WO2023184597A1

WO2023184597A1 - Simulated heart, heart simulation device, and heart simulation method

Info

Publication number: WO2023184597A1
Application number: PCT/CN2022/087071
Authority: WO
Inventors: 彭钰楠; 胡冠彤; 张立炜; 王贝西; 彭胡
Original assignee: 胡冠彤
Priority date: 2022-03-31
Filing date: 2022-04-15
Publication date: 2023-10-05

Abstract

A simulated heart, a heart simulation device, and a heart simulation method. The simulated heart comprises a simulated heart body, which comprises an upper portion (1), a middle portion (2) and a lower portion (3) which are connected in sequence, wherein the middle portion (2) comprises a middle portion body and a valve assembly, and the valve assembly comprises a valve mounting structure (21) and a valve (22). The simulated heart is divided into the upper portion (1), the middle portion (2) and the lower portion (3) that are prepared separately, such that the simulated heart modelled according to three-dimensional data of an actual heart and then 3D printed has the feasibility of being used as a simulated heart for research, so that the simulated heart replicates an actual heart structure as much as possible and performs simulation according to different clinical characteristics of different patients, and the simulated heart has the possibility of clinic use.

Description

A simulated heart, a heart simulation device and a heart simulation method

Technical field

The invention belongs to the field of heart valve biomechanics research and the field of cardiac surgery, and specifically relates to a simulated heart, a heart simulation device and a heart simulation method.

Background technique

The field of heart valve biomechanics is a rapidly expanding research area that is highly clinically relevant. Although most valvular pathologies have their roots in biomechanical changes, the technology to study these lesions and determine treatments is largely limited. However, significant progress has been made in this area to better understand heart valve biomechanics, pathology, and interventional therapies, driven primarily by key in silico, in vitro, and in vivo modeling techniques. These techniques have yielded new insights into relevant native, disease, and repair physiology, but each development has unique advantages and limitations. These studies use creative, interdisciplinary approaches to recreate in vivo physiology, which has transformed clinical understanding and practice in cardiovascular surgery.

There are three existing technologies closest to the present invention: one is a paper from Stanford University published in Frontiers in Cardiovascular Medicine in 2021; one is a paper from Georgia Institute of Technology and Emory University published in Ann Biomed Eng; one is Vivitro plus emulator from a Canadian company.

A paper published in Frontiers in Cardiovascular Medicine by Stanford University in the United States in 2021, written by Y. Heart simulator developed by a research team led by Professor Joseph Woo. This in vitro heart simulator has relatively complete functions, but it does not have the structure of a real heart.

The advantage of Professor Y. Joseph Woo's invention is that it can simulate the hemodynamic characteristics of the four chambers of the heart (left ventricle, right ventricle, left atrium, right atrium), and at the same time, a papillary muscle simulation device is built into the simulator. , and then simulate the dynamic changes of hemodynamics under the condition of valve opening and closing. The shortcomings are also very obvious. Because it basically stays at the laboratory prototype stage, it uses a regular cavity structure to simulate the chambers of the heart. Its internal and external structures do not have the 1:1 structure of the real heart, which results in the data generated by its simulation being very different from the real human heart data. Far. It does not have the conditions for clinical and large-scale laboratory research. In addition, because its internal and external structures are relatively regular, it cannot simulate the conditions after intracardiac thrombosis.

Georgia Tech and Emory University Published in Ann Biomed Papers by Eng. Ventricular simulator developed by a research team led by Professor Ajit P. Yoganathan. The in vitro simulator they created does not have a complete four-chamber heart, but a structure pieced together from two relatively simple cylinders, which is then used for the atrium and ventricle structure of one side. The research point also has a movable papillary muscle structure to simulate the valve opening and closing movement during heart contraction. At the same time, this structure can also be equipped with real valves to simulate the impact of real valves on intracardiac hemodynamics to a greater extent.

However, the invention of the research team led by Professor Jit P. Yoganathan also has fatal problems: incomplete heart chamber structure and overly idealized fluid dynamics model. This also causes the data generated by its simulation to be far different from the real human heart data. Therefore, it also does not have the conditions for clinical use. In addition, because its internal and external structures are relatively regular, it cannot simulate the conditions after intracardiac thrombosis.

