CN110974318A - External simulation device and simulation system for transcatheter aortic valve replacement - Google Patents
External simulation device and simulation system for transcatheter aortic valve replacement Download PDFInfo
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Abstract
The invention discloses an in-vitro simulation device and system for transcatheter aortic valve replacement. The device comprises a model to be tested, a mounting test bench, a circulating pump, a control device, an ultrasonic detector, a coronary blood flow receptor and two backflow receptors. The disclosed system includes a 3D modeling system, a 3D printing device, and a simulation device of the present invention. According to the invention, the 3D printing model is connected to the specific simulation device, so that the transcatheter aortic valve replacement can be accurately simulated before the operation, and the specific data of the patient, such as coronary blood flow, perivalvular regurgitation and trans-valvular pressure difference, can be recorded, so that the specific risk and possible complications of the patient can be evaluated, the accurate evaluation can be provided for the actual operation, and the operation complications and risks can be reduced.
Description
Technical Field
The invention belongs to the technical field of cardiovascular surgery transcatheter valve replacement external simulation equipment, and relates to an external simulation device for a transcatheter aortic valve replacement or repair operation based on a 3D printing heart model.
Background
Transcatheter Aortic Valve Replacement (TAVR) is considered the treatment of choice for elderly, intra-operative/high risk aortic valve patients. The operation has small wound, does not need extracorporeal circulation, can recover quickly after the operation, and is popularized in clinic more and more. Nevertheless, a number of serious complications, such as annulus rupture, acute coronary ostial obstruction, paravalvular leaks, three-degree atrioventricular block, peripheral vascular injury, thrombosis, valve dislodgement, etc., plague the development of this technology. Among them, the rupture of the valve ring and the blockage of the acute coronary artery opening are dangerous and urgent complications, which can lead to the deterioration of the disease and even the death of the patient; complications such as paravalvular leak, valve displacement, three-degree atrioventricular block, thrombus and the like often cause poor postoperative prognosis of patients, increase the risk of multiple operations and the possibility of hospitalization again. Therefore, accurate assessment before surgery, and thus guidance in selecting the appropriate balloon, valve, and possibly risk plan during surgery are critical to TAVR surgery.
TAVR has very big difference with the conventional chest surgery, and the doctor can't look directly at the heart in the operation, even can't cut open the heart and observe its internal microstructure, therefore, before operation image science evaluation and navigation are vital. No matter CT, MRI, B-ultrasonic examination and the like, the two-dimensional visual field can be provided on the screen, preoperative doctors still need to carefully study and measure the heart and aorta image data of patients, secondary processing is carried out in the brains of the doctors, the images are reconstructed into a three-dimensional configuration, and the intuitiveness and the adjustability are poor.
Disclosure of Invention
In response to the shortcomings or drawbacks of the prior art, the present invention provides an in vitro simulation device for transcatheter aortic valve replacement.
The device provided by the invention comprises a test board for installing a model to be tested, a circulating pump, an ultrasonic detector, a coronary blood flow receptor and a backflow receptor;
the installation test bench is used for placing or/and installing a model to be tested;
the circulating pump is used for simulating heart blood supply and providing blood for the model to be tested in the simulation process;
the ultrasonic detector is arranged in an aortic sinus region of the model to be tested and used for collecting ultrasonic data in the simulation process;
the coronary blood flow receptor is arranged on an ascending aorta of a model to be tested and used for monitoring blood flow of left and right coronary arteries during simulation so as to evaluate whether coronary artery opening blockage exists during balloon expansion or valve release;
the reflux receptor is arranged on the side of a simulation heart chamber of the model to be tested and is used for monitoring the blood flow pressure in diastole during simulation.
Furthermore, the simulation device of the invention also comprises a control device which is used for controlling the operation of the circulating pump, the ultrasonic detector, the coronary blood flow receptor and the reflux receptor.
