Positioning device for a capture loop, capture assembly and prosthetic valve system

Abstract

The present application relates to a kind of positioning device for fishing ring, fishing assembly and artificial valve system, wherein, fishing assembly is made of positioning device and fishing ring;Positioning device is hollow long tubular structure, including connecting portion and positioning portion, connecting portion can be set in the first turn of the functional segment of fishing ring near annulus, positioning portion is preferably cut from connecting portion and heat set, when in vivo transport positioning device and fishing ring, the outer peripheral side wall of connecting portion can be in the same camber with positioning portion, to reduce the volume when transport, improve the passability of both in blood vessel cavity, when releasing fishing ring, positioning portion can be radially outward and extend to annulus side in radial direction, so that positioning device is located together with fishing ring in the bottom of annulus, when ventricle contracts and pumps blood, the amplitude of axial movement of fishing ring when being impacted by blood will be greatly weakened, so as to greatly slow down the pulling force on chordae tendineae, improve the fatigue life of chordae tendineae, to prevent its rupture.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac interventional procedures, and more particularly to a positioning device, a retrieval assembly, and an artificial valve system for a retrieval ring. Background Technology

[0002] For the treatment of valvular heart disease, surgery remains the preferred treatment for patients with severe valvular disease. However, for elderly patients, those with multiple organ diseases, those with a history of open-heart surgery, and those with poor cardiac function, the mortality rate of surgery is high, and some patients even lose the opportunity for surgery altogether. In recent years, transcatheter valve replacement / repair has gradually matured and become widely used. In particular, the successful advancement of aortic valve replacement has spurred exploration into transcatheter mitral valve replacement for the treatment of regurgitation.

[0003] However, mitral valve replacement is far more difficult than aortic valve replacement in many ways. For example, the mitral valve has a saddle-shaped spatial structure rather than the traditional round shape; it has a more complex tissue structure (annulus, leaflets, chordae tendineae, papillary muscles); it is larger and more elongated than the aorta; and its leaflets are softer. Compared to aortic stenosis or calcification, the mitral valve cannot provide adequate fixation for the replacement valve. Furthermore, because the pressure in the left ventricle rises sharply during left ventricular contraction, if the replaced valve stent fails to establish sufficient anchorage at the mitral valve annulus, displacement may occur. Therefore, effective mitral valve replacement for regurgitation treatment requires not only withstanding the large cyclic load from the mitral valve but, more importantly, establishing a stable and robust anchorage.

[0004] To enhance the radial support provided by the native leaflet to the valve stent and firmly fix the stent to the leaflet, an anchoring device, also known as a catching ring, is usually added to the chordae tendineae plexus outside the leaflet. The catching ring can hold the leaflet and the valve stent together. However, because the anchoring of the catching ring to the valve stent is subject to the tension of the chordae tendineae, the chordae tendineae experience fatigue under the continuous impact of blood flow, leading to tearing or rupture and causing the valve stent to shift.

[0005] Given the above shortcomings, how to stably position the fishing ring and avoid excessive traction on the tendineae when the fishing ring is subjected to blood impact has become an urgent technical problem to be solved. Summary of the Invention

[0006] This invention discloses a positioning device, a fishing component, and an artificial valve system for a fishing ring, aiming to solve the problem in the prior art that the fishing ring is prone to excessive traction on the chordae tendineae when subjected to blood impact, ultimately leading to chordae tendineae tearing.

[0007] The present invention adopts the following technical solution:

[0008] On one hand, the present invention provides a positioning device for a fishing ring, comprising:

[0009] - Connecting part, the connecting part is tubular, and can be fitted onto the outer periphery of at least one turn of the fishing ring adjacent to the petal ring, and conforms to the shape change of the fishing ring;

[0010] - Positioning section, the positioning section includes a plurality of positioning elements, the positioning elements are spaced apart on at least a portion of the outer periphery of the connecting section; when the positioning elements are delivered in the body, they are on the same curved surface as the outer periphery of the connecting section, and the plurality of positioning elements are radially arranged after implantation into the heart, extending radially outward and toward the valve annulus side, so that the positioning device can be confined to the bottom of the valve annulus.

[0011] As a preferred technical solution, the inner diameter of the connecting part is configured to be able to transition fit or clearance fit with the fishing ring;

[0012] The outer diameter of the connecting part is configured such that at least one turn of the adjacent petal ring corresponding to the fishing ring has a larger outer diameter than the fishing ring.

[0013] As a preferred technical solution, the connecting part has a cut in at least a portion of its inner circumferential side, and the direction of the cut is perpendicular to the axial direction of the connecting part.