Technical solutions

In order to solve the above technical problems, the present invention proposes a simulated heart, a heart simulation device and a heart simulation method, which overcome the problems of the existing technology and have practical clinical significance.

In order to achieve the above objects, the technical solution of the present invention is as follows: a simulated heart, including:

The simulated heart body includes an upper part containing simulated left and right atria, a middle part and a lower part containing left and right ventricles. The upper part, the middle part and the lower part are connected together in sequence. The middle part includes a middle part body and a valve assembly. The valve assembly includes a valve mounting structure and a valve.

Furthermore, the body and valves of the middle part, or the entire middle part, are prepared using 3D printing technology based on the three-dimensional model data of the actual heart.

The simulated heart is divided into the upper part, the middle part and the lower part and prepared separately, so that the simulated heart that is modeled based on the three-dimensional data of the actual heart and then 3D printed has the feasibility of being studied as a simulated heart. We know that one-piece molding 3D printing a complete heart cannot install a valve opening and closing drive device, nor can the valves be replaced. Therefore, the present invention creatively divides the simulated heart into upper, middle and lower parts to facilitate the installation and replacement of each valve (tricuspid valve, pulmonary valve , aortic valve and mitral valve), and the installation of each valve opening and closing drive device, so that the simulated heart can replicate the actual structure of the actual heart (such as the heart of a certain patient or an animal) and simulate its operating characteristics as much as possible , making the simulated heart possible for clinical use. In addition, because the structural differences between the upper part and the lower part respectively corresponding to the upper part of the left and right atrium and the lower part of the left and right ventricle are small, these differences have a small impact on intracardiac hemodynamics. In order to save costs, the upper part is The upper and lower parts can also adopt a common structure. Therefore, only the middle part needs to be modeled and 3D printed according to the three-dimensional data of a specific heart, and sealed and connected with the universal upper and lower parts to well simulate the intracardiac hemodynamic model of a specific heart. .

Further, the valve installation structure is an annular structure, the outer peripheral edge is sealingly connected or integrally formed with the inner wall of the middle part body, and the inner peripheral edge is provided with a valve installation part; the valve is detachably installed on the valve installation structure through the valve installation part superior.

Replaceable and removable valve mounting modules available. Comprehensively provide a good structural and functional basis for clinical application.

The technical solution of the present invention can use 3D printing technology to restore or highly approximate the human heart or the heart of other mammals (such as mice, pigs, etc.) in a 1:1 manner. Fully simulates the complex internal structures of the four cardiac chambers, providing a structural basis for simulating intracardiac thrombosis. At the same time, the present invention also provides a detachable valve modular design, which can meet the individual differences of different clinical patients and help clinicians perform preoperative surgical rehearsals and predict postoperative adverse events.

Further, the valve mounting part is a C-shaped annular groove, a connecting part is provided on the outer periphery of the valve, and the connecting part is embedded in the C-shaped annular groove.

Further, the cross-section of the C-shaped annular groove is a pentagon, the opening connection line is one of the sides, the two sides away from the opening intersect, and the included angle is an acute angle, and the shape of the connecting part is consistent with the C-shaped annular groove. Structural adaptation of grooves.

Further, a plurality of valve clamps are provided circumferentially along the edge of the C-shaped annular groove. The valve clamp has a pentagonal cross-section with an opening. The connecting line of the opening is one of the sides, and the two valve clamps are away from the opening. The edges intersect and the included angle is an acute angle, and the shape of the connecting portion is adapted to the structure of the valve clip.

Further, the valve assembly also includes a valve opening and closing driving device. The valve opening and closing driving device includes a power component and a traction mechanism. One end of the traction mechanism is drivingly connected to the power component, and the other end is connected to the valve installation structure or the valve. The traction mechanism The reciprocating motion of the mechanism drives the valve to open or reset and close.

Further, a through hole is provided on the side wall of the middle part body; the traction mechanism includes a pulling cable and an elastic or telescopic sheath wrapping the pulling cable; one end of the pulling cable is connected to the power element, and the other end passes through The through hole is connected to the valve installation structure or the valve; one end of the sheath is sealingly connected to the outer wall of the middle part of the circumference of the through hole, and the other end is slidingly and sealingly connected to the pull cable, or is sealingly connected to the shell of the power component, while the power component is connected to the pulley Cable sliding seal connection.

