A personalized in vitro testing and evaluation device for aortic valve and ascending aorta

Abstract

This invention proposes an in vitro testing device for the aortic valve and ascending aorta, comprising a chamber system, a drive system, a circuit system, a chamber auxiliary system, a control system, and a particle image velocimetry system. Based on patient medical images, this device constructs a 1:1 personalized aortic valve and ascending aorta vascular model, realistically simulating an individualized hemodynamic environment through closed-loop pulsatile flow circulation. It can rapidly and quantitatively acquire complex functional parameters such as blood flow velocity, pressure, wall shear force, and relative particle residence time, overcoming the limitations of traditional imaging providing only morphological data and CFD simulation relying on ideal assumptions. Simultaneously, it can be used for individualized in vitro testing of artificial aortic valves, evaluating their performance in specific anatomical structures, significantly improving the accuracy of preoperative planning, postoperative prediction, and device development. This device has advantages such as high physiological fidelity, high testing efficiency, and strong result repeatability, making it suitable for precision cardiovascular diagnosis and treatment and evaluation of implantable interventional devices.

Description

Technical Field

[0001] This invention belongs to the field of personalized aortic valve and ascending aorta performance testing, and specifically relates to a personalized aortic valve and ascending aorta in vitro testing and evaluation device. Background Technology

[0002] The personalized aortic valve is located between the left ventricle and the ascending aorta. Normally, it consists of three leaflets and controls unidirectional blood flow. Common conditions include personalized aortic stenosis (inability to open) and regurgitation (inability to close properly), which can be caused by congenital malformations, calcification, or inflammation. These conditions not only affect cardiac function but can also lead to aortic dilation, aneurysm, or even tearing due to abnormal blood flow impact.

[0003] Currently, clinical practice primarily relies on imaging techniques such as CT, MRI, or ultrasound to assess the morphology of the aortic valve and ascending aorta, including the number of leaflets, annular diameter, and vessel width, and combines this with simple mechanical parameters such as flow velocity and pressure gradient to determine whether surgery is necessary. However, these methods cannot directly obtain complex hemodynamic parameters closely related to disease progression, such as wall shear force and blood flow residence time. Although these complex parameters can be estimated through computational fluid dynamics (CFD), simulations rely on various idealized assumptions, are computationally time-consuming, and the results may deviate from reality.

[0004] In terms of treatment, transcatheter implantation of personalized aortic valves has become an important approach. Studies have shown that the same valve can exhibit significant differences in performance among different patients. While it may perform well in an ideal model, it may deform, leak, or fail prematurely after actual implantation. Therefore, current assessment methods lack personalized biomechanical characteristic analysis, and in vitro testing models cannot accurately reflect the patient's internal environment, limiting precise diagnosis and treatment and the prediction of device efficacy. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a personalized in vitro testing and evaluation device for the aortic valve and ascending aorta, so as to solve the problems that existing evaluation methods lack personalized mechanical characteristic analysis and that in vitro testing models are difficult to truly reflect the patient's internal environment, thus limiting the accuracy of diagnosis and treatment and the prediction of device effects.

[0006] To achieve the above and other related objectives, this invention proposes a personalized in vitro testing and evaluation device for the aortic valve and ascending aorta, comprising: a chamber system, a drive system, a chamber auxiliary system, a circuit system, a control system, and a particle image velocimetry system;

[0007] The chamber system is used to simulate blood flow paths, including:

[0008] The left ventricular system is used to simulate the contraction of the left ventricle to drive fluid.

[0009] The personalized aortic valve and ascending aortic vascular system are manufactured by reverse modeling based on specific medical imaging data, and are consistent with the actual personalized aortic valve maximum opening shape, aortic sinus geometry and ascending aortic course.

[0010] The ascending aortic fluid buffer chamber is connected to the outlet end of the chamber of the personalized aortic valve and the ascending aortic vascular system, and is used to temporarily store the fluid flowing out from the personalized aortic valve and the ascending aortic vascular system.

[0011] The left atrial system and its corresponding fluid buffer chamber are connected to the left ventricular system and are used to receive the returning fluid and form a closed loop.

[0012] The drive system is connected to the left ventricular system and is used to provide periodic pulsatile driving force to simulate heartbeats;

[0013] The circuit system connects the outlet of the personalized aortic valve and the ascending aortic vascular system to the left atrial fluid buffer chamber, forming a closed loop for the test fluid, and includes components for regulating fluid temperature and peripheral resistance.

[0014] The chamber assist system includes an aortic sinus compliance chamber that communicates with the aortic sinus region of the personalized aortic valve and ascending aortic vascular system to simulate physiological coronary compliance.

[0015] The control system is used to set the target pressure or flow curve, and to implement closed-loop feedback control of the drive system based on the real-time collected pressure signal, so that the pressure at the test point dynamically tracks the preset target.

[0016] The particle image velocimetry system is configured in the optically visible area of ​​the personalized aortic valve and ascending aortic vascular system to non-invasively acquire hemodynamic parameters such as fluid velocity field, wall shear force, and relative particle residence time.

[0017] In one embodiment of the present invention, the left ventricular system includes:

[0018] An outer chamber is provided with an outer chamber sealing valve and an inner chamber sealing valve at its bottom. The outer chamber sealing valve is connected to the outer chamber. An opening is also provided at its bottom, and the opening is connected to the drive system.

[0019] An inner chamber is located inside the outer chamber, and its bottom is connected to the inner chamber sealing valve via a hose;

[0020] An inclined beam cover is disposed on the top of the outer chamber and the inner chamber and is sealed to them. The inclined beam cover is respectively connected to the personalized aortic valve and the ascending aortic vascular system and the left atrial system.

[0021] In one embodiment of the present invention, the inclined beam cover has two inclined surfaces, respectively provided with a first inclined opening communicating with the personalized aortic valve and the ascending aortic vascular system and a second inclined opening communicating with the left atrial system, the first inclined opening and the second inclined opening communicating with the inner chamber.

[0022] In one embodiment of the present invention, a removable one-way valve is provided at the first oblique opening and / or the second oblique opening, the one-way valve being configured to allow fluid to flow unidirectionally only from the left ventricle to the ascending aorta or from the left atrium to the left ventricle.

[0023] In one embodiment of the invention, a flow meter is further included, which is detachably disposed between the inclined surface having the first oblique opening and the personalized aortic valve and the ascending aortic vascular system.

[0024] In one embodiment of the present invention, the personalized aortic valve and ascending aortic vascular system includes:

[0025] chamber;

[0026] The aortic sinus compliant cavity connection port has one end communicating with the aortic sinus portion of the cavity and the other end connected to the cavity auxiliary system;

[0027] The liquid outlet is connected at one end to the top of the chamber and at the other end to the loop system;

[0028] The lower three-way valve interface and the upper three-way valve interface are connected to the inlet and outlet of the chamber, respectively.

[0029] In one embodiment of the present invention, the personalized aortic valve and ascending aortic vascular system are rigid structures integrally formed by 3D printing.

[0030] In one embodiment of the present invention, the personalized aortic valve and ascending aortic vascular system includes a transparent shell and a chamber disposed within the shell, wherein the chamber wall and the transparent shell are hollow, and the chamber wall is a flexible structure.

[0031] In one embodiment of the present invention, the personalized aortic valve and ascending aortic vascular system are prepared by the following steps:

[0032] Obtain CT, MRI, or ultrasound images of the patient at the end of cardiac systole;

[0033] The three-dimensional contours of the aortic root, aortic sinus, valve leaflets, and ascending aorta are segmented.

[0034] After removing significantly calcified areas, reverse modeling is performed to generate an STL / CAD model;

[0035] A physical model with an internal cavity is created using 3D printing, molding, or machining.

[0036] In one embodiment of the present invention, the control system integrates a pressure feedback regulation subsystem, which sets a high-speed pressure sensor near the valve orifice, in the middle of the ascending aorta, or at the aortic sinus, and dynamically adjusts the drive system based on the real-time pressure signal using a PID control algorithm, so that the measured pressure waveform tracks the preset clinical target pressure curve.

[0037] The personalized aortic valve and ascending aorta in vitro testing device described in this invention has the following beneficial effects:

[0038] The in vitro testing device described in this invention can output complex mechanical characteristic parameters based on the patient's personalized physiological and anatomical features (such as personalized aortic valve and ascending aortic vessel morphology). These parameters include, but are not limited to, wall shear force and relative particle residence time, which help to more accurately assess the patient's physiological state.

