An extracorporeal vascular model for simulating use of a valve repair instrument

Abstract

The utility model discloses a kind of extracorporeal blood vessel models for valve repair instrument simulation use, belong to medical teaching and medical instrument simulation test technical field.The model includes: from inside to outside inner layer silica gel layer, intermediate high molecular fiber layer and outer layer silica gel layer, intermediate high molecular layer is net structure, and is made into by high molecular fiber interlaced weaving or stacking.This utility model is reinforced framework layer by intermediate intermediate high molecular fiber layer, can effectively disperse and bear the concentrated stress generated by instrument puncture, suture and pull, so that blood vessel model has excellent tear resistance and puncture resistance, realizes the function of suture, simultaneously meets long time, multiple repeated training or test requirement.

Description

Technical Field

[0001] This utility model relates to an in vitro vascular model for simulating valve repair devices, belonging to the field of medical teaching and medical device simulation testing technology. Background Technology

[0002] In transcatheter valve repair, instruments need to be delivered, positioned, and used within a vascular model cavity to complete the valve repair procedure. To develop new instruments, optimize their design, and conduct pre-operative clinical simulations, silicone vascular models are typically used to simulate the real vascular environment. However, while existing silicone vascular models can reproduce vascular anatomy well in terms of morphology and transparency, their mechanical properties differ significantly from those of real human blood vessels.

[0003] In particular, the inherent toughness of silicone material is limited. While it may be sufficient for simulating simple implantable devices such as vascular stents and heart valves, it is inadequate for repair devices, such as mitral valve annulus retraction devices and aortic valve annulus repair devices. Simulating valve repair procedures requires inserting the device into the tissue or performing suturing. Under these conditions, silicone vascular models are prone to tearing due to suturing, traction, or repeated punctures. This not only affects the continuity and reliability of experiments but also fails to accurately reflect the vessel wall's resistance and response to the device during clinical procedures. Furthermore, silicone vascular models are insufficient in terms of fatigue resistance and tear resistance, making them unsuitable for prolonged, repeated training or testing.

[0004] Therefore, there is an urgent need to provide a vascular model that can significantly improve toughness, tear resistance, puncture resistance, and sutureability, so as to provide a more realistic and reliable experimental environment in the research and development of repair devices and clinical simulation. Utility Model Content

[0005] To address the problems of existing vascular models being prone to tearing due to suturing, traction, or repeated punctures when used with repair devices, and their insufficient fatigue and tear resistance, making them unsuitable for long-term, repeated training or testing, this invention provides an in vitro vascular model for simulating valve repair devices. The technical solution is as follows: An in vitro vascular model for simulating valve repair devices includes an inner silicone layer, a middle polymer fiber layer, and an outer silicone layer, from the inside out. The middle polymer layer has a mesh structure and is made of polymer fibers that are interwoven or stacked.

[0006] Furthermore, the intermediate polymer fiber layer has a multi-layer structure, with multiple sets of circumferentially distributed layered protrusions along its length.

[0007] Furthermore, the intermediate polymer fiber layer uses polymer fibers with a diameter of 10 to 100 micrometers and a mesh pore size of 0.01–0.5 millimeters.

[0008] Furthermore, the thickness of the inner silicone layer is 0.1~1.0 mm.

[0009] Furthermore, the thickness of the outer silicone layer is 0.1~1.5 mm.

[0010] The beneficial effects of this utility model are: By setting up a three-layer vascular model consisting of an inner silicone layer, a middle polymer fiber layer, and an outer silicone layer, it more closely resembles real vascular tissue. At the same time, the middle polymer fiber layer, as a reinforcing skeleton layer, can effectively disperse and withstand the concentrated stress generated by instrument puncture, suturing, and traction, giving the vascular model excellent tear resistance and puncture resistance, achieving the function of suturing, and meeting the needs of long-term, repeated training or testing. Attached Figure Description

[0011] Figure 1 This is an overall view of the blood vessel model according to an embodiment of the present invention; Figure 2 This is a cross-sectional view of a blood vessel model according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the intermediate polymer fiber layer in an embodiment of the present invention; Figure 4 This is a cross-sectional schematic diagram of the intermediate polymer fiber layer in an embodiment of this utility model; Explanation of reference numerals in the attached figures: 1. Inner silicone layer; 2. Middle polymer fiber layer; 3. Outer silicone layer; 4. Protrusion. Detailed Implementation

[0012] The following is a detailed description of this utility model.

