In-vitro simulation demonstration device for structural heart disease interventional medical instrument

Abstract

The utility model relates to the technical field of interventional medical instrument in-vitro simulation demonstration, in particular to a structural heart disease interventional medical instrument in-vitro simulation demonstration device. The 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 device can be used for simulation device demonstration of heart valve intervention medical instrument in-vitro performance research, instrument operation training of an operator in vitro and operation process practice.

Description

Technical Field

[0001] This utility model relates to the field of in vitro simulation demonstration technology of interventional medical devices, and in particular to the in vitro performance research and operation demonstration training of transcatheter interventional devices for valvular disease, specifically to an in vitro simulation demonstration device for interventional medical devices for structural heart disease. Background Technology

[0002] For valvular heart diseases, such as tricuspid regurgitation, mitral regurgitation, and aortic stenosis / regurgitation, minimally invasive interventional treatment is currently the fastest-growing technology in this field. Compared to traditional surgery, this method has advantages such as less trauma, shorter postoperative recovery time, and is more suitable for elderly patients who cannot tolerate the risks of open-heart surgery. However, for these interventional medical devices, in the early performance research stages, there are no good in vitro simulation devices to verify the feasibility of the product's performance. Furthermore, in later clinical trials or market launches, it is also difficult to provide adequate simulation training and instruction for operators on device operation and surgical procedures.

[0003] Patent application CN212208704U provides a structural cardiac intervention training model, which includes a fixation base and a cardiovascular model placed inside it. The cardiovascular model includes a cardiac module and a vascular module. This model has the effect of helping doctors learn and master surgical skills and shortening the learning curve of surgery.

[0004] Patent application CN116453408A also provides a structural cardiac intervention training model. This model has a heart model installed inside. By setting up a human body model and an anterior chamber model, it can train operators to perform femoral vein puncture. The training difficulty can be adjusted according to the different skill levels of the operators, allowing for a gradual progression and enhancing the practicality of the training module. By installing cameras on the right ventricular model and the inner wall of the left ventricular ventricle, the location of the ventricular septum gap can be observed on the display screen. The entire process of closing the gap can be viewed on the display screen, simulating the angiographic images during the closure surgery, ensuring the success of the surgical simulation. Utility Model Content

[0005] In view of the above-mentioned technological status, this utility model aims to provide a simulation device that can be used for in vitro performance research of cardiac valve interventional medical devices; at the same time, this device can also be used for operators to conduct instrument operation training and surgical procedure practice in vitro. In the early research and development process of transcatheter interventional medical devices for treating cardiac valve diseases, the products can be tested on the simulation device of this utility model, 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.

[0006] In addition, this invention can also be used for product demonstrations, training surgeons on instrument operation and surgical procedures, etc.

[0007] This invention relates to a simulation device for in vitro performance research of cardiac valve interventional medical devices. It includes a base, a support, and a model fixator. The model fixator is located inside the support, and a camera is mounted on the support. Optionally, cameras in other locations may also be included.

[0008] In the extracorporeal simulation demonstration device for interventional treatment of structural heart disease described in this utility model, the model fixator can fix models including: a heart model, a right heart system model, a left heart system model, an aortic valve model or a pulmonary valve model, or a detachable leaflet model. The leaflet model includes a mitral valve leaflet or a tricuspid valve leaflet model. The tricuspid valve leaflet model is fixed on the model fixator through a sliding groove and inserted into the heart model. The mitral valve leaflet or tricuspid valve leaflet model can be disassembled and replaced as needed.

[0009] In this invention, as one of the embodiments, the leaflet model is a tricuspid valve leaflet model.

[0010] In this utility model, as one embodiment, 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.

[0011] In this utility model, 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.

[0012] In this utility model, as one of the implementation schemes, the bracket is equipped with 1 to 6 cameras; the direction of the camera lens can be adjusted, the camera is connected to the display screen (not shown), and the camera is fixed to the crossbeam and the base frame by a buckle.

