Valvuloplasty ring

Abstract

The invention discloses an annuloplasty ring which comprises a main body ring and an outer layer body, and the outer layer body wraps the periphery of the main body ring. The main body ring is a closed ring body formed by matching a front ring section, a rear ring section, a left ring section and a right ring section, the softness of the front ring section and the rear ring section is smaller than that of the left ring section and that of the right ring section, and the softness of the rear ring section is larger than that of the front ring section; the left ring section and the right ring section each comprise a plurality of connecting pieces arranged in sequence, at least two adjacent connecting pieces are movably connected, a movable gap exists in the connecting position, and the connecting pieces can be driven to stretch out and draw back in the perimeter direction of the main body ring relative to the other adjacent connecting piece so as to change the perimeter of the main body ring. And the connecting piece is driven to rotate relative to the other adjacent connecting piece so as to drive the main body ring to deform in the circumferential direction and the axial direction of the main body ring. On one hand, the annuloplasty ring can provide proper strength and prevent the annuloplasty ring from expanding, and on the other hand, the annuloplasty ring has proper flexibility and can adapt to the physiological change curvature of a heart valve in the systolic-diastolic-systolic movement process.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a valvuloplasty ring. Background Art

[0002] During the systolic and diastolic cycles of the heart, blood flows in one direction through four heart valves: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. When the mitral and tricuspid valves are closed, the aortic and pulmonary valves open, and the blood in the left ventricle flows into the aorta, preventing the blood in the ventricle from flowing back to the atrium. Therefore, the mitral and tricuspid valves act as one-way valves. Taking the mitral valve as an example, when the mitral valve is diseased, the leaflets cannot close completely normally, and the valve ring expands, which will cause blood to flow back from the left ventricle to the left atrium. Mitral regurgitation may reduce cardiac output and ejection fraction, thereby significantly increasing the left ventricular end-diastolic volume and pressure. Patients may develop pulmonary hypertension and heart failure, eventually leading to death.

[0003] A common treatment for mitral regurgitation is valvuloplasty. Under extracorporeal circulation, surgeons repair the damaged heart valve morphology and correct the enlarged valve ring to treat mitral regurgitation. In order to maintain long-term treatment effects, after valvuloplasty, surgeons often implant an artificial valvuloplasty ring in the patient's valve ring position to ensure good shaping of the autologous valve ring and prevent the valve ring from further expanding to maintain the treatment effect.

[0004] Currently, the plasty rings available in clinical practice mainly include soft rings, hard rings and semi-hard rings.

[0005] Soft rings are often made of polymer materials, which are too soft and not conducive to the effective closure of the valve leaflets and the shaping of the valve ring. They cannot effectively restore the physiological structure of the heart valve and there is also the problem of re-expansion in the long term.

[0006] Hard rings are mostly made of metal and have good ring support strength. However, during the opening and closing of the mitral valve leaflets, the physiological curvature of the valve ring changes accordingly. Currently, the appearance design of some products tends to be in a three-dimensional saddle shape that conforms to the physiological curvature, but the hard ring is not easy to bend and cannot realize the change of the physiological curvature of the valve ring during the cardiac cycle.

[0007] The semi-rigid ring body can be rigidly adjusted to maintain a certain support strength while satisfying a certain degree of curvature change between the front ring and the back ring. From the perspective of design concept, the semi-rigid ring compromises the product characteristics of the soft ring and the hard ring, which can prevent long-term re-expansion while maintaining a certain physiological curvature. At present, the semi-rigid ring mainly adopts a metal ring body structure, and the purpose of adjustable hardness is achieved by adding or removing materials in certain parts. This design seems to meet the requirements of "ring body support strength" and "good adaptation to physiological curvature", but in fact it needs to strike a balance between the above two characteristics. If the support strength is guaranteed, the ring body cannot be designed to be too soft. When the mitral valve ring contracts, the hardness of the ring body produces a certain reverse obstruction. Therefore, this design sacrifices the adaptability of physiological curvature to a certain extent.

