CN219354275U - Valve repair device and system - Google Patents

Abstract

The utility model relates to a valve repair device and a valve repair system, wherein the repair device comprises an external expansion assembly and an annular contraction assembly; the external expansion assembly comprises an inflow end which is in a horn shape, a funnel shape or a rotary arc shape; the inflow end can at least elastically deform in the radial direction to closely fit and conform to the shape of the native annulus; the annular contraction component is annular or spiral and can encircle the mitral valve/tricuspid valve chordae tendineae; be equipped with first connecting piece on the outer subassembly that expands, be equipped with the second connecting piece on the ring contracts the subassembly, first connecting piece and/or second connecting piece can run through native valve leaflet or native valve annulus tissue for outer expand the subassembly and the ring contracts the subassembly and be connected. The utility model completes the repair of the damaged valve through the cooperation of the external expansion component and the annular contraction component, and can provide positioning or fixing for the artificial valve which is implanted subsequently.

Description

Valve repair device and system

Technical Field

The utility model relates to the field of medical instruments for heart surgery, in particular to a valve repair device and a valve repair system.

Background

Mitral valve (bicuspid valve), also known as the mitral valve, is a pair of heart valves that are located between the left atrium and the left ventricle and flap up and down. Tricuspid valve (also known as the right atrioventricular valve) is a pair of valves located between the right atrium and right ventricle. The mitral and tricuspid valves are collectively referred to as atrioventricular valves.

The valves incorporate leaflets or cusps, wherein each valve has three cusps, except for a mitral valve having only two cusps. The mitral and tricuspid valves are located between the atria and ventricles, respectively, and prevent regurgitation from the ventricles into the atria during systole. They are anchored to the wall of the ventricle by chordae that prevent valve inversion. The chordae tendineae attach to the papillary muscles, which cause tension to better hold the valve. The papillary muscles and chordae tendineae together are referred to as subvalvular structures. Although the function of the under-valve structure is to keep the valve from sagging into the atrium when the valve is closed, the under-valve structure has no effect on the opening and closing of the valve, which is entirely caused by the pressure gradient across the valve.

Taking the mitral valve as an example, during diastole, the normally functioning mitral valve opens due to the hyperemic pressurization of the left atrium. When the left atrial pressure is higher than the left ventricular pressure, the mitral valve opens, allowing blood to passively flow into the left ventricle. Diastole ends with atrial contraction, eventually ejecting 20% of the blood from the atrium to the ventricle. While mitral valve closure prevents regurgitation of blood after atrial contraction. Heart valves may be affected by a variety of conditions. For example, the mitral valve may be affected by mitral regurgitation, mitral valve prolapse, and mitral stenosis.

Valve regurgitation is also a common problem and occurs when the heart valve fails to close tightly, with the result that the valve fails to seal and blood leaks back through the valve. This condition-also known as valve insufficiency-reduces the pumping efficiency of the heart: when the heart contracts, blood is pumped forward in the correct direction, but is also forced backward through the damaged valve. When the leak worsens, the heart has to work harder to compensate for the leaking valve and less blood will flow to other parts of the body. The condition is known as tricuspid regurgitation, pulmonary regurgitation, mitral regurgitation or aortic regurgitation.

Mitral regurgitation (mitralregulation), i.e. leakage of blood from the left ventricle through mitral valve abnormalities and into the left atrium when the left ventricle contracts, is a common valve abnormality that occurs in 24% of adults with valvular heart disease and 7% of the 75 year old population. Surgical intervention is recommended for symptomatic severe mitral regurgitation or asymptomatic severe mitral regurgitation with left ventricular dysfunction or enlargement.

Interventional surgical treatments of the mitral valve are divided into mitral valve replacement (transcatheter Mitral valve replacement, TMVR) and mitral valve repair (transcatheter Mitral valve repair, TMVR). There is a strict technical difference between the two, mainly in the presence or absence of replacement of the mitral valve, and in the absence of replacement of the prosthetic valve in mitral valve repair.

The mitral and tricuspid valves are each defined by the annulus fibrosis of the collagen, each referred to as the annulus, which forms part of the fibrous skeleton of the heart. The annulus provides a peripheral attachment for the two cusps or the three leaflets of the mitral valve and the two leaflets and the three leaflets. The free edge of the leaflet attaches to chordae tendineae from more than one papillary muscle. In a healthy heart, these muscles and their chordae support the mitral and tricuspid valves, enabling the leaflets to resist the high pressures that develop during contraction (aspiration) of the left and right ventricles.

The current treatment options for functional tricuspid regurgitation are mainly surgery. It is estimated that patients with moderate to severe tricuspid regurgitation are one hundred and sixty thousand in the united states. Of these, only 8,000 patients undergo tricuspid surgery annually.

