In-vitro simulation demonstration system for interventional therapy of structural heart disease and operation method of in-vitro simulation demonstration system

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an in-vitro simulation demonstration system for a structural heart disease interventional therapy operation and an operation method of the in-vitro simulation demonstration system. The system comprises an in-vitro simulation demonstration device, a display and software, the in-vitro simulation demonstration device comprises a model fixing device (3), a heart model (31) and a detachable valve leaflet model (32) are fixed on the model fixing device (3), a camera (5) is further arranged on the device, and the display is connected with the camera (5). The device can be used for simulation device demonstration of heart valve interventional medical instrument in-vitro performance research, and in-vitro instrument operation training and operation process practice of an operator.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular to in vitro performance research and operation demonstration training of transcatheter interventional treatment devices for valvular diseases, and specifically relates to an in vitro simulation demonstration system for interventional treatment of structural heart disease and an operation method thereof. Background Art

[0002] The treatment of heart valve diseases, such as tricuspid regurgitation, mitral regurgitation, aortic stenosis / regurgitation, etc., through minimally invasive intervention is currently the fastest-growing technology in this field. Compared with traditional surgery, this method has the advantages of less trauma, shorter postoperative recovery time, and is more suitable for elderly patients who cannot bear the risk of surgical thoracotomy. However, for this type of interventional medical device, in the early performance research of the product, there is no good in vitro simulation device to verify the feasibility of the product performance. At the same time, in the later clinical trials or market promotion of the product, it is not possible to complete the simulation training and training of the operator on the instrument operation and surgical process.

[0003] Patent application CN212208704U provides a structural heart disease intervention training model, which includes a fixing seat and a cardiovascular model placed inside the fixing seat. The cardiovascular model includes a heart module and a blood vessel module. The model helps doctors learn and master surgical skills and shortens the learning curve of the surgery.

[0004] Patent application CN116453408A also provides a structural heart disease intervention training model, which has a heart model installed inside. By setting up a human body model and anterior cavity model, the operator can be trained in femoral vein puncture, and the training difficulty can be adjusted accordingly for people with different proficiency, step by step, to enhance the practicality of the training module; by installing cameras on the right ventricle model and the inner wall of the left ventricle, the position of the gap in the ventricular septum can be observed on the display screen, and the entire process of blocking the gap can be watched from the display screen, simulating the angiographic images during the blocking operation, and ensuring the successful implementation of the surgical simulation process. Summary of the invention

[0005] In view of the above technical status, the present invention provides an in vitro simulation demonstration system for interventional treatment of structural heart disease, the system comprising an in vitro simulation demonstration device, a display and software, wherein:

[0006] The in vitro simulation demonstration device comprises a base, a bracket and a model holder, wherein the model holder is located inside the bracket, a camera is arranged on the bracket, and optionally further comprises cameras at other positions;

[0007] The display and software are capable of displaying the actual simulated surgery imaging screen and the standard surgery result screen captured by the camera for comparison to determine whether the actual simulated surgery result is consistent with the standard surgery result.

[0008] The present invention aims to provide a simulation system that can be used for in vitro performance research of heart valve interventional medical devices; at the same time, the system can also be used for operators to conduct in vitro device operation training and surgical process practice.

[0009] In the early development process of transcatheter interventional medical devices for treating heart valve diseases, the products can be tested on the simulation device of the present invention, and the performance of the products can be evaluated by observing the operation process of the products and the real-time status of the devices in the heart in real time. In addition, the present invention can also be used for product demonstration, equipment operation and surgical process training for operators, etc.

[0010] In the in vitro simulation demonstration system for interventional treatment of structural heart disease described in the present invention, the models that can be fixed by the model holder include: a heart model, a right heart system model, a left heart system model, an aortic valve model or a pulmonary valve model, and a detachable leaflet model, wherein the leaflet model includes a mitral valve leaflet model or a tricuspid valve leaflet model, which can be disassembled and replaced according to needs, wherein the tricuspid valve leaflet model is fixed to the model holder by a slide groove and inserted into the heart model.

[0011] In the system of the present invention, as one of the implementation schemes, the leaflet model is a tricuspid valve leaflet model.

[0012] In the system of the present invention, as one of the implementation schemes, the bracket includes a bracket body, a crossbeam and a base frame; the bracket is fixed to the base by screws or clips, and the model holder is located inside the bracket and fixed to the base by screws or clips.