[0008] In summary, as a repair device, the annuloplasty ring needs to have two basic properties at the same time:

[0009] The ring body provides sufficient strength to prevent the annulus from expanding;

[0010] The ring is flexible enough to adapt to the physiological curvature during contraction.

[0011] Obviously, it is difficult to achieve the optimal effect by achieving two contradictory goals through the characteristics of the material itself. Summary of the invention

[0012] The object of the present invention is to provide an annuloplasty ring which can provide suitable strength to prevent the annulus from expanding, and has suitable flexibility to adapt to the physiological curvature during contraction.

[0013] The above-mentioned purpose is achieved by the following technical solutions.

[0014] A valvuloplasty ring, comprising a main body ring and an outer layer body, wherein the outer layer body is coated on the outer circumference of the main body ring;

[0015] The main body ring is a closed ring body formed by the cooperation of a front ring segment, a rear ring segment, a left ring segment and a right ring segment. The softness of the front ring segment and the rear ring segment is less than that of the left ring segment and the right ring segment, and the softness of the rear ring segment is greater than that of the front ring segment. The left ring segment and the right ring segment each include a plurality of connecting parts arranged in sequence, at least two adjacent connecting parts are movably connected and there is a movable gap at the connection, the connecting part can be extended and retracted relative to another adjacent connecting part along the circumference direction of the main body ring to change the circumference of the main body ring, and the connecting part can be rotated relative to another adjacent connecting part to drive the main body ring to deform along its own circumferential and axial directions.

[0016] In some embodiments, the left ring segment and the right ring segment each include a main body segment and two transition segments, the two transition segments are arranged at opposite ends of the main body segment and are respectively connected to the front ring segment and the rear ring segment; the main body segment includes at least two connecting parts, the transition segment includes at least one connecting part, and the overall deformation amplitude of the transition segment is smaller than the overall deformation amplitude of the main body segment.

[0017] In some embodiments, the deformation angle range of two adjacent connecting members in the transition section is 1° to 5°, and the overall deformation angle range of the transition section is 0° to 25°;

[0018] The deformation angle range of two adjacent connecting members in the main body section is 1° to 5°, and the overall deformation angle range of the main body section is 0° to 30°.

[0019] In some embodiments, the connecting member is provided with a first matching portion and a second matching portion at opposite ends, and two adjacent connecting members are movably connected via the first matching portion of the preceding connecting member and the second matching portion of the succeeding connecting member, and a movable gap exists at the connection.

[0020] In some embodiments, the spacing distance between two adjacent connecting parts of the main section is smaller than the spacing distance between two adjacent connecting parts of the transition section; the first matching part and the second matching part are arranged in plurality along the circumferential direction of the connecting part, and the number of the first matching part and the second matching part of the connecting part in the main section is greater than the number of the first matching part and the second matching part of the connecting part in the transition section.

[0021] In some embodiments, the first matching portion is a plug-in slot that is recessed inward to form a concave arc petal shape, and the width of the slot opening of the plug-in slot is smaller than the slot inner width of the plug-in slot; the second matching portion is a plug-in component that protrudes outward to form a convex arc petal shape that matches the plug-in slot, and the plug-in component is rotatably plugged into the plug-in slot and there is the movable gap.

[0022] In some embodiments, the plug-in slot is arranged obliquely along the circumferential direction of the connector, and the angle between the center line of the plug-in slot and the center axis of the connector in space is in the range of 1° to 5°.

[0023] In some embodiments, the first matching portion is a circular groove, the second matching portion includes a pushing portion and a clamping piece, the clamping piece includes a connecting tube with a through structure, and two hemispherical elastic clamping portions are provided at the end of the connecting tube. When the two elastic clamping portions are in a normal state, they can cooperate to form a spherical clamping body and extend into or out of the first matching portion. The pushing portion can pass through the connecting tube and squeeze into the position between the two elastic clamping portions so that the two elastic clamping portions are opened to each other and confined within the first matching portion.

[0024] In some embodiments, the first mating portion is a polygonal plug-in slot that is recessed inward, and the width of the slot opening of the plug-in slot is smaller than the inner width of the slot; the second mating portion is a polygonal connector that protrudes outward to form a polygonal connector that matches the plug-in slot, and the connector is rotatably plugged into the plug-in slot and there is a movable gap.

