. The heater can be a resistance heater, where current passes through a resistance wire to generate heat, and it has an insulating layer and a metal sheath, such as a heating jacket wrapped around the reactor 1, or a heating rod inserted inside the equipment. Electromagnetic induction heating is suitable for metal reactors 1, where the reactor body heats itself through electromagnetic induction, resulting in high efficiency and rapid temperature rise. Infrared radiation heating is a non-contact heating method used for special materials or in situations requiring a clean environment. Circulating fluid heating first heats the heat transfer oil or water, and then a pump transports the hot fluid to a jacket or coil to heat the equipment. The temperature monitor can be a thermocouple, resistance temperature detector (RTD), thermistor, or infrared sensor. The temperature control system can use a PID algorithm. The heater, temperature monitor, and temperature control system constitute a classic closed-loop feedback control system, jointly achieving precise, stable, and automated temperature control. Those skilled in the art can adapt the heater, temperature monitor, and temperature control system to their specific needs.

[0060] In this invention, the peristaltic pump circulation device 2 can adopt a basic peristaltic pump component, which is a positive displacement pump suitable for circulating, metering and distributing fluids. It is usually composed of a peristaltic pump main unit (driver + pump head), a special hose and an external pipeline system. The external pipeline can be connected to the water inlet 14 and the water outlet 13, so as to pump in cleaning fluid to circulate and clean the vascular tissue in the reaction vessel chamber 5. Those skilled in the art can make appropriate selections for the specific model of the peristaltic pump according to actual needs.

[0061] In some embodiments, the bracket mounting device 3 is a traction bracket mounting device or a round rod bracket mounting device.

[0062] In some implementations, such as Figure 3 As shown, the traction bracket installation device includes a connecting buckle 7, a traction line 12, and a bracket receiving assembly; one end of the connecting buckle 7 is connected to the reactor cover 6, the other end of the connecting buckle 7 is connected to the traction line 12, and the end of the traction line 12 away from the connecting buckle 7 is connected to the bracket receiving assembly.

[0063] like Figure 4 , Figure 5 and Figure 6 As shown, the stent accommodating assembly includes a mesh frame 9 and a central rod 8. A connecting buckle is provided inside the mesh frame 9. An opening is provided on one side of the mesh frame 9, and the central rod 8 is placed inside the opening. The interior of the central rod 8 is used to place the vascular tissue stent and is fixed by the connecting buckle. A connector 10 is provided on the side of the mesh frame 9 facing the traction wire 12. The connector 10 is used to connect the traction wire 12. An opening and closing part 11 is provided at the opening. The opening and closing part 11 is used to open and insert the central rod 8. The central rod 8 has a hollow porous structure.

[0064] In this invention, the connecting buckle 7 and the traction line 12 are used to connect the stent housing assembly, preventing the stent housing assembly from moving due to water flow. To enhance the stability of the stent housing assembly after the vascular stent is installed inside, five connecting buckles 7 can be provided (one located at the center of the reactor lid 6, and four connected buckles 7 arranged around the perimeter, evenly distributed around the center of the reactor lid 6). To increase the flushing effect on the vascular tissue, the stent housing assembly is flush with the water inlet 14 of the chamber. In addition, the stent housing assembly includes a mesh frame 9, a central rod 8, and a connector 10. The mesh frame 9 is a closed hollow component with one side that can be opened and closed. The surface of the hollow component is covered with a certain number of through holes, the area of ​​which can be set to circular or square, etc., and the area of ​​the through holes should be 1-5 cm². 2 (The maximum area of ​​the through-hole depends on the shortest side length of the inserted blood vessel and stent; the hole size of the mesh frame 9 should be as large as possible while being smaller than the shortest side length) to achieve faster blood flow flushing; the connector 10 can be connected to the traction line 12 and the connecting buckle 7. The vascular tissue is inserted into the central rod 8 and snapped into the mesh frame 9 by the connector 10, and fluid flushes the vascular tissue through the holes.

[0065] In some implementations, such as Figure 7As shown, the round rod support installation device includes a round rod 16 and a limiting member 17; one end of the round rod 16 is snapped to the reactor cover 6, and the other end of the round rod 16 is connected to the limiting member 17. The outer wall of the round rod 16 is used to fit the vascular tissue support, and the height of the vascular tissue support is limited by the limiting member 17; the limiting member 17 is a protruding structure, which is located at the inner bottom of the reactor chamber 5, and the end of the protruding structure away from the inner bottom of the reactor chamber 5 is connected to the round rod 16.

[0066] In this invention, to avoid the dissolution effect of the mesh frame 9 on vascular tissue and to achieve a better flushing effect, the stent mounting device 3 can adopt a round rod stent mounting device, that is, using a round rod 16 instead of the mesh frame 9. The upper end of the round rod 16 is connected to the reactor lid 6 via a connecting buckle. The connecting buckle and the reactor lid 6 are not detachable. The round rod 16 is connected to the connecting buckle in a buckle manner. The lower end of the round rod 16 needs to be connected to the bottom of the reactor 1 via a limiting member 17 to prevent vascular tissue from being placed on the round rod 16 and directly connected to the bottom of the reactor 1 after insertion, which would cause local overheating and affect decomposition. The connection method between the limiting member 17 and the reactor 1 can be riveting, threaded connection, etc. The diameter of the round rod 16 needs to be set smaller than the inner diameter of the stent in the vascular tissue to allow the vascular tissue to rotate around the round rod 16 and accelerate the flushing.