[0013] In the system of the present invention, as one of the implementation schemes, the bracket is fixed to the base by screws, and the model holder is fixed to the base by screws.

[0014] In the system of the present invention, as one of the implementation schemes, the bracket is provided with 1 to 6 cameras; the direction of the camera lens on the bracket can be adjusted, the camera is connected to the computer and the display screen, and the camera is fixed to the crossbeam and the base frame by buckles.

[0015] In the system of the present invention, as one of the implementation schemes, at least one camera is respectively arranged on the bracket body, the crossbeam and the base frame, wherein the camera arranged on the base frame is located below the heart model, and the heart model is fixed to the model holder by screws, wherein the heart model is also provided with a socket, which is convenient for inserting the leaflet model into the heart model along the slide groove, and is the entrance for the leaflet model to enter the heart model.

[0016] In the system of the present invention, as one of the implementation schemes, the base is provided with a through hole, and the through hole is used to place a camera installed on the base frame; the edge of the base is also provided with a groove, and the groove is connected to the base of the blood vessel model.

[0017] In the system of the present invention, the camera on the bracket is an X-ray field of view, and other cameras (for example, on the crossbeam and the base frame) are set to ultrasound fields of view at different angles, and the position of the camera can be configured and adjusted according to different heart models.

[0018] In the system of the present invention, as one of the embodiments, the device also includes a blood vessel model, which is composed of a base, a blood vessel and a blood vessel stent, simulating the left internal jugular vein and the right internal jugular vein, and the blood vessel model is connected to the model fixator.

[0019] In the system of the present invention, as one of the implementation schemes, the heart model is made of PC, PP, PVC or acrylic material, and the bracket, base and model holder are made of ABS or POM material.

[0020] In the system of the present invention, as one of the implementation schemes, the heart model is made of PC material, and the bracket, base and model holder are made of POM material.

[0021] In the system of the present invention, as one of the implementation schemes, the camera can be used in conjunction with display software to achieve overlapping matching of ultrasound or X-ray images of real patients during surgery and images obtained by the real-time heart model.

[0022] The present invention provides an operation method of an in vitro simulation demonstration device for interventional treatment of structural heart disease, the method comprising:

[0023] 1) Assembling the simulation device, fixing the heart model and the tricuspid valve leaflet model on the model holder;

[0024] 2) Turn on the computer, open the software, and connect the camera;

[0025] 3) Select the X-ray field of view of camera 5A in the software;

[0026] 4) The operating instrument enters the heart model through the right internal jugular vein;

[0027] 5) Operate the instrument and observe the operating status of the instrument on the monitor until the instrument reaches the appropriate position, and compare it with the video animation in the software to see whether it reaches the ideal state;

[0028] 6) Switch to the ultrasound field of view of cameras 5B, 5C, and 5D, and observe the position and status of the instrument from different angles. If the ideal status is not reached, continue to operate the instrument until the ideal position and status are reached;

[0029] 7) Continue to operate the instrument until the surgery is completed and remove the instrument from the model.

[0030] The present invention provides an operation method of an in vitro simulation demonstration system for interventional treatment of structural heart disease, the method further comprising: Figure 8 The operation flow shown.

[0031] The present invention also provides an in vitro simulation demonstration device in the in vitro simulation demonstration system for interventional treatment of structural heart disease.

[0032] The present invention is more suitable for simulation demonstration of structural heart disease related devices, such as tricuspid valve, mitral valve repair and / or replacement, aortic valve replacement, pulmonary valve replacement, foramen ovale, left atrial appendage closure, etc.; multiple cameras are arranged on the simulation demonstration device of the present invention, and the position and angle of the camera are more convenient for the operator to observe the heart structure and the device position; it can simulate the 2D and / or 3D ultrasound and DSA image field of view in real surgery, and more realistically restore the image field of view requirements and process of intraoperative operation;

[0033] All the connecting parts in the present invention can be manually disassembled, which is easier to assemble and carry; and the heart structure part of the device of the invention is designed to be replaceable, which is convenient for observing the position and effect of each training demonstration. The present invention can simulate and demonstrate not only the edge-to-edge repair technology for the valve leaflets of the tricuspid valve and the mitral valve, but also the valve ring shrinkage repair technology.