Further, the pull cable is an elastic or rigid filamentary element, the valve mounting part is provided with a first pull cable connection part, and the front end of the pull cable is provided with a second pull cable that is adapted to the first pull cable connection part. Cable connection part.

The present invention also provides a heart simulation device. The shape simulation device includes any of the above-mentioned simulated hearts, and also includes a blood circulation simulation device. The blood circulation simulation device includes a liquid delivery pump, a liquid storage box and a plurality of connections. pipeline, one end of the connecting pipeline is connected to the aorta, main vein, pulmonary artery and pulmonary vein of the simulated heart respectively, and the other end is connected to the liquid transfer pump and the liquid storage box respectively. The liquid transfer pump drives the liquid in the liquid storage box through the connection Tubing enters and exits the simulated heart, and the flow of fluid in the simulated heart is consistent with that of an actual heart.

The invention also provides a heart simulation method, which includes the following steps:

S1, based on the actual three-dimensional modeling of the heart, 3D print the middle part body and valve components;

S2, install the valve assembly onto the middle part body;

S3, connect the valve opening and closing driving device and the valve assembly;

S4, connect the upper and lower parts of the universal simulated heart with the middle part body to form a complete simulated heart;

S5, connect the blood circulation simulation device to the simulated heart, inject fluorescent liquid and maintain the set pressure value;

S6, start the valve opening and closing driving device, open and close the valve assembly according to the set time value, the fluorescent liquid flows in the simulated heart according to the blood flow state of the actual heart;

S7, observe the flow information of fluorescent liquid in the simulated heart.

beneficial effects

This invention can 3D print a 1:1 model of the middle part of the patient's heart valve before the patient undergoes heart surgery (especially heart valve disease), install the personalized printed heart valve to the middle part body, and then install the middle part To the universal upper and lower heart simulator, the fluorescent liquid is pumped into the simulator driven by a device such as the Vivitro plus, and the valve opens and closes under the drive of the valve opening and closing driving device (movable papillary muscle simulator). Then simulate the real intracardiac hemodynamics. These simulation data will provide clinicians with a reference, thereby providing the possibility to preview the surgical process and predict postoperative adverse events.

Description of drawings

In order to explain the technical solutions of the embodiments of the present invention more clearly, the drawings required to be used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and therefore do not It should be regarded as a limitation of the scope. For those of ordinary skill in the art, other relevant drawings can be obtained based on these drawings without exerting creative efforts.

Figure 1 is a schematic diagram of a simulated heart according to the present invention.

Figure 2 is a schematic diagram of the valve of the present invention.

Figure 3 is a schematic diagram of the valve installation structure of the present invention.

Figure 4 is a schematic diagram of the valve and valve mounting structure assembled together.

Embodiments of the invention

The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of the present invention.

The use of the ordinal words "first", "second", "third", etc. to describe ordinary objects merely means that different instances of similar objects are involved, and is not intended to imply that the objects so described must have temporal, spatial, or A given order in terms of sorting or in any other way.

In addition, the expression "comprising" an element is an "open" expression. This "open" expression only refers to the presence of corresponding components or steps and should not be interpreted to exclude additional components or steps.

As shown in Figure 1-4, a simulated heart includes:

The simulated heart body includes an upper part 1 containing the simulated left and right atria, a middle part 2, and a lower part 3 containing the left and right ventricles. The upper part 1, the middle part 2, and the lower part 3 are connected together in sequence to form a complete heart structure. The middle part includes a middle part body and a valve assembly, and the valve assembly includes a valve mounting structure 21 and a valve 22 . As shown in Figure 1, the middle portion contains four valve components, namely tricuspid valve 7, pulmonary valve 6, aortic valve 8, and mitral valve 9.

In order to make the experimental verification data more suitable for the heart of a specific patient or animal, the middle part body and valve, or the middle part are all prepared using 3D printing technology based on the three-dimensional model data of the actual heart.

