CN118121365A

CN118121365A - Valve frame assembly and artificial heart valve

Info

Publication number: CN118121365A
Application number: CN202211532970.7A
Authority: CN
Inventors: 徐澧; 欧文灏; 李阳; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2022-12-01
Filing date: 2022-12-01
Publication date: 2024-06-04

Abstract

The invention relates to a valve frame assembly and a prosthetic heart valve. Wherein the valve frame assembly comprises a valve frame body for receiving the artificial valve leaflet and having a compressed configuration and an expanded configuration, an anchor having a compressed configuration and an expanded configuration, wherein the anchor is configured to receive the valve frame body in the expanded configuration and retain the native valve leaflet therebetween in its expanded configuration; the connecting mechanism connects the valve frame body and the anchor and is configured to be at least partially swingable therebetween upon relative axial movement of the anchor in the expanded configuration and the valve frame body in the compressed configuration, wherein the connecting mechanism is movably connected with the anchor such that at least a portion of the connecting mechanism is slidable radially outward of the anchor relative to the anchor. The prosthetic heart valve includes the valve frame assembly and a prosthetic leaflet received within the valve frame body.

Description

Valve frame assembly and artificial heart valve

Technical Field

The invention relates to the field of medical equipment, in particular to a valve frame assembly and a prosthetic heart valve.

Background

Existing prosthetic heart valves are mostly anchored by radial expansion against the native annulus, which on the one hand can stress the native annulus, and on the other hand the position of the prosthetic heart valve may be unreliable. Currently, the Valve-in-Ring technique has emerged to alleviate this problem to some extent. In the annulus valve operation, an anchoring ring is implanted first, and then the valve frame body containing the artificial valve leaf is placed in the anchoring ring to fix the valve frame body by means of the anchoring ring. However, this technique still has drawbacks: the implantation of the anchoring ring and the valve frame body needs to be carried by different conveyers and via different intervention paths, and the whole operation process is complex in operation and difficult.

Disclosure of Invention

In view of the above, the present invention aims to provide a valve frame assembly and a prosthetic heart valve that can solve or at least alleviate to some extent the above problems.

To this end, one aspect of the present invention provides a valve frame assembly comprising: the valve frame comprises a valve frame body, an anchoring piece and a connecting mechanism. The valve frame body is used for accommodating the artificial valve leaflet and has a compression configuration and an expansion configuration; the anchor having a compressed configuration and an expanded configuration, wherein the anchor is configured to receive the valve frame body in its expanded configuration and retain a native leaflet therebetween; the connection mechanism connects the valve frame body and the anchor and is configured to be at least partially swingable therebetween upon relative axial movement of the anchor in an expanded configuration and the valve frame body in a compressed configuration, wherein the connection mechanism is movably connected with the anchor such that at least a portion of the connection mechanism is slidable radially outward of the anchor relative to the anchor.

In another aspect, the present invention also provides a prosthetic heart valve, including the aforementioned valve frame assembly, and the prosthetic leaflet housed in the valve frame body.

Compared with the split design of the valve frame body and the anchoring piece in the prior art, the invention is provided with the connecting mechanism for connecting the anchoring piece and the valve frame body, and the anchoring piece and the valve frame body can be conveyed and implanted to the diseased native valve at one time without conveying the valve frame body and the anchoring piece in a divided manner, so that the operation difficulty is greatly reduced, and the operation process is simplified. In particular, at least a portion of the connection mechanism of the valve frame assembly of the present invention is capable of swinging between the valve frame body in the compressed configuration and the anchor in the expanded configuration, and another portion of the connection mechanism is capable of sliding radially outward of the anchor relative to the anchor, which may avoid the following: when the connecting mechanism is fixedly connected with the anchor, and the length of the connecting mechanism is larger than the radial distance between the anchor in the expanded configuration and the valve frame body in the compressed configuration, the connecting mechanism forcibly expands the anchor, thereby increasing the difficulty of operation implementation and the risk of damaging tissue around or around the valve.