[0014] As a preferred technical solution, the connecting part and the positioning part are fixedly connected or integrally formed; the connecting part has a groove on its outer peripheral side, the groove matches the contour of the positioning element, the groove can accommodate the positioning element when transported in the body, so that the positioning element can be on the same curved surface as the outer peripheral sidewall of the connecting part.

[0015] As a preferred technical solution, the angle between the positioning element and the outer peripheral wall of the connecting part after implantation in the heart is 60-90°.

[0016] As a preferred technical solution, a number of positioning elements are arranged at equal or unequal intervals on the outer periphery of the connecting part.

[0017] As a preferred technical solution, a number of positioning elements are arranged at equal or unequal intervals on the outer periphery of the connecting part.

[0018] As a preferred technical solution, the positioning element is polygonal or semi-circular.

[0019] As a preferred technical solution, the positioning device also includes a fixing part, which is disposed at both ends or one end of the connecting part along the axial direction. The fixing part has a hollow cylindrical structure and can be sleeved on the outside of the fishing ring.

[0020] The inner diameter of the fixing part is configured to allow for a transition fit or interference fit with the fishing ring.

[0021] As a preferred technical solution, the connecting part, positioning part and fixing part are integrally formed, and all three are made of shape memory alloy material.

[0022] As a preferred technical solution, it also includes a flexible auxiliary expansion portion, which is disposed in at least a portion of the outer periphery of the connecting portion, and the auxiliary positioning portion extends radially outward to reduce perivalvular leakage.

[0023] As a preferred technical solution, the auxiliary expansion section includes a PET film.

[0024] In a second aspect, the present invention provides a fishing assembly, including a positioning device for a fishing ring as described in any of the preceding claims, and further including a fishing ring, the fishing ring being spiral-shaped and capable of being positioned outside the chordae tendineae of the native valve and conforming to changes in the morphology of the native valve annulus.

[0025] Thirdly, the present invention provides an artificial valve system, including a retrieval assembly as described in any of the preceding claims, and a valve stent; at least a portion of the valve stent defines a flow channel for blood flow; the valve stent is capable of being positioned inside the native valve and replacing the physiological function of the native valve; at least a portion of the valve stent cooperates with the retrieval assembly.

[0026] The technical solution adopted in this invention can achieve the following beneficial effects:

[0027] This invention provides a positioning device and a catching assembly for a catching ring. The catching assembly consists of a positioning device and a catching ring. The positioning device is a hollow, elongated tubular structure, including a connecting part and a positioning part. The connecting part can be fitted onto the outer periphery of the first turn of the catching ring near the valve annulus. The positioning part is preferably cut and heat-formed from the connecting part. During in vivo delivery of the positioning device and the catching ring, the positioning part can be on the same curved surface as the outer peripheral sidewall of the connecting part to reduce the volume during delivery and improve the passage of both in the vascular lumen. After the catching ring is released, the positioning part can extend radially outward and toward the valve annulus, so that the positioning device together with the catching ring is confined to the bottom of the valve annulus. When the ventricle contracts and pumps blood, the axial movement of the catching ring under the impact of blood is greatly reduced, thereby significantly reducing the traction force on the chordae tendineae, improving the fatigue life of the chordae tendineae, and preventing its breakage.

[0028] To enhance the positioning performance of the positioning device, the size of the connecting part can be appropriately increased to provide a larger contact area between the entire catching assembly and the valve ring, thereby further restricting the axial movement of the catching ring. In addition, an auxiliary expansion part, such as a PET membrane, can be set on the outer periphery of the connecting part. On the one hand, when the heart contracts, blood will impact the mitral valve plane, and the risk of paravalvular leakage will be further reduced under the protection of the PET membrane. On the other hand, setting a PET membrane outside the positioning device is also beneficial for myocardial tissue.

[0029] Another aspect of the present invention provides an artificial valve system, including a valve stent and the aforementioned retrieval assembly. The retrieval assembly can surround the chordae tendineae, capturing the native valve leaflet while providing a positioning point for subsequent valve stent implantation. The valve stent can be implanted into the mitral or tricuspid valve and replace the physiological function of the native valve. Because the retrieval assembly contains a positioning device, it can be axially limited, preventing undesirable displacement of the retrieval assembly during the cardiac cycle due to tissue relaxation / contraction. This avoids excessive traction on the chordae tendineae, causing tearing, and also prevents displacement or misalignment of the valve stent. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0031] Figure 1 This is a schematic diagram of the positioning device in a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0032] Figure 2 This is a top view of the positioning device in use according to a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0033] Figure 3 This is a top view of the positioning device in use in another preferred embodiment of the present invention disclosed in Embodiment 1;