The simulated heart is divided into the upper part, the middle part and the lower part and prepared separately, so that the simulated heart that is modeled based on the three-dimensional data of the actual heart and then 3D printed has the feasibility of being studied as a simulated heart. We know that one-piece molding A complete 3D printed heart cannot install a valve opening and closing drive device, nor can the valves be replaced. Therefore, the present invention creatively divides the simulated heart into upper, middle and lower parts to facilitate the installation and replacement of each valve (tricuspid valve, pulmonary valve , aortic valve and mitral valve), and the installation of each valve opening and closing drive device, so that the simulated heart can replicate the actual structure of the actual heart (such as the heart of a certain patient or an animal) and simulate its operation as much as possible Features make the simulated heart possible for clinical use. In addition, because the structural differences between the upper part and the lower part respectively corresponding to the upper part of the left and right atrium and the lower part of the left and right ventricle are small, these differences have a small impact on intracardiac hemodynamics. In order to save costs, the upper part is The upper and lower parts can also adopt a common structure. Therefore, only the middle part needs to be modeled and 3D printed according to the three-dimensional data of a specific heart, and sealed and connected with the universal upper and lower parts to well simulate the intracardiac hemodynamic model of a specific heart. .

As shown in Figure 3, the valve installation structure 21 is an annular structure, and the middle through hole 212 is used to install the valve 22; the outer peripheral edge is sealed or integrally formed with the inner wall of the middle part body, and the inner peripheral edge is provided with a valve installation portion 213; The valve 22 is detachably mounted on the valve mounting structure 21 through the valve mounting portion 213 . As shown in Figure 2, the valve has an annular connecting portion 221. In the middle of the connecting portion 221 is a valve body 3D printed based on solid modeling. The connecting portion 221 is adapted and sealedly connected to the valve mounting portion 213.

In the example of FIGS. 2-4 , the valve mounting portion 213 is a C-shaped annular groove, and a connecting portion 221 is provided on the outer periphery of the valve, and the connecting portion 221 is embedded in the C-shaped annular groove.

In the example of Figure 3-4, the cross-section of the C-shaped annular groove is a pentagon, the opening connection line is one of the sides, the two sides away from the opening intersect, and the included angle is an acute angle, and the connecting portion The shape of 221 is adapted to the structure of the C-shaped annular groove (valve mounting portion 213).

In some embodiments, multiple valve clamps are provided circumferentially along the edge of the C-shaped annular groove (valve mounting portion 213). The valve clamp is a pentagonal structure with an opening, and the connecting line of the openings is One of the sides, two sides away from the opening intersect, and the included angle is an acute angle. The shape of the connecting portion 221 is adapted to the structure of the valve clip. In this way, the structure of the C-shaped annular groove can undergo various structural deformations according to the needs of sealing.

As shown in Figures 1 and 4, the valve assembly also includes a valve opening and closing driving device. The valve opening and closing driving device includes a power component 5 and a traction mechanism. One end of the traction mechanism is drivingly connected to the power component 5, and the other end is connected to the power component 5. The valve installation structure 21 or the valve 22 are connected, and the reciprocating motion of the traction mechanism drives the valve 22 to open or reset and close.

In some embodiments, a through hole is provided on the side wall of the middle part body; the traction mechanism includes a pulling cable 41 and an elastic or telescopic sheath 42 wrapping the pulling cable; one end of the pulling cable 41 is connected to a power source The other end of the element 5 passes through the through hole and is connected to the valve installation structure 21 or the valve 22 (generally it is preferred to connect to the valve installation structure 21, because it is more convenient to set the hooking structure 211 connected to the pull cable 41 on the valve installation structure 21, and it is more convenient for the blood. The influence of dynamics is smaller); one end 421 of the sheath 42 is sealingly connected to the outer wall of the middle part of the circumference of the through hole, and the other end 422 is connected to the cable sliding seal or fixed sealing, or to the shell of the power component, and at the same time The power component 5 is connected with the cable 41 in a sliding and sealing manner. The power element 5 drives the cable to reciprocate, and the actual reciprocating distance is at the millimeter level, which can drive the opening and closing of the valve 22 and is similar to the actual heart.

In practical applications, the pulling cable 41 can be selected as an elastic or rigid filamentary element. A first pulling cable connection part 211 is provided on the outside of the membrane valve mounting part 213. The front end of the pulling cable 41 is provided with a first pulling cable connecting part 211. The cable connection part 213 is adapted to the second cable connection part.

S2, install the valve assembly onto the middle part body;

S7, observe the flow information of fluorescent liquid in the simulated heart.

