Mitral valve forming ring

Abstract

The invention discloses a mitral valve forming ring which is used for being sewn at the valve ring position, surrounding an anterior valve leaflet and a posterior valve leaflet, in a mitral valve. The mitral valve forming ring has a continuous peripheral shape surrounding the center hole, the mitral valve forming ring comprises a front section and a rear section which are oppositely arranged, and a pair of junction narrowing sections located at the junction of the front section and the rear section, and the junction narrowing sections are locally arranged in the circumferential direction of the mitral valve forming ring in an outward protruding mode; the junction narrowing section can enable the junction area to be narrowed so as to increase the involution area of the anterior valve leaflet and the posterior valve leaflet in the junction area. According to the mitral valve forming ring, regurgitation of a junction area is accurately restrained through a differential strengthening structure, and the postoperative residual regurgitation rate is reduced; the limitation that an existing product is single in indication is broken through, clinical coverage of all disease causes and multiple disease types can be achieved, and the method is suitable for repairing various complex mitral valve lesions; the bionic physiological structure design is optimized, the biocompatibility and the long-term stability after implantation are improved, postoperative complications are reduced, and the prognosis of patients is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an artificial mitral valve repair ring for heart valve repair, and more particularly to a modified mitral valve repair ring that can effectively reduce mitral commissural regurgitation and is suitable for repairing mitral regurgitation caused by various etiologies. This technology is typically applied to the repair of rheumatic mitral valve disease, and is also applicable to most clinical scenarios requiring mitral valve repair, falling within the scope of cardiovascular surgical implantable medical device technology. Background Technology

[0002] Mitral regurgitation is a common valvular heart disease that can be caused by a variety of factors, including rheumatic heart valve disease, degenerative mitral valve disease, ischemic mitral regurgitation, functional mitral regurgitation, congenital mitral valve malformation, traumatic mitral valve injury, and mixed valvular diseases. Among these, rheumatic mitral valve disease is the most common type of disease in clinical practice in China. This type of disease is often accompanied by annular dilation, leaflet thickening and contracture, and incomplete separation of commissural adhesions, which in turn induces commissural-specific regurgitation. Mitral regurgitation caused by other factors also often involves problems such as destruction of the physiological structure of the annulus, poor leaflet occlusion, and widening of commissural separation, all of which can easily lead to significant valvular regurgitation, affecting cardiac function, and in severe cases, can lead to serious complications such as heart failure and arrhythmia, endangering the patient's life.

[0003] Currently, the mainstream annular products used clinically for mitral valve repair mainly include traditional semi-rigid, flexible, or saddle-shaped annular products from manufacturers such as Edwards, Medtronic, and Abbott (Solin). Although these products can achieve the basic effects of conventional annular reduction and improved leaflet occlusion, they generally have significant technical defects: most existing products are designed with uniform overall stiffness or conventional anterior and posterior annular stiffness partitioning, without specific mechanical optimization and structural reinforcement for the two key high-incidence areas of regurgitation at the anterior-external commissure and posteromedial commissure of the mitral valve. They cannot accurately constrain abnormal separation of the commissure zone or compensate for the gap in leaflet occlusion at the commissure zone. The control effect on commissural regurgitation is poor, especially for patients with rheumatic mitral valve disease with abnormal commissural structure, degenerative lesions with commissural dilatation, and ischemic functional regurgitation with commissural displacement. The incidence of residual commissural regurgitation after surgery is high, affecting the long-term prognosis of the surgery.

