CN211787810U - 3D model in-vitro simulation device for transcatheter mitral valve disease treatment operation - Google Patents
3D model in-vitro simulation device for transcatheter mitral valve disease treatment operation Download PDFInfo
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Abstract
The utility model discloses a 3D model in vitro simulation device for transcatheter mitral valve disease treatment operation. The disclosed device comprises a water pump, an air bag, an ultrasonic detector, a pressure sensor and a blood flow detector; the water pump is used for supplying liquid for the 3D model to be tested so as to simulate blood flow; the air bag is used for simulating the peripheral tissues of the heart in the human body; the air bag pump simulates the change of peripheral tissues during the contraction and the relaxation of the heart by inflating and deflating the air bag; the ultrasonic sensor, the pressure sensor and the blood flow detector are respectively used for detecting relevant operation parameters in simulation, and the disclosed simulation device further comprises a 3D printing system. The utility model discloses a print the model with 3D and be connected to specific analogue means, can be accurate simulation before the art through pipe mitral valve flap takes shape and the replacement art, the risk of aassessment patient specificity and the complication that probably exists reduce operation complication and risk.
Description
Technical Field
The utility model belongs to the technical field of cardiovascular surgery is through the external analog equipment of pipe valve restoration and replacement art, a through the external analogue means of 3D model of pipe mitral valve disease treatment operation is related to.
Background
The mitral valve disease of the old is the most common valvular disease in clinic, the incidence rate of the old is about 7-13%, and the life quality of the old is seriously influenced. Once severe mitral insufficiency is diagnosed, the traditional treatment method needs open chest and descending valve replacement or repair operation in extracorporeal circulation, and has great operation risk and extremely high trauma.
Recently, the rapidly advancing treatment of transcatheter mitral valve disease, including Transcatheter Mitral Valvuloplasty (TMVP) and replacement (TMVR), does not require open-chest extracorporeal circulation, and valve repair or replacement can be accomplished in a minimally invasive manner on the beating heart. At present, the technology is mainly applied to aortic valve replacement, and the application of transcatheter technology to the mitral valve is very limited because of the limitation of complex anatomical structure, pathological changes, lack of effective evaluation and instrument design and the like of the mitral valve, so that complications such as residual reflux, paravalvular leakage, left ventricular outflow obstruction, left heart failure and the like are difficult to effectively evaluate.
Disclosure of Invention
Aiming at the defects or shortcomings of the prior art, the utility model provides a 3D model in-vitro simulation device for transcatheter mitral valve disease treatment operation.
The device provided by the utility model comprises a water pump, an air bag, an ultrasonic detector, a pressure sensor and a blood flow detector;
a water pump: interfaces at two ends of the water pump are respectively connected with the left atrium and the ascending aorta port of the 3D model to be tested and used for supplying liquid for the 3D model to be tested so as to simulate the blood flow;
an air bag: the air bag is used for simulating the peripheral tissues of the heart in the human body and is provided with an air inlet and an air outlet;
an air bag pump: the air bag pump is connected with an air inlet and an air outlet on the air bag, and the air bag is inflated and deflated by the air bag pump to enable the air bag to simulate the change of peripheral tissues during the contraction and the relaxation of the heart;
an ultrasonic sensor: the device is arranged in the mitral valve and left ventricular outflow tract side wall area of a 3D model to be tested and used for detecting dynamic change data of the mitral valve in the simulation process;
a pressure sensor: the device is arranged in the left atrium region of the 3D model to be detected and used for detecting the blood flow returning to the atrium during the simulated systole and measuring the pressure of the backflow water flow during the diastole;
a blood flow detector: and the device is connected with the left coronary artery circumflex of the 3D model to be detected and is used for detecting the blood flow of the left coronary artery circumflex during simulation.
Furthermore, the device also comprises a control device which is used for regulating and controlling the work of the water pump and the air bag pump and collecting signal data fed back by different detectors.