[0034] Figure 4 This is a schematic diagram of the structure of the fishing assembly in a preferred embodiment of Embodiment 2 of the present invention;

[0035] Figure 5 This is a diagram showing the usage state of the fishing component in a preferred embodiment of Embodiment 2 of the present invention;

[0036] Figure 6 for Figure 5 A magnified view of a portion of the image;

[0037] Figure 7 This is a schematic diagram of the structure of an artificial valve system in a preferred embodiment of the present invention, as disclosed in Embodiment 3 of the present invention;

[0038] Figure 8 This is a diagram showing the usage status of an artificial valve system in a preferred embodiment of the present invention, as disclosed in Embodiment 3 of the present invention.

[0039] Explanation of reference numerals in the attached figures:

[0040] Positioning device 100, connecting part 110, positioning part 120, positioning element 121, groove 122, fixing part 130, through hole 131, auxiliary expansion part 140; catching ring 200, functional segment 210, atrial segment 220, ventricular segment 230, transition segment 240; valve stent 300; left atrium 400; left ventricle 500; original leaflet 600; chordae tendineae 700; valve annulus 800. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0042] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or a magnetic connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0043] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0044] To address the problems existing in the prior art, embodiments of the present invention provide a positioning device for a fishing ring. The positioning device includes a connecting part, a positioning part, and a fixing part. The connecting part is tubular and can be fitted onto the outer periphery of at least one turn of the fishing ring adjacent to the valve annulus, adapting to changes in the shape of the fishing ring. The positioning part includes a plurality of positioning elements, which are spaced apart and disposed in at least a portion of the outer periphery of the connecting part. When the positioning elements are transported in the body, they are on the same curved surface as the outer periphery of the connecting part. After implantation into the heart, the positioning elements are radially arranged and extend radially outward and toward the valve annulus, so that the positioning device can be confined to the bottom of the original valve annulus. The fixing part is disposed at least at one end of the positioning device along its axial direction for fixing to the fishing ring.

[0045] Example 1

[0046] To address the problems existing in the prior art, this embodiment provides a positioning device for a fishing ring, which needs to be used in conjunction with the fishing ring; for ease of understanding, this embodiment will describe the positioning device in conjunction with the structure of the fishing ring.

[0047] refer to Figure 8 Taking mitral valve implantation as an example, in a preferred embodiment, the retrieval ring 200 is generally spiral-shaped and can be implanted into the chordae tendineae of the mitral valve through the vascular lumen via the delivery system. It provides axial and radial forces to cooperate with the valve stent 300 implanted in the mitral valve and interact with it. The cooperation of the two can reduce the size of the natural mitral valve and reduce mitral regurgitation in the natural valve leaflet. At the same time, the retrieval ring 200 can more firmly anchor the valve stent 300 in the position of the native valve, effectively preventing the valve stent 300 from shifting during myocardial movement. Preferably, after the catching ring 200 is implanted around the chordae tendineae, the section that directly interacts with the valve stent 300 is defined as the functional segment 210. The functional segment 210 includes one to several turns of a spiral coil structure. In a preferred embodiment, the upper end of the functional segment 210 has one turn of the spiral coil structure close to or abutting against the valve annulus 800, and the lower end of the functional segment 210 is adjacent to the left ventricle 500. Optionally, the upper and lower ends of the functional segment 210 may have different spiral diameters.

[0048] Those skilled in the art should understand that the above-mentioned "approaching" or "contacting" means: the functional segment 210 can directly contact the valve annulus 800, which is "contacting"; or it can be close to the valve annulus 800 but not in direct contact with it, which is "approaching".

[0049] Since the upper end of the functional segment 210 of the capture ring 200 cannot be directly and stably positioned at the valve annulus 800, when the left ventricle 500 contracts and pumps blood into the aorta, the capture ring 200 is impacted by the blood flow and tends to move upward (i.e. towards the left atrium 400). Furthermore, because the anchoring of the capture ring 200 and the valve stent 300 is pulled by the chordae tendineae 700, over time, the capture ring 200 will be continuously impacted by the blood flow, causing the chordae tendineae 700 to experience fatigue, resulting in tearing or rupture of the chordae tendineae 700.

[0050] refer to Figures 1-3 In a preferred embodiment, a positioning device 100 is provided at least on one turn of the spiral coil structure at the upper end of the functional section 210 of the fishing ring 200 to reduce the tendency and amplitude of axial movement of the fishing ring 200 when it is impacted, thereby minimizing the pulling force on the tendon 700 and preventing the tendon 700 from breaking.