[0034] Beneficial effects of the present invention:

[0035] 1. Solved the problem of being unable to provide intuitive equipment operation training demonstrations to operators;

[0036] 2. Provides a simulation device for in vitro verification of product performance;

[0037] 3. Provide the surgeon with a simulation device for preoperative in vitro instrument operation and practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 : Schematic diagram of the simulation device assembly;

[0039] Figure 2 : Schematic diagram of the base;

[0040] Figure 3 : Schematic diagram of the bracket;

[0041] Figure 3-1 : Schematic diagram of the left side structure of the bracket;

[0042] Figure 3-2 : Schematic diagram of the right side structure of the bracket;

[0043] Figure 4 : Schematic diagram of the model holder;

[0044] Figure 4-1 : Schematic diagram of the model holder being fixed to the base by screws;

[0045] Figure 4-2 : Schematic diagram of the heart model being fixed on the model holder by screws;

[0046] Figure 4-3 : Schematic diagram of the tricuspid valve being fixed on the model holder through a slide groove and inserted into the heart model;

[0047] Figure 4-4 : Schematic diagram of the right heart system model;

[0048] Figure 4-5 :Schematic diagram of tricuspid valve leaflet model;

[0049] Figure 5-1 : Schematic diagram of the blood vessel model;

[0050] Figure 5-A: Schematic diagram of X-ray field of view ( Figure 5-A1 : X-ray field of view, 5-A2: simulator camera field of view, 5-A3: X-ray and simulator field of view overlap);

[0051] Figure 5-B: 2D schematic diagram of the right atrium and right ventricle surgical field ( Figure 5-B1 : Ultrasound field of view, 5-B2: simulator camera field of view, 5-B3: ultrasound and simulator field of view overlap);

[0052] Figure 5-C: 2D schematic diagram of the four-chamber heart surgical field ( Figure 5-C1 : Ultrasound surgical field image, 5-C2: simulator camera surgical field image, 5-C3: ultrasound and simulator surgical field overlap image);

[0053] Figure 5-D: Schematic diagram of the tricuspid valve surgical field viewed from the right atrium to the right ventricle 3D ( Figure 5-D1 : Ultrasound surgical field image, 5-D2: simulator camera surgical field image, 5-D3: ultrasound and simulator surgical field overlap image);

[0054] Figure 6 : Schematic diagram of the camera being fixed on the bracket;

[0055] Figure 7 : Schematic diagram of the assembly of the bracket and the base;

[0056] Figure 8 :Device operation flow chart.

[0057] Explanation of the reference numerals: 1 base; 11 positioning hole; 12 through hole; 13 groove; 2 bracket; 21 main body; 22 crossbeam; 23 bottom frame; 3 model holder; 31 heart model; 5 cameras (5A, 5B, 5C, 5D); 6 blood vessel model; 61 base; 62 blood vessel; 63 blood vessel bracket; 64 right atrium; 64-1 left atrium; 66-1 left ventricle; 65 tricuspid valve leaflet; 66 right ventricle; 67 socket; 68 slide groove; 69-1 left internal jugular vein; 69-2 right internal jugular vein; 70 right heart system model; 71 tricuspid valve leaflet model; 72 tricuspid valve leaflet support frame. DETAILED DESCRIPTION

[0058] The following examples are used to further illustrate the present invention, but are not intended to limit the effective scope of the present invention in any way.

[0059] In a specific embodiment, the "distal end" mentioned in the present invention is the end away from the operator when the operator holds the handle part during the operation, and the "proximal end" is the end close to the operator when the operator holds the handle part during the operation. The "upper", "lower", "left", "right", "front", "back", "top", "bottom", "inside", "outside", "middle", etc. indicated directions or positional relationships mentioned in the present invention are based on the directions or positional relationships shown in the accompanying drawings. These terms are mainly for better describing the present invention and its embodiments, and are not used to limit the indicated system, nor do they constitute limitations on the present invention.

[0060] In addition, the words "set", "provided with", "connected", "connected" and the like mentioned in the present invention should be understood in a broad sense, and may be a fixed connection or a non-fixed connection, a mechanical connection or any other connection method, a direct connection or an indirect connection through a medium. All connection methods commonly used by technicians in this field are within the protection scope of the present invention.

[0061] The materials used in the system in this embodiment are only exemplary descriptions and do not mean that the system can only be made of this material.

[0062] In the present invention, as one of the embodiments, as shown in the attached Figure 1 As shown, the in vitro simulation demonstration device includes a base 1, a bracket 2 and a model holder 3. The model holder is located inside the bracket, and a camera is arranged on the bracket.