Drawings

FIG. 1A is a perspective view of a prosthetic heart valve replacement system of a first embodiment of the present invention, wherein both the anchor and the valve frame body of the prosthetic heart valve are in a compressed configuration;

FIG. 1B is another perspective view of the prosthetic heart valve replacement system of FIG. 1A with the anchor partially released;

FIG. 1C is a further perspective view of the prosthetic heart valve replacement system of FIG. 1A with the anchor and attachment mechanism fully released;

FIG. 1D-1 is a further perspective view of the prosthetic heart valve replacement system of FIG. 1A, with the valve frame body moved relative to the anchor;

FIGS. 1D-2 are schematic illustrations of the connectors sliding radially outward of the anchor during movement of the valve frame body relative to the anchor as shown in FIGS. 1D-1;

FIG. 1E is a perspective view of a prosthetic heart valve of the prosthetic heart valve replacement system of FIG. 1A, wherein the anchor and the valve frame body of the prosthetic heart valve are fully expanded;

FIG. 1F is a further perspective view of the prosthetic heart valve of FIG. 1E, wherein the anchor is not shown for ease of illustration of the connector;

FIG. 2A is a front view of the valve frame assembly of the prosthetic heart valve of FIG. 1E, wherein only a front half of the valve frame assembly is shown and a rear half of the valve frame assembly is not shown for clarity and brevity of illustration;

FIG. 2B is a view of the valve frame assembly of FIG. 2A in a contracted state;

FIG. 2C is a perspective view of the anchor of the valve frame assembly of FIG. 2A, wherein the anchor is in an expanded configuration;

FIG. 2D is a front view of the anchor of FIG. 2C;

FIG. 2E is a top view of the anchor of FIG. 2C;

FIG. 2F illustrates a compressed configuration of the anchor shown in FIG. 2C;

FIG. 3A is a front view of a modified example of an anchor;

FIG. 3B is a side view of the anchor of FIG. 3A;

FIG. 4A shows a variation of the connector;

FIG. 4B is a schematic illustration of the connection of the connector of FIG. 4A to the base portion;

FIG. 4C is a schematic illustration of the attachment member of FIG. 4A to a ventricular side valve frame section;

FIG. 5A shows a variation of the connector;

FIG. 5B shows another variation of a connector;

FIG. 5C shows a further variation of the connector;

FIG. 5D shows a further variation of the connector;

fig. 5E shows a further variant of a connection;

FIG. 5F shows a further variation of the connector;

FIG. 6A is a schematic illustration of the attachment of another variation of the attachment member to the base portion;

FIG. 6B is a schematic illustration of the attachment member of FIG. 6A to a ventricular side valve frame section;

FIG. 7A shows another variation of a connector;

FIG. 7B shows a further variation of the connector;

FIG. 7C shows a further variation of the connector;

FIG. 7D shows a further variation of the connector;

FIG. 8A is a state diagram of delivery of the prosthetic heart valve of FIG. 1E, wherein the prosthetic heart valve is contracted within the delivery device;

FIG. 8B is another state diagram of delivery of the prosthetic heart valve of FIG. 1E, with the anchors of the prosthetic heart valve released and over the native leaflets;

FIG. 8C is yet another state diagram of delivery of the prosthetic heart valve of FIG. 1E, with the anchors of the prosthetic heart valve released and positioned below the native leaflets;

FIG. 8D is a further state diagram of delivery of the prosthetic heart valve of FIG. 1E, wherein the native leaflets enter the space between the anchor and the valve frame body of the prosthetic heart valve;

FIG. 8E is yet another state diagram of delivery of the prosthetic heart valve of FIG. 1E, wherein the valve frame body of the prosthetic heart valve is moved upward relative to the anchor;

FIG. 8F is a further state diagram of delivery of the prosthetic heart valve of FIG. 1E, wherein the anchor and valve frame body of the prosthetic heart valve are fully expanded;

FIG. 9A is a perspective view of a prosthetic heart valve according to a second embodiment of the present invention;

FIG. 9B is a perspective view of the valve frame assembly of the prosthetic heart valve of FIG. 9A; and

Fig. 9C is a schematic view of the native mitral valve of the prosthetic heart valve of fig. 9A implanted in a patient.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention. In addition, as long as there is no conflict or conflict between the embodiments described below, the same or similar concepts or processes may not be described in detail in some embodiments.