Preferably, after the air bag is inflated, a concave area capable of wrapping the heart model exists, the concave area is provided with a sheath channel, and the sheath channel is positioned at the right apex of the left ventricle of the heart model and corresponds to the position of the side hole on the model.
Furthermore, the present medical 3D printing device (such as J750DAP and objet260Connex3 of Stratasys) can be connected to form a whole set of simulation system based on the simulation apparatus of the present invention.
The utility model has the advantages that:
the utility model discloses a print the model with 3D and be connected to specific analogue means, can be accurate simulation before the art through pipe mitral valve flap takes shape and the replacement art, record patient specific data, for example coronary artery blood flow, the valve and the valve week reflux, cross valve pressure differential, left ventricle outflow tract pressure differential, and then the risk of assessing patient specificity and the complication that probably exists, provide accurate aassessment for formal operation, help reduces operation complication and risk.
Drawings
FIG. 1 is a schematic structural diagram of the device of the present invention;
fig. 2 is a schematic structural view of the airbag of the present invention.
Detailed Description
Unless otherwise indicated, the terms in the present disclosure are to be understood in accordance with conventional wisdom in the relevant art.
The utility model discloses an external analogue means, through 3D await measuring model mitral valve that prints 3D and on structure connection to relevant test equipment around, can carry out left ventricle system in vitro, especially valve release simulation, and can further measure hydrodynamics and relevant data, the process of reduction redisplaying TMVP and TMVR operation that can be more true, it is effective, real aassessment valve aversion, the risk that left ventricle outflow was blocked and was influenced aortic valve, improve accuracy nature and the patient specificity of evaluation before the art, provide accurate ground guide for the operation, thereby reduce complication and the mortality that the operation arouses. Suitable for the utility model discloses a 3D printing apparatus is like J750DAP and objet260Connex 3.
The 3D model to be tested of the utility model is a human heart tissue imitation model which is prepared by taking a material (such as soft silica gel which is processed by transparentization) with proper elasticity, strength and relevant characteristic requirements as a raw material and adopting a 3D printing technology, the 3D model to be tested comprises a mitral valve and a peripheral structure, according to the mechanism requirement of disease diagnosis and treatment, the physiological tissue structure of the 3D model to be tested 13 at least comprises the left atrium of a patient, the left ventricle, the mitral valve and the subglobic chordae tendineae, papillary muscles, the left ventricular outflow tract, the aortic valve and the sinus, the ascending aorta and the left coronary artery circumflex, wherein, the left ventricle side (the apex of the heart) of the 3D model to be tested is provided with a side hole, during simulation, the side hole is connected with an 18-24F arterial sheath (generally, a 22F sheath can be directly used, an arterial sheath with proper model can be selected according to the physiological tissue characteristics of the patient), and, or artificial intervention valves to perform valve release surgery simulation.
Further, for convenience of installation and testing, the distal end of the ascending aorta ostium and the distal end of the left atrium on the 3D model to be tested are designed and processed into circular channels 11.
In a further scheme, the model is made of transparent materials so as to facilitate observation of the simulation operation process.
As shown in fig. 1, the simulation apparatus of the present invention includes a water pump (or a circulation pump) 1, an air bag pump 2, an air bag 3, an ultrasonic detector 4, a pressure sensor 5, and a blood flow detector 6.
The two-end interface of the water pump (or the circulating pump) of the utility model is respectively connected with the left atrium and the ascending aorta interface of the model to be tested. The utility model discloses a circulating pump is for the model that awaits measuring supplies liquid (like water) with the simulation blood flow. Be applicable to the utility model discloses a function that liquid was supplied with in circulation can be realized to the pump, for example: the Fujiwara circulating pump can also be a circulating pump with the model number SHS-1000 produced by Suzhou Midiewei detection technology Limited.