[0063] In the present invention, as one of the embodiments, as shown in the attached Figure 2-3 As shown, the bracket includes a bracket body 21, a crossbeam 22 and a base frame 23, which are fixed to the base 1 by screws. The model holder is located inside the bracket and fixed to the base by screws.

[0064] In the present invention, as one of the embodiments, as shown in the attached Figure 4As shown, a heart model 31 and a detachable tricuspid valve leaflet or mitral valve leaflet are fixed on the model holder. The heart model is made of transparent material, and the camera can see the operating status of the device in the heart through the heart model. The model holder is fixed to the base plate by screws.

[0065] In the present invention, as one of the implementation schemes, as shown in Figures 5-6, camera 5A is above the model to simulate the X-ray heart image in the positive position during surgery, camera 5B is in front of the model to simulate the 2D images of the ventricles and atria provided by esophageal ultrasound during surgery, and camera 5C is on the right side of the model to simulate the 2D heart four-chamber heart surgical field provided by esophageal ultrasound during surgery. Camera 5D is below the model to simulate the image of the tricuspid valve ring viewed from the atrium provided by esophageal ultrasound during surgery. The angle and number of cameras are set according to the image needs of different models to simulate the real surgery. For example, in tricuspid regurgitation repair surgery, X-rays, 2D and 3D esophageal ultrasounds at different angles are usually used during the operation. Therefore, during the demonstration, these supporting cameras will present an image field similar to that during surgery, as shown in Figures 5-A, 5-B, 5-C, and 5-D.

[0066] In the present invention, as one of the embodiments, as shown in the attached Figure 7 As shown, there are cameras in multiple directions on the bracket, and the cameras are fixed in different directions by buckles. Camera 5A is an X-ray field of view, and cameras 5B, 5C, and 5D are ultrasound fields of view at different angles. The positions of the cameras can be configured and adjusted according to different heart models.

[0067] In the present invention, as one of the embodiments, the camera is connected to the computer and the display, and the demonstration state of the device can be seen on the display through the camera. The bracket is fixed to the base by screws or buckles.

[0068] The present invention provides an in vitro simulation demonstration system for interventional treatment of structural heart disease, and the working principle is: a camera is arranged on the simulation demonstration device, and the camera can capture the state of the instrument in the heart model in real time, and display it on the monitor in real time through software, and the operator can watch the state of the instrument in the model in real time through the monitor.

[0069] The camera set on the simulation demonstrator captures the position of the heart model in real time, simulating the field of view of ultrasound and / or X-ray to obtain the patient's heart image during the actual operation. By switching different camera fields of view, the heart field of view of different imaging tools at different angles during the operation can be simulated, which more realistically restores the actual instrument operation process and image guidance during the operation.

[0070] In the present invention, as an exemplary description, the display software that can be used in conjunction with the camera on the simulator is vMix, which can overlap and match the ultrasound or X-ray images of a real patient during surgery with the images obtained by the real-time heart model, thereby simulating the position and operation of the instruments during surgery in real time in vitro.

[0071] The present invention provides an in vitro simulation demonstration system for interventional treatment of structural heart disease, and the simulation operation process of tricuspid valve surgery is as shown in the attached figure. Figure 8 As shown:

[0072] 1. Assemble the simulation device and fix the heart model and tricuspid valve leaflet model on the model holder;

[0073] 2. Turn on the software and display, and connect the camera;

[0074] 3. Select the X-ray field of view of camera 5A in the software;

[0075] 4. Operate the instrument and observe the operating status of the instrument on the monitor until the instrument reaches the appropriate position, and compare it with the video animation in the software to see if it reaches the ideal state;

[0076] 5. Switch to the ultrasound field of view of cameras 5B, 5C, and 5D, and observe the position and status of the instrument from different angles. If the ideal status is not reached, continue the operation until the ideal position and status are reached;

[0077] 6. Continue to operate the instrument until the surgery is completed and remove the instrument from the model.

[0078] The above is the operation process of the demonstration device for the tricuspid valve model. The camera 5A in the example is the X-ray field of view, and the cameras 5B, 5C, and 5D are ultrasound fields of view at different angles. The model holder may be a model of the tricuspid valve of the heart, a model of the mitral valve of the heart, or a model of the aorta or other organ models. The position of the camera can be configured and adjusted according to different heart models.