[0051] It should be noted that although the upper end of the functional segment 210 is defined as approaching or abutting the petal ring 800 in the above embodiments, the fishing rings 200 from different manufacturers have different structures. Therefore, not all fishing rings 200 have their upper end of the functional segment 210 abutting or approaching the petal ring 800. That is, the spiral coil structure that approaches / abuts the bottom of the petal ring 800 may not belong to the functional segment 210. Therefore, without departing from the spirit of the present invention, those skilled in the art should understand that regardless of whether the spiral coil structure at the upper end of the functional segment 210 approaches / abuts the bottom of the petal ring 800, the positioning device 100 is always disposed on the outer periphery of the spiral coil structure of the fishing ring 200 that approaches / abuts the petal ring 800. Preferably, the positioning device 100 includes a connecting portion 110, a positioning portion 120, and a fixing portion 130, which are fixedly connected or integrally formed. The connecting portion 110 is a hollow tube that can be fitted onto at least one outer circumference of the catching ring 200 near the valve annulus 800, directly abutting the bottom of the valve annulus 800. The material of the connecting portion 110 is also configured to allow it to adapt to changes in the shape of the catching ring 200. The positioning portion 120 is disposed in at least a portion of the outer periphery of the connecting portion 110, and after implantation and release, extends radially outward and upward (i.e., towards the valve annulus 800). At this time, the entire positioning portion 120 unfolds like a petal, allowing the positioning device 100 to be confined to the bottom of the valve annulus 800. Figure 6 Preferably, the fixing part 130 is provided at least at one end of the connecting part 110 for fixing to the fishing ring 200.

[0052] In a preferred embodiment, both the connecting part 110 and the fixing part 130 are tubular. The fixing part 130 is disposed at the distal or proximal end of the connecting part 110, and the fixing part 130 has a variable diameter structure. The inner diameter of the fixing part 130 matches the outer diameter of the fishing ring 200, and the two can be interference fit or transition fit, so that the fixing part 130 can be fixed to the outside of the fishing ring 200.

[0053] In another preferred embodiment, both the connecting part 110 and the fixing part 130 are tubular. The fixing part 130 is provided at both the distal and proximal ends of the connecting part 110. The fixing part 130 is a variable diameter structure. The inner diameter of the fixing part 130 matches the outer diameter of the fishing ring 200. The two can be interference fit or transition fit, so that the fixing part 130 can be fixed to the outside of the fishing ring 200.

[0054] Compared to providing one fixing part 130, providing two fixing parts 130 at each end of the connecting part 110 allows the positioning device 100 to be connected to the fishing ring 200 more stably. However, a potential problem is that since the fishing ring 200 is transported in a straight line, the positioning device 100 is also in a straight tube shape. But when the fishing ring 200 is positioned on the outer circumference of the petal ring 800, it will return to a predetermined spiral shape. At this time, the positioning device 100 will bend into an arc shape (or an open ring). If two fixing parts 130 are provided, it may restrict the bending of the positioning device 100, and may even restrict the fishing ring 200 from returning to a spiral shape. To solve the aforementioned problems, preferably, the connecting part 110 has a cut in at least a portion of its inner circumference, and the direction of the cut is perpendicular to the axial direction of the connecting part 110. When the positioning device 100 deforms with the deformation of the fishing ring 200, the cut can provide suitable radial deformation space for the bending of the positioning device 100 (especially the connecting part 110).

[0055] In one preferred embodiment, the fixing part 130 can be glued or welded to the outside of the fishing ring 200; in another preferred embodiment, the fixing part 130 is provided with a through hole 131, and the fishing ring 200 is also provided with a through hole 131 at the same position. After aligning the through holes 131, the fixing part 130 and the fishing ring 200 are sewn and fixed.

[0056] Preferably, the inner diameter of the connecting portion 110 is configured to be able to transition fit or clearance fit with the fishing ring 200; preferably, the outer diameter of the connecting portion 110 is configured to have a larger outer diameter than the fishing ring 200 at least in one turn corresponding to the adjacent petal ring 800 of the fishing ring 200.

[0057] When the inner diameter of the connecting part 110 is in transition fit with the fishing ring 200, the relative positional relationship between the two can be made more stable, and the entire positioning device 100 can be connected to the fishing ring 200 more stably. When the inner diameter of the connecting part 110 is in clearance fit with the fishing ring 200, it can provide a suitable radial deformation space for the bending of the positioning device 100, and avoid the bending of the connecting part 110 being restricted.

