CN115737207A - Heart valve positioning device, artificial valve system and implantation method thereof - Google Patents

Abstract

The present application provides a heart valve positioning device removably attachable to a delivery system, the heart valve including a native annulus and native leaflets, the heart valve positioning device comprising: a cylindrical support provided with at least one connecting piece; the first clamping pieces are distributed along the periphery of the support and connected with the support; the second clamping piece is configured to be sleeved on the periphery of the first clamping piece; in a delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting piece is connected with the delivery system; in a release state, the connecting member is detached from the delivery system, the native valve leaflet is clamped between the first clamping member and the support, and the second clamping member is folded over from the outer periphery of the first clamping member and clamps the native valve leaflet, so that the native valve leaflet forms a folded structure. The heart valve positioning device can easily pass through chordae tendinae to hook and hold native valve leaflets, and is simple in operation and quick and easy.

Description

Heart valve positioning device, artificial valve system and implantation method thereof

technical field

The embodiments of the present application relate to the technical field of medical devices, in particular to a heart valve positioning device, an artificial valve system and an implantation method thereof.

Background technique

Mitral valve, tricuspid valve, aortic valve, pulmonary valve and other common diseases are valvular insufficiency. Taking mitral valve as an example, during systole, part of the blood of the left ventricle flows to the left atrium through the incomplete mitral valve orifice. reflux. The left atrium receives blood from the left ventricular regurgitation and blood from the pulmonary vein at the same time, and the blood volume and pressure of the left atrium increase significantly, resulting in left atrial hypertrophy. During the diastolic period, more blood flows from the left atrium to the left ventricle, causing the left ventricle to hypertrophy due to the strengthening of contraction. After the compensation period progresses to the decompensation period, heart failure occurs in both the left atrium and left ventricle, and then in turn Pulmonary congestion, pulmonary hypertension, right ventricular hypertrophy, right atrial hypertrophy, right heart failure, and systemic circulation congestion occurred.

Traditional treatment options include aggressive surgical approaches or palliative drugs to combat inevitable heart failure. Among them, surgical methods also include valve replacement and valvuloplasty. Among surgical methods, typical thoracotomy is highly invasive, requires extracorporeal circulation, and has a high complication rate and risk of infection. Many patients cannot tolerate the huge surgical risk.

At present, there are few replacement products approved for minimally invasive transcatheter treatment of secondary and tricuspid regurgitation in China. These products are difficult to operate and take a long time during the healing process, so the success rate is low; Weekly leakage and other problems will weaken the treatment effect and even worsen the condition. For example, Chinese patent CN109789019B requires the coil to enter the ventricle from the atrium through the junction of the anterior and posterior valve leaflets through the delivery system, and the coil needs to be remotely controlled to pass between the chordae and the ventricular wall, that is, the chordae need to be wrapped into the coil . The operation is difficult, the operation time is long, and the success rate of the operation is low.

Therefore, there is an urgent need for a product that is easy to operate, reliable in positioning, and fits well with human valves to treat valvular regurgitation through a minimally invasive approach.

Contents of the invention

In view of the above problems, the present application provides a heart valve positioning device, an artificial valve system and an implantation method thereof, so as to overcome the above problems or at least partly solve the above problems.

An embodiment of the present application provides a heart valve positioning device, which is detachably connected to a delivery system. The heart valve includes a native valve ring and native valve leaflets. The heart valve positioning device includes: a cylindrical stent, and the stent is provided with at least one connecting piece several first clips, the first clips are distributed along the periphery of the bracket, and the first clips are connected to the bracket; the second clips are configured to be sleeved on the first clip The outer periphery of the holder; in the delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting piece is connected with the delivery system; Hold between the first clamping part and the bracket, and the second clamping part is folded from the outer periphery of the first clamping part and clamps the original leaflet, so that the original leaflet forms a folded structure.

Optionally, the folding structure includes a first folding part and a second folding part connected to each other; in a released state, the first folding part is clamped between the bracket and the first clamping part, and the second folding part The folded part is clamped between the first clamping part and the second clamping part.

Optionally, the first folded part and the second folded part respectively comprise a front surface located inside the original valve leaflet and a back surface located outside the native valve leaflet; abut against, the back of the first folding part abuts against the inner side of the first clamping part, the front of the second folding part abuts against the second clamping part, and the back of the second folding part abuts against the first clamping part. The outer side of the clip abuts.

Optionally, the bracket includes a body and an extension column, the extension column extends axially upward from the body, and is connected to the connecting piece at an extension end, and the bottom of the first clamping piece is connected to the bottom of the body.

Optionally, the first clip includes a first extension and a second extension connected to each other, the first extension extends downward from the bottom of the body, and an extension end is connected to the bottom of the second extension A docking portion is formed, and the second extension portion extends upward from the docking portion.

Optionally, the first folding part is connected to the second folding part at the top of the second extending part.

Optionally, the first clamping part includes an adjustment part, and the delivery system includes an adjustment sheath. When the adjustment sheath enters between the first clamping part and the stent, the adjustment sheath pushes against the adjustment portion so that the top of the second extension portion is away from the outer surface of the bracket.

Optionally, the adjusting portion includes the docking portion and at least a part of the second extending portion.

Optionally, the second clamping part extends from the top of the body and forms a ring along the outer periphery of the first clamping part.

Optionally, the second clamping member is provided with a third extending portion and a fourth extending portion connected to each other, the third extending portion extends radially outward from the top of the body to form an arc, and the highest point of the arc is The point is higher than the highest point of the first clamping part, and the fourth extension extends circumferentially from the end of the arc to surround the first clamping part in a circumferential direction. Optionally, the second clamping part includes at least two clamping units, each clamping unit is respectively provided with a third extension part and a fourth extension part, and each fourth extension part is located on the outer circumference of the first clamping part extended to form a non-closed loop.

