A two-leaflet aortic valve endoprosthesis

Abstract

This invention provides a bicuspid aortic valve implantable annuloplasty ring, comprising two symmetrically arranged semi-annular bodies. The two ends of the two semi-annular bodies are connected in a saddle shape by a connecting post, and the connecting post extends upward by a predetermined length, forming the highest point of the annuloplasty ring. At the connection point, the two semi-annular bodies form a first predetermined angle. The semi-annular bodies are made of flexible material, and the connecting post is made of rigid material. This invention can be conveniently implanted into the bicuspid aortic valve annuli and can be operated within the aorta, eliminating the need for dissection outside the vessel wall.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a bicuspid aortic valve implantable angioplasty ring. Background Technology

[0002] Bicuspid aortic valve (BAV) is a congenital heart defect. A normal aortic valve should have three leaflets, but BAV only has two. This can lead to valvular dysfunction and aortic regurgitation, usually requiring surgical treatment. Tricuspid aortic valves can also become insufficient due to annular dilation and valve prolapse, causing regurgitation. Surgery typically requires an angioplasty ring to close the aortic leaflets and prevent further annular dilation. Because bicuspid and tricuspid valves differ significantly in anatomical junction location, leaflet fusion morphology, annular curvature, and hemodynamics, tricuspid angioplasty rings cannot be used in bicuspid aortic valve regurgitation surgery. Currently, suitable bicuspid aortic valve angioplasty rings are lacking. Methods for fixing the bicuspid valve annulus require extensive dissection of the adventitia to the aortic root fat and even myocardium, which can easily cause bleeding and accidental injury. Lateral aortic valve wall padding suture fixation of the valve annulus requires high surgical skill, has uncertain efficacy, and cannot be universally applied.

[0003] Therefore, there is an urgent need for a bicuspid aortic valve implantable annuloplasty ring that can be easily implanted onto the bicuspid aortic valve annuloplasty ring and can be operated within the aortic vessel, eliminating the need for dissection outside the vessel wall. Utility Model Content

[0004] The purpose of this invention is to provide a bicuspid aortic valve implantable angioplasty ring, which aims to solve the technical problem that the traditional tricuspid aortic valve angioplasty ring cannot be used in BAV regurgitation surgery.

[0005] To achieve the above objectives, this utility model provides a bicuspid aortic valve implantable angioplasty ring, comprising two symmetrically arranged semi-annular bodies. The two ends of the two semi-annular bodies are respectively connected by a connecting post to form a saddle shape, and the connecting post extends upward to a predetermined length and constitutes the highest point of the angioplasty ring.

[0006] Furthermore, at the connection point, the two semi-lobe ring bodies form a first preset angle, the semi-lobe ring bodies are made of flexible material, and the connecting column is made of rigid material.

[0007] As a further improvement to the above solution, the outer surface of the forming ring is wrapped with a fabric that is easy to sew, preferably polyester fabric.

[0008] As a further improvement to the above scheme, the two joint columns are inclined outwards respectively, and the axis of the joint column forms a second preset angle with the vertical plane.

[0009] As a further improvement to the above scheme, the first preset included angle is 130°~140°, preferably 135°.

[0010] As a further improvement to the above scheme, the second preset included angle is 3°~8°, preferably 5°.

[0011] As a further improvement to the above solution, the preset length is 3mm to 8mm, preferably 5mm.

[0012] As a further improvement to the above scheme, the material of the joint column is titanium alloy.

[0013] Because this utility model adopts the above technical solutions, the beneficial effects of this application are as follows:

[0014] This invention provides an internal angioplasty ring for a bicuspid aortic valve, comprising two symmetrically arranged semi-annular bodies. The two ends of each semi-annular body are connected by a connecting column to form a saddle shape, with the connecting column extending upwards by a predetermined length to form the highest point of the angioplasty ring. At the connection point, the two semi-annular bodies form a first predetermined angle. The semi-annular bodies are made of flexible material, while the connecting column is made of rigid material. In this invention, the symmetrical double-semi-annular body structure, designed based on the "complete bisection method" (Bicuspidization), highly matches the bipartite physiological morphology of the bicuspid aortic valve, effectively eliminating the morphological mismatch problem between traditional three-lobed angioplasty rings and the bicuspid structure. The saddle-shaped topological conformation formed by the extended connecting column precisely matches the anatomical features of the aortic sinus, ensuring the physiological reconstruction of the three-dimensional morphology of the valve annulus; thus avoiding deep dissection, reducing surgical difficulty, saving surgical time, and preventing intraoperative bleeding.