[0025] In some embodiments, the outer layer includes a silicone layer and a polymer material layer, the silicone layer and the polymer material layer are sequentially coated on the outer circumference of the main ring, and the silicone layer is located between the polymer material layer and the main ring, and the polymer material layer extends outward from the main ring to form a suture portion.

[0026] The technical solution provided by the present invention has the following advantages and effects:

[0027] The valvuloplasty ring is covered with an outer layer body through the outer periphery of the main ring, and the main ring can be sutured with the heart through the outer layer body so as to be firmly fixed to the position of the heart valve ring; wherein the main ring is provided with a front ring segment, a rear ring segment, a left ring segment and a right ring segment to cooperate to form a closed ring body, and the front ring segment and the rear ring segment are less flexible than the left ring segment and the right ring segment, and the rear ring segment is more flexible than the front ring segment, so that the front ring segment and the rear ring segment have better ring body support strength during movement, and the left ring segment and the right ring segment are each movably connected through a plurality of connecting pieces and there is a connection at the connection The movable gap can drive the connecting member to expand and contract relative to another adjacent connecting member along the circumference direction of the main ring to change the circumference of the main ring, and drive the connecting member to rotate relative to another adjacent connecting member to drive the main ring to deform along its own circumferential and axial directions, so that the annuloplasty ring has appropriate deformation performance. On the one hand, it can provide suitable strength to prevent the annulus from expanding, and on the other hand, it has suitable soft deformation performance and elasticity, and can adapt to the physiological change curvature of the heart valve during the systolic-diastolic-systolic movement process. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic structural diagram of a valvuloplasty ring according to a first embodiment of the present invention;

[0029] Figure 2yes Figure 1 A schematic structural diagram of a partial cross-section of an annuloplasty ring;

[0030] Figure 3 yes Figure 1 A schematic cross-sectional structure diagram of the overall structure of the annuloplasty ring;

[0031] Figure 4 yes Figure 1 A schematic diagram of a connection structure of a connector of a valvuloplasty ring;

[0032] Figure 5 yes Figure 1 A schematic diagram of the movement angle of rotation of the connector of the annuloplasty ring;

[0033] Figure 6 is a schematic structural diagram of a valvuloplasty ring connector in a disconnected state according to a second embodiment of the present invention;

[0034] Figure 7 yes Figure 6 A schematic structural diagram of a connecting member of a valvuloplasty ring in a connected state;

[0035] Figure 8 yes Figure 1 A schematic structural diagram of a cross section of a main ring of an annuloplasty ring;

[0036] Fig. 9 yes Figure 1 Schematic diagram of the structure of the radial cross-section of the annuloplasty ring.

[0037] Description of reference numerals:

[0038] 100. Annuloplasty ring;

[0039] 1. Main body ring; 11. Front ring section; 12. Rear ring section; 13. Left ring section; 131. Main body section; 132. Transition section; 14. Right ring section; 15. Connector; 151. First matching part; 152. Second matching part; 153. Pushing part; 154. Clamping part; 155. Connecting tube; 156. Elastic clamping part; 2. Outer layer; 21. Silicone layer; 22. Polymer material layer; 23. Suture part. DETAILED DESCRIPTION

[0040] In order to facilitate the understanding of the present invention, specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings.

[0041] Unless otherwise specified or defined, the "first, second..." used in this article is merely used to distinguish names and does not represent a specific quantity or order.

[0042] Unless specifically stated or defined otherwise, the term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0043] It should be noted that, in this document, “fixed to” or “connected to” may mean directly fixing or connecting to an element, or indirectly fixing or connecting to an element.

[0044] It should be noted that the annuloplasty ring 100 can be implanted in the annulus position of the patient to ensure good shaping of the native annulus, better conforming to the movement of the mitral valve or tricuspid valve, while preventing the annulus from further expanding to maintain the treatment effect.