Optionally, the fourth extension forms a closed loop.

Optionally, the second clamping member includes a closed ring, and the closed ring is provided with an interface for detachable connection with the delivery system.

Another aspect of the present application also provides an artificial valve system, including: the above-mentioned heart valve positioning device; an artificial valve, which includes: an artificial valve leaflet; and a cylindrical support member, the artificial valve leaflet is circumferentially fixed on the inside, and the support member is adapted to the stent, so that when the heart valve positioning device is released, the artificial valve is implanted inside the stent.

Another aspect of the present application also provides a method for implanting the above-mentioned artificial valve system into the heart, including: contracting the heart valve positioning device in the delivery system, delivering it to the heart valve, releasing the heart valve positioning device, and placing the original valve The leaves are clamped between the first clamping part and the bracket, the second clamping part clamps the original valve leaflet from the outer periphery of the first clamping part, so that the original valve leaflet forms a folded structure, and the connecting part Breaking away from the delivery system, and then delivering the artificial valve to the heart valve for release, so that the artificial valve is implanted inside the stent.

It can be seen from the above technical solutions that the heart valve positioning device according to the embodiment of the present application can easily pass through the chordae tendineae to hold the original leaflet hook, and the operation is simple, easy and fast. The original leaflet is folded and squeezed around the outer side of the first clamping part by the second clamping part, so that the positioning and clamping are simple and reliable.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments described in the embodiments of the present application, and those skilled in the art can also obtain other drawings based on these drawings.

Fig. 1 is a simple view of the human heart mitral valve;

Fig. 2A is a perspective view of an embodiment of a heart valve positioning device of the present application;

Fig. 2B is a cross-sectional view of the original valve leaflet clamped by the heart valve positioning device shown in Fig. 2A after being released;

3A-3B are respectively a perspective view and a cross-sectional view of another embodiment of a heart valve positioning device of the present application;

Fig. 3C is a schematic diagram of the state of clamping the native valve leaflet after the heart valve positioning device shown in Fig. 3A is released;

4A-4B are respectively a perspective view and a top view of another embodiment of a heart valve positioning device of the present application in a non-use state;

4C-4D are respectively a perspective view and a cross-sectional view of the original valve leaflet clamped by the heart valve positioning device shown in FIGS. 4A-4B ;

Fig. 5 is a cross-sectional view of the heart valve positioning device and the artificial valve respectively released on the heart valve;

6A-6F are schematic diagrams of different states of delivering the heart valve positioning device to the heart valve and gradually releasing it, wherein FIG. 6C is a cross-sectional view of the state shown in FIG. 6B;

6G-6H are schematic diagrams of different states of implanting the artificial valve into the heart valve and gradually releasing it;

Fig. 7 is a schematic diagram of the heart valve positioning device in a compressed state;

FIG. 8A is a schematic structural view of an embodiment of the artificial valve system of the present application;

8B-8C are respectively a perspective view and a cross-sectional view of an embodiment of the artificial valve system shown in FIG. 8A clamping the original leaflet after release;

Fig. 8D is a schematic diagram of an embodiment of the artificial valve system shown in Fig. 8A in a delivery state;

8E-8F are respectively a perspective view and a cross-sectional view of an embodiment of the artificial valve system shown in FIG. 8A capturing the original leaflet;

8G-8H are respectively a perspective view and a cross-sectional view of an embodiment of the artificial valve system shown in FIG. 8A connected to the delivery system;

Fig. 9A is a schematic structural view of another embodiment of the artificial valve system of the present application;

9B-9C are respectively a perspective view and a cross-sectional view of another embodiment of the artificial valve system shown in FIG. 9A clamping the original leaflet after release;

Fig. 10A is a schematic structural view of another embodiment of the artificial valve system of the present application;

10B-10C are respectively a perspective view and a cross-sectional view of yet another embodiment of the artificial valve system shown in FIG. 10A after releasing and clamping the native valve leaflet.

Component number

10: Heart valve positioning device; 20: Delivery system; 101: Stent; 1011: Connector;

102: first clamping part; 103: second clamping part; 30: native leaflet; 301: first folding part;

302: the second folding part; 3011: the front side of the first folding part; 3012: the back side of the first folding part;

3021: the front of the second folding part; 3022: the back of the second folding part; 1012: the main body; 1013: the extension post; 1011a: the through hole; 202: the second pull wire; 203: the adjustment sheath; 1021: the first extension ; 1022: second extension; 1023: docking portion; 1024: adjustment portion; 1031: third extension; 1032: fourth extension; 1033: clamping unit; 1034: closed ring; 1035: interface; 40: Artificial valve; 401: artificial valve leaflet; 402: support; 50: artificial valve system; 501: support; 502: biocompatible membrane; 503: first puller.

Detailed ways

In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the following will clearly and completely describe the technical solutions in the embodiments of the present application in conjunction with the drawings in the embodiments of the present application. Obviously, the described The embodiments are only some of the embodiments of the present application, but not all of them. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the embodiments of the present application shall fall within the protection scope of the embodiments of the present application.

The "top" and "upper" refer to the relative upper side in terms of the paper where the illustration is located. The "bottom" and "bottom" refer to the relative bottom in terms of the paper where the illustration is located.

The "proximal end" refers to the end close to the operator's hand when the heart valve positioning device is delivered, and the "distal end" refers to the end away from the operator's hand when the heart valve positioning device is delivered.

The specific implementation of the embodiment of the present application will be further described below in conjunction with the accompanying drawings of the embodiment of the present application.