[0004] Therefore, the need to design a mitral valve repair ring that can specifically address junctional regurgitation while covering all disease indications has become a pressing technical problem in clinical practice. Summary of the Invention

[0005] To address the aforementioned deficiencies in existing technologies, the present invention aims to provide a mitral valve annuloplasty ring that can effectively reduce mitral valve commissural regurgitation. This invention addresses the technical problems of existing annuloplasty rings in mitral valve repair surgery, including poor control of commissural regurgitation, limited applicability to specific diseases, and inability to adapt to complex clinical cases. Through specific structural optimization, the invention achieves the technical effects of annular physiological morphology reshaping, precise leaflet alignment, and effective suppression of commissural regurgitation, making it suitable for mitral valve annuloplasty rings used in the repair of mitral regurgitation caused by various etiologies.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: A mitral valve annuloplasty ring is disclosed for suturing in the mitral valve at the annulus position surrounding the anterior and posterior leaflets. The mitral valve annuloplasty ring has a continuous peripheral shape surrounding a central orifice. It includes an anterior and posterior segments disposed opposite each other, and a pair of junctional narrowing segments located at the junction of the anterior and posterior segments. The radius of curvature of the anterior segment is greater than that of the posterior segment. The junctional narrowing segments are partially convex outward in the circumferential direction of the mitral valve annuloplasty ring. When the mitral valve annuloplasty ring is suturing to the annulus of the mitral valve, the junctional narrowing segments are positioned corresponding to the junctional area where the anterior and posterior leaflets meet on both sides of the annulus. The junctional narrowing segments narrow the junctional area to increase the contact area between the anterior and posterior leaflets near the junctional area.

[0007] Furthermore, a V-shaped angled region is formed on the inner side of the narrowed boundary section.

[0008] Further, the axial direction extending between the two said junctional narrowing segments and passing through the vertices of the two said included angle regions is defined as the BB axis direction; the center point of the line segment connecting the vertices of the two said included angle regions is defined as point O; the axial direction extending between the front segment and the rear segment, perpendicular to the BB axis direction and passing through point O is defined as the AP axis direction; the dimension of the mitral valve annuloplasty ring in the BB axis direction is L1, and the dimension of the mitral valve annuloplasty ring in the AP axis direction is L2; ​​satisfying: 0.63≤L2 / L1≤0.67.

[0009] Furthermore, the dimension L1 of the mitral valve shaping ring in the BB axis direction satisfies: 24mm≤L1≤40mm.

[0010] Furthermore, the dimension L1 of the mitral valve shaping ring in the BB axis direction and the dimension L2 in the AP axis direction can be any of the following schemes: L1 is 24mm, and L2 is 16.0mm; L1 is 26mm, and L2 is 17.3mm; L1 is 28mm, and L2 is 18.7mm; L1 is 30mm, and L2 is 20.0mm; L1 is 32mm, and L2 is 21.3mm; L1 is 34mm, and L2 is 22.7mm; L1 is 36mm, and L2 is 24.0mm; L1 is 38mm, and L2 is 25.3mm; L1 is 40mm and L2 is 26.7mm.

[0011] Furthermore, the boundary narrowing segment includes a first segment and a second segment that respectively form two sides of the included angle region. The inner side of the connection between the first segment and the second segment is the vertex of the included angle region. One end of the first segment is integrally connected to the front segment, and the other end of the second segment is integrally connected to the rear segment. The length L3 of the first segment satisfies: 2mm≤L3≤6mm.

[0012] Furthermore, the length L3 of the first segment is positively correlated with the dimension L1 of the mitral valve angioplasty ring in the BB axis direction.

[0013] Furthermore, in the plan view of the mitral valve angioplasty ring, the anterior segment is an approximately straight line with a first preset curvature, the radius of curvature of the first preset curvature being greater than 3 times the dimension L1 of the mitral valve angioplasty ring in the BB axis direction; the posterior segment is an approximately elliptical arc with a second preset curvature, the radius of curvature of the second preset curvature being 0.6-0.9 times the dimension of the mitral valve angioplasty ring in the BB axis direction.

[0014] Furthermore, the flexibility of the rear segment is greater than that of the front segment.

[0015] Furthermore, when the junctional narrowing segment of the mitral valve annuloplasty ring is sutured to the junctional region of the mitral valve, the tissue in the junctional region is stretched and deformed under the force of the junctional narrowing segment maintaining its own shape, thereby narrowing the distance between the portions of the anterior leaflet and the posterior leaflet that are close to the junctional region.