Disclosure of Invention

The utility model discloses a valve repair device and a valve repair system, and aims to solve the technical problems in the prior art.

The utility model adopts the following technical scheme:

in a first aspect, the present utility model provides a valve repair device comprising an outer expanding assembly and an annular contracting assembly;

the external expansion assembly comprises an inflow end which is cylindrical, trumpet-shaped, funnel-shaped or rotary arc-shaped; the inflow end can at least elastically deform in the radial direction to closely fit and conform to the shape of the native annulus;

the annular contraction component is annular or spiral and can encircle the mitral valve/tricuspid valve chordae tendineae;

the external expansion assembly is detachably connected with the ring contraction assembly.

As the preferable technical scheme, be equipped with first connecting piece on the flaring subassembly, be equipped with the second connecting piece on the ring is contracted the subassembly, first connecting piece and/or second connecting piece can run through native valve leaflet or native valve annulus tissue for the flaring subassembly is connected with the ring is contracted the subassembly two.

As the preferable technical scheme, the external expansion assembly further comprises an outflow end, wherein the outflow end is connected with the inflow end, and the outflow end is cylindrical, waisted cylindrical or annular.

As a preferable technical scheme, friction fit is realized between the outflow end and the primary valve tissue and between the annular shrinkage component and the valve tissue; the length of the outflow end satisfies: when the native valve leaflet is opened or closed, the outflow end does not affect the function of the native valve leaflet, or retains the function of a portion of the native valve leaflet.

As a preferred solution, the outer contour of the outflow end matches the outer contour of the annular constriction assembly.

As a preferred solution, at least the outflow end of the flaring assembly is circular or D-shaped in cross section.

As a preferred technical scheme, at least the inflow end of the flaring assembly is provided with a skirt, barb or bulge for enhancing the anchoring of the flaring assembly to the heart's native tissue.

As the preferable technical scheme, the inner side of the flaring component is provided with a third connecting piece, and the third connecting piece can be clamped and fixed with a valve bracket which is implanted subsequently.

As a preferred technical solution, the ring-shrinking assembly comprises at least two half-ring subassemblies, the ends of which are circumferentially closed and are used for ring-shrinking and tightening the native valve leaflets and/or chordae tendineae.

As the preferable technical scheme, the ring shrinkage component is a plurality of coils extending spirally; the annular contraction component comprises an atrial section and a functional section, wherein the functional section is used for carrying out annular contraction and tightening on the native valve leaflet and/or the chordae tendineae.

As the preferable technical proposal, the ring contraction component is provided with a hook thorn or a bulge which is used for strengthening the anchoring of the external expansion component and the heart primary tissue;

or, the annular shrinkage assembly is also provided with a positioning part extending outwards in a radial direction.

As a preferable technical scheme, the cross section of the ring shrinkage component is round or is in a special shape matched with the outer expansion component.

As an optimized technical scheme, the first connecting piece and the second connecting piece are of bayonet fitting structures.

In a second aspect, the present utility model also provides a valve repair system comprising a valve repair device according to any one of the preceding claims.

As a preferred technical solution, the valve repair system comprises a first delivery device for delivering the flaring assembly and a second delivery device for delivering the crimping assembly.

As a preferred technical scheme, the device further comprises a third conveying device and a valve stent, wherein the valve stent is used for being implanted into the flaring assembly, and the third conveying device is used for conveying the valve stent.

In a third aspect, the present utility model also provides a valve repair method, comprising the steps of:

implanting a ring contraction component outside the chordae tendineae around the mitral valve/tricuspid valve, wherein the ring contraction component is in a continuous ring shape or a discontinuous ring shape or a spiral shape;

implanting an flaring assembly at a native annulus of a mitral/tricuspid valve, the flaring assembly comprising an inflow end that is cylindrical, flared, funnel-shaped or arc-shaped; the inflow end can at least elastically deform in the radial direction to closely fit and conform to the shape of the native annulus;

be equipped with first connecting piece on the outer subassembly that expands, be equipped with the second connecting piece on the ring contracts the subassembly, first connecting piece and/or second connecting piece can run through native valve tissue for outer subassembly and the ring contracts the subassembly and be connected.

In the valve repair method, the outer expanding assembly further comprises an outflow end, the outflow end is connected with the inflow end, and the outflow end is cylindrical, waisted cylindrical or annular.

As a preferred technical solution, in the valve repair method, the outflow end, the native valve tissue and the annuloplasty assembly are combined by friction, and the length of the outflow end satisfies: when the native leaflet opens or closes, the outflow end does not affect or preserve the function of a portion of the native leaflet.

