Vascular stent device and a drug-coated balloon drug release rate detection system

Abstract

The utility model discloses a kind of vascular stent devices, comprising: two pipelines of interval arrangement, the two pipelines are used to place experimental blood vessels;The two pipelines outside the position of placing experimental blood vessels are provided with outer tube, and the both ends of the outer tube are provided with threaded interface;The two pipelines extend and extend out of the threaded interface;Two first sealing parts are respectively sealed and connected to the both ends of the outer tube by the pipeline passing through. Animal blood vessels can be cultured in vitro and observed, and animal blood vessels can be directly installed or disassembled in vascular assembly, facilitating operation.

Description

Technical Field

[0001] This utility model relates to a testing device for medical devices, and more particularly to a vascular stent device and a drug release rate detection system for a drug-coated balloon. Background Technology

[0002] Intracranial atherosclerotic stenosis (ICAS) is currently a major cause of ischemic stroke. Traditional treatment options include drug therapy and endovascular therapy, but these have some limitations. Intracranial drug-coated balloons (DCBs) combine the dual functions of conventional balloon dilation and drug delivery. Their working principle involves delivering a drug-loaded balloon to the intracranial vascular lesion site via an interventional route. After inflation and dilation, the drug is rapidly released and diffuses into the vessel wall tissue, inhibiting excessive intimal proliferation and preventing restenosis.

[0003] Intracranial drug-coated balloons, as a novel interventional device, can effectively reduce the risk of restenosis and postoperative complications. Clinical trials have shown that intracranial drug-coated balloons have high safety and efficacy in treating intracranial arterial stenosis and restenosis after stent placement.

[0004] The drug release rate of the drug-coated balloon is a key parameter for this type of device. In the early stages of formula exploration, a large number of animal experiments are usually required for comparison. The experiments require the use of digital angiography (DSA) to observe the balloon expansion in the blood vessels and the release position of the drug-coated balloon in real time, which is extremely costly. Utility Model Content

[0005] The purpose of this invention is at least to provide a vascular stent device and a drug-coated balloon drug release rate detection system. This addresses the problems of high cost and low efficiency in current detection devices.

[0006] To achieve the above objectives, this utility model provides a vascular stent device, comprising: two pipes spaced apart, the two pipes including a first pipe and a second pipe, the first pipe being used to allow liquid to enter, the second pipe being used to allow liquid to exit, and the second pipe being provided with an exit hole; experimental blood vessels being placed in the two pipes; an outer tube being provided outside the two pipes at the location where the experimental blood vessel is placed, and two first sealing parts being respectively sealed and connected to the two ends of the outer tube through which the pipes pass.

[0007] Optionally, the outer tube has threaded interfaces at both ends; the two first sealing parts are sealed to the outer tube through the threaded connection ports; the two pipes extend out of the threaded interfaces; the inner tube and the outer tube are transparent tubes. The threaded connection ports of the outer tube are recessed.

[0008] Optionally, the ends of the two pipes used to connect to the experimental blood vessel are connection ends, and the connection ends are provided with stepped portions for fixing the two ends of the experimental blood vessel.

[0009] Optionally, the two pipes are made of stainless steel.

[0010] Optionally, one of the two pipes is an inlet pipe, and the other is an outlet pipe.

[0011] A second aspect of this application provides a drug-eluting balloon drug release rate detection system, including the vascular stent device described in any one of the above claims; further comprising: a pump for pumping liquid, the pump outlet being connected to the inlet of a flow stabilizer, and the flow stabilizer outlet being connected to a three-way connector; one end of the three-way connector being the balloon inlet and the other end being the liquid outlet; the liquid outlet being connected to the inlet of the vascular stent device, the outlet of the vascular stent device being connected to a storage container, and the outlet of the storage container being connected to the inlet of the pump.

[0012] Optionally, the flow stabilizer includes a hollow first liquid storage section, in which a flow stabilizing ball is disposed, and the length of the outlet of the flow stabilizer in the liquid storage section is greater than the length of the inlet.

[0013] Optionally, the flow stabilizing ball is an elastic ball, that is, the flow stabilizing ball is made of elastic material.

[0014] Optionally, the storage tank includes a hollow second liquid storage section, and the length of the outlet of the storage tank in the liquid storage section is greater than the length of the inlet.

[0015] Optionally, the storage container is used to hold a certain concentration of drug solution.

