A device and method for testing the performance of a vascular anastomosis device

Abstract

The present application provides a kind of vascular anastomat performance testing device and method, for evaluating the performance of vascular anastomosis in tensile property and leakage property.The device includes a simulated blood flow part, a loading test part and an anastomosis experiment part.The simulated blood flow part includes a centrifugal pump, a solenoid valve, a temperature transmitter, a pressure transmitter, a flowmeter, a throttle valve, a heater and a liquid tank, for simulating the physical characteristics of actual blood pulsatile flow, the loading test part is used to evaluate the characteristics of the anastomosis performance of the anastomosis under load.The anastomosis experiment part can be used for vascular anastomosis experiment and leakage property evaluation in this part, to detect the leakage of anastomat in simulated blood flow circuit.The present application can comprehensively evaluate the performance of vascular anastomat, and provide reliable test data for clinical application.

Description

Technical Field

[0001] The present invention relates to the technical field of anastomosis apparatuses, and in particular to a device and method for testing the performance of a vascular anastomosis apparatus. Background Art

[0002] Vascular anastomosis performance testing includes tensile testing and leakage testing. The tensile testing evaluates the stability and durability of the anastomosis device under tension, while the leakage testing detects leakage within a simulated blood vessel. Currently, no device comprehensively tests and evaluates the performance of vascular anastomosis devices. Summary of the Invention

[0003] In view of this, the object of the present invention is to provide a vascular anastomosis performance testing device and method, which can achieve the purpose of vascular anastomosis training, testing manual vascular suturing and testing the performance of vascular anastomosis devices.

[0004] To achieve the above objectives, the present invention adopts the following technical solutions: a vascular anastomosis device performance test device, comprising a blood flow simulation portion, a load test portion, and an anastomosis test portion; the blood flow simulation portion is used to simulate the physical characteristics of actual blood pulsation flow; the load test portion is used to evaluate the anastomosis performance of the blood vessel under load after anastomosis; and the anastomosis test portion is used for vascular anastomosis testing and leakage performance evaluation.

[0005] The blood flow simulation part consists of a centrifugal pump, a solenoid valve, a temperature transmitter, a pressure transmitter, a flow meter, a throttle valve, a heater, a liquid storage tank and a hose;

[0006] The loading test part includes a dual-axis ball screw slide, a pressure sensor, a flange, a tensile tube, a right-angle fixing plate and a box-type linear slide;

[0007] The anastomosis experiment part includes an anastomosis box, a male thread pagoda connector, a flange, a stretch tube, a collection box, a liquid level transmitter and a solenoid valve.

[0008] In a preferred embodiment, the blood flow simulation part is used to simulate the pulsating characteristics of blood flow by controlling a centrifugal pump and an electromagnetic valve; and the blood vessel pressure in the loop is adjusted by adjusting the power of the centrifugal pump and the size of the throttle valve.

[0009] In a preferred embodiment, the pressure sensor is used to detect the axial load of the blood vessel; by controlling the rotation of the motor on the dual-axis ball screw slide, a load is applied to the anastomosed blood vessel, and the linear motion of the dual-axis ball screw slide brings about the movement of the right-angle fixed plate. The pressure sensor is fixed between the right-angle fixed plate and the flange, and the extrusion force of the right-angle fixed plate and the flange is received and transmitted by the pressure sensor.

[0010] In a preferred embodiment, in the anastomosis test part, the outer thread pagoda connector with appropriate diameter is replaced according to the size of the blood vessel to perform anastomosis of blood vessels of different sizes; after the blood vessel anastomosis, the leakage performance is evaluated by measuring the simulated artificial blood leaking out of the anastomosis test box.

[0011] In a preferred embodiment, the leakage performance is evaluated. During the leakage test, the leaked simulated artificial blood flows from the anastomosis test box into the collection box and is detected and transmitted in real time by the liquid level transmitter. Before the leakage test begins, the solenoid valve is opened to empty the liquid in the collection box.

[0012] In a preferred embodiment, the heater and thermometer in the simulated blood flow part control the power of the heater according to the temperature, so that the temperature of the simulated body fluid is kept constant at close to human body temperature.

