Mitral annuloplasty device

Abstract

This invention discloses a mitral valve annulus retraction device, comprising a distal anchor for anchoring in a great cardiac vein near the crossing point of the circumflex artery, and a proximal anchor for anchoring in the coronary sinus; the proximal and distal anchors are connected by a connector; an arched member is provided at the distal end of the distal anchor, at the proximal end of the distal anchor, or within the distal anchor for crossing the circumflex coronary artery, the arched member arching towards the top of the distal anchor. This invention is applicable to different patients, does not compress the circumflex artery, ensures that the mitral valve annulus retraction device can surround the mitral valve annulus for as long a distance as possible, and when the mitral valve annulus retraction device is tightened, it can increase the degree of mitral valve annulus retraction, improve the efficacy of mitral regurgitation treatment, and adapt to a wider range of clinical applications.

Description

Technical Field

[0001] This invention belongs to the field of interventional medical device technology and relates to a mitral valve annulus retraction device. Background Technology

[0002] The mitral valve is the most crucial valve in the heart. Located in the opening of the left ventricle between the left atrium and left ventricle, it prevents blood from flowing back from the left ventricle into the left atrium when the left ventricle contracts. In a healthy mitral valve, the geometry ensures that the leaflets overlap to prevent backflow during left ventricular contraction. Dilated cardiomyopathy, caused by disease or certain natural defects, can impair the mitral valve's normal function in preventing regurgitation. For example, certain diseases can cause dilation of the mitral annulus and deformation of the mitral valve geometry, leading to incomplete mitral closure during left ventricular contraction, resulting in blood leakage and regurgitation.

[0003] Surgical treatment is an effective way to treat mitral regurgitation, but because surgery is highly invasive, it can lead to more complications and a higher mortality rate, especially for elderly patients and those with multiple comorbidities.

[0004] Minimally invasive interventional surgery is now a better option for treating most valvular heart diseases. The main interventional treatments include artificial chordae tendineae implantation, mitral valve annulus repair, and mitral valve edge-to-edge repair. Annulus repair includes direct and indirect methods. Indirect annulus repair primarily utilizes the tightening of the blood vessels surrounding the mitral valve annulus to achieve constriction of the annulus and ensure tight closure of the mitral valve leaflets. The coronary sinus-greater cardiac veins, which mainly surround the mitral valve annulus, make them the optimal implantation site for indirect annulus repair.

[0005] One existing technique involves inserting a device into the coronary sinus and great cardiac vein via the jugular vein. This device has two anchors: a distal anchor at the great cardiac vein and a proximal anchor at the coronary sinus, connected by a connector. Tightening the device applies inward pressure to the mitral valve annulus, causing it to contract and essentially restore its normal geometry, thus closing the mitral valve leaflets tightly and improving mitral regurgitation. However, in some individuals, the coronary circumflex artery is located below the coronary sinus and great cardiac vein, crossing it. To achieve optimal therapeutic effect, the distal anchor is positioned as close as possible to the intersection of the circumflex artery and the coronary sinus and great cardiac vein. However, when the device is tightened, the backward pulling force of the distal anchor can straighten and compress the great cardiac vein above the circumflex artery, compressing the circumflex artery and leading to insufficient blood flow, potentially causing myocardial infarction. To minimize compression of the coronary circumflex artery, the device can only be placed between the proximal end of the crossing of the circumflex artery and the great cardiac vein and the coronary sinus ostium. Because the distance between the proximal end of the crossing of the circumflex artery and the great cardiac vein and the coronary sinus ostium is relatively small, corresponding to the P2-P3 region of the mitral valve's post-valvular annulus, the device's tightening and contraction distance is relatively small, resulting in a limited degree of mitral valve annulus constriction and poor efficacy in treating mitral valve disease. The indications are limited.

[0006] Another technical solution uses a ligation cord that enters the right atrium through the jugular vein, then the coronary sinus, passes through the great cardiac vein, enters the right ventricle through the proximal ventricular septal vein, passes through the tricuspid valve, and returns to the right atrium. This path forms a closed loop around the mitral valve annulus. Tightening the ligation cord then tightens the mitral valve annulus, effectively closing the mitral valve leaflets tightly and improving mitral regurgitation. A coronary artery protector is attached to the ligation cord using PTFE biocompatible material. This protector prevents the ligation cord from compressing the coronary circumflex artery when tightened. However, while the coronary artery protector is coated with PTFE and other biocompatible polymers, this coating creates a soft connection with insufficient strength, potentially leading to displacement between the protector and the ligation cord during heartbeats. In addition, although the cerclage cord is tightened, it is not effectively fixed in the coronary sinus-greater heart vein. When the heart beats, the cerclage cord may shift, causing the coronary artery protector to also shift, thus failing to protect the coronary circumflex artery from compression. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a mitral valve annulus constriction device in view of the defects of the prior art. This device is suitable for different patients, does not compress the circumflex artery, ensures that the mitral valve annulus constriction device can surround the periphery of the mitral valve annulus for as long as possible, and when the mitral valve annulus constriction device is tightened, it can increase the degree of mitral valve annulus constriction, improve the efficacy of mitral regurgitation, and adapt to a wider range of clinical applications.