[0058] When the outer diameter of the connecting part 110 is larger than the outer diameter of the catching ring 200, the contact area between it and the petal ring 800 can be increased. On the one hand, this allows the positioning device 100 and the catching ring 200 to be positioned more stably on the outer periphery of the petal ring 800. On the other hand, it can further reduce the risk of periphery leakage.

[0059] Preferably, the connecting part 110 and the fixing part 130 are integrally formed from a nickel-titanium metal tube; in a preferred embodiment, the connecting part 110 and the fixing part 130 have the same wall thickness, which is 0.2 to 0.5 mm, and their total axial length is 75 to 85 mm. The inner diameter of the connecting part 110 is 3 to 6 mm, and the inner diameter of the fixing part 130 is 2 to 3 mm.

[0060] Those skilled in the art should understand that the actual dimensions of the connecting part 110 and the fixing part 130 depend on the size of the catching ring 200, which in turn depends on the patient's different physiological and pathological conditions. When the patient is a child, the mitral valve size is small, so the required size of the catching ring 200 is also correspondingly smaller, and the size of the positioning device 100 should also decrease as the size of the catching ring 200 decreases. When the patient is an adult, the mitral valve size is large, so the required size of the catching ring 200 is also correspondingly larger, and the size of the positioning device 100 should also increase as the size of the catching ring 200 increases. Since the functional segment 210 dimensions of catching rings 200 of different sizes are not nearly the same, the lengths and dimensions of the connecting part 110 and the fixing part 130 described above are merely examples. Those skilled in the art can make specific adjustments to the dimensions of the connecting part 110 and the fixing part 130 based on the actual size of the catching ring 200, which will not be illustrated here.

[0061] Preferably, the positioning part 120 includes a plurality of positioning elements 121. When the connecting part 110 bends with the catching ring 200, the connecting part 110 becomes annular. At this time, the positioning elements 121 are spaced apart on the outer periphery of the connecting part 110. Preferably, when the positioning elements 121 are transported in the body, they are on the same curved surface as the outer periphery of the connecting part 110. After implantation into the heart, the plurality of positioning elements 121 extend radially outward and upward (in the direction of the valve annulus 800). Figure 2 To anchor the position of the fishing ring 200.

[0062] In a preferred embodiment, the positioning part 120 is formed by cutting and heat-setting the connecting part 110. At this time, the outer peripheral side of the connecting part 110 has a groove 122. The groove 122 is the through hole 131 or blind hole when the positioning element 121 is cut from the connecting part 110. Therefore, the groove 122 matches the contour / size of the positioning element 121. The groove 122 can accommodate the positioning element 121 when it is transported in the body, so that the positioning element 121 can be on the same curved surface as the outer peripheral sidewall of the connecting part 110.

[0063] Preferably, both the positioning part 120 and the connecting part 110 are made of nickel-titanium alloy. This material has shape memory properties, which can be pre-shaped into the working state at high temperatures and have a certain degree of elasticity at low temperatures, so as to ensure that it can be transported in the human blood vessel cavity along with the fishing ring 200. Therefore, during delivery, the positioning element 121 can be temporarily engaged in the groove 122, at which time the positioning part 120 and the connecting part 110 form a complete tubular structure. When the positioning element 121 is released in the heart along with the catching ring 200, the positioning element 121 extends outward radially. Preferably, after the positioning element 121 is released in the heart, the angle between the positioning element 121 and the outer peripheral sidewall of the connecting part 110 is 60-90°, so that the positioning part 120 can stably rest against the root of the mitral valve. When the catching ring 200 is impacted by blood flow, the catching ring 200 will move axially, but due to the restriction of the "petal-like" positioning part 120, the axial movement of the catching ring 200 will be significantly reduced, thereby reducing the traction force on the chordae tendineae 700, improving the fatigue life of the chordae tendineae 700, and preventing its breakage.

[0064] In one preferred embodiment, the positioning element 121 is a polygon, such as a triangle, quadrilateral, pentagon, etc.; in another preferred embodiment, the positioning element 121 is configured as a semi-circular arc.

[0065] Those skilled in the art will understand that when the positioning element 121 is configured as a polygon (such as a triangle), the positioning element 121 has sharp corners that can penetrate into the patient's original tissue. Although this can increase the anchoring effect of the entire positioning device 100 and the catching ring 200, there is a possibility of myocardial injury. When the positioning element 121 is configured as a semi-circular arc, the positioning element 121 no longer has sharp corners. Although the anchoring effect may not be as good as the polygonal solution, it will not cause damage to the myocardium and is safer to use.