Further, the installation and test platform comprises a platform, two installation bases are arranged on the platform, and a model connector is arranged on each installation base.
Further, the invention also provides an in-vitro simulation system for the transcatheter aortic valve replacement. The in-vitro simulation system further comprises a 3D modeling system, a 3D printing device and the device of claim 1 on the basis of the simulation device.
The invention has the beneficial effects that:
according to the invention, the 3D printing model is connected to the specific simulation device, so that the transcatheter aortic valve replacement can be accurately simulated before the operation, and the specific data of the patient, such as coronary blood flow, perivalvular regurgitation and trans-valvular pressure difference, can be recorded, so that the specific risk and possible complications of the patient can be evaluated, the accurate evaluation can be provided for the actual operation, and the operation complications and risks can be reduced.
Drawings
FIG. 1 is a schematic diagram of the apparatus of the present invention;
FIG. 2 is a schematic diagram of the structure of the 3D model of the present invention;
FIG. 3 is a schematic diagram of a patient 3D printed aortic root model according to an embodiment;
FIG. 4 is a diagram of a preoperative ultrasound acquisition of a patient according to an embodiment; FIG. 4A is a systolic diastolic ultrasound view and FIG. 4B is an aortic valve ultrasound view;
FIG. 5 is a ventricular systolic-diastolic ultrasound image after valve release during a patient simulation of an example.
Detailed Description
Unless otherwise indicated, the terms in the present invention are understood according to conventional knowledge in the relevant art.
Example (b):
the simulation device provided by the invention has the advantages that the 3D printed aortic valve and the surrounding structure are connected to the device, balloon pre-expansion and valve release simulation can be carried out in vitro, hydrodynamics and related data can be further measured and collected, the process of in-vivo TAVR surgery can be more truly restored, risks of coronary artery, perivalvular leakage and valve displacement can be scientifically and effectively evaluated, the accuracy of preoperative evaluation and the specificity of a patient are improved, accurate guidance is provided for the surgery, and therefore complications and death rate caused by the surgery are greatly reduced. 3D printing devices suitable for use with the present invention are, for example, J750DAP and objet260 Connex 3.
The structure of the model to be measured of the invention is shown in fig. 1 and 2, the 3D model structure mainly comprises a tissue body model 13, mounting parts 12 at two ends, the mounting parts can be designed into tubular connecting pipes, and side holes arranged on the mounting part wall at one side of the left ventricular outflow tract, wherein the tissue body model 13 comprises the left ventricular outflow tract, aortic valve leaflets, aortic sinuses, coronary openings and ascending aorta physiological tissue structures. In a further preferred scheme, the model to be tested is made of a transparent material, so that the change condition of the interior of the tissue in the simulation process can be observed conveniently. Wherein the side hole is used for installing an arterial sheath 11 (such as an arterial sheath with the model of 18-24F/french1F ≈ 0.33mm, and the appropriate model of the arterial sheath is selected according to the physiological tissue characteristics of a patient). When the transcatheter aortic valve replacement operation is simulated, the saccules with the corresponding sizes are sent from the position of the arterial sheath 11 to carry out a valve sacculus expansion experiment, and the saccules can also be sent into the valve by means of the arterial sheath to carry out a valve release experiment, so that the operation process is simulated.
The model to be tested can be obtained by adopting the existing 3D printing. Specifically, modeling is carried out based on physiological and pathological characteristics of the root of the cardiac aortic valve of a specific patient and requirements of model installation and operation simulation, and then a 3D model of the root structure of the cardiac aortic valve is manufactured by selecting materials with proper elasticity and hardness as raw materials and carrying out a 3D printing process. In a preferred scheme, the printing material is a transparent material with corresponding characteristics.
