Portable in-vitro simulation demonstration device

Abstract

The utility model relates to the technical field of medical instruments, in particular to a portable in-vitro simulation demonstration device which comprises a supporting device (2), a heart model (3) and a blood vessel model (4), and the heart model (3) is detachably fixed on a supporting plate (21) of the supporting device (2). The in-vitro simulation demonstration device is used for in-vitro simulation demonstration of medical instruments for interventional therapy of tricuspid regurgitation, is simple and convenient, and can more intuitively realize simulation demonstration operation of a heart structure.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an in vitro simulation demonstration device for interventional treatment of tricuspid regurgitation. Background Technology

[0002] Minimally invasive interventional treatment of tricuspid regurgitation is currently the fastest-growing technology in this field. Compared with 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. Interventional treatment for tricuspid regurgitation includes repair and replacement. The medical devices used in these two methods mostly involve inserting a catheter into the right atrium through the superior or inferior vena cava. The catheter tip is then positioned, punctured, anchored, pulled, clamped, and released on the tricuspid valve annulus and / or leaflets by manipulating the device handle. However, the positioning of the catheter tip on the tricuspid valve annulus and / or leaflets is difficult and complex due to variations in the structure, size, and degree of regurgitation among different patients, and can only be observed using ultrasound and X-rays. Currently, there is no suitable in vitro simulation device to verify the feasibility of this type of device catheter tip positioning. Furthermore, in later-stage clinical trials or market promotion, it is also difficult to provide adequate simulation training for operators on device operation and surgical procedures.

[0003] Against this backdrop, it is necessary to provide a new, simple, simulated device for studying the in vitro performance of catheter tip positioning in interventional treatment of tricuspid regurgitation. Utility Model Content

[0004] In view of the above-mentioned technical status, this utility model aims to provide an in vitro simulation demonstration device for interventional treatment of tricuspid regurgitation medical devices, especially for the in vitro simulation performance research and operation demonstration training of the catheter tip of the medical device for transcatheter interventional treatment of tricuspid regurgitation on the tricuspid valve annulus and / or leaflets.

[0005] This invention provides a portable in vitro simulation demonstration device, which includes a support device, a heart model, and a blood vessel model. The heart model is detachably fixed to the support plate of the support device, and the heart model and the blood vessel model are detachably connected.

[0006] In this utility model, as one of the embodiments, the support device further includes the following structure: a support plate, a support frame, a rotating shaft, and a bushing. The support plate is fixed to the support frame by the bushing, and the support plate can rotate along the rotating shaft.

[0007] In this invention, as one of the implementation schemes, the support device can drive the heart model to rotate 180° and be positioned.

[0008] In this invention, as one embodiment, the heart model is fixed to the support device by detachable threaded posts. The threaded posts can be inserted into threaded holes on the support plate, or they can be directly mounted on the heart model, with the other end of each post inserted one-to-one into a threaded hole in the support plate of the support device. The number of threaded posts can be set according to actual needs, for example, 2, 3, 4, 5, 6, 7, or 8, or more.

[0009] In this utility model, as one embodiment, the device further includes a vascular model support, which includes a support base, a support lifting rod, and a support buckle, with the support lifting rod connecting the support base and the support buckle.

[0010] In this invention, as one of the implementation schemes, the vascular model is fixed to the vascular model support by a stent clip.

[0011] In this utility model, as one embodiment, the device further includes a base, and the heart model is fixed to the base by a support frame of the support device; the blood vessel model is fixed to the base by a support base of the blood vessel model support.

[0012] In this utility model, as one of the implementation schemes, the connection method between the support frame or bracket base and the base includes screw connection, welding connection or fitting connection, with screw connection being preferred.

[0013] In this utility model, as one embodiment, the support device and the vascular model support are detachably fixed to the base by screws, and the vascular model support is set to 2 to 4, for example, 2, 3 or 4; preferably 3.

[0014] In this utility model, as one of the implementation schemes, the heart model is a 3D printed model of the left or right heart, and the heart model includes the ventricle, atrium, tricuspid valve, and superior vena cava. The right heart model includes the right ventricle, right atrium, tricuspid valve, and superior vena cava. The tricuspid valve includes the anterior valve, posterior valve, septal valve, and valve annulus.