[0016] The technical solution of this invention has the following advantages: 1. The mitral valve annuloplasty ring provided by the present invention, by setting a locally outwardly protruding commissural narrowing segment at a pair of junctions between the anterior and posterior segments, when the mitral valve annuloplasty ring is sutured to the mitral valve annulus, the commissural narrowing segment will be sutured to the corresponding commissural area of ​​the annulus. After the commissural narrowing segment is sutured, the commissural area at the junction of the anterior and posterior leaflets can be automatically narrowed, realizing the physiological morphological reshaping of the annulus. This allows the anterior and posterior leaflets to better mate near the commissural area, increasing the commissural area and reducing residual regurgitation caused by commissural area defects or incision of the commissural area. This significantly reduces residual regurgitation and can effectively reduce mitral valve commissural regurgitation and cover the annuloplasty and repair needs of mitral valve regurgitation caused by various etiologies. Compared to existing technologies where surgeons manually suture the gaps in the leaflet alignment near the commissure after the angioplasty ring is implanted, this method addresses the commissure area through the design of the angioplasty ring's own structure. This enhances the alignment area and height of the leaflets in the commissure area, transforming the surgeon's experience-based suturing into a standardized fixation design. This reduces the need for additional suturing or repair during surgery, shortens the operation time, and minimizes the impact of surgeon experience differences on the repair outcome.

[0017] 2. The mitral valve annuloplasty ring provided by this invention, by designing the size of the mitral valve annuloplasty ring to be 0.63≤L2 / L1≤0.67, has a smaller L2 size compared to the annuloplasty rings with the same L1 size in the prior art. This is equivalent to reducing the distance between the anterior and posterior segments. While maintaining the central hole area of ​​the mitral valve annuloplasty ring without significantly reducing it, the three-dimensional geometry of the valve is optimized, and the occlusion height when the anterior and posterior leaflets occlude is increased. This can significantly reduce the incidence of residual regurgitation, making the repaired valve function more stable, and the long-term efficacy is superior to that of repair annuloplasty rings of existing sizes.

[0018] In summary, the core objectives of this invention are: first, to overcome the shortcomings of existing annuloplasty rings, such as insufficient support in the junctional region and poor regurgitation control, by precisely suppressing junctional regurgitation through a differentiated strengthening structure, thereby reducing the postoperative residual regurgitation rate; second, to break through the limitation of existing products having only one indication, taking rheumatic mitral valve repair as an example, to achieve clinical coverage of all etiologies and multiple diseases, and to adapt to the repair of various complex mitral valve lesions; and third, to optimize the physiologically mimicking structural design, improve post-implantation biocompatibility and long-term stability, reduce postoperative complications, and improve patient prognosis. Attached Figure Description

[0019] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0020] Figure 1a This is a schematic diagram of a normal mitral valve during systole and diastole. Figure 1b This is a schematic diagram of a normal mitral valve during diastole. Figure 1c This is a schematic diagram of the mitral valve during systole in patients with rheumatic diseases. Figure 1d This is a schematic diagram of the mitral valve in diastole during a rheumatic disease. Figure 1e A schematic diagram illustrating the cutting and implantation of an annuloplasty ring in the mitral valve commissure region for rheumatic lesions using existing techniques. Figure 2 This is a schematic diagram of the mitral valve repair ring in an embodiment of the present invention; Figure 3 This is a schematic diagram showing the dimensions of the mitral valve repair ring in the AP axis direction and the BB axis direction in an embodiment of the present invention; Figure 4 This is a schematic diagram showing the dimensions of the first segment of the junctional narrowing section in the mitral valve annuloplasty ring in an embodiment of the present invention; Figure 5 This is a schematic diagram of cutting open the leaflet tissue of the mitral valve commissure region in a rheumatic disease and implanting a mitral valve annuloplasty ring in an embodiment of the present invention.