[0039] Capable of outputting diverse parameters, this device can provide not only morphological parameters such as diameter and area, and simple mechanical parameters such as flow velocity and pressure, but also complex mechanical parameters based on patient-specific data, such as wall shear force and relative particle residence time. This multi-dimensional data output provides strong support for a comprehensive assessment of cardiovascular health.

[0040] This invention reduces computational errors. Compared to traditional virtual simulation methods, it uses an actual physical model to minimize computational errors caused by mathematical assumptions, ensuring more accurate test parameter values. Furthermore, since it eliminates the need for complex computer simulations, the device significantly reduces time consumption and computational performance requirements.

[0041] The in vitro testing device described in this invention can also be used for individualized in vitro testing of artificial personalized aortic valves. Compared to traditional testing methods based on generalized idealized models, this device can output device performance evaluation results that more closely reflect the patient's actual condition. This allows for more precise preoperative planning and facilitates optimized device design and customized medical services.

[0042] Capable of rapid and comprehensive output of functional parameters, this device can quickly output various functional parameters based on the individual physiological and anatomical characteristics of different patients, including blood flow velocity, blood ejection angle, blood flow pressure, fluid wall shear force, and relative particle residence time. These parameters provide clinicians with rich data support, which is helpful for preoperative surgical planning, postoperative outcome prediction, and device optimization design.

[0043] This device can assist in personalized medical treatment by generating performance evaluation results tailored to the patient's specific condition through detailed analysis of the individual patient's aortic valve and ascending aortic morphology. This not only improves surgical success rates but also provides a scientific basis for personalized medical treatment, further promoting the development of precision medicine.

[0044] In summary, the personalized aortic valve and ascending aorta in vitro testing device described in this invention enables in vitro testing of personalized aortic valves and ascending aorta vessels based on the individualized physiological and anatomical characteristics of different patients. It not only rapidly outputs diverse functional parameters but also performs individualized in vitro testing of the artificial personalized aortic valve, providing device performance evaluation results that are more closely aligned with the patient's actual condition. These features significantly improve the accuracy and reliability of preoperative surgical planning, postoperative outcome prediction, device optimization design, and personalized medical customization.

[0045] Through the aforementioned technical effects, this invention not only addresses many shortcomings of existing technologies but also provides strong technical support for the diagnosis, treatment planning, and research and development of medical devices for cardiovascular diseases. Its modular design and flexible expandability also offer ample room for future research and application. Attached Figure Description

[0046] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0047] Figure 1 This is a schematic diagram of a personalized aortic valve and ascending aorta external testing device.

[0048] Figure 2 This is a schematic diagram of a personalized aortic valve and ascending aorta external testing device from another angle.

[0049] Figure 3 This is a schematic diagram of the chamber system structure.

[0050] Figure 4 This is a schematic diagram of the internal structure of the chamber system.

[0051] Figure 5 This is a frontal sectional view of the chamber system.

[0052] Figure 6 This is a schematic diagram of the left ventricular system.

[0053] Figure 7 This is one embodiment of a one-way valve.

[0054] Figure 8 This is another embodiment of a one-way valve.

[0055] Figure 9 This is a schematic diagram of a flow meter.

[0056] Figure 10 A frontal schematic diagram of the personalized aortic valve and ascending aortic vascular system.

[0057] Figure 11 A schematic diagram of the rear of the personalized aortic valve and ascending aortic vascular system.

[0058] Figure 12 A schematic diagram of the internal structure of the personalized aortic valve and ascending aortic vascular system.

[0059] Figure 13 A schematic diagram of the fabrication process for a personalized aortic valve and ascending aortic vascular system.

[0060] Figure 14 This is one embodiment of a personalized aortic valve and ascending aortic vascular system.

[0061] Figure 15 This is another embodiment of a personalized aortic valve and ascending aortic vascular system.

[0062] Figure 16 A schematic diagram of the fluid buffer chamber structure of the ascending aorta.

[0063] Figure 17 A schematic diagram of the internal structure of the fluid buffer chamber in the ascending aorta.

[0064] Figure 18 This is a schematic diagram of the left atrial system and the left atrial fluid buffer chamber.

[0065] Figure 19 This is a schematic diagram of the left atrial system and the internal structure of the left atrial fluid buffer chamber.

[0066] Figure 20 This is a schematic diagram of the drive system and the power system.

[0067] Figure 21 This is a schematic diagram of the chamber auxiliary system, circuit system, and control system.

[0068] Figure 22 This is an example of a time-displacement-velocity curve set by the pump based on actual pressure feedback.

[0069] Figure 23 This is a flowchart illustrating a personalized in vitro assessment method for the aortic valve and ascending aorta provided in one embodiment of the present invention.

[0070] Figure 24This is a flowchart illustrating a personalized in vitro assessment method for the aortic valve and ascending aorta provided in another embodiment of the present invention. Detailed Implementation

[0071] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0072] It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components relevant to the present invention and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0073] like Figure 1 and Figure 2 As shown, the present invention provides a personalized in vitro testing and evaluation device for the aortic valve and ascending aorta, comprising: a chamber system 11, a drive system 12, a power system 13, a chamber auxiliary system 14, a loop system 15, a control system 16, and a particle image velocimetry system 17. This device achieves precise acquisition of personalized hemodynamic parameters by constructing a physical model highly consistent with the patient's anatomical structure, combined with closed-loop pressure feedback control and high-precision flow field measurement.

[0074] During device operation, the drive system 12 periodically compresses the left ventricular system 111, propelling the test fluid (such as a glycerol-water mixture simulating blood) through the personalized aortic valve and ascending aortic vascular system 113, then through the ascending aortic fluid buffer chamber 114 and the loop system 15 back to the left atrial fluid buffer chamber 116, forming a closed loop. The control system 16 adjusts the drive intensity in real time according to a preset clinical pressure curve to ensure that the pressure at key measuring points dynamically matches the target value; simultaneously, the particle image velocimetry system 17 synchronously collects flow field data to calculate complex hemodynamic parameters such as wall shear force, oscillatory shear index, and relative particle residence time.

[0075] The chamber system 11 is a core component system used to simulate the complete blood flow path of "blood in the left ventricle being squeezed by the heartbeat, ejected from the abnormal personalized aortic valve, flowing through the diseased ascending aorta, recirculating to the left atrium, passing through the mitral valve, and finally flowing back to the left ventricle". It is also a key carrier for characterizing the complex mechanical characteristics corresponding to the patient's personalized aortic valve and ascending aortic vascular morphology.

[0076] like Figure 3As shown, the 11-chamber system includes: a left ventricular system 111, a flow meter 112, a personalized aortic valve and ascending aortic vascular system 113, an ascending aortic fluid buffer chamber 114, a left atrial system 115, and a left atrial fluid buffer chamber 116.

[0077] Figure 4 This is a schematic diagram of the internal structure of the chamber system 11. Figure 5 Its frontal sectional view. For example... Figure 4 and Figure 5 As can be seen, the internal cavities of adjacent components in the chamber system 11 are interconnected, allowing the test liquid to flow continuously throughout the entire interconnected flow channel. The components are fixed together by appropriate mechanical connections such as welding, threaded connections, and snap-fits, and further sealed with gaskets and sealant to ensure that the system operates without leakage.

[0078] The left ventricular system 111 is used to simulate the periodic contraction of the left ventricle and apply pulsating pressure to the fluid in the chamber, thereby driving fluid flow. The left ventricular system 111 includes: an inner chamber 1111, an outer chamber 1112, a sloping beam cover 1113, an outer chamber sealing valve 1114, an inner chamber sealing valve 1115, and an inner chamber three-way valve 1116.

[0079] The inner chamber 1111 is a U-shaped open cavity made of a transparent film material, and its bottom is connected to the inner chamber sealing valve 1115 via a hose. Alternatively, the transparent film material is preferably high-transmittance medical silicone to balance flexibility and optical visibility.

[0080] The outer chamber 1112 is made of a transparent rigid material and has an open oral structure, used to enclose and accommodate the inner chamber 1111. Its bottom is equipped with an outer chamber sealing valve 1114 and an inner chamber sealing valve 1115. The outer chamber sealing valve 1114 is directly connected to the body of the outer chamber 1112, while the inner chamber sealing valve 1115 is connected to the inner chamber 1111 via a flexible tube. Alternatively, the transparent rigid material can be glass, acrylic, or similar materials with good optical properties and high mechanical strength.

