Intravascular stent in-vitro degradation testing device

Abstract

The utility model relates to the technical field of medical instruments, and discloses an intravascular stent in-vitro degradation testing device which comprises a liquid storage tank, a first pump, a sample testing tube, a temperature sensor, a dissolved oxygen sensor, a pH sensor, a temperature adjusting mechanism, a dissolved oxygen adjusting mechanism and a pH adjusting mechanism. The liquid feeding pipe is connected with the input end of the first pump, the output end of the first pump is connected with one end of the sample testing pipe through a pipeline, the other end of the sample testing pipe is communicated with the liquid storage tank through the backflow pipe, the temperature sensor, the dissolved oxygen sensor and the pH sensor are arranged in the liquid storage tank, and the temperature adjusting mechanism is electrically connected with the temperature sensor. The dissolved oxygen adjusting mechanism is electrically connected with the dissolved oxygen sensor, and the pH adjusting mechanism is electrically connected with the pH sensor. The physical and chemical properties of the simulated body fluid in the test can be ensured to accord with the actual condition of the body fluid in the human body, and the test accuracy is ensured.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an in vitro degradation testing device for a vascular stent. Background Art

[0002] Vascular stents are medical devices used to treat cardiovascular diseases such as coronary heart disease. Degradable vascular stents can provide sufficient mechanical support for damaged blood vessels during the initial implantation phase. As vascular function in the affected area gradually recovers, the degradable vascular stent will be degraded and absorbed by the matrix at an appropriate rate. During the research and development of degradable vascular stents, it is necessary to simulate the corrosion of the vascular stent in the in vivo environment. Existing testing equipment fails to control the physical and chemical properties of simulated body fluids. As the degradable stent continues to degrade in the in vitro testing equipment, the physical and chemical properties of the simulated body fluids, such as pH and dissolved oxygen concentration, will continue to change, deviating from the range of actual parameters of body fluids in the human body, resulting in inaccurate test results. Utility Model Content

[0003] The technical problem to be solved by the utility model is to provide a device for testing the degradation of a vascular stent in vitro, which can ensure that the physical and chemical properties of the simulated body fluid in the test are consistent with the actual conditions of the body fluid in the human body.

[0004] In order to solve the above technical problems, the utility model provides an in vitro degradation test device for a vascular stent, comprising a liquid storage tank, a first pump, a sample test tube, a temperature sensor, a dissolved oxygen sensor, a pH sensor, a temperature regulating mechanism capable of regulating the temperature of the liquid in the liquid storage tank, a dissolved oxygen regulating mechanism capable of regulating the dissolved oxygen concentration of the liquid in the liquid storage tank, and a pH regulating mechanism capable of regulating the pH value of the liquid in the liquid storage tank. A liquid feeding pipe is provided at the bottom of the liquid storage tank, the liquid feeding pipe is connected to the input end of the first pump, the output end of the first pump is connected to one end of the sample test tube via a pipeline, and the other end of the sample test tube is connected to the liquid storage tank via a reflux pipe. The temperature sensor, the dissolved oxygen sensor, and the pH sensor are respectively arranged in the liquid storage tank, the temperature regulating mechanism is electrically connected to the temperature sensor, the dissolved oxygen regulating mechanism is electrically connected to the dissolved oxygen sensor, and the pH regulating mechanism is electrically connected to the pH sensor.

[0005] As a preferred embodiment of the present invention, a microporous membrane is provided in the sample test tube, and the microporous membrane is in the shape of a circular tube. A holding cavity capable of accommodating the test sample is formed between the inner side of the sample test tube and the outer side of the microporous membrane. The output end of the first pump is connected to one end of the microporous membrane through a pipeline, and the other end of the microporous membrane is connected to the reflux pipe.

[0006] As a preferred solution of the present invention, the end of the microporous membrane is provided with a flange portion extending out of the sample test tube, the flange portion is sleeved on the end of the sample test tube, and a fixing sleeve is sleeved on the flange portion.

[0007] As a preferred solution of the present invention, a flow meter, a flow regulating valve and a pressure transmitter are provided on the connecting pipe between the first pump and the sample testing tube.