[0066] Preferably, the positioning elements 121 are spaced apart on the outer periphery of the connecting portion 110. The specific spacing can be freely set according to the size of the positioning elements 121 or the connecting portion 110, and is not limited in this embodiment.

[0067] Preferably, the length of the positioning element 121 is less than half the circumference of the connecting portion 110, so as to avoid the positioning element 121 being too long and unable to unfold after being released into the heart; more preferably, the length of the positioning element 121 is 1 / 4 of the circumference of the connecting portion 110.

[0068] In one optional embodiment, the positioning elements 121 on the outer periphery of the connecting portion 110 can be arranged at equal intervals or at unequal intervals; in another optional embodiment, adjacent positioning elements 121 can be arranged with the same size / shape or with unequal size / different shapes. For example, the cross-sectional shape of the mitral valve is approximately D-shaped. The positioning elements 121 are larger in size and smaller in spacing in the straight section corresponding to the mitral valve annulus 800 to increase the contact area thereon. The positioning elements 121 are smaller in size and larger in spacing in the curved section corresponding to the mitral valve annulus 800, and their curvature can properly adapt to the curvature of the annulus 800.

[0069] In an optional embodiment, the size and spacing of each positioning element 121 in the positioning unit 120 can be determined or designed according to the actual size of the patient's mitral valve. For example, before the operation begins, the shape of the mitral valve can be determined in the imaging system, and then the structure of each positioning element 121 can be determined.

[0070] like Figure 3 In a preferred embodiment, a flexible auxiliary expansion portion 140 is provided outside the connecting portion 110. The auxiliary expansion portion 140 is disposed in at least a portion of the outer periphery of the connecting portion 110. The auxiliary positioning portion 120 extends radially outward. When the heart contracts, blood impacts the mitral valve plane, and the auxiliary expansion portion 140 can further reduce the risk of paravalvular leakage.

[0071] Preferably, the auxiliary expansion portion 140 is a PET film. Since PET film has the characteristics of high tensile strength, thin thickness, high coefficient of friction and high surface tension, PET film is selected as the material of the auxiliary expansion portion 140. In addition, using the auxiliary expansion portion 140 is also beneficial to protect myocardial tissue.

[0072] In a preferred embodiment, the auxiliary expansion portion 140 is disposed on the outer periphery of the connecting portion 110, below the positioning element 121 after it is unfolded.

[0073] In a preferred embodiment, the auxiliary expansion portion 140 is provided individually and independently, and is respectively provided in the gap between adjacent positioning elements 121.

[0074] In another preferred embodiment, since the cross-sectional shape of the mitral valve is approximately D-shaped, an auxiliary expansion portion 140 is provided only at the position of the connecting portion 110 corresponding to the straight section of the mitral valve annulus 800, so as to increase the contact area with the original tissue at that location and reduce paravalvular leakage.

[0075] Preferably, the PET film can be pasted or sewn onto the connecting part 110. The thickness of the PET film is not limited in this embodiment, but can be determined according to the size of the connecting part 110 or the shape of the mitral valve.

[0076] It should be noted that although the positioning device 100 and the fishing ring 200 are described together in this embodiment, the solution to be protected in this embodiment does not include the positioning device 100 itself, which does not include the fishing ring 200, but rather the component formed by the connection of the two.

[0077] Example 2

[0078] This embodiment 2 provides a fishing assembly. Based on the structure of the positioning device 100 disclosed in embodiment 1, this embodiment adds a fishing ring 200. The positioning device 100 and the fishing ring 200 are connected to form a fishing assembly. The technical features already described in embodiment 1 are naturally inherited in this embodiment.

[0079] refer to Figures 4-6 In a preferred embodiment, the catching ring 200 includes a functional segment 210, which is generally coiled and spirally positioned at the annulus 800 of the native mitral valve to support the valve stent 300 implanted in the mitral valve. On the one hand, the spiral-shaped catching ring 200 can provide the ability to deform axially to adapt to the morphological changes of the left ventricular myocardial tissue throughout the cardiac cycle. On the other hand, the spiral-shaped catching ring 200 is also more convenient to insert during surgery.

[0080] Preferably, the uppermost end of the functional segment 210 is close to or abuts against the bottom of the valve annulus 800, and the lower end of the functional segment 210 is adjacent to the ventricle; alternatively, the upper and lower ends of the functional segment 210 may have different helical diameters.

[0081] Preferably, a positioning device 100 is provided on the functional segment 210 of the catching ring 200, forming a catching assembly. The positioning device 100 can reduce the tendency and amplitude of axial movement of the catching ring 200 when subjected to blood flow impact, minimizing the tensile force on the chordae tendineae 700 and preventing its breakage. Since the functional segment 210 may have a multi-turn helical structure, in a preferred embodiment, the positioning device 100 is provided at least on the uppermost turn of the functional segment 210, that is, the turn of the functional segment 210 that is close to or abuts against the annulus 800 of the mitral valve, as shown in the reference section. Figure 6 .