1 to 7, in a specific implementation of the present application, a heart valve positioning device 10 is provided, which is detachably connected to a delivery system 20. The heart valve includes a native valve ring and a native valve leaflet. The heart valve positioning device 10 includes: a cylindrical bracket 101, the bracket 101 is provided with at least one connecting piece 1011; several first clamping pieces 102, the first clamping pieces 102 are distributed along the periphery of the bracket 101, and the first clamping pieces 102 is connected to the stent 101; the second clamping member 103 is configured to be sleeved on the outer periphery of the first clamping member 102; in the delivery state, the heart valve positioning device 10 is shrunk in the delivery system 20, and The connector 1011 is connected to the delivery system 20; in the released state, the connector 1011 is separated from the delivery system 20, the native leaflet 30 is captured between the first clamping member 102 and the stent 101, and the The second clamping part 103 is folded from the outer periphery of the first clamping part 102 to clamp the native leaflet 30 so that the native leaflet 30 forms a folded structure. The native valve leaflet 30 captured between the first clamping part 102 and the stent 101 can be initially clamped by the first clamping part 102 and the stent 101, and the second clamping part 103 can further tighten the captured native valve leaflet 30. clamping.

The bracket 101, the first clamping part 102, and the second clamping part 103 all have elasticity, so that the bracket 101 can be compressed for delivery, and the first clamping part 102 and the second clamping part 103 can be opposite to the bracket 101 The outer surface is based on radial expansion or contraction. In the non-use state (the heart valve positioning device 10 is released when the heart is not implanted), the diameter of the closed or non-closed ring formed by the second clamping part 103 can be greater than, equal to or smaller than that formed by the first clamping part 102 The diameter of the ring.

The first clamping part 102 can pass through the chordae tendineae, push and hook on the tissue surface on the ventricle side, thereby providing support for the second clamping part 103 to turn over the original valve leaflet 30, and the second clamping part 103 can restore the elastic force to the Rolling up on the outside pushes the inner side of the original valve leaflet 30 , rolling and pressing the leaflet on the outer periphery of the first clamping member 102 .

The stent 101 can be a net-like elastic structure, which can be compressed into a smaller outer diameter so as to be accommodated in the sheath of the delivery system 20. When the stent 101 is pushed away from the lumen of the sheath of the delivery system 20, the stent 101 can It expands to an open state under the action of elasticity. The first clamping part 102 and the second clamping part 103 can also be compressed and expanded after being released.

In an embodiment of the present application, the folded structure formed by the native leaflet 30 includes a first folded portion 301 and a second folded portion 302 connected to each other; in a released state, the first folded portion 301 is clamped to the bracket 101 and the first clamping part 102 , the second folding part 302 is clamped between the first clamping part 102 and the second clamping part 103 . The front side 3011 of the first folded part 301 and the front side 3021 of the second folded part 302 are located inside the original leaflet 30 , and the back side 3012 of the first folded part 301 and the back side 3022 of the second folded part 302 are located outside the original leaflet 30 . In the released state, the front side 3011 of the first folding part 301 abuts against the outside of the bracket 101, the back side 3012 of the first folding part 301 abuts against the inside of the first clip 102, and the second folding part The front 3021 of the folded part 302 abuts against the second clamping part 103 , and the back 3022 of the second folded part 302 abuts against the outer side of the first clamping part 102 .

In an embodiment of the present application, the bracket 101 includes a body 1012 and an extension column 1013 , the extension column 1013 extends axially upward from the top of the body 1012 , and is connected to the connector 1011 at an extension end. The connecting part 1011 can be a through hole 1011a, and the delivery system 20 is provided with a first puller wire, which is used to connect to the through hole 1011a or to separate from the through hole 1011a. During delivery, the first puller wire passes through the through hole 1011a to make the heart valve positioning device 10 is connected to the delivery system 20 , and after being released, the first puller wire is disengaged from the through hole 1011a, and the extension column 1013 clamps the inner side of the native valve leaflet 30 from the front side 3011 of the first folded part 301 . The delivery system 20 may not be provided with the first pull wire, and may be connected to or disconnected from the connecting member 1011 in other suitable ways. For example, the delivery system 20 may be provided with a protrusion that can engage or disengage with the through hole 1011a.

The conveying system 20 can also be provided with a second pull wire 202, which is used to connect to the second clamping member 103 or disengage from the second clamping member 103. When conveying, as shown in FIGS. 6B-6D, the second pull wire 202 passes through the The second clamping part 103, by pulling the second pull wire 202 passing through the second clamping part 103, the second clamping part 103 can be pulled up, the second pull wire 202 is released, and the second pull wire 202 is separated from the second clamping part 103, the second clamping part 103 will deform under its own elastic action, the second clamping part 103 stretches to the outer periphery of the first clamping part 102, and clamps the original leaflet 30 from the front side 3021 of the second folding part 302. inside.

In an embodiment of the present application, there may be two or more first clamping pieces 102 , and the bottom of the first clamping piece 102 is connected to the bottom of the main body 1012 . The first clip 102 includes a first extension 1021 and a second extension 1022 connected to each other. The first extension 1021 extends downward from the bottom of the body 1012 , and the end of the extension is connected to the bottom of the second extension 1022 The connection forms a docking portion 1023 , and the second extension portion 1022 extends upward from the docking portion 1023 . The second extension portion 1022 may gradually approach the outer surface of the stent 101 when extending upward, or extend upward along the axial direction (parallel to the axis of the stent 101 ), that is, parallel to the outer surface of the stent 101 . The first folding part 301 can be connected with the second folding part 302 at the top of the second extension part 1022 .

