CN114869545A

CN114869545A - Valve leaf capturing device, system and artificial heart valve

Info

Publication number: CN114869545A
Application number: CN202210345616.7A
Authority: CN
Inventors: 周刚; 徐亚鹏; 虞奇峰; 秦涛
Original assignee: Shanghai Newpulse Medical Technology Co ltd
Current assignee: Shanghai Newpulse Medical Technology Co ltd
Priority date: 2022-03-31
Filing date: 2022-03-31
Publication date: 2022-08-09
Also published as: WO2023185248A1

Abstract

The invention relates to a valve leaflet capturing device, a system and a prosthetic heart valve, wherein the valve leaflet capturing device comprises a capturing ring, the capturing ring is spiral and can be wound around a mitral valve/tricuspid valve chordae tendineae, and the capturing ring comprises a core body, a first wrapping layer and a second wrapping layer from inside to outside; the core is made of preformed memory metal and is used for conforming to the deformation of myocardial tissue; the first wrapping layer is a microporous membrane with a smooth surface and is used for inducing tissue cells to grow inwards; the surface of the second wrapping layer is rough and is used for providing friction force for the artificial heart valve stent implanted in the mitral valve/tricuspid valve. The valve leaf capturing device can be stably matched with an implanted artificial heart valve stent and stably anchored at a proper position, so that mutual displacement of the valve leaf capturing device and the implanted artificial heart valve stent in the cardiac cycle is avoided, and the risk of operation failure is reduced.

Description

Valve leaflet capturing device and system and artificial heart valve

Technical Field

The invention relates to the field of medical instruments for cardiac surgery, in particular to a valve leaflet capturing device, a system and a prosthetic heart valve.

Background

The heart includes four pump chambers, the left and right atria and the left and right ventricles, respectively, each having a valve controlling its one-way outflow. The mitral valve (mitral valve) is positioned between the left atrium and the left ventricle, and when the ventricles contract, the mitral valve can tightly close the atrioventricular orifice to prevent blood from flowing back into the left atrium; located between the right atrium and right ventricle is the tricuspid valve (tricuspid valve), which when the right ventricle contracts squeezes blood in the chamber to impact the tricuspid valve to close, preventing backflow of blood into the right atrium.

A fully functioning mitral or tricuspid valve can ensure proper blood circulation is maintained during the heart cycle, but Mitral Regurgitation (MR) or Tricuspid Regurgitation (TR) can occur when the leaflets of the valve fail to come into full contact (coaptation) due to disease; on the other hand, abnormal cardiac structures may also be the cause of reflux, and these two processes may accelerate abnormal cardiac function due to "synergy".

Currently, standard heart valve regurgitation treatments typically require the selection of surgical procedures, and standard surgical repair or replacement procedures require open heart surgery, the use of cardiopulmonary bypass, and cardiac arrest, and because of the invasive nature of these procedures, death, stroke, bleeding, respiratory problems, kidney problems, and other complications are common, patients are often rejected or judged as unsuitable for traditional open surgery due to high risk.

In recent years, the search for transcatheter mitral/tricuspid valve replacement therapy for regurgitation has been motivated by the successful advancement of aortic valve replacement procedures. Mitral/tricuspid valve replacement, however, is much more difficult than aortic replacement in many ways, such as mitral/tricuspid valve is not a traditional circular shape in spatial structure, mitral/tricuspid valve has a more complex tissue structure (annulus, leaflets, chordae tendineae, papillary muscles), mitral/tricuspid valve is larger than aortic, and is more elongated in shape, the leaflets of mitral/tricuspid valve are soft in nature, mitral/tricuspid valve does not provide good retention for replacement valve compared to aortic stenosis or calcification, and because pressure in the ventricle rises sharply when the ventricle contracts, there is a risk of displacement if the replacement valve fails to establish sufficient anchoring at the annulus of mitral/tricuspid valve. Thus, effective mitral/tricuspid replacement therapy for regurgitation is not only subject to large cyclical loads from the mitral/tricuspid valve, but more importantly, establishes a stable and strong anchor.