It is first noted that "proximal" as used herein refers to the end of the device or element that is proximal to the operator. "distal" refers to the end of the device or element that is remote from the operator. "axial" refers to a direction coincident with or parallel to the central axis of a device or element. "radial" refers to a direction perpendicular or substantially perpendicular to the axial direction and along a radius or diameter of a device or element. "circumferential" refers to a direction about the axial direction.

It should be noted that the above terms indicating orientation or positional relationship are merely for convenience of description and simplification of the description, and are not intended to indicate or imply that the apparatus or elements in question must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the invention.

Referring to fig. 1A-1F, a prosthetic heart valve replacement system 2000 of a first embodiment of the present invention includes a delivery device 100 and a prosthetic heart valve 300, the delivery device 100 being configured to deliver the prosthetic heart valve 300. The conveying device 100 comprises an outer tube 101 and an inner tube 102 penetrating the outer tube 101, wherein the outer tube 101 comprises a front section 103 and a rear section 105 which are axially oppositely arranged, and the inner tube 102 comprises a front section 104 and a rear section 106 which are axially oppositely arranged. The prosthetic heart valve 300 includes a valve frame assembly 301 and two prosthetic leaflets 204 received therein. The valve frame assembly 301 has a compressed configuration and an expanded configuration, including a valve frame body 202, an anchor 203 attached to the outside of the valve frame body 202, and a connection mechanism 306 for connecting the valve frame body 202 and the anchor 203. At least two prosthetic leaflets 204 are fixedly received within the valve frame body 202 and are openable and closable relative to each other to act as "one-way valves" for allowing the flow of downstream blood therethrough to prevent backflow of blood, for example, the prosthetic heart valve 300 is adapted to replace a native mitral valve, downstream being blood flowing from a left atrium to a left ventricle through the mitral valve, and upstream being blood flowing from the left ventricle to the left atrium through the mitral valve. In this embodiment, the at least two artificial leaflets 204 comprise two artificial leaflets 204, although in other embodiments the at least two artificial leaflets 204 may comprise three or four artificial leaflets 204, e.g., the artificial heart valve 300 may be applied to replace a native tricuspid valve, then the at least two artificial leaflets 204 comprise three artificial leaflets; the prosthetic heart valve 300 is also applicable to replace a native aortic valve, then the at least two prosthetic leaflets 204 also include three prosthetic leaflets.

Compared with the split design of the valve frame body and the anchoring piece in the prior art, the anchoring piece 203 and the valve frame body 202 are connected through the connecting mechanism 306, the anchoring piece 203 and the valve frame body 202 can be conveyed and implanted to the diseased native valve at one time, the valve frame body 202 and the anchoring piece 203 do not need to be conveyed in a divided mode, the operation difficulty is greatly reduced, and the operation process is simplified.

As shown in fig. 1F, in this embodiment, the valve frame body 202 further includes an atrial side valve frame section 220 and a ventricular side valve frame section 240 that are connected to each other. Preferably, in the expanded configuration, the atrial side valve frame section 220 protrudes at least radially outward relative to the ventricular side valve frame section 240. Thus, when the prosthetic heart valve 300 of the present embodiment is implanted with a native valve, such as a mitral valve, the atrial side frame section 220 may prevent the prosthetic heart valve 300 from moving entirely to the left ventricular side. Preferably, the valve frame body 202 is made of a self-expanding metal material with shape memory function, such as nickel-titanium alloy. The self-expanding stent body 202 may be compressed to be received within the outer tube 101 of the delivery device 100 as previously described and may self-expand to its pre-set shape and size when the constraint of the outer tube 101 is eliminated. It will be appreciated that in other embodiments, the valve frame body 202 may also be made of a non-self-expanding metallic material, such as cobalt chrome, stainless steel, etc., in which case the valve frame body 202 may be radially expandable by a balloon. Preferably, a coating may be provided (e.g., by suture) on the inner and/or outer surfaces of the valve frame body 202 to prevent perivalvular leakage while facilitating rapid endothelialization of the valve frame body 202 after implantation.