In an embodiment of the present application, the first clamping part 102 includes an adjustment part 1024, and the delivery system includes an adjustment sheath 203. When the adjustment sheath 203 enters between the first clamping part 102 and the stent 101, The adjusting sheath 203 pushes against the adjusting portion 1024 so that the top of the second extending portion 1022 is away from the outer surface of the stent 101 . The adjustment part 1024 may include the docking part 1023 and at least a part of the second extension part 1022 , and the adjustment part 1024 may not include the docking part 1023 but only include a part of the second extension part 1022 . For example, as shown in FIG. 6C , when the regulating sheath 203 enters between the first clamping member 102 and the stent 101, the regulating sheath 203 can first contact the docking portion 1023, since the connecting member 1011 is connected to the delivery system 20, The operator can control the adjustment sheath 203 to gradually move downward relative to the stent 101 (that is, the direction of the ventricle). The top of the extension 1022 is away from the outer surface of the stent 101 , that is, the gap between the second extension 1022 and the outer surface of the stent 101 becomes larger, so that the original leaflet 30 is captured between the second extension 1022 and the outer surface of the stent 101 After that, when the regulating sheath 203 is withdrawn gradually, the gap between the second extension part 1022 and the outer surface of the stent 101 becomes smaller, and the second extension part 1022 and the stent 101 limit and initially clamp the native leaflet 30 . After the first extension part 1021 is connected with the second extension part 1022, it can form an arc shape (as shown in FIGS. 2A-5 ), V shape, U shape or other suitable shapes.

In the delivery state, the second extension part 1022 can be folded 180 degrees to the distal end and shrunk into the delivery system 20, as shown in FIG. 6A; it can also be directly compressed and shrunk into the delivery system 20 without turning over, as Figure 7 shows.

The delivery system 20 may include a plurality of sub-delivery systems, and each sub-delivery system is respectively provided with a first puller wire, a second puller wire 202 and an adjustment sheath tube 203 .

The second clip 103 extends from the top of the body 1012 and forms a ring along the outer periphery of the first clip 102 . The second clamping member 103 may comprise a plurality of arc-shaped circles forming an unclosed loop (as shown in FIG. 2A ), or comprise a closed full loop (as shown in FIGS. 3A and 4A ).

In an embodiment of the present application, as shown in FIG. 2A , the second clamping member 103 includes two clamping units 1033, and each clamping unit 1033 is respectively provided with a third extension 1031 and a fourth extension 1032 connected to each other, The third extension portion 1031 of each clamping unit 1033 extends radially outward from the top of the body 1012 to form an arc, the highest point of the arc is higher than the highest point of the first clamping member 102, each clamping unit The fourth extension 1032 of 1033 extends circumferentially from the end of the arc, so that each clamping unit 1033 is connected end to end to form an unclosed ring, thereby circumferentially surrounding the first clamping member 102 . Each clamping unit 1033 may include two third extensions 1031 , and the fourth extension 1032 is clamped between the two third extensions 1031 to form a part of a ring. The highest point of the arc can also be lower than the highest point of the first clamping member 102 . In this embodiment, the second clamping part 103 is integrated with the bracket 101 and the first clamping part 102 , so that the clamping and positioning of the original leaflet 30 are more stable and reliable. The number of clamping units can also be three or more.

In another embodiment of the present application, as shown in FIG. 3A , the second clamping member 103 includes a closed ring 1034, and the closed ring 1034 is provided with two interfaces 1035 for detachable with the delivery system 20 connect.

In yet another embodiment of the present application, as shown in FIG. 4A , the second clamping member 103 only includes one clamping unit, and the fourth extension 1032 forms a closed loop, that is, the second clamping member 103 includes a third extension 1031 and a closed loop connected to the third extension 1031. There may be at least one third extension part 1031, such as two or more.

As shown in Fig. 5, in another embodiment of the present application, an artificial valve system is also provided, which includes the above-mentioned heart valve positioning device 10 and an artificial valve 40, wherein the artificial valve 40 includes an artificial valve leaflet 401 and a cylindrical A support member 402, the artificial valve leaflet 401 is circumferentially fixed on the inner side of the support member 402, and the support member 402 is adapted to the bracket 101, so that when the heart valve positioning device 10 is released, the artificial valve 40 is implanted into the inside of the bracket 101.

The prosthetic valve 40 may include a self-expandable or expandable support 402, and a plurality of prosthetic valve leaflets 401 disposed inside the support 402 to control blood flow. When the prosthetic valve 40 is in a compressed state, it can be received in a delivery tube for delivery to a target location. When the heart valve positioning device 10 has been set on the native valve, the artificial valve 40 is coaxially delivered to the central hole of the stent 101, the artificial valve 40 is released, and its outer periphery squeezes the inner periphery of the stent 101, thereby making the artificial valve 40 and the heart valve positioning device 10 are fixed together. At this time, the inner side of the leaflet is pressed by the artificial valve 40, and the outer side is restricted by the second clamping member 103, so that it is clamped more tightly.

The present application also provides a method for implanting the above-mentioned artificial valve system into the heart, including: contracting the heart valve positioning device 10 in the delivery system 20, delivering it to the heart valve, releasing the heart valve positioning device 10, and placing the original valve leaflet 30 Captured between the first clamping part 102 and the bracket 101, the second clamping part 103 clamps the native valve leaflet 30 from the outer periphery of the first clamping part 102, so that the native valve leaflet 30 forms a folded structure, The connector 1011 is separated from the delivery system 20 , and then the artificial valve 40 is delivered to the heart valve for release, so that the artificial valve 40 is implanted inside the stent 101 .