As shown in fig. 1, the simulation apparatus of the present invention includes a test bench 4 for mounting a model to be tested, a circulation pump 2, an ultrasonic probe 6, a coronary blood flow receptor 8 (for two coronary blood flow receptors, the left and right coronary blood flow are detected respectively), and a reflux receptor 7; when the device is subjected to simulation test:
the installation test bench 4 is used for placing or/and installing the model to be tested. It can be a platform, also can be a platform equipped with model to be tested. For example, in one embodiment, as shown in fig. 1, two mounting bases 9 are provided on the installation and test stand 4, and each mounting base is provided with a model connector 1. In assembly relation with other components, the model connectors 1 on two sides are respectively communicated with the circulating pump 2 through a liquid conveying pipe I5 and a liquid conveying pipe II on the other side, the liquid conveying pipe I5 is used for being communicated with a connecting pipe on one side of the left ventricular outflow tract (the end B shown in figure 1), and the liquid conveying pipe II is used for being connected with a connecting pipe on one side of the ascending aorta (the end A shown in figure 1). In a more preferred embodiment, the distance between the two mounting seats 9 can be adjusted correspondingly according to different sizes of the model to be measured.
The circulation pump 2 is used for simulating the heart to provide a motive force for simulating the flow of the priming solution for blood flow in the test process, and the function of the circulation pump can be realized by adopting the existing circulation pump, such as a Tayota/Fujiwara circulation pump, and the power is as follows: 380W, rotating speed: 2860r/min, maximum flow: 1.8m3。
As shown in fig. 1, the operation of the circulation pump includes intermittently simulating systole and diastole from the B side or the a side, and driving the flow of the liquid (the liquid may preferably be water), during the simulation, systole is output from the B side to the a side, and diastole is output from the a side to the B side.
The ultrasonic detector 6 is installed in the aortic sinus region of the model to be tested, reduces artifacts and interference through a coupling agent during simulation operation, acquires ultrasonic data, and acquires leaflet activity, orifice opening area, blood flow rate, trans-valve pressure difference, perivalvular back flow and the like according to the ultrasonic data.
The coronary blood flow receptor 8 is arranged in the ascending aorta of the model to be tested and is used for monitoring the blood flow of the left and right coronary arteries during in-vitro simulation so as to evaluate whether the opening of the coronary artery is blocked when the balloon is expanded or the valve is released. Furthermore, two coronary blood flow sensors 8 are respectively installed at the coronary ostia of the aortic sinus to respectively collect the left and right coronary blood flow signals.
The backflow receptor 7 is installed at the B end (simulated ventricle side) of the model to be tested, can measure the pressure of backflow water flow during diastole (pumping water at the A end), and can convert the pressure into estimated liquid backflow (specifically, by converting the pressure value into less, medium and large amount of valve circumference backflow (for example, when the liquid pressure position is 0mmHg, the backflow is equal to 0ml, the pressure is 0-10mmHg, the backflow is about a small amount, the pressure is 10-20mmHg, the flooding flow medium amount is greater than 20mmHg, namely a large amount), so that the valve circumference backflow is estimated.
In a specific embodiment, the ultrasonic detector 6, the coronary blood flow receptor 8 and the reflux receptor 7 can be devices of proper types. If the ultrasonic detector 6 is a general medical ultrasonic detector, the flow sensor can be a Transonic T400 ultrasonic blood flow instrument, and the reflux receptor 7 can be a TE Connectivity (TE) pressure sensor.
In a further scheme, the simulation device also comprises a control device 3, and the work of the whole device is controlled; the circulating pump 2, the ultrasonic detector 6, the two coronary blood flow sensors 8 and the reflux sensor 7 are respectively in signal transmission with the control device 3 through signal transmission leads or wireless communication.