[0013] In a preferred embodiment, the upper box-type linear slider is used to guide the stretch tube and provide support in the radial direction.

[0014] In a preferred embodiment, the centrifugal pump, solenoid valve, heater and dual-axis ball screw slide are all controlled by a console, and the detected pressure, load, temperature, flow and leakage signals are collected in the console and displayed on the console display.

[0015] The present invention provides a method for testing the performance of a vascular anastomosis device, which uses the aforementioned device for testing the performance of a vascular anastomosis device; the method comprises the following steps:

[0016] Step 1: Control the motor of the dual-axis ball screw slide to adjust the distance between the two ends of the external wire pagoda joint in the anastomosis test box;

[0017] Step 2: Select a complete and leak-free blood vessel, replace the appropriate external wire pagoda connector according to the size of the blood vessel, and fix the two ends of the blood vessel to the external wire pagoda connector;

[0018] Step 3: Open the simulated blood flow circuit and adjust the throttle valve and the power of the centrifugal pump to make the pressure in the blood vessel reach the standard value in the human body;

[0019] Step 4: Perform vascular anastomosis using the vascular anastomosis device to be tested in an anastomosis test box;

[0020] Step five, different loads were applied and the leaked fluid was collected to evaluate the anastomotic performance.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. Simulating blood pulsation circuit: By simulating the circuit of blood pulsation flow, the present invention can accurately simulate the flow of blood in the body, thereby improving the authenticity and reliability of the test results.

[0023] 2. Performance testing under loading conditions: The present invention can apply load to the vascular anastomosis device while simulating blood flow to test its performance under different load conditions, thereby ensuring the stability and reliability of the vascular anastomosis device in actual applications.

[0024] 3. Suitable for vascular anastomosis practice and evaluation: This device can not only be used to test the performance of new vascular anastomosis devices, but also can be used by doctors to practice vascular anastomosis and evaluate the anastomosis performance after manual suturing, providing doctors with a platform for practice and improvement of technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Shown is a top view of a vascular anastomosis device performance test device;

[0026] Figure 2 Display as Figure 1 Front view of the performance test device for a medium-sized vascular anastomosis device;

[0027] Figure 3 Display as Figure 1 Schematic diagram of the structure of the performance test device for medium-sized vascular anastomosis devices;

[0028] Figure 4 Display as Figure 1 Schematic diagram of the structure of the middle loading device;

[0029] Figure 5 Display as Figure 1 Schematic diagram of the structure of the anastomosis experiment operation box in the anastomosis experiment section;

[0030] Figure 6 Shown is a schematic diagram of the structure after anastomosis by the stapler in the anastomosis test box;

[0031] Figure 7 Shown is a schematic diagram of the structure of the stapler;

[0032] Figure 8 Display as Figure 1 A partial cross-sectional view of the leakage performance evaluation box in the middle matching experiment section;

[0033] Figure 9 Schematic diagram showing the structure of the leakage performance evaluation box. DETAILED DESCRIPTION

[0034] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0035] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0036] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application; as used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form, and it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or their combinations.

[0037] Unless otherwise defined, the technical or scientific terms used herein shall have the usual meaning as understood by a person of ordinary skill in the field to which the invention belongs. The terms "first" and "second" etc. used in the present invention are used to distinguish different objects, rather than to describe a specific order, quantity or importance. Similarly, similar terms such as "one", "an" or "the" do not indicate a quantity limitation, but are only used to indicate the existence of at least one. Similar terms such as "include" or "comprising" mean that the elements or objects preceding the term include the elements or objects listed after the term and their equivalents, without excluding other elements or objects. The term "connection" in the present invention includes direct and indirect connections unless otherwise specified.