[0079] The present invention has been physically manufactured and verified. During the entire test process, the operation process of the equipment can be clearly seen on the display, and the state of the equipment can be observed from different angles. The operator can practice multiple times to improve his proficiency.

Claims

1. An in vitro simulation demonstration system for interventional treatment of structural heart disease, characterized in that: The system includes an in vitro simulation demonstration device, a display and software, wherein: The in vitro simulation demonstration device comprises a base (1), a support (2) and a model holder (3), wherein the model holder (3) is located inside the support (2), and a camera (5) is arranged on the support (2), and optionally further comprises cameras at other positions; The display and software are capable of displaying the actual simulated surgery imaging screen and the standard surgery result screen captured by the camera for comparison to determine whether the actual simulated surgery result is consistent with the standard surgery result.

2. The system according to claim 1, characterized in that: The model holder (3) can fix models including: a heart model (31), a right heart system model (70), an aortic valve model or a pulmonary valve model, and a detachable valve leaflet model (32), wherein the valve leaflet model (32) includes a mitral valve leaflet model or a tricuspid valve leaflet model (71), which can be disassembled and replaced according to needs, wherein the tricuspid valve leaflet model (71) is fixed to the model holder (3) via a slide groove (68) and inserted into the heart model (31).

3. The system according to claim 1, characterized in that: The support (2) comprises a support body (21), a crossbeam (22) and a base frame (23); the support (2) is fixed to the base (1) by means of screws or buckles, and the model holder (3) is fixed to the base (1) by means of screws or buckles.

4. The system according to claim 3, characterized in that The bracket (2) is provided with 1 to 6 cameras (5); the direction of the camera (5) lens can be adjusted, the camera (5) is connected to a computer and a display screen, and the camera (5) is fixed to the crossbeam (22) and the bottom frame (23) by buckles.

5. The system according to claim 4, characterized in that At least one camera (5) is respectively arranged on the support body (21), the crossbeam (22) and the base frame (23), wherein the camera arranged on the base frame (23) is located below the heart model (31), and the heart model (31) is fixed to the model holder (3) by screws, wherein the heart model (31) is also provided with a socket (67) for facilitating the insertion of the leaflet model into the heart model (31) along the slide groove (68), and is the entrance for the leaflet model to enter the heart model (31).

6. The system according to claim 5, characterized in that The camera (5) arranged on the base frame (23) is an X-ray field of view, and the cameras (5) on the bracket and the crossbeam are ultrasound fields of view at different angles. The position of the camera can be configured and adjusted according to different heart models (31).

7. The system according to claim 4, characterized in that The base (1) is provided with a through hole (12), and the through hole (12) is used to place a camera installed on the base frame (23); the edge of the base (1) is also provided with a groove (13), and the groove (13) is connected to the base (61) of the blood vessel model (6).

8. The system according to claim 1, characterized in that The device also includes a blood vessel model (6), which is composed of a base (61), a blood vessel (62) and a blood vessel support (63). The blood vessel model (6) is connected to the model fixture (3) and simulates the left internal jugular vein (69-1) and the right internal jugular vein (69-2).

9. The system according to claim 1, characterized in that The heart model (31) is made of a transparent material, preferably PC, PP, PVC or acrylic material, and the bracket, base and model holder are made of ABS or POM material.

10. The system according to claim 9, characterized in that The heart model (31) is made of PC material, and the support, base and model holder are made of POM material.

11. The system according to claim 5, characterized in that The camera can be used in conjunction with the display software vMix to achieve overlapping and matching of ultrasound or X-ray images of real patients during surgery with images obtained by the real-time heart model.

12. An operating method of an in vitro simulation demonstration system for interventional treatment of structural heart disease, characterized in that: The method comprises: 1) Assembling a simulation device, fixing a heart model (31) and a tricuspid valve leaflet model (71) on a model fixture; 2) Turn on the computer, open the software, and connect the camera; 3) Select the X-ray field of view of camera 5A in the software; 4) Operate the instrument and observe the operating status of the instrument on the monitor until the instrument reaches the appropriate position, and compare it with the video animation in the software to see whether it reaches the ideal state; 5) Switch to the ultrasound field of view of cameras 5B, 5C, and 5D to observe the position and status of the instrument from different angles. If the ideal status is not reached, continue the operation until the ideal position and status are reached; 6) Continue to operate the instrument until the surgery is completed and remove the instrument from the model.

13. An in vitro simulation demonstration device in the system according to any one of claims 1 to 12.

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