Send into corresponding big or small sacculus from artery sheath pipe department and carry out valve sacculus expansion experiment, also can send into the valve with the help of artery sheath pipe and carry out valve release experiment, simulation TAVR operation process, in-process controlling means 3 implements following control work:
1. the end of the circulating water pump B, A is controlled and driven to work alternately in order to simulate the blood flow direction during the contraction and the diastole of the heart;
2. a, B when the pump is working, the control device instructs the coronary blood flow receptor 8 to work, and collects and displays the blood flow of the coronary in the systole and diastole of the model;
3. when the A-end pump works (when the simulation diastole is performed), the control device instructs the reflux receptor 7 to work, collects and displays the pressure of the left ventricle when the simulation diastole is performed, and evaluates the peripheral reverse flow;
4. when the water pump works, the control device instructs the ultrasonic detector 6 to work, and relevant data of the valve in the whole process are collected and displayed.
Medical staff analyzes risks such as coronary artery opening blockage, paravalvular leakage, valve displacement and the like according to data acquired by the device and observation phenomena.
The sorting and using process of the device mainly comprises the steps of printing of a model to be tested, installation of the model to be tested, parameter setting, preoperative simulation test, intraoperative simulation test, postoperative simulation test and risk assessment. Wherein:
one specific implementation of the printing of the model to be tested is as follows:
(1) 4D CT scanning is carried out on the cardiovascular structure line of the patient to obtain DICOM data and establish a contraction period file;
(2) the method comprises the following steps of retaining a left ventricular outflow tract at the root of the aorta, aortic valve leaflets, aortic sinuses, coronary ostia and an ascending aorta structure in image data, wherein the far ends of the left ventricular outflow tract and the ascending aorta are artificially made into a cylindrical link structure during 3D modeling so as to be connected with a simulation device conveniently; meanwhile, a hole is formed at the far side of the ascending aorta (A end) to form a side hole, so that an arterial sheath tube can be conveniently installed during simulation;
(3) and forming a 3D data file, importing the 3D data file into a 3D printer, and printing out the model by using transparent materials with different hardness according to the characteristics of human tissues, wherein the valve leaflet is printed by using a soft material, and the calcified part is printed by using a hard material. The final model may be treated in whole or in part.
The specific implementation mode of the installation of the model to be tested is as follows:
after each communication port is installed, the communication ports are connected with main pipeline interfaces on two sides of the circulating pump, one side of the communication port is connected with the left ventricular outflow tract (end A), and the other side of the communication port is connected with the ascending aorta (end B), so that a circulating loop of 'pump-A end interface-left ventricular outflow tract-ascending aorta-B end interface-pump' is formed.
The specific implementation mode of the parameter setting is as follows:
setting the working times of the pump per minute, the water flow rate of each pumping, the output time of the pump A end and the output time of the pump B end on a control device according to the heart rate, the stroke volume, the systolic period duration and the diastolic period duration data of a patient; the corresponding relationship between the patient physical sign parameters and the device parameters is shown in table 1, and the values of the corresponding parameters shown in table 1 are the same. Specifically, the stroke volume and the heart rate of a patient can be calculated according to preoperative ultrasound and CT data, the flow rate, the pressure (the flow rate corresponds to the blood flow rate, and the pressure corresponds to the systolic pressure or the aortic blood pressure) and the volume of pumped water flow are set, and the blood flow mode of a human body is simulated.
TABLE 1
| Patient sign parameters | Simulation device |
| Heart rate (times/minute) | Number of pump operations per minute |
| Stroke volume (ml) | Each time pumping water flow |
| Duration of systole (seconds) | Pump a end output time |
| Diastolic time duration (seconds) | Pump B end output time |
Preoperative simulation test:
after the device is installed on the model to be tested, the interior of the model to be tested is filled with liquid, the water pump is alternately arranged in a contraction mode and a relaxation mode, the water pump is arranged at the A end during contraction, the water pump is arranged at the B end during relaxation, and the dynamic change of ventricular blood pumping or blood filling during systole and diastole of a human body is simulated. Monitoring and recording the preoperative trans-valvular pressure difference, coronary blood flow and aortic valve regurgitation of the preoperative 3D model.
Intraoperative simulation test:
according to TAVR surgical planning, a catheter guidewire is implanted through the ascending aorta (a-side) lateral arterial sheath to simulate a trans-aortic valve procedure, which can help find the optimal trans-aortic angle and method.