When loaded, as shown in fig. 1A, the valve frame body 202 may be compressed and received within the inner tube 102, the anchor 203 compressed and received between the outer tube 101 and the inner tube 102, wherein the connecting mechanism 306 is straightened (i.e., not stacked, and therefore does not increase the crimping loading size of the prosthetic heart valve), and the end of the connecting mechanism 306 connected to the ventricular side valve frame section 240 is distal (to the right in the drawing) of the end of the connecting mechanism 306 connected to the anchor 203, such that the anchor 203 is compressed on the atrial side valve frame section 220, thereby reducing the crimping size of the entire prosthetic heart valve 300. When it is desired to release the prosthetic heart valve 300, as shown in fig. 1B, the partial anchor 203 may be released by pushing the rear section 105 of the outer tube 101 distally and retracting the front section 103 of the outer tube 101 proximally, the released partial anchor 203 self-expanding. Next, as shown in fig. 1C, the posterior segment 105 of the outer tube 101 can be pushed further distally to fully release the anchor 203 and the connecting mechanism 306, the connecting mechanism 306 following the outward swinging, expansion of the anchor 203 relative to the valve frame body 202 to accommodate the expanded anchor 203. Then, as shown in fig. 1D-1, the inner tube 102 may be moved entirely so that the valve frame body 202 moves proximally to such an extent that the end of the connecting mechanism 306 connected to the ventricular side valve frame section 240 is located proximal (left side in the drawing) of the end of the connecting mechanism 306 connected to the anchor 203, during which the end of the connecting mechanism 306 connected to the valve body 202 moves proximally following the movement of the valve body 202, so that the end of the connecting mechanism 306 connected to the anchor 203 swings distally (right side in the drawing) relative to the end of the connecting mechanism 306 connected to the valve body 202 (as can be clearly seen in comparing fig. 1C and 1D-1). In other words, in this embodiment, there is an axial relative displacement between the valve frame body 202 and the anchor 203. Finally, the valve frame body 202 is released by pushing the rear section 106 of the inner tube 102 distally and withdrawing the front section 104 of the inner tube 102 proximally, the valve frame body 202 being balloon-inflated or self-inflated to a fully inflated state as shown in fig. 1E. As can be seen in fig. 1E, the ventricular side frame section 240 is located within the anchor 203, the anchor 203 is located entirely below the atrial side frame section 220, and the end of the connection mechanism 306 connected to the ventricular side frame section 240 is located proximal to the end of the connection mechanism 306 connected to the anchor 203. At this point, the anchor 203 in the expanded configuration and the valve frame body 202 in the expanded configuration may collectively grip the native valve leaflets, thereby securing the prosthetic heart valve 300 at the native valve to replace the native valve, with the valve frame body 202 in the expanded configuration housed within the anchor 203 in the expanded configuration.

Preferably, the outer diameter of the valve frame body 202 in the expanded configuration is slightly larger than the inner diameter of the anchor 203 in the expanded configuration, e.g., 0.5mm larger, so that when the valve frame body 203 in the expanded configuration is positioned within the anchor 203 in the expanded configuration, the two form an interference fit to more stably grip the native leaflet therebetween.

In this embodiment, the connection mechanism 306 is movably connected with the anchor 203 such that at least a portion of the connection mechanism 306 can slide radially outward of the anchor 203 relative to the anchor 203. The connection mechanism 306 includes two connection members 32 that are independent of each other. The connector 32 may be made of a metal material such as nickel-titanium alloy wire, stainless steel multi-strand wire, or a polymer material such as PTFE and PET wire, and for example, nickel-titanium alloy wire is preferred. One end of each connector 32 is fixedly or movably connected to the branches of ventricular side valve frame section 240 that constitute the inflow row mesh, and the other end is movably connected to anchor 203. Thus, as the anchor 203 and the valve frame body 202 switch between their respective expanded and compressed configurations, each connector 32 correspondingly accommodates changes in the configuration of the anchor 203 and the valve frame body 202.

For example, when the prosthetic heart valve 300 transitions from the state shown in fig. 1B to the state shown in fig. 1C, the end of each connector 32 connected to the anchor 203 swings outwardly relative to the valve frame body 202 such that each connector 32 is disposed at an acute angle relative to the central axis of the valve frame body 202 for accommodating the expanded anchor 203. Preferably, each attachment element 32 is adapted to accommodate an expanded anchor 203 having an angle of oscillation θ ₁ in the range of 30 ° to 60 ° relative to the central axis of the valve frame body 202, which facilitates expansion of the anchor 203 to have sufficient room to accommodate the ventricular side valve frame section 240. It is also preferred that the effective length of the connector 32 corresponds to the height of the anchor 203 after it has been fully expanded.