[0013] In this utility model, as one of the implementation schemes, at least one camera is respectively provided on the main body of the support, the crossbeam and the base frame, wherein the camera provided on the base frame is located below the heart model, and the heart model is fixed to the model fixator by screws. The heart model is also provided with an insertion port to facilitate the insertion of the leaflet model into the heart model along the sliding groove, which is the entrance for the leaflet model to enter the heart model.

[0014] In this invention, as one of the implementation schemes, the camera installed on the base frame provides an X-ray field of view, while the cameras on the support and crossbeam provide ultrasound fields of view at different angles. The positions of the cameras can be configured and adjusted according to different heart models.

[0015] In this utility model, as one embodiment, the base is provided with a through hole for placing a camera mounted on the base frame; the edge of the base is also provided with a groove, which is connected to the base of the blood vessel model.

[0016] In this utility model, as one of the embodiments, the device further includes a vascular model, which consists of a base, blood vessels and a vascular stent, simulating the left internal jugular vein and the right internal jugular vein. The vascular model is connected to the model fixator.

[0017] In this invention, as one of the implementation schemes, the camera can be used in conjunction with the display software vMix to achieve overlapping and matching of ultrasound or X-ray images during the actual patient's surgery with images acquired from a real-time cardiac model.

[0018] This invention is more suitable for simulating and demonstrating instruments related to structural heart disease, such as tricuspid and mitral valve repair and / or replacement, aortic valve replacement, pulmonary valve replacement, foramen ovale occlusion, and left atrial appendage closure. The simulation device is equipped with multiple cameras, whose positions and angles facilitate operator observation of the heart structure and instrument locations. It can simulate 2D and / or 3D ultrasound and DSA imaging during real surgery, more realistically reproducing the intraoperative imaging requirements and process. All connecting parts in this invention are manually detachable, making assembly and portability easier; and the heart structure parts are replaceable, facilitating observation of the position and effect during each training demonstration. For tricuspid and mitral valves, this invention can simulate not only edge-to-edge repair techniques for the leaflets but also annular constriction repair techniques.

[0019] The beneficial effects of this utility model are:

[0020] 1. It solved the problem of not being able to provide operators with intuitive training demonstrations on equipment operation;

[0021] 2. A simulation device was provided for verifying product performance in vitro;

[0022] 3. It provides surgeons with a simulation device for preoperative operation and practice of external instruments. Attached Figure Description

[0023] Figure 1 : Schematic diagram of the simulation device assembly;

[0024] Figure 2 : Base diagram;

[0025] Figure 3 : Schematic diagram of the support frame;

[0026] Figure 3-1 : Schematic diagram of the left side of the bracket;

[0027] Figure 3-2 : Schematic diagram of the right side of the bracket;

[0028] Figure 4 : Schematic diagram of the model fixation device;

[0029] Figure 4-1 : A diagram showing the model holder being fixed to the base with screws;

[0030] Figure 4-2 : A schematic diagram showing the heart model being fixed to the model holder with screws;

[0031] Figure 4-3 A schematic diagram showing the tricuspid valve being fixed to the model fixator via a groove and inserted into the heart model;

[0032] Figure 4-4 Schematic diagram of the right heart system model;

[0033] Figure 4-5 Schematic diagram of the tricuspid valve leaflet model;

[0034] Figure 5-1 Schematic diagram of a blood vessel model;

[0035] Figure 5-A: Schematic diagram of X-ray field of view ( Figure 5-A1 5-A2: X-ray field of view; 5-A3: Simulator camera field of view; 5-A4: Overlapping image of X-ray and simulator fields of view.

[0036] Figure 5-B: Schematic diagram of the right atrium and right ventricle surgical field in 2D ( Figure 5-B1 5-B2: Ultrasound field of view; 5-B3: Overlapping image of ultrasound and simulator fields of view.

[0037] Figure 5-C: Schematic diagram of the four-chamber surgical field of the heart in 2D ( Figure 5-C1 5-C1: Surgical field image with ultrasound, 5-C2: Surgical field image with simulator camera, 5-C3: Overlapping image of ultrasound and simulator surgical fields.