The technical scheme adopted by the utility model can achieve the following beneficial effects:

in one aspect, the utility model provides a valve repair device, the structure of which comprises an outer expanding component and a ring contracting component which can be detachably connected; the external expansion component is of a bracket-shaped structure without valve leaves, can enter a diseased native valve in a compressed state and expand, has a short outflow end, does not influence the normal closing and physiological functions of the native valve, does not exist in the external expansion component, is used for fixing the annular contraction component, and can position a subsequently implanted artificial valve; the annular contracting assembly may be configured in a ring or spiral shape and may be configured to encircle the mitral/tricuspid valve chordae tendineae and cooperate with the flaring assembly while simultaneously constricting the native valve leaflet. The outer expanding component and the annular contracting component are respectively provided with a first connecting piece and a second connecting piece which can penetrate through the primary valve leaflet and are connected with each other so as to repair the lesion valve.

The repair of mitral regurgitation, particularly annular contraction, requires an instrument to strengthen the bond strength with the native valve, and the utility model improves the stability and durability of the system by strengthening the cooperation of the flaring and annular contraction components.

On the other hand, the utility model also provides a valve repair system which comprises the valve repair device, a first conveying device and a second conveying device, wherein the first conveying device is used for conveying the compressed expanding assembly, and the second conveying device is used for conveying the ring contracting assembly. More preferably, the valve repair system further comprises a third delivery device for implantation in the flaring assembly to complete replacement of the valve and a valve stent for delivery of the valve stent.

The utility model can divide the treatment of the mitral valve into two stages, namely, the external expansion assembly and the annular contraction assembly can be implanted firstly to treat the patient, the external expansion assembly and the annular contraction assembly can be implanted to have the functions of tightening and clamping the mitral valve, the treatment can be performed without implanting a prosthetic valve, a reserved interface is arranged in the external expansion assembly, and the later treatment can judge whether or when the prosthetic valve is needed or not according to the condition of the later patient, so that the treatment is more flexible, and meanwhile, the function of the organ or tissue of the patient can be fully exerted.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings required for the description of the embodiments are briefly described below to form a part of the present utility model, and the exemplary embodiments of the present utility model and the description thereof illustrate the present utility model and do not constitute undue limitations of the present utility model. In the drawings:

FIG. 1 is a schematic view of a valve repair device according to a preferred embodiment of the present disclosure as disclosed in example 1;

FIG. 2 is a front view of a valve repair device according to a preferred embodiment of the present disclosure as disclosed in example 1;

FIG. 3 is a view showing the state of use of the valve repair device according to a preferred embodiment of the present utility model disclosed in example 1;

FIG. 4 is a schematic view of the construction of a flaring assembly according to a preferred embodiment of the present utility model disclosed in example 1;

FIG. 5 is a schematic view of the structure of the annular assembly in a preferred embodiment of the utility model disclosed in example 1;

FIG. 6 is a schematic view of a ring assembly in accordance with another preferred embodiment of the present utility model as disclosed in example 1;

FIG. 7 is a diagram showing the puncture location of a mitral valve by a valve repair device according to a preferred embodiment of the present utility model as disclosed in example 1;

FIG. 8 is a schematic view of the structure of the annular assembly in a preferred embodiment of the utility model disclosed in example 1;

reference numerals illustrate:

a flaring assembly 10, an inflow end 11, an outflow end 12, barbs 13, a first connector 14; the ring shrink assembly 20, 20', the second connector 21, the positioning part 22; the mitral valve annulus 30, tricuspid annulus 40, native leaflets 50, and preferably the puncture points 60, 60'.

Detailed Description

In order to make the objects, technical solutions and advantages of the present utility model more apparent, the technical solutions of the present utility model will be clearly and completely described below with reference to specific embodiments of the present utility model and corresponding drawings. In the description of the present utility model, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present utility model, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art. In addition, in the description of the present application, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

It will be apparent that the described embodiments are only some, but not all, embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

In order to solve the problems in the prior art, the embodiment of the application provides a valve repair device, which comprises an external expansion component and a ring contraction component; the external expansion assembly comprises an inflow end which is in a horn shape, a funnel shape or a rotary arc shape; the inflow end can at least elastically deform in the radial direction to closely fit and conform to the shape of the native annulus; the annular contraction component is in a continuous annular shape or a discontinuous annular shape or a spiral shape, and can encircle the mitral valve/tricuspid valve chordae tendineae; be equipped with first connecting piece on the outer subassembly that expands, be equipped with the second connecting piece on the ring contracts the subassembly, first connecting piece and/or second connecting piece can run through native valve leaflet or native valve annulus tissue for outer expand the subassembly and the ring contracts the subassembly and be connected.