[0067] In some embodiments, a temperature control device 4 is provided at the bottom of the reaction vessel chamber 5 (see reference). Figure 3 ).

[0068] In some implementations, such as Figure 8 As shown, the interior of the reactor chamber 5 is divided into a reaction chamber 18 and a heating chamber 19. The reaction chamber 18 is located on one side of the heating chamber 19. The reaction chamber 18 is equipped with a support mounting device 3 and a water outlet 13. The top of the heating chamber 19 is equipped with a temperature control device 4, and the side of the heating chamber 19 away from the reaction chamber 18 is equipped with a water inlet 14.

[0069] In some embodiments, the reaction chamber 18 and the heating chamber 19 are separated by a baffle plate 21; the baffle plate 21 is provided with an inclined liquid channel 20, the inlet 14 of the inclined liquid channel 20 is located near the inner top of the heating chamber 19, and the height of the outlet 13 of the inclined liquid channel 20 is greater than the height of the vascular tissue stent placed in the stent mounting device 3.

[0070] In some embodiments, small holes are evenly distributed on the barrier plate 21, which are used for the liquid in the heating chamber 19 to flow into the reaction chamber 18.

[0071] In this invention, to avoid the heater's influence on vascular tissue during the heating process, the reaction vessel chamber 5 is divided into a reaction chamber 18 and a heating chamber 19. A heater and a temperature monitor are placed on top of the heating chamber 19. After the solution is heated in the heating chamber 19, it flows into the reaction chamber 18 through an inclined liquid channel 20. The heating temperature of the solution in the heating chamber 19 is 37℃±2℃. Alternatively, small holes can be provided at intervals on the baffle plate 21 between the reaction chamber 18 and the heating chamber 19 to ensure that the solution in the heating chamber 19 enters the reaction chamber 18 evenly, making the solution heating more uniform. The solution with the required temperature flows into the reaction chamber 18 through the small holes, thereby flushing and decomposing the vascular tissue.

[0072] In some embodiments, filter 15 is an ultrafiltration membrane assembly.

[0073] The ultrafiltration membrane module in this invention can retain elastase and collagenase. The specific material can be PVDF, PES, PVC, etc., and those skilled in the art can make an appropriate selection according to the actual situation.

[0074] In some embodiments, the molecular weight cutoff of the ultrafiltration membrane module is 20 to 50 kDa, such as 20 kDa, 25 kDa, 30 kDa, 35 kDa, 40 kDa, 45 kDa, 50 kDa, etc., but is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0075] The molecular weight cutoff of the ultrafiltration membrane module in this invention is 20-50 kDa because the filter screen 15 at the inlet 14 can block impurities in the pump tube from contaminating the vascular tissue, and the filter screen 15 at the outlet 13 can prevent the decomposition of vascular tissue from flowing into the pump tube, thus achieving the purpose of thorough cleaning; further preferably, it is 25-30 kDa.

[0076] In another specific embodiment, the present invention provides a system for decomposing and circulating vascular tissue, such as... Figure 9 As shown, the vascular tissue decomposition and circulation device system includes an automated control device and at least one set of decomposition and circulation devices; the automated control device is used to control the decomposition operation of the decomposition and circulation devices; each set of decomposition and circulation devices includes three vascular tissue decomposition and circulation devices connected in series, which are respectively referred to as the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26; the outlet 13 of the first vascular tissue decomposition and circulation device 24 is connected to the inlet 14 of the second vascular tissue decomposition and circulation device 25, and the outlet 13 of the second vascular tissue decomposition and circulation device 25 is connected to the inlet 14 of the third vascular tissue decomposition and circulation device 26.

[0077] The inlet 14 of the first vascular tissue decomposition and circulation device 24 is the main inlet 28, and the outlet 13 of the third vascular tissue decomposition and circulation device 26 is the main outlet 29; a filter screen 15 is provided at the inlet 14 and outlet 13 of the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26; the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26 all adopt the above-mentioned vascular tissue decomposition and circulation device.

[0078] In some embodiments, the automated control device includes an automated device 22 and a conveying device 23; the automated device 22 is connected to the conveying device 23 via wired or wireless means; the conveying device 23 is connected to the top of the reactor lid 6 of the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26 via a snap fastener 27.

[0079] The vascular tissue decomposition and circulation device system of this utility model introduces an automated control device, which can avoid manual replacement of the cleaning solution. The automatic control device can set the time program and operation program accordingly. Through the action of the buckle 27 and the conveying device 23, the reaction vessel cover 6, the support mounting device 3 and the vascular tissue are transferred between the reaction vessels 1. Each vascular tissue decomposition and circulation device has a filter screen 15 at its inlet 14 and outlet 13. The filter screen 15 is set with a 50kDa molecular weight cutoff (MWCO) ultrafiltration membrane. Since the 50kDa ultrafiltration membrane can retain elastase and collagenase, it can prevent the solution from mixing between the three vascular tissue decomposition and circulation devices connected in series.