[0021] Explanation of reference numerals in the attached figures: 11. Valve annulus; 12. Anterior leaflet; 13. Posterior leaflet; 14. Anterior commissure zone; 15. Posterior commissure zone; 16. Valve orifice; 17. Leaflet fusion zone; 18. Leaflet incomplete closure zone; 200a. Forming ring; 200. Mitral valve forming ring; 210. Anterior segment; 220. Posterior segment; 230. Commissural narrowing segment; 231. First segment; 232. Second segment. Detailed Implementation

[0022] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0023] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0024] This embodiment uses clinical repair of a patient with rheumatic mitral regurgitation as a specific application example to illustrate the structure, usage, and technical effects of the mitral valve annuloplasty ring of the present invention. The embodiment described is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any non-creative modifications or equivalent substitutions made to the structure based on the core technical concept of the present invention are within the protection scope of the present invention. The application scenarios, indications, and technical effects of the annuloplasty ring of the present invention are also applicable to various types of mitral regurgitation cases, such as degenerative, ischemic, functional, and congenital mitral regurgitation, as described in this specification. In clinical application, the corresponding specification of the annuloplasty ring product can be selected according to parameters such as patient age, lesion type, annulus size, and regurgitation location.

[0025] Figure 1a This is a schematic diagram of a normal mitral valve during systole and diastole. Figure 1b This is a schematic diagram of a normal mitral valve during diastole. Figure 1c This is a schematic diagram of the mitral valve during systole in patients with rheumatic diseases. Figure 1d This is a schematic diagram of the mitral valve in diastole during a rheumatic disease. Based on the above... Figures 1a to 1d It is known that the main characteristics of the mitral valve in rheumatic disease are: deformation of the valve annulus 11, fusion of the anterior leaflet 12 and posterior leaflet 13 at the anterior commissure 14 and posterior commissure 15, and a reduced valve orifice 16 area, resulting in incomplete closure of the valve orifice 16 during mitral valve systole. In the repair surgery of the mitral valve in rheumatic disease, it is necessary to first open... Figure 1c and Figure 1d The leaflet junction fusion zone 17 shown is used to restore the area of ​​the valve orifice 16, and then the forming ring is sutured and fixed at the valve annulus 11 position to repair the shape of the valve annulus 11.

[0026] Clinical practice shows that even if mitral valve repair surgery for rheumatic diseases successfully relieves the stenosis, approximately 18-41% of patients will still have a high probability of mild residual regurgitation, far exceeding the 4-10% in degenerative mitral valve repair. This residual regurgitation is mostly concentrated in the junctional area where the anterior leaflet 12 and posterior leaflet 13 meet on both sides of the annulus 11, i.e. Figure 1e The diagram illustrates the incomplete closure zone 18 at the leaflet junction. The main reason is that after the leaflet tissue in the leaflet junction fusion zone 17 is cut, defects appear; insufficient alignment of the anterior leaflet 12 and posterior leaflet 13 results in a gap; or the alignment height of the anterior leaflet 12 and posterior leaflet 13 at the cut location is too low. Figure 1eAs shown, in the prior art, surgeons often rely on experience to select a smaller annuloplasty ring 200a to increase the occlusion height. Simultaneously, in the incomplete closure area 18 at the leaflet junction, they use sutures for highly subjective narrowing treatment. This results in low standardization and unstable postoperative outcomes in mitral valve repair surgery for rheumatic diseases. To address these problems, this application provides a mitral valve annuloplasty ring for mitral valve repair surgery, used for suturing at the annulus position surrounding the anterior and posterior leaflets of the mitral valve.