[0038] The present invention provides a vascular anastomosis performance testing device and testing method, referring to Figure 1-9 , Figure 1 This is a top view of a vascular anastomosis performance test device, which includes a liquid reservoir 1, a centrifugal pump 2, a solenoid valve 3, a temperature transmitter 4, a pressure transmitter 5, a console 6, a vascular anastomosis device 7, an anastomosis experimental part 8, a loading device 9, a hose 10, a flow meter 11, a throttle valve 12, and a heater 13. The simulated blood flow part consists of the liquid reservoir 1, the centrifugal pump 2, the solenoid valve 3, the temperature transmitter 4, the pressure transmitter 5, the hose 10, the flow meter 11, the throttle valve 12, and the heater 13, and can simulate the pulsating flow of blood. Figure 2 This is a front view of the vascular anastomosis performance testing apparatus. Vascular suturing exercises and vascular anastomosis are performed in the anastomosis sample test section 8. During the anastomosis test, leaked fluid is collected in a leakage performance evaluation tank 14. Loading device 9 applies a load to both ends of the blood vessel to test its stability. Figure 3 This is a schematic diagram of the structure of a vascular anastomosis device performance test device.

[0039] In the present invention, Figure 4The schematic diagram of the loading device structure of the vascular anastomosis performance test device is shown. The loading device consists of a stretching tube 901, a box-type linear slider 902, a right-angle fixing plate 903, a pressure sensor 904, a flange 905, a dual-axis ball screw slide 906 and a motor 907. The stretching tube 901 is connected to the flange 905 through a threaded connection. The flange 905 is fixed to one end of the pressure sensor 904 and is fixed together on the right-angle fixing plate 903. As the slider on the dual-axis ball screw slide 906 moves, the flange 905 and the right-angle fixing plate 903 generate an extrusion force on the pressure sensor 904, which can detect the load on the blood vessel. The box-type linear slider 902 provides radial support for the stretching tube 901, thereby reducing the influence of radial gravity on the experiment.

[0040] In the present invention, Figure 5 The diagram shows the structure of the stapler operating box used in the anastomosis experiment. The box consists of a first male thread pagoda connector 801, anastomosis box 802, a second male thread pagoda connector 803, a stretch tube 804, and a flange 805. During the anastomosis experiment, male thread pagoda connectors 801 and 803 are replaced according to the vessel diameter, and the two ends of the vessel are secured to the box. During the leakage experiment, simulated artificial blood leaking from the anastomosis box 802 is collected to evaluate its leakage performance. Figure 6 The diagram shows the structure of the stapler after anastomosis in the stapler experimental operation box, wherein the blood vessel 701 is fixed on the first external wire pagoda connector 801 and the second external wire pagoda connector 803, and the stapler 702 performs anastomosis at the middle position of the blood vessel 701. The schematic diagram of the structure of the stapler 702 is shown in FIG. Figure 7 The vascular anastomosis device comprises an inner ring and an outer ring. The inner ring is used to support the blood vessel 701 and fix the blood vessel 701 together with the outer ring. The outer ring is tightened by rotating to achieve rapid anastomosis of the blood vessel.

[0041] In the present invention, Figure 8 The diagram shows a partial cross-sectional view of the leakage performance evaluation box of the anastomosis test section. The anastomosis performance evaluation box comprises a collection box 141, a liquid level transmitter 142, and a solenoid valve 143. During the leakage test, the leaked simulated artificial blood flows from the anastomosis test box into the collection box 141 and is detected and transmitted in real time by the liquid level transmitter 142. Before the leakage test begins, the solenoid valve 143 is opened to drain the liquid from the collection box to ensure the accuracy of the experiment. The solenoid valve 143 in the leakage performance evaluation box is controlled by the console 6. The structural diagram of the leakage performance evaluation box is shown in FIG. Figure 9 shown.

[0042] In this example of the present invention, the centrifugal pump 2, the solenoid valve 3, the heater 13 and the dual-axis ball screw slide 907 are all controlled by the console 6, and the pressure, load, temperature, flow and leakage signals detected by the pressure transmitter, pressure sensor, temperature transmitter, flow meter and liquid level transmitter are all collected in the console and displayed on the console display.

[0043] In an embodiment of the present invention, the present invention mainly simulates blood flow in the blood flow simulation part, applies load to the anastomosed blood vessel in the loading test part, and performs blood vessel anastomosis and leakage test in the anastomosis test part. The specific method of using the test device is as follows: Step 1, control the motor of the dual-axis ball screw slide to adjust the distance between the two ends in the anastomosis test box; Step 2, select a complete and leak-free blood vessel, and fix the two ends of the blood vessel on the external wire pagoda connector; Step 3, open the simulated blood flow circuit, adjust the power of the throttle valve and the centrifugal pump, so that the pressure in the blood vessel reaches the standard value in the human body; Step 4, use the vascular anastomosis device to be tested in the anastomosis test box to perform vascular anastomosis or manual suture operation; Step 5, apply different loads and collect leaked liquid to evaluate its anastomosis performance.