After crossing the aortic valve into the left ventricle, the stiffened guidewire is replaced. According to the measurement before the operation, a proper balloon is selected, the balloon is expanded through the transvalvular after the ascending aorta (A end) side artery sheath is placed, the expansion condition of the balloon is observed in the operation, and the coronary blood flow and the peripheral return flow of the valve are monitored and recorded.
The postoperative simulation test comprises:
selecting a proper stent valve to be placed through an arterial sheath tube by combining pre-operation CT evaluation and balloon expansion, simulating a valve replacement operation, and monitoring and recording pre-operation and post-operation stent valve forms, trans-valve pressure difference, coronary blood flow and aortic valve regurgitation after valve release is finished;
the risk assessment includes:
analyzing coronary artery opening obstruction according to a blood flow value acquired by a coronary artery blood flow receptor; when the measured value is stable and unchanged, the risk does not exist, and when the measured value is sharply reduced or disappears, the risk of coronary artery obstruction exists.
Analyzing the perivalvular leakage degree according to the numerical value of the backflow water pressure collected by the baroreceptor; when the pressure value is equal to 0, there is no perivalvular leakage risk, when the pressure value rises, there is perivalvular leakage risk, and the rising value is directly proportional to perivalvular leakage severity.
And analyzing risks such as valve displacement and the like (observable by naked eyes) according to the actual observed stent valve position.
The following is a simulation and risk assessment of a TAVR procedure for a particular patient using the apparatus of the present invention.
Simulating an object:
the patient is a patient with severe aortic stenosis, 60 years old and has heart failure; the patient is diagnosed 2 years ago because of chest distress and shortness of breath, and the aortic valve is found to be severely narrow by the heart ultrasonic wave, so that the patient is not treated. The symptoms are aggravated due to cold before 4 months, and poor cardiac function is prompted by the doctor of the Xijing hospital, and the EF value is 30%. Ordering to discharge, taking medicine, regulating cardiac function, and performing selective admission operation. During the period, the heart color Doppler ultrasound is rechecked every month, which indicates that the heart function is not improved obviously.
The patient is admitted after 11 months in 2018, and the left limb is in movement disorder. After the patient is admitted to the hospital, the patient is suffered from chronic decubitus complicated with pneumonia, acute cardiac insufficiency, pink foam phlegm cough and edema of the lower limbs. After a large amount of cardiotonic, diuretic, anti-inflammatory and cardiac muscle nourishing treatments, the general condition is improved, and multiple heart color ultrasonography prompts progressive decline of the heart function and continuous decline of the EF value.
Therefore, acute transcatheter aortic valve replacement is his only opportunity, but this patient was evaluated by preoperative CT as the transverse heart (heart angle greater than 60 degrees from horizontal), type 0 bileaflet valve, very heavily calcified. Therefore, TAVR surgery is very challenging, and various pre-proposals must be made before surgery to succeed.
TAVR surgical planning:
ECMO or extracorporeal circulation assist-left femoral artery and vein;
sequentially expanding balloons with the diameters of 18mm and 23 mm;
valve selection No. 29 Venus-A recoverable valve;
entering a path: the right femoral artery is recommended as the main road;
the transverse heart-valve conveying system adopts the bending skill, and the valve 0 is released;
overall evaluation: the difficulty is very high, and the risk is extremely high.
The 3D model of the patient to be tested is shown in fig. 3.
Setting parameters:
the working parameters are as follows: the water pump outputs A, B ends which are set 100 times per minute to work alternately, the B end (ventricular side) outputs 40ml/s and 40mmHg (simulating ventricular pressure and stroke volume) each time; the A end (output on ascending aorta side each time) is 50ml/s, and the pressure is 60mmHg (simulated average aortic pressure); diastolic period: the time length is 1: 1, 100 times per minute;
preoperative ultrasound acquisition information for the patient: the two figures are respectively a systolic diastolic ultrasound image (fig. 4A), an aortic valve ultrasound image (fig. 4B), and heart valve related data collected by a pre-operative ultrasound report of a patient as shown in table 2.
