CN107610571A - Simulate blood pathway system - Google Patents

Abstract

The invention provides a kind of simulation blood pathway system for being used to assess Vascular implant, the simulation blood pathway system includes：Simulated blood vessel component, simulation heart components and simulation blood, simulation blood is located in simulated blood vessel component, simulation blood is set to form blood pathway circulation in simulated blood vessel component by simulating heart components, wherein, simulated blood vessel component includes at least two sections of simulated blood vessels and at least two sections of simulated blood vessels is connected at least one connection component of simulation blood circulation stream, and at least one connection component is arranged to be suitable for implantation into thing into simulated blood vessel.The system of this simulation blood circulation of human body of the present invention can simulate the intravascular environment under different heart rate, cardiac output in vitro, realize the monitoring of the use state of heart valve prosthesis and Vascular implant under simulated environment and the assessment of performance.

Description

Simulated blood flow system

technical field

The present invention relates to a simulated blood flow path system, more particularly, to a simulated blood flow path system for evaluating vascular implants.

Background technique

The blood circulation system (cardiovascular system) of the human body is composed of three parts: blood, blood vessels and heart. Among them, blood is a viscous liquid rich in various nutrients, blood vessels provide channels for the flow of blood, and the heart is the heart for blood. Circulation provides power (pressure and velocity of blood). When the blood vessels of the human body are aging, blocked and diseased, it will seriously affect the flow of blood. In order to improve this problem, a stent is implanted in the lesion to support the stenotic occlusion segment of the blood vessel, reduce the elastic recoil and reshaping of the blood vessel, and maintain the smooth blood flow in the lumen.

Whether it is a stent research and development company or a medical staff, it is necessary to evaluate the stent implanted in the human body. Common evaluations include: whether the stent can effectively prevent restenosis, whether the stent is displaced in the body, and the strength and fatigue of the stent itself. Whether the characteristics can meet the needs of long-term work in the human body. At present, the evaluation of the performance of the stent is to use imaging equipment to observe outside the body after the stent is implanted in the patient's body. This will not only increase the difficulty of observation, but more importantly, it will bring great risks to the patient. Unexpected conditions for vascular problems.

In order to solve this problem, simulated human blood vessels have emerged, which can be used by clinicians, medical device product R&D companies, etc. to simulate the clinical use environment of devices. However, most of the simulated blood vessels in the prior art are single local blood vessel pipelines, which can only simply simulate the local human blood circuit structure (for example, the pressure and flow velocity of the liquid in the simulated blood vessels are constant), and cannot simulate the physiological conditions in the human blood vessels (For example, it is impossible to match the pressure and flow velocity of the liquid in the simulated blood vessel with the blood pressure of the human body), let alone objectively reflect the state of the implanted medical device when it is used in the human blood vessel, such as the impact of the implanted device on the fluid flow rate and flow rate , the effect on the load on the heart and the load on the device itself.

Contents of the invention

In view of the problems of conventional simulation systems, an object of the present invention is to provide a simulated blood flow channel system capable of simulating a human body environment and evaluating vascular implants.

In order to achieve the above object, the present invention provides a simulated blood flow path system for evaluating vascular implants, the simulated blood flow path system includes: simulated blood vessel components, simulated heart components and simulated blood, the simulated blood is located in the simulated In the blood vessel assembly, the simulated blood is formed in the simulated blood vessel assembly through the simulated heart assembly to form a blood circulation, wherein the simulated blood vessel assembly includes at least two sections of simulated blood vessels and the at least two sections of simulated blood vessels are connected to form a simulated blood At least one connection component of the circulation flow path, the at least one connection component is configured to be suitable for the implant to enter the simulated blood vessel.

In some embodiments, the connection assembly includes a connection body connected to a simulated blood vessel, and the connection body is provided with a valve for the implant to enter. The valve includes a valve body, a knob disposed on the valve body, and a knob plug. The valve body is provided with a channel for the implant to enter. The knob is matched with the knob plug and is configured to move the Knob to change the channel size of the valve. A rubber tube runs through the channel of the valve, and the implant enters the simulated blood vessel through the rubber tube. The rubber tube and the valve body are sealed by a sealing plug, and the sealing plug is in interference fit with the valve body.

In a preferred embodiment, the connecting body is made of transparent material.