[0081] The inclined beam cover 1113 is made of a transparent rigid material and has an overall "eaves" shape, with an angle α° between its bottom plane and the two top inclined planes. Through openings are provided on the bottom plane and the two top inclined planes. The side wall of the inclined beam cover 1113 is equipped with an internal chamber three-way valve 1116 for connecting a pressure sensor or an exhaust device.

[0082] like Figure 5 and Figure 6As shown, the top opening of the inner chamber 1111, the top opening of the outer chamber 1112, and the bottom opening of the inclined beam cover 1113 are identical in size and are tightly assembled through a sealing connection. Under this connection, the inner chamber 1111 and the inner cavity of the inclined beam cover 1113 are interconnected, forming the main blood flow channel; while the outer chamber 1112 is independent of this channel, serving only as a driving medium cavity and not communicating with the inner cavity of the inner chamber 1111 or the inner cavity of the inclined beam cover 1113.

[0083] The opening at the bottom of the outer chamber 1112 is connected to the drive system 12 to receive the pressure input of the drive medium (such as water or silicone oil), thereby indirectly squeezing the inner chamber 1111 to simulate ventricular contraction.

[0084] The top of the inclined beam cover 1113 has two inclined openings: the first inclined opening 11131 is connected to the flow meter 112 and is used to guide the outflow fluid into the aortic passage; the second inclined opening 11132 is connected to the left atrial system 115 and is used to guide the diastolic reflux fluid back to the left atrial side.

[0085] As a preferred embodiment, the included angle α° of the inclined beam cover 1113 should be set according to the actual spatial angle between the personalized aortic valve plane, mitral valve plane and the long axis of the left ventricle in the patient's medical images, so as to truly restore the spatial geometric relationship between the blood flow ejection direction and the return path.

[0086] Furthermore, the size of the first oblique opening 11131 should be customized based on the individualized aortic valve annulus diameter or effective opening area in the patient's image; the size of the second oblique opening 11132 should be set according to the mitral valve annulus size, so as to match individualized anatomical features.

[0087] In addition, the diameters of the openings of the inner chamber 1111, the top opening of the outer chamber 1112, and the bottom opening of the inclined beam cover 1113 are preferably not less than 10 mm to avoid excessive flow resistance affecting physiological authenticity.

[0088] The overall dimensions of the outer chamber 1112 must also meet the requirements of the drive stroke. Its length is preferably not less than 250 mm, its width is not less than 150 mm, and its height is not less than 200 mm.

[0089] In one embodiment, a one-way valve can be snap-fitted into the first oblique opening 11131 and / or the second oblique opening 11132. This one-way valve is designed to allow fluid to flow only from the inner chamber 1111 towards the flow meter 112, or from the left atrial system 115 towards the inner chamber 1111, while blocking reverse flow, thus simulating the one-way conduction function of a valve. The one-way valve has a detachable structure, and its installation can be flexibly selected according to the specific testing purpose. Preferably, the outer frame of the one-way valve is made of soft silicone material to achieve a good interface seal during snap-fit ​​installation and prevent bypass leakage.

[0090] Figure 7 An embodiment of a one-way valve is shown: its inner baffle elastically pops outward to open under the impact of liquid on one side, and automatically rebounds to close when the pressure difference on both sides disappears; if it is pressed in the opposite direction, the inner baffle is blocked and cannot open.

[0091] Figure 8 Another implementation is shown: the inner baffle rotates around the axis to open under unilateral pressure, and closes by elastic reset after the pressure difference is balanced; it cannot rotate to open under reverse pressure due to structural limitations.

[0092] like Figure 9 As shown, the flow meter 112 is a transitional assembly with an internal cylindrical conduit for connecting the left ventricular system 111 to the individual aortic valve and ascending aortic vascular system 113. As the test fluid flows through its internal conduit, a built-in sensor detects and outputs instantaneous flow data in real time.

[0093] It must be ensured that the diameter of the cylindrical pipe inside the flow meter 112 is equal to the diameter of the first oblique opening 11131, and that the two are reliably sealed during assembly using sealing rings, sealant, or other suitable methods to prevent leakage and ensure the continuity of the flow path.

[0094] In one embodiment, the sensor used in the flow meter 112 may be an ultrasonic flow sensor, an electromagnetic flow sensor, or other flow sensing devices suitable for simulating blood flow measurement. The specific type can be selected according to actual needs such as test accuracy, fluid conductivity, and optical transparency.

[0095] Furthermore, the external structural shape of the flow meter 112 is not limited and can be designed as an "I" shape, cuboid, or other geometric forms that facilitate installation and connection. The preferred connection method between it and adjacent components is threaded connection or snap-fit ​​connection to balance sealing performance and ease of assembly and disassembly.

[0096] In another embodiment, the flow meter 112 is a non-essential component. When real-time monitoring of flow parameters is not required during testing, it can be completely removed, and the left ventricular system 111 can be directly and sealed to the personalized aortic valve and ascending aortic vascular system 113 via threads, snaps, or other compatible interfaces, thereby simplifying the flow path structure and reducing system complexity.

[0097] The chamber design of the personalized aortic valve and ascending aortic vascular system 113 is completely consistent with the patient's actual personalized aortic valve and ascending aortic vascular morphology. This system 113 is the main component for achieving a 1:1 mapping of the patient's actual blood flow state and assessing the complex biomechanical characteristics of the patient's personalized aortic valve and ascending aortic vascular morphology.

[0098] Figure 10 A frontal schematic diagram of the personalized aortic valve and ascending aortic vascular system 113; Figure 11 A schematic diagram of its reverse side; Figure 12 This shows a schematic diagram of its internal structure.

[0099] like Figure 11 , Figure 12 and Figure 13 As shown, in one embodiment of the personalized aortic valve and ascending aortic vascular system 113, although its outer shell shape can be any suitable form, the internal chamber is strictly designed according to the patient's physiological anatomy to ensure a realistic reproduction of fluid flow. This personalized aortic valve and ascending aortic vascular system 113 includes: an aortic sinus compliance lumen connection 1131, a fluid outlet 1132, a subvalve three-way valve interface 1133, and an supravalve three-way valve interface 1134. The aortic sinus compliance lumen connection 1131 communicates with the aortic sinus region within the chamber and is connected to the chamber support system 14 via a hose to simulate sinus coronary compliance under physiological conditions. The fluid outlet 1132 is located at the top of the chamber (i.e., the top of the ascending aorta) and is connected to the circuit system 15 via a hose. The subvalve three-way valve interface 1133 and the supravalve three-way valve interface 1134 correspond to the chamber inlet and outlet positions, respectively, facilitating the connection of pressure sensors or other monitoring devices.

[0100] The personalized aortic valve and ascending aortic vascular system 113 can be connected and installed with adjacent components by means of suitable methods such as threads or snaps. In order to ensure the continuity and sealing of the flow path, the inlet diameter of the system 113 should match the diameter of the internal cylindrical pipe of the flow meter 112 (or the diameter of the first oblique opening 11131), and necessary sealing measures should be taken during connection.

[0101] Figure 13The fabrication process of the personalized aortic valve and ascending aortic vascular system 113 is shown in detail:

[0102] Step 1: Obtain CT, MRI, or ultrasound images of the patient at the end of cardiac systole; for example, use medical imaging equipment (such as CT, MRI, or ultrasound) to obtain images of the patient's physiological and anatomical features at the end of cardiac systole (i.e., the moment of maximum aortic valve opening).

[0103] Step 2: Segment the three-dimensional contours of the aortic root, aortic sinus, valve leaflets, and ascending aorta;

[0104] Step 3: After removing significant calcification areas, reverse modeling is performed to generate an STL / CAD model; for example, using computer reverse modeling technology, a personalized three-dimensional model of the aortic valve and ascending aorta is reconstructed, paying special attention to the details of the valve opening (if there is significant calcification, it should be removed from the model) and using computer-aided design to trim and smooth the three-dimensional model.

[0105] Step 4: Use 3D printing, molding or machining to create a physical model with an internal cavity; for example, use rapid 3D printing technology to directly create a personalized aortic valve and ascending aortic vascular system 113, the model area being the cavity area.