[0015] Furthermore, this invention employs a heterogeneous composite structure of a flexible semi-annular body and a rigid conjoint column, forming a stress distribution pattern of "rigid anchor point - flexible arc segment" in the annular plane. Experimental data shows that this structure reduces circumferential stress in the annulus, enhances axial support strength, and effectively balances annular flexibility and structural stability. The preset angle between the semi-annular bodies (θ=135°±5°) combined with the conjoint column height (h=3-8mm) forms a physiological-like mating surface. In vitro simulations show that this reduces peak leaflet closure stress and significantly improves the diastolic regurgitation volume index (EROA≤0.3cm²). Preferably, the flexible semi-annular body uses a super-elastic nickel-titanium alloy wire core + polyester braided composite structure, which maintains shape memory function while increasing the surface endothelialization rate by 40%. The microporous titanium alloy structure of the conjoint column promotes local tissue endogenous growth; long-term follow-up data shows that the fiber coverage rate reaches 92%±5% at 6 months post-surgery.

[0016] The bicuspid aortic valve implantable angioplasty ring provided by this utility model achieves a technological breakthrough in the field of bicuspid aortic valve repair through multi-dimensional innovations in morphological reconstruction, mechanical optimization, and surgical procedure improvement, and has significant clinical translational value. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0018] Figure 1 This is a three-dimensional structural schematic diagram of a bilobed aortic valve internal angioplasty ring disclosed in this utility model.

[0019] Figure 2 This is a front view schematic diagram of a bilobed aortic valve internal angioplasty ring disclosed in this utility model;

[0020] Figure 3 This is a three-dimensional schematic diagram of the measuring device disclosed in this utility model.

[0021] Figure label:

[0022] 1. Half-lobe ring body; 2. Connecting column; 3. First preset included angle; 4. Second preset included angle.

[0023] The realization of the purpose, functional features and advantages of this utility model will be further explained in conjunction with the implementation methods and with reference to the accompanying drawings. Detailed Implementation

[0024] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] It should be noted that all directional indicators (such as up, down, etc.) in the embodiments of this utility model are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indicator will also change accordingly.

[0026] Furthermore, in this utility model, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features.

[0027] Furthermore, the technical solutions of the various embodiments of this utility model can be combined with each other, but only if they are based on the ability of a person skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by this utility model.

[0028] See Figure 1 and Figure 2 This utility model provides a bicuspid aortic valve implantable angioplasty ring, which includes two symmetrically arranged semi-annular bodies 1. The two ends of the two semi-annular bodies 1 are connected to form a saddle shape by a connecting post 2, and the connecting post 2 extends upward to a predetermined length and forms the highest point of the angioplasty ring.

[0029] Furthermore, at the connection point, the two semi-lobe ring bodies 1 form a first preset angle 3, the two connecting columns 2 are inclined outwards respectively, and the axis of the connecting column 2 forms a second preset angle 4 with the vertical plane;

[0030] The semi-lobe ring body 1 is made of flexible material, and the connecting column 2 is made of rigid material;

[0031] In this invention, the symmetrical double-half-valve annulus main body 1 structure, designed based on the "complete bipartition method," highly matches the bidifferentiated physiological morphology of the bicuspid aortic valve, effectively eliminating the morphological mismatch problem between the traditional three-valve annuloplasty ring and the bicuspid structure. The saddle-shaped topological conformation formed by the extension of the connecting column 2 precisely matches the anatomical features of the aortic sinus, ensuring the physiological reconstruction of the three-dimensional morphology of the valve annulus. The upward extension and outward tilt of the connecting column 2 (the second preset tilt angle is 3°~8°) can simulate the "towers" at both ends of a suspension bridge. After suturing, the anatomical junction can be fixed and kept upward and outward to maintain a physiological-like structure and stability, so as to bear the tension in the tangential and axial directions of the aortic valve when it closes. This avoids deep dissection, reduces surgical difficulty, saves surgical time, and avoids intraoperative bleeding.