[0008] As a preferred embodiment of the present invention, the outer side of the liquid storage tank is provided with a jacket, and there is a interlayer between the inner side of the jacket and the outer side of the liquid storage tank. The temperature regulating mechanism includes a water storage tank, an electric heater, a second pump and a temperature controller. The water storage tank is connected to the interlayer through a circulation pipeline. The electric heater is arranged in the water storage tank, the second pump is arranged on the circulation pipeline, and the temperature controller is electrically connected to the electric heater and the temperature sensor respectively.

[0009] As a preferred embodiment of the present invention, the dissolved oxygen regulating mechanism includes a first ventilation pipe, a second ventilation pipe, and a dissolved oxygen controller. One end of the first ventilation pipe and one end of the second ventilation pipe are respectively extended into the liquid storage tank, the other end of the first ventilation pipe is connected to the oxygen source, and the other end of the second ventilation pipe is connected to the argon source. The first ventilation pipe is provided with a first control valve, and the second ventilation pipe is provided with a second control valve. The dissolved oxygen controller is electrically connected to the first control valve, the second control valve and the dissolved oxygen sensor, respectively.

[0010] As a preferred solution of the present invention, a first aeration head is provided at one end of the first vent pipe extending into the liquid storage tank, and a second aeration head is provided at one end of the second vent pipe extending into the liquid storage tank.

[0011] As a preferred embodiment of the present invention, the pH adjustment mechanism includes a pH controller, a third pump and a solution bottle. The pH controller is electrically connected to the pH sensor and the third pump, respectively. The input end of the third pump is connected to the solution bottle through a pipeline, and the output end of the third pump is connected to the liquid storage tank through a pipeline.

[0012] As a preferred solution of the present invention, the device further comprises an agitator located above the liquid storage tank, and a stirring paddle of the agitator extends into the liquid storage tank.

[0013] The embodiment of the present utility model provides an in vitro degradation test device for a vascular stent. Compared with the prior art, its beneficial effects are as follows: during the test, a test sample is first placed in a sample test tube, and simulated body fluid is poured into a liquid storage tank; then a first pump is controlled to transport the simulated body fluid in the liquid storage tank to one end of the sample test tube through a liquid delivery tube, and then transported from the other end of the sample test tube to a reflux tube, and finally transported back to the liquid storage tank; during the transportation of the simulated body fluid in the sample test tube, the simulated body fluid will flush the test sample located in the sample test tube, thereby performing a simulated test on the corrosion condition of the test sample in the in vivo environment; the provision of a temperature sensor, a dissolved oxygen sensor, a pH sensor, a temperature regulating mechanism, a dissolved oxygen regulating mechanism, and a pH regulating mechanism can prevent the temperature, dissolved oxygen concentration, and pH value of the simulated body fluid in the liquid storage tank from deviating from the range of actual parameters of body fluid in the human body, thereby ensuring the accuracy of the test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 It is a structural diagram of the utility model;

[0015] Figure 2 This is a schematic diagram of the structure of the microporous membrane of the present invention disposed in a sample test tube;

[0016] In the figure, 1, liquid storage tank; 11, first pump; 111, flow meter; 112, flow control valve; 113, pressure transmitter; 12, liquid delivery pipe; 13, reflux pipe; 14, jacket; 141, interlayer; 15, stirrer; 2, sample test tube; 21, microporous mold; 211, flange; 22, receiving chamber; 23, fixing sleeve; 3, temperature sensor; 4, dissolved oxygen sensor; 5, pH sensor; 6, temperature adjustment mechanism; 61, Water storage tank; 62. Electric heater; 63. Second pump; 64. Circulation line; 65. Temperature controller; 7. Dissolved oxygen adjustment mechanism; 71. First vent pipe; 711. First control valve; 712. First aeration head; 72. Second vent pipe; 721. Second control valve; 722. Second aeration head; 73. Dissolved oxygen controller; 8. pH adjustment mechanism; 81. pH controller; 82. Third pump; 83. Solution bottle; 9. Test sample. DETAILED DESCRIPTION