[0045] Embodiment 1

[0046] The present invention provides a valvuloplasty ring 100, such as Figures 1 to 9 As shown, the annuloplasty ring 100 comprises a main body ring 1 and an outer layer 2, wherein the outer layer 2 is coated on the outer periphery of the main body ring 1. The outer layer 2 protects the structure of the main body ring 1 on the one hand, and facilitates suturing with the heart on the other hand. The outer layer 2 may be one layer or multiple layers, and its material may be specifically selected according to the needs of suturing and coating.

[0047] The main ring 1 is a closed ring body formed by the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14. Unless otherwise specified, when the main ring 1 is a closed ring body, the closed connection position of the main ring 1 can be connected by suturing, bonding, welding, plugging or snapping. The softness of the front ring segment 11 and the rear ring segment 12 is less than that of the left ring segment 13 and the right ring segment 14, and the softness of the rear ring segment 12 is greater than that of the front ring segment 11; the left ring segment 13 and the right ring segment 14 each include a plurality of connecting members 15 arranged in sequence, at least two adjacent connecting members 15 are movably connected and there is a movable gap at the connection, the connecting member 15 can be extended and retracted relative to another adjacent connecting member 15 along the circumference direction of the main ring 1 to change the circumference of the main ring 1, and the connecting member 15 can be rotated relative to another adjacent connecting member 15 to drive the main ring 1 to deform along its own circumferential and axial directions; it should be noted that the front connecting member 15 and the rear connecting member 15 described in this embodiment only refer to and distinguish two adjacent connecting members 15, but are not limited to the front and rear positions in the forward rotation direction or the front and rear positions in the reverse rotation direction.

[0048] Specifically, in the movement law of the mitral valve or tricuspid valve, the valve is in a cyclic movement process of systole-diastole-systole, and in the systole of the heart, the valve opening of the mitral valve or tricuspid valve contracts, the heart valve ring is saddle-shaped, and the valve leaflets are closed. Therefore, in this embodiment, according to the state of the saddle-shaped heart valve ring, the front ring segment 11 and the rear ring segment 12 are set to be less flexible than the left ring segment 13 and the right ring segment 14, and the softness of the rear ring segment 12 is greater than the softness of the front ring segment 11, and the front ring segment 11 and the rear ring segment 12 form a good ring body support strength, and according to the left ring segment 13 and the right ring segment 14 are each connected by a plurality of connecting members 15, at least two adjacent connecting members 15 are movably connected and there is a movable gap at the connection, so that the left ring segment 13 and the right ring segment 14 can both form a main deformation area, and the connecting member 15 is relative to another adjacent connecting member 15 along the circumference direction of the main ring 1 The telescopic activity can drive the main ring 1 to telescope along its own circumference direction to change the circumference of the main ring 1, so that the circumference of the main ring 1 is in a fixed range of activity to prevent the valve from expanding again. At the same time, the connecting member 15 rotates along the connecting member 15 relative to another adjacent connecting member 15 to drive the main ring 1 to deform along its own circumferential and axial directions. For example, the main ring 1 can be deformed back and forth between a saddle shape and a flat ring shape according to the shape of the heart valve, and the main ring 1 can be deformed back and forth between an arc shape and a straight line shape corresponding to the position of the left ring segment 13 and the right ring segment 14 to adapt to the physiological curvature of the heart valve in the systolic-diastolic-systolic movement process. During the systolic period of the heart, the mitral valve orifice contracts, the heart valve ring is saddle-shaped, and the leaflets are closed. At this time, the main ring 1 can fill the gap and adapt to the contraction of the heart valve ring. The rigid connection of the main ring 1 ensures the strength of the ring body support and avoids long-term expansion.