In order to enhance the radial support provided by the native leaflets to the valve stent, and to secure the valve stent to the leaflets, a catching ring is usually added to the chordae tendineae outside the leaflets, and the catching ring can hold the leaflets and the support frame together. However, the catching ring is made of a smooth material and cannot be guaranteed to be stably matched with the valve support in shape, so that the catching ring and the valve support may be displaced from each other in a cardiac cycle, a replaced valve cannot be continuously and stably fixed at a proper position, and the risk of valve displacement exists.

Disclosure of Invention

The invention discloses a valve leaflet capturing device, a valve leaflet capturing system and a prosthetic heart valve, and aims to solve the technical problems in the prior art.

The invention adopts the following technical scheme:

in one aspect, the present invention provides a leaflet capturing device comprising a capturing ring:

the catching ring is spiral and can be wound around the mitral valve/tricuspid valve chordae tendineae and position the artificial heart valve stent implanted in the mitral valve/tricuspid valve;

the fishing ring comprises a core body, a first wrapping layer and a second wrapping layer from inside to outside;

the core is made of preformed memory metal, which can be elastically deformed at least in radial and axial directions to conform to the change of the shape of the myocardial tissue;

the first wrapping layer is configured to be a fiber layer with smaller pores, the size of the pores allows tissue cells to grow in, and adjacent pores are communicated with each other to allow extracellular matrixes generated after the cells grow in to be mutually connected;

the outer surface of the second wrapping layer is provided with a hair surface structure which is used for providing friction force for the fishing ring; at least one part outside the first wrapping layer is provided with a second wrapping layer;

or the second wrapping layer is arranged outside the first wrapping layer at intervals.

As a preferred technical scheme, the first wrapping layer continuously covers the outside of the core body from the far end to the near end of the core body.

Preferably, the diameter of the pores in the first coating layer is 5-20 μm.

As a preferred technical solution, the first wrapping layer is prepared by weaving or 3D printing.

As a preferred solution, the first wrapping layer comprises an ePTFE microporous membrane.

As a preferred technical solution, the second wrapping layer is configured as a woven layer having larger pores;

or the second wrapping layer is made of a high polymer material with a high friction coefficient;

or the second wrapping layer is made of a high polymer material provided with patterned hollows.

Preferably, the polymer material includes a PET film or a PTFE film.

Preferably, the core comprises nitinol.

As a preferred technical scheme, the catching ring is sequentially provided with an atrium section, a transition section, a functional section and a ventricle section from the near end to the far end;

an atrial segment positioned in the atrium and configured to curve generally following the curvature of the atrial wall;

the transition segment is configured to extend from the functional segment to an atrial segment located in the left atrium.

The functional section is positioned at the native valve ring, is coiled and is used for supporting the implanted artificial heart valve support;

the ventricular segment extends from the functional segment to the ventricle and is configured in a curved shape that generally follows the curvature of the native chordae tendineae.

Preferably, the second coating covers the functional section, and/or the atrial section, and/or the transition section, and/or the ventricular section in the area contacting the prosthetic heart valve stent.

As a preferred technical solution, the second wrapping layer is continuously provided in the functional section.

According to the preferable technical scheme, except for the area contacted with the chordae tendineae, the second wrapping layer covers the first wrapping layer corresponding to the functional section at intervals.

As the preferred technical scheme, a first connecting piece is arranged at the near end of the catching ring, a far end protecting piece is arranged at the far end of the catching ring, and at least one developing ring is further arranged on the catching ring.

In another aspect, the invention also provides a leaflet capturing system comprising the leaflet capturing device of any one of the above and a delivery device for delivering the leaflet capturing device, wherein the delivery device has a distal end provided with a second connector that is detachably connected to the first connector.

