Calibration device for pressure guide wire

Abstract

This application relates to the field of medical device technology, and provides a calibration device for a pressure guidewire, including a vascular simulation circuit and a pressure testing device. The vascular simulation circuit includes a connecting pipe, and a pump and a control valve connected sequentially through the connecting pipe. A biomimetic solution is placed inside the connecting pipe, and the pump provides power to drive the biomimetic solution to circulate. The pressure testing device is connected to the connecting pipe and has a head end for acquiring the liquid pressure in the connecting pipe. The control valve includes a main pipe and a first branch pipe and a second branch pipe respectively disposed on the main pipe. The connecting pipe includes a first pipe and a second pipe. One end of the first pipe is connected to the pump and the other end is connected to the second branch pipe. One end of the second pipe is connected to the pump and the other end is connected to the main pipe. The second branch pipe is used for inserting the pressure guidewire to be tested. The vascular simulation circuit simulates the real human intervention environment, reduces the influence of environmental errors, and improves calibration accuracy.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a calibration device for a pressure guidewire. Background Technology

[0002] Coronary artery disease (CAD) is a condition in which the coronary arteries become narrowed or blocked due to the accumulation of atherosclerotic plaques, leading to myocardial ischemia, angina pectoris, and even myocardial infarction. Fractional flow reserve (FFR) is a core physiological and functional indicator used to assess the impact of coronary artery stenosis on blood flow. It measures the pressure at different locations within the coronary arteries—specifically, the ratio of the pressure distal to the stenosis at the point of maximum myocardial congestion to the mean pressure in the aorta proximal to the stenosis—to determine whether the stenosis caused by plaque is severe enough to require intervention. This assessment technique has become the gold standard for diagnosing coronary artery disease in clinical practice. Currently, FFR values ​​are primarily obtained by clinicians through interventional measurement of the coronary arteries using a pressure guidewire.

[0003] The accuracy of pressure guidewire testing directly affects diagnostic outcomes and patient prognosis, its importance being self-evident. Therefore, calibration of medical pressure guidewires is a crucial step in ensuring their measurement accuracy and reliability. Current methods involve applying pressure to the guidewire tip using a standard pressure source, recording the guidewire's output values ​​under different standard pressures, and then correcting the correlation between the guidewire's output signal and the actual pressure. However, the pressure environment of the guidewire in an interventional vessel differs from that in a non-interventional environment. Consequently, the above calibration method is susceptible to environmental errors, leading to discrepancies between the guidewire's measurement data in a real human interventional setting and actual blood pressure, thus affecting the accuracy of guidewire testing. Utility Model Content

[0004] The purpose of this application is to provide a calibration device for pressure guidewires, which aims to solve the problem that existing calibration methods for pressure guidewires in non-invasive environments suffer from environmental errors that affect the calibration accuracy of the guidewires.

[0005] In a first aspect, embodiments of this application provide a calibration device for a pressure guidewire, comprising a vascular simulation circuit and a pressure testing device; the vascular simulation circuit includes a connecting pipe, and a pump body and a control valve connected sequentially through the connecting pipe; a biomimetic solution is disposed within the connecting pipe, and the pump body provides power to drive the biomimetic solution to circulate; the pressure testing device is connected to the connecting pipe; the pressure testing device has a head end for acquiring the liquid pressure in the connecting pipe; the control valve includes a main pipe, and a first branch pipe and a second branch pipe respectively disposed on the main pipe; the connecting pipe includes a first pipe and a second pipe; one end of the first pipe is connected to the pump body, and the other end is connected to the second branch pipe; one end of the second pipe is connected to the pump body, and the other end is connected to the main pipe; the second branch pipe is used for inserting the pressure guidewire to be tested.

[0006] In some embodiments, the second pipeline has a detection segment connected to the main pipe, and the head end is located at the detection segment; the axial direction of the detection segment, the axial direction of the main pipe, and the axial direction of the second branch pipe coincide.

[0007] In some embodiments, the second branch pipe is provided with a leak-proof valve assembly for the guide wire of the pressure to be tested to pass through, and the leak-proof valve assembly is used to seal the guide wire of the pressure to be tested.

[0008] In some embodiments, the connecting pipe is made of silicone.