[0008] The technical solution adopted by this invention to solve its technical problem is:

[0009] A mitral valve annulus retraction device includes a distal anchor for anchoring in a great cardiac vein near a crossing point with the circumflex artery, and a proximal anchor for anchoring in the coronary sinus; the proximal anchor and the distal anchor are connected by a connector.

[0010] An arched member is provided at the distal end of the distal anchor, at the proximal end of the distal anchor, or in the distal anchor for crossing the coronary circumflex artery, the arched member arching toward the top of the distal anchor.

[0011] Furthermore, in the aforementioned mitral valve annular retraction device, the arched member preferably includes an arched portion that extends axially outward from the bottom of the distal anchor or is disposed at the bottom within the distal anchor and arches towards the top of the distal anchor.

[0012] Furthermore, in the mitral valve annular constriction device, preferably the arched portion of the arched member has at least a smooth, non-sharp structure at its top.

[0013] Furthermore, in the aforementioned mitral valve annular constriction device, preferably, the arched portion of the arched member located outside the distal end of the distal anchor has a guide portion extending outward.

[0014] Furthermore, in the aforementioned mitral valve annular retraction device, the guide portion preferably has a hollow structure or a concave structure to improve the flexibility of the guide portion; or the guide portion is a flexible structure made of a flexible material.

[0015] Furthermore, in the mitral valve annular constriction device, the arched component is preferably a single tubular or coarse filament, or the arched component is a double or multi-strand twisted structure, or the arched component is a double or multi-strand wound structure.

[0016] Furthermore, in the mitral valve annular constriction device, preferably at least a portion of the surface of the tubular arched member has a hollow structure extending at least in the circumferential direction; or at least a portion of the surface of the filamentous arched member has a concave structure extending at least in the circumferential direction.

[0017] Furthermore, in the aforementioned mitral valve annular constriction device, preferably, an anti-puncture component is provided on the distal end of the arched member at the distal end of the distal anchor to prevent puncture of blood vessels.

[0018] Furthermore, in the mitral valve annular retraction device, the puncture-proof component is preferably a solid or hollow structure with a smooth surface and a diameter or width greater than that of the arched component.

[0019] Furthermore, in the aforementioned mitral valve annular retraction device, the guide portion preferably has a hollow structure or a concave structure to improve the flexibility of the guide portion.

[0020] Furthermore, in the mitral valve annular retraction device, preferably, the distal end of the arched member is provided with a positioning element to prevent the arched member and the annular retraction device from tipping over.

[0021] Furthermore, in the mitral valve annular constriction device, the positioning element is preferably a closed-loop structure or an open-loop structure.

[0022] Furthermore, in the mitral valve annular constriction device, the closed-loop structure preferably includes one of a single-ring structure, a multi-ring structure, a radial loop structure, and an axial three-dimensional ring structure.

[0023] Furthermore, in the mitral valve annular constriction device, the positioning element is preferably a structure with the same diameter, a radially variable diameter structure, or an axially variable diameter structure.

[0024] Furthermore, in the mitral valve annular retraction device, preferably the proximal anchor, distal anchor, connector, and arched component are an integral structure woven together; or at least two of the proximal anchor, distal anchor, connector, and arched component are separately fixedly connected together.

[0025] Furthermore, in the mitral valve annular retraction device, preferably, the bottom of the proximal anchor and the distal anchor are respectively fitted with a fixing sleeve, and the bottom of the proximal anchor and the distal anchor are provided with a locking knot outside the fixing sleeve, locking the proximal anchor and the distal anchor to extend into a three-dimensional structure.

[0026] Furthermore, in the mitral valve annular constriction device, preferably, the top of at least one of the proximal anchor and the distal anchor has an interwoven braided structure.