[0038] Figure 5-D: Schematic diagram of the surgical field of tricuspid valve surgery from the right atrium to the right ventricle 3D ( Figure 5-D1 5-D2: Surgical field image of ultrasound, 5-D3: Surgical field image of simulator camera, 5-D4: Surgical field image of ultrasound and simulator overlapping;

[0039] Figure 6 : A diagram showing how a camera is fixed to a bracket;

[0040] Figure 7 Assembly diagram of the bracket and base;

[0041] Explanation of reference numerals in the attached drawings: 1. Base; 11. Positioning hole; 12. Through hole; 13. Groove; 2. Bracket; 21. Main body; 22. Crossbeam; 23. Base frame; 3. Model fixator; 31. Heart model; 5. Cameras (5A, 5B, 5C, 5D); 6. Blood vessel model; 61. Base; 62. Blood vessel; 63. Blood vessel stent; 64. Right atrium; 64-1. Left atrium; 66-1. Left ventricle; 65. Tricuspid valve leaflet; 66. Right ventricle; 67. Insertion port; 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 Implementation

[0042] The following embodiments are used to further illustrate the present invention, but do not limit the effective scope of the present invention in any way.

[0043] In specific embodiments, the "distal end" of this utility model refers to the end away from the operator when the operator holds the handle during the operation, and the "proximal end" refers to the end close to the operator when the operator holds the handle during the operation. The terms "upper," "lower," "left," "right," "front," "back," "top," "bottom," "inner," "outer," "middle," etc., used in this utility model to indicate directions or positional relationships are based on the directions or positional relationships shown in the accompanying drawings. These terms are mainly used to better describe this utility model and its embodiments, and are not intended to limit the indicated device, nor do they constitute a limitation on this utility model.

[0044] Furthermore, the terms "set", "equipped", "connected", and "connected" used in this utility model should be interpreted broadly. They can refer to fixed connections or non-fixed connections, mechanical connections or any other type of connection, direct connections or indirect connections through a medium. All connection methods commonly used by those skilled in the art are within the protection scope of this utility model.

[0045] The materials used in the device in this embodiment are merely illustrative and do not imply that the device can only be made of that material.

[0046] In this utility model, as one of the implementation schemes, as shown in the appendix... Figure 1 As shown, the in vitro simulation demonstration device includes a base, a support, and a model fixator. The model fixator is located inside the support, and a camera is installed on the support.

[0047] In this utility model, as one of the implementation schemes, as shown in the appendix... Figure 2-3 As shown, the bracket includes a bracket body, a crossbeam, and a base frame, which are fixed to the base with screws. The model holder is located inside the bracket and is fixed to the base with screws.

[0048] In this utility model, as one of the implementation schemes, as shown in the appendix... Figure 4As shown, the model retainer holds a heart model and detachable tricuspid or mitral valve leaflets. The heart model is made of transparent material, allowing a camera to view the operation of the instruments inside the heart. The model retainer is fixed to the base plate with screws.

[0049] In this invention, as one implementation scheme, as shown in Figures 5-6, camera 5A is positioned above the model, simulating intraoperative X-ray images of the heart in the anterior position; camera 5B is positioned in front of the model, simulating 2D images of the ventricles and atria provided by intraoperative transesophageal ultrasound; camera 5C is positioned to the right of the model, simulating the 2D four-chamber surgical field of the heart provided by intraoperative transesophageal ultrasound; and camera 5D is positioned below the model, simulating the tricuspid valve annulus image viewed from the atrium provided by intraoperative transesophageal ultrasound. The angle and number of cameras are set according to the imaging needs of different models simulating real surgical procedures. For example, in tricuspid regurgitation repair surgery, X-rays and 2D and 3D transesophageal ultrasound at different angles are typically used. Therefore, during the demonstration, these accompanying cameras will present an image field of view similar to that during the surgery, as shown in Figures 5-A, 5-B, 5-C, and 5-D.

[0050] In this utility model, as one of the implementation schemes, as shown in the appendix... Figure 7 As shown, the support has cameras positioned in multiple directions, secured by clips. Camera 5A provides an X-ray view, while cameras 5B, 5C, and 5D provide ultrasound views at different angles. The camera positions can be configured and adjusted according to different heart models.