[0009] In some embodiments, the inner diameter of the connecting pipe is in the range of 2 to 10 mm.

[0010] In some embodiments, the wall thickness of the connecting pipe ranges from 0.5 to 2 mm.

[0011] In some embodiments, the connecting conduit is transparent.

[0012] In some embodiments, the pump body is a pulsating pump; the pulsation frequency range of the pump body is set to 30–200 bpm.

[0013] In some embodiments, the pump body is a pulse pump; the pressure range of the pump body is set to 0–200 mmHg.

[0014] In some embodiments, the vascular simulation circuit further includes a T-connector, the T-connector having a "T"-shaped structure, the T-connector including a horizontal tube and a branch tube vertically disposed on the horizontal tube; the horizontal tube is connected to the second pipeline, and the head end of the pressure testing device is inserted into the branch tube.

[0015] In some embodiments, the calibration device further includes a test circuit assembly, which includes a signal tester, a first electrical wire and a second electrical wire disposed at both ends of the signal tester; the first electrical wire is connected to the proximal end of the pressure guide wire to be tested, and the second electrical wire is disposed in the connecting conduit to contact the biomimetic solution.

[0016] The beneficial effects of this application are as follows: The vascular simulation circuit forms a fluid circulation loop through the pump body, connecting pipeline, and control valve; the pump body provides power to control the biomimetic solution to circulate along the loop at a set flow rate in the connecting pipeline, simulating the blood circulation system in the human body; during calibration, the pressure guidewire under test is inserted into the connecting pipeline through the control valve and outputs hydraulic signal parameters according to the hydraulic output signal parameters in the connecting pipeline, thereby simulating the real human intervention environment, reducing the influence of environmental errors, and improving calibration accuracy. Electrical signal parameter data at different times can be obtained through the pressure guidewire under test, while the pressure testing device is used to obtain standard pressure data at the same location at different times. By correlating multiple sets of electrical signal parameters at the same time with the standard pressure data, relevant calibration curves can be obtained, completing the calibration and correction of the signal parameters output by the pressure guidewire under test, achieving the purpose of accurate calibration, and improving the measurement accuracy and reliability of the pressure guidewire under test. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the structure of a calibration device provided in one embodiment of this application;

[0019] Figure 2 A schematic diagram of the structure of a calibration device for calibrating a pressure guide wire under test, as provided in an embodiment of this application;

[0020] Figure 3 This is a schematic diagram of the structure of a pressure testing device connected to a blood vessel simulation circuit according to an embodiment of this application.

[0021] The following are the labeling elements in the figure:

[0022] 100. Vascular simulation circuit; 200. Pressure guidewire to be tested;

[0023] 1. Connecting pipeline; 110. First pipeline; 120. Second pipeline; 101. Inspection section;

[0024] 2. Pump body;

[0025] 3. Control valve; 310. Main pipe; 320. First branch pipe; 330. Second branch pipe;

[0026] 4. Pressure testing device; 410. Head end;

[0027] 5. Leak-proof valve assembly;

[0028] 6. Tee connector; 610. Horizontal pipe; 620. Branch pipe.

[0029] 300. Test circuit components;

[0030] 7. Signal tester; 710. First conductor; 720. Second conductor. Detailed Implementation

[0031] The embodiments of this application are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this application, and should not be construed as limiting this application.

[0032] In the description of this application, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0033] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0034] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0035] In this application, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0036] In the field of interventional medical device technology, the direction closer to the operator is generally defined as proximal, and the direction farther from the operator is defined as distal. The direction of the central axis of objects such as cylinders and tubes is defined as axial. Radial refers to the direction passing through the central axis in the radial plane, for example, a straight line along a diameter or radius, or a straight line perpendicular to the central axis.