The basic principles and main features of the present invention and the advantages of the present invention have been shown and described above. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and specifications is only to illustrate the present invention. principle, without departing from the spirit and scope of the present invention, there will be various changes and improvements in the present invention. These changes and improvements all fall within the scope of the claimed invention, which is defined by the appended rights. Definition of requirements and their equivalents.

Claims

A simulated heart, characterized by including:

The simulated heart body includes an upper part containing simulated left and right atria, a middle part and a lower part containing left and right ventricles. The upper part, the middle part and the lower part are connected together in sequence. The middle part includes a middle part body and a valve assembly. The valve assembly includes a valve mounting structure and a valve.
The simulated heart according to claim 1, characterized in that the valve installation structure is an annular structure, the outer peripheral edge is sealed or integrally formed with the inner wall of the middle body, and the inner peripheral edge is provided with a valve installation portion; the valve can The disassembled valve mounting part is installed on the valve mounting structure.
The simulated heart according to claim 2, characterized in that the valve mounting part is a C-shaped annular groove, the outer periphery of the valve is provided with a connecting part, and the connecting part is embedded in the C-shaped annular groove. middle.
The simulated heart according to claim 3, characterized in that the cross section of the C-shaped annular groove is a pentagon, the opening line is one of the sides, the two sides away from the opening intersect, and the included angle is an acute angle. , the shape of the connecting portion is adapted to the structure of the C-shaped annular groove.
The simulated heart according to claim 3, characterized in that a plurality of valve clamps are provided along the circumferential direction of the C-shaped annular groove, and the valve clamp is a pentagonal structure with an opening, and the openings are connected to each other. The line is one of the sides, the two sides away from the opening intersect, and the included angle is an acute angle. The shape of the connecting portion is adapted to the structure of the valve clip.
The simulated heart according to any one of claims 1 to 5, characterized in that the valve assembly further includes a valve opening and closing driving device, the valve opening and closing driving device includes a power component and a traction mechanism, one end of the traction mechanism is connected to The power component is driven and connected, and one end is connected to the valve installation structure or the valve. The reciprocating motion of the traction mechanism drives the valve to open or reset and close.
The simulated heart according to claim 6, characterized in that a through hole is provided on the side wall of the middle part body; the traction mechanism includes a pulling cable and an elastic or retractable sheath wrapping the pulling cable; One end of the cable is connected to the power component, and the other end passes through the through hole and is connected to the valve installation structure or valve; one end of the sheath is sealingly connected to the outer wall of the middle part of the circumference of the through hole, and the other end is connected to the cable in a sliding and sealing manner, or with the power element. The shell of the component is connected in a sealed manner, while the power component is connected in a sliding and sealed manner with the cable.
The simulated heart according to claim 7, characterized in that the pull cord is an elastic or rigid filament element, the valve mounting part is provided with a first pull cord connection part, and the front end of the pull cord is provided with a third pull cord. One cable connection portion is adapted to a second cable connection portion.
A heart simulation device, characterized in that the shape simulation device includes the simulated heart according to any one of claims 1 to 8, and also includes a blood circulation simulation device, the blood circulation simulation device includes a liquid delivery pump and a liquid storage box and a plurality of connecting pipelines. One end of the connecting pipelines is connected to the aorta, main vein, pulmonary artery and pulmonary vein of the simulated heart respectively, and the other end is connected to a liquid transfer pump and a liquid storage box respectively. The liquid transfer pump drives the liquid storage box. The liquid enters and flows out of the simulated heart through connecting pipes, and the flow of liquid in the simulated heart is consistent with the actual heart.
A heart simulation method is characterized by including the following steps:

S1, based on the actual three-dimensional modeling of the heart, 3D print the middle part body and valve components;

S2, install the valve assembly onto the middle part body;

S3, connect the valve opening and closing driving device and the valve assembly;

S4, connect the upper and lower parts of the universal simulated heart with the middle part body to form a complete simulated heart;

S5, connect the blood circulation simulation device to the simulated heart, inject fluorescent liquid and maintain the set pressure value;

S6, start the valve opening and closing driving device, open and close the valve component according to the real cardiac cycle set time value, the fluorescent liquid flows in the simulated heart according to the blood flow state of the actual heart;

S7, observe the flow information of fluorescent liquid in the simulated heart.