[0027] This invention features an arched component located outside the distal end of the distal anchor, outside the proximal end of the distal anchor, or within the distal anchor. This arched component arches towards the top of the distal anchor and can span the coronary circumflex artery. When the distal anchor is oriented and tightened, the greater cardiac vein above the coronary circumflex artery is also straightened, tightened, and compressed. However, at this time, the arched component pushes the greater cardiac vein upwards, protecting the coronary circumflex artery from compression. Furthermore, after the distal anchor is released, it is firmly anchored to the wall of the greater cardiac vein, ensuring reliable fixation. Therefore, the arched component is accurately and stably positioned and will not shift with heartbeats, resulting in high safety. Additionally, the arched component can be positioned in three locations, accommodating different patients, thus offering greater adaptability and a wider range of applications. Attached Figure Description

[0028] The present invention will be further described below with reference to the accompanying drawings and embodiments. In the accompanying drawings:

[0029] Figure 1 This is a schematic diagram of the structure of the first embodiment of the present invention;

[0030] Figure 2 This is a schematic diagram of the structure of the second embodiment of the present invention;

[0031] Figure 3 This is a schematic diagram of the third embodiment of the present invention;

[0032] Figure 4 This is a schematic diagram of the fourth embodiment of the present invention;

[0033] Figure 5-6 This is a schematic diagram of the location of the mitral valve annulus constriction device in the heart according to Embodiment 1 of the present invention;

[0034] Figure 7 This is a schematic diagram of the structure of the first embodiment of the present invention, Example 2;

[0035] Figure 8 This is a schematic diagram of the structure of the second embodiment of the present invention;

[0036] Figure 9 This is a schematic diagram of the location of the mitral valve annulus constriction device in the heart according to Embodiment 2 of the present invention;

[0037] Figure 10 This is a schematic diagram of the mitral valve annulus closing device of Embodiment 2 of the present invention closing the mitral valve leaflets;

[0038] Figure 11 This is a schematic diagram of the structure of Embodiment 3 of the present invention;

[0039] Figure 12 This is a schematic diagram of the structure of the first embodiment of the present invention, Example 4;

[0040] Figure 13 This is a schematic diagram of the structure of the second embodiment of the present invention, which is shown in Example 4.

[0041] Figure 14 This is a schematic diagram of the third embodiment of the present invention, which is shown in Embodiment 4.

[0042] Figure 15 This is a schematic diagram of the fourth embodiment of the present invention. Detailed Implementation

[0043] To provide a clearer understanding of the technical features, objectives, and effects of the present invention, specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0044] A component is referred to as being "fixed to" or "set on" another component, and it may be located directly or indirectly on that other component. When a component is referred to as being "connected to" another component, it may be directly or indirectly connected to that other component.

[0045] The terms “up,” “down,” “left,” “right,” “front,” “back,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” and “outer” indicate the orientation or position based on the orientation or position shown in the attached drawings.

[0046] The terms "axial" and "radial" refer to the length of the entire device or component as "axial" and the direction perpendicular to the axial direction as "radial".

[0047] The term "circumferential" refers to the direction along the circumference of a circle.

[0048] The terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or specifying the number of technical features. "Multiple" means two or more, unless otherwise explicitly defined.

[0049] "Near" and "far" are based on the operator; the direction that is relatively closer to the operator is considered near, and the direction that is farther away from the operator is considered far.

[0050] The terms used above are for ease of description only and should not be construed as limitations on this technical solution.

[0051] like Figure 1-15 As shown, a mitral valve annulus constriction device is used to be placed in the coronary sinus-greater cardiac vein, wherein the distal anchor 100 is fixed in the greater cardiac vein 1, the proximal anchor 200 is fixed in the coronary sinus 3, and the arched member 300 is placed in the greater cardiac vein 1 above the coronary circumflex artery 2 to ensure that the circumflex artery 2 is not compressed.

[0052] The mitral valve annulus device includes a distal anchor 100 for anchoring in a great cardiac vein 1 near the crossing point of the circumflex artery 2, and a proximal anchor 200 for anchoring in the coronary sinus 3; the proximal anchor 200 and the distal anchor 100 are connected by a connector 500; an arched member 300 for crossing the circumflex coronary artery 2 is provided at the distal end of the distal anchor 100, at the proximal end of the distal anchor 100, or in the distal anchor 100, the arched member 300 arching towards the top of the distal anchor 100.