As shown in Figures 6A-6G, in a specific embodiment, the method for implanting the above-mentioned artificial valve system into the heart is as follows: the heart valve positioning device 10 is compressed in the sheath of the delivery system 20, and enters through the human blood vessels and atrial septum. In the left atrium and left ventricle, the heart valve positioning device 10 is gradually pushed out of the sheath, the first clamping part 102 is opened under the action of its own elasticity, and the second extension part 1022 is aligned with the bracket 101 by adjusting the sheath 203 against the adjustment part 1024 The gap between the outer surfaces becomes larger. When the second extension 1022 is opened to a suitable size, the delivery system 20 is used to make the second extension 1021 pass through the chordae and hook up to hold the outer side of the original leaflet 30 near the periphery of the annulus. At this time, the native leaflet 30 is captured between the second extension 1022 and the outer surface of the stent 101 . At this point, part of the main body of the stent 101 and the second clamping member 103 are confined within the delivery system 20 . The heart valve positioning device 10 is further pushed out of the sheath, the stent 101 and the first clamping member 102 continue to elastically recover and deform, and the original valve leaflet 30 is further clamped between the stent 101 and the second extension part 1022 . After the second puller 202 is released and withdrawn, the second clamping member 103 rolls outwards under its own elasticity, and folds and squeezes the original leaflet 30 around the outside of the first clamping member 102 . The delivery system 20 is dissociated, the interface is released, and the anchoring of the heart valve positioning device 10 on the native valve leaflet 30 is completed.

As shown in Figure 5, when the artificial valve 40 has a self-expandable support 402, the artificial valve 40 is compressed in the sheath of the delivery system (not shown in the figure), and after being delivered to the target position, the artificial valve 40 is pushed out The sheath tube, the artificial valve 40 expands and extrudes itself to fit inside the stent 101, and disengages the delivery system. The pushing force generated by the expansion of the cylindrical support member 402 makes the heart valve positioning device 10 , the native valve leaflet 30 and the artificial valve 40 press together more tightly in the circumferential direction, so that the artificial valve 40 is reliably fixed on the heart valve.

As shown in Figure 6G, when the artificial valve 40 has an expandable support member 402, the artificial valve 40 is compressed in the sheath tube of the delivery system, and after being delivered to the target position, the artificial valve 40 is pushed out of the sheath tube, and passes through the delivery system circumferentially. The expansion frame, the thrust generated by the expansion makes the heart valve positioning device 10, the original valve leaflet 30 and the artificial valve 40 squeeze together more tightly in the circumferential direction, so that the artificial valve system is reliably fixed on the original valve. When the prosthetic valve 40 is placed, it will squeeze the bracket 101 to expand outward in the circumferential direction, and relatively, the second clamping member 103 is tightened inward at the outermost side, so as to securely clamp the folded original valve leaflet 30 . The application is simple to operate, firmly and reliably fixed on the original valve of the human body, and greatly reduces the risk of displacement of the artificial valve system after implantation. In addition, by pressing the second clamping member 103 circumferentially inward, paravalvular leakage can be effectively prevented.

Due to the softness of the tissue of the native valve leaflet 30 , the deformation of the heart valve positioning device 10 is controlled by the delivery system 20 , gradually driving the deformation of the tissue of the native valve leaflet 30 , and finally tightening and positioning on the native valve leaflet 30 . The heart valve positioning device 10 of the present application can easily hook the native valve leaflet 30 through the chordae, and the operation is simple, easy and fast. The native leaflet 30 is folded and squeezed around the outside of the first clamping component 102 by the second clamping component 103 , and the positioning is simple and reliable.

As shown in Figures 8A-10C, different from the above-mentioned embodiments, the following embodiment is an artificial valve system 50 that integrates an artificial valve and a heart valve positioning device. Specifically, the artificial valve system 50 includes: a cylindrical support Body 501, the support body 501 is provided with at least one connecting piece, the inner side of the support body 501 is provided with artificial leaflets; several first clamping pieces, the first clamping piece is connected to the bottom of the support piece and distributed On the outer periphery of the support body 501; the second clamping part is configured to be sleeved on the outer periphery of the first clamping part; in the delivery state, the connecting part is connected with the delivery system, and the artificial valve system 50 contracts In the delivery system; in the released state, the connector is disengaged from the delivery system, the native valve leaflet is captured between the first clamping member and the support body 501, and the second clamping member is released from the first clamping member The outer periphery of a clamping part is folded and clamps the original leaflet so that the original leaflet forms a folded structure. The native valve leaflet 30 captured between the first clamping part 102 and the support body 501 can be preliminarily clamped by the first clamping part 102 and the support body 501, and the second clamping part 103 can hold the captured native valve leaflet 30 for further clamping.

The supporting body 501, the first clamping part 102, the second clamping part 103, and the artificial valve leaflets all have elasticity, so that the artificial valve system 50 can be compressed for delivery. The first clamping part 102, the second clamping part The member 103 can expand or shrink relative to the outer surface of the support body 501 based on the radial direction. In the non-use state (the artificial valve system 50 is released when the heart is not implanted), the diameter of the closed or non-closed ring formed by the second clamping part 103 can be greater than, equal to or smaller than that formed by the first clamping part 102. The diameter of the ring. In an optional embodiment, the inner side or the inner side and the outer side of the support body 501 are provided with the biocompatible film 502 by sewing, ironing or other processes. The artificial valve leaflet may include one or more leaflets for controlling blood flow, and may be connected inside the support body 501 by suturing or other techniques. The prosthetic leaflets contract radially when squeezed and expand radially when released.

The support body 501 can be a net-like elastic structure, and the net-like elastic structure can be composed of a plurality of rhomboid units, parallelogram units or units of other shapes, and can be compressed into a smaller outer diameter so as to be accommodated in the sheath tube of the delivery system 20 Here, when the support body 501 is pushed away from the lumen of the sheath tube of the delivery system 20, the support body 501 can expand into an open state under the action of its own elasticity. The first clamping part 102 and the second clamping part 103 can also be compressed and expanded after being released.