[0037] refer to Figure 1 and Figure 2 This application provides a calibration device for a pressure guidewire, including a vascular simulation circuit 100 and a pressure testing device 4. The vascular simulation circuit 100 includes a connecting pipe 1, and a pump body 2 and a control valve 3 connected sequentially through the connecting pipe 1. A biomimetic solution is placed inside the connecting pipe 1, and the pump body 2 provides the power to drive the biomimetic solution to circulate. The pressure testing device 4 is connected to the connecting pipe 1 and has a head end 410 for acquiring the liquid pressure in the connecting pipe 1. The control valve... 3 includes a main pipe 310, and a first branch pipe 320 and a second branch pipe 330 respectively disposed on the main pipe 310; the connecting pipe 1 includes a first pipe 110 and a second pipe 120; one end of the first pipe 110 is connected to the pump body 2, and the other end is connected to the second branch pipe 320; one end of the second pipe 120 is connected to the pump body 2, and the other end is connected to the main pipe 310; the main pipe 310 and the first branch pipe 320 are respectively connected to the connecting pipe 1; the second branch pipe 330 is used for the guide wire 200 to be tested to pass through.

[0038] During the specific test, the pressure guide wire 200 to be tested is inserted into the second pipeline 120 through the second branch pipe 330; and the distal end of the pressure guide wire 200 to be tested extends to the position of the head end.

[0039] Specifically, the vascular simulation circuit 100 forms a fluid circulation circuit through the pump body 2, the connecting pipe 1, and the control valve 3; the two ends of the pump body 2 are respectively connected to the first pipe 110 and the second pipe 120. The pump body 2 is used to provide power to control the biomimetic solution to circulate along the circuit at a set flow rate in the connecting pipe 1, thereby simulating the blood circulation system in the human body; during the calibration process, the pressure guide wire 200 to be tested is inserted into the connecting pipe 1, and according to the hydraulic output signal parameters in the connecting pipe 1, the real human intervention environment is simulated to reduce the influence of environmental errors.

[0040] It should be noted that by adjusting the output power of the pump body 2 and the size parameters (inner diameter, thickness) of the connecting pipe 1, the fluid dynamic parameters of the biomimetic fluid in the connecting pipe 1, such as flow rate, flow volume, and pressure, can be adjusted so that the dynamic parameters of the biomimetic fluid are as close as possible to those of human blood.

[0041] The biomimetic solution can be set as, but is not limited to, salt solution, artificial blood, etc.

[0042] refer to Figure 1 The head end 410 of the pressure testing device 4 is placed in the biomimetic solution of the second pipeline 120, and the pressure testing device 4 can monitor the pressure of the biomimetic solution at the current position of the second pipeline 120 in real time. Understandably, the blood vessel simulation circuit 100 of this application is used to simulate the blood circulation system in the human body, connects the pipeline 1 to simulate blood vessels, and then the pressure value detected by the pressure testing device 4 is the simulated blood pressure value.

[0043] The pressure testing device 4 is a standard pressure sensor used to provide high-precision, high-stability, and traceable pressure measurements. It is a device that can be used as a reference to calibrate the pressure guide wire 200 under test.

[0044] refer to Figure 2 The main pipe 310 of the control valve 3 is connected to the first branch pipe 320 and serves as part of the circuit, through which the biomimetic solution flows. The second branch pipe 330 of the control valve 3 is connected to the main pipe 310. The pressure test guide wire 200 can pass through the second branch pipe 330 and the main pipe 310 to enter the second pipeline 120, and control the distal end of the pressure test guide wire 200 to extend into and stay at the position of the head end 410, that is, to ensure that the hydraulic pressure on the distal end of the pressure test guide wire 200 is consistent with the hydraulic pressure tested by the pressure testing device 4.

[0045] Understandably, the pressure testing device 4 can be connected to external devices such as computers to collect pressure data at different times.

[0046] In some embodiments, the pressure guidewire 200 of this application is a precision instrument for interventional medical diagnosis. The distal end of the pressure guidewire 200 has a sensing structure with a capacitive effect (capacitance changes with stress). When the distal end of the guidewire is subjected to pressure, the sensing structure deforms, causing a change in capacitance. By constructing a bridge circuit with a testing instrument, the testing instrument outputs a digital parameter value (capacitance parameter). The testing instrument collects capacitance parameter data at different times. Simultaneously, the pressure testing device 4 is used to test the standard pressure data at different times at the distal end of the guidewire. By correlating multiple sets of capacitance parameters (C) at the same time with the standard pressure (P) data, the calibration curve P = f(C) of pressure and capacitance can be obtained. Then, based on the capacitance parameter detected by the pressure guidewire, the required pressure value is accurately obtained according to the calibration curve P = f(C), thereby completing the calibration and correction of the capacitance signal output by the pressure guidewire 200, ensuring that its measurement result is consistent with the actual pressure value, achieving the purpose of accurate calibration, and improving the measurement accuracy and reliability of the pressure guidewire 200.