[0015] The heart model support device of the portable in vitro simulation demonstration device of this utility model can be fixed, non-removable, and non-rotatable, and the right heart model can be molded.

[0016] In this invention, as one of the implementation schemes, the heart model and blood vessel model are both made of transparent or semi-transparent soft material.

[0017] In this utility model, as one of the embodiments, the instruments applicable to the simulated device include, but are not limited to, transcatheter tricuspid regurgitation repair or replacement instruments and transcatheter mitral regurgitation repair or replacement instruments.

[0018] This invention is a simple simulation device for studying the in vitro performance of catheter tip positioning in interventional treatment of tricuspid regurgitation; it can also be used for operators to conduct in vitro device operation training and surgical procedure practice.

[0019] In the early stages of research and development of transcatheter interventional medical devices for treating tricuspid regurgitation, this invention allows for product testing on a portable in vitro simulation demonstration device. The device enables real-time observation of the catheter tip's positioning on the tricuspid valve annulus and / or leaflets, thus evaluating the product's performance. Furthermore, it can be used for product demonstrations, and for training operators in device operation and surgical procedures.

[0020] This utility model is an external simulation demonstration device specifically designed for tricuspid valve transcatheter treatment devices. Its features include the design of a 3D-printed heart structure (right heart part) for different patients, and an external device operation simulation, which more realistically reproduces the expected operation of the device in the heart part of the patient's body.

[0021] This invention can support 3D printed models of different patients' heart structures and cooperate with these support structures to complete the demonstration and simulation of instruments operating inside the patient's heart structure in vitro. It can predict the possible risks of instrument operation inside the patient's heart as well as the expected operation method and location in advance, so that the instruments can avoid the identified risks in the patient's heart during the subsequent actual surgery and successfully complete the surgery.

[0022] This utility model is relatively small and portable. If the 3D printed model of the heart structure can be printed according to a certain design, its demonstration in conjunction with the device will be more intuitive.

[0023] Compared with the prior art, the portable in vitro simulation demonstration device of this utility model solves the problem of not being able to train and demonstrate to operators, and provides operators with a simple simulation device for preoperative operation and practice of in vitro instruments. It can plan the instrument position by using 3D printed models according to the heart structure and size of different patients. Attached Figure Description

[0024] Figure 1 : A bottom view of the base described in Example 1;

[0025] Figure 2 : Schematic diagram of the heart model support device described in Example 1;

[0026] Figure 3Schematic diagram of the right heart 3D printed model described in Example 1;

[0027] Figure 4 Schematic diagram of the blood vessel model described in Example 1;

[0028] Figure 5 Schematic diagram of the vascular model stent described in Example 1;

[0029] Figure 6 Example 1: Schematic diagram of the overall assembly of the in vitro simulation demonstration device;

[0030] Figure 7 : Schematic diagram of catheter tip positioning in an in vitro simulation demonstration device for tricuspid valve repair surgery;

[0031] Figure 8 : Schematic diagram of the location of the tricuspid valve annulus structure by the catheter tip in the in vitro simulation demonstration device for tricuspid valve repair surgery;

[0032] Figure 9 : Schematic diagram of the threaded post connected to the heart model as described in Example 1;

[0033] Figure 10 Schematic diagram of the completed assembly of the heart model and the threaded column;

[0034] Explanation of reference numerals in the attached drawings: 1: Base; 2: Support device; 21: Support plate; 22: Support frame; 23: Rotating shaft; 24: Bushing; 25: Threaded hole; 3: Heart model; 31: Right ventricle; 32: Right atrium; 33: Tricuspid valve; 34: Superior vena cava; 35: Tricuspid valve orifice; 36: Combination of the posterior septum and annulus of the tricuspid valve; 37: Position of the posterior valve annulus; 4: Vascular model; 41: Opening of the superior vena cava; 5: Vascular model support; 51: Support base; 52: Support lifting rod; 53: Support buckle; 81: Anterior valve; 82: Posterior valve; 83: Septal valve; 84: Valve annulus; 9: Threaded column. Detailed Implementation

[0035] The following embodiments, in conjunction with the accompanying drawings, are used to further illustrate the present invention, but do not limit the effective scope of the present invention in any way. The following embodiments are merely one specific implementation of the present invention, and other similar or analogous implementations are also within the protection scope of the present invention.