[0032] Furthermore, this invention employs a heterogeneous composite structure of a flexible semi-annular body 1 and a rigid connecting column 2, forming a stress distribution pattern of "rigid anchor point - flexible arc segment" in the annular plane. Experimental data shows that this structure reduces circumferential stress in the annulus, enhances axial support strength, and effectively balances annular flexibility and structural stability. The preset angle (θ=135°±5°) between the semi-annular bodies 1, combined with the height of the connecting column 2 (h=3~8mm), forms a physiological-like mating surface. In vitro simulations show that this reduces the peak stress at leaflet closure and significantly improves the diastolic regurgitation volume index (EROA≤0.3cm²). Preferably, the flexible semi-annular body 1 uses a super-elastic nickel-titanium alloy wire core + polyester braided composite structure, which maintains shape memory function while increasing the surface endothelialization rate by 40%. The microporous titanium alloy structure of the connecting column 2 promotes local tissue endogenous growth; long-term follow-up data shows that the fiber coverage rate reaches 92%±5% at 6 months post-surgery.

[0033] For asymmetric bicuspid aortic valve disease, with a small correction angle (the angle between the fusion junction lines is ≥140°), the aortic valve can be corrected according to the "complete bisection" principle by implanting this annuloplasty ring and folding the valve margin, which brings hemodynamic benefits without significantly affecting the original valve annulus and excessive deformation and tension changes of the valve margin.

[0034] The bicuspid aortic valve implantable angioplasty ring provided by this utility model achieves a technological breakthrough in the field of bicuspid aortic valve repair through multi-dimensional innovations in morphological reconstruction, mechanical optimization, and surgical procedure improvement, and has significant clinical translational value.

[0035] In a preferred embodiment, the forming ring is wrapped with a fabric that facilitates sewing. Specifically, a double-layer densely woven polyester fabric (thickness 0.20±0.05mm) is wrapped around the outside of the forming ring, and the fabric is tightly bonded to the ring body through a hot-pressing process. Preferably, the polyester fabric is treated to resist calcification, forming a microporous structure of 10-20μm on the surface, and the sewing edges are reinforced with overlock stitching (linear density ≥8 stitches / cm). The coefficient of friction of the surface polyester fabric (μ=0.35±0.05) is optimally matched with the surgical suture (polypropylene suture), and the measured suture slippage force is ≥3.5N, which is 200% higher than that of a bare metal ring. The double-layer woven structure gives the ring a suture tear resistance of 45±5N / cm, ensuring no risk of fabric delamination during sewing.

[0036] In a preferred embodiment, the main body structure of the conjoint column 2 and the semi-annular body near the conjoint column 2 is a rigid ring "ring" with a titanium alloy internal framework. The semi-annular body structure converges towards the center along a downward arc to form the lower part of the three-dimensional annular structure arc, which is a soft band "band" without a titanium alloy internal framework. Using a soft band to construct the main body of the annular body can provide certain support and fixation to the aortic annulus itself, while also maintaining the aortic annulus's ability to deform in accordance with physiological conditions. In the early stage of cardiac systole, the aortic annulus expands under stress from the left ventricle to the aorta, and the leaflets open to facilitate blood ejection. During cardiac diastole, the aortic annulus contracts under stress from the aorta to the left ventricle, and the leaflets close while the sinus relatively expands to facilitate coronary blood supply. The soft material also ensures that the main body angle of the annulus can adapt to different degrees of deformation of the autologous annulus at 135°, so as to achieve better fit and fixation. The soft material retains a certain degree of elasticity after implantation, meeting the needs of subsequent interventional surgeries for the "in-circuit valve" in the whole life cycle management.

[0037] It should be noted that this angioplasty ring can be manufactured in different sizes, such as 19mm, 21mm, 23mm, and 25mm. In clinical use, a specialized measuring instrument is required to measure the patient's bivalve aortic sinus before selecting the appropriate angioplasty ring size. In this embodiment, the following size is selected: Figure 3 The measuring device shown includes a hemispherical body and a measuring rod vertically positioned in the middle of the hemispherical body. Specifically, the flat end of the hemispherical body is marked with a cross-diameter area of ​​a certain width (the effective measurement area). The measurement is completed in two steps: First, the hemispherical body is vertically inserted axially into the bicuspid aortic sinus without the fusion ridge. When the free edge of the leaflet without the fusion ridge is completely and wrinkle-free against the spherical arc of the hemispherical body, and the anatomical junction line of the bicuspid valve annulus falls exactly within the effective measurement area, the selected measuring device model is the reference size for selecting the annulus. Figure 3 As shown; the second step is to pass the measuring device of this model and the larger model perpendicularly through the bivalve aortic valve orifice along the axial direction. If the former can pass through easily or overcome a certain frictional force to pass through the valve orifice, while the latter cannot pass through the valve orifice, then the selected measuring device model is the correct size for selecting the angioplasty ring. Typically, six measuring device models are required, such as 19mm, 21mm, 23mm, 25mm, and 27mm.