[0053] The near-end anchor 200 and the far-end anchor 100 form the main structure. The far-end anchor 100 is a cage-shaped structure woven from nickel-titanium wire, including two annular support rings 110. The two annular support rings 110 are connected to form a cage by a top braided wire 120 and a bottom braided wire 130. Preferably, a fixing sleeve 150 is fitted over the bottom of the far-end anchor 100, i.e., the braided wire 130, to maintain the bottom structure of the far-end anchor 100 and provide support. Similarly, the near-end anchor 200 is a cage-shaped structure woven from nickel-titanium wire, including two annular structures 210. The two annular structures 210 are connected to form a cage by a top braided wire 220 and a bottom braided wire 230. Preferably, a fixing sleeve 270 is fitted over the bottom braided wire 230 of the near-end anchor 200. The braided wires 130 and 230 can be single strands or multiple strands twisted together. At least one of the near-end anchor 200 and the far-end anchor 100 has a top braided wire 120 and braided wire 220 with an interwoven twisted structure, preferably both of them are twisted structures. The twisted structure has stronger support and is more conducive to maintaining the three-dimensional cage structure of the far-end anchor and the near-end anchor compared with the existing single wire or single wire crossing top structure.

[0054] A locking ring 160 is provided near the proximal end of the bottom fixing sleeve 150 of the distal anchor 100. The locking ring 160 is obtained by winding nickel-titanium wire around the braided wire 130 at the bottom of the distal anchor 100. The locking ring 160 can slide at the bottom of the distal anchor 100. Similarly, a locking ring 260 is provided near the proximal end of the bottom fixing sleeve 250 of the proximal anchor 200. The locking ring 260 is also obtained by winding nickel-titanium wire around the braided wire 230 at the bottom of the proximal anchor 200. The diameters of the two locking rings 160 and 260 are larger than those of the fixing sleeves 150 and 250 respectively provided next to them, in order to maintain the cage-like three-dimensional structure of the distal anchor 100.

[0055] The bottoms of the proximal anchor 200 and the distal anchor 100 are located outside the fixing sleeves 150 and 250, specifically outside the proximal ends of the locking rings 160 and 260, respectively, with locking knots 170 and 270. Locking knots 170 and 270 are extensions of braided wires 130 and 230, respectively. The fixing sleeve 150 and locking knot 170, and the fixing sleeve 250 and locking knot 270, respectively, restrict the positions of the locking rings 160 and 260 on the distal anchor 100 and the proximal anchor 200, maintaining the expanded shape of the proximal anchor 200 and the distal anchor 100.

[0056] During delivery within the sheath, both the distal anchor 100 and the proximal anchor 200 are in a collapsed state. At this time, the locking ring 160 is on the proximal side of the locking knot 170, facilitating the advancement of the distal anchor 100. Once the distal anchor 100 expands within the blood vessel, it pushes the locking ring 160 to the distal side of the locking knot 170, causing the distal anchor 100 to expand and hold, thus strengthening its support. The locking ring 260 of the proximal anchor 200 is on the proximal side of the locking knot 270. The locking knot 270 is connected to the push rod of the delivery device, and the locking ring 260 is fitted onto the push rod. When the proximal anchor 200 is released, the locking ring 260 is pushed distally along the push rod, passing over the locking knot 270 and locking, causing the proximal anchor 200 to expand and hold, further strengthening its support.

[0057] The connector 500 is positioned between the distal anchor 100 and the proximal anchor 200, and is made of braided yarn. It can be a single strand, or two or more braided yarns arranged side by side, twisted together, or wound together. Twisting refers to binding multiple yarns together by twisting; winding refers to a structure formed by wrapping the remaining yarns around one or more yarns as the center. Other twisting and winding methods in this invention are the same and will not be described further.

[0058] Specifically, since the distance from the intersection of the circumflex artery and the great cardiac vein to the coronary sinus ostium may vary among different patients, there are three implementation methods for the placement of the arched member 300 to accommodate different patients. The first implementation method is to place it on the distal outer side of the distal anchor 100. The second implementation method is to place it on the proximal outer side of the distal anchor 100, either integrally formed with or fixedly connected to the connector 500. The third implementation method is to place it within the distal anchor 100, where the braided wire 130 at the bottom of the distal anchor 100 arches towards the top of the distal anchor 100 to form the arched member 300. The arched member 300 is integrally formed with the braided wire 130 at the bottom of the distal anchor 100, or the braided wire is fixedly connected to the arched member 300.

[0059] The main structure of the arched component 300 is as follows: the arched component 300 includes an arched portion 310, which has three corresponding locations: extending axially outward from the bottom of the distal anchor 100 (including extending outward from the distal end and extending outward from the proximal end) or located at the bottom within the distal anchor 100, arching towards the top of the distal anchor 100. The arched component 300 is made of elastic memory metal wire. The present invention extends outward in the distal or proximal direction of the pointing device, or generally (mainly in the extension direction) in both directions.