For another example, as the prosthetic heart valve 300 transitions from the state shown in fig. 1C to the state shown in fig. 1D-1, the end of each connector 32 connected to the ventricular side valve frame section 240 adaptively follows the movement of the valve frame body 202 to move proximally (left side in the illustration) to an obtuse angle arrangement relative to the central axis of the valve frame body 202, during which the end of the connector 32 connected to the anchor 203 swings distally (right side in the illustration) relative to the end of the connector 32 connected to the valve body 202. Preferably, each of the connectors 32 swings through an angle in the range of 90 ° to 120 ° following the axial movement of the valve frame body 202, and the angle θ ₂ between each of the connectors 32 and the central axis of the valve frame body 202 after the swing is completed is in the range of 140 ° to 170 °, which facilitates the axial alignment of the ventricular side valve frame section 240 of the valve frame body 202 with the anchor 203. In particular, during transition of prosthetic heart valve 300 from the state shown in fig. 1C to the state shown in fig. 1D-1, coupling mechanism 306 or a portion of each coupling member 32 (the portion relatively closer to valve frame body 202 along the length of coupling member 32) swings between valve frame body 202 and anchor 203, and the other portion (the portion relatively farther from valve frame body 202 along the length of coupling member 32) is able to slide radially outward of anchor 203 relative to anchor 203 as shown in fig. 1D-2, particularly as each coupling member 32 swings to be generally perpendicular to the axial directions of anchor 203 and valve frame body 202, which avoids the following: if the connecting element is fixedly connected with the anchoring element, and the length of the connecting element is larger than the radial distance between the anchoring element in the expanded configuration and the valve frame body in the compressed configuration, the operator needs to apply a larger force to drive the connecting mechanism to forcibly expand the anchoring element, so that the operation implementation difficulty and the risk of damaging the tissue around the valve or the valve tissue due to the fact that the anchoring element is strongly expanded beyond the set size are increased.

It is noted that "rocking" herein is not strictly geometrically based on a base or pivot point. The term "swing" is used in a relative sense herein to mean that one end of the connecting mechanism 306 (i.e., each of the connecting members 32 in this embodiment) is constrained to the valve frame body 202 while maintaining its position substantially unchanged, and the other end follows the movement of the valve frame body 202 relative to the anchor 203 to undergo a change in position, thereby causing the connecting members 32 to "swing" through an angle as a whole.

Referring to fig. 2A to 2C, in the present embodiment, the anchor 203 is made of a material having elasticity and self-expansion, and includes an anchoring mechanism 210, a plurality of extension portions 230, and at least two base portions 250. The anchoring mechanism 210 includes at least two circumferentially spaced apart anchor segments 211. Both ends of each anchor segment 211 are respectively connected to one end of an extension 230. The other ends of two adjacent extensions 230 between two adjacent anchor segments 211 are connected to a base portion 250. Wherein the anchoring mechanism 210 is proximate to the blood inflow end of the ventricular side valve frame section 240 and the base portion 250 is proximate to the blood outflow end of the ventricular side valve frame section 240. Preferably, the anchoring mechanism 210, the extension 230 and the base portion 250 are integrally formed, such as by cutting and shaping nickel-titanium alloy tubing. It will be appreciated that in other embodiments, the anchoring mechanism 210, extension 230, and base 250 may be separately fabricated and then assembled to form the anchor 203. For example, the extension portion 230 and the base portion 250 may be integrally formed by machining or by cutting a shape memory alloy, and each of the anchor segments 211 of the anchor mechanism 230 may be individually made of, for example, nitinol or polymer material, and then connecting both ends of each of the anchor segments 211 to the corresponding extension portion 230, respectively, to form the anchor 203.