[0106] Thanks to advancements in medical imaging, computer modeling, and 3D printing technologies, personalized aortic valves and ascending aortic vascular systems113 can precisely replicate a patient's key anatomical features, such as the maximum valve opening area, morphology, calcified areas, and ascending aortic curvature. Currently, based on these advanced technologies, the system can be fabricated within one hour and rapidly assembled with other components.

[0107] As an alternative, the personalized aortic valve and ascending aortic vascular system 113 can also be manufactured using various methods such as molding and machining, either alone or in combination. In particular, the design of the transparent shell should be rationally configured based on the morphology of the personalized aortic valve and ascending aortic vessels in actual images to ensure the structural stability of the entire system.

[0108] Figure 14 One embodiment is illustrated, in which the chamber shell is made of a transparent and rigid material, suitable for one-piece 3D printing, with lower economic, time, and technical costs. The rigid chamber wall does not deform significantly due to fluid impact, which is beneficial for subsequent analysis of mechanical parameters such as fluid flow field and wall shear force.

[0109] Figure 15Another embodiment is shown, in which the chamber and the transparent shell are hollow, and the chamber walls are made of a thin-layer material, which can be either soft (such as soft silicone) or rigid. When a flexible material is used, the chamber walls expand or rebound with fluid impact. This dynamic change is closer to the real physiological environment and helps to improve the accuracy of the assessment of mechanical parameters such as fluid flow field and wall shear force.

[0110] In this embodiment, the ascending aortic fluid buffer chamber 114 is connected to the chamber outlet end of the personalized aortic valve and ascending aortic vascular system 113, and is used to temporarily store the test fluid flowing out from the personalized aortic valve and ascending aortic vascular system 113.

[0111] like Figure 16 and Figure 17 As shown, the ascending aortic fluid buffer chamber 114 mainly includes three components: a fluid storage chamber 1141, an observation chamber 1142, and an ascending aortic fluid buffer chamber guide port 1143.

[0112] The liquid storage chamber 1141 is a hollow chamber, and its external shape can be designed into any suitable geometric shape according to the connection layout or the aesthetic requirements of the overall device.

[0113] The observation chamber 1142 is a U-shaped transparent component inserted into the top of the fluid reservoir 1141. Its top is open, and its bottom is closed, achieving a sealed connection with the fluid reservoir 1141. Both the fluid reservoir 1141 and the observation chamber 1142 are made of transparent rigid materials (such as acrylic or medical-grade transparent resin). Operators can directly observe the fluid flow at the outlet of the personalized aortic valve and ascending aortic vascular system 113 in real time through the observation chamber 1142. A miniature camera can also be installed inside the observation chamber 1142 to record the dynamic behavior of the fluid after it exits the personalized aortic valve and ascending aortic vascular system 113.

[0114] The ascending aortic fluid buffer chamber inlet 1143 is directly connected to the fluid reservoir 1141. When the fluid level in the fluid reservoir 1141 reaches the height of the inlet 1143, excess fluid will flow into the connecting pipe through the inlet 1143 and be transported to the left atrial fluid buffer chamber 116 through the circuit system 15, thereby completing the closed loop.

[0115] like Figure 1 , Figure 18 and Figure 19As shown, the left atrial system 115 and the left atrial fluid buffer chamber 116 are interconnected, and the left atrial system 115 is also connected to the second oblique opening 11132 at the top of the oblique beam cover 1113. The left atrial system 115 includes a left atrial chamber 1151 and a left atrial chamber three-way valve 1152. The left atrial fluid buffer chamber 116 includes a fluid buffer cavity 1161 and a left atrial fluid buffer chamber inlet 1162. The left atrial fluid buffer chamber interface 1163 is a non-essential component and can be a compliant chamber interface or a three-way valve interface.

[0116] In one embodiment of the invention, the liquid buffer cavity 1161 is L-shaped and connected to the side of the left atrial ventricle 1151. Alternatively, the liquid buffer cavity 1161 can also be designed as a straight cylinder, directly vertically connected to the top of the left atrial ventricle 1151.

[0117] The inner diameter of the left atrial chamber 1151 should be the same as the inner diameter of the second oblique opening 11132, and a seal must be applied during connection to ensure no leakage. This can be achieved by using a sealing ring, sealant, or other suitable sealing method.

[0118] Optionally, the left atrial system 115 and the left atrial fluid buffer chamber 116 can adopt the same design principles and manufacturing processes as the left ventricular system 111 to ensure the compatibility and consistency of the entire system. The left atrial system 115 includes a left atrial chamber 1151 and a left atrial chamber three-way valve 1152. The left atrial chamber 1151 is designed to simulate the function of the human left atrium, receiving blood returning from the circuit system 15 and facilitating flexible connection with other components via the three-way valve 1152, enabling pressure monitoring or venting operations. The left atrial fluid buffer chamber 116 includes a fluid buffer cavity 1161 and a left atrial fluid buffer chamber inlet 1162. The shape of the fluid buffer cavity 1161 can be designed as an "L" shape or a straight cylinder according to actual needs. The fluid buffer cavity 1161 is mainly used to temporarily store the fluid flowing in from the left atrial chamber 1151, while the left atrial fluid buffer cavity outlet 1162 is responsible for transporting excess fluid back to the left atrial fluid buffer cavity 116 or other designated locations through the loop system 15.

[0119] In addition, the left atrial fluid buffer chamber interface 1163 can be installed or not depending on specific testing needs. If it is necessary to simulate the effect of coronary perfusion on sinus pressure under physiological conditions, it can be set as a compliant chamber interface; if multi-channel fluid management is required, a three-way valve interface can be selected.

[0120] Through the above design, the left atrial system 115 and the left atrial fluid buffer chamber 116 can effectively simulate the physiological functions of the human left atrium and its related blood vessels, working together with other components to complete the closed-loop test process. This modular design not only improves the system's flexibility and adaptability but also facilitates maintenance and expansion.

[0121] like Figure 20 As shown, the drive system 12 should include at least three components: piston 121, drive chamber 122, and drive chamber vent valve 123.

[0122] Piston 121 is a reciprocating component that simulates the heart's pumping function by periodically squeezing the fluid in drive chamber 122. Drive chamber 122 is directly connected to outer chamber 1112, and together they form a sealed chamber that is filled with fluid during machine operation. When piston 121 reciprocates, it repeatedly squeezes the fluid in drive chamber 122, thereby applying pressure to inner chamber 1111 to pump out the fluid from inner chamber 1111, simulating the contraction and relaxation of the left ventricle.

[0123] The drive chamber vent valve 123 is connected to the drive chamber 122 and is used to vent air and balance the pressure in the drive chamber, ensuring that the fluid dynamic characteristics of the system are not affected by the presence of air bubbles during operation.

[0124] The embodiment of the drive system 12 described in this invention only shows the simplest schematic structure. In practical applications, as an option, components or technologies such as a viscoelastic damping tube that can be permeated by liquid can be added to the drive cavity 122 to achieve a more stable liquid drive effect. For example, the viscoelastic damping tube can help absorb vibrations generated during the drive process, improving the stability and accuracy of the system.

[0125] The specific structure and shape of the drive cavity 122 should be designed according to the actual situation or aesthetic requirements to meet the needs of different application scenarios.

[0126] To ensure proper system operation, piston 121 must achieve a high-precision structural and dimensional fit and installation with the wall of drive chamber 122. This not only guarantees a good sealing effect but also ensures that piston 121 is not subjected to unnecessary interference during reciprocating motion. Specifically, piston 121 should be manufactured with high-precision processes to minimize the gap between it and the wall of drive chamber 122, preventing leakage and avoiding excessive friction. The internal surface of drive chamber 122 should be smooth and uniform to reduce resistance during piston 121 movement and ensure consistent sealing performance throughout the entire working stroke.

[0127] Through the above design, the drive system 12 can effectively simulate the pumping function of the heart, working in conjunction with other components to complete the closed-loop test process. This modular design not only improves the system's flexibility and adaptability but also facilitates maintenance and expansion. Furthermore, by introducing advanced damping technology and precision manufacturing processes, the system's stability and reliability can be further enhanced.