[0051] In this invention, as one embodiment, the camera is connected to a computer and a monitor, allowing the user to view the demonstration status of the equipment on the monitor via the camera. The bracket is fixed to the base using screws or clips.

[0052] This invention relates to a simulation device for studying the in vitro performance of cardiac valve interventional medical devices. The working principle is that the simulation demonstration device is equipped with a camera, which can capture the state of the device inside the cardiac model in real time and display it on a monitor in real time through software. The operator can watch the state of the device inside the model in real time through the monitor.

[0053] The camera on the simulator captures the position of the heart model in real time, simulating the field of view of ultrasound and / or X-ray imaging of the patient's heart during actual surgery. By switching between different camera views, the simulator can simulate the different angles of the heart view from different imaging tools during surgery, more realistically reproducing the instrument operation process and image guidance during actual surgery.

[0054] The vMix display software, used in conjunction with the camera on the simulator, can overlay and match ultrasound or X-ray images from a real patient's surgery with images acquired from a real-time cardiac model, thus simulating the position and operation of instruments during surgery in real time outside the body.

[0055] This invention has been physically manufactured and verified. Throughout the testing process, the operation of the equipment can be clearly seen on the monitor, and the status of the equipment can be observed from different angles. Operators can practice multiple times to improve their proficiency.

Claims

1. An external simulation demonstration device for structural cardiac interventional medical devices, characterized in that, The device includes a base (1), a bracket (2) and a model holder (3), the model holder (3) being located inside the bracket (2), and a camera (5) being mounted on the bracket (2). The model fixator (3) can fix models including: a heart model (31), a right heart system model (70), a left heart system model, an aortic valve model or a pulmonary valve model, or a detachable leaflet model (32). The leaflet model (32) includes a mitral valve leaflet or a tricuspid valve leaflet model (71). The tricuspid valve leaflet model (71) is fixed to the model fixator (3) by a groove (68) and inserted into the heart model (31). The heart model (31) is fixed to the model holder (3) by screws. The heart model (31) is also provided with an insertion port (67) to facilitate the insertion of the leaflet model into the heart model (31) along the sliding groove (68). This is the entry point for the leaflet model into the heart model (31). The camera (5) mounted on the bracket (2) is an X-ray field of view or an ultrasound field of view at different angles. The device also includes a vascular model (6), which is connected to the model fixator (3) to simulate the left internal jugular vein (69-1) and the right internal jugular vein (69-2).

2. The apparatus according to claim 1, characterized in that, The bracket (2) includes a bracket body (21), a crossbeam (22) and a base frame (23); the bracket (2) is fixed to the base (1) by screws or buckles, and the model holder (3) is fixed to the base (1) by screws or buckles.

3. The apparatus according to claim 1, characterized in that, The bracket (2) is equipped with cameras (5), the number of which is 1 to 6; the direction of the lens of the camera (5) is adjustable, the camera (5) is connected to the display screen, and the camera (5) is fixed to the crossbeam (22) and the base frame (23) by buckles.

4. The apparatus according to claim 2, characterized in that, At least one camera (5) is provided on the main body (21), crossbeam (22) and base frame (23) respectively, wherein the camera provided on the base frame (23) is located below the heart model (31).

5. The apparatus according to claim 2, characterized in that, The camera (5) installed on the base frame (23) is an X-ray field of view, and the cameras (5) on the support body (21) and crossbeam (22) are ultrasound fields of view at different angles. The position of the camera can be configured and adjusted according to different heart models (31).

6. The apparatus according to claim 1, characterized in that, The base (1) is provided with a through hole (12) for placing a camera installed on the base frame (23); the edge of the base (1) is also provided with a groove (13) which is connected to the base (61) of the blood vessel model (6).

7. The apparatus according to claim 2, characterized in that, The vascular model (6) consists of a base (61), a blood vessel (62), and a vascular stent (63).

8. The apparatus according to claim 4, characterized in that, The camera can be used in conjunction with the display software vMix to achieve overlay matching between ultrasound or X-ray images of real patients during surgery and images acquired from real-time cardiac models.

Images