Preferably, in the expanded configuration, the locations of the anchor segments 211 of the anchoring mechanism 210 are co-axially horizontal (i.e., the anchor segments 211 lie in a plane perpendicular to the central axis of the anchor 203) or substantially co-axially horizontal (i.e., the anchor segments 211 lie substantially in a plane perpendicular to the central axis of the anchor 203. Further, a maximum axial spacing of less than 5mm between the locations of the anchor segments 211 can be considered to be substantially in a plane perpendicular to the central axis of the anchor 203), whereby the anchoring mechanism 210 provides a near-complete circumferential anchoring force to the ventricular side frame segment 240 when the leaflet is clamped between the anchoring mechanism 210 and the ventricular side frame segment 240 such that the relative positional relationship of the anchor 203 and the frame body 202 does not change, the positioning of the frame body 202 is stable, the frame body 202 is effectively prevented from being shifted with respect to the atrial side of the anchor 203, and the prosthetic heart valve 200 can be more reliably secured to the mitral valve and prevented from leaking around the annulus.

Referring to fig. 2C-2F, in the expanded configuration, the anchor 203 is generally annular in circumferential direction, with an inner diameter d ₁ preferably in the range of 20mm to 40mm to be able to accommodate the ventricular side valve frame section 240, more preferably in the range of 25mm to 28 mm. To better adapt to the physiological anatomy of the mitral valve, in this embodiment, the anchoring mechanism 210 of the anchor 203 is composed of two anchoring segments 211, and each anchoring segment 211 has a central angle in the range of 135 degrees to 175 degrees. By way of example, in the present embodiment, each anchor segment 211 is configured as a linear arcuate segment 211 extending in the circumferential direction in the expanded configuration. The cross-sectional dimensions of the linear arc segment 211 are uniform throughout, although in other embodiments the cross-sectional dimensions of the linear arc segment 211 may vary.

The cross-sectional dimensions of the extension 230 may be the same as or different from the cross-sectional dimensions of the anchor segment 211. The cross-sectional dimension of extension 230 is preferably greater than the cross-sectional dimension of anchor segment 211 in this embodiment. It is also preferred that the cross-sectional dimension of the extension 230 increases gradually from top to bottom to increase the strength of the extension 230 and to provide sufficient restraint to the anchoring segment 211 in the expanded configuration to prevent the anchoring mechanism 210 from becoming too large in diameter under the action of the ventricular side valve frame section 240 so that the anchoring mechanism 210 can provide a greater anchoring force to the ventricular side valve frame section 240.

In this embodiment, each base portion 250 of the anchor 203 is provided with at least one first through hole 252 penetrating radially therethrough for penetrating the corresponding connecting member 32 so that the connecting member 32 can slide along the at least one first through hole 252 to the radially outer side of the anchor 203 with respect to the anchor 203. As an example, in the present embodiment, each base portion 250 has two first through holes 252. The two first through holes 252 are located at the same axial level and are circumferentially spaced apart. The circumferential distance between the two first through holes 252 may be in the range of 0.5mm to 10 mm. The shape of the first through hole 252 is preferably, but not limited to, circular. It will be appreciated that in other embodiments, one, three, or other number of first through holes 252 may be provided per base portion 250.

As shown in fig. 2B, in the present embodiment, each connecting piece 32 includes two first linear sections 321 and a linear first limiting portion 320 connected to the first ends of the two first linear sections 321, wherein each first linear section 321 movably passes through a corresponding first through hole 252, and the linear first limiting portion 320 is located radially outside the two first through holes 252. In this embodiment, the second ends of the two first linear sections 321 opposite to the first limiting portion 320 are fixedly connected to the branches of the inflow row grid of the ventricular side frame section 240, for example, by binding the second ends of the two first linear sections 321 with the corresponding branches of the inflow row grid of the ventricular side frame section 240 respectively by means of the suture 206. It will be appreciated that in other embodiments, the connector 32 and the ventricular side frame section 240 may be fixedly connected by welding or snap-fit.

Further, as can be seen from the above-described anchoring mechanism 210 being near the blood inflow end of the ventricular side valve frame section 240 and the base portion 250 being near the blood outflow end of the ventricular side valve frame section 240, in the expanded configuration, the locations of the base portion 250 are at different axial levels from the locations of the anchoring mechanism 210 with a certain axial distance therebetween. In this embodiment, as shown in fig. 2C to 2D, in the expanded configuration, the axial distance between the base portion 250 and the anchoring mechanism 210 is approximately equal to the length of the extension 230, i.e. each anchoring segment 211 of the anchoring mechanism 210 is substantially flush with the upper end of the extension 230, although in other embodiments, each anchoring segment 211 of the anchoring mechanism 210 may be higher than the upper end of the extension 230.