[0128] The power system 13 is equipped with a high-precision motor to drive the piston 121 in reciprocating motion. This motor is the power source for the entire drive system 12, ensuring precise control of the liquid during the simulated heart pumping process. Preferably, the high-precision motor in the power system 13 should have excellent linear output capability. This means that the motor can provide stable and linear displacement output under different load conditions, thereby ensuring that the reciprocating motion of the piston 121 can accurately simulate the contraction and relaxation process of the heart. Specifically, the high-precision motor needs to have high response speed and position control accuracy to ensure that the displacement, velocity, and acceleration of the piston 121 in each cycle can accurately match the preset heart motion curve. This not only helps to achieve precise control of fluid flow but also improves the reliability and repeatability of test results. The linear output capability of the motor is crucial because it directly affects the movement trajectory of the piston 121. Excellent linear output means that the motor can maintain consistent performance under different loads, avoiding displacement deviations or velocity fluctuations caused by load changes. This stability is particularly important for simulating complex physiological conditions, such as human blood circulation under different heart rates or stress conditions.

[0129] The chamber assist system 14 consists of two enclosed hollow chambers, each with an interface communicating with an internal chamber and connected to other components via a hollow flexible tube. These two chambers are the aortic sinus compliance chamber 141 and the ascending aortic compliance chamber 142.

[0130] exist Figure 21 In the embodiment shown, both the aortic sinus compliance cavity 141 and the ascending aortic compliance cavity 142 are hollow cylindrical in shape, but their shape is not limited to this and can be designed into any suitable geometric shape according to actual needs.

[0131] The typical dimensions of the aortic sinus compliance lumen 141 and the ascending aortic compliance lumen 142 are approximately 10 mm in diameter and 30 mm in height. These dimensions may be the same or different, depending on the physiological compliance requirements being simulated. For example, the aortic sinus compliance lumen 141 can be connected via a flexible tube to the aortic sinus compliance lumen connector 1131 on the personalized aortic valve and ascending aortic vascular system 113 to simulate the buffering effect of the coronary arteries on the aortic sinus region; the ascending aortic compliance lumen 142 can be connected to the corresponding location on the ascending aorta to simulate the elastic expansion and contraction of the vessel wall, thereby more realistically reproducing the in vivo hemodynamic environment.

[0132] By setting the above-mentioned compliance cavity structure, the chamber assist system 14 can effectively introduce the dynamic compliance characteristics of the vascular system and significantly improve the physiological authenticity of the in vitro test model.

[0133] The loop system 15 is used to deliver fluid from the ascending aortic fluid buffer chamber 114 to the left atrial fluid buffer chamber 116, thereby forming a complete closed-loop flow path. The loop system 15 mainly consists of a fluid heater 151, a peripheral damping regulator 152, and several connecting hoses.

[0134] The liquid heater 151 is a device that can heat the test liquid flowing through it and can set a target heating temperature (typically 37°C) to simulate the normal human body temperature environment and ensure that the fluid properties (such as viscosity) are consistent with physiological conditions.

[0135] The peripheral damping regulator 152 is used to adjust the flow resistance of the fluid in the entire loop system 15. By setting different damping values, the flow characteristics of the fluid can be changed, thereby simulating the resistance effect generated by the human peripheral vascular system. This regulator can be implemented using a variable orifice valve, capillary array, or other equivalent structure to flexibly match the hemodynamic characteristics of different patients.

[0136] The connecting hoses are used to connect the aforementioned components to the ascending aortic fluid buffer chamber 114, the left atrial fluid buffer chamber 116, and other relevant interfaces. The connection methods for the hoses have been detailed in the descriptions of the aforementioned components (such as the ascending aortic fluid buffer chamber 114 and the left atrial system 115), and will not be repeated here. However, it is important to emphasize that all interfaces should be reliably sealed during assembly (e.g., using sealing rings, clamps, or medical adhesive) to prevent leakage during operation and ensure the stability of system pressure and flow.

[0137] With the above configuration, the loop system 15 not only realizes the circulation and reflux of the test liquid, but also has temperature control and peripheral resistance simulation functions, which significantly improves the physiological realism of the in vitro test environment.

[0138] The control system 16 integrates equipment for controlling the power system 13, a computer for connecting to other external devices, signal conversion devices, and image processing devices. Its internal components should be adjusted accordingly for different testing requirements and evaluation functions.

[0139] By connecting the three-way valves on the aforementioned components to the interface on the control system operation panel 161, the display device on the operation panel can display the corresponding pressure values ​​and other parameters in real time. The control system platform 162 can also be used to temporarily house an external laptop computer to improve the comfort and flexibility of human-computer interaction.

[0140] The control system 16 is used for centralized and standardized processing of data from various sensors, including but not limited to flow meters (electromagnetic, ultrasonic, etc.), pressure sensors, PIV / LDV / PTV velocity field measurements, structural displacement / strain measurements, and other external data sources. This system can perform preprocessing steps on raw time-series or phase data, such as synchronization and phase alignment, sensor calibration and physical quantity conversion, filtering and denoising, wall positioning and near-wall interpolation / fitting, and velocity gradient and strain rate tensor calculations. The system automatically generates a series of time-domain and frequency-domain mechanical parameters, such as instantaneous flow rate, average flow rate, instantaneous / periodic pressure distribution, TAWSS, OSI, RRT, WSSG, local maximum shear, vortex intensity, TKE, energy dissipation rate, pulse wave velocity (PWV), and input impedance spectrum, and provides uncertainty assessment and statistical confidence intervals.

[0141] Control system 16 supports both real-time and offline operating modes:

[0142] Real-time mode: During the experiment, key quantities are transmitted back to the controller via a streaming interface for closed-loop pump control or alarm.

[0143] Offline mode: Batch processing of phase-resolved data for subsequent analysis and visualization.

[0144] The output adopts a standardized data structure and multiple export formats (CSV / NetCDF / HDF5 / VTK), and provides visualization instruments and machine interfaces (API / SDK) to facilitate integration with numerical simulation, databases or machine learning pipelines.

[0145] This module adopts a modular plug-in architecture, which allows the insertion of new sensor drivers, near-wall derivative algorithms, or custom derivative calculators, and forces the recording of measurement metadata (sampling rate, calibration coefficients, tracer particle information, fluid properties, etc.) to ensure the repeatability, traceability, scalability, and compliance of the results in product scenarios.

[0146] To improve the physiological relevance of in vitro pulsating flow reproduction, a new pressure feedback regulation subsystem is added to this module. This subsystem reserves and connects three-way valve interfaces at several key measurement locations in the personalized aortic model (e.g., near the valve orifice, mid-ascending aorta, or aortic sinus) to connect the measured site to a high-speed pressure sensor without disrupting the closed loop. The sensor used can be a piezoelectric, strain gauge, or miniature pressure transmitter. After low-noise amplification and anti-aliasing filtering, the sensor synchronously acquires and outputs real-time pressure signals to the control unit via a unified clock and particle image velocimetry system 17.

[0147] The pressure signal is fed into the closed-loop controller of the pump controller. The controller can function as a pure pressure controller (i.e., automatically adjusting pump displacement / speed / valve position based on the set target pressure-time curve) or as a hybrid controller (considering flow and pressure targets simultaneously in parallel or cascade). It supports common control strategies (PID-based real-time control) and reserves more advanced control algorithms (feedforward compensation, model predictive control, MPC) as options to improve transient tracking performance.

[0148] Operators can directly import clinically measured pressure-time curves or manually edit / generate custom pressure waveform files (multiple formats supported) via the computer's human-machine interface. Before starting the experiment, the controller performs low-pass filtering and safety verification of the target curve (detecting over-limits, abrupt changes, etc.). During operation, it executes closed-loop regulation at a preset sampling frequency (recommended range for experiments: hundreds to thousands of hertz to ensure time resolution), sending pump drive commands (displacement / velocity / valve position) to the pump drive unit in real time. To ensure stability and safety, the controller includes anti-windup, sampling delay compensation, filtering / noise reduction, and anti-oscillation strategies, and sets upper / lower safety thresholds and emergency shutdown logic: when the measured pressure exceeds the safety threshold or the sensor malfunctions / loses a signal, the system automatically enters safety mode (stops the pump or switches to a predefined safety curve) and displays an alarm on the interface.