[0082] As described in Embodiment 1 above, the spiral coil structure that approaches or abuts the bottom of the petal ring 800 in the fishing ring 200 may not necessarily belong to the functional segment 210. Without departing from the spirit of the present invention, regardless of whether the upper spiral coil structure of the functional segment 210 approaches / abuts the bottom of the petal ring 800, the positioning device 100 is always set on the outer periphery of the spiral coil structure that approaches / abuts the petal ring 800 in the fishing ring 200.

[0083] Preferably, the positioning device 100 includes a connecting part 110, a positioning part 120, and a fixing part 130, which are fixedly connected or integrally formed; wherein, the connecting part 110 is a hollow tube that can be fitted at least on the upper outer periphery of the functional segment 210 of the catching ring 200, and directly abuts against the bottom of the valve ring 800. At the same time, the material of the connecting part 110 is configured to allow the connecting part 110 to conform to changes in the shape of the catching ring 200; the positioning part 120 is disposed in at least a portion of the outer periphery of the connecting part 110, and can extend radially outward and upward (i.e., to the valve ring 800 side) after implantation into the heart and release. At this time, the entire positioning part 120 unfolds like a petal, so that the positioning device 100 can be confined to the bottom of the valve ring 800; preferably, the fixing part 130 is disposed at least at one end of the connecting part 110 for fixed connection with the catching ring 200.

[0084] Specifically, the structure of the positioning device 100 and its position and connection relationship with the fishing ring 200 are the same as in Embodiment 1 above, and will not be described again here.

[0085] Preferably, in order to more stably fix the catching ring 200 to the mitral valve, the catching ring 200 may further be provided with an atrial segment 220 and a ventricular segment 230.

[0086] In a preferred embodiment, the atrial segment 220 is curved and coiled within the left atrium 400, and the curvature of its curvature is approximately the same as the curvature of the wall of the left atrium 400, so as to ensure that the atrial segment 220 and the contour of the left atrium 400 are more closely matched.

[0087] Preferably, a transition segment 240 is provided between the atrial segment 220 and the functional segment 210. The shape of the transition segment 240 is configured to extend from the functional segment 210 to the atrial segment 220. Since the functional segment 210 is located outside the mitral valve and the atrial segment 220 is located inside the left atrium 400, after the catching ring 200 is inserted into the body, the transition segment 240 spirals upward from outside the mitral valve through the junction of the original leaflets 600 and extends to the atrial segment 220.

[0088] In a preferred embodiment, the ventricular segment 230 extends downward from the aforementioned functional segment 210 and joins the left ventricle 500, and is configured to be curved in a manner that generally follows the curvature of the native chordae tendineae 700 plexus.

[0089] More preferably, for different patients, their physiological and pathological states are different. Therefore, the dimensions of the atrial segment 220, ventricular segment 230 and transition segment 240 can be adapted to the actual situation of the patient. Examples will not be listed here.

[0090] In this embodiment, when the above-mentioned catching assembly is used, it is released into the mitral valve chordae tendineae 700 plexus via a conveying device. The functional segment 210 of the catching ring 200 is adjacent to the bottom of the mitral valve annulus 800. The atrial segment 220 extends upward from the annulus 800 through the leaflet commissure and has a radially expanding force, which can abut against the wall of the left atrium 400 to prevent displacement of the catching assembly. The ventricular segment 230 extends downward from the functional segment 210 and surrounds the mitral valve chordae tendineae 700 plexus. The ventricular segment 230 has a radially tightening force, which can further enhance the positioning capability of the catching assembly.

[0091] The positioning device 100 located on the functional section 210 of the fishing ring 200 has a positioning part 120. The positioning part 120 can return to a pre-formed shape as the temperature rises after the entire fishing assembly is released, that is, it extends radially outward and upward (i.e., on the side of the valve annulus 800). At this time, the entire positioning part 120 unfolds like a petal, so that the positioning device 100 can be limited to the bottom of the valve annulus 800. When the left atrium 400 contracts and pumps blood, the axial movement of the fishing assembly is smaller due to the impact of blood flow, which can reduce the traction force on the chordae tendineae 700 and prevent the chordae tendineae 700 from breaking.

[0092] Furthermore, the valve stent 300 is implanted into the native mitral valve. The valve stent 300 expands radially outward and interacts with the radially tightening functional segment 210 to anchor the valve stent 300 and prevent it from shifting.