The air bag of the utility model is used for simulating the peripheral tissues of the heart in the human body and compressing the left ventricle when the heart contracts; in a specific example, as shown in fig. 2, the shape of the air bag matches with the shape of the left ventricle, the air bag can wrap the left ventricle after being inflated, meanwhile, a sheath channel 8 is arranged on the air bag, the air bag is an annular wrapping type air bag after being inflated, and an air inlet and an air outlet 10 are arranged on the wall of the air bag. In operation, the sheath channel is located at the right apex of the left ventricle, i.e. corresponding to the position of the side hole on the model, and is opposite to the mitral valve annulus, and the sheath 9 is the approach for placing the valve during the extracorporeal operation. The air bag can be made of polyethylene material.
The utility model discloses an air bag pump is connected with business turn over gas port 10 on the gasbag, and the purpose of air bag pump is mainly through aerifing the gasbag, the change or the parcel effect of gassing simulation left ventricle shrink, peripheral tissue when relaxing, works through adjustment large pressure (kpa) and air current speed (m 3/h). The large pressure range suitable for the air bag pump of the utility model is 11-65kpa, and the air flow rate range is 40-780m 3/h. Is suitable for the utility model discloses the gasbag pump is like XGB type swirl air pump, and the strong tai mechanical production of tin-free provides the power of aerifing, gassing for the sacculus.
Water pump, gasbag pump and gasbag set up the diastole and contract the mode and work in turn, mainly include:
when simulating diastole, the A end of the water pump supplies water to fill the atrium and the ventricle, and simultaneously the air bag pump pumps air and the air bag deflates;
simulating systole: the air bag pump is inflated, the air bag expands to press the model to enable the ventricle to contract, water flow is pressed into the aorta, and the air bag serves as ventricular muscle in the process to cause the ventricle to contract; in the process, the water pump does not work or can pump water away by the aid of the pump when needed.
The utility model discloses an ultrasonic sensor installs in mitral valve and left ventricle outflow tract lateral wall region for detect the dynamic change data of detecting the simulation in-process mitral valve, concrete data are gathered according to clinical operation needs, mainly include that the mitral valve is open area, the blood velocity of flow, cross valve pressure differential, remaining return flow, the valve week returns flow, valve leaflet activity degree, and left ventricle outflow tract blood velocity of flow and pressure differential. The ultrasonic sensor of the utility model can be selected from medical ultrasonic sensors, such as the ultrasonic instrument probe of Siemens or Philips.
The utility model discloses a pressure sensor installs in left atrium end (the position of the 5 shown in fig. 1), further can install in left atrium end distal end pipeline inner wall, returns the blood flow of atrium when detecting the systole and the rivers pressure that flows back when measuring the diastole turns into the estimation and returns the flow, reaches the valve week in the aassessment mitral valve lamella and returns the flow. The pressure sensor of the present invention can monitor the above-mentioned related parameters of the simulation process, such as TE Connectivity (TE) pressure sensor.
The blood flow detector of the utility model is connected with the left coronary artery circumflex branch (shown in figure 1 by the number 6) of the model to be detected, and mainly used for detecting the blood flow of the left coronary artery circumflex branch. Be applicable to the utility model discloses a blood flow detector can select for use medical blood flow appearance, like US Transonic T400 ultrasonic blood flow appearance, measures the blood flow velocity of coronary artery of flowing through.
The water pump, the ultrasonic detector, the pressure sensor, the blood flow detector and the air bag pump can adopt equipment with independent functions, and can also be controlled by the control device to work. In a further aspect, the simulation apparatus of the present invention further comprises a control device 7, wherein the control device mainly comprises: the output work of the water pump and the air bag pump is regulated and controlled according to specific data (preoperative detection data) of a patient, signal data fed back by different detectors are collected, and the control device displays related collected data through a display. Based on the realization of the control device, the hardware structure of the control device belongs to the conventional design of the related field, and the control can be realized by selecting a proper control chip, and the control can also be realized by a user port or a mobile port by means of the Internet technology. The circulating pump, the air bag pump, the ultrasonic sensor, the pressure sensor and the blood flow sensor are respectively in signal transmission with the control device through signal transmission leads or wireless communication.