[0044] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any other manner. Any person skilled in the art may utilize the above-disclosed technical content to modify or modify the present invention into equivalent embodiments. However, any simple modifications, equivalent variations, and modifications to the above embodiments that do not depart from the technical content of the present invention and are based on the technical essence of the present invention remain within the scope of protection of the present invention.

Claims

1. A vascular anastomosis performance testing device, characterized in that: It consists of a blood flow simulation part, a loading test part and an anastomosis test part; the blood flow simulation part is used to simulate the physical characteristics of actual blood pulsation flow, the loading test part is used to evaluate the anastomosis performance of the blood vessels after anastomosis, and the anastomosis test part is used for vascular anastomosis experiments and leakage performance evaluation. The blood flow simulation part consists of a centrifugal pump, a solenoid valve, a temperature transmitter, a pressure transmitter, a flow meter, a throttle valve, a heater, a liquid storage tank and a hose; The loading test part includes a dual-axis ball screw slide, a pressure sensor, a flange, a tensile tube, a right-angle fixing plate and a box-type linear slide; The anastomosis experiment part includes anastomosis box, external thread pagoda connector, flange, stretch tube, collection box, liquid level transmitter and solenoid valve; The blood flow simulation part simulates the pulsation characteristics of blood flow by controlling the centrifugal pump and the electromagnetic valve; the blood vessel pressure in the loop is adjusted by adjusting the power of the centrifugal pump and the size of the throttle valve; The pressure sensor is used to detect the axial load of the blood vessel. The load is applied to the anastomosed blood vessel by controlling the rotation of the motor on the dual-axis ball screw slide. The linear motion of the dual-axis ball screw slide causes the movement of the right-angle fixing plate. The pressure sensor is fixed between the right-angle fixing plate and the flange. The squeezing force of the right-angle fixing plate and the flange is received and transmitted by the pressure sensor. In the anastomosis test, the outer thread pagoda connector with the appropriate diameter is replaced according to the size of the blood vessel to perform anastomosis of blood vessels of different sizes; after the blood vessel anastomosis, the leakage performance is evaluated by measuring the simulated artificial blood leaking from the anastomosis test box; During the leakage performance evaluation test, the leaking simulated artificial blood flows from the anastomosis test box into the collection box and is detected and transmitted in real time by the liquid level transmitter. Before the leakage test begins, the solenoid valve is opened to empty the liquid in the collection box.

2. A vascular anastomosis performance testing device according to claim 1, characterized in that: The heater and thermometer in the simulated blood flow part control the power of the heater according to the temperature, so that the temperature of the simulated body fluid is kept constant at a temperature close to that of the human body.

3. A vascular anastomosis performance testing device according to claim 1, characterized in that: The box-type linear slider is used to guide the stretch tube and plays a supporting role in the radial direction.

4. A vascular anastomosis performance testing device according to claim 1, characterized in that: The centrifugal pump, solenoid valve, heater and dual-axis ball screw slide are all controlled by the console, and the detected pressure, load, temperature, flow and leakage signals are all collected in the console and displayed on the console display.

5. A method for testing the performance of a vascular anastomosis device, characterized in that: A vascular anastomosis performance testing device according to any one of claims 1 to 4 is used; comprising the following steps: Step 1: Control the motor of the dual-axis ball screw slide to adjust the distance between the two ends of the external wire pagoda joint in the anastomosis test box; Step 2: Select a complete and leak-free blood vessel, replace the appropriate external wire pagoda connector according to the size of the blood vessel, and fix the two ends of the blood vessel to the external wire pagoda connector; Step 3: Open the simulated blood flow circuit and adjust the throttle valve and the power of the centrifugal pump to make the pressure in the blood vessel reach the standard value in the human body; Step 4: Perform vascular anastomosis using the vascular anastomosis device to be tested in an anastomosis test box; Step five, different loads were applied and the leaked fluid was collected to evaluate the anastomotic performance.

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