[0027] like Figures 2 to 5 As shown, the mitral valve annuloplasty ring 200 has a continuous peripheral shape surrounding a central aperture. The mitral valve annuloplasty ring 200 includes an anterior segment 210, a posterior segment 220, and a pair of junctional narrowing segments 230. The anterior segment 210 and the posterior segment 220 are disposed opposite to each other, and the junctional narrowing segment 230 is integrally connected to the junction of the anterior segment 210 and the posterior segment 220. The anterior segment 210 has an approximately straight shape similar to the root of the anterior leaflet 12, and the posterior segment 220 has an approximately elliptical arc shape similar to the root of the posterior leaflet 13. The radius of curvature of the anterior segment 210 is larger than that of the posterior segment 220. The junctional narrowing segment 230 is partially convex outward in the circumferential direction of the mitral valve annuloplasty ring 200, forming an approximately V-shaped angled region on its inner side. The flexibility of the posterior segment 220 is greater than that of the anterior segment 210. When the mitral valve annuloplasty ring 200 is sutured to the mitral valve annulus 11, a pair of commissural narrowing segments 230 are positioned at the commissural area where the anterior leaflet 12 and posterior leaflet 13 meet on both sides of the annulus 11. The commissural narrowing segments 230 narrow the mitral valve commissural area to a more concentric position, meaning the concentric line between the anterior leaflet 12 and posterior leaflet 13 becomes longer. The actual effect is to make the commissural area of ​​the mitral valve more concentric. Figure 1e At position 18, where the closure of the middle leaflet junction is incomplete, the anterior leaflet 12 and posterior leaflet 13, which originally had a gap, mate. The state of the anterior leaflet 12 and posterior leaflet 13 after mates near the junction is as follows... Figure 5 As shown, from Figure 5 and Figure 1e The comparison clearly shows that the anterior leaflet 12 and posterior leaflet 13 have significantly better alignment at the positions of the anterior commissure zone 14 and posterior commissure zone 15. When the commissural narrowing segment 230 of the mitral valve annuloplasty ring 200 is sutured to the anterior commissure zone 14 and posterior commissure zone 15 of the mitral valve, the tissues of the anterior commissure zone 14 and posterior commissure zone 15 are stretched and deformed under the force of the commissural narrowing segment 230 maintaining its own shape, so that the narrowing of the portions of the anterior leaflet 12 and posterior leaflet 13 near the commissure zone is aligned.

[0028] By setting a pair of locally protruding commissural narrowing segments 230 at the anterior commissural region 14 and posterior commissural region 15 of the anterior segment 210 and posterior segment 220, when the mitral valve annuloplasty ring 200 is sutured to the mitral valve annulus 11, the commissural narrowing segments 230 will be sutured at the positions corresponding to the anterior commissural region 14 or posterior commissural region 15 of the annulus 11. After suturing, the commissural narrowing segments 230 can automatically narrow the commissural region at the junction of the anterior leaflet 12 and the posterior leaflet 13, thereby achieving physiological morphological reshaping of the annulus. This increases the contact area between the anterior leaflet 12 and the posterior leaflet 13 near the commissural region, reducing residual regurgitation caused by commissural region defects or incision of the commissural region, and significantly reducing residual regurgitation. This can effectively reduce mitral valve commissural regurgitation and cover the annuloplasty and repair needs of mitral valve regurgitation caused by various etiologies. Compared to existing technologies where surgeons manually suture the gaps in the leaflet alignment near the commissure after the angioplasty ring is implanted, the commissure alignment is achieved through the design of the mitral valve angioplasty ring 200 itself. This significantly enhances the alignment area and height of the leaflets in the commissure area, transforms the surgeon's experience-based suturing into a standardized fixation design, reduces the need for additional suturing or repair during surgery, shortens the operation time, and reduces the impact of surgeon experience differences on the repair outcome.

[0029] like Figure 3 As shown, the axial direction extending between the two constricted segments 230 and passing through the vertices of the two included angle regions is defined as the BB axis direction. The center point of the line segment connecting the vertices of the two included angle regions is defined as point O. The axial direction extending between the front segment 210 and the rear segment 220, perpendicular to the BB axis direction and passing through point O, is defined as the AP axis direction. The dimension of the mitral valve annuloplasty ring 200 in the BB axis direction is L1, satisfying 24mm≤L1≤40mm. The dimension of the mitral valve annuloplasty ring 200 in the AP axis direction is L2, satisfying: 0.63≤L2 / L1≤0.67. Compared to existing annuloplasty rings with the same dimensions in the BB axis direction (width direction), this size of mitral valve annuloplasty ring 200 has a smaller dimension L2 in the AP axis direction, which is equivalent to reducing the distance between the anterior segment 210 and the posterior segment 220. While maintaining the central hole area of ​​the mitral valve annuloplasty ring 200 without significantly reducing it, it optimizes the three-dimensional geometry of the valve and increases the occlusion height of the anterior leaflet 12 and the posterior leaflet 13. This can significantly reduce the incidence of residual regurgitation, making the repaired valve function more stable and providing better long-term efficacy than existing annuloplasty rings.