[0060] The arched portion 310 of the arched member 300 has at least a smooth, non-sharp structure at its top, such as an arc, a non-sharp angle, or a plane. This invention requires that the top of the arched portion 310 contact the blood vessel wall, preferably in an arc shape, to prevent puncture of the blood vessel and to provide a large contact area with the blood vessel wall, which is beneficial for positioning. Apart from the top surface being arc-shaped, the shape of other positions is not limited, as long as there are no sharp structures. Preferably, the specific shape of the arched portion 310 can be an arc structure with the same curvature, an arc structure formed by the sequential connection and smooth transition of multiple arc segments with different curvatures, a chamfered angle, or a rectangular structure.

[0061] The arched component 300 can be a single tubular or coarse filament, or it can be a double-strand or multi-strand twisted structure. Alternatively, it can be a double-strand or multi-strand wound structure. The arched portion 310 of the main structure of the arched component 300 adopts the above-described structure. A single arched component 300 can be a tubular or coarse filament with a relatively large diameter, while a double-strand or multi-strand structure is a fine filament structure. The terms "twisted" and "wound" have the same meaning as above.

[0062] The arched portion 310 can be provided independently, that is, an arched portion 310 of the arched member 300 is provided on the outer side of the far end of the far anchor 100, or an arched portion 310 is provided on the outer side of the near end of the far anchor 100, or an arched portion 310 is provided inside the far anchor 100. The independently provided arched portion 310 needs to have its free end blunted, that is, it needs to be provided with a structure without sharp edges.

[0063] To facilitate shaping or bending, the arched portion 310 may at least partially undergo surface structural treatment, i.e., the surface of the tubular arched portion 310 may have a perforated structure extending at least in the circumferential direction; or at least part of the surface of the filamentous arched portion 310 may have a concave structure extending at least in the circumferential direction. For example, the perforated structure and the concave structure may be provided on the inner side of the top surface of the arched portion 310, at the bending positions at both ends of the bottom of the arched portion 310, or on the inner side of both sides of the arched portion 310. This facilitates bending of the arched portion 310 and helps it maintain its bent state. The perforated structure and the concave structure may be slits, grooves, etc., provided on the circumferential surface, wherein the perforated structure extends into the inner cavity.

[0064] To prevent the arched component 300 from puncturing blood vessels due to its suspended distal end and excessive hardness, a puncture-resistant component 600 is provided at the distal end of the arched component 300, which is located outside the distal end of the distal anchor 100. The puncture-resistant component 600 is a solid or hollow structure with a smooth surface and a diameter or width larger than that of the arched component 300. For example, the puncture-resistant component 600 is a smooth sphere, hemisphere, or other structure without sharp edges.

[0065] In another structure, the arched portion 310 of the arched member 300 extends distally to a guide portion 320. The guide portion 320 can be formed by directly extending the arched member 300 outwards. The guide portion 320 has a hollow structure or a concave structure to improve the flexibility of the guide portion 320. For example, it can be cut into a spiral spring shape or a snake bone shape using laser cutting to increase the elasticity and flexibility of the puncture-resistant member 600.

[0066] The arched component 300 is provided with a positioning element 700 at its distal end to prevent the arched component and the annular device from tipping over. The positioning element 700 is used to position and fix the arched component 300. Since the arched component 300, located at the distal end of the distal anchor 100, can swing and bend freely, it cannot be accurately positioned within the great cardiac vein 1 above the coronary circumflex artery 2. If it cannot be positioned within the great cardiac vein 1, it may not function properly. Therefore, it is preferable to have a positioning element 700 at the distal end of the arched component 300. Positioning requires that the diameter or width of the positioning element 700 be equivalent to or substantially equivalent to the diameter or width of the distal anchor 100. "Equivalent" means the same or substantially the same; that is, the difference between them does not affect the function of the positioning element 700, allowing it to provide anchoring and prevent the arched component 300 from tipping over. Furthermore, it is preferable that the center or central axis of the positioning element 700 coincides with or substantially coincides with the central axis of the distal anchor or the entire device to ensure that the center of gravity of the positioning element 700 does not shift, further increasing the stability of the device.

[0067] The positioning element 700 can be a closed-loop structure or an open-loop structure. A closed-loop structure refers to a structure without openings in the circumferential direction, while an open-loop structure refers to a structure with openings in the circumferential direction. The shape or cross-sectional shape of the closed-loop and open-loop structures can be a ring, a ring formed by connecting the ends of curved surfaces with different curvatures, or a ring formed by connecting the ends of multiple straight lines and curves.

[0068] The closed-loop structure includes one of the following: single-loop structure, multi-loop structure, radial loop structure, and axial three-dimensional loop structure. A single-loop structure refers to the braided yarns forming a loop once. A multi-loop structure refers to the braided yarns forming multiple loops. A radial loop structure refers to the braided yarns reciprocating around a central point to form a ring-shaped surface structure. A circumferential three-dimensional loop structure is a cylindrical structure formed by the braided yarns reciprocating around a central axis.