[0149] The hardware interface for pressure feedback regulation is modularly designed: the three-way valve, pressure sensor, signal conditioner, and pump controller connect via standardized electrical / fluid interfaces, facilitating rapid assembly between different customized models. The controller records real-time pressure-flow timing, control commands, and event logs, packaging this data into metadata and transmitting it to the computer for subsequent mechanical evaluation and uncertainty analysis. This subsystem also supports empirical calibration steps (e.g., obtaining sensor-pump response mapping through a known impedance network or known input-output curves) to improve closed-loop tracking accuracy.

[0150] Through the above design, pressure feedback regulation is implemented in the pump operation in the form of closed-loop control: the system collects the pressure signal of the measured part in real time and compares the measured pressure with the preset target curve. The closed-loop controller dynamically adjusts the instantaneous motion of the pump (displacement / velocity, etc.) accordingly to make the pressure at the measured point approach the target value. Simultaneously, the system generates and outputs the corresponding time-displacement curve based on real-time feedback and control commands, serving as the execution trajectory for the pump drive unit and recording it in the experimental log for reproduction and error analysis. Figure 22 An example of a time-displacement-velocity curve set by the pump based on actual pressure feedback is given.

[0151] The device is used to perform in vitro hemodynamic testing after implantation of the personalized aortic valve prosthesis in the personalized aortic valve and ascending aortic vascular system, in order to evaluate the prosthesis's opening / closing performance, transvalvular pressure gradient, paravalvular leakage, wall shear force distribution, and long-term fatigue risk under specific patient anatomical conditions.

[0152] Please see Figure 23 As shown, a personalized in vitro assessment method for the aortic valve and ascending aorta is applied to a testing system based on a patient-customized physical model of the aortic valve and ascending aorta, comprising:

[0153] Step S100: Control the liquid pressure based on the preset pressure timing curve so that the liquid flows from the left atrial buffer chamber into the left atrial model and then into the left ventricular model through the one-way valve.

[0154] Step S200: Drive the squeezing chamber to periodically move based on a preset frequency so that the left ventricular model ejects liquid, which flows through a flow meter into the physical model of the personalized aortic valve and ascending aorta, and then into the ascending aortic fluid buffer chamber; wherein, the liquid flows back from the ascending aortic fluid buffer chamber to the left atrial buffer chamber to form a closed loop.

[0155] Step S300: During the simulation test of the patient's personalized aortic valve and ascending aorta solid model, flow meters, pressure sensors, and high-frequency cameras pre-positioned in the personalized aortic valve and ascending aorta solid model are used to collect PIV velocity field, multi-point pressure time series, and flow time series, and the corresponding time-domain-frequency domain mechanical parameters are calculated based on these parameters, including:

[0156] a. Calculate the instantaneous wall shear force based on the collected PIV velocity field, and the instantaneous wall shear force ;in, The dynamic viscosity of the liquid. The tangential velocity gradient of the wall is obtained by interpolation / fitting the PIV velocity field of the near-wall profile.

[0157] b. Calculate the time average value based on the instantaneous wall shear force, and the time average value... ;in, The preset testing period (heartbeat period).

[0158] c. Calculate the oscillatory shear index based on the instantaneous wall shear force, and the oscillatory shear index .

[0159] d. Calculating the flow disturbance intensity based on the acquired PIV velocity field, including: calculating the pulsatility characteristic parameters of blood flow based on multiple continuously acquired velocity parameters and their corresponding average velocities; converting the pulsatility characteristic parameters into velocity magnitude representations and performing normalization processing to obtain the flow disturbance intensity; wherein, the flow disturbance intensity is expressed as... ,and The blood flow velocity being collected, This represents the average velocity corresponding to blood flow.

[0160] Step S400, calculating the corresponding cycle consistency index based on the test cycle of the simulated test, includes: calculating the relative deviation between the velocity field of each test cycle and the average velocity across cycles, and performing normalization processing to obtain the total jitter index; wherein, the velocity field of a cycle is formed by all velocity parameters of that cycle; averaging the total jitter index to obtain the cycle consistency index; wherein, the cycle consistency index... Represented as ,and This represents the velocity field over one test cycle.

[0161] Step S500 integrates all time-domain and frequency-domain mechanical parameters and periodic consistency parameters, and uses them to assess the patient's individual aortic valve and ascending aorta condition as a basis for preoperative decision-making and device evaluation.

[0162] Specifically, in practical applications, testing equipment for personalized aortic valve and ascending aorta solid models can be found in [reference needed]. Figures 1 to 21 As shown, by conducting functional and mechanical tests on personalized aortic valve and ascending aorta solid models in vitro, the physiological and anatomical characteristics of patients can be accurately simulated, facilitating in vitro analysis and evaluation of the personalized aortic valve and ascending aorta vessels. Simultaneously, simulation tests on personalized aortic valve and ascending aorta solid models can output device performance evaluation results that better reflect the patient's actual condition, thereby assisting in preoperative surgical planning, postoperative outcome prediction, device optimization design, and personalized medical customization.

[0163] The testing device comprises a fluid supply and buffer chamber (left atrial buffer chamber), a one-way valve, a left ventricular model and a variable pressure squeezing chamber (or a servo-driven reciprocating chamber), optional compliance or impedance units, a flow meter (electromagnetic / ultrasound optional), an ascending aortic fluid buffer chamber, and connecting tubing and interfaces. The personalized aortic valve and ascending aortic model are installed in the testing device in a replaceable manner. Accordingly, personalized aortic valves and ascending aortic models can be customized based on the patient's CT or MRI images, thereby enabling in vitro simulation testing.

[0164] During the test, fluid needs to be driven from the left atrial buffer chamber into the left atrial model, and then through a one-way valve into the left ventricular model. At the same time, the pump periodically drives the squeezing chamber to produce blood ejection from the left ventricular model. The ejected fluid flows through a flow meter into the personalized aortic valve and ascending aorta solid model, and then into the ascending aorta fluid buffer chamber, and finally flows back to the left atrial buffer chamber, forming a closed loop.

[0165] Therefore, pressure sensors, flow meters, and high-frequency cameras can be installed at the inlet / outlet and several key locations to collect relevant mechanical parameters. Simultaneously, programmable drivers (servo / stepping / reciprocating pumps or extrusion mechanisms) can be used to drive the extrusion chamber with adjustable amplitude and frequency to simulate heart rate and ejection curves. Pressure / flow data from pressure sensors / flow meters can also be accepted for closed-loop control to accurately reproduce the target pressure-flow waveform.

[0166] Furthermore, to improve the physiological relevance of the in vitro pulsating flow reproduction, three-way valve interfaces can be reserved and connected at several key measurement locations (such as near the valve orifice, the middle segment of the ascending aorta, or the aortic sinus) of the personalized aortic valve and ascending aorta solid model, so as to connect the measured part to the high-speed pressure sensor without disrupting the closed loop.

[0167] In practical applications, operators can directly import clinically measured pressure-time curves or manually edit and generate pressure waveforms, i.e., pressure-time curves, through the human-computer interaction interface. During operation, the pump controller will perform closed-loop regulation at a preset sampling frequency and send the pump drive commands (displacement / speed / valve position) to the pump drive unit in real time to drive the fluid to complete a closed loop, simulating the patient's personalized aortic valve and ascending aorta physiological conditions.

[0168] Finally, based on the mechanical parameters collected during the testing process, the corresponding time-domain and frequency-domain mechanical indices and period consistency indices are calculated to generate a standardized report (including the original time series, phase mean field, near-wall profile, and wall stress risk heat map) as the basis for preoperative decision-making and instrument evaluation.

[0169] It should be added here that the flow disturbance intensity in the time-frequency domain mechanical index is a dimensionless "chaos index" obtained by comparing the "velocity jitter amplitude" (root mean square) with the "average velocity". The larger this index is, the more unstable the flow is. It can be used to quantify the instability of disturbances in the high shear region and recirculation region under the quantization lobe, and as a threshold quantity for risk warning or test condition screening.

[0170] Therefore, by and The mean is removed by subtraction, retaining only the pulsation characteristics of blood flow. The square root of the square is then used to prevent positive and negative pulsation characteristics from canceling each other out, and this indicator is expressed as velocity. Finally, normalization is applied for cross-sectional comparison of flow disturbance intensity under different test conditions. It can be written as Alternatively, it can be written as the root mean square of the three-component composite velocity, or as a monotonic transformation of the second moment such as the standard deviation, etc., without any restrictions.