TABLE 2
| Area of valve orifice | 0.4cm2 | Annulus inner diameter | 29.7mm |
| Index of orifice | 0.43 | Fraction of ejection | 14％ |
| Average cross-petal pressure difference | 50mmHg | Inner diameter of Zuochu powder | 55mm |
| Peak flow rate | 366cm/s | Volume of the powder for relaxing the left ventricle | 186ml |
Preoperative simulation test:
the data of the coronary artery blood flow detector on both sides before the operation are respectively 60ml/s and 72 ml/s. The reflux receptor number was 0 and the transvalvular pressure difference averaged 55 mmHg. The aortic valve stenosis and coronary patency of the patient can be predicted.
Intraoperative simulation test:
performing operation simulation operation according to TAVR operation plan, firstly putting an 18mm saccule into the A end, and firstly expanding the saccule;
the opening degree of the valve is increased and the cardiac function is relieved through ultrasonic prompt after the saccule is expanded;
results of other sensor tests: as can be seen by naked eyes, the activity of the ultrasonic feedback valve leaflet of the patient is increased (the trans-valve pressure difference is reduced (30mmHg), the blood flow speed is reduced (280cm/s),
and (3) postoperative simulation test:
proper valves are selected to be placed, the postoperative ultrasound prompts the improvement of the cardiac function, and the valve positions are good:
results of other sensor tests: the ultrasound data (shown in figures 4 and 5) suggests that the pressure difference and flow rate across the aortic valve are reduced and the leaflet mobility is good; coronary blood flow receptor data suggest that the coronary is unaffected and blood perfusion is increased; the reflux receptor detects a small amount of reflux.
Simulation results are as follows:
selecting a balloon with a proper size for pre-expansion on an in-vitro simulation device according to a preoperative CT evaluation result, and opening a stenotic valve on the basis of not damaging an aorta root structure; and a valve with a proper size is further selected for implantation, the valve is released at a correct position, the valve does not shift, and the ultrasonic probe detects that the valve leaf works well. The simulation successfully completes one external TAVR operation, provides accurate preoperative guidance for the next emergency operation, and can effectively guide the doctor to carry out the operation more safely.
The simulation device can completely simulate the in-vivo environment, and can truly restore the operation process by virtue of the operation on the 3D printing model. The method provides more vivid and real preoperative assessment for the preoperative operation of the aortic valve patient with high difficulty and high risk than two-dimensional image assessment such as CT, ultrasound and the like, can timely discover the operation difficulty in the operation and estimate the occurrence condition of the risk, and can help reduce the complications in the operation and guide the making of a risk plan.
Claims (4)
1. An in vitro simulation device for transcatheter aortic valve replacement is characterized by comprising a test board for installing a model to be tested, a circulating pump, an ultrasonic detector, a coronary blood flow receptor and a reflux receptor;
the installation test bench is used for placing or/and installing a model to be tested;
the circulating pump is used for simulating heart blood supply and providing blood for the model to be tested in the simulation process;
the ultrasonic detector is arranged in an aortic sinus region of the model to be tested and used for collecting ultrasonic data in the simulation process;
the coronary blood flow receptor is arranged on an ascending aorta of a model to be tested and used for monitoring blood flow of left and right coronary arteries during simulation so as to evaluate whether coronary artery opening blockage exists during balloon expansion or valve release;
the reflux receptor is arranged on the side of a simulation heart chamber of the model to be tested and is used for monitoring the blood flow pressure in diastole during simulation.
2. The in vitro simulation apparatus of a transcatheter aortic valve replacement of claim 1, wherein the apparatus further comprises a control device for controlling the operation of the circulatory pump, the ultrasound probe, the coronary flow receptors, and the regurgitant flow receptors.