[0080] Example 1

[0081] This embodiment provides a device for decomposing and circulating vascular tissue, wherein:

[0082] The vascular tissue decomposition and circulation device includes a reaction vessel 1, a support mounting device 3, a temperature control device 4, and a peristaltic pump circulation device 2. The reaction vessel 1 includes a reaction vessel chamber 5 and a reaction vessel cover 6 located on top of the reaction vessel chamber 5. The support mounting device 3 is located inside the reaction vessel chamber 5, with one end connected to the reaction vessel cover 6 and the other end used to place the vascular tissue support, which does not contact the inner wall of the reaction vessel chamber 5. The reaction vessel chamber 5 has an inlet 14 and an outlet 13, both of which are equipped with filters 15. The water inlet height of the inlet 14 is the same as the height at which the support mounting device 3 places the vascular tissue support. The inlet 14 and outlet 13 are respectively used to connect pipelines to the outlet and inlet of the peristaltic pump circulation device 2. The temperature control device 4 is located at the bottom of the reaction vessel chamber 5 and is used to control the temperature of the liquid inside the reaction vessel chamber 5.

[0083] The stent mounting device 3 is a traction stent mounting device 3, which includes a connecting buckle 7, a traction line 12, and a stent receiving assembly. One end of the connecting buckle 7 is connected to the reactor cover 6, and the other end of the connecting buckle 7 is connected to the traction line 12. The end of the traction line 12 away from the connecting buckle 7 is connected to the stent receiving assembly. The stent receiving assembly includes a mesh frame 9 and a central rod 8. A connecting buckle is provided inside the mesh frame 9, and an opening is provided on one side of the mesh frame 9. The central rod 8 is placed inside the opening, and is fixed by the connecting buckle. A connector 10 is provided on the side of the mesh frame 9 facing the traction line 12. The connector 10 is used to connect the traction line 12. An opening and closing part 11 is provided at the opening. The opening and closing part 11 is used to open and insert the central rod 8. The central rod 8 has a hollow porous structure.

[0084] Filter 15 is an ultrafiltration membrane module with a molecular weight cutoff of 50 kDa.

[0085] Example 2

[0086] This embodiment provides a vascular tissue decomposition and circulation device, which differs from Embodiment 1 in that:

[0087] The support mounting device 3 is a round rod support mounting device, which includes a round rod 16 and a limiting member 17. One end of the round rod 16 is snapped to the reactor cover 6, and the other end of the round rod 16 is connected to the limiting member 17. The outer wall of the round rod 16 is used to mount the vascular tissue support, and the height of the vascular tissue support is limited by the limiting member 17. The limiting member 17 is a protruding structure, which is located at the inner bottom of the reactor chamber 5, and the end of the protruding structure away from the inner bottom of the reactor chamber 5 is connected to the round rod 16.

[0088] Example 3

[0089] This embodiment provides a vascular tissue decomposition and circulation device, which differs from Embodiment 1 in that:

[0090] The interior of the reaction vessel chamber 5 is divided into a reaction chamber 18 and a heating chamber 19. The reaction chamber 18 is located on one side of the heating chamber 19. The reaction chamber 18 is equipped with a support mounting device 3 and a water outlet 13. The top of the heating chamber 19 is equipped with a temperature control device 4, and the side of the heating chamber 19 away from the reaction chamber 18 is equipped with a water inlet 14. The reaction chamber 18 and the heating chamber 19 are separated by a baffle plate 21. The baffle plate 21 is equipped with an inclined liquid channel 20. The water inlet 14 of the inclined liquid channel 20 is located near the inner top of the heating chamber 19. The height of the water outlet 13 of the inclined liquid channel 20 is greater than the height of the vascular tissue support placed by the support mounting device 3.

[0091] Example 4

[0092] This embodiment provides a vascular tissue decomposition and circulation device, which differs from Embodiment 2 in that:

[0093] The interior of the reaction vessel chamber 5 is divided into a reaction chamber 18 and a heating chamber 19. The reaction chamber 18 is located on one side of the heating chamber 19. The reaction chamber 18 is equipped with a support mounting device 3 and a water outlet 13. The top of the heating chamber 19 is equipped with a temperature control device 4, and the side of the heating chamber 19 away from the reaction chamber 18 is equipped with a water inlet 14. The reaction chamber 18 and the heating chamber 19 are separated by a baffle plate 21. The baffle plate 21 is equipped with an inclined liquid channel 20. The water inlet 14 of the inclined liquid channel 20 is located near the inner top of the heating chamber 19. The height of the water outlet 13 of the inclined liquid channel 20 is greater than the height of the vascular tissue support placed by the support mounting device 3.