The present invention still further relates to a prosthetic heart valve comprising a leaflet capturing device as described in any of the above, further comprising a prosthetic heart valve stent configured to expand at the native mitral/tricuspid valve and interact with the leaflet capturing device.

As the preferred technical scheme, the artificial heart valve stent comprises a balloon-expandable stent which is cylindrical, a sealing membrane is arranged on the outer wall of the balloon-expandable stent, and an artificial valve leaflet is arranged in the balloon-expandable stent.

As preferred technical scheme, the artificial heart valve support includes from inflation formula support, and the support that expands from including the ring flange and the cylindricality support of locating the atrium, is equipped with the seal membrane on the outer wall of support that expands from, and the inside of support that expands from is equipped with artificial valve leaf.

The technical scheme adopted by the invention can achieve the following beneficial effects: the fishing ring is provided with three layers of structures from inside to outside, namely a core body, a first wrapping layer and a second wrapping layer. Wherein the core is used for positioning the artificial heart valve stent which is implanted into the mitral valve/tricuspid valve; the first wrapping layer is smooth and can induce tissue cells to grow into the first wrapping layer, and the matching relation between the catching ring and the mitral valve/tricuspid valve is strengthened; the second wrapping layer is arranged on the outer surface of the catching ring, and is directly matched with the implanted artificial heart valve support through the valve leaves of the native mitral valve/tricuspid valve, so that a high-molecular material with high friction performance or a large-pore woven material is selected, larger friction force can be provided, and the displacement risk of the catching ring is reduced to a certain extent; the outer surface of the second wrapping layer is also provided with a hair side structure, so that a certain buffering effect can be provided, and the situation that the valve leaflets are torn in the cardiac cycle due to overlarge friction force between the valve leaflets and the fishing ring is prevented. Furthermore, the catching ring is also provided with an atrium section and a ventricle section which respectively extend from the native valve annulus to the atrium and the ventricle and have the bending curvature matched with the shapes of the atrium and the native chordae tendineae, so that the fixing position of the catching ring can be effectively ensured, and the catching ring can better conform to the normal physiological functions of the mitral valve/tricuspid valve.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:

FIG. 1 is a schematic cross-sectional view of a fishing ring according to a preferred embodiment of the present invention, as disclosed in example 1;

FIG. 2 is an expanded view of PET knitted pile face in accordance with a preferred embodiment of the present invention as disclosed in example 1;

FIG. 3 is a schematic structural diagram of a leaflet capturing device in a preferred embodiment disclosed in example 1 of the present invention;

FIG. 4 is a schematic structural diagram of a leaflet capturing device in another preferred embodiment disclosed in example 1 of the present invention;

FIG. 5 is a schematic view of a preferred embodiment of the leaflet capturing device being positioned in a heart, as disclosed in example 1 of the present invention;

fig. 6 is a schematic structural diagram of a prosthetic heart valve disclosed in embodiment 3 of the present invention.

Description of reference numerals:

the heart valve prosthesis comprises a catching ring 10, a ventricular segment 11, a functional segment 12, a transition segment 13, an atrial segment 14, a core 20, a first wrapping layer 30, a second wrapping layer 40, a knitted fluff surface 41, a visualization ring 50, a first connector 60, a distal protector 70, a heart valve prosthesis support 80, a mitral valve 90, a left atrium 100, and a left ventricle 110.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is 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 invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.

As used herein, "helical" refers to a catching ring that is similar in structure to a helical spring, but is not an absolute/standard helix because it contains multiple functional segments; by "substantially follows the curvature of the native mitral/tricuspid chordae," it is meant that the lower segment of the harvesting ring is able to match the shape of the mitral/tricuspid chordae to enhance its stability, rather than having a shape that fully conforms to the curvature of the native mitral/tricuspid chordae; by "substantially follows the curvature of the atrial wall" it is meant that the upper section of the harvesting ring can substantially match the shape of the atrial wall to effectively fix the position of the harvesting ring, rather than having a shape that closely conforms to the shape of the atrial wall.