[0093] Example 3

[0094] like Figure 7 , 8 This embodiment 3 provides an artificial valve system. Based on the structure of the fishing component disclosed in embodiment 2, this embodiment adds a valve stent 300. The valve stent 300 can be positioned inside the original valve to replace the physiological function of the original valve. The technical features already included in embodiment 1 or embodiment 2 are naturally inherited in this embodiment.

[0095] Preferably, the valve stent 300 is configured to expand at the native mitral valve to eliminate mitral regurgitation; the main body of the valve stent 300 defines a flow channel for blood flow, and the main body can cooperate with the functional segment 210 of the capture ring 200; preferably, the valve stent 300 has a sealing membrane on its outer wall and an artificial valve leaflet inside.

[0096] Optionally, the valve stent 300 can be a balloon-expandable stent or a self-expanding stent. The specific structure of the valve stent 300 can be any structure in the prior art, which will not be described in detail here.

[0097] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other modifications under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these modifications are within the protection scope of the present invention.

Claims

1. A positioning device for a fishing ring, characterized in that, include: - Connecting part, the connecting part is tubular, and can be sleeved on the outer periphery of at least one turn of the fishing ring adjacent to the petal ring, and conforms to the shape change of the fishing ring; - A positioning part, comprising a plurality of positioning elements, the positioning elements being spaced apart in at least a portion of the outer periphery of the connecting part; when the positioning elements are transported in the body, they are on the same curved surface as the outer periphery of the connecting part, at which time the positioning part and the connecting part form a complete tubular structure; after being implanted in the heart, the plurality of positioning elements are radially arranged and extend radially outward and toward the valve annulus side, so that the positioning device can be confined to the bottom of the valve annulus to limit the axial movement of the catching ring.

2. The positioning device according to claim 1, characterized in that, The inner diameter of the connecting part is configured to allow for a transition fit or clearance fit with the fishing ring. The outer diameter of the connecting part is configured such that at least one turn of the adjacent petal ring corresponding to the fishing ring has a larger outer diameter than the fishing ring.

3. The positioning device according to claim 2, characterized in that, The connecting portion has a cut in at least a portion of its inner circumferential side, and the direction of the cut is perpendicular to the axial direction of the connecting portion.

4. The positioning device according to claim 1, characterized in that, The connecting part is fixedly connected to or integrally formed with the positioning part; the connecting part has a groove on its outer peripheral side, the groove matches the contour of the positioning element, the groove can accommodate the positioning element when transported in the body, so that the positioning element can be on the same curved surface as the outer peripheral sidewall of the connecting part.

5. The positioning device according to claim 4, characterized in that, After implantation into the heart, the positioning element forms an angle of 60° to 90° with the outer peripheral wall of the connecting part.

6. The positioning device according to claim 4, characterized in that, Several positioning elements are arranged at equal or unequal intervals on the outer periphery of the connecting portion.

7. The positioning device according to claim 4, characterized in that, Several positioning elements are arranged at equal or unequal intervals on the outer periphery of the connecting portion.

8. The positioning device according to claim 4, characterized in that, The positioning element is polygonal or semi-circular.

9. The positioning device according to claim 1, characterized in that, It also includes a fixing part, which is disposed at both ends or one end of the connecting part along the axial direction. The fixing part has a hollow cylindrical structure and can be sleeved on the outside of the fishing ring. The inner diameter of the fixing part is configured to allow for a transition fit or an interference fit with the fishing ring.

10. The positioning device according to claim 9, characterized in that, The connecting part, the positioning part, and the fixing part are integrally formed, and all three are made of shape memory alloy material.

11. The positioning device according to claim 1, characterized in that, It also includes a flexible auxiliary expansion portion, which is disposed in at least a portion of the outer periphery of the connecting portion to assist the positioning portion in extending radially outward, thereby reducing perivalvular leakage.

12. The positioning device for a fishing ring according to claim 11, characterized in that, The auxiliary expansion section includes a PET film.

13. A fishing assembly, characterized in that, The device includes a positioning device for a catching ring as described in any one of claims 1-12, and further includes a catching ring that is spiral-shaped, capable of being positioned outside the chordae tendineae of the native valve, and conforming to changes in the morphology of the native valve annulus.

14. An artificial valve system, characterized in that, The fishing assembly of claim 13 also includes a valve stent; At least a portion of the valve stent defines a flow channel for blood flow; the valve stent can be positioned medial to the native valve and replace the physiological function of the native valve. At least a portion of the valve stent cooperates with the fishing assembly.

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