[0094] Example 5

[0095] This embodiment provides a system for decomposing and circulating vascular tissue, wherein:

[0096] The vascular tissue decomposition and circulation device system includes an automated control device and a set of decomposition and circulation devices. The automated control device is used to control the decomposition operation of the decomposition and circulation devices. The set of decomposition and circulation devices includes three vascular tissue decomposition and circulation devices connected in series, which are respectively referred to as the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26. The outlet 13 of the first vascular tissue decomposition and circulation device 24 is connected to the inlet 14 of the second vascular tissue decomposition and circulation device 25, and the outlet 13 of the second vascular tissue decomposition and circulation device 25 is connected to the inlet 14 of the third vascular tissue decomposition and circulation device 26.

[0097] The inlet 14 of the first vascular tissue decomposition and circulation device 24 is the main inlet 28, and the outlet 13 of the third vascular tissue decomposition and circulation device 26 is the main outlet 29. Filter screens 15 are provided at the inlet 14 and outlet 13 of the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26. The filter screens 15 are ultrafiltration membrane components, and the molecular weight cutoff of the ultrafiltration membrane components is 50kDa.

[0098] The automated control device includes an automated device 22 and a conveying device 23; the automated device 22 is connected to the conveying device 23 via wired or wireless means; the conveying device 23 is connected to the top of the reactor lid 6 of the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26 via a buckle 27.

[0099] The support mounting devices 3 of the first vascular tissue decomposition and circulation device 24, the second vascular tissue decomposition and circulation device 25, and the third vascular tissue decomposition and circulation device 26 are all traction support mounting devices 3.

[0100] The traction stent installation device 3 includes a connecting buckle 7, a traction wire 12, and a stent receiving assembly. One end of the connecting buckle 7 is connected to the reactor cover 6, and the other end of the connecting buckle 7 is connected to the traction wire 12. The end of the traction wire 12 away from the connecting buckle 7 is connected to the stent receiving assembly. The stent receiving assembly includes a mesh frame 9 and a central rod 8. A connecting buckle is provided inside the mesh frame 9, and an opening is provided on one side of the mesh frame 9. The central rod 8 is placed inside the opening and is fixed by the connecting buckle. A connector 10 is provided on the side of the mesh frame 9 facing the traction wire 12. The connector 10 is used to connect the traction wire 12. An opening and closing part 11 is provided at the opening. The opening and closing part 11 is used to open and insert the central rod 8. The central rod 8 has a hollow porous structure.

[0101] Application Example 1

[0102] This application example uses the vascular tissue decomposition and circulation device from Example 1 to clean vascular tissue, wherein the cleaning steps include:

[0103] (1) Tissue removal: The vascular tissue is separated from the body, and excess tissue blocks that are not in contact with the implant are removed using tools such as scissors and scalpels to form an implant with tissue (it is not necessary to remove it completely, but the vascular stent should not be damaged).

[0104] (2) Tissue fixation: The pretreated implant with tissue was immersed in freshly prepared formalin and fixed for 24 hours. After fixation, the vascular tissue was rinsed with deionized water (about 6 times), dried and weighed, and recorded as the mass at time 0.

[0105] (3) Prepare sufficient volumes of solution A, solution B and solution C.

[0106] (4) Add solution A into the vascular tissue decomposition and circulation device along the reaction vessel chamber 5. Stop adding when the solution level reaches 2 / 3 of the volume of the reaction vessel chamber 5, and cover the reaction vessel with the lid 6. Turn on the peristaltic pump, adjust the parameters to 3 mL / min, set the temperature to 37℃, and turn on the temperature control device 4 to heat and circulate the solution. Observe whether the temperature and flow rate are stable; after the temperature and flow rate have stabilized for 5 minutes, open the reaction vessel lid 6, take out and open the support mounting device 3, insert the vascular tissue into the central rod 8 of the support mounting device 3, and place it into the 3cm through hole. 2The stent is placed in the mesh frame 9. After closing the mesh frame 9, the stent mounting device 3 is hung on the reactor lid 6 and placed vertically into the reactor. After reacting for 2 hours, the stent mounting device 3 (containing vascular tissue) is removed, and the device is rinsed with PBS solution at pH=7.4. The vascular tissue (containing stent) is then removed, and the stent is rinsed with PBS aqueous solution and deionized water in sequence (rinsing 3 times each). The stent is then dried and weighed.

[0107] (5) Add solution B along reactor 1 into the vascular tissue decomposition and circulation device. The operation method is the same as that of solution A in step (4). After 24 hours of reaction, remove the stent mounting device 3 (containing vascular tissue) and rinse it with PBS solution of pH=7.4. Remove the vascular tissue (containing stent) at 4 hours (6 hours combined with solution A), 10 hours (12 hours combined with solution A), and 24 hours (26 hours combined with solution A), respectively. Rinse the stent with PBS aqueous solution and deionized water (3 times each), dry and weigh.