[0049] In summary, the annuloplasty ring 100 is provided with an outer layer body 2 wrapped around the outer periphery of the main ring 1, and the main ring 1 can be sutured with the heart through the outer layer body 2 so as to be firmly fixed at the position of the heart valve ring; wherein the main ring 1 is provided with a front ring segment 11, a rear ring segment 12, a left ring segment 13 and a right ring segment 14 to cooperate to form a closed ring body, and the front ring segment 11 and the rear ring segment 12 are less flexible than the left ring segment 13 and the right ring segment 14, and the rear ring segment 12 is more flexible than the front ring segment 11, so that the front ring segment 11 and the rear ring segment 12 have better ring body support strength during movement, and the left ring segment 13 and the right ring segment 14 are each connected by a plurality of The connecting piece 15 is movably connected and there is a movable gap at the connection, which can drive the connecting piece 15 to expand and contract relative to another adjacent connecting piece 15 along the circumference direction of the main ring 1 to change the circumference of the main ring 1, and drive the connecting piece 15 to rotate relative to another adjacent connecting piece 15 to drive the main ring 1 to deform along its own circumferential and axial directions, so that the annuloplasty ring 100 has appropriate deformation performance. On the one hand, it can provide appropriate strength to prevent the valve ring from expanding, and on the other hand, it has suitable soft deformation performance and elasticity, and can adapt to the physiological change curvature of the heart valve during the systolic-diastolic-systolic movement process.

[0050] In some embodiments, Figure 3 and Figure 8As shown, the left ring segment 13 and the right ring segment 14 each include a main body segment 131 and two transition segments 132. The two transition segments 132 are arranged at opposite ends of the main body segment 131 and are respectively connected to the front ring segment 11 and the rear ring segment 12. The main body segment 131 includes at least two connecting members 15, the transition segment 132 includes at least one connecting member 15, and the overall deformation amplitude of the transition segment 132 is smaller than the overall deformation amplitude of the main body segment 131. It can be understood that, since the left ring segment 13 and the right ring segment 14 are transition areas for connecting the front ring segment 11 and the rear ring segment 12, the left ring segment 13 and the right ring segment 14 are divided into a main segment 131 and a transition segment 132 according to the degree of their deformation; wherein the transition segment 132 is located between the front ring segment 11 and the main segment 131, and is located before the rear ring segment 12 and the main segment 131, so the degree of deformation of the transition segment 132 is smaller than that of the main segment 131, so that the activity angle of the left ring segment 13 and the right ring segment 14 is controlled in a specific direction and range, specifically Different numbers of connectors 15 are provided between the transition segment 132 and the main body segment 131, so that the amplitude of the overall deformation of the transition segment 132 is smaller than that of the overall deformation of the main body segment 131, so that the left ring segment 13 or the right ring segment 14 formed by the transition segment 132 and the main body segment 131 can connect the front ring segment 11 and the rear ring segment 12 to form a closed ring, and the deformation area between the left ring segment 13 and the right ring segment 14 has a moderate range of motion to adapt to the physiological curvature of the heart valve in the systolic-diastolic-systolic movement process as much as possible. In addition, the transition segment 132 and the front ring segment 11 and the rear ring segment 12 can also be connected by a matching connection, or other suturing, bonding, welding or clamping methods to achieve connection.

[0051] Specifically, in some embodiments, Figure 3 and Figure 5 As shown, the deformation angle range of two adjacent connectors 15 in the transition section 132 is 1° to 5°, and the overall deformation angle range of the transition section 132 is 0° to 25°; the deformation angle range of two adjacent connectors 15 in the main section 131 is 1° to 5°, and the overall deformation angle range of the main section 131 is 0° to 30°. The left ring section 13 and the right ring section 14 formed by the transition section 132 and the main section 131 within this numerical range can well adapt to the physiological curvature of the heart valve during the systolic-diastolic-systolic movement process, and have appropriate strength to prevent the valve ring from expanding.

[0052] In some embodiments, the connecting member 15 is provided with a first matching portion 151 and a second matching portion 152 at opposite ends, and two adjacent connecting members 15 are movably connected through the first matching portion 151 of the previous connecting member 15 and the second matching portion 152 of the next connecting member 15, and there is a movable gap at the connection.