[0047] In some other embodiments, the pressure guidewire 200 of this application is a precision instrument for interventional medical diagnosis. The distal end of the pressure guidewire 200 has a sensing structure with a piezoresistive effect (resistance changes with stress). When the distal end of the guidewire is subjected to pressure, the sensing structure deforms, causing a change in resistance. By constructing a bridge circuit with a signal instrument, the signal instrument outputs a digital parameter value (resistance parameter). The signal instrument collects resistance parameter data at different times. Simultaneously, the pressure testing device 4 is used to test the pressure at the distal end of the guidewire. By mapping multiple sets of resistance parameters (Ω) at the same time to standard pressure (P) at different times, a calibration curve P = f(Ω) for pressure versus capacitance can be obtained. Then, based on the resistance parameter detected by the pressure guide wire under test, the required pressure value can be accurately obtained according to the calibration curve P = f(Ω). This completes the calibration and correction of the resistance signal output by the pressure guide wire 200 under test, ensuring that the measurement result is consistent with the actual pressure value, achieving the purpose of accurate calibration, and improving the measurement accuracy and reliability of the pressure guide wire 200 under test.

[0048] It should be noted that the sensing structure at the distal end of the pressure measuring guide wire 200 is not limited to having a capacitive effect or a piezoresistive effect, but may also have a piezoelectric effect, etc.; the device of this application can be used to calibrate the pressure measuring guide wire 20.

[0049] refer to Figure 1 and Figure 2In some embodiments, the second pipeline 120 has a detection segment 101 connected to the main pipe 310, and the head end 410 is located at the detection segment 101; the axial direction of the detection segment 101, the axial direction of the main pipe 310 and the axial direction of the second branch pipe 330 coincide.

[0050] Specifically, the head end 410 of the pressure testing device 4 is used to measure the hydraulic pressure at the test segment 101, and then the distal end of the pressure test guide wire 200 is used to extend into the test segment 101. The axial directions of the test segment 101, the main pipe 310, and the second branch pipe 330 are coincident, so the pressure test guide wire 200 can be quickly inserted into the connecting pipe 1 by passing through the second branch pipe 330 and the main pipe 310, making it easier to push the pressure test guide wire 200 and making the operation more convenient. Subsequently, the pressure test guide wire 200 tends to be inserted into the test segment 101 in a straight line, effectively reducing the interference of bending stress on the guide wire, so that the pressure measured by the pressure test guide wire 200 is ideally close to the standard pressure at the current position, improving the measurement accuracy of the pressure test guide wire 200.

[0051] refer to Figure 1 In some embodiments, the second branch pipe 330 is provided with a leak-proof valve assembly 5 through which the pressure test guide wire 200 passes, and the leak-proof valve assembly 5 is used to seal the pressure test guide wire 200.

[0052] Understandably, the pressure test guide wire 200 is inserted into the second pipeline 120, and the leak-proof valve assembly 5 is used to seal the pressure test guide wire 200, effectively limiting the bionic leakage in the circuit and improving the reliability of the device.

[0053] In some embodiments, the control valve 3 of this application is a medical Y-type valve, which is a device specifically designed for medical interventional procedures. It is mainly used for guidewire insertion and at the same time ensures a leak-proof seal.

[0054] In one specific embodiment of this example, the main pipe 310 is threadedly connected to the second pipe 120, and the first branch pipe 320 is threadedly connected to the first pipe 110; this ensures that the control valve 3 is tightly connected to the connecting pipe 1 to prevent leakage.

[0055] Preferably, a sealing silicone sealant can be installed at the connection between the control valve 3 and the connecting pipe 1 to enhance the sealing effect.

[0056] The leak-proof valve assembly 5 can be a silicone / rubber diaphragm, a pressure valve, a check valve, or other structures. This application does not limit the specific structure of the leak-proof valve assembly 5, as long as it can achieve a sealing and leak-proof effect on the guide wire after the pressure to be tested guide wire 200 is inserted.