The first clamping part 102 can pass through the chordae tendineae, push and hook on the tissue surface on the ventricle side, thereby providing support for the second clamping part 103 to turn over the original valve leaflet 30, and the second clamping part 103 can restore the elastic force to the Rolling up on the outside pushes the inner side of the original valve leaflet 30 , rolling and pressing the leaflet on the outer periphery of the first clamping member 102 .

In an embodiment of the present application, the folded structure formed by the native leaflet 30 includes a first folded portion 301 and a second folded portion 302 connected to each other; in a released state, the first folded portion 301 is clamped on the support Between the body 501 and the first clamping part 102 , the second folding part 302 is clamped between the first clamping part 102 and the second clamping part 103 . The front side 3011 of the first folded part 301 and the front side 3021 of the second folded part 302 are located inside the original leaflet 30 , and the back side 3012 of the first folded part 301 and the back side 3022 of the second folded part 302 are located outside the original leaflet 30 . In the released state, the front 3011 of the first folding part 301 abuts against the outside of the support body 501, the back 3012 of the first folding part 301 abuts against the inside of the first clamping member 102, and the second fold The front 3021 of the part 302 abuts against the second clamping part 103 , and the back 3022 of the second folded part 302 abuts against the outer side of the first clamping part 102 .

The connecting piece 1011 can be a through hole 1011a arranged on the top of the support body 501. The conveying system 20 is provided with a first pull wire 503, which is used to connect to or separate from the through hole 1011a. When transporting, the first pull wire 503 passes through The artificial valve system 50 is connected to the delivery system 20 through the through hole 1011a. After being released, the first pull wire 503 is separated from the through hole 1011a, and the support body 501 clamps the inner side of the original valve leaflet 30 from the front side 3011 of the first folding part 301. The conveying system 20 may not be provided with the first pull wire 503 , and may be connected or disconnected from the connecting member 1011 in other suitable ways. For example, the conveying system 20 may be provided with a protrusion that can engage or disengage with the through hole 1011 a.

The conveying system 20 can also be provided with a second pull wire 202, which is used to connect to the second clamping member 103 or disengage from the second clamping member 103. When conveying, as shown in FIGS. 8G-8H, the second pull wire 202 passes through the The second clamping part 103, by pulling the second pull wire 202 passing through the second clamping part 103, the second clamping part 103 can be pulled up, the second pull wire 202 is released, and the second pull wire 202 is separated from the second clamping part 103, the second clamping part 103 will deform under its own elastic action, the second clamping part 103 stretches to the outer periphery of the first clamping part 102, and clamps the original leaflet 30 from the front side 3021 of the second folding part 302. inside.

In an embodiment of the present application, there may be two or more first clamping pieces 102 , and the bottom of the first clamping piece 102 is connected to the bottom of the supporting body 501 . The first clip 102 includes a first extension 1021 and a second extension 1022 connected to each other, the first extension 1021 extends downward from the bottom of the support body 501 , and the end of the extension is connected to the bottom of the second extension 1022 The connection forms a docking portion 1023 , and the second extension portion 1022 extends upward from the docking portion 1023 . The second extension portion 1022 may gradually approach the outer surface of the support body 501 when extending upward, or extend upward along the axial direction (parallel to the axis of the support body 501 ), that is, parallel to the outer surface of the support body 501 . The first folding part 301 can be connected with the second folding part 302 at the top of the second extension part 1022 .

In an embodiment of the present application, the first clamping part 102 includes an adjustment part 1024, and the delivery system includes an adjustment sheath 203. When the adjustment sheath 203 enters between the first clamping part 102 and the support body 501, The adjusting sheath 203 pushes against the adjusting portion 1024 so that the top of the second extending portion 1022 is away from the outer surface of the supporting body 501 . The adjustment part 1024 may include the docking part 1023 and at least a part of the second extension part 1022 , and the adjustment part 1024 may not include the docking part 1023 but only include a part of the second extension part 1022 . For example, as shown in FIG. 8F , when the regulating sheath 203 enters between the first clamping member 102 and the support body 501, the regulating sheath 203 can first contact the docking portion 1023, since the connecting member 1011 is connected to the delivery system 20 , the operator can control the adjustment sheath 203 to gradually move downward relative to the support body 501 (that is, the direction of the ventricle). The top of the second extension part 1022 is away from the outer surface of the support body 501, that is, the gap between the second extension part 1022 and the outer surface of the support body 501 becomes larger, so that the original valve leaflet 30 is caught between the second extension part 1022 and the support body. between the outer surface of the body 501; when the regulating sheath 203 is withdrawn gradually, the gap between the second extension 1022 and the outer surface of the support body 501 becomes smaller, and the second extension 1022 and the support body 501 limit and preliminarily The native valve leaflet 30 is clamped. After the first extension part 1021 is connected with the second extension part 1022, it can form an arc shape (as shown in FIGS. 2A-5 ), V shape, U shape or other suitable shapes.

In the delivery state, the second extension part 1022 can be folded 180 degrees to the distal end and shrunk into the delivery system 20 , as shown in FIG. 8D ; it can also be directly compressed and shrunk into the delivery system 20 without turning over.

The delivery system 20 may include multiple sub-delivery systems, and each sub-delivery system is respectively provided with a first puller 503 , a second puller 202 and an adjustment sheath 203 .

In one embodiment, the second clamping part 103 extends on the top of the supporting body 501 and forms a ring along the outer periphery of the first clamping part 102 . The second clamping member 103 may comprise a plurality of arc-shaped loops forming an unclosed loop (as shown in FIGS. 8A-8H ), or comprise a closed full loop (as shown in FIGS. 9A-10C ).