3. The in vitro simulator of claim 1, wherein the mounting and test stand comprises a platform with two mounting sockets, each mounting socket having a model connector.
4. An in vitro simulation system for transcatheter aortic valve replacement comprising a 3D modeling system, a 3D printing device, and the device of claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201911164764.3A CN110974318A (en) | 2019-11-25 | 2019-11-25 | External simulation device and simulation system for transcatheter aortic valve replacement |
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| CN201911164764.3A CN110974318A (en) | 2019-11-25 | 2019-11-25 | External simulation device and simulation system for transcatheter aortic valve replacement |
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| CN201911164764.3A Pending CN110974318A (en) | 2019-11-25 | 2019-11-25 | External simulation device and simulation system for transcatheter aortic valve replacement |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113749687A (en) * | 2020-06-03 | 2021-12-07 | 株式会社日立制作所 | Test apparatus, test method, and test phantom |
| CN113782202A (en) * | 2021-08-31 | 2021-12-10 | 拓微摹心数据科技(南京)有限公司 | Transverse heart risk assessment method based on virtual annulus plane included angle of aortic valve root |
| CN114305323A (en) * | 2020-09-27 | 2022-04-12 | 四川大学华西医院 | Method, device and equipment for predicting postoperative complications of transcatheter aortic valve replacement |
Citations (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007100090A1 (en) * | 2006-03-03 | 2007-09-07 | Waseda University | System for evaluating cardiac surgery training |
| CN201268704Y (en) * | 2008-09-26 | 2009-07-08 | 中国人民解放军第四军医大学 | Dynamic bionic pulsating movement bioreactor |
| CN102949252A (en) * | 2012-10-16 | 2013-03-06 | 北京迈迪顶峰医疗科技有限公司 | Test device for in vitro release and performance simulation of intervening valves |
| CA2956923A1 (en) * | 2014-07-31 | 2016-02-04 | Vascular Simulations, Llc | Cardiac simulation device |
| CN106037931A (en) * | 2015-04-16 | 2016-10-26 | 西门子公司 | Method and system for advanced transcatheter aortic valve implantation planning |
| CN106730081A (en) * | 2016-12-02 | 2017-05-31 | 卫洪超 | Artificial heart |
| CN107615360A (en) * | 2015-03-30 | 2018-01-19 | 国立大学法人大阪大学 | Catheter simulation device container and the cardiac module being contained in the container |
| CN107773328A (en) * | 2016-08-24 | 2018-03-09 | 上海市同济医院 | Testing external performance system and its method of testing through conduit mitral valve support |
| CN109044565A (en) * | 2018-09-17 | 2018-12-21 | 武汉唯柯医疗科技有限公司 | Prosthetic device is used in a kind of operation of tritubercular cycloid |
| CN109172047A (en) * | 2018-09-18 | 2019-01-11 | 上海工程技术大学 | Heart valve prosthesis function test system |
| US20190027065A1 (en) * | 2016-01-11 | 2019-01-24 | The Regents Of The University Of California | Systems and methods for simulating hemodynamically responsive vasculatures |
| CN109841137A (en) * | 2019-02-14 | 2019-06-04 | 上海长海医院 | Root of ascending aorta intracavitary therapy training pattern |
| CN109939282A (en) * | 2019-04-23 | 2019-06-28 | 四川大学 | A kind of percutaneous Left heart assistanee system |
| CN110168626A (en) * | 2016-11-14 | 2019-08-23 | 米兰综合工科大学 | For simulating the testboard component of openheart surgery and/or insertion type cardiac surgery and/or process |
| CN110478083A (en) * | 2019-08-21 | 2019-11-22 | 沛嘉医疗科技(苏州)有限公司 | A kind of valvular vitro test system and its test method |