It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

To solve the problems in the prior art, embodiments of the present application provide a leaflet capturing device, a system and a prosthetic heart valve, wherein the leaflet capturing device includes a capturing ring, which is substantially helical and can be wound around the mitral/tricuspid chordae tendineae and position a prosthetic heart valve stent implanted in the mitral/tricuspid valve; the fishing ring comprises a core body, a first wrapping layer and a second wrapping layer from inside to outside; the core body is made of preformed memory metal which can be elastically deformed at least in the radial direction and the axial direction so as to conform to the change of the shape of the myocardial tissue; the first wrapping layer is a microporous membrane with a smooth surface and is used for inducing tissue cells to grow inwards; the surface of the second wrapping layer is rough and is used for providing friction force for the fishing ring.

Example 1

Taking mitral valve implantation as an example, this embodiment 1 provides a leaflet capturing device to solve the technical problems in the prior art. According to fig. 3-6, the leaflet capturing device includes a capturing ring 10, wherein the capturing ring 10 is substantially helical, and can be implanted into the chordae tendineae of the human mitral valve and provide axial and radial forces to cooperate with and interact with the stent of the artificial heart valve implanted in the mitral valve, and the cooperation of the capturing ring 10 and the stent of the artificial heart valve can reduce the size of the native mitral valve and the mitral regurgitation of the leaflets of the native valve, and meanwhile, the capturing device of the leaflet can more firmly anchor the position of the stent 80 of the implanted artificial heart valve, and effectively avoid the displacement of the artificial heart valve in the process of the movement of the myocardium.

As shown in fig. 3 and 4, the leaflet capturing device includes a catching ring 10, a first connector 60 disposed at a proximal end of the catching ring 10, a distal end protector 70 disposed at a distal end of the catching ring 10, and a plurality of developing rings 50 disposed on the catching ring 10. Wherein the first connector 60 is for detachable connection with a delivery device that delivers the leaflet capturing device; the distal protector 70 is used to protect the myocardial tissue during delivery of the leaflet capture device; the visualization ring 50 is used to observe and determine the position of the capture ring 10 during the procedure and to indicate its movement from the atrial side to the ventricular side, with the capture ring 10 encircling the mitral chordae tendineae plexus for positioning the prosthetic heart valve holder 80 implanted in the mitral valve.

Preferably, in order to fix the leaflet capturing device to the mitral valve more stably, the capturing ring 10 is provided with an atrial section 14, a transition section 13, a functional section 12 and a ventricular section 11 in sequence from the proximal end to the distal end, wherein:

the atrial section 14 is curved around the left atrium 100 and has a curvature substantially the same as the curvature of the atrial wall to ensure that the atrial section 14 of the harvesting ring 10 can be more closely matched to the left atrium 100. further, the shape and size of the atrium can vary from patient to patient, and it will be understood by those skilled in the art that the specific curvature and size of the atrial section 14 can be adapted to the patient, and in a preferred embodiment, before surgery on different patients, the patient's heart can be modeled by imaging to determine the appropriate shape and size of the harvesting ring 10.

Referring to fig. 5, the functional segment 12 is positioned in a coil at the annulus of the native mitral valve for supporting a prosthetic heart valve stent 80 implanted within the mitral valve.

Preferably, the transition section 13 is disposed between the atrial section 14 and the functional section 12, and is shaped to extend from the functional section 12 to the atrial section 14 located in the left atrium 100. since the functional section 12 is disposed outside the mitral valve and the atrial section 14 is located in the left atrium 100, the transition section 13 spirals up from outside the mitral valve through the leaflet gap and extends to the atrial section 14 after placement in the body.

The ventricular segment 11 extends down from the functional segment 12 to and is joined to the left ventricle 110 and is configured in a curved shape that generally follows the curvature of the native mitral chordae tendinae, as shown in fig. 5. Further, since the ventricular segment 11 and the functional segment 12 are both located outside the mitral valve, there is no need to provide the transition segment 13; preferably, the particular size and curvature of the ventricular segment 11 can be adapted to the particular condition of the patient.