[0053] In some embodiments, the spacing distance between two adjacent connectors 15 of the main section 131 is smaller than the spacing distance between two adjacent connectors 15 of the transition section 132; multiple first matching portions 151 and second matching portions 152 are arranged at intervals along the circumferential direction of the connector 15, and the number of first matching portions 151 and second matching portions 152 of the connector 15 in the main section 131 is greater than the number of first matching portions 151 and second matching portions 152 of the connector 15 in the transition section 132. It can be understood that the spacing between adjacent connectors 15 and the number of first matching portions 151 and second matching portions 152 directly affect the deformation amplitude of the corresponding ring segment. Specifically, the smaller the spacing between two adjacent connecting members 15, the larger the deformation angle. Therefore, by setting the spacing distance between two adjacent connecting members 15 of the main section 131 to be smaller than the spacing distance between two adjacent connecting members 15 of the transition section 132, the overall deformation amplitude of the main section 131 is greater than the overall deformation amplitude of the transition section 132, and the number of the second matching parts 152 and the first matching parts 151 affects the rotation direction of the two adjacent connecting members 15. By providing a plurality of, for example, at least four and an even number of second matching parts 152 and first matching parts 151 at both ends of the connecting member 15 in the main section 131, the main section 131 as a whole can be rotated in the up-down direction and the left-right direction, so as to form a main section 131 with a larger deformation amplitude, so as to The main body section 131 is made to have a flexible deformation ability to adapt to the physiological curvature changes during the movement of the heart valve, and the second matching parts 152 and the first matching parts 151 are provided at both ends of the transition section 132, which are less than the matching parts of the main body section 131, so that the rotation direction of the transition section 132 is limited, so that the transition section 132 can only rotate in the up and down direction, but cannot rotate in the left and right direction, and can form a transition section 132 with directional rotation, so that the transition section 132 can better serve as a transition area between the front ring section 11, the rear ring section 12 and the flexible deformation main body section 131, on the one hand, cooperate with the front ring section 11 and the rear ring section 12 to ensure appropriate strength and prevent the valve ring from expanding, and on the other hand, cooperate with the main body section 131 to adapt to the physiological curvature changes during the movement of the heart valve. In addition, it should be noted that when the connector 15 at the end of the transition section 132 is connected to the connector 15 at the end of the main body section 131, the number of the second matching parts 152 and the first matching parts 151 is adapted to enable the two connectors 15 to be smoothly connected and transitionally arranged.

[0054] Specifically in this embodiment, the transition section 132 is composed of at least 1 and no more than 9 connectors 15, and the length of each connector 15 ranges from 2 mm to 10 mm; the main section 131 is composed of 2 to 10 connectors 15, and the length of the connector 15 ranges from 2 mm to 10 mm. Of course, in other embodiments, the number and length of the connectors 15 of the transition section 132 and the main section 131 are not limited to the above ranges, and other numbers and lengths are applicable.

[0055] In some embodiments, Figure 3 and Figure 4 As shown, the first matching portion 151 is a plug-in slot that is recessed inward to form a concave arc petal shape, and the width of the slot opening of the plug-in slot is smaller than the slot width of the plug-in slot; the second matching portion 152 is a plug-in component that protrudes outward to form a convex arc petal shape that matches the plug-in slot, and the plug-in component is rotated and plugged into the plug-in slot and there is the movable gap. It can be understood that the plug-in component is plugged into the plug-in slot, and the plug-in component can rotate relative to the plug-in slot so that the rear connector 15 can rotate relative to the front connector 15, and it can prevent the plug-in component from being separated from the slot opening of the plug-in slot during the rotation of two adjacent connectors 15, thereby avoiding affecting the normal working state of the annuloplasty ring 100.

[0056] In some embodiments, Figure 5 As shown, the plug-in slot is inclined along the circumferential direction of the connector 15, and the angle α between the center line of the plug-in slot and the center axis of the connector 15 in space ranges from 1° to 5°. The shape of the connector is adapted to the shape of the plug-in slot, so that the rear connector 15 can rotate relative to the front connector 15 toward the side of the rear ring segment 12 to form a closed ring with a moderate deformation area.

[0057] In some embodiments, Fig. 9 As shown, the outer layer 2 includes a silicone layer 21 and a polymer layer 22, which are sequentially coated on the outer periphery of the main ring 1, and the silicone layer 21 is located between the polymer layer 22 and the main ring 1, and the polymer layer 22 extends outward from the main ring 1 to form a suture portion 23. It should be noted that, since the main ring 1 is a deformable closed ring structure, the outer layer 2 coated on the outside of the main ring 1 needs to be able to meet the function of free contraction and stable fixation on the heart valve ring, wherein the outer layer 2 is respectively a silicone layer 21 with good elongation and a polymer layer 22 from the inside to the outside, wherein the polymer layer 22 is a hollow structure, and the hollow shape can be circular, triangular, hexagonal, etc., and no special restrictions are made here, and the suture portion 23 is a dense hollow structure, which is convenient for suturing.