[0057] In some embodiments, the leak-proof valve assembly 5 can be a silicone / rubber valve (such as an umbrella-shaped or slit-type design). After the pressure test guide wire 200 is inserted into the valve, the valve uses an elastic material to adaptively wrap the guide wire, achieving an effective seal. In other embodiments, the leak-proof valve assembly 5 has a sealing ring. After the pressure test guide wire 200 is inserted into the sealing ring, the sealing ring seals the guide wire. In still other embodiments, the leak-proof valve assembly 5 is a rotary clamping valve. After the pressure test guide wire 200 is inserted, the seal is enhanced by manually tightening it.

[0058] In some embodiments, the connecting pipe 1 is made of silicone.

[0059] Understandably, the connecting tube 1 is made of silicone tubing. The elasticity and softness of silicone are close to those of real blood vessels (especially veins), which can simulate the expansion, contraction and pulsation behavior of blood vessels; and it can withstand repeated deformation (such as simulating blood flow pressure) and is not easy to break.

[0060] Furthermore, the connecting pipe 1 can be made from silicone material using injection molding, 3D printing, or mold forming, exhibiting excellent processing performance and low manufacturing cost.

[0061] In some embodiments, the inner diameter of the connecting pipe 1 ranges from 2 to 10 mm.

[0062] Specifically, the pressure guidewire 200 of this application is used to measure the fractional flow reserve (FFR), that is, to be used in the coronary artery in the human body; then, in order to simulate the real detection environment, the inner diameter of the connecting tube 1 is designed to be close to the inner diameter of the human coronary artery; specifically, the inner diameter of the connecting tube 1 can be within the range of 2-4mm, 4-6mm, 6-8mm, and 8-10mm in the human body.

[0063] In some embodiments, the wall thickness of the connecting pipe 1 ranges from 0.5 to 2 mm.

[0064] Understandably, the wall thickness of connecting pipe 1 is close to the wall thickness of the human coronary artery. Specifically, the wall thickness of connecting pipe 1 can be any value among 0.5mm, 1.0mm, 1.5mm, and 2.0mm.

[0065] In some embodiments, the connecting conduit 1 is transparent. The transparency of the connecting conduit 1 refers to its property of allowing light to pass through without significant scattering or absorption, so that its internal structure can be clearly seen.

[0066] Specifically, the connecting pipe 1 is made of transparent material, which makes the connecting pipe 1 transparent and realizes the internal visualization effect of the connecting pipe 1. That is, it is convenient for the operator to directly observe the internal liquid flow of the connecting pipe 1 and accurately control the distal end of the pressure test guide wire 200 to extend to the head end 410.

[0067] Preferably, the material of the connecting pipe 1 is transparent silicone.

[0068] In some embodiments, the pump body 2 is a pulse pump.

[0069] A pulse pump is a type of positive displacement pump. Its core working principle is to deliver fluid by periodically changing the volume of the working chamber, creating a pulsating flow characteristic. In the medical field, pulse pumps can simulate the beating characteristics of the human heart and generate periodic pulsating flow (rather than continuous flow), allowing the vascular simulation circuit 100 of this application to simulate the blood circulation system in the human body; the pulse frequency, pressure, temperature, and other parameters of the pulse pump are all adjustable.

[0070] In some embodiments, the pulsation frequency range of the pump body 2 is set to 30–200 bpm.

[0071] Understandably, the circuit of this application simulates the blood circulation system in the human body, and the pulsation frequency of the pump body 2 should match the heart rate under the physiological state of the human body. The pulsation frequency range of the pump body 2 covers the normal pulsation frequency range (60-100 bpm) and the abnormal pulsation frequency range (40-60 bpm and 120-180 bpm); the pulsation frequency range of the pump body 2 can specifically be any interval among 30-60 bpm, 60-100 bpm, 100-140 bpm, 140-170 bpm, and 170-200 bpm.

[0072] In some embodiments, the pressure range of the pump body 2 is set to 0–200 mmHg.

[0073] The pressure range output by pump body 2 matches the systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) of the human coronary artery under physiological conditions. The pulsation frequency range of pump body 2 includes the normal and abnormal blood pressure range of the human body. Specifically, the pressure range of pump body 2 can be any interval among: 0-40 mmHg, 40-60 mmHg, 60-90 mmHg, 90-140 mmHg, 140-180 mmHg, and 180-200 mmHg.