[0030] In some specific embodiments, the dimensions L1 of the mitral valve annuloplasty ring 200 in the BB axis direction and L2 in the AP axis direction can be any of the options shown in Table 1 below. Table 1:

[0031] like Figure 3 and Figure 4As shown, the junctional narrowing segment 230 includes a first segment 231 and a second segment 232 that form two sides of the included angle region. The inner side of the connection between the first segment 231 and the second segment 232 is the vertex of the included angle region. One end of the first segment 231 is integrally connected to the front segment 210, and the other end of the second segment 232 is integrally connected to the rear segment 220. The length L3 of the first segment 231 satisfies: 2mm ≤ L3 ≤ 6mm. The length L3 of the first segment 231 is positively correlated with the dimension L1 of the mitral valve annuloplasty ring 200 in the BB axis direction.

[0032] In the plan view of the mitral valve annuloplasty ring 200, the anterior segment 210 has an approximately straight line shape with a first preset curvature, the radius of curvature of the first preset curvature is greater than 3 times the dimension L1 of the mitral valve annuloplasty ring 200 in the BB axis direction; the posterior segment 220 has an approximately elliptical arc shape with a second preset curvature, the radius of curvature of the second preset curvature is 0.6-0.9 times the dimension L1 of the mitral valve annuloplasty ring 200 in the BB axis direction.

[0033] This type of annuloplasty ring, which is a closed annuloplasty ring without an opening, has the following advantages: 1. It is applicable to a wide range of lesions, including lesions in both anterior and posterior valves, severe calcification of the valve annulus, and severe abnormalities in valve annulus morphology (such as congenital valve annulus malformation); 2. It can completely cover the valve annulus, while correcting overall valve annulus dilation, abnormal ellipticity (such as nearly circular diseased valve annulus), and asymmetry between the anterior and posterior valve annulus. After repair, the valve annulus morphology is closer to the physiological state, reducing the risk of long-term regurgitation; 3. The closed annuloplasty ring has higher long-term stability and can effectively limit postoperative valve annulus dilation. Its disadvantages are: the anterior segment covers the anterior valve annulus, which will slightly compress the anterior valve leaflet, resulting in narrowing of the left ventricular outflow tract space. For patients with a small left ventricular cavity and a small anterior valve leaflet area, the incidence of postoperative obstruction is relatively high. The surgical procedure is relatively more complicated: the two commissural narrowing segments 230 of the mitral valve annuloplasty ring 200 need to be precisely aligned with the anterior commissural region 14 and the posterior commissural region 15 of the valve annulus, which requires slightly higher surgeon skills than the annuloplasty ring with an opening in the anterior segment 210.

[0034] The mitral valve repair ring described in this invention is used as a typical example of repairing regurgitation caused by rheumatic mitral valve disease. It is particularly suitable for repair surgery of leaflet contracture, junctional adhesion / separation abnormalities, and junctional regurgitation caused by rheumatic heart disease. However, the indications are by no means limited to rheumatic diseases. The clinical application scope comprehensively covers mitral regurgitation caused by the following etiologies: Degenerative mitral regurgitation includes conditions such as Barlow syndrome, chordae tendineae rupture or elongation, leaflet prolapse, and simple annular dilatation. Ischemic mitral regurgitation: functional annular dilation and regurgitation caused by myocardial ischemia, left ventricular remodeling after myocardial infarction, and papillary muscle dysfunction; Functional mitral regurgitation: heart failure, atrial fibrillation, secondary annular dilatation due to left ventricular enlargement, and leaflet malalignment; Congenital mitral valve malformation: mitral regurgitation caused by congenital abnormalities in the valve annulus, leaflet defects, or commissural hypoplasia; Other secondary mitral valve diseases include: traumatic valve injury, annular dilatation and regurgitation after recovery from infective endocarditis (inactive period), and mixed valvular diseases.