In a preferred embodiment, the connecting body includes an intermediate body between the joint port connecting the simulated blood vessel and the joint port, and the valve is arranged on the intermediate body.

In some embodiments, the simulated blood vessel is formed of a flexible material or a mixture of a flexible material and a imaging material. For example, flexible materials may include: silica gel, latex, rubber, and plexiglass, and developing materials may include silver iodide, barium sulfate, and calcium sulfate. Optionally, the inner wall of the simulated blood vessel may also be coated with a lubricating material to adjust the coefficient of friction of the inner wall of the blood vessel.

In some embodiments, the simulated blood flow system further includes a control device, the control device includes a pressure sensor, a flow meter and a thermometer, the pressure sensor is configured to detect the pressure of the simulated blood passing through the simulated blood vessel, and the flow meter arranged to detect flow of simulated blood passing through said simulated blood vessel, said thermometer arranged to detect a temperature of simulated blood passing through said simulated blood vessel, said control device being arranged to be based at least in part on said pressure sensor, flow meter and thermometer The detected parameters of the simulated blood are used to control the simulated heart component.

In some embodiments, the simulated blood flow system further includes a detection and evaluation device connected to the simulated blood flow system and configured to detect parameters of the implant based at least in part on Detected parameters to assess the performance of the implant. For example, the detected parameters include diameter change and displacement of the implant. The detection and evaluation equipment includes an image recognition device, a laser caliper and an evaluation device, the image recognition device is configured to detect the displacement of the implant, and the laser caliper is configured to detect the diameter of the implant Alternatively, the evaluating device is configured to evaluate the performance of the implant based at least in part on the detected parameter.

In a preferred embodiment, the detection and evaluation device further includes a computing device, the computing device calculates the twist degree, fatigue life and opening degree of the implant based at least in part on the detected parameters.

In a preferred embodiment, the implant is a stent.

Compared with the prior art, the present invention has the following beneficial technical effects:

In the present invention, since the simulated blood vessel assembly includes the simulated blood vessel and the connection assembly, which is a multi-segment blood vessel model, blood vessels in different parts can be connected into the system according to needs, without having to make a complete system for connecting all blood vessels. Thereby increasing the flexibility of using this system. At the same time, the location of the connecting components can also facilitate the implantation of the implant, so that this system can be used to evaluate the performance of vascular implants and the like.

At the same time, since the simulation system includes control equipment, the system can better simulate the heart rate and cardiac output of the human body, thereby better simulating the intravascular environment.

In addition, the simulation system can also include detection and evaluation equipment, which can monitor and evaluate the use of the vascular implant in the simulated environment.

This system for simulating human blood circulation of the present invention can be used for evaluating vascular implants, which can simulate the intravascular environment under different heart rates and cardiac output in vitro, and realize artificial heart valves and vascular implants in a simulated environment. Monitoring of usage status and evaluation of performance.

Description of drawings

FIG. 1 is a schematic diagram of a simulated blood flow path system according to an embodiment of the present invention;

Fig. 2 is a schematic diagram of the separation of the simulated blood vessels in Fig. 1;

Fig. 3 is the schematic diagram of the connection assembly of the partition in Fig. 2;

Figure 4a and Figure 4b are schematic diagrams of the working state and closed state of the valve of the connecting assembly;

Fig. 5 is a schematic diagram of a simulated blood flow path system according to a preferred embodiment of the present invention;

Fig. 6 is a schematic diagram of a simulated blood flow path system according to another embodiment of the present invention.

detailed description

Various aspects of the present invention will be described in detail below with reference to the drawings and specific embodiments. Wherein, the components in the drawings are not necessarily drawn to scale, and the emphasis is on illustrating the principles of the present invention.

In various embodiments of the invention, well-known structures or materials are not shown or described in detail. Furthermore, the described features, structures or characteristics of the invention may be combined in any manner in one or more embodiments. In addition, those skilled in the art should understand that the various implementations described below are only for illustration, rather than limiting the protection scope of the present invention. It will also be readily understood that the components of the various embodiments described herein and shown in the drawings may be arranged and designed in many different configurations or proportions.