[0074] refer to Figure 3 In some embodiments, the vascular simulation circuit 100 further includes a tee connector 6, which has a "T" shaped structure and includes a horizontal pipe 610 and a branch pipe 620 vertically disposed on the horizontal pipe 610; the horizontal pipe 610 is connected to the second pipeline 120, and the head end 410 of the pressure testing device 4 is inserted into the branch pipe 620.

[0075] Specifically, by setting a three-way connector 6, the horizontal pipe 610 is connected to the second pipe 120, allowing the biomimetic solution to flow in the horizontal pipe 610; the head end 410 of the pressure testing device 4 is inserted into the branch pipe 620, which is connected to the horizontal pipe 610, so that the head end 410 of the pressure testing device 4 can be involved in the circulating biomimetic solution to measure the pressure of the biomimetic solution.

[0076] In some embodiments, the head end 410 of the pressure testing device 4 is subjected to anti-corrosion treatment, such as by providing an inert metal layer, to enhance the wear resistance and corrosion resistance of the head end 410.

[0077] In some embodiments, the tee connector 6 is made of transparent silicone. The two ends of the horizontal tube 610 are respectively sleeved with the connecting pipe 1 to achieve communication while ensuring a good sealing effect at the connection to prevent leakage. The branch pipe 620 is sleeved on the head end 410 of the pressure testing device 4. The branch pipe 620 can be sealed outside the head end 410 to prevent liquid leakage and improve the reliability of the device.

[0078] In some embodiments, the biomimetic solution may be, but is not limited to, a salt solution, artificial blood, etc.

[0079] By configuring the viscosity and density of the biomimetic solution to be close to that of human blood, the pressure guide wire 200 to be tested is inserted into the connecting tube 1, which is close to the real human intervention environment, thus improving the calibration accuracy.

[0080] For example, the biomimetic solution can be a salt solution, which is low-cost and highly stable for simulating human blood. Furthermore, by adding additives (such as polymers) to the salt solution, solution parameters such as viscosity, density, and osmotic pressure can be adjusted, making the biomimetic solution closely resemble the physical properties of blood.

[0081] refer to Figure 2 In some embodiments, the calibration device of this application further includes a test circuit assembly 300, which includes a signal tester 7 and a first electrical wire 710 and a second electrical wire 720 respectively disposed at both ends of the signal tester 7; the first electrical wire 710 is connected to the proximal end of the pressure guide wire 200 to be tested, and the second electrical wire 720 is disposed in the connecting pipe 1 to contact the biomimetic solution.

[0082] Specifically, the signal tester 7 is connected to an external power supply, and the first electrical wire 710 forms an electrical connection with the proximal end of the pressure guide wire 200 to be tested; the second electrical wire 720 is placed in the biomimetic solution of the connecting pipe 1, and the biomimetic solution is conductive, so that the second electrical wire 720 forms an electrical connection with the distal end of the pressure guide wire 200 to be tested; then an electric field is applied to the sensing structure at the distal end of the pressure guide wire 200 to be tested through the first electrical wire 710 and the second electrical wire 720; and then the pressure guide wire to be tested is connected in series to the test circuit.

[0083] In some embodiments, the portion of the second conductor 720 located in the biomimetic solution is subjected to anti-corrosion treatment, such as by providing an inert metal layer, to enhance the wear resistance, corrosion resistance, and optimize the electrical performance of the second conductor 720.

[0084] In some embodiments, the sensing structure at the distal end of the pressure test guide wire 200 of this application exhibits a capacitive-capacitive effect (capacitance changes with stress); when pressure is applied to the distal end of the guide wire, the sensing structure deforms, causing a change in capacitance. The pressure test guide wire 200 is connected in series in the test circuit assembly 300 to form a capacitance detection circuit. Based on the capacitance change of the sensing structure, the signal tester 7 outputs a corresponding digitized parameter value (capacitance parameter), and the signal tester 7 collects capacitance parameter data at different times. Meanwhile, the pressure testing device 4 is used to test the standard pressure data at different times at the distal end of the guidewire. By matching multiple sets of capacitance parameters (C) at the same time with the standard pressure (P) data, the calibration curve P = f(C) of pressure and capacitance can be obtained. Then, based on the capacitance parameter detected by the pressure guidewire under test, the required pressure value is accurately obtained according to the calibration curve P = f(C), thereby completing the calibration and correction of the capacitance signal output by the pressure guidewire under test 200, ensuring that its measurement result is consistent with the actual pressure value, achieving the purpose of accurate calibration, and improving the measurement accuracy and reliability of the pressure guidewire under test 200.