[0069] The structures described above can be categorized by diameter or width as follows: same-diameter structures, radially variable-diameter structures, or axially variable-diameter structures. A same-diameter structure refers to a positioning element composed of multiple rings with the same diameter or width, forming a cylindrical structure. Examples include helical rings of the same diameter, helical square rings of the same diameter, and irregular helical rings of the same diameter. A radially variable-diameter structure is a ring-shaped planar structure with multiple rings nested together. An axially variable-diameter structure is generally a cylindrical structure with different diameters or widths at different positions along the axial direction. Examples include trumpet-shaped, ellipsoidal, and spherical shapes.

[0070] In this invention, all components can be made of elastic shape memory metal wire, such as nickel, titanium, or an alloy of both, for example, nickel-titanium wire. The proximal anchor 200, distal anchor 100, connector 500, and arched component 300 are a woven integral structure; or at least two of the proximal anchor 200, distal anchor 100, connector 500, and arched component 300 are separately fixedly connected together. The fixed connection can be achieved by using a connecting sleeve, or by riveting, welding, screwing, snap-fitting, etc.

[0071] The following is an illustration through specific examples:

[0072] Example 1, as Figure 1-6 As shown, the mitral valve annular constriction device consists of a distal anchor 100, a proximal anchor 200, a connector 500, and an arched component 300. Both the distal anchor 100 and the proximal anchor 200 are cage-shaped by braiding nickel-titanium wire. The distal anchor 100 includes two opposing annular support rings 110, connected at the top by braided strands 120 and at the bottom by parallel braided strands 130. The proximal anchor 200 also includes two opposing annular support rings 210, connected at the top by braided strands 220 and at the bottom by parallel braided strands 230. The connector 500 and the distal anchor 100 are respectively provided with a locking ring 160 and a locking knot 170 at their distal and proximal ends, respectively. The proximal anchor 200 is provided with a locking ring 260 and a locking knot 270 at its proximal end. The locking ring 160, through the fixing sleeve 150 and the locking knot 170 provided on the bottom braided strands 130, keeps the distal anchor 100 in an expanded shape. The locking ring 260 is positioned by a retaining sleeve 250 and a locking knot 270 provided on the bottom braided wire 230, which keeps the proximal anchor 200 in an expanded shape. Preferably, the locking knot 170 is a structure formed by the distal end of the connector 500 arching to both sides.

[0073] In this embodiment, the arched component 300 is located outside the distal end of the distal anchor 100 and is made of nickel-titanium tubing. The arched component 300 is semi-circular in shape, approximately 10mm-15mm long and 4-10mm high. The arched component 300 is placed on the circumflex artery 2, and its semi-circular shape allows the circumflex artery 2 to pass through without compressing it. To prevent the distal end (free end) of the arched component 300 from being suspended and too rigid to puncture blood vessels, the distal end of the arched component 300 is laser-cut to create a shape similar to... Figure 1 The shape is that of a helical spring, or cut into the shape of a coil spring. Figure 7 The snake-bone shape increases the elasticity and flexibility of the distal end. The nickel-titanium wire ends of the distal ends of the arched component 300, the connector 500, and the distal anchor 100 are fixed by a fixing sleeve 150, which can be fixed by riveting, welding, or structural snap-fitting. In this embodiment, the arched component 300 only has an arched portion 310.

[0074] The proximal end of the near-end anchor 200 is provided with a locking knot 270 and a fixing sleeve 250 to restrict the position of the locking ring 260 of the near-end anchor 200, so that the near-end anchor 200 maintains its expanded shape. The connector 500, the nickel-titanium wire end of the near-end anchor 200 and the locking knot 270 are connected and fixed by the fixing sleeve 250, which can also be fixed by riveting, welding or structural snap-fit.

[0075] The arched component 300 is placed above the coronary circumflex artery 2. When the distal anchor 100 is anchored and tightened, the arched component 300 will push the great cardiac vein 1 upward, preventing it from being pressed down and thus avoiding compression of the circumflex artery 2.

[0076] This type of arched component 300, with the device at the distal end of the distal anchor 100, is suitable for patients whose coronary sinus 3 vent is located at the intersection of the circumflex artery 2 and the great cardiac vein 1.

[0077] like Figure 2 As shown, the arched component 300 has a stab-proof component 600 at its distal end. The stab-proof component 600 can be directly welded using laser welding or argon arc welding to create a smooth, non-sharp surface at the end of the arched component 300, such as a spherical or hemispherical structure. Figure 1 When the anti-stab part 600 is not used, mechanical grinding is required to smooth the far end of the arched part 300.