[0108] (6) Add solution C along reaction vessel 1 into the vascular tissue decomposition and circulation device. The operation method is the same as that of solution A in step (4). After reacting for 20 hours, remove the stent installation device 3 (containing vascular tissue) and rinse the device with ethanol and deionized water in sequence. Remove the stent and rinse it with PBS aqueous solution and deionized water in sequence (rinse 3 times each). After rinsing clean, dry it and observe the surface under a microscope.

[0109] The components of solutions A, B, and C in the above application examples are shown in Table 1.

[0110] Table 1

[0111] Collagenase type I 2 2 1 elastase 1 2.5 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0112] Application Example 2

[0113] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1, wherein the cleaning steps are the same as in Application Example 1.

[0114] The composition of solutions A, B and C is shown in Table 2. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0115] Table 2

[0116]

[0117]

[0118] After 3 hours of treatment, it was observed that the vascular tissue on the stent surface was completely decomposed, and the stent was not destroyed.

[0119] Application Example 3

[0120] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1. The cleaning steps are the same as in Application Example 1, except that in step (6), the reaction is carried out in solution C for 7 hours.

[0121] The composition of solutions A, B and C is shown in Table 3. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0122] Table 3

[0123] Collagenase type I 1.8 1.8 0.8 elastase 0.8 2.2 1.8 Calcium chloride 33 33 17 Magnesium chloride 17 38 24 ammonium chloride 2.1 2.1 2.1

[0124] After 38 hours of treatment, it was observed that the vascular tissue on the stent surface was completely decomposed, and the stent was not destroyed.

[0125] Application Example 4

[0126] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1. The cleaning steps are the same as in Application Example 1, except that: in step (4), the peristaltic pump is turned on and the parameter is adjusted to 1 mL / min, and in step (5), the peristaltic pump is turned on and the parameter is adjusted to 5 mL / min.

[0127] The composition of solutions A, B and C is shown in Table 4. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0128] Table 4

[0129] Collagenase type I 2 2 1 elastase 1 2.5 2 Calcium nitrate 66 82 33 Magnesium sulfate 24 48 48 ammonium nitrate 4.8 5.6 4.8

[0130] The total processing time was 23.5 hours. Combined with the flushing effect of the fluid on the support, the removal efficiency was improved.

[0131] Application Example 5

[0132] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device system in Example 5, the specific steps of which include:

[0133] (1) Obtaining the stent after implantation into the blood vessel;

[0134] (2) Prepare solutions A, B and C.

[0135] (3) Set up the equipment (connect three reactors 1 in series, add solutions A, B and C to reactor 1 in sequence, turn on the equipment, set the flow rate to 5 mL / min, the temperature to 37℃, and stabilize for 5 min).

[0136] (4) Place the stent with vascular tissue into the stent installation device 3, place it into the solution A reaction vessel 1, and hang it in the buckle.

[0137] (5) The stent was removed from the reactor and rinsed with deionized water. The complete decomposition of vascular tissue on the stent surface was observed. Using the series reactor 1 significantly reduced the number of manual operation steps. Combined with the flushing effect of the fluid on the stent, the total treatment time was 18 hours, which improved the removal efficiency.

[0138] The composition of solutions A, B and C is shown in Table 5. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0139] Table 5

[0140] Collagenase type I 2 2 1 elastase 1 2.5 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38

[0141] Application Example 6

[0142] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0143] Compared with Application Example 4, the only difference was that collagenase I in each solution was replaced with an equal amount of collagenase II, and the vascular tissue on the surface of the stent was completely decomposed.

[0144] Application Example 7

[0145] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0146] Compared with Application Example 4, the only difference is that collagenase I in each solution was replaced with an equal amount of mixed collagenase (the mass ratio of collagenase I and collagenase II does not need to be specially restricted and can be designed according to actual needs, as long as the total amount of collagenase remains unchanged, for example, it can be 1:1). It was observed that the vascular tissue on the surface of the stent was completely decomposed.

[0147] Application Example 8

[0148] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0149] The composition of solutions A, B and C is shown in Table 6. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0150] Table 6

[0151] Collagenase type I 1.93 2 1 elastase 1.07 2.5 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0152] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0153] Application Example 9

[0154] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0155] The composition of solutions A, B and C is shown in Table 7. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0156] Table 7

[0157] Collagenase type I 2.15 2 1 elastase 0.85 2.5 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0158] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0159] Application Example 10

[0160] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0161] The composition of solutions A, B, and C is shown in Table 8. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0162] Table 8

[0163] Collagenase type I 2.2 2 1 elastase 0.8 2.5 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0164] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0165] Application Example 11

[0166] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0167] The compositions of solutions A, B, and C are shown in Table 9. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0168] Table 9

[0169]

[0170]

[0171] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0172] As can be seen from the results of application examples 1, 8, 9, 10, and 11, the specific concentration ratio of collagenase and elastase in solution A designed in this invention can further improve the removal effect.