[0035] This product is suitable for various adult and adolescent patients who do not require valve replacement and can preserve their own mitral valve through annulus repair. It is suitable for repair surgery of mild, moderate and severe mitral regurgitation.

[0036] In summary, the mitral valve repair ring provided by this invention has the following outstanding beneficial effects compared to existing traditional mitral valve repair rings, and the effects can cover all indications. The significant effect is verified by taking rheumatic mitral valve repair as an example, and the same principle applies to other diseases: 1. Significantly reduces residual regurgitation: After traditional mitral valve repair surgery, approximately 30% of patients experience mild regurgitation, mainly concentrated in the commissural region of the mitral valve. This approach, by reducing the size of the mitral annuloplasty ring 200 along the AP axis, can increase the occlusal height of a pair of leaflets. Furthermore, by narrowing the commissural region through the commissural stenosis segment 230, the occlusal height of the leaflets in the commissural region is increased, compensating for the leaflet occlusal gap. Theoretically, this can significantly reduce the incidence of residual regurgitation. Compared to conventional annuloplasty rings, this approach can significantly reduce commissural regurgitation caused by various diseases such as rheumatic, degenerative, and ischemic lesions, and is especially suitable for complex cases of rheumatic mitral valve disease with abnormal commissural structures.

[0037] 2. Comprehensive indication coverage with no disease limitations: Taking rheumatic mitral valve repair as a typical example, it is also compatible with all common clinical causes of mitral regurgitation, such as degenerative, ischemic, functional, and congenital mitral regurgitation. There is no need to change products according to the cause, adapting to various complex clinical cases, greatly expanding the scope of clinical application, and solving the pain point of existing products having only one applicable disease.

[0038] 3. Strong clinical adaptability and convenient operation: Standardized junctional zone positioning marks are set to facilitate rapid and accurate positioning during surgery. It is compatible with various surgical methods such as open-chest surgery, minimally invasive surgery, and robotic surgery. The suturing and fixation method is consistent with conventional angioplasty rings, so there is no need to change the surgeon's surgical habits, making it easy to promote and apply in clinical practice.

[0039] 4. Improved repair durability: Residual regurgitation is an important risk factor for long-term valve function and reoperation; this approach optimizes the occlusion height and commissural occlusion, making the repaired valve function more stable and the long-term efficacy superior to existing repair annuloplasty rings.

[0040] 5. Improve the standardization and repeatability of mitral valve repair surgery: Current mitral valve repair surgery relies on the surgeon's personal experience, resulting in significant differences in the suture method of the commissure zone and the selection of the annuloplasty ring; this approach directly solidifies the commissure zone narrowing effect in the structure of the mitral valve annuloplasty ring 200, ensuring stable commissure zone alignment, reducing surgeon subjectivity, and improving repeatability among different hospitals and doctors.

[0041] 6. Optimize valve geometry while maintaining valve orifice area: By reducing the size of the mitral valve annuloplasty ring 200 in the AP axis direction, the lateral width of the mitral valve annuloplasty ring 200 is maintained. This ensures that the valve orifice area is not significantly reduced, thus avoiding aggravation of stenosis, while also optimizing the three-dimensional geometry of the valve, which is consistent with the pathological characteristics of rheumatic diseases.

[0042] 7. Simplified intraoperative procedures: This approach utilizes the inherent structural design of the mitral valve annuloplasty ring 200 to treat the commissural area, reducing additional suturing or repair steps during the operation, shortening the operation time, and lowering the risk of failure due to lack of experience.