Further, since the atrial segment 14 is positioned in the atrium and the functional segment 12 and the ventricular segment 11 are positioned outside the mitral valve, the atrial segment 14 is configured to provide a radially outward expanding force to ensure that the segment is stably positioned in the left atrium 100, while the functional segment 12 and the ventricular segment 11 provide a radially inward tightening force to anchor the prosthetic heart valve stent 80 positioned in the mitral valve to simultaneously secure the prosthetic heart valve stent 80 to itself and also tighten the mitral valve to reduce mitral regurgitation.

Further, the generally helical fishing ring 10 may also provide axial deformability to accommodate changes in the morphology of the left cardiac myocardium tissue throughout the cardiac cycle, as well as ease of surgical placement.

Due to the large atrial volume, the narrowest mitral annulus, and the gradual expansion of the chordae tendineae under the mitral valve, in a preferred embodiment, the functional segment 12 has a smaller diameter than the ventricular segment 11, and the ventricular segment 11 has a smaller diameter than the atrial segment 14, in multiple segments of the harvesting ring 10, in order to obtain the best fixation point. In other embodiments, if the ratio in the above embodiments is not applicable after the imaging examination of the heart of the patient before the operation, the size and ratio can be selected more appropriately according to the actual situation.

According to the cross section of the above-mentioned fishing ring 10 shown in fig. 1, the structure comprises three layers from the inside to the outside: a core 20, a first wrapper 30 and a second wrapper 40.

The core 20 is formed by spirally winding at least one elastic wire, has at least radial and axial deformation capacity, can conform to the change of the shape of the mitral valve, and supports and positions the artificial heart valve stent 80 implanted in the mitral valve; preferably, since the core 20 does not directly contact with the myocardial tissue, there is no need to select a biocompatible material, specifically, a memory alloy, a polymer, a fiber or other high molecular material, in a preferred embodiment, the core 20 is preferably heat set from a memory alloy, more preferably a nickel titanium alloy, the nickel-titanium alloy has the expansion rate of more than 20 percent, high damping, high elasticity and long fatigue life, and thus maintain a stable shape, either during delivery to the body or after implantation, and, more importantly, if the first and

second wraps

30, 40 of the core 20 are damaged, the core 20 may come into direct contact with myocardial tissue, the nickel-titanium alloy as a biocompatible material is safer, has wear resistance and corrosion resistance, and does not produce rejection reaction.

The surface of the first wrapping layer 30 is smooth, and can induce the myocardial tissue to grow inwards, so that the matching relation between the catching ring 10 and the mitral valve is further strengthened; preferably, the pores are small throughout the surface and the layer structure of the first wrapping layer 30, and are sized to allow tissue cell growth, and in a preferred embodiment, the pores have a diameter of 5-20 μm to allow passage of single cells, and further, the pores are interconnected in the layer structure of the first wrapping layer 30 to allow the extracellular matrix generated after tissue cell growth.

In a preferred embodiment, first wrapping layer 30 may be prepared by weaving, 3D printing, electrospinning, laser etching energy; when the processes of weaving, electrostatic spinning and the like are adopted, the used material needs to be ensured to have certain elasticity so as to avoid tearing or damage along with the contraction or expansion of the core body 20; when 3D printing, laser etching, etc. are used, the inner diameter of the first cladding layer 30 should be slightly smaller than the outer diameter of the core 20, so that the two layers can be in interference fit, and a more stable combined structure can be obtained.