Example 1

The valve repair device provided in this embodiment may be used in a mitral valve or a tricuspid valve, and preferably, in the example of mitral valve implantation, the valve repair device provided in this embodiment 1 is used to solve the technical problems existing in the prior art.

According to fig. 1-6, the valve repair device comprises an outer expanding component 10 and an annular contracting component 20, wherein no artificial valve is arranged in the outer expanding component 10, the outer expanding component 10 is in a cylindrical shape in a collapsed state so as to be convenient for a conveying device to install and fix the outer expanding component 10 and convey the outer expanding component through a guide catheter, the outer expanding component 10 in an expanded state comprises a plurality of connected diamond grid structures after reaching a mitral valve, adjacent grid structures are connected through waverods or nodes with certain elasticity, and the expanded outer expanding component 10 can be supported and fixed at a native valve annulus; the telescoping assembly 20 is capable of axial bending deformation for release outside the mitral valve chordae tendineae by a delivery device or guide catheter to cooperate with the flaring assembly 10 while the native valve leaflet 50 is contracted.

In a preferred embodiment, the main body of the flaring assembly 10 is configured in a horn, funnel or arc of revolution shape, and accordingly, the main body of the flaring assembly 10 is capable of radial expansion and compression to ensure that it is in a compressed state when delivered in a blood vessel and then opened by self-expansion or balloon expansion after reaching the annulus of the native mitral valve. In a preferred embodiment, the flaring assembly 10 is constructed substantially in accordance with the valve stent structure, but does not have artificial leaflets on the inside and has a relatively short axial length that does not interfere with the physiological function of the native leaflets 50 after dilation (i.e., does not replace the native mitral valve); preferably, the flaring assembly 10 is a self-expanding stent, a balloon expandable stent, or a controlled expandable stent or the like.

In a preferred embodiment, the flaring assembly 10 is a self-expanding stent; preferably, the flaring assembly 10 is made of metal or polymer material, such as nickel titanium alloy memory material or other memory polymer material or alloy, and in this embodiment, a plurality of interconnected polygonal mesh structures are formed by processing nickel titanium alloy memory material or the like; optionally, the above-mentioned processing means include, but are not limited to, braiding, laser cutting, welding, rivet connection, screw connection, and the like.

In another preferred embodiment, the flaring assembly 10 is a balloon expandable stent; the flaring assembly 10 is made of medical stainless steel, cobalt-chromium alloy and other materials, and is pretreated by weaving, welding, rivet connection, threaded connection and other modes to form a plurality of mutually connected polygonal grid structures.

Preferably, the flaring assembly 10 includes at least an inflow end 11; optionally, the flaring assembly 10 is also provided with an outflow end 12; it will be appreciated by those skilled in the art that depending on the direction of blood flow, the outflow end 12 is downstream of the inflow end 11, the inflow end 11 corresponding to the portion of the outer dilator assembly 10 into which blood flows after implantation of the outer dilator assembly 10, and the outflow end 12 corresponding to the portion of the outer dilator assembly 10 from which blood flows after implantation of the outer dilator assembly 10.

In a preferred embodiment, the inflow end 11 and the outflow end 12 of the flaring stack 10 each comprise a plurality of interconnected polygonal mesh structures, and adjacent mesh structures are connected by waverods or nodes with certain elasticity, wherein the polygonal mesh is preferably a diamond, a hexagon or the like unit capable of forming a closed shape; in a preferred embodiment, the inflow end 11 has a denser lattice structure than the outflow end 12 to provide more directional elastic deformations, such as axial elastic deformations, radial elastic deformations, and transverse elastic deformations; while the outflow end 12 provides greater resistance to deformation to prevent displacement of the flaring assembly 10 during the cardiac cycle; in another embodiment, both the outflow end 12 and the inflow end 11 are of a dense lattice structure, both providing the same deformability. In other embodiments, the material selection of the inflow end 11 and the outflow end 12 may be adjusted, and the two may be made of materials with different elastic coefficients, and then connected as a whole.

Preferably, the inflow end 11 is positioned in the left atrium and the outflow end 12 extends towards the mitral valve leaflet closure; in a preferred embodiment, the length of the outflow end 12 should be as short as possible, preferably the length of the outflow end 12 is such that: when the native leaflet 50 opens or closes, the outflow end 12 does not affect the function of the native leaflet 50, or alternatively, retains a portion of the native leaflet 50 function; in another preferred embodiment, only the inflow end 11 is provided to avoid the outflow end 12 blocking the closure of the native leaflet 50; in other alternative preferred embodiments, the outflow end 12 is annular to ensure that its axial length is as short as possible, avoiding affecting the opening and closing of the native leaflets 50.