[First Embodiment]

Fig. 1 is a schematic diagram of a simulated blood flow path system according to an embodiment of the present invention; Fig. 2 is a schematic diagram of the separation of the simulated blood vessel in Fig. 1; Fig. 3 is a schematic diagram of the connecting components at the partition in Fig. 2; Fig. 4a and Fig. 4b is a schematic diagram of the working state and closed state of the valve of the connection assembly.

As shown in Fig. 1, the simulated blood flow path system of the present invention includes: a simulated blood vessel component 1, simulated blood 2 and simulated heart component 3, the simulated blood 2 is located in the simulated blood vessel component 1, and the simulated blood 2 is placed in the simulated blood vessel component 3 through the simulated heart component 3 A blood circulation is formed in the simulated blood vessel assembly 1 .

The simulated blood is a liquid having a viscosity similar to that of blood. For example, a method of adding a thickener to ordinary water can be used to achieve a viscosity similar to that of real blood.

The simulated blood vessel component 1 is preferably a multi-segment blood vessel model, that is, it has multiple (at least two) simulated blood vessels 11, and the multiple simulated blood vessels are connected in series through the connecting component 12 to form a simulated blood circulation flow path. In this way, blood vessels in different parts can be connected to the system according to needs, without making a complete system for connecting all blood vessels, which can increase the flexibility of use. At the same time, the position of the connecting component can also facilitate the implantation of the implant.

For example, the simulated blood vessel component can simulate the human aortic vascular system, the simulated blood vessel can simulate the blood vessel of a healthy person, and can also simulate a diseased blood vessel and make a simulated blood vessel after bypass surgery. Fistula, vascular tumors, vascular sclerosis, etc. The simulated blood vessel can have the compliance of a real blood vessel, and implants (such as stents and/or catheters and/or guide wires) can be placed anywhere in the blood vessel.

For example, for a long simulated blood vessel, it can be processed in sections, and then connected with a connecting component; or according to the needs of the simulated operation, select the part where the incision needs to be made, cut off the complete simulated blood vessel, and then use the connecting component Connect the severed simulated blood vessels. As shown in Fig. 2, the entire aortic vascular system may have 17 cut-off points, and each cut-off point is connected by a connection assembly. The connection assembly 12 is configured to be suitable for an implant (not shown) to enter the simulated blood vessel 11, for example, when performing a simulated operation, the position can be used as a surgical incision to introduce guide wires, catheters (and stents) and the like.

As shown in FIG. 3 , the connection assembly 12 includes a connection body connected to the simulated blood vessel 11 , and the connection body is provided with a valve 122 for the implant (such as a catheter and/or guide wire 4 ) to enter. For example, the connecting body can be a tubular component. Preferably, after the connecting body connects two sections of simulated blood vessels, there is no protrusion or depression between the inner wall of the simulated blood vessel and the inner wall of the connecting body, so as to ensure that the flow of simulated blood is not hindered.

The connecting body may include the joint port 121 connecting the simulated blood vessel and the intermediate body 123 between the joint ports. The simulated blood vessel 11 and the joint port 121 are bonded with glue to achieve a better sealing effect. A joint intermediate body 123 is clamped between two joint ports 121 , and the joint port and the intermediate body are sealed with a sealing O-ring 124 , and the three can be fixedly connected by bolts 125 . The connecting body (ie, the joint port 121 and the joint intermediate body 123 ) is made of transparent materials. In an optional embodiment, the connecting body may also be an integral part, or made of other materials, as long as it can connect the simulated blood vessel 11 .

The valve 122 may be provided on the intermediate body 123 . The valve 122 includes a valve body 1221, a knob 1222 disposed on the valve body and a knob plug 1223. The valve body 1221 is provided with a channel for the implant 4 to enter. The channel size of the valve. A rubber tube 1224 passes through the channel of the valve, and the implant 4 enters the simulated blood vessel through the rubber tube 1224 .

As shown in Fig. 4a and Fig. 4b, the knob 1222 can be turned to move linearly, and the rubber tube 1224 can be compressed through the cooperation of the knob 1222 and the knob plug 1223, thereby reducing fluid leakage.