[0085] It should be noted that the sensing structure at the distal end of the pressure guide wire 200 under test is not limited to a sensing structure with a pressure-capacitance effect, but can also be a sensing structure with a piezoresistive effect / piezoelectric effect.

[0086] In some embodiments, the signal tester 7 is an LCR meter, which is an electronic instrument used to measure the parameters of passive devices such as inductance (L), capacitance (C) and resistance (R), thereby forming a capacitance detection circuit that converts the capacitance change of the distal sensing structure of the pressure guide wire 200 under test into a measurable capacitance signal, and accurately and effectively collects capacitance parameter data.

[0087] Preferably, the signal tester 7 is an LCR meter, and the accuracy of the LCR meter reaches 0.00001pF. The higher the accuracy of the LCR meter, the more effectively the accuracy of the measured signal parameters can be improved, thereby reducing the error during calibration.

[0088] Preferably, the data recording interval of the LCR meter is within 30ms. Short time interval recording can more accurately capture minute changes in the measurement parameters. In dynamic testing scenarios, it can reduce the accumulation of errors caused by environmental interference or signal fluctuations, and ensure the reliability of calibration data.

[0089] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A calibration device for a pressure guidewire, characterized in that, include: A blood vessel simulation circuit includes connecting pipes, and a pump and a control valve connected in sequence through the connecting pipes; the connecting pipes are used to contain a biomimetic solution, and the pump is used to provide the power to drive the biomimetic solution to circulate. A pressure testing device is connected to the connecting pipeline; the pressure testing device has a head end for acquiring the liquid pressure in the connecting pipeline; The control valve includes a main pipe and a first branch pipe and a second branch pipe respectively disposed on the main pipe; the connecting pipeline includes a first pipeline and a second pipeline; one end of the first pipeline is connected to the pump body and the other end is connected to the second branch pipe; one end of the second pipeline is connected to the pump body and the other end is connected to the main pipe; the second branch pipe is used for the guide wire of the pressure to be measured to pass through.

2. The calibration device for the pressure guidewire according to claim 1, characterized in that: The second pipeline has a detection segment, which is connected to the main pipe, and the head end is located at the detection segment; the axial direction of the detection segment, the axial direction of the main pipe, and the axial direction of the second branch pipe coincide.

3. The calibration device for the pressure guidewire according to claim 1 or 2, characterized in that: The second branch pipe is provided with a leak-proof valve assembly for the guide wire of the pressure to be tested to pass through, and the leak-proof valve assembly is used to seal the guide wire of the pressure to be tested.

4. The calibration device for the pressure guidewire according to claim 1, characterized in that: The connecting pipe is made of silicone.

5. The calibration device for the pressure guidewire according to claim 1 or 4, characterized in that: The inner diameter of the connecting pipe is in the range of 2–10 mm; and / or, The wall thickness of the connecting pipe ranges from 0.5 to 2 mm.

6. The calibration device for the pressure guidewire according to claim 1 or 4, characterized in that: The connecting pipes are transparent.

7. The calibration device for the pressure guidewire according to claim 1 or 2, characterized in that, The vascular simulation circuit also includes a T-connector, which has a "T" shaped structure and includes a horizontal tube and a branch tube vertically disposed on the horizontal tube; the horizontal tube is connected to the second pipeline, and the head end of the pressure testing device is inserted into the branch tube.

8. The calibration device for the pressure guidewire according to claim 1, characterized in that, The calibration device further includes a test circuit assembly, which includes a signal tester, a first electrical wire and a second electrical wire disposed at both ends of the signal tester; the first electrical wire is used to connect to the proximal end of the pressure guide wire to be tested, and the second electrical wire is used to be disposed in the connecting pipeline to contact the biomimetic solution.

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