[0058] In some embodiments, the thickness of the silicone layer 21 is in the range of 0.2 mm to 1 mm, the thickness of the polymer material layer 22 is in the range of 0.1 to 0.3 mm, and the thickness of the suture portion 23 is in the range of 0.3 to 1 mm.

[0059] In some embodiments, each of the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14 of the main body ring 1 can be a solid structure or a hollow structure, and no special restrictions are made here. Each of the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14 of the main body ring 1 can be made of a single material or a plurality of materials. Specifically in this embodiment, each of the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14 of the main body ring 1 is a tubular structure with a hollow interior, and each ring segment has a consistent outer diameter, ranging from 1 mm to 3 mm, and each ring segment is made of a metal material with relatively high strength, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other metal materials commonly used in implantable devices.

[0060] Embodiment 2

[0061] In this embodiment, the structure of the annuloplasty ring 100 is substantially the same as that of the first embodiment. Figure 6 and Figure 7 As shown, the difference from the first embodiment is that:

[0062] The first matching portion 151 is a circular groove, the second matching portion 152 includes a pushing portion 153 and a clamping member 154, the clamping member 154 includes a connecting tube 155 with a through structure, and two hemispherical elastic clamping portions 156 are arranged at the end of the connecting tube 155. When the two elastic clamping portions 156 are in a normal state, they can cooperate to form a spherical clamping body and can extend into or out of the first matching portion 151. The pushing portion 153 can be passed through the connecting tube 155 and squeezed into the position between the two elastic clamping portions 156, so that the two elastic clamping portions 156 can open to each other and be restricted in the first matching portion 151.

[0063] It can be understood that, in the unassembled state, the radial length of the spherical structure formed by the two elastic clamping portions 156 is smaller than the slot width of the first fitting portion 151, so the elastic clamping portion 156 can smoothly extend into or extend out of the first fitting portion 151. When it is necessary to assemble and connect the various connecting parts 15, the elastic clamping portion 156 is extended into the first fitting portion 151, and the pushing portion 153 is squeezed between the two elastic clamping portions 156 to allow the two elastic clamping portions 156 to move outward, thereby increasing the radial length of the spherical structure formed by the two elastic clamping portions 156, so that the spherical structure of the elastic clamping portion 156 can be accommodated in the first fitting portion 151 and restricted from extending out, and the spherical structure of the elastic clamping portion 156 can rotate in the first fitting portion 151, so that the latter connecting part 15 can rotate relative to the previous connecting part 15.

[0064] Compared with the first embodiment, the annuloplasty ring 100 is provided by cooperating the pushing portion 153 and the clamping member 154 so that the connecting members 15 can be flexibly assembled, and can be assembled according to specific shaping needs in clinical practice, thereby improving the flexibility of use.

[0065] Embodiment 3

[0066] In this embodiment, the structure of the annuloplasty ring 100 is substantially the same as that of the first embodiment. Figure 8 As shown, the difference from the first embodiment is that:

[0067] The first matching portion 151 is a polygonal plug-in slot that is recessed inwards, and the width of the slot opening of the plug-in slot is smaller than the slot width of the plug-in slot; the second matching portion 152 is a polygonal plug-in component that protrudes outwards to form a polygonal plug-in component that matches the plug-in slot. The polygonal plug-in slot and the plug-in component structure are easy to cut and process, and the processing precision is low, which can reduce the processing cost, and also has good connection performance.