The rubber tube 1224 and the valve body 1221 can also be sealed by a sealing plug 1225, which can be made of rubber, and the sealing plug 1225 is in interference fit with the valve body 1221, for example, the diameter of the sealing plug 1225 is larger than that of the valve body 1221 inner hole diameter. In this way, during assembly, the sealing plug 1225 can be squeezed firmly to make it enter the valve body 1221. Diameter, forming an interference fit (for example, the tapered shape of the sealing plug), can realize the self-locking of the sealing plug, and can reduce the gap between the rubber tube 1224 and the implant, and can greatly reduce fluid leakage. At the same time, the water pressure in the blood vessel will also compress the rubber tube 1224 and the sealing plug 1225, reducing the gap between the rubber tube 1224 and the implant again.

The rubber tube 1224 can be replaced according to the thickness of the implant (such as a guide wire/catheter), and the inner diameter of the rubber tube 1224 can be selected to be equivalent to the outer diameter of the implant (such as a guide wire/catheter) to make the implant better It fits closely with the inner wall of the rubber tube 1224 to reduce the fit gap between the two so as to reduce fluid leakage. At the same time, when the implant is placed, the pressure of the fingers can also be used to press the outer wall of the rubber tube 1224 protruding from one end of the valve, so as to block part of the rubber tube to prevent fluid from leaking out.

In an optional embodiment, the valve can also be a shut-off valve such as a gate valve, a globe valve, a ball valve, a butterfly valve, a needle valve, and a diaphragm valve. The simulated blood inside does not leak out.

The simulated blood vessel may be formed from a flexible material or a mixture of a flexible material and a visualization material. For example, the flexible material includes: silica gel, latex, rubber and organic glass (preferably silica gel or latex), and the developing material includes silver iodide, barium sulfate, calcium sulfate. The simulated blood vessel formed after adding the developing material can be developed under X-ray, which is convenient for simulating the doctor's operation environment. Simulated blood vessels can be transparent or different colors. The inner wall of the simulated blood vessel can be coated with a lubricating material to adjust the friction coefficient of the inner wall of the blood vessel to ensure that the friction coefficient of the blood vessel wall is close to the physiological state of the human blood vessel.

In this embodiment, based on the CT scan data, data analysis software such as minics (interactive medical image control system of Materialize Company) can be used to establish a three-dimensional model of human blood vessels, thereby making (for example, 3D printing and injection molding can be used) Production technology) Simulated blood vessels that simulate human blood vessels. Such fabrication methods allow for accurate models of major blood vessels. For small blood vessels in the human body (that is, it is difficult to reconstruct or make a model in three dimensions), the structure of the blood vessel can be simplified, such as assuming that the curved blood vessel with variable cross-section is a straight blood vessel with a constant diameter under the premise of ensuring similar diameter and length. A model simulating blood vessels is thereby obtained.

This method can also be used to model the heart in a simulated heart assembly to obtain an accurate 3D model of the heart.

As shown in Figure 1, the simulated heart assembly also includes a reservoir 30 for storing simulated blood, a simulated heart 31, an electric valve 32 connected between the reservoir 30 and the simulated heart 31, a compression piston 33 and a one-way valve 34. The end of the simulated blood vessel is provided with a water outlet switch valve 13 for controlling the passage of simulated blood. As shown in Figure 1, the simulated blood flows out of the reservoir through the one-way valve 34, the compression piston 33 and the electric valve 32 into the simulated heart, and the simulated heart distributes the simulated blood to each simulated blood vessel, and when the simulated blood flows to the end of each blood vessel Flow out through the water outlet valve 13 and get back in the liquid reservoir. This blood circulation can be a closed circuit system.

The simulated heart component 3 can use a motor to drive the piston 33 to make the simulated blood flow through the simulated blood vessel component in a pulsating flow. The motor includes but is not limited to a linear motor, an electromagnetic motor, a solenoid valve, a centrifugal pump, etc. Usually, the movement frequency and stroke of the piston can be calculated from the heart rate and cardiac output of normal people. By controlling the opening and closing of the valves 32/34 and the movement of the piston 33, the simulated heart can be controlled to output the simulated blood to each simulated blood vessel according to a certain frequency, so that the simulated blood flows through the simulated blood vessel components. By controlling the opening and closing of the valve 13, the blood can be controlled to flow back into the reservoir at a certain frequency. Thus controlling the simulated heart component can simulate the human heart to affect the blood flow.

The simulated heart can be an output that simulates a constant heart rate, or an output that simulates a different heart rate. The simulated heart assembly can also be turbine-driven, and the power can be derived from pneumatics.