[0016] Optionally, the pump includes at least two outlets for connection to different flow stabilizers. This allows the pump to connect to multiple channels, enabling independent observation of changes in blood vessels under various formulations, with each system operating independently and without interference from others.

[0017] Optionally, it also includes: a constant temperature chamber, wherein the constant temperature chamber is filled with liquid to maintain the system at a certain temperature.

[0018] This invention provides a drug release rate detection system for a drug-coated balloon. The pump continuously circulates the liquid, and the flow stabilizer transforms the pulsating water flow into a steady flow, making the experiment more closely resemble blood flow in animals. Furthermore, the vascular stent device provided in this invention places the experimental blood vessel (such as a rabbit or pig vessel) between two pipes. A suitable length of blood vessel is connected to a first pipe at one end and a second pipe at the other. The first pipe is the inlet pipe, and the second pipe is the outlet pipe. An inner tube surrounds the pipes to protect the experimental blood vessel, simulating the situation where blood vessels are immersed in blood in animals, and allows any leakage from the blood vessel to flow back into the device, ensuring a tight seal. The second pipe has a drain hole. During the drug-coated balloon experiment, a large amount of liquid will seep out from the experimental blood vessel. This liquid will accumulate in the lumen of the outer tube. Without the drain hole, this liquid would accumulate in the lumen, eventually putting pressure on the outer tube and causing leakage, affecting the experimental results. By adding a drain hole to the second pipe, fluid leaking from the experimental blood vessel can be drained through the drain hole and recirculated into the system, thus ensuring the experimental effect and the accuracy of the final results. The drug-coated balloon is inserted through one port of a three-way connector and then into the experimental blood vessel, enabling in vitro culture and observation of animal blood vessels. Animal blood vessels can be directly installed or removed from the vascular assembly, facilitating operation.

[0019] The drug release rate of the drug-coated balloon is a key parameter for such devices. In the early stages of formulation development, extensive animal experiments are typically required for comparison. These experiments necessitate real-time observation of balloon expansion within the blood vessels and the release location of the drug-coated balloon using digital angiography (DSA), resulting in extremely high experimental costs. This device enables in vitro culture of animal blood vessels and, through the application of a vascular stent, allows for clear observation of vascular status, balloon positioning, and the balloon release process. This reduces the cost of animal experiments in the early stages of formulation development, shortens experimental time, and improves the efficiency of formulation development.

[0020] The above and other objects, advantages and features of this utility model will become more apparent to those skilled in the art from the following detailed description of specific embodiments of this utility model in conjunction with the accompanying drawings. Attached Figure Description

[0021] The following sections will describe some specific embodiments of the present invention in a detailed manner by way of example and not limitation, with reference to the accompanying drawings. The same reference numerals in the drawings denote the same or similar parts or components. Those skilled in the art should understand that these drawings are not necessarily drawn to scale. In the drawings:

[0022] Figure 1 This is a schematic diagram of the drug release rate detection system of the drug-coated balloon in an embodiment of this utility model.

[0023] Figure 2 This is a schematic diagram of the vascular stent device in an embodiment of the present invention.

[0024] Figure 3 This is a schematic diagram of the stepped portion of the vascular stent device in an embodiment of the utility model.

[0025] Figure 4 This is a schematic diagram of the outer tube of the vascular stent device in an embodiment of the utility model.

[0026] Figure 5 This is a schematic diagram of the flow stabilizer of the drug release rate detection system for the drug-coated balloon in the embodiment of the utility model.

[0027] Figure 6 This is a schematic diagram of the storage tank of the drug release rate detection system for the drug-coated balloon in the embodiment of the utility model.

[0028] Figure label:

[0029] A. Pump, B. Flow stabilizer, C. T-connector, D. Vascular stent device, E. Storage vessel, F. Drug-coated balloon, G. Incubator, 1-1 First pipe, 1-2 Second pipe, 111 Stepped section, 112 Discharge hole, 12 Outer tube, 121 Threaded connection, 122 Pipe wall, 123 Inner cavity, 13 First sealing section, 14 Second sealing section, 15 Experimental blood vessel, 21 Inlet of reservoir, 22 Outlet of reservoir, 23 First reservoir, 24 Flow stabilizer, 31 Inlet of storage vessel, 32 Outlet of storage vessel, 33 Reservoir Detailed Implementation

[0030] It should be noted that, where there is no conflict, the embodiments and features in the embodiments of this utility model can be combined with each other. The present utility model will now be described in detail with reference to the accompanying drawings and embodiments.