[0078] like Figure 3 As shown, the arched component 300 can be made by twisting together one or more strands of nickel-titanium wire into a braid-like shape, and then shaping it into an arch. Both ends of the nickel-titanium wire are placed in the fixing sleeve 150 of the distal anchor 100. The arched component 300 includes an arched portion 310 and a guiding portion 320, with the guiding portion 320 located at the distal end of the arched portion 310. In this embodiment, the distal end of the guiding portion 320 is woven from braided wire and has no sharp parts, making it ready for direct use.

[0079] like Figure 4 As shown, the arched member 300 includes an arched portion 310 and a guide portion 320, with the guide portion 320 disposed at the distal end of the arched portion 310. A puncture-resistant member 600 is disposed at the free end of the guide portion 320.

[0080] like Figure 5-6 The diagram shown is an effect of the mitral valve annulus device being implanted into the heart in this embodiment. The distal anchor 100 is fixed in the great cardiac vein 1, the proximal anchor 200 is fixed in the coronary sinus 3, and the arched member 300 is placed in the great cardiac vein 1 above the coronary circumflex artery 2 to ensure that the circumflex artery 2 is not compressed.

[0081] Example 2, as Figure 7-10As shown, this embodiment is an improvement on embodiment 1. The mitral valve annulus retraction device consists of a distal anchor 100, a proximal anchor 200, and a connector 500. The structures of the distal anchor 100 and the proximal anchor 200 are the same as in embodiment 1. They will not be described again here.

[0082] like Figure 7-8 As shown, the difference from Embodiment 1 is that the arched member 300 is positioned outside the proximal end of the distal anchor 100, meaning the arched member 300 is connected to the connector 500. The arched member 300 can be positioned in two ways, one of which is as follows: Figure 7 The distal anchor 100 is positioned between the connector 500 as shown; the second type is as follows: Figure 8 The connector 500 shown is divided into two parts, and the arched member 300 is disposed between the two parts of the connector 500.

[0083] like Figure 7 As shown, the arched member 300 is disposed between the distal anchor 100 and the connector 500. The arched member 300 is directly disposed at the proximal end of the distal anchor 100. The connector 500 is formed by shaping nickel-titanium wire. The arched member 300 can be an integral structure with the connector 500, or it can be fixedly connected together. The locking knot 160 at the farthest end of the connector 500 becomes part of the arched member 300. Starting from the locking knot 160, the arched member 300 deforms upward.

[0084] like Figure 8 As shown, the arched member 300 can also be set in the connector 500, that is, the connector 500 connects a part at the far end and the near end of the arched member 300, and the far end anchor 100 connects the locking ring 160 and the locking knot 170 at the near end.

[0085] like Figure 9-10 As shown, the distal anchor 100 is fixed in the great cardiac vein 1, the proximal anchor 200 is fixed in the coronary sinus 3, and the arched member 300 is placed in the great cardiac vein 1 above the coronary circumflex artery 2 to ensure that the circumflex artery 2 is not compressed. In this embodiment, the arched member 300 is designed on the proximal side of the distal anchor 100, so that the distal anchor 100 can cross the coronary circumflex artery 2 and be anchored further distally in the great cardiac vein 1. The anchoring position of the entire mitral valve annulus constriction device in the great cardiac vein 1 corresponds to the P1-P3 region of the mitral valve, surrounding the mitral valve annulus by a longer distance. When the device is tightened, it can increase the degree of mitral valve annulus constriction, allowing the mitral valve leaflets to close completely, resulting in better treatment of mitral regurgitation.

[0086] Example 3, as Figure 11 As shown, this embodiment is an improvement on embodiment 1. The mitral valve annulus retraction device consists of a distal anchor 100, a proximal anchor 200, and a connector 500. The proximal anchor 200 and connector 500 have the same structure as in embodiment 1, and will not be described again here.

[0087] The difference from Embodiment 1 is that: the distal anchor 100 is provided with an arched member 300, which is connected to the braided wire 130 at the bottom of the distal anchor 100. That is, the braided wire 130 at the bottom of the distal anchor 100 arches upward to form the arched member 300. Alternatively, the arched member 300 can be made separately and fixedly connected to the middle of the braided wire 130. The arched member 300 is formed by shaping nickel-titanium wire or nickel-titanium tube.

[0088] The arched component 300 inside the distal anchor 100 is placed on the upper side of the circumflex artery 2 to avoid compression of the circumflex artery 2.