[0171] Furthermore, the cycle consistency index treats the "entire waveform / entire velocity sample" of each test cycle as a velocity field. With cross-cycle To determine the magnitude of the difference between the two values, the ||·|| operation is used to quantify the difference into a scalar value that considers strength only, regardless of sign. This is then divided by ||·|| to achieve dimensionlessness, avoiding the dimensional / scaling effect where a large mean naturally implies a large difference. Finally, the average across all test periods is used to transform the total occasional fluctuations into an overall consistency level. This level represents the degree of inconsistency of the test across different periods, with smaller values ​​indicating greater consistency.

[0172] Therefore, without changing the essential meaning of "comparing the relative deviation of each cycle from the mean across cycles," all fall within the scope of protection of this application. For example, the final averaging method could be an arithmetic mean of the test cycles, a weighted average (based on heart rate stability, cardiac phase weights, etc.), or other methods; or complementary parameters of the cycle consistency index could be used, such as... Alternatively, other parameters can be used for calculation, such as pressure and flow rate.

[0173] At the same time, periodic consistency indicators can also be used. Replace the norm in the expression, such as compressing "square-integral-square root" into the L2 norm:

[0174] .

[0175] Modifications and refinements made by those skilled in the art to the embodiments of the present invention without departing from the spirit of the present invention still fall within the scope of the invention application patent.

[0176] In one specific embodiment, a personalized physical model of the patient's aortic valve and ascending aorta can be customized using the following method:

[0177] Taking a CT image of a patient's heart as an example, the complete CT image is first segmented using a grayscale threshold. From this segmentation, a voxel region of interest containing only the individual aortic valve and ascending aorta is extracted, which is the corresponding image region. Then, morphological processing is used to eliminate noise and fill gaps after threshold segmentation, making the extracted image region more complete.

[0178] Secondly, based on this, sub-blocks containing only personalized aortic valve and ascending aorta regions are cropped to reduce redundant information and lower data dimensionality, thereby improving the computational efficiency of subsequent convolutional neural networks. Simultaneously, several sub-blocks are standardized, their sizes are uniformized, and then integrated.

[0179] Furthermore, the processed image data is input into a convolutional neural network (first convolutional neural network) to achieve multi-class segmentation, namely, segmenting the valves, main trunk, and branches of the aortic valve / ascending aorta individually. If an aneurysm or dissection exists in the ascending aorta, the curved ascending aorta in the image is straightened using a skeletonization and centerline optimization algorithm based on the ascending aorta mask output by the first convolutional neural network. This simplifies the relative positions of the true lumen, aneurysm, or false lumen in the ascending aorta. The processed image is then input into a second convolutional neural network to accurately distinguish the true lumen, aneurysm, or false lumen in the ascending aorta.

[0180] Finally, the segmentation results of the first and second convolutional neural networks are mapped back to the original space through inverse transformation, and morphological restoration is performed to obtain personalized vascular images of the aortic valve and ascending aorta.

[0181] Based on the above, personalized aortic valve and ascending aorta models can be generated through reverse 3D modeling using images of the patient's personalized aortic valve and ascending aorta, as well as vascular images of these locations. For example, DICOM / tomography images are acquired and preprocessed (registration, denoising, and pixel-level intensity normalization) to preprocess the images of the patient's personalized aortic valve and ascending aorta, and the vascular images of these locations. The processed image data is then converted into voxels or surface meshes to generate an "intuitive 3D model" (initial model of the personalized aortic valve / ascending aorta) based on the original images. The initial model is then smoothed, hole repaired, topology corrected, and thin-wall / thick-wall consistency checked to identify and repair fracture edges and unreasonable geometry, resulting in the final personalized aortic valve and ascending aorta models. Finally, the personalized aortic valve and ascending aorta solid models are customized using 3D printing, supporting stereolithography / powder bed fusion 3D printing, silicone / resin molding, CNC machining, and arbitrary combinations. Meanwhile, transparent or semi-transparent shell materials can be selected according to experimental requirements to ensure optical imaging conditions.

[0182] It is understandable that, such as Figure 13 As shown, by customizing a patient's individual aortic valve and ascending aorta physical model, it can be ensured that the intracavitary surface morphology (valve opening area, calcification morphology, sinus structure, bending radius, etc.) is mapped one-to-one with the patient's image. If necessary, replaceable valve leaflets or calcification components can be embedded in the lumen for repeated testing.

[0183] Furthermore, by segmenting the patient's CT images and reverse-engineering them to generate a manufacturable STL / CAD model, a physical model can be customized via 3D printing / casting. Correspondingly, after printing, the geometry of the physical model can be measured using optical measurements or a second CT scan to calibrate the error values ​​between the model and the actual physiological structure.

[0184] To address this, CT images of personalized aortic valve and ascending aorta solid models can be obtained and compared with images of personalized aortic valve and ascending aorta obtained by processing CT images of the patient's heart to verify whether the personalized aortic valve and ascending aorta solid models meet the standards.

[0185] Specifically, the scale index for defining error values, namely geometric reproducibility (comparison results), is as follows: =Volume overlap / Reference volume, which can be further expressed as This allows for image comparison.

[0186] in, CT images representing a personalized aortic valve / ascending aorta solid model. This refers to personalized images of the aortic valve / ascending aorta obtained through CT image processing of the patient's heart.

[0187] Understandably, the geometric reproducibility provided above is used to calibrate the overlap between medical images and printed physical models as a constraint on "morphological reliability" in the "morphological-mechanical" closed loop. However, it is not limited to this one comparison method. For example, the difference between the two can also be measured by Hausdorff distance and its monotonic transformation. Furthermore, the two can also be represented in other data formats such as CT / segmented voxels, meshes, or point clouds. There are no restrictions on this.

[0188] Based on the above, the actual procedure of the personalized aortic valve and ascending aorta in vitro assessment method provided in this embodiment can be found in [reference needed]. Figure 24 The illustration includes:

[0189] Step 1: Image Acquisition and Intelligent Segmentation

[0190] Acquire patient CT / MRI images (at least one frame from systole and diastole to display the morphology of the largest valve leaflet opening), and segment the aortic root, aortic sinus, valve leaflets, and ascending aorta volume / surface contours through image processing. Output reference geometry data (3D surface or voxel data) to ensure that the fabricated solid model is consistent with the actual geometry of the patient.

[0191] Step 2: Rapid Manufacturing and Calibration of Individualized Physical Models

[0192] Based on the segmented data obtained from the above steps, a manufacturable STL / CAD model is generated through reverse modeling, and a solid model is then created through 3D printing / casting. The entrance area and shape of the chamber are determined by the shape of the largest valve leaflet opening. Furthermore, after printing, the geometry of the solid model is obtained through optical measurement or a secondary CT scan to calibrate the error value between the model and the actual physiological structure.

[0193] Step 3: Implantation of the artificial prosthetic valve

[0194] Before the individualized physical model is installed, the artificial prosthetic valve is loaded and released into the personalized ascending aortic chamber through a specialized intervention, and the release pattern of the artificial prosthetic valve will be consistent with the real situation.

[0195] Step 4: Module Assembly and Sensor Placement

[0196] The physical model was loaded into the chamber of the test device, and pressure sensors were installed at key locations (subvalvular, near the valve orifice, mid-segment of the ascending aorta, and sinus region). Flow meters were placed at the inlet / outlet, and an optical window was reserved for the PIV and a high-frequency camera was arranged.

[0197] Step 5: Initial Test (Filling in two water channels and purging gas)

[0198] Drive water circuit (referred to as circuit A): Pump + driving medium → squeeze the outer cavity 1112 to drive the deformation of the "inner cavity 1111" (Note: Circuit A is not connected to the fluid circuit under test).

[0199] Test water path (denoted as path B): Inner lumen → flows through personalized model → ascending aortic buffer → returns to left atrium (forming a closed loop) — all data from in vitro tests come from path B (velocity field, pressure, WSS, etc.).

[0200] Step 6: Set the target and start the pump (using a pressure target or a flow rate target).

[0201] The user interface imports preset pressure time-series curves and uses pressure feedback to better reproduce the clinical pressure field.

[0202] Step 7: Start the device to begin the initial loop.

[0203] The pump starts working according to the initial rhythm, first stabilizing the circulation in open-loop mode, and checking for air bubbles, seal loss, or abnormal resistance in circuit B.