In a preferred embodiment, the inflow end 11 of the flaring assembly 10 is generally flared or tapered and abuts the intersection of the left atrium and the mitral annulus, while the outflow end 12 is cylindrical or annular.

In another more preferred embodiment, the inflow end 11 is generally flared and the outflow end 12 is in a waisted cylindrical configuration.

Preferably, the middle of the outflow end 12 is waisted inwardly in a generally arcuate slot shape for mating with the telescoping assembly 20; preferably, the arc of the arcuate slot is greater than the arc of the outer contour of the annular retraction assembly 20 so that the annular retraction assembly 20 still matches the arcuate slot after the annular retraction of the valve leaflet. After both the outer expansion assembly 10 and the annular contraction assembly 20 are implanted in the heart, the outer expansion assembly 10 and the original valve tissue and the annular contraction assembly 20 are matched in pairs through friction.

Preferably, the outflow end 12 is circular in cross-section; more preferably, the outflow end 12 is D-shaped in cross-section or shaped to fit the native annulus.

Preferably, the mesh structures of the free ends of the inflow end 11 and the outflow end 12 are all continuously and completely distributed in the circumferential direction, so that the radial supporting force is not affected, and the undesired displacement of the flaring assembly 10 after the mitral valve is implanted is avoided.

Preferably, there are also a plurality of visualization points on the flaring assembly 10 to assist the physician in determining whether the implantation site is accurate.

In a preferred embodiment, barbs 13 or protrusions are provided on the outside of the inflow end 11 of the flaring assembly 10 for enhancing anchoring between the flaring assembly 10 and the native heart tissue.

In another preferred embodiment, a skirt is sewn to at least a portion of the inner and/or outer surface of the flaring assembly 10 for increasing the sealing performance, preferably the material of the skirt may be animal pericardium, such as bovine pericardium, porcine pericardium, etc., or polymeric material, such as polytetrafluoroethylene, fiber cloth or fiber film, etc.; those skilled in the art should know that the materials and the installation of the skirt are all prior art, and will not be described herein. Preferably, a third connector is provided on the inside of the flaring assembly 10 for providing a fixation site with a subsequently implanted valve stent (with artificial leaflets) and for snap-fit connection therewith. It will be appreciated by those skilled in the art that since the flaring assembly 10 described in the present utility model does not include artificial leaflets and the outflow end 12 is of a relatively short length, it does not interfere with the normal physiological function of the native leaflets 50, and therefore the flaring assembly 10 and the telescoping assembly 20 cooperate to repair the mitral valve (TMVr); when the native valve leaflet 50 is further deteriorated, mitral valve replacement (TMVR) may be considered, and the valve stent with the artificial valve leaflet may be released in the outer expansion assembly 10 directly by the delivery device without removing the outer expansion assembly 10 or the annular contraction assembly 20, so as to replace the physiological function of the native valve.

In a preferred embodiment, the third connecting piece is an L-shaped chute, which is symmetrically arranged at the inner side of the expanding component 10, the L-shaped chute comprises a vertical section and a horizontal section which are matched with each other, a bump is arranged at the outer side of the valve bracket implanted subsequently, and the size of the bump is matched with the width of the L-shaped chute; preferably, the free end of the vertical section is an inlet of the L-shaped chute, and the size of the inlet is larger than that of the lug so as to ensure that the lug can smoothly enter, and the notch of the L-shaped chute is smaller than that of the lug except the inlet so as to avoid the lug from falling out of the L-shaped chute; in a preferred embodiment, the cross section of the lug is T-shaped and the cross section of the L-shaped chute is generally concave.

In another alternative embodiment, the third connecting piece is two symmetrically arranged circular grooves, and the outer side of the valve support which is implanted later is provided with a convex block, and the size and the position of the convex block are matched with the width of the circular grooves.

Preferably, the third connecting piece is also woven by shape memory metal or engraved by laser, and is fixedly connected with the expansion assembly 10, and when the expansion assembly 10 is compressed and conveyed, the third connecting piece is compressed similarly.

When the valve stent is fixed, the conveying device is controlled to control the valve stent to expand in the expanding assembly 10, the convex blocks on the valve stent are released in the vertical sections of the L-shaped sliding grooves and move to the horizontal sections under the assistance of the medical imaging system, and the horizontal sections are used for limiting the valve stent in the axial direction so as to prevent the valve stent from shifting or even falling off when the heart contracts and pumps blood.