In a preferred embodiment, the first wrapping layer 30 may be made of a smooth and dense polymer material, preferably polyurethane, polytetrafluoroethylene, expanded polytetrafluoroethylene, alginic acid/alginate, fibroin, chitin, gelatin, collagen, hyaluronic acid, chitosan, polycaprolactone, polylactic acid, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyglycolic acid, polymethacrylic acid, polylactic acid-polyglycolic acid, carboxymethyl starch, starch acetate, carboxymethyl chitosan, carboxymethyl cellulose, polyvinyl alcohol, polyacrylamide, polyacrylic acid, and polyvinylpyrrolidone; in a more preferred embodiment, the first wrapping layer 30 is made of expanded polytetrafluoroethylene (ePTFE) microporous membrane, which is a membrane formed by expanding and stretching ptfe, and has numerous micropores to facilitate cell entry, and no pores need to be made by weaving or 3D printing, and the first wrapping layer is light in weight and does not increase burden after the mitral valve is placed.

The surface of the second wrapping layer 40 is rough and is used for providing a certain friction force for the fishing ring 10 and reducing the risk of displacement of the fishing ring 10 in the cardiac cycle; preferably, the material of the second wrapping layer 40 may be a woven material with large pores, a polymer material with a high friction coefficient, or a polymer material with patterned hollows; preferably, PTFE may be selected as the material from which the second wrapping layer 40 is made; more preferably, the PET film has the characteristics of high tensile strength, thin thickness, high friction coefficient, high surface tension and the like, so that the PET film is selected as a manufacturing material of the second wrapping layer 40; in a more preferred embodiment, the surface of the PET film is provided with patterned hollows, such as a stripe pattern, a wave dot pattern, a sawtooth line pattern or other patterns, in advance when the PET film is provided, so as to further improve the friction performance.

In order to avoid or reduce the possibility of the leaflets tearing and the like during the cardiac cycle if the friction between the second wrapping layer 40 and the leaflets is too great, in a more preferred embodiment, the outer surface of the second wrapping layer 40 is also provided with a loose arrangement of hairy surface structures to provide a certain buffering effect and prevent the catching ring 10 from tearing the leaflets during the cardiac cycle. In particular, when selecting the material of the second wrapping layer 40, a PET film with a knitted pile face 41 attached thereto, as shown in fig. 1-2, can be selected to provide a cushioning effect while ensuring a certain flexibility, so as to balance the protection of the valve leaflets and the positioning of the prosthetic heart valve stent 80.

In one embodiment, the second wrapping layer 40 continuously covers the first wrapping layer 30; preferably, since only the functional section 12 of the catching ring 10 is in contact with the prosthetic heart valve stent 80, the second wrapping layer 40 is provided only on the functional section 12 of the catching ring 10, as shown in fig. 3; in a more preferred embodiment, after implanting the prosthetic heart valve stent 80, the functional section 12 of the capture ring 10 does not completely match the stent, but only partial areas contact each other, so that the second wrapping layer 40 is only covered at intervals in the area where the functional section 12 of the capture ring 10 contacts the prosthetic heart valve stent 80, as shown in fig. 4; at the same time, to prevent the catching ring 10 from being displaced locally during the cardiac cycle, the second wrapping layer 40 can be provided with a slightly larger contact area of the catching ring 10 with the prosthetic heart valve holder 80.

In another preferred embodiment, the second wrapping layers 40 are spaced apart from each other on the functional segment 12, but the partial region of the functional segment 12 contacting the chordae tendineae is not provided with the second wrapping layers 40, so as to avoid pressing or rubbing the chordae tendineae during implantation of the harvesting ring 10, and avoid the chordae tendineae from being broken due to shear force generated by excessive friction force. More preferably, in the functional segment 12, the distribution density of the second wrapping layer 40 is greater at the proximal atrial segment 14 than at the proximal ventricular segment 11, so as to reduce the damage to the chordae tendineae while ensuring a reduction in paravalvular leakage, and optionally, the second wrapping layer 40 is continuously disposed in a region of the functional segment 12 close to the annulus and then spaced apart, and spaced apart more closely to the ventricular segment 11, until the second wrapping layer 40 is no longer disposed close to the chordae tendineae region. In a more preferred embodiment, the second coating 40 is provided continuously in the region of the functional segment 12 close to the valve union, and no second coating 40 is provided in other regions, or the second coating 40 is provided at intervals.