[0017] The following embodiments are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0018] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like used in the present invention to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second" and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0019] like Figure 1 As shown, a preferred embodiment of the present invention is a vascular stent in vitro degradation test device, comprising a liquid storage tank 1, a first pump 11, a sample test tube 2, a temperature sensor 3, a dissolved oxygen sensor 4, a pH sensor 5, a temperature regulating mechanism 6 capable of regulating the temperature of the liquid in the liquid storage tank 1, a dissolved oxygen regulating mechanism 7 capable of regulating the dissolved oxygen concentration of the liquid in the liquid storage tank 1, and a pH regulating mechanism 8 capable of regulating the pH value of the liquid in the liquid storage tank 1. The liquid storage tank 1 is used to store simulated body fluids. A liquid feeding pipe 12 is provided at the bottom of the liquid storage tank 1. The liquid feeding pipe 12 is connected to the input end of the first pump 11 and the output end of the first pump 11. It is connected to one end of the sample test tube 2 through a pipeline, and the other end of the sample test tube 2 is connected to the liquid storage tank 1 through a reflux pipe 13. The temperature sensor 3, the dissolved oxygen sensor 4 and the pH sensor 5 are respectively arranged in the liquid storage tank 1. The temperature sensor 3 can detect the temperature of the simulated body fluid in the liquid storage tank 1, the dissolved oxygen sensor 4 can detect the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1, and the pH sensor 5 can detect the pH value of the simulated body fluid in the liquid storage tank 1. The temperature adjustment mechanism 6 is electrically connected to the temperature sensor 3, the dissolved oxygen adjustment mechanism 7 is electrically connected to the dissolved oxygen sensor 4, and the pH adjustment mechanism 8 is electrically connected to the pH sensor 5.

[0020] The working principle of this embodiment is as follows: during the test, the test sample 9 (vascular stent) is first placed in the sample test tube 2, and the simulated body fluid is poured into the liquid storage tank 1; then the first pump 11 is controlled to transport the simulated body fluid in the liquid storage tank 1 to one end of the sample test tube 2 through the liquid delivery pipe 12, and then transported from the other end of the sample test tube 2 to the return pipe 13, and finally transported back to the liquid storage tank 1; during the transportation of the simulated body fluid in the sample test tube 2, the test sample 9 in the sample test tube 2 will be flushed, thereby simulating the corrosion of the test sample 9 in the body environment; during the test, when the temperature sensor 3 detects the temperature of the liquid storage tank 1, the simulated body fluid will be transported to the liquid storage tank 1. When the temperature of the simulated body fluid in the liquid storage tank exceeds the set range, the temperature sensor 3 feedback signal controls the temperature regulating mechanism 6 for adjustment. When the dissolved oxygen sensor 4 detects that the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1 exceeds the set range, the dissolved oxygen sensor 4 feedback signal controls the dissolved oxygen regulating mechanism 7 for adjustment. When the pH sensor 5 detects that the pH value of the simulated body fluid in the liquid storage tank 1 exceeds the set range, the pH sensor 5 feedback signal controls the pH regulating mechanism for adjustment, thereby preventing the temperature, dissolved oxygen concentration and pH value of the simulated body fluid in the liquid storage tank 1 from deviating from the range of actual parameters of body fluids in the human body, thereby ensuring the accuracy of the test results.

[0021] In actual use, after the degradable stent is installed in the blood vessel for a period of time, a cell layer will form in the blood vessel to wrap the stent. At this time, the body fluid flushing in the human body no longer dominates the corrosion of the stent. In order to simulate this situation, for example, Figure 2 As shown, a microporous membrane 21 is provided in the sample test tube 2. The microporous membrane 21 is uniformly distributed with micropores (pore diameter of 1 μm). The microporous membrane 21 is in the shape of a circular tube. A holding cavity 22 capable of accommodating the test sample 9 is formed between the inner side of the sample test tube 2 and the outer side of the microporous membrane 21. The output end of the first pump 11 is connected to one end of the microporous membrane 21 through a pipe, and the other end of the microporous membrane 21 is connected to the return pipe 13. The arrangement of the microporous membrane 21 can simulate the cell layer wrapped around the vascular stent. During the test, the simulated body fluid is delivered to the inner side of one end of the microporous membrane 21 through the liquid delivery pipe 12, and then delivered to the return pipe 13 from the inner side of the other end of the microporous membrane 21. During this process, part of the simulated body fluid on the inner side of the microporous membrane 21 will diffuse into the holding cavity 22 through the micropores on the microporous membrane 21, thereby exchanging substances with the test sample 9, and then return to the inner side of the microporous membrane 21 through the micropores on the microporous membrane 21, thereby simulating the situation when the body fluid flushing no longer dominates the corrosion.