It will be appreciated by those skilled in the art that valve stents include self-expanding valve stents, which are made of shape memory metal, self-expand due to an increase in temperature after release in the heart, and have some elasticity, as well as balloon-expanded valve stents, which do not undergo radial elastic deformation after expansion due to rigid deformation. Based on the difference between the two, when the valve stent to be implanted subsequently is a self-expanding valve stent, the valve stent with barbs on the outer side can be directly selected without arranging a third connecting piece in the expanding component 10, and the inverted puncture of the valve stent can penetrate into the grid gaps of the expanding component 10 and penetrate into the primary valve component so as to perform self stable positioning.

In a preferred embodiment, the annular contracting assembly 20 is a two-half ring sub-assembly with the ends thereof circumferentially closed to form a generally annular structure around the mitral valve chordae, and provides radial force for engagement with the outflow end 12 of the flaring assembly 10, which engagement reduces the size of the native mitral valve and improves mitral valve prolapse or mitral regurgitation.

Preferably, the circumferential inner and/or outer sides of the annular retraction assembly 20 are provided with barbs, protrusions, lips, or structures intended to create mechanical interference or increase friction between the annular retraction assembly 20 and the outer flaring assembly 10 to enhance the anchoring relationship between the annular retraction assembly 20 and the native valve annulus or outer flaring assembly 10.

In other preferred embodiments, as shown in fig. 6, the circumferential outer side of the annular compression assembly 20 is further provided with a positioning portion 22. The positioning portion 22 can be radially expanded after the annular compression assembly 20 is released and extended to the inner wall of the ventricle to further position the annular compression assembly 20 while imparting a radially inward force thereto.

Preferably, the positioning portion 22 is preferably made of an elastic material or a material having shape memory, and is provided with barbs or protrusions for engaging the ventricular wall, and is secured to the native tissue at the annular retraction assembly 20 to further enhance the positioning or restraining action of the annular retraction assembly 20.

Preferably, the positioning portion 22 is made of a shape memory metal, such as nickel titanium alloy.

Preferably, the annular constriction assembly 20 is provided with a channel for the passage of a guide wire; in a preferred embodiment, the configuration of the telescoping assembly 20 is consistent with the prior art leaflet capturing structures used for mitral valve replacement.

Preferably, the annular constriction assembly 20 is provided with a second connector 21 and the flaring assembly 10 is provided with a first connector 14 mating therewith, the first connector 14 and/or the second connector 21 being capable of piercing the valve leaflet such that the flaring assembly 10 and the annular constriction assembly 20 are both detachably connected. The first and second connectors 14, 21 may be provided in one or more pairs.

In a preferred embodiment, the first connector 14 is disposed outside of the flaring assembly 10 and extends downward; preferably, the first connector 14 is a pin or similar structure.

In a preferred embodiment, the second connection piece 21 is provided at the end of the half-ring assembly and extends vertically upwards for connection with the first connection piece 14 and assumes an orientation outside the annular plane with the first connection piece 14; preferably, the second connection 21 is an axial hole or similar structure for connection with a pin.

It will be appreciated by those skilled in the art that in the above embodiments, either the pin/axial bore or other similar structure should be configured such that it axially allows the guided wire to pass therethrough to ensure that the delivery device is able to successfully connect the two.

In other preferred embodiments, the first connecting member 14 and the second connecting member 21 may also be configured as a snap-fit structure that can be detachably connected to each other.

After both the outer expansion assembly 10 and the annular contraction assembly 20 are implanted in the heart, the outer expansion assembly 10 and the original valve tissue and the annular contraction assembly 20 are matched in pairs through friction.

It will be appreciated by those skilled in the art that when both the outer and inner expandable assemblies 10, 20 are implanted in the heart, they are in one aspect frictionally engaged and positioned two by clamping the native valve tissue, and are also connected and positioned with respect to each other by the first and second connectors 14, 21 after piercing the native tissue; in some other embodiments, the flaring assembly 10 is further positioned by the barbs 13 and the telescoping assembly 20 by the positioning portions 22.

Referring to fig. 7, a right superior view of the heart, including the mitral valve annulus 30 and the tricuspid valve annulus 40, the mitral valve annulus 30 includes an anterior superior leaflet and a posterior inferior leaflet, and in fig. 7, the aortic annulus is between the mitral valve annulus 30 and the tricuspid valve annulus 40, and the pulmonary valve annulus is above the aortic annulus. Preferably, the atrial septum between the mitral valve annulus 30 and the tricuspid valve annulus 40 is a preferred puncture site 60, and the upper left side of the mitral valve annulus 30 in the figure is another preferred puncture site 60', representing a transapical puncture path.