Further, in the case of delivering the leaflet capturing device to the mitral valve position during the operation, the doctor needs to determine whether the installed position is accurate through the visualization ring 50 provided on the capturing ring 10, and since the heart valve is a three-dimensional structure, it is usually necessary to determine whether the spatial position is accurate, it needs to determine whether the spatial position is accurate through the positions of the plurality of visualization rings 50. In order to facilitate the determination of the spatial position of the leaflet capturing device during the implantation process, the developing rings 50 are disposed at the upper and lower ends of the transition section 13 of the capturing ring 10, and are used for prompting the movement of the capturing ring 10 from the left atrium 100 side to the left ventricle 110 side during the operation process; preferably, the development ring 50 may be any biocompatible metal or polymeric material with development property, preferably nickel titanium, stainless steel or injection molding with barium sulfate added; specifically, the developing ring 50 may be fixed to the catching ring 10 by means of glue bonding or sewing.

Preferably, the distal end protector 70 is formed in a hemispherical shape and is fixed to the distal end of the fishing ring 10, and the material thereof may be any biocompatible metal or polymer material having developability, and the same material as that of the development ring 50 may be selected.

Preferably, the first connector 60 is a snap-fit structure with the distal end of the delivery device for delivering the leaflet capturing device, and is used for limiting and releasing the catching ring 10 during the delivery process.

In this embodiment, after the capturing ring 10 is released to the mitral chordae tendineae by the delivery device, the functional section 12 of the capturing ring is positioned at the annulus of the native mitral valve, the transition section 13 extends upward from the annulus through the leaflet gap, the atrial section 14 has a radial expanding force to prevent the leaflet capturing device from being displaced, the ventricular section 11 extends downward from the functional section 12 and surrounds the mitral chordae tendineae, and both the ventricular section 11 and the functional section 12 have a radial tightening force to further enhance the positioning of the leaflet capturing device. Further, a prosthetic heart valve stent 80 is implanted within the native mitral valve, the stent expanding radially outward, interacting with the radially tightened functional segments 12 to anchor the stent against displacement. Since the fishing ring 10 has a three-layer structure, the first wrapping layer 30 wrapped outside the core 20 has a compact and smooth texture and is distributed throughout the pores, and can induce the growth of tissue cells therein and enhance the anchoring effect of the core 20; outmost second wrapping layer 40 is direct and the support contact, and its surface still is equipped with the hair side structure, not only can prevent to catch ring 10 and take place to shift, still provides certain buffering, avoids tearing the leaflet for the cooperation of the leaflet of mitral valve and leaflet capture device is safer and stable.

Example 2

Embodiment 2 provides a leaflet capturing system, which is additionally provided with a delivery device for delivering the leaflet capturing device on the basis of the structure of embodiment 1, wherein a second connecting piece is arranged at the distal end of the delivery device and is detachably connected with the first connecting piece 60 at the proximal end of the capturing ring 10, and the second connecting piece of the delivery device and the capturing ring 10 pass through a guide catheter to reach a left-heart preset position and release the capturing ring 10.

Example 3

Still taking mitral valve implantation as an example, referring to fig. 6, embodiment 3 provides a prosthetic heart valve, which further includes a prosthetic heart valve stent 80 based on the structure of embodiment 1, as described in embodiment 1, the prosthetic heart valve stent 80 being configured to expand at the native mitral valve and interact with the leaflet capturing device described above to eliminate mitral regurgitation. The artificial heart valve stent 80 can be a balloon-expandable stent or a self-expandable stent, a sealing membrane is arranged on the outer wall of the stent, and an artificial valve leaflet is arranged inside the stent.