| CN211749774U (en) * | 2019-11-25 | 2020-10-27 | 西安马克医疗科技有限公司 | External simulation device and simulation system for transcatheter aortic valve replacement |
-
2019
- 2019-11-25 CN CN201911164764.3A patent/CN110974318A/en active Pending
Patent Citations (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007100090A1 (en) * | 2006-03-03 | 2007-09-07 | Waseda University | System for evaluating cardiac surgery training |
| CN201268704Y (en) * | 2008-09-26 | 2009-07-08 | 中国人民解放军第四军医大学 | Dynamic bionic pulsating movement bioreactor |
| CN102949252A (en) * | 2012-10-16 | 2013-03-06 | 北京迈迪顶峰医疗科技有限公司 | Test device for in vitro release and performance simulation of intervening valves |
| CA2956923A1 (en) * | 2014-07-31 | 2016-02-04 | Vascular Simulations, Llc | Cardiac simulation device |
| CN107615360A (en) * | 2015-03-30 | 2018-01-19 | 国立大学法人大阪大学 | Catheter simulation device container and the cardiac module being contained in the container |
| CN106037931A (en) * | 2015-04-16 | 2016-10-26 | 西门子公司 | Method and system for advanced transcatheter aortic valve implantation planning |
| US20190027065A1 (en) * | 2016-01-11 | 2019-01-24 | The Regents Of The University Of California | Systems and methods for simulating hemodynamically responsive vasculatures |
| CN107773328A (en) * | 2016-08-24 | 2018-03-09 | 上海市同济医院 | Testing external performance system and its method of testing through conduit mitral valve support |
| CN110168626A (en) * | 2016-11-14 | 2019-08-23 | 米兰综合工科大学 | For simulating the testboard component of openheart surgery and/or insertion type cardiac surgery and/or process |
| CN106730081A (en) * | 2016-12-02 | 2017-05-31 | 卫洪超 | Artificial heart |
| CN109044565A (en) * | 2018-09-17 | 2018-12-21 | 武汉唯柯医疗科技有限公司 | Prosthetic device is used in a kind of operation of tritubercular cycloid |
| CN109172047A (en) * | 2018-09-18 | 2019-01-11 | 上海工程技术大学 | Heart valve prosthesis function test system |
| CN109841137A (en) * | 2019-02-14 | 2019-06-04 | 上海长海医院 | Root of ascending aorta intracavitary therapy training pattern |
| CN109939282A (en) * | 2019-04-23 | 2019-06-28 | 四川大学 | A kind of percutaneous Left heart assistanee system |
| CN110478083A (en) * | 2019-08-21 | 2019-11-22 | 沛嘉医疗科技(苏州)有限公司 | A kind of valvular vitro test system and its test method |
| CN211749774U (en) * | 2019-11-25 | 2020-10-27 | 西安马克医疗科技有限公司 | External simulation device and simulation system for transcatheter aortic valve replacement |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113749687A (en) * | 2020-06-03 | 2021-12-07 | 株式会社日立制作所 | Test apparatus, test method, and test phantom |
| CN113749687B (en) * | 2020-06-03 | 2024-05-14 | 富士胶片医疗健康株式会社 | Test device, test method, and test phantom |
| CN114305323A (en) * | 2020-09-27 | 2022-04-12 | 四川大学华西医院 | Method, device and equipment for predicting postoperative complications of transcatheter aortic valve replacement |
| CN114305323B (en) * | 2020-09-27 | 2023-10-31 | 四川大学华西医院 | Method, device and equipment for predicting complications after transcatheter aortic valve replacement operation |
| CN113782202A (en) * | 2021-08-31 | 2021-12-10 | 拓微摹心数据科技(南京)有限公司 | Transverse heart risk assessment method based on virtual annulus plane included angle of aortic valve root |
| CN113782202B (en) * | 2021-08-31 | 2023-08-01 | 拓微摹心数据科技(南京)有限公司 | Transverse heart risk assessment method for virtual annulus plane included angle based on aortic valve root |
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