The utility model discloses analogue means's working process includes:
step one, printing a model
And (4) acquiring the scanning data of the patient, modeling, printing and preparing the model to be tested. A specific preparation method comprises the following steps:
(1) 4D CT scanning is carried out on the cardiovascular structure line of the patient to obtain DICOM data and establish a left ventricular diastolic file;
(2) removing useless parts in the image data, and reserving a mitral valve and an adjacent structure model, wherein the model specifically comprises a left atrium, a left ventricle, the mitral valve, a subvalvular chordae tendineae, papillary muscles, a left ventricular outflow tract, an aortic valve, a sinus part, an ascending aorta and a left coronary artery circumflex; wherein, the whole model is printed by using transparentization treatment; artificially making the distal end of the left atrium and the ascending aorta into a cylinder during 3D modeling so as to be convenient for connecting with the device; aortic sinus and leaflet printing with flexible material; the left ventricular myocardium was printed using flexible elastic material;
(3) and forming a 3D data file, importing the 3D data file into a 3D printer, and printing the model by using the corresponding material.
Step two, installing the model and the device
The far end (end A) of the left atrium on both sides of the model and the far end (end B) of the ascending aorta are respectively connected with a circulating water pump; the air inlet and outlet of the air bag are connected with an air bag pump;
the left ventricle is fixed into a wrapping type air bag, more specifically, two thirds of the left ventricle is placed into the wrapping type pressure air bag, and a sheath canal channel on the air bag is positioned at the right apex of the left ventricle and is opposite to the mitral valve annulus; the ultrasonic detector, the pressure sensor and the blood flow detector are arranged at corresponding tissue positions of the model;
step three, setting working parameters of the device
The connecting device collects relevant data of a patient before a simulation operation, sets specific parameters (such as table 1) of the patient, and then performs operation simulation;
TABLE 1
| Physiological parameters of human body | Simulation device |
| Heart rate (times/minutes) | Number of water pump operations per minute |
| Stroke volume (ml) | Water flow rate of each water pump |
| Length of contraction period (seconds) | Length of time for inflating air bag pump |
| Diastolic duration (seconds) | The water supply time of the end A of the water pump is long; air pumping duration of air bag pump |
| Pressure difference across the valve (ultrasound data) (mmHg) | Cross-petal pressure difference (ultrasonic sensor data) |
| Back flow (ml) | Pressure sensor detection value |
| Pressure of the left ventricular outflow tract (mmHg) | Left ventricular outflow tract pressure (ultrasonic sensor data) |
| Coronary blood flow (ml/min) | Blood flow detector values |
Transcatheter Mitral Valvuloplasty (TMVP) simulation:
after a water pump is started up to collect relevant preoperative data (initial data can be collected on a 3D model), the data are sent into an interventional mitral valve forming instrument through a sheath tube at the apex of a heart, and the mitral valve leaflets of the 3D model are simulated to be clamped or the artificial chordae tendineae are implanted;
the working process of the circulating pump and the air bag pump in the process is as follows: the water pump sets a contraction mode and a relaxation mode to be alternately carried out; collecting the collected data of each sensor after the operation process and the simulation operation are finished; according to each item data (cross valve pressure difference, blood flow speed, valve mouth area, remaining back flow), judge the operation effect, if: compared with the ultrasonic data before the operation, the reduction of the trans-valvular pressure difference (lower than 15mmHg) and the reduction of the blood flow speed represent good operation improvement effect, and/or the reduction of the residual reflux (less than 5ml) represents good operation effect.