In this embodiment, when the valve repair device is in use, a vascular passageway is established through the puncture and guide catheter, specifically, the puncture path may be punctured transapically, transseptally downwardly, or transseptally upwardly, and then the retraction assembly 20 is placed into the mitral valve chordae tendineae through the guide wire and a delivery device to retract and repair the native valve leaflet 50 and provide a site for implantation of the subsequent flaring assembly 10.

The outer dilator assembly 10 is advanced through another delivery device, through an established vascular access (which may or may not coincide with the delivery path of the telescoping assembly 20) into the mitral valve and released at the telescoping site of the telescoping assembly 20, the outer dilator assembly 10 being radially expandable and the telescoping assembly 20 being radially contractible, the two cooperating to create a firm anchoring force to prevent displacement of the outer dilator assembly 10.

Upon release of the flaring assembly 10, the first connector 14 is aligned with the second connector 21, and preferably the first connector 14 of the flaring assembly 10 extends vertically downward, is capable of piercing the native valve leaflet 50 or native annulus, and is connected with the second connector 21.

The closure of the native leaflet 50 is not impeded because the outflow end 12 of the flaring assembly 10 is relatively short. When further lesions occur in the mitral valve, such that the valve repair device fails, the valve stent with the prosthetic valve leaflets can be delivered directly to the flaring assembly 10 by another delivery device and released within the flaring assembly 10 to replace the physiological function of the native valve. Specifically, upon release, the third connector mates with and connects to the tab on the valve holder.

Example 2

Still taking mitral valve implantation as an example, referring to fig. 8, in this embodiment, a valve repair device is provided that includes a flaring assembly 10 and a telescoping assembly 20', and features already included in embodiment 1 with respect to the flaring assembly 10 are naturally inherited in this embodiment.

Preferably, the annular contracting assembly 20 'is substantially helical and is capable of providing axial and radial forces to cooperate with and interact with the flaring assembly 10 implanted within the mitral valve, the cooperation of the two being capable of reducing the size of the native mitral valve, reducing mitral regurgitation, and the annular contracting assembly 20' being capable of not only being used for annular contraction and repair of the mitral valve, but also being capable of more tightly anchoring the location of the flaring assembly 10, effectively preventing the flaring assembly 10 from shifting during myocardial motion.

In a preferred embodiment, the annular compression assembly 20' includes an atrial segment with radially outwardly expanding forces and a functional segment with radially inwardly tightening forces; the functional segments are positioned in a coil shape at the annulus of the native mitral valve for cooperation with the outflow end 12 of the flaring assembly 10; the structure of the atrial segment is approximately the same as the atrial arm structure of the left atrium, and the atrial segment and the atrial arm structure are attached and fixed.

Preferably, barbs, protrusions, lips, or structures intended to create mechanical interference or increased friction between the annular constriction assembly 20 'and the outer flaring assembly 10 are provided on the circumferentially inner side of the functional segment to strengthen the anchoring relationship between the annular constriction assembly 20' and the native annulus or outer flaring assembly 10.

Preferably, the annular constriction assembly 20 'is provided with a second connector 21 and the outflow end 12 is provided with a first connector 14 mating therewith, the first connector 14 and/or the second connector 21 being capable of piercing the native leaflet 50 or annulus such that the flaring assembly 10 is detachably connected to both the annular constriction assembly 20'.

In a preferred embodiment, the first connector 14 is disposed outside the outflow end 12 and extends upwardly from the bottom of the outflow end 12; preferably, the first connector 14 is a pin or similar structure.

In a preferred embodiment, the second connection piece 21 is arranged on top of the functional section for connection with the first connection piece 14 and assumes an orientation outside the annular plane with the first connection piece 14; preferably, the second connection 21 is an axial hole or similar structure for connection with a pin.

It will be appreciated by those skilled in the art that in the above embodiments, either the pin/axial bore or other similar structure should be configured such that it axially allows the guided wire to pass therethrough to ensure that the delivery device is able to successfully connect the two.

In other embodiments, the first connecting member 14 and the second connecting member 21 may be configured as a snap-fit structure that can be detachably connected to each other.

In this embodiment, the conveying, mounting and matching manners of the ring-shrinking assembly 20' and the expanding assembly 10 can refer to the above embodiment 1, and will not be described herein.

Example 3

In this embodiment, a valve repair system is provided that includes a first delivery device, a second delivery device, a third delivery device, and a flaring assembly 10, a telescoping assembly 20, and a valve stent; wherein a first delivery device is used to deliver the flaring assembly 10, a second delivery device is used to deliver the crimping assembly 20, and a third delivery device is used to deliver the valve stent.