[0043] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A mitral valve annuloplasty ring (200) for suturing at the position of the valve annulus (11) surrounding the anterior leaflet (12) and posterior leaflet (13) in the mitral valve; characterized in that, The mitral valve annuloplasty ring (200) has a continuous peripheral shape surrounding a central hole. The mitral valve annuloplasty ring (200) includes a front section (210) and a rear section (220) disposed opposite to each other, and a pair of junctional narrowing sections (230) located at the junction of the front section (210) and the rear section (220). The radius of curvature of the front section (210) is larger than the radius of curvature of the rear section (220). The junctional narrowing sections (230) are partially convex outward in the circumferential direction of the mitral valve annuloplasty ring (200). When the mitral valve annuloplasty ring (200) is sutured to the mitral valve annulus (11), the junctional narrowing section (230) is provided at the junctional area where the anterior leaflet (12) and the posterior leaflet (13) meet on both sides of the annulus (11). The junctional narrowing section (230) can narrow the junctional area to increase the contact area of ​​the anterior leaflet (12) and the posterior leaflet (13) near the junctional area.

2. The mitral valve angioplasty ring according to claim 1, characterized in that, The inner side of the narrowed boundary section (230) forms a V-shaped angled region.

3. The mitral valve angioplasty ring according to claim 2, characterized in that, The axial direction extending between the two junctional narrowing segments (230) and passing through the vertices of the two included angle regions is defined as the BB axis direction; the center point of the line segment connecting the vertices of the two included angle regions is defined as point O; the axial direction extending between the front segment (210) and the rear segment (220) perpendicular to the BB axis direction and passing through point O is defined as the AP axis direction; the dimension of the mitral valve annuloplasty ring (200) in the BB axis direction is L1, and the dimension of the mitral valve annuloplasty ring (200) in the AP axis direction is L2; It satisfies: 0.63≤L2 / L1≤0.

67.

4. The mitral valve angioplasty ring according to claim 3, characterized in that, The mitral valve shaping ring (200) has a dimension L1 in the BB axis direction that satisfies: 24mm≤L1≤40mm.

5. The mitral valve angioplasty ring according to claim 4, characterized in that, The mitral valve annuloplasty ring (200) can have a dimension L1 in the BB axis direction and a dimension L2 in the AP axis direction, which can be any of the following: L1 is 24mm, and L2 is 16.0mm; L1 is 26mm, and L2 is 17.3mm; L1 is 28mm, and L2 is 18.7mm; L1 is 30mm, and L2 is 20.0mm; L1 is 32mm, and L2 is 21.3mm; L1 is 34mm, and L2 is 22.7mm; L1 is 36mm, and L2 is 24.0mm; L1 is 38mm, and L2 is 25.3mm; L1 is 40mm and L2 is 26.7mm.

6. The mitral valve angioplasty ring according to claim 3, characterized in that, The narrowing section (230) includes a first segment (231) and a second segment (232) that form the two sides of the included angle region. The inner side of the connection between the first segment (231) and the second segment (232) is the vertex of the included angle region. One end of the first segment (231) is integrally connected to the front segment (210), and the other end of the second segment (232) is integrally connected to the rear segment (220). The length L3 of the first segment (231) satisfies: 2mm≤L3≤6mm.

7. The mitral valve angioplasty ring according to claim 6, characterized in that, The length L3 of the first segment (231) is positively correlated with the dimension L1 of the mitral valve annuloplasty ring (200) in the BB axis direction.

8. The mitral valve angioplasty ring according to claim 3, characterized in that, In the plan view of the mitral valve angioplasty ring (200), the front section (210) has an approximately straight shape with a first preset curvature, the radius of curvature of the first preset curvature being greater than 3 times the dimension L1 of the mitral valve angioplasty ring (200) in the BB axis direction; the rear section (220) has an approximately elliptical arc shape with a second preset curvature, the radius of curvature of the second preset curvature being 0.6-0.9 times the dimension of the mitral valve angioplasty ring (200) in the BB axis direction.

9. The mitral valve angioplasty ring according to claim 1, characterized in that, The flexibility of the rear section (220) is greater than that of the front section (210).

10. The mitral valve angioplasty ring according to claim 1, characterized in that, When the junctional narrowing segment (230) of the mitral valve annuloplasty ring (200) is sutured to the junctional region of the mitral valve, the tissue in the junctional region is stretched and deformed under the force of the junctional narrowing segment (230) maintaining its own shape, so that the distance between the anterior leaflet (12) and the posterior leaflet (13) near the junctional region is narrowed.

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