Transcatheter Mitral Valve Replacement (TMVR) simulation:
in combination with pre-operative CT evaluation, selecting a proper stent valve to be placed through an arterial sheath at the apex of the heart (the arterial sheath is the sheath at the apex of the heart chamber and is equivalent to the approach of transapical surgery), and simulating valve replacement;
after the valve is released, monitoring and recording the shape of the postoperative stent valve, the trans-valve pressure difference, the coronary blood flow, the peripheral regurgitation flow, the left ventricular outflow tract pressure and the aortic valve condition according to the data detected by the ultrasonic probe;
collecting monitoring data in the process, such as: according to the data detected by the ultrasonic probe, if the pressure difference is reduced and the blood flow velocity are reduced, the improvement effect of the operation is good, and the reduction of the residual backflow rate represents that the operation effect is good; according to the data detected by the pressure sensor, if the valve circumference return flow is small or no representation indicates that the operation effect is good, and no concurrent valve circumference leakage exists; according to the data detected by the ultrasonic probe, if the pressure of the left ventricular outflow tract is not increased, the operation does not affect the obstruction of the left ventricular outflow tract; the coronary artery blood flow can be detected by the blood flow detector, so as to judge whether the coronary artery is blocked; meanwhile, the normal coronary blood flow means that the coronary artery is not influenced by combining artificial observation of valve morphology.
In the operation simulation process, the circulating pump and the air bag pump alternately work according to the preoperative parameters by setting a contraction and relaxation mode: when the A end pumps water (simulating atrial contraction), the air bag pump pumps the air state (simulating ventricular diastole), then the air bag pump inflates air (simulating ventricular systole), and the B end pumps water;
example 1:
simulation object of this embodiment: simulating TMVP in vitro by using a 3D model of a patient with mitral insufficiency;
the patient's condition is as follows: by age 76, mitral insufficiency was found for 2 years, and prolapse in the posterior valve P2 area was severe with massive regurgitation (30 ml).
And (3) surgical planning: percutaneous mitral valve edge-to-edge shaping.
And (3) simulation process:
(1) printing a 3D model of a patient;
(2) the device is installed, relevant data before the operation are collected, specific parameters of a patient are set, a water pump is started and simulation is collected, the mitral valve forming simulation through a catheter is started, and relevant data after the operation are collected. The ultrasonic data before the operation is measured on the 3D printing model, which prompts that the mitral valve is in massive regurgitation and the valve leaflets prolapse, and the ultrasonic prompts that the mitral valve is not aligned by the thoracic surgery and the valve regurgitates. The patient preoperatively set device parameters are shown in table 2;
TABLE 2
| Physiological parameters of human body | Specific numerical value |
| Heart rate (times/minutes) | 60 |
| Stroke volume (ml) | 70 |
| Length of contraction period (seconds) | 0.4 |
| Diastolic duration (seconds) | 0.6 |
| Pressure difference across the valve (ultrasound data) (mmHg) | 11 |
| Back flow (ml) | 20 |
| Pressure of the left ventricular outflow tract (mmHg) | 8 |
| Coronary blood flow (ml/min) | 55 |
(3) In the operation, the miralcip instrument is used in a simulated mode, the incomplete mitral valve is clamped and closed through the reverse clamping effect of the air sac sheath tube through the atrium, the valve regurgitation is reduced, and the valve leaflets are clamped;
during operation, the ultrasonic result is dynamically monitored, and the ultrasonic detector can collect the changes of the return flow, the pressure difference and the flow speed. In the simulation process of the patient, the return flow is reduced from 20ml to 3ml, the pressure difference is maintained at 10mmHg, the flow rate is 1.5m/min, the coronary blood flow is 55ml/m, and the effect is good;
(4) performing postoperative simulation: the ultrasonic result after the operation is collected and displayed, the mitral insufficiency is successfully repaired through the catheter, the TMVP is simulated smoothly, the result prompts that the in vitro simulation can restore the authenticity of the operation to the maximum extent, the process and the difficulty of the operation can be observed by naked eyes in the whole process, the operation teaching is convenient, and the preoperative preparation and the risk assessment are facilitated. Can ensure the operation safety to the maximum extent and guide the optimization of the operation.