[0022] Exemplarily, the end of the microporous membrane 21 is provided with a flange portion 211 extending out of the sample test tube 2 , the flange portion 211 is sleeved on the end of the sample test tube 2 , and a fixing sleeve 23 is sleeved on the flange portion 211 to fix the microporous membrane 21 .

[0023] Illustratively, a flow meter 111, a flow regulating valve 112 and a pressure transmitter 113 are provided on the connecting pipe between the first pump 11 and the sample test tube 2. The flow regulating valve 112 can adjust the flow rate of the simulated body fluid delivered by the liquid delivery pipe 12 to the sample test tube 2. The flow meter 111 can detect the flow rate in the sample test tube 2. The pressure transmitter 113 can detect the pressure in the sample test tube 2. In this embodiment, the sample test tube 2 is connected to the return pipe 13 through a pipe. A stop valve is provided on the pipe between the sample test tube 2 and the return pipe 13. The liquid delivery pipe 12 is provided with a sampling port and a discharge port, that is, the liquid delivery pipe 12 is a four-way pipe, a sampling valve is provided at the sampling port, and a discharge valve is provided at the discharge port.

[0024] For example, the outer side of the liquid storage tank 1 is provided with a jacket 14, and there is an interlayer 141 between the inner side of the jacket 14 and the outer side of the liquid storage tank 1. The temperature regulating mechanism 6 includes a water storage tank 61, an electric heater 62, a second pump 63 and a temperature controller 65. The water storage tank 61 is connected to the interlayer 141 through a circulation pipeline 64. The electric heater 62 is provided in the water storage tank 61, the second pump 63 is provided on the circulation pipeline 64, and the temperature controller 65 is electrically connected to the electric heater 62 and the temperature sensor 3 respectively. 41 is filled with water, and circulates through the circulation pipe 64 under the action of the second pump 63. When the temperature sensor 3 detects that the temperature of the simulated body fluid in the liquid storage tank 1 is lower than the set range, the temperature sensor 3 feeds back a signal value to the temperature controller 65, thereby controlling the electric heater to heat the water in the water storage tank 61. The heated water is transported to the interlayer 141 and exchanges heat with the simulated body fluid in the liquid storage tank 1, thereby achieving the temperature regulation of the simulated body fluid. The electric heater 62 does not need to be in direct contact with the simulated body fluid.

[0025] Exemplarily, the dissolved oxygen regulating mechanism 7 includes a first vent pipe 71, a second vent pipe 72, and a dissolved oxygen controller 73. One end of the first vent pipe 71 and one end of the second vent pipe 72 are respectively extended into the liquid storage tank 1, the other end of the first vent pipe 71 is connected to the oxygen source, and the other end of the second vent pipe 72 is connected to the argon source. A first control valve 711 is provided on the first vent pipe 71, and a second control valve 721 is provided on the second vent pipe 72. The dissolved oxygen controller 73 is electrically connected to the first control valve 711, the second control valve 721 and the dissolved oxygen sensor 4, respectively. When the dissolved oxygen sensor When the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1 is detected to be lower than the set range, the dissolved oxygen sensor 4 feeds back a signal value to the dissolved oxygen controller 73, thereby controlling the first control valve 711 to open, and oxygen is transported into the liquid storage tank 1 through the first vent pipe 71 to increase the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1. Similarly, when the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1 is higher than the set range, the dissolved oxygen controller 73 controls the second control valve 721 to open, and argon is transported into the liquid storage tank 1 through the second vent pipe 72 to reduce the dissolved oxygen concentration of the simulated body fluid in the liquid storage tank 1.

[0026] For example, a first aeration head 712 is provided at one end of the first vent pipe 71 extending into the liquid storage tank 1 , and a second aeration head 722 is provided at one end of the second vent pipe 72 extending into the liquid storage tank 1 , so as to improve the gas transmission efficiency.

[0027] Exemplarily, the pH adjustment mechanism 8 includes a pH controller 81, a third pump 82 and a solution bottle 83. The pH controller 81 is electrically connected to the pH sensor 5 and the third pump 82, respectively. The input end of the third pump 82 is connected to the solution bottle 83 through a pipeline, and the output end of the third pump 82 is connected to the liquid storage tank 1 through a pipeline. Generally, the solution bottle 83 is filled with hydrochloric acid solution. When the pH sensor 5 detects that the pH value of the simulated body fluid in the liquid storage tank 1 is higher than the set range, the pH sensor 5 feeds back a signal value to the pH controller 81, thereby controlling the operation of the third pump 82 to pump the hydrochloric acid solution in the solution bottle 83 into the liquid storage tank 1, thereby achieving the adjustment of the pH value of the simulated body fluid.