[0068] The above embodiments are not exhaustive enumerations of the present invention, and there may be multiple other implementations not listed. Any replacement and improvement made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

1. An annuloplasty ring, characterized in that: The annuloplasty ring comprises a main body ring and an outer layer body, wherein the outer layer body is coated on the outer circumference of the main body ring; The main body ring is a closed ring body formed by the cooperation of a front ring segment, a rear ring segment, a left ring segment and a right ring segment. The softness of the front ring segment and the rear ring segment is less than that of the left ring segment and the right ring segment, and the softness of the rear ring segment is greater than that of the front ring segment. The left ring segment and the right ring segment each include a plurality of connecting parts arranged in sequence, at least two adjacent connecting parts are movably connected and there is a movable gap at the connection, the connecting part can be extended and retracted relative to another adjacent connecting part along the circumference direction of the main body ring to change the circumference of the main body ring, and the connecting part can be rotated relative to another adjacent connecting part to drive the main body ring to deform along its own circumferential and axial directions.

2. The annuloplasty ring according to claim 1, characterized in that: The left ring segment and the right ring segment each include a main body segment and two transition segments, the two transition segments are arranged at opposite ends of the main body segment and are respectively connected to the front ring segment and the rear ring segment; the main body segment includes at least two connecting parts, the transition segment includes at least one connecting part, and the overall deformation amplitude of the transition segment is smaller than the overall deformation amplitude of the main body segment.

3. The annuloplasty ring according to claim 2, characterized in that: The deformation angle range of two adjacent connecting members in the transition section is 1° to 5°, and the overall deformation angle range of the transition section is 0° to 25°; The deformation angle range of two adjacent connecting members in the main body section is 1° to 5°, and the overall deformation angle range of the main body section is 0° to 30°.

4. The annuloplasty ring according to claim 2, characterized in that: The connecting piece is provided with a first matching portion and a second matching portion at opposite ends, and two adjacent connecting pieces are movably connected through the first matching portion of the preceding connecting piece and the second matching portion of the following connecting piece, and a movable gap exists at the connection.

5. The annuloplasty ring according to claim 4, characterized in that: The spacing distance between two adjacent connecting parts of the main section is smaller than the spacing distance between two adjacent connecting parts of the transition section; the first matching part and the second matching part are arranged in multiple intervals along the circumferential direction of the connecting part, and the number of the first matching part and the second matching part of the connecting part in the main section is more than the number of the first matching part and the second matching part of the connecting part in the transition section.

6. The annuloplasty ring according to claim 4, characterized in that: The first matching portion is a plug-in slot that is recessed inward to form a concave arc petal shape, and the width of the slot opening of the plug-in slot is smaller than the slot inner width of the plug-in slot; the second matching portion is a plug-in component that protrudes outward to form a convex arc petal shape that matches the plug-in slot, and the plug-in component is rotatably plugged into the plug-in slot and there is the movable gap.

7. The annuloplasty ring according to claim 6, characterized in that: The plug-in slot is arranged obliquely along the circumferential direction of the connector, and the angle between the center line of the plug-in slot and the center axis of the connector in space ranges from 1° to 5°.

8. The annuloplasty ring according to claim 4, characterized in that: The first matching portion is a circular groove, the second matching portion includes a pushing portion and a clamping piece, the clamping piece includes a connecting tube with a through structure, and two hemispherical elastic clamping portions are arranged at the end of the connecting tube. When the two elastic clamping portions are in a normal state, they can cooperate to form a spherical clamping body and extend into or out of the first matching portion. The pushing portion can be penetrated through the connecting tube and squeezed into the position between the two elastic clamping portions so that the two elastic clamping portions are opened to each other and confined within the first matching portion.

9. The annuloplasty ring according to claim 4, characterized in that: The first matching portion is a polygonal plug-in slot that is recessed inward, and the width of the slot opening of the plug-in slot is smaller than the inner width of the slot; the second matching portion is a polygonal plug-in component that protrudes outward to form a polygonal plug-in component that is adapted to the plug-in slot, and the plug-in component is rotatably plugged into the plug-in slot and there is the movable gap.

10. The annuloplasty ring according to any one of claims 1 to 9, characterized in that: The outer layer includes a silicone layer and a polymer material layer, which are sequentially coated on the outer circumference of the main ring, and the silicone layer is located between the polymer material layer and the main ring, and the polymer material layer extends outward from the main ring to form a suture portion.

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