Example 2:
simulating an object: TMVR in patients with mitral stenosis with insufficiency;
the patient's condition is as follows: 72 years old, rheumatic heart disease for more than 10 years, moderate stenosis of the mitral valve with moderate insufficiency;
and (3) surgical planning: percutaneous mitral valve replacement, a 36 gauge interventional mitral valve is placed.
And (3) simulation process:
(1) printing a 3D model of a patient;
(2) a mounting device, wherein preoperative ultrasonic data of the patient are measured on the 3D printing model, and preoperative setting parameters of the patient are shown in table 3;
TABLE 3
| Physiological parameters of human body | Specific numerical value |
| Heart rate (times/minutes) | 65 |
| Stroke volume (ml) | 55 |
| Length of contraction period (seconds) | 0.3 |
| Diastolic duration (seconds) | 0.55 |
| Pressure difference across the valve (ultrasound data) (mmHg) | 12 |
| Back flow (ml) | 50 |
| Pressure of the left ventricular outflow tract (mmHg) | 12 |
| Coronary blood flow (ml/min) | 44 |
(3) Intraoperatively simulating the use of Mithos to access the mitral valve, transapically passing a valve transporter across the incompetent mitral valve, releasing the valve; observing the shape of a stent valve, the trans-valve pressure difference, the coronary blood flow, the peripheral regurgitation flow, the left ventricular outflow tract pressure and the aortic valve condition in the operation, wherein: the peripheral return flow of the valve is 2ml, the left ventricular outflow tract pressure is 12mmHg, and the coronary blood flow of a blood flow detector is 44 ml/m;
(4) the ultrasonic data is acquired after the valve replacement and the morphology of the stent valve, the trans-valve pressure difference, the coronary blood flow, the peripheral valve return flow, the left ventricular outflow tract pressure and the aortic valve condition are observed, and the ultrasonic data shows that the position and the morphology of the stent valve are good, the peripheral valve leakage is avoided, the blood flow speed and the pressure difference are normal, and the left ventricular outflow tract pressure is not obviously abnormal.
Claims (4)
1. A3D model in vitro simulation device for a transcatheter mitral valve disease treatment operation is characterized by comprising a water pump, an air bag, an ultrasonic detector, a pressure sensor and a blood flow detector;
a water pump: interfaces at two ends of the water pump are respectively connected with the left atrium and the ascending aorta port of the 3D model to be tested and used for supplying liquid for the 3D model to be tested so as to simulate the blood flow;
an air bag: the air bag is used for simulating the peripheral tissues of the heart in the human body and is provided with an air inlet and an air outlet;
an air bag pump: the air bag pump is connected with an air inlet and an air outlet on the air bag, and the air bag is inflated and deflated by the air bag pump to enable the air bag to simulate the change of peripheral tissues during systole and diastole;
an ultrasonic sensor: the device is arranged in the mitral valve and left ventricular outflow tract side wall area of a 3D model to be tested and used for detecting dynamic change data of the mitral valve in the simulation process;
a pressure sensor: the device is arranged in the left atrium region of the 3D model to be detected and used for detecting the blood flow returning to the atrium during the simulated systole and measuring the pressure of the backflow water flow during the diastole;
a blood flow detector: and the device is connected with the left coronary artery circumflex of the 3D model to be detected and is used for detecting the blood flow of the left coronary artery circumflex during simulation.
2. The device for in vitro simulation of a 3D model for a procedure for treatment of mitral valve disease via catheter of claim 1, further comprising a control device for controlling the operation of the water pump and the balloon pump and collecting signal data fed back by different detectors.
3. The apparatus according to claim 1, wherein the balloon is inflated to form a recessed region that can be wrapped around the heart model, the recessed region is provided with a sheath channel, and the sheath channel is located at the right apex of the left ventricle of the heart model and corresponds to the position of the side hole on the model.
4. The in vitro simulator of 3D models of transcatheter mitral valve disease treatment surgery of claim 1, further comprising a 3D printing device.
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