Specifically, the prosthetic heart valve stent 80 is secured to the native mitral valve and is specifically anchored by the functional segment 12 of the capture ring 10, the atrial segment 14 of the capture ring 10 is secured in the left atrium 100, and the ventricular segment 11 encircles the mitral chordae tendineae.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A leaflet capturing device comprising a capturing ring, characterized in that:

the core body is made of preformed memory metal which can be elastically deformed at least in the radial direction and the axial direction so as to conform to the change of the shape of the myocardial tissue;

the first wrapping layer is configured to be a fiber layer with smaller pores, the pores are sized to allow the cells to grow in, and adjacent pores are communicated with each other to allow the extracellular matrixes generated after the cells grow in to be mutually connected;

the outer surface of the second wrapping layer is provided with a hair surface structure which is used for providing friction force for the fishing ring; at least one part outside the first wrapping layer is provided with the second wrapping layer;

or the second wrapping layers are arranged outside the first wrapping layers at intervals.

2. The leaflet capture device of claim 1, wherein the first wrapping layer continuously covers the core from a distal end to a proximal end of the core.

3. The leaflet capture device of claim 1, wherein the pores have a diameter of 5-20 μ ι η.

4. The leaflet capture device of claim 3, wherein the first wrapping layer is prepared by weaving or 3D printing.

5. The leaflet capture device of claim 4, wherein the first wrapping layer comprises an ePTFE microporous membrane.

6. The leaflet capture device of claim 1, wherein the second wrapping layer is configured as a woven layer having a larger pore;

or the second wrapping layer is made of the high polymer material provided with the patterned hollows.

7. The leaflet capture device of claim 6, wherein the polymeric material comprises a PET film or a PTFE film.

8. The leaflet capture device of claim 1, wherein the core comprises nitinol.

9. The leaflet capturing device of any one of claims 1-8, wherein the capturing ring is configured as an atrial segment, a transitional segment, a functional segment, and a ventricular segment in order from a proximal end to a distal end;

the atrial segment positioned in the atrium and configured to be curved to generally follow the curvature of the atrial wall;

the transition segment is configured to extend from the functional segment to the atrial segment at the left atrium;

the ventricular segment extends from the functional segment to the ventricle and is configured to be curved to generally follow the curvature of the native chordae tendineae.

10. The leaflet capturing device of claim 9, wherein the second wrapping layer covers a region of the functional segment, and/or the atrial segment, and/or the transition segment, and/or the ventricular segment that contacts a prosthetic heart valve stent.

11. The leaflet capture device of claim 9, wherein the second wrapping layer is disposed continuously over the functional segment.

12. The leaflet capturing device of claim 9, wherein the second wrapping layer is spaced apart over the first wrapping layer corresponding to the functional segment except for an area in contact with chordae tendineae.

13. The leaflet capturing device of claim 1, wherein the proximal end of the capturing ring is provided with a first connector, the distal end of the capturing ring is provided with a distal end protector, and the capturing ring is further provided with at least one visualization ring.

14. A leaflet capturing system comprising the leaflet capturing device of any one of claims 1-13, further comprising a delivery device for delivering the leaflet capturing device, the delivery device having a distal end with a second connector that is removably coupled to the first connector.

15. A prosthetic heart valve comprising the leaflet capture device of any of claims 1-13, further comprising a prosthetic heart valve stent configured to expand at a native mitral/tricuspid valve and interact with the leaflet capture device.

16. The prosthetic heart valve of claim 15, wherein the prosthetic heart valve stent comprises a balloon-expandable stent having a cylindrical shape, a sealing membrane disposed on an outer wall of the balloon-expandable stent, and a prosthetic leaflet disposed inside the balloon-expandable stent.

17. The prosthetic heart valve of claim 15, wherein the prosthetic heart valve stent comprises a self-expanding stent comprising a flange positioned in an atrium and a cylindrical stent, wherein a sealing membrane is disposed on an outer wall of the self-expanding stent, and wherein a prosthetic leaflet is disposed inside the self-expanding stent.