In this embodiment, the structures of the outer expanding assembly 10 and the annular contracting assembly 20 are the same as those of the above-mentioned embodiment 1 or 2, and will not be described here again.

As described in embodiment 1 above, the construction of the flaring assembly 10 is similar to that of a valve stent and thus can be delivered using a delivery device of a valve stent. It will be appreciated by those skilled in the art that the delivery devices of current valve stents are well known in the art and the manner of connecting the various components thereof will not be described in detail herein.

Preferably, in use, the valve repair system described above is first used to create a vascular passageway through a puncture and guide catheter, specifically, the puncture path may be through the apex of the heart, transseptal or transseptal upward, and then the retraction assembly 20 is placed into the mitral or tricuspid valve chordae tendineae through a guidewire and a second delivery device to retract and repair the native valve leaflet 50 and provide a site for implantation of the subsequent flaring assembly 10.

The outer dilator assembly 10 is passed through the first delivery device through the established vascular access (which may or may not coincide with the delivery path of the telescoping assembly 20) into the mitral valve or tricuspid valve and released at the telescoping site of the telescoping assembly 20. The outer dilator assembly 10 is radially expandable and the telescoping assembly 20 is radially contractible, both of which frictionally engage the native valve to create a firm anchoring force to prevent displacement of the outer dilator assembly 10.

Upon release of the flaring assembly 10, the first connector 14 is aligned with the second connector 21, and preferably the first connector 14 of the flaring assembly 10 extends vertically downward and is capable of piercing the native valve leaflet 50 or annulus and connecting with the second connector 21.

The closure of the native leaflet 50 is not impeded because the outflow end 12 of the flaring assembly 10 is relatively short. When further lesions occur in the mitral valve, such that the valve repair device fails, the valve stent with the artificial leaflets can be delivered directly to the flaring assembly 10 by the third delivery device and released within the flaring assembly 10 to replace the physiological function of the native valve.

The embodiments of the present utility model have been described above with reference to the accompanying drawings, but the present utility model is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present utility model and the scope of the claims, which are to be protected by the present utility model.

Claims (10)

1. A valve repair device, comprising:

-an outer flaring assembly comprising an inflow end that is cylindrical, flared, funnel-shaped or arc-shaped of revolution; the inflow end can at least elastically deform in the radial direction to closely fit and conform to the shape of the native annulus;

-a annuloplasty assembly, annular or helical, capable of encircling the mitral/tricuspid valve chordae tendineae;

the expansion assembly is detachably connected with the ring shrinkage assembly.

2. The valve repair device of claim 1, wherein a first connector is provided on the outer expandable assembly and a second connector is provided on the annuloplasty assembly, the first connector and/or the second connector being capable of penetrating native valve tissue such that the outer expandable assembly is connected to both the annuloplasty assembly;

the first connecting piece and the second connecting piece are of a bayonet lock matching structure.

3. The valve repair device of claim 1 or 2, wherein the flaring assembly further comprises an outflow end connected to the inflow end, the outflow end being cylindrical, waisted cylindrical or annular;

friction fit is achieved between the outflow end and the native valve tissue and between the annuloplasty assembly and the native valve tissue;

the length of the outflow end satisfies: the outflow end does not affect the function of the native leaflet, or retains a portion of the function of the native leaflet when the native leaflet is opened or closed.

4. The valve repair device of claim 3, wherein an outer contour of the outflow end matches an outer contour of the annuli assembly;

the cross section of at least the outflow end of the flaring component is circular, elliptical or D-shaped;

the cross section of the ring shrinkage component is round or is shaped in a way of being matched with the outer expansion component.

5. The valve repair device of claim 1, wherein at least the inflow end of the flaring assembly is provided with a skirt, barb or bump for enhancing anchoring of the flaring assembly to heart native tissue.

6. The valve repair device of claim 1, wherein a third connector is provided on the inside of the flaring assembly, said third connector being capable of being snapped into place with a subsequently implanted valve stent.

7. The valve repair device of claim 1, wherein the telescoping assembly comprises at least two half-ring subassemblies, the ends of both of which are circumferentially closed and are used to perform the telescoping cinching of the native leaflets and/or chordae tendineae.

8. The valve repair device of claim 1, wherein the telescoping assembly is a helically extending coil of turns; the annuloplasty assembly comprises an atrial segment and a functional segment for annuloplasty tightening of native leaflets and/or chordae tendineae.

9. The valve repair device of claim 1, wherein the telescoping assembly is provided with barbs or protrusions for enhancing anchoring of the flaring assembly to native heart tissue;

or, the annular shrinkage assembly is also provided with a positioning part extending outwards in a radial direction.

10. A valve repair system comprising a valve repair device according to any one of claims 1-9.