[0036] Example 1

[0037] like Figure 7 As shown, as one of the embodiments of this utility model, this embodiment discloses a portable in vitro simulation demonstration device. The device includes a support device 2, a heart model 3 and a blood vessel model 4. The heart model 3 is detachably fixed to the support plate 21 of the support device 2, and the heart model 3 and the blood vessel model 4 are detachably connected.

[0038] like Figure 6 As shown, in one embodiment of this utility model, the heart model support device 2 is fixed on the left side of the base 1 (fixed with screws, detachable), the blood vessel model bracket 5 is fixed on the right side of the base 1 (fixed with screws, detachable), the right heart 3D printed model (heart model 3) is fixed on the heart model support device 2 (fixed with screws, quick to detach), the superior vena cava blood vessel model 4 is fixed on the blood vessel model support bracket 5 (snap fastener, quick to detach), and the left port of the superior vena cava blood vessel model 4 is inserted into the superior vena cava blood vessel of the right heart 3D printed model (soft connection, quick to detach).

[0039] like Figure 8 As shown, in one embodiment of this utility model, the heart model 3 can be a left heart 3D printed model or a right heart 3D printed model. For illustrative purposes, this embodiment 1 uses a right heart 3D printed model. The heart model includes the ventricle, atrium, tricuspid valve, and superior vena cava. The right heart model includes the right ventricle 31, right atrium 32, tricuspid valve 33, and superior vena cava 34. Figure 3 As shown; the tricuspid valve includes anterior leaflet 81, posterior leaflet 82, septal leaflet 83, and annulus 84.

[0040] like Figure 2 As shown in the figure, as one embodiment of this utility model, the heart model support device 2 includes the following structure: a support plate 21, a support frame 22, a rotating shaft 23, and a bushing 24. The support plate 21 is connected to the bushing 24, and the rotating shaft 23 is provided inside the bushing 24. The support plate 21 can rotate 180° along the rotating shaft 23, so that the heart model mounted on the support plate for simulation demonstration can be observed from all directions at 180°. The support plate 21 is provided with threaded holes 25, and detachable threaded posts 9 are connected one-to-one with the threaded holes 25. The heart model 3 is held on the support plate 21 by the detachable threaded posts 9 and can be removed after the demonstration as needed. A schematic diagram of the threaded posts 9 connected to the heart model 3 is attached. Figure 9 As shown, the assembled state of the heart model and the threaded column is as follows. Figure 10 As shown. Because the heart model is fixed by multiple threaded posts 9 connected and locked to the corresponding threaded holes 25, this ensures that the heart model 3 can be firmly fixed on the support plate 21 and will not fall off when the support plate 21 rotates 180° along the rotation axis.

[0041] like Figure 3As shown, in one embodiment of this utility model, the right ventricular 3D printed model (heart model 3) is made of transparent or semi-transparent soft material (silicone, PVC), allowing clear observation of the positions of the tricuspid valve annulus and leaflets within the atria and ventricles. The superior vena cava model 4 is also made of transparent or semi-transparent soft material (silicone, PVC), allowing clear observation of the instrument's access route and position. The heart model support device 2 can rotate and position the right ventricular 3D printed model 180° by rotation, facilitating observation from multiple angles.

[0042] like Figure 5 As shown, as one of the embodiments of this utility model, the vascular model support 5 includes a support base 51, a support lifting rod 52, and a support buckle 53. The support lifting rod 52 is connected to the support base 51 and its height can be adjusted according to actual needs. The support buckle 53 fixes the vascular model with bolts and nuts. The vascular model support 5 is fixed to the base 1 by the support base 51.