[0089] Example 4, as Figure 12-13 As shown, this embodiment is an improvement on the basis of embodiment 1. The difference from embodiment 1 is that a positioning member 700 is connected to the far end of the arched member 300.

[0090] The positioning element 700 extends outward from the distal end of the arched element 300 and can be formed by shaping a nickel-titanium wire. The positioning element 700 has a radially variable diameter multi-ring structure; specifically, the positioning element 700 is a single-ring or multi-ring structure, such as... Figure 12 As shown, in this embodiment, the ring has one and a half turns, but it can also be wound multiple times. Each subsequent turn is inside the previous turn, and the nickel-titanium wire end is located at the innermost turn to prevent the wire end from piercing blood vessels. The outermost diameter of the ring structure at the distal end of the arched component 300 is equivalent to that of the distal anchor 100, which can serve as an anchor and prevent the arched component 300 from tipping over.

[0091] In addition to the above structure, the positioning component 700 can be: the arched component 300 can be multiple shapes of gradually decreasing size, such as a circle with a gradually decreasing diameter, a fan shape with a gradually decreasing side, etc. It can also be: such as... Figure 13 The spiral rings of the same diameter shown are as follows: Figure 14 The examples shown are helical square rings of the same diameter and irregular helical rings of the same diameter.

[0092] like Figure 15 As shown, the arched component 300 has a wave-like structure, meaning that the braided threads reciprocate around the central axis to form a cylindrical structure. This three-dimensional cylindrical structure can support the blood vessel wall, providing better anchoring and preventing the arched component 300 from tipping over.

Claims

1. A mitral valve annulus retraction device, comprising a distal anchor for anchoring in a great cardiac vein near the crossing point with the circumflex artery, and a proximal anchor for anchoring in the coronary sinus; said proximal anchor and distal anchor are connected by a connector; characterized in that, An arched member is provided at the distal end of the distal anchor for crossing the coronary circumflex artery, the arched member arching toward the top of the distal anchor; The far end of the arched component is provided with a positioning component to prevent the arched component and the ring-shrinking device from tipping over. The diameter or width of the positioning component is equivalent to the diameter or width of the far end anchor. The arched member includes an arched portion that extends axially outward from the bottom of the distal anchor and arches towards the top of the distal anchor; the arched portion has at least a smooth, non-sharp structure at its top. The center or central axis of the positioning component coincides or substantially coincides with the central axis of the distal anchor or the entire device; the positioning component is a closed-loop structure or an open-loop structure, and the cross-sectional shape of the closed-loop structure and the open-loop structure is a circular ring, or a ring formed by connecting the ends of arc surfaces with different curvatures, or a ring formed by connecting the ends of multiple straight lines and curves.

2. The mitral valve annulus retraction device according to claim 1, characterized in that, The arched portion of the arched member located outside the far end of the far anchor has a guide portion extending outward.

3. The mitral valve annulus retraction device according to claim 2, characterized in that, The guide portion is provided with a hollow structure or a concave structure to improve the flexibility of the guide portion; or the guide portion is a flexible structure made of flexible material.

4. The mitral valve annulus retraction device according to claim 1, characterized in that, The arched component is a single tubular or coarse filament, or it is a double or multi-strand twisted structure, or it is a double or multi-strand wound structure.

5. The mitral valve annulus retraction device according to claim 4, characterized in that, At least a portion of the tubular arched member has a hollow structure extending at least in the circumferential direction on its surface; or at least a portion of the filamentous arched member has a concave structure extending at least in the circumferential direction on its surface.

6. The mitral valve annulus retraction device according to claim 1, characterized in that, The closed-loop structure includes one of the following: single-ring structure, multi-ring structure, radial loop structure, and axial three-dimensional ring structure.

7. The mitral valve annulus retraction device according to claim 1, characterized in that, The positioning element can be a structure with the same diameter, a radially variable diameter structure, or an axially variable diameter structure.

8. The mitral valve annulus retraction device according to claim 1, characterized in that, The near-end anchor, far-end anchor, connector, and arched component are an integral woven structure; or at least two of the near-end anchor, far-end anchor, connector, and arched component are separately fixed together.

9. The mitral valve annulus retraction device according to claim 8, characterized in that, The bottom of the near-end anchor and the far-end anchor are respectively fitted with a fixing sleeve, and the bottom of the near-end anchor and the far-end anchor are provided with a locking knot outside the fixing sleeve, locking the near-end anchor and the far-end anchor to extend into a three-dimensional structure.

10. The mitral valve annulus retraction device according to claim 1, characterized in that, The top of at least one of the near-end anchors and the far-end anchors has an interwoven braided structure.

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