In an optional embodiment, the simulated blood vessel component may only include arteries, may also include veins, or may be a certain segment of blood vessels. It can also be used as a human blood vessel model, or an animal blood vessel model. The size of the model can be a real human blood vessel size, or a reduced or enlarged model.

[Second Embodiment]

Embodiments of the present invention also provide a preferred solution of the above simulated blood flow path system.

Fig. 5 is a schematic diagram of a simulated blood flow path system according to a preferred embodiment of the present invention.

As shown in FIG. 1 and FIG. 5 , the simulated heart component 3 is connected in series with the simulated blood vessel component 1 , and the simulated blood 2 forms a blood circulation in the simulated blood vessel component 1 through the simulated heart component 3 .

As shown in Figure 5, the simulated blood flow system further includes a control device 5, the control device 5 includes a pressure sensor (not shown), a flow meter (not shown) and a thermometer (not shown), the pressure sensor is set to detect the simulated The pressure of the simulated blood passing through the blood vessel assembly, the flow meter is set to detect the flow rate of the simulated blood passing through the simulated blood vessel assembly, the thermometer is set to detect the temperature of the simulated blood passing through the simulated blood vessel assembly, and the control device 5 is set to at least partially ground pressure Parameters of simulated blood detected by sensors, flow meters, and thermometers are used to control simulated heart components. Pressure sensors, flow meters, and thermometers may also be placed at the distal end of the simulated blood vessel or at other locations. For example, the movements of the pistons and valves of the simulated heart assembly are adjusted based on the measured pressure and flow to control the simulated heart to output a simulated heart rate.

By detecting the pressure and flow of simulated blood, fluid evaluation of heart valves and implants can also be performed, such as the impact of implants on the heart load, the regurgitation of heart valves can be calculated, and the flow of implants in blood vessels can also be monitored. Whether the movement of the implant will cause blockage of other branch vessels, and the impact of the implant on the normal flow of blood, etc.

It can also be used in combination with a heating rod to adjust the temperature in the blood vessel line in real time according to the temperature measured by the thermometer.

In other embodiments, it is also possible to simulate the vascular fluid distribution after vascular bypass and test the blood flow distribution at the bypass by connecting the blockage of vascular lesions.

[Third Embodiment]

The embodiment of the present invention also provides another preferred solution of the above simulated blood flow path system.

Fig. 6 is a schematic diagram of a simulated blood flow path system according to another preferred embodiment of the present invention.

As shown in FIG. 6, the simulated blood flow system further includes a detection and evaluation device 6, which is connected to the simulated blood flow system and configured to detect parameters of the implant (such as a stent) and at least partially based on the detection and evaluation device 6. parameters to evaluate the performance of the implant. For example, detected parameters may include diameter change and displacement of the implant, among others. The detection and evaluation equipment may include an image recognition device, a laser caliper, and an evaluation device, etc., wherein the evaluation device is configured to evaluate the performance of the implant based at least in part on the detected parameters.

The image recognition device can be configured to detect the displacement of the implant, for example, the image recognition device can be a camera, and obtain the position of the implant at different time points by taking pictures, so as to obtain the displacement of the implant.

A laser caliper may be configured to detect changes in the diameter of the implant. According to the YY/T 0808-2010 standard, during the stent fatigue test, the outer diameter of the stent is equal to the inner diameter of the simulated blood vessel, and the standard also lists the relationship between the inner diameter and the outer diameter of the simulated blood vessel. Therefore, the outer diameter of the stent can be estimated by measuring the outer diameter of the simulated blood vessel. In the actual operation process, the outer diameter of the simulated blood vessel can be measured with the help of a laser caliper, which is a non-contact measuring instrument, and the measurement process will not affect the flow of blood in the simulated blood vessel. Such measurement monitoring can measure and monitor the change in diameter of the simulated blood vessel at the implantation site, so as to obtain the change in diameter of the implant.

Preferably, the detection and evaluation device further comprises computing means based at least in part on the detected parameters to calculate the torsion, fatigue life and opening area of the implant. For example, the fatigue life can be evaluated through the S/N fatigue life curve. The aperture can be calculated by the ISO 5840 formula. It is also possible to mark several marks on the implant (such as a stent), and use an image recognition device (camera, etc.) to shoot and evaluate the relative displacement between each mark, thereby calculating the degree of distortion.