[0173] Application Example 12

[0174] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0175] The composition of solutions A, B, and C is shown in Table 10. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0176] Table 10

[0177] Collagenase type I 2 2.25 1 elastase 1 2.25 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0178] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0179] Application Example 13

[0180] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0181] The composition of solutions A, B, and C is shown in Table 11. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0182] Table 11

[0183] Collagenase type I 2 1.95 1 elastase 1 2.55 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0184] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0185] Application Example 14

[0186] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0187] The composition of solutions A, B, and C is shown in Table 12. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0188] Table 12

[0189] Collagenase type I 2 2.3 1 elastase 1 2.2 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0190] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0191] Application Example 15

[0192] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0193] The composition of solutions A, B, and C is shown in Table 13. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0194] Table 13

[0195] Collagenase type I 2 1.8 1 elastase 1 2.7 2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0196] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0197] As can be seen from the results of application examples 1, 12, 13, 14, and 15, the specific concentration ratio of collagenase and elastase in solution B designed in this invention can further improve the removal effect.

[0198] Application Example 16

[0199] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0200] The composition of solutions A, B, and C is shown in Table 14. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0201] Table 14

[0202]

[0203]

[0204] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0205] Application Example 17

[0206] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0207] The composition of solutions A, B, and C is shown in Table 15. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0208] Table 15

[0209] Collagenase type I 2 2 0.85 elastase 1 2.5 2.15 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0210] The cleaning procedure was the same as in Application Example 1, and the complete decomposition of vascular tissue on the stent surface was observed.

[0211] Application Example 18

[0212] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0213] The composition of solutions A, B, and C is shown in Table 16. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0214] Table 16

[0215] Collagenase type I 2 2 1.2 elastase 1 2.5 1.8 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0216] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0217] Application Example 19

[0218] This application example provides a method for cleaning vascular tissue using the vascular tissue decomposition and circulation device in Example 1.

[0219] The composition of solutions A, B, and C is shown in Table 17. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0220] Table 17

[0221] Collagenase type I 2 2 0.8 elastase 1 2.5 2.2 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0222] The cleaning procedure was the same as in Application Example 1, and it was observed that the vascular tissue on the stent surface was not completely decomposed.

[0223] As can be seen from the results of application examples 1, 16, 17, 18, and 19, the specific concentration ratio of collagenase and elastase in solution C designed in this invention can further improve the removal effect.

[0224] Comparative Application Example 1

[0225] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0226] The composition of solutions A, B, and C is shown in Table 18. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0227] Table 18

[0228] Collagenase type I 1.5 1.6 0.5 elastase 0.75 2 1 Calcium chloride 11 11 11 Magnesium chloride 9.5 9.5 9.5 ammonium chloride 1.06 1.06 1.06

[0229] The cleaning procedure is the same as in Application Example 1, except that the reaction time in solution A is 5 hours, the reaction time in solution B is 35 hours, and the reaction time in solution C is 25 hours. It was observed that the vascular tissue on the stent surface was not completely decomposed, and some vascular tissue remained on the stent surface (about 20%). Even if the reaction time of solution C is further extended, vascular tissue residue was still observed when the morphology of the stent surface was observed under a microscope.

[0230] Comparative Application Example 2

[0231] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0232] The composition of solutions A, B, and C is shown in Table 19. The solvent for all solutions is an aqueous PBS solution with pH = 7.4.

[0233] Table 19

[0234] Collagenase type I 3 3.5 2 elastase 1.5 4.4 4 Calcium chloride 66 77 44 Magnesium chloride 47 66 57 ammonium chloride 5.3 5.3 5.3

[0235] The cleaning procedure is the same as in Application Example 1, except that the reaction time in solution A is 5 hours, in solution B it is 35 hours, and in solution C it is 25 hours. It was observed that the vascular tissue on the stent surface was not completely decomposed, and some vascular tissue remained on the stent surface.

[0236] As can be seen from Application Examples 1-3 and Comparative Application Examples 1 and 2, the decomposition solution designed with a specific enzyme concentration range in this invention can achieve effective decomposition. However, when the enzyme concentration range is too low or too high, it may lead to insufficient enzymatic hydrolysis efficiency or steric hindrance, neither of which can achieve effective decomposition.

[0237] Comparative Application Example 3

[0238] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0239] Solutions A, B, and C have the composition shown in Table 20. The solvent for all solutions is PBS aqueous solution with pH = 7.4. Based on Application Example 1, the total amount of enzyme was kept constant, and the reaction was carried out without a stepwise concentration.

[0240] Table 20

[0241]

[0242]

[0243] The cleaning steps are the same as in Application Example 1, except that: in reaction step (5), the stent is not removed and the reaction continues in solution A for 30 hours; in step (6), the stent is not removed and the reaction continues in solution A for 5 hours. It was observed that the vascular tissue on the stent surface was not completely decomposed and some vascular tissue remained on the stent surface.

[0244] Comparative Application Example 4

[0245] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0246] Solutions A, B, and C have the composition shown in Table 21. The solvent for all solutions is PBS aqueous solution with pH = 7.4. Based on Application Example 1, the total amount of enzyme is kept constant, and the reaction has no stepwise concentration.