[0013] Example 1 like Figures 1 to 4 As shown, this invention provides an in vitro vascular model for simulating valve repair devices. It comprises, from the inside out, an inner silicone layer 1, a middle polymer fiber layer 2, and an outer silicone layer 3. This three-layer composite structure more closely resembles real human vascular tissue, especially in maintaining structural integrity and stability during the expansion, puncture, and suturing simulations of valve repair devices. Simultaneously, the middle polymer fiber layer, with its multi-layered structure, enhances the bonding strength of the silicone body, effectively dispersing and bearing the concentrated stress generated by device puncture, suturing, and traction. This gives the vascular model excellent tear resistance and puncture resistance, enabling suturing and meeting the needs of long-term, repeated training or testing.

[0014] Specifically, the inner silicone layer 1 is located on the innermost side of the blood vessel model of this invention. During application, it adheres closely to the blood vessel cavity and is mainly used to form the basic shape of the blood vessel and provide a smooth internal surface. The thickness of the inner silicone layer 1 can be set in the range of 0.3–1.0 mm to ensure both flexibility and basic strength.

[0015] Specifically, the intermediate polymer fiber layer 2, disposed on the outer surface of the inner silicone layer 1, serves as a reinforcing framework layer. This layer is in the form of a woven mesh or fiber fabric, composed of interwoven or stacked polymer fibers (such as nylon or polyester fibers). The polymer fibers used in this layer preferably have a diameter of 10–100 micrometers, and the mesh aperture of the woven intermediate polymer fiber layer 2 is preferably 0.01–0.5 millimeters. Furthermore, this polymer fiber layer has a multi-layered structure to enhance the bonding force with the silicone body. Multiple sets of circumferentially distributed layered protrusions 4 are provided along its length. The protrusions 4 increase the bonding strength with the inner and outer silicone layers, preventing delamination during use when using a single layer of fiber and the inner and outer silicone layers. Through this woven fiber framework, the stress generated during the expansion, traction, and friction of the repair device can be effectively dispersed, significantly improving the tear resistance of the model, while also giving the vascular model puncture resistance and sutureability.

[0016] Specifically, the outer silicone layer 3 covers the outside of the intermediate polymer fiber 2, serving to fix the polymer fiber layer 2 and provide an overall outer wall. The thickness of this outer silicone layer can be set in the range of 0.1–1.5 mm to ensure that the vascular model does not deform or fail during instrument operation.

[0017] The beneficial effects of this utility model are as follows: 1. Excellent mechanical properties: The intermediate polymer fiber layer 2 is like the steel skeleton of a building, which can effectively disperse and bear the concentrated stress generated by instrument puncture, suturing and traction, so that the model has excellent tear resistance and puncture resistance, and realizes the function of suturing.

[0018] 2. Good structural stability: The layered protrusion structure on the surface of the middle polymer fiber layer 2 forms a strong mechanical bond with the inner and outer silicone layers, which fundamentally solves the problem of easy delamination of composite structures and ensures the structural integrity and lifespan of the vascular model under long-term and repeated use.

[0019] 3. High degree of functional biomimicry: The vascular model adopts a three-layer composite structure, and its mechanical response, especially its tear resistance and puncture resistance, is closer to the real human vascular tissue, providing a more realistic and reliable mechanical environment for the testing of valve repair devices.

[0020] 4. Strong process compatibility: This vascular model can be manufactured using mature lamination, dip coating or molding processes, and is easy to industrialize based on existing silicone vascular model manufacturing, while retaining the transparency and biomimetic advantages of silicone material.

[0021] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be determined by the claims.

Claims

1. An in vitro vascular model for simulating valve repair devices, characterized in that: It includes an inner silicone layer, a middle polymer fiber layer and an outer silicone layer from the inside out. The middle polymer fiber layer has a mesh structure and is made by interlacing or stacking polymer fibers.

2. The in vitro vascular model for simulating valve repair devices according to claim 1, characterized in that, The intermediate polymer fiber layer has a multi-layer structure, with multiple sets of circumferentially distributed layered protrusions along its length.

3. The in vitro vascular model for simulating valve repair devices according to claim 1, characterized in that, The intermediate polymer fiber layer uses polymer fibers with a diameter of 10-100 micrometers and a mesh pore size of 0.01-0.5 millimeters.

4. The in vitro vascular model for simulating valve repair devices according to claim 1, characterized in that, The thickness of the inner silicone layer is 0.1~1.0 mm.

5. An in vitro vascular model for simulating valve repair devices according to claim 1, characterized in that, The thickness of the outer silicone layer is 0.1~1.5 mm.

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