[0043] The tricuspid regurgitation interventional catheter is inserted into the right atrium of a 3D-printed right ventricular model through the superior vena cava vascular model opening. The position of the catheter tip within the atrium and on the atrial side of the tricuspid valve annulus and leaflets can be clearly observed. The catheter tip then enters the right ventricle through the tricuspid valve orifice; the position of the catheter tip within the ventricle and on the ventricular side of the tricuspid valve annulus and leaflets can also be clearly observed.

[0044] The procedure for simulating catheter tip positioning in tricuspid valve repair surgery, as described in this invention, is as follows:

[0045] 1. Assemble the simulation device. Fix the selected right heart 3D printed model 3 on the heart model support device 2, and fix the corresponding superior vena cava model 4 on the blood vessel model support 5.

[0046] 2. The adjustable delivery sheath of the tricuspid valve repair device enters the right atrium (position 32) through the superior vena cava opening (position 41), with the tip of the sheath aligned with the tricuspid valve orifice (position 35), and the adjustable delivery catheter enters the right ventricle (position 31) through the sheath.

[0047] 3. Bend the catheter so that the tip of the catheter is facing the junction of the posterior septum of the tricuspid valve annulus (position 36), and then manipulate the sheath and catheter to align the tip of the catheter with the desired position of the posterior valve annulus (position 37).

[0048] 4. By rotating the heart model support device, the heart model can be rotated and positioned, allowing observation of the catheter tip position and status from different angles. If the ideal state is not achieved, continue the operation until the ideal position and status are achieved.

[0049] 5. Withdraw the catheter and sheath; the procedure is now complete.

[0050] This invention has been physically fabricated and verified. Throughout the entire testing process, the positioning operation of the catheter tip can be clearly and intuitively observed on the heart model, and the state of the catheter tip can be observed from different angles. Operators can practice repeatedly to improve their proficiency.

Claims

1. A portable external simulation demonstration device, characterized in that, The device includes a support device (2), a heart model (3) and a blood vessel model (4), wherein the heart model (3) is detachably fixed to the support plate (21) of the support device (2), and the heart model (3) is detachably connected to the blood vessel model (4). The support device (2) includes a support plate (21), a support frame (22), a rotating shaft (23) and a bushing (24).

2. The apparatus according to claim 1, characterized in that, The support plate (21) is fixed to the support frame (22) by a bushing (24), and the support plate (21) can rotate along the rotation axis (23).

3. The apparatus according to claim 1, characterized in that, The support device (2) can drive the heart model (3) to rotate 180° and be positioned.

4. The apparatus according to claim 1, characterized in that, The heart model (3) is fixed to the support device (2) by a detachable threaded post (9), which can be inserted into a threaded hole (25) provided on the support plate (21).

5. The apparatus according to claim 1, characterized in that, The device also includes a vascular model stent (5), which includes a stent base (51), a stent lifting rod (52), and a stent buckle (53). The stent lifting rod (52) connects the stent base (51) and the stent buckle (53).

6. The apparatus according to claim 1, characterized in that, The vascular model (4) is fixed to the vascular model support (5) by the support clip (53).

7. The apparatus according to claim 1, characterized in that, The device also includes a base (1), the heart model (3) is fixed to the base (1) by the support frame (22) of the support device (2); the blood vessel model (4) is fixed to the base (1) by the support base (51) of the blood vessel model support (5).

8. The apparatus according to claim 1, characterized in that, The connection between the support frame (22) or the bracket base (51) and the base (1) includes screw connection, welding connection or fitting connection, with screw connection being preferred.

9. The apparatus according to claim 8, characterized in that, The support device (2) and the vascular model support (5) are detachably fixed to the base (1) by screws, and the vascular model support (5) is set to 2 to 4.

10. The apparatus according to claim 1, characterized in that, The heart model (3) is a 3D printed model of the left or right heart. The right heart model includes the right ventricle (31), right atrium (32), tricuspid valve (33), and superior vena cava (34).

11. The apparatus according to claim 1, characterized in that, The heart model (3) and blood vessel model (4) are both made of transparent or semi-transparent soft material.

Images