In an embodiment of the present application, as shown in FIG. 8A , the second clamping member 103 includes two clamping units 1033, and each clamping unit 1033 is respectively provided with a third extension 1031 and a fourth extension 1032 connected to each other, The third extension 1031 of each clamping unit 1033 extends radially outward from the top of the support body 501 to form an arc, the highest point of which is higher than the highest point of the first clamping member 102, each clamping unit The fourth extension 1032 of 1033 extends circumferentially from the end of the arc, so that each clamping unit 1033 is connected end to end to form an unclosed ring, thereby circumferentially surrounding the first clamping member 102 . Each clamping unit 1033 may include two third extensions 1031 , and the fourth extension 1032 is clamped between the two third extensions 1031 to form a part of a ring. The highest point of the arc can also be lower than the highest point of the first clamping member 102 . In this embodiment, the second clamping part 103 is integrated with the support body 501 and the first clamping part 102 , so that the clamping and positioning of the original leaflet 30 are more stable and reliable. The number of clamping units can also be three or more.

In another embodiment of the present application, as shown in FIG. 3A , the second clamping member 103 includes a closed ring 1034, and the closed ring 1034 is provided with two interfaces 1035 for detachable with the delivery system 20 connect.

In yet another embodiment of the present application, as shown in FIG. 9A , the second clamping member 103 only includes one clamping unit, and the fourth extension 1032 forms a closed loop, that is, the second clamping member 103 includes a third extension. 1031 and a closed loop connected to the third extension 1031. There may be at least one third extension part 1031, such as two or more.

The present application also provides a method for implanting the above-mentioned artificial valve system 50 into the heart, including: contracting the artificial valve system 50 in the delivery system 20, delivering it to the heart valve, releasing the artificial valve system 50, and capturing the native valve leaflet 30 in the heart valve Between the first clamping part 102 and the support body 501, the second clamping part 103 clamps the original valve leaflet 30 from the outer periphery of the first clamping part 102, so that the original valve leaflet 30 forms a folded structure, and the connection Part 1011 is disengaged from the delivery system 20.

In a specific embodiment, the method for implanting the above-mentioned artificial valve system 50 into the heart is as follows: compress the artificial valve system 50 in the sheath of the delivery system 20, enter the left atrium and left ventricle through the human blood vessels and interatrial septum, and insert the artificial valve system 50 into the heart. The valve system 50 is gradually pushed out of the sheath tube, the first clamping part 102 is opened under its own elasticity, and the gap between the second extension part 1022 and the outer surface of the support body 501 is changed by adjusting the sheath tube 203 against the adjustment part 1024. Large, when the second extension part 1022 is opened to a suitable size, the second extension part 1021 passes through the chordae tendineae through the delivery system 20, and hooks upward to hold the outer side of the original valve leaflet 30 near the periphery of the valve annulus. At this time, the original valve leaflet 30 is Captured between the second extension 1022 and the outer surface of the support body 501 . At this time, part of the support body 501 and the second clamping member 103 are confined within the delivery system 20 . The heart valve positioning device 10 is further pushed out of the sheath, the support body 501 and the first clamping member 102 continue to elastically recover and deform, and the original valve leaflet 30 is further clamped between the support body 501 and the second extension part 1022 . After the second puller 202 is released and withdrawn, the second clamping member 103 rolls outwards under its own elasticity, and folds and squeezes the original leaflet 30 around the outside of the first clamping member 102 . The delivery system 20 is dissociated, the interface is released, and the anchoring of the support body 501 on the native leaflet 30 is completed.

Due to the flexibility of the tissue of the native valve leaflet 30 , the deformation of the artificial valve system 50 is controlled by the delivery system 20 , which gradually drives the deformation of the tissue of the native valve leaflet 30 , and is finally tightened and positioned on the native valve leaflet 30 . The artificial valve system 50 of the present application can easily pass through the chordae to hook the original valve leaflet 30 , and the operation is simple, easy and fast. The native leaflet 30 is folded and squeezed around the outside of the first clamping component 102 by the second clamping component 103 , and the positioning is simple and reliable.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, and are not intended to limit them; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and spirit of the technical solutions of the various embodiments of the present application. scope.

Claims (28)

1. A heart valve positioning device for removable attachment to a delivery system, the heart valve including a native annulus and native leaflets, the heart valve positioning device comprising:

the cylindrical bracket is provided with at least one connecting piece;

the first clamping pieces are distributed along the periphery of the support and are connected with the support;

the second clamping piece is configured to be sleeved on the periphery of the first clamping piece;

in a delivery state, the heart valve positioning device is contracted in the delivery system, and the connecting piece is connected with the delivery system; in a released state, the connecting member is disengaged from the delivery system, the native leaflet is captured between the first retaining member and the stent, and the second retaining member is folded over from the periphery of the first retaining member and retains the native leaflet such that the native leaflet forms a folded structure.

2. The heart valve positioning device of claim 1, wherein the folded structure includes a first fold and a second fold connected to one another; in a release state, the first folding part is clamped between the bracket and the first clamping piece, and the second folding part is clamped between the first clamping piece and the second clamping piece.

3. A heart valve positioning device as claimed in claim 2 in which the first fold and the second fold each comprise a front surface located inside the native leaflet and a back surface located outside the native leaflet; under the release state, the front surface of the first folding part abuts against the outer side of the support, the back surface of the first folding part abuts against the inner side of the first clamping piece, the front surface of the second folding part abuts against the second clamping piece, and the back surface of the second folding part abuts against the outer side of the first clamping piece.

4. The device as claimed in claim 2, wherein the holder comprises a body and an extending post extending axially upward from the body and connected to the connecting member at an extending end, and the bottom of the first clamping member is connected to the bottom of the body.

5. The heart valve positioning device of claim 4, wherein the first clamping member includes a first extension and a second extension connected to each other, the first extension extends downward from the bottom of the body, and an extension end is connected to the second extension to form an abutment, and the second extension extends upward from the abutment.