[0038] To further illustrate the inventive concept of this angioplasty ring, the implantation method is as follows: The aortic valve angioplasty method is used. In the rigid angioplasty area, the ring is sutured with interrupted horizontal mattress pads using 2-0 braided sutures. The first needle enters below the aortic valve angioplasty ring, exits above the angioplasty ring, passes through one side of the angioplasty ring conjoint column 2 from bottom to top, then passes through the other symmetrical side of the angioplasty ring conjoint column 2 from top to bottom, and then enters again from the aortic valve angioplasty ring near the anatomical junction, exiting below the angioplasty ring, with an autologous pericardium or a bovine pericardial pad of appropriate size. The second needle is a horizontal mattress suture, slightly below the suture ring and the entry / exit point at the anatomical junction, passing through the autologous pericardium or a bovine pericardial pad of appropriate size again. The two needles are knotted and fixed below the suture ring, forming a fold in the anatomical junction area. In the soft angioplasty area, the ring is sutured with interrupted horizontal mattress pads using 3-0 braided sutures. The needle enters from the left ventricular side, exits from the aortic side, passes through the angioplasty ring suture ring, and the two needles are knotted and fixed on the suture ring. One stitch is sutured in each of the two hard annular areas; 4-5 stitches are evenly sutured in each of the two soft band areas, that is, the main body area of ​​the valve annulus on both sides, for a total of 10-12 stitches to fix and enclose the valve annulus.

[0039] This invention achieves the goal of annular contraction and fixation of the aortic valve while overcoming the technical difficulties, potential damage to surrounding tissues, and long surgical time associated with extra-annular aortic valve anastomosis. It also avoids the problems associated with aortic valve replacement, such as anticoagulation of the allogeneic implant, valve failure, and insufficient effective orifice area. Compared to subvalvular angioplasty, this method avoids potential risks such as conduction block, annular hemorrhage, and even damage to the mitral valve curtain or ventricular septum. The "soft and hard combination" design maintains the physiological activity of the aortic valve annulus during the cardiac cycle, ensuring an effective orifice area and preventing postoperative relative stenosis. While annularizing and fixing the bicuspid aortic valve annulus, this angioplasty also converges the aortic leaflets towards the center. Through leaflet folding technology, the annulus and leaflets are symmetrically "divided" into two parts, thereby increasing the effective height and occlusion height of the aortic leaflets and achieving satisfactory repair results.

[0040] The above are merely preferred embodiments of this utility model and do not limit the patent scope of this utility model. Any equivalent structural transformations made based on the inventive concept of this utility model and the contents of this utility model specification and drawings, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this utility model.

Claims

1. A bicuspid aortic valve implantable angioplasty ring, characterized in that, It includes two symmetrically arranged semi-circular ring bodies. The two ends of the two semi-circular ring bodies are connected by a joint post to form a saddle shape, and the joint post extends upward to a predetermined length and forms the highest point of this formed ring. Furthermore, at the connection point, the two semi-lobe ring bodies form a first preset angle, the semi-lobe ring bodies are made of flexible material, and the connecting column is made of rigid material.

2. The two-leaflet aortic endoprosthesis according to claim 1, characterized in that The outside of the forming ring is wrapped with fabric that facilitates sewing.

3. The two-leaflet aortic endoprosthesis according to claim 1 or 2, characterized in that The two connecting columns are inclined outwards respectively, and the axis of the connecting columns forms a second preset angle with the vertical plane.

4. The two-leaflet aortic endoprosthesis according to claim 1 or 2, characterized in that The first preset included angle is 130°~140°.

5. The bicuspid aortic valve implantable angioplasty ring according to claim 3, characterized in that, The second preset included angle is 3°~8°.

6. A bicuspid aortic valve implantable angioplasty ring according to claim 1 or 2, characterized in that, The preset length is 3mm to 8mm.

7. The two-leaflet aortic endoprosthesis according to one of claims 1 or 2, characterized in that The joint column is made of titanium alloy.

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