[0247] Table 21

[0248] Collagenase type I 2 3 0 elastase 1 4.5 0 Calcium chloride 44 77 0 Magnesium chloride 19 76 0 ammonium chloride 3.2 6.9 0

[0249] The cleaning steps are the same as in Application Example 1, except that: in step (6), the stent is not removed and continues to react in solution B for 5 hours; the decomposition effect of vascular tissue on the stent surface is better than that in Comparative Example 4, but it is still not completely decomposed, and some vascular tissue remains on the stent surface.

[0250] Comparative Application Example 5

[0251] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0252] Solutions A, B, and C have the composition shown in Table 22. The solvent for all solutions is PBS aqueous solution with pH = 7.4. Based on Application Example 1, the total amount of enzyme was kept constant, and the reaction was carried out without a stepwise concentration.

[0253] Table 22

[0254] Collagenase type I 0 4 1 elastase 0 3.5 2 Calcium chloride 0 99 22 Magnesium chloride 0 57 38 ammonium chloride 0 6.9 3.2

[0255] The cleaning steps are the same as in Application Example 1, except that there is no reaction in step (4) and step (5) is reacted for 31 hours; it is observed that the vascular tissue on the stent surface is not completely decomposed and some vascular tissue remains on the stent surface.

[0256] As can be seen from the results of comparative application examples 3-5, it is difficult to effectively remove vascular tissue without using the specific first decomposition solution, second decomposition solution and third decomposition solution designed in this utility model.

[0257] Comparative Application Example 6

[0258] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0259] Solutions A, B, and C have the composition shown in Table 23. The solvent for all solutions is PBS aqueous solution with pH = 7.4. Based on Application Example 1, the total amount of enzyme was kept constant, and the reaction was carried out without a stepwise concentration.

[0260] Table 23

[0261]

[0262]

[0263] The cleaning procedure is the same as in Application Example 1. Observe the surface of the stent. The collagen of the vascular tissue outer membrane cannot be decomposed, the solution cannot be dispersed inside the vascular tissue, and the vascular tissue cannot be decomposed.

[0264] Comparative Application Example 7

[0265] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0266] Solutions A, B, and C have the composition shown in Table 24. The solvent for all solutions is an aqueous PBS solution with pH = 7.4. Based on Application Example 1, the total amount of enzyme was kept constant, and the reaction was carried out without a stepwise concentration.

[0267] Table 24

[0268] Collagenase type I 3 4.5 3 elastase 0 0 0 Calcium chloride 44 55 22 Magnesium chloride 19 38 38 ammonium chloride 3.2 3.7 3.2

[0269] The cleaning procedure is the same as in Application Example 1. Observe the surface of the stent. The elastin in the outer membrane of the vascular tissue cannot be broken down. After the solution breaks down some of the collagen, it cannot break down the elastin further. As a result, the solution is blocked by the elastin and cannot break down it further. The collagen fiber network is broken down, resulting in the vascular tissue becoming tight.

[0270] As can be seen from the results of comparative application examples 6 and 7, it is difficult to effectively remove vascular tissue without the synergistic treatment of collagenase and elastase designed in this invention.

[0271] Comparative Application Example 8

[0272] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0273] Solutions A, B, and C have the composition shown in Table 25. The solvent for all solutions is an aqueous PBS solution with pH = 7.4. The amount of ions was changed based on Application Example 2.

[0274] Table 25

[0275] Collagenase type I 2.2 2.5 1.2 elastase 1.2 2.8 2.2 Calcium chloride 44 55 22 Magnesium chloride 29 38 38 ammonium chloride 0 0 0

[0276] The cleaning procedure was the same as in Application Example 2, and some vascular tissue remained on the stent surface (approximately 10% remained).

[0277] Comparative Application Example 9

[0278] This comparative application example provides a method for cleaning vascular tissue using a vascular tissue decomposition and circulation device.

[0279] Solutions A, B, and C have the composition shown in Table 26. The solvent for all solutions is an aqueous PBS solution with pH = 7.4. The amount of ions was changed based on Application Example 2.

[0280] Table 26

[0281]

[0282]

[0283] The cleaning procedure was the same as in Application Example 2. The decomposition efficiency of each solution was relatively fast in the early stage, but after 2-3 hours, the decomposition gradually slowed down, and some vascular tissue was observed to remain on the surface of the stent.

[0284] As can be seen from the results of comparative applications 8 and 9, it is difficult to effectively remove vascular tissue without using the ion system designed in this invention for synergistic processing.

[0285] In summary, this utility model, through the structural design of the vascular tissue decomposition and circulation device, uses a matching enzyme decomposition solution to circulate and clean vascular tissue, achieving rapid decomposition of vascular tissue while avoiding impact or damage to the biodegradable materials on the surface of the vascular stent. The structure is simple, highly operable, and suitable for widespread use.

[0286] The above description is only a specific embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present utility model fall within the protection and disclosure scope of the present utility model.