[0204] Step 8: Activate pressure feedback control

[0205] The goal of closed-loop pressure feedback control is to ensure that the instantaneous pressure at the measured point is constant. Follow the preset target pressure curve The system acquires pressure signals in real time at pre-calibrated measurement points (e.g., near the valve orifice or mid-ascending aorta) and calculates the pressure error:

[0206] ,

[0207] The error e(t) is fed into the controller, which generates a control output u(t) according to a predetermined control law. The common form is PID control.

[0208] ,

[0209] The control output u(t) is converted into a pump drive command. If the pump is a reciprocating type, u(t) is usually considered as the displacement rate, i.e.:

[0210] (If u is output in the form of displacement rate)

[0211] The instantaneous flow rate is approximately:

[0212] ,

[0213] in This represents the effective area of ​​the piston.

[0214] The control cycle operates continuously, adjusting the pump's displacement / speed in real time to ensure... Approaching Meanwhile, the actual time-displacement curve x(t) (or displacement rate u(t)) is recorded in the experimental log for reproduction and error analysis.

[0215] Step 9, Synchronous Acquisition: PIV and Multi-point Measurement

[0216] According to the set phase triggering scheme (phase-locked or time-resolved), PIV camera, pressure sampling and flow meter recording are synchronously triggered. The acquired mechanical parameters include, but are not limited to, v(x,t) (velocity field), p(x_i,t) (multi-point pressure time series), and Q(t) (flow time series).

[0217] Step 10: Exception Handling and Security Strategies

[0218] If the sensor fails or p_ meas(t) If the value exceeds the safety range, the controller should trigger an emergency shutdown and record a fault log. It is recommended to implement robust control measures such as anti-windup, anti-oscillation filtering, and time delay compensation. Step 8: Summarize the calculated index data and, based on repeated cycle or repeated assembly tests, provide confidence intervals.

[0219] Step 11: Generate a standardized report

[0220] A standardized report is generated, including the original time series, phase mean field, near-wall profile, and wall stress risk heat map, which can be used as a basis for preoperative decision-making and instrument evaluation.

[0221] In another specific embodiment, considering the patient's personalized aortic valve and the implantation of an artificial prosthesis valve in the ascending aorta, the artificial prosthesis valve can be loaded and released into the chamber of the ascending aortic model via a specialized intervention after the physical model is fabricated, and the release morphology of the artificial prosthesis valve will be consistent with the actual situation. Finally, the time-domain and frequency-domain mechanical properties and periodic consistency properties of the implanted and non-implanted artificial prosthesis valves are compared, the differences are analyzed and statistically tested to generate a standardized report.

[0222] It should be noted that the steps of the various methods described above are only for clarity. In practice, they can be combined into one step or some steps can be split into multiple steps. As long as they contain the same logical relationship, they are all within the scope of protection of this patent. Adding insignificant modifications or introducing insignificant designs to the algorithm or process, but without changing the core design of the algorithm and process, are also within the scope of protection of this patent.

[0223] This invention discloses a personalized aortic valve and ascending aorta in vitro testing device. Based on the individualized physiological and anatomical characteristics of different patients, it enables in vitro testing of personalized aortic valves and ascending aortic vessels. It not only rapidly outputs diverse functional parameters but also performs individualized in vitro testing of the artificial personalized aortic valve, providing device performance evaluation results that are more closely aligned with the patient's actual condition. These features significantly improve the accuracy and reliability of preoperative surgical planning, postoperative outcome prediction, device optimization design, and personalized medical customization.

[0224] Through the aforementioned technical effects, this invention not only addresses many shortcomings of existing technologies but also provides strong technical support for the diagnosis, treatment planning, and research and development of medical devices for cardiovascular diseases. Its modular design and flexible expandability also offer ample room for future research and application.

[0225] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. An in vitro testing and evaluation device for the aortic valve and ascending aorta, characterized in that, include: Chamber system, drive system, chamber auxiliary system, loop system, control system, and particle image velocimetry system; The chamber system is used to simulate blood flow paths, including: The left ventricular system is used to simulate the contraction of the left ventricle to drive fluid. The personalized aortic valve and ascending aortic vascular system have an internal cavity structure that is reverse-engineered and manufactured based on specific medical imaging data. The structure is consistent with the actual maximum opening shape of the aortic valve, the geometry of the aortic sinus, and the orientation of the ascending aorta. The personalized aortic valve and ascending aortic vascular system are rigid structures formed in one piece by 3D printing. The ascending aortic fluid buffer chamber is connected to the outlet end of the chamber of the personalized aortic valve and the ascending aortic vascular system, and is used to temporarily store the fluid flowing out from the personalized aortic valve and the ascending aortic vascular system. The left atrial system and its corresponding fluid buffer chamber are connected to the left ventricular system and are used to receive the returning fluid and form a closed loop. The drive system is connected to the left ventricular system and is used to provide periodic pulsatile driving force to simulate heartbeats; The circuit system connects the outlet of the personalized aortic valve and the ascending aortic vascular system to the left atrial fluid buffer chamber, forming a closed loop for the test fluid, and includes components for regulating fluid temperature and peripheral resistance. The chamber assist system includes an aortic sinus compliance chamber that communicates with the aortic sinus region of the personalized aortic valve and ascending aortic vascular system to simulate physiological coronary compliance. The control system is used to set the target pressure or flow curve, and to implement closed-loop feedback control of the drive system based on the real-time collected pressure signal, so that the pressure at the test point dynamically tracks the preset target. The particle image velocimetry system is configured in the optically visible area of ​​the personalized aortic valve and ascending aortic vascular system, and is used to non-invasively acquire hemodynamic parameters such as fluid velocity field, wall shear force and relative particle residence time. The left ventricular system includes: An outer chamber is provided with an outer chamber sealing valve and an inner chamber sealing valve at its bottom. The outer chamber sealing valve is connected to the outer chamber. An opening is also provided at its bottom, and the opening is connected to the drive system. An inner chamber is located inside the outer chamber, and its bottom is connected to the inner chamber sealing valve via a hose; An inclined beam cover is disposed on the top of the outer chamber and the inner chamber and is sealed to them. The inclined beam cover is respectively connected to the personalized aortic valve and the ascending aortic vascular system and the left atrial system. The inclined beam cover has two inclined surfaces, with a first inclined opening communicating with the personalized aortic valve and the ascending aortic vascular system and a second inclined opening communicating with the left atrial system, respectively. The first inclined opening and the second inclined opening communicate with the inner chamber.

2. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 1, characterized in that, A removable one-way valve is provided at the first oblique opening and / or the second oblique opening, the one-way valve being configured to allow fluid to flow unidirectionally only from the left ventricle to the ascending aorta or from the left atrium to the left ventricle.

3. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 1, characterized in that, It also includes a flow meter, which is detachably disposed between the inclined surface having the first oblique opening and the personalized aortic valve and ascending aortic vascular system.

4. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 1, characterized in that, The personalized aortic valve and ascending aortic vascular system includes: chamber; The aortic sinus compliant cavity connection port has one end communicating with the aortic sinus portion of the cavity and the other end connected to the cavity auxiliary system; The liquid outlet is connected at one end to the top of the chamber and at the other end to the loop system; The lower three-way valve interface and the upper three-way valve interface are connected to the inlet and outlet of the chamber, respectively.

5. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 4, characterized in that, The personalized aortic valve and ascending aortic vascular system includes a transparent shell and a chamber disposed within the shell. The chamber wall and the transparent shell are hollow, and the chamber wall is a flexible structure.

6. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 1, characterized in that, The personalized aortic valve and ascending aortic vascular system are prepared through the following steps: Obtain CT, MRI, or ultrasound images of the patient at the end of cardiac systole; The three-dimensional contours of the aortic root, aortic sinus, valve leaflets, and ascending aorta are segmented. After removing significantly calcified areas, reverse modeling is performed to generate an STL / CAD model; A physical model with an internal cavity is created using 3D printing, molding, or machining.

7. The in vitro testing and evaluation device for the aortic valve and ascending aorta according to claim 1, characterized in that, The control system integrates a pressure feedback regulation subsystem, which sets up high-speed pressure sensors near the valve orifice, in the middle of the ascending aorta, or at the aortic sinus. Based on the real-time pressure signal, it uses a PID control algorithm to dynamically adjust the drive system so that the measured pressure waveform tracks the preset clinical target pressure curve.

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