For example, the displacement parameter can be used to evaluate the deformation of the implant, and then inversely deduce various mechanical properties, so as to predict and calculate the performance of the product after a long time, such as fatigue life.

The terms and expressions used in the description of the present invention are for the purpose of illustration only and are not meant to be limiting. Those skilled in the art will understand that various changes may be made to the details of the above-described embodiments without departing from the basic principles of the disclosed embodiments. Therefore, the protection scope of the present invention is determined only by the claims, and in the claims, unless otherwise stated, all terms should be interpreted in the broadest and reasonable sense.

Claims (16)

1. A simulated blood flow path system for evaluating vascular implants, characterized in that the simulated blood flow path system includes: a simulated blood vessel component, a simulated heart component and simulated blood, the simulated blood is located in the simulated blood vessel component, through The simulated heart component makes the simulated blood form a blood circulation in the simulated blood vessel component, Wherein, the simulated blood vessel assembly includes at least two sections of simulated blood vessels and at least one connection component connecting the at least two sections of simulated blood vessels into a simulated blood circulation flow path, and the at least one connection component is configured to be suitable for the implant into the simulated blood vessel. 2 . The simulated blood flow system according to claim 1 , wherein the connection assembly includes a connection body connected to a simulated blood vessel, and the connection body is provided with a valve for the implant to enter. 3 . 3. The simulated blood flow system according to claim 2, wherein the valve comprises a valve body, a knob disposed on the valve body and a knob plug, and the valve body is provided with a channel for the implant Entering, the knob cooperates with the knob plug and is configured to change the channel size of the valve by moving the knob. 4. The simulated blood flow system according to claim 3, wherein a rubber tube runs through the channel of the valve, and the implant enters the simulated blood vessel through the rubber tube. 5 . The simulated blood flow path system according to claim 4 , wherein the rubber tube and the valve body are sealed by a sealing plug, and the sealing plug is an interference fit with the valve body. 6 . 6. The simulated blood flow path system according to claim 2, wherein the connecting body is made of transparent material. 7 . The simulated blood flow system according to claim 2 , wherein the connecting body includes an intermediate body between the joint port connecting the simulated blood vessel and the joint port, and the valve is arranged on the intermediate body. 8 . 8. The simulated blood flow path system according to claim 1, wherein the simulated blood vessel is formed of a flexible material or a mixture of a flexible material and a developing material. 9 . The simulated blood flow path system according to claim 8 , wherein the flexible material comprises: silica gel, latex, rubber and plexiglass, and the developing material comprises silver iodide, barium sulfate, and calcium sulfate. 10. The simulated blood flow path system according to claim 1, wherein the inner wall of the simulated blood vessel is coated with lubricating material to adjust the friction coefficient of the inner wall of the blood vessel. 11. The simulated blood flow system according to claim 1, wherein the simulated blood flow system further comprises a control device, the control device includes a pressure sensor, a flow meter and a thermometer, and the pressure sensor is set to Detecting the pressure of the simulated blood passing through the simulated blood vessel, the flowmeter is set to detect the flow rate of the simulated blood passing through the simulated blood vessel, the thermometer is set to detect the temperature of the simulated blood passing through the simulated blood vessel, the control device The simulated heart assembly is configured to be controlled based at least in part on parameters of the simulated blood detected by the pressure sensor, flow meter and thermometer. 12. The simulated blood flow system according to any one of claims 1 to 11, characterized in that, the simulated blood flow system further comprises detection and evaluation equipment connected to the simulated blood flow A system configured to detect a parameter of the implant and to assess performance of the implant based at least in part on the detected parameter. 13. The simulated blood flow path system according to claim 12, wherein the detected parameters include diameter change and displacement of the implant. 14. The simulated blood flow path system according to claim 13, wherein the detection and evaluation equipment comprises an image recognition device, a laser caliper and an evaluation device, and the image recognition device is configured to detect the implant The laser caliper is configured to detect a change in diameter of the implant, and the evaluation device is configured to evaluate performance of the implant based at least in part on the detected parameter. 15. The simulated blood flow path system according to claim 14, characterized in that, the detection and evaluation equipment further comprises a computing device, and the computing device calculates the Twist, fatigue life and opening. 16. The simulated blood flow path system according to claim 12, wherein the implant is a stent.