[0031] The following is for reference. Figures 1-6 This invention describes an embodiment of the drug-coated balloon drug release rate detection system. Pump A provides power to the system and delivers liquid to a flow stabilizer B. The flow stabilizer B further stabilizes the liquid's flow rate and volume. The liquid passes through the flow stabilizer and enters a three-way connector C. The drug-coated balloon F enters the system through the balloon inlet of the three-way connector C. The drug-coated balloon F extends into a vascular stent device D, which contains an experimental blood vessel 15. The experimental blood vessel 15 can be a segment of blood from animals such as pigs, rabbits, or mice. The drug-coated balloon F completes the drug release rate detection within the vascular stent device D.

[0032] like Figures 2 to 4As shown, the vascular stent device D includes an outer tube 12, which is a hollow, transparent tube with a wall 122 of a certain thickness to withstand a certain water pressure. An inner cavity 123 accommodates two tubes. The unconnected end between the first tube 1-1 and the second tube 1-2 is located within the inner cavity 123. This unconnected section is used to connect to an experimental blood vessel 15. Both ends of the experimental blood vessel 15 are connected to the first tube 1-1 and the second tube 1-2, respectively. Each of the two tubes has a stepped portion 111 at its connection point with the experimental blood vessel 15. Figure 3 As shown, the end of the experimental blood vessel 15 is covered by a step portion 111, and then the experimental blood vessel 15 is fixed at the step portion 111. This ensures a more stable connection of the experimental blood vessel 15, preventing it from detaching or breaking due to the scouring of the liquid flow. A drain hole 112 is provided on the second pipe 1-2. During the drug-coated balloon experiment, a large amount of liquid will seep out from the experimental blood vessel 15. By adding a drain hole 112 to the second pipe 1-2, the liquid seeping out from the experimental blood vessel 15 can enter the second pipe through the drain hole 112, and then recirculate in the system. This ensures the experimental effect and the accuracy of the final result. Threaded connection ports 121 are provided at both ends of the outer tube 12. The threaded connection ports 121 are recessed inside the outer tube 12, and two pipes 11 extend out of the threaded connection ports. Two first sealing parts 13 pass through the two pipes and connect to the threaded connection ports 121, respectively, sealing the outer tube 12. The outer tube 12 protects the experimental blood vessel 15, keeping it stable during the test and blocking external interference.

[0033] Stabilizer B, for example Figure 5 As shown, the flow stabilizer B has a sealed bottle opening and a first liquid storage section 23 at the bottom, inside which a flow stabilizing ball 24 is installed. The length of the flow stabilizer inlet 21 within the first liquid storage section 23 is shorter than the flow stabilizer outlet 22, ensuring the stability of the outflowing liquid. The flow stabilizing ball 24 is used to reduce the water pressure of pump A, controlling the liquid flow within a certain range. In particular, the elastic flow stabilizing ball 24 can effectively act as a buffer. The flow stabilizer inlet 21 is connected to pump A, and the flow stabilizer outlet 22 is connected to one inlet of the tee connector C. When the liquid flows into the elastic flow stabilizing ball 24, it expands, but the size of the sealed container remains unchanged, thus limiting the volume of the flow stabilizing ball 24 and increasing the pressure inside the flow stabilizing ball 24. After reaching a certain pressure, the liquid flows out from the outlet, and the liquid becomes a steady flow after passing through the flow stabilizing ball 24. Compared with other brands of flow stabilizers, the flow stabilization effect is more obvious under low-flow conditions. The flow regulator B of this application can make the transition of liquid from pulsed form to continuous fluid form more obvious at lower flow rates compared to existing flow regulators on the market.

[0034] The device uses a three-way connector C with a screw-lock Luer connector. The device connected to the screw-lock Luer connector provides a valve and pathway for the drug-eluting balloon to enter the experimental blood vessel, allowing for precise positioning and drug release of the balloon without affecting system operation. The screw-lock Luer connector is opened when the drug-eluting balloon F passes through; it is closed when the balloon needs to be secured after reaching the designated position. The third end of the three-way connector C is connected to a second sealing part 14 of the vascular stent device D via a transparent tube.