Claims

1. A device for decomposing and circulating vascular tissue, characterized in that, The vascular tissue decomposition and circulation device includes a reaction vessel, a support mounting device, a temperature control device, and a peristaltic pump circulation device. The reactor includes a reactor chamber and a reactor cover disposed on top of the reactor chamber; The stent mounting device is installed inside the reaction vessel chamber. One end of the stent mounting device is connected to the reaction vessel cover, and the other end of the stent mounting device is used to place a vascular tissue stent, and the vascular tissue stent does not contact the inner wall of the reaction vessel chamber. The reaction vessel chamber is provided with an inlet and an outlet. Both the inlet and the outlet are equipped with filters. The water inlet height is the same as the height at which the vascular tissue support is placed in the support mounting device. The inlet and the outlet are respectively used to connect the pipeline to the outlet and inlet of the peristaltic pump circulation device. The temperature control device is installed on one side of the reaction vessel chamber, and the temperature control device is used to control the temperature of the liquid in the reaction vessel chamber.

2. The vascular tissue decomposition and circulation device according to claim 1, characterized in that, The bracket installation device is a traction bracket installation device or a round rod bracket installation device.

3. The vascular tissue decomposition and circulation device according to claim 2, characterized in that, The traction bracket installation device includes a connecting buckle, a traction line, and a bracket housing assembly; One end of the connecting buckle is connected to the reactor lid, the other end of the connecting buckle is connected to the traction line, and the end of the traction line away from the connecting buckle is connected to the support housing assembly; The stent receiving assembly includes a mesh frame and a central rod. A connecting buckle is provided inside the mesh frame. An opening is provided on one side of the mesh frame. The central rod is provided inside the opening, and the interior of the central rod is used to place a vascular tissue stent and is fixed by the connecting buckle. A connector is provided on the side of the mesh frame facing the traction line, and the connector is used to connect the traction line.

4. The vascular tissue decomposition and circulation device according to claim 3, characterized in that, The opening is provided with an opening and closing component, which is used to open and insert the center rod. And / or, the central rod is a hollow porous structure.

5. The vascular tissue decomposition and circulation device according to claim 2, characterized in that, The round rod bracket mounting device includes a round rod and a limiting component; One end of the round rod is snapped to the reactor lid, and the other end of the round rod is connected to the limiting member. The outer wall of the round rod is used to fit a vascular tissue scaffold, and the height of the vascular tissue scaffold is limited by the limiting member. The limiting member is a protruding structure, which is located at the inner bottom of the reaction vessel chamber, and the end of the protruding structure away from the inner bottom of the reaction vessel chamber is connected to the round rod.

6. The vascular tissue decomposition and circulation device according to claim 1, characterized in that, The temperature control device is installed at the bottom of the reaction vessel chamber; Alternatively, the interior of the reactor chamber is divided into a reaction chamber and a heating chamber. The reaction chamber is located on one side of the heating chamber. The reaction chamber is equipped with the support mounting device and the water outlet. The temperature control device is located on the top of the heating chamber, and the water inlet is located on the side of the heating chamber away from the reaction chamber.

7. The vascular tissue decomposition and circulation device according to claim 6, characterized in that, The reaction chamber and the heating chamber are separated by a partition plate; The barrier plate is provided with an inclined liquid channel. The inlet of the inclined liquid channel is located near the inner top of the heating chamber, and the height of the outlet of the inclined liquid channel is greater than the height of the vascular tissue scaffold placed in the scaffold mounting device. Alternatively, small holes are evenly distributed on the barrier plate, which are used for the liquid in the heating chamber to flow into the reaction chamber.

8. The vascular tissue decomposition and circulation device according to claim 1, characterized in that, The filter screen is an ultrafiltration membrane module; The ultrafiltration membrane module has a molecular weight cutoff of 20–50 kDa.

9. A system for decomposing and circulating vascular tissue, characterized in that, The vascular tissue decomposition and circulation device system includes an automated control device and at least one set of decomposition and circulation devices; The automated control device is used to control the decomposition operation of the decomposition cycle device. Each set of decomposition and circulation devices includes three vascular tissue decomposition and circulation devices connected in series, which are respectively referred to as the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device, and the third vascular tissue decomposition and circulation device. The outlet pipe of the first vascular tissue decomposition and circulation device is connected to the inlet of the second vascular tissue decomposition and circulation device, and the outlet pipe of the second vascular tissue decomposition and circulation device is connected to the inlet of the third vascular tissue decomposition and circulation device. The inlet of the first vascular tissue decomposition and circulation device is the main inlet, and the outlet of the third vascular tissue decomposition and circulation device is the main outlet. The filter screen is provided at the inlet and outlet of the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device and the third vascular tissue decomposition and circulation device. The first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device, and the third vascular tissue decomposition and circulation device all adopt the vascular tissue decomposition and circulation device according to any one of claims 1-8.

10. The vascular tissue decomposition and circulation device system according to claim 9, characterized in that, The automated control device includes automated equipment and a conveying device; The automated equipment is connected to the transmission device via wired or wireless means. The conveying device is connected to the top of the reactor lid of the first vascular tissue decomposition and circulation device, the second vascular tissue decomposition and circulation device, and the third vascular tissue decomposition and circulation device via snap-fit ​​connections.

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