6. The heart valve positioning device of claim 5, wherein the first fold and the second fold are connected at a top of the second extension.

7. The heart valve positioning device of claim 5, wherein the first clamping member includes an adjustment portion, and the delivery system includes an adjustment sheath that pushes against the adjustment portion to move the top of the second extension away from the outer surface of the stent after the adjustment sheath enters between the first clamping member and the stent.

8. A heart valve positioning device according to claim 7, wherein the adjustment portion comprises at least a portion of the abutment portion and the second extension.

9. The heart valve positioning device of claim 4, wherein the second retaining member extends from the top of the body and forms a loop around the periphery of the first retaining member.

10. The heart valve positioning device of claim 9, wherein the second clamping member has a third extension and a fourth extension connected to each other, the third extension extending radially outward from the top of the body to form an arc, the highest point of the arc is higher than the highest point of the first clamping member, and the fourth extension extends circumferentially from the end of the arc to circumferentially surround the first clamping member.

11. A heart valve positioning device as claimed in claim 10, in which the second clamping member comprises at least two clamping units, each clamping unit being provided with a third extension and a fourth extension, respectively, each fourth extension extending circumferentially around the periphery of the first clamping member to form a non-closed loop.

12. A heart valve positioning device as claimed in claim 10, in which the fourth extension forms a closed loop.

13. The heart valve positioning device of claim 9, wherein the second retaining member includes a closed ring with an interface for removable connection to the delivery system.

14. A prosthetic valve system, comprising:

the heart valve positioning device of any one of claims 1-13;

a prosthetic valve, comprising:

artificial valve leaflets; and

the cylindrical support piece is circumferentially fixed on the inner side of the support piece, and the support piece is matched with the support frame so as to implant the artificial valve into the inner side of the support frame after the heart valve positioning device is released.

15. A method of implanting the prosthetic valve system of claim 14 into a heart, comprising: the heart valve positioning device is contracted in the conveying system and conveyed to a heart valve, the heart valve positioning device is released, the native valve leaflet is clamped between the first clamping piece and the support, the second clamping piece clamps the native valve leaflet from the periphery of the first clamping piece, the native valve leaflet is made to form a folding structure, the connecting piece is separated from the conveying system, and then the artificial valve is conveyed to the heart valve to be released, so that the artificial valve is implanted into the inner side of the support.

16. A prosthetic valve system removably attachable to a delivery system, the prosthetic valve system comprising:

the cylindrical support body is provided with at least one connecting piece, and the inner side of the support body is circumferentially provided with artificial valve leaflets;

the first clamping pieces are connected with the bottom of the supporting piece and distributed on the periphery of the supporting body;

the second clamping piece is configured to be sleeved on the periphery of the first clamping piece;

in a delivery state, the connecting piece is connected with the delivery system, and the artificial valve system is contracted in the delivery system; in a released state, the connecting member is detached from the delivery system, the native valve leaflet is captured between the first holding member and the support body, and the second holding member is folded over from the outer periphery of the first holding member and holds the native valve leaflet, so that the native valve leaflet forms a folded structure.

17. The heart valve positioning device of claim 16, wherein the folding structure includes a first fold and a second fold connected to one another; in a released state, the first folding part is clamped between the support body and the first clamping piece, and the second folding part is clamped between the first clamping piece and the second clamping piece.

18. The heart valve positioning device of claim 17, wherein the first fold and the second fold each include a front side located inside the native leaflet and a back side located outside the native leaflet; in a release state, the front surface of the first folding part abuts against the outer side of the support body, the back surface of the first folding part abuts against the inner side of the first clamping piece, the front surface of the second folding part abuts against the second clamping piece, and the back surface of the second folding part abuts against the outer side of the first clamping piece.

19. The heart valve positioning device of claim 17, wherein the first clamping member includes a first extension and a second extension connected to each other, the first extension extends downward from the bottom of the support body, and an extension end is connected to the second extension to form an abutment, and the second extension extends upward from the abutment.

20. The heart valve positioning device of claim 19, wherein the first fold and the second fold are connected at a top of the second extension.

21. The heart valve positioning device of claim 19, wherein the first clamping member includes an adjustment portion, and the delivery system includes an adjustment sheath that pushes against the adjustment portion to move the top of the second extension away from the outer surface of the support when the adjustment sheath is disposed between the first clamping member and the support.

22. The heart valve positioning device of claim 19, wherein the adjustment portion includes at least a portion of the abutment portion and the second extension.

23. The heart valve positioning device of claim 16, wherein the second clamping member extends at a top of the support and forms a loop around an outer periphery of the first clamping member.

24. The heart valve positioning device of claim 23, wherein the second clamping member has a third extension and a fourth extension connected to each other, the third extension extending radially outward from the top of the support to form an arc, the highest point of the arc being higher than the highest point of the first clamping member, the fourth extension extending circumferentially from the end of the arc to circumferentially surround the first clamping member.

25. A heart valve positioning device as claimed in claim 24, in which the second clamping member comprises at least two clamping units, each clamping unit being provided with a third and fourth extension, respectively, each fourth extension extending circumferentially around the periphery of the first clamping member to form a non-closed loop.

26. A heart valve positioning device as claimed in claim 24, in which the fourth extension forms a closed loop.

27. The heart valve positioning device of claim 23, wherein the second clamp comprises a closed ring with an interface for removable connection to the delivery system.

28. A method of implanting the prosthetic valve system of claim 16 into a heart, comprising: the artificial valve system is contracted in the conveying system, conveyed to a heart valve, released and clamped between the first clamping piece and the support body, the second clamping piece clamps the native valve leaflets from the periphery of the first clamping piece, so that the native valve leaflets form a folding structure, and the connecting piece is separated from the conveying system.

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