[0035] Storage container E such Figure 6 As shown, the storage vessel E has a sealed neck, and the lower part is the second liquid storage section 33. The neck of storage vessel E is equipped with a storage vessel inlet 31 and a storage vessel outlet 32, and its inlet and outlet settings are similar to those of the flow stabilizer B. Storage vessel E contains medication to maintain a consistent drug concentration within the system, allowing for more accurate measurement of the drug-eluting balloon's parameters. The storage vessel inlet 31 is connected to one end of the vascular stent device D via a second sealing section 14 connected to two pipes. The storage vessel outlet 32 ​​is connected to the pump inlet, ultimately forming a circulation loop. Both pipes are made of stainless steel and may have a certain degree of reinforcement. Multiple discharge holes 112 can be provided on the second pipe 1-2 to increase the efficiency of liquid discharge.

[0036] In the drug release rate detection system for the drug-coated balloon, all devices except pump A are housed within a constant temperature chamber G. Chamber G is typically maintained at 37°C, the same temperature as human body temperature. Chamber G contains a liquid, which can be water, serum, or other drug solutions, ensuring the necessary temperature and liquid environment for the experiment.

[0037] Pump A can be either a centrifugal pump or an axial flow pump, with an axial flow pump being preferred. To simulate the characteristics of the heart pumping blood, the blood flow velocity in the blood vessels is not entirely uniform. Pump A can be equipped with multiple outlets, connecting to multiple drug-coated balloon F drug release rate detection systems, allowing for simultaneous execution of multiple drug-coated balloon experiments and improving efficiency.

[0038] The above description is merely a preferred embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the scope of the claims.

Claims

1. A vascular stent device, characterized in that, include: Two pipes spaced apart, The two pipes include a first pipe and a second pipe. The first pipe is used to allow liquid to enter, and the second pipe is used to allow liquid to exit. The second pipe is provided with a discharge hole. The two tubes are used to place experimental blood vessels; An outer tube is provided outside the two tubes at the location where the experimental blood vessel is placed; The two first sealing parts are respectively sealed to both ends of the outer tube through which the pipe passes.

2. The vascular stent device according to claim 1, characterized in that, The outer tube is provided with threaded interfaces at both ends; The two first sealing parts are sealed to the outer tube through the threaded interface; The pipes of the two pipes extend out of the threaded interface and extend; The outer tube is a transparent tube, and the threaded connection port of the outer tube is recessed.

3. The vascular stent device according to claim 1, characterized in that, The ends of the two tubes used to connect to the experimental blood vessel are connection ends. The connecting end is provided with a stepped portion for fixing both ends of the experimental blood vessel.

4. A drug release rate detection system for a drug-coated balloon, characterized in that, Includes the vascular stent device according to any one of claims 1 to 3 above; Also includes: pumps, The pump is used to pump liquid, and the pump outlet is connected to the inlet of the flow stabilizer. The outlet of the current stabilizer is connected to a three-way plug; One end of the three-way connector is the balloon inlet, and the other end is the liquid outlet. The liquid outlet is connected to the inlet of the vascular stent device, the outlet of the vascular stent device is connected to a storage vessel, and the outlet of the storage vessel is connected to the inlet of the pump.

5. The drug release rate detection system for drug-coated balloons according to claim 4, characterized in that, The flow stabilizer includes a hollow first liquid storage section, and a flow stabilizing ball is disposed inside the liquid storage section. The outlet of the flow stabilizer is longer than the inlet in the liquid storage section.

6. The drug release rate detection system for drug-coated balloons according to claim 5, characterized in that, The stabilizing sphere is an elastic sphere.

7. The drug release rate detection system for drug-coated balloons according to claim 4, characterized in that, The storage tank includes a hollow liquid storage section, and the length of the outlet of the storage tank in the liquid storage section is greater than the length of the inlet.

8. The drug release rate detection system for drug-coated balloons according to claim 4, characterized in that, The storage container is used to hold a certain concentration of medicine solution.

9. The drug release rate detection system for a drug-coated balloon according to claim 4, characterized in that, The pump includes at least two outlets for connection to different flow stabilizers.

10. The drug release rate detection system for a drug-coated balloon according to any one of claims 5 to 9, characterized in that, Also includes: A constant temperature chamber, which contains liquid to maintain the system at a certain temperature.

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