[0028] Exemplarily, the device further comprises a stirrer 15 located above the liquid storage tank 1 , wherein a stirring paddle of the stirrer 15 extends into the liquid storage tank 1 , and the stirring paddle stirs the simulated body fluid in the liquid storage tank 1 to ensure its uniformity.

[0029] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and replacements can be made without departing from the technical principles of the present invention. These improvements and replacements should also be regarded as the scope of protection of the present invention.

Claims

1. An in vitro degradation test device for a vascular stent, characterized by: The invention comprises a liquid storage tank, a first pump, a sample test tube, a temperature sensor, a dissolved oxygen sensor, a pH sensor, a temperature regulating mechanism capable of regulating the temperature of the liquid in the liquid storage tank, a dissolved oxygen regulating mechanism capable of regulating the dissolved oxygen concentration of the liquid in the liquid storage tank, and a pH regulating mechanism capable of regulating the pH value of the liquid in the liquid storage tank. A liquid delivery pipe is provided at the bottom of the liquid storage tank, the liquid delivery pipe is connected to the input end of the first pump, the output end of the first pump is connected to one end of the sample test tube through a pipeline, and the other end of the sample test tube is connected to the liquid storage tank through a reflux pipe. The temperature sensor, the dissolved oxygen sensor, and the pH sensor are respectively arranged in the liquid storage tank, the temperature regulating mechanism is electrically connected to the temperature sensor, the dissolved oxygen regulating mechanism is electrically connected to the dissolved oxygen sensor, and the pH regulating mechanism is electrically connected to the pH sensor.

2. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: A microporous membrane is provided in the sample test tube, and the microporous membrane is in a circular tube shape. A holding cavity capable of accommodating the test sample is formed between the inner side of the sample test tube and the outer side of the microporous membrane. The output end of the first pump is connected to one end of the microporous membrane through a pipeline, and the other end of the microporous membrane is connected to the reflux pipe.

3. The in vitro degradation testing device for a vascular stent according to claim 2, characterized in that: The end of the microporous membrane is provided with a flange portion extending out of the sample testing tube. The flange portion is sleeved on the end of the sample testing tube. A fixing sleeve is sleeved on the flange portion.

4. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: A flow meter, a flow regulating valve and a pressure transmitter are provided on the connecting pipe between the first pump and the sample testing tube.

5. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: The outer side of the liquid storage tank is provided with a jacket, and there is a interlayer between the inner side of the jacket and the outer side of the liquid storage tank. The temperature regulating mechanism includes a water storage tank, an electric heater, a second pump and a temperature controller. The water storage tank is connected to the interlayer through a circulation pipeline. The electric heater is arranged in the water storage tank, the second pump is arranged on the circulation pipeline, and the temperature controller is electrically connected to the electric heater and the temperature sensor respectively.

6. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: The dissolved oxygen regulating mechanism includes a first ventilation pipe, a second ventilation pipe, and a dissolved oxygen controller. One end of the first ventilation pipe and one end of the second ventilation pipe respectively extend into the liquid storage tank, the other end of the first ventilation pipe is connected to an oxygen source, and the other end of the second ventilation pipe is connected to an argon source. A first control valve is provided on the first ventilation pipe, and a second control valve is provided on the second ventilation pipe. The dissolved oxygen controller is electrically connected to the first control valve, the second control valve and the dissolved oxygen sensor, respectively.

7. The in vitro degradation testing device for a vascular stent according to claim 6, characterized in that: A first aeration head is provided at one end of the first vent pipe extending into the liquid storage tank, and a second aeration head is provided at one end of the second vent pipe extending into the liquid storage tank.

8. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: The pH adjustment mechanism includes a pH controller, a third pump and a solution bottle. The pH controller is electrically connected to the pH sensor and the third pump respectively. The input end of the third pump is connected to the solution bottle through a pipeline, and the output end of the third pump is connected to the liquid storage tank through a pipeline.

9. The in vitro degradation testing device for a vascular stent according to claim 1, characterized in that: The invention also comprises a stirrer located above the liquid storage tank, wherein a stirring paddle of the stirrer extends into the liquid storage tank.

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