Also preferably, a hollowed out groove 270 is formed between two adjacent extensions 230 between two adjacent anchor segments 211 and the base portion 250. In the expanded configuration of the anchor 203, the hollowed out groove 270 is generally U-shaped or V-shaped, and the angle between the two walls of the U-shaped or V-shaped hollowed out groove 270 may be in the range of 5 degrees to 60 degrees, and most preferably 10 degrees to 30 degrees. The smaller the opening angle of the hollowed out groove 270, the more the ring formed by the anchoring mechanism 210 approaches to a complete circle, and the larger the arc length or contact area of the anchoring mechanism 210 for clamping the native valve leaflet in cooperation with the ventricular side valve frame section 240, the more advantageous is to prevent insufficient acting force between the anchoring mechanism 210 and the ventricular side valve frame section 240, so that the anchoring is more stable. In addition, the hollowed out groove 270 design also helps to compress the anchor 203.

As shown in fig. 2F, when the anchor 203 is compressed, the hollow groove 270 is designed such that two adjacent extending portions 230 can be close to each other, and the anchor segment 211 is folded and received between the two extending portions 230 connected to the anchor segment 211, so that the anchor 203 is cylindrical as a whole. Preferably, the overall height h ₁ of the compressed anchor 203 (i.e., the height of the extension 230 in this embodiment) is in the range of 10mm to 20mm, most preferably 15mm. It is also preferred that the overall height h ₂ of the folded anchor segment 211 be less than the overall height h ₁ of the anchor 203 to reduce the overall compressed radial dimension of the anchor 203. For example, the overall height h ₂ of the folded anchor segment 211 may be in the range of 8mm to 15mm, most preferably 12mm.

Fig. 3A and 3B show a modified example of the anchor 203 shown in fig. 2C. As shown in fig. 3A and 3B, although the anchor segments 311 of the anchor 303 in this example are also generally configured as linear arcuate segments 311, the portions of each linear arcuate segment 311 are no longer precisely at the same axial level, but extend slightly in a wave shape to form peaks 312 and valleys 313. Specifically, each linear arc segment 311 includes a middle section 314 and outer edge sections 316 symmetrically distributed on both sides of the middle section 314, wherein the highest point (approximately middle position) of the middle section 314 forms a peak portion 312, the lowest point (approximately middle position) of the outer edge sections 316 forms a trough portion 313, and each outer edge section 316 is connected with a corresponding extension portion 230. Preferably, the highest point of the intermediate section 314 has a horizontal section that is higher than or flush with the horizontal section of the upper end of the extension 230 to enhance the anchoring effect of the anchoring section 311. It is also preferred that the maximum axial distance between the peaks 312 and the valleys 313 is less than 5mm so that the intermediate section 314 and the outer edge section 316 are approximately at the same axial level, thereby making the ventricular side frame section 240 more evenly stressed circumferentially when the anchoring ring 303 interacts with the ventricular side frame section 240.

Fig. 4A to 4C show a variant of the connecting piece 32. The main difference between the connector 232 in this example and the connector 32 described above is that: the connecting piece 232 in this example is movably connected with the anchor 203, and also movably connected with the ventricular side frame section 240, so that the connecting piece 232 can adaptively keep its natural form during the swinging process, and thus the connecting piece 232 is not limited by the ventricular side frame section 240 to generate a bouncing phenomenon (for example, in the case that the connecting piece is fixedly connected with the ventricular side frame section, since the connecting piece is usually made of an elastic material, when the connecting piece is straightened to the state shown in fig. 1A, a part of the connecting piece adjacent to the fixedly connected position of the connecting piece with the ventricular side frame section is forced to bend to form an arc-shaped structure, and the arc-shaped structure drives the connecting piece to generate a bouncing phenomenon under the action of elastic restoring force after losing the constraint of the outer tube), so that the bouncing of the connecting piece 232 is avoided to drive the anchor 203 to be positioned and then displaced. In operation, as long as the end of the connector 232 that is movably connected to the ventricular side valve frame section 240 remains within the outer tube 101, the anchor 203 is still in a "trumpet" shape (i.e., the distal end of the anchor 203 is constrained to the connector 232 and does not fully expand, as shown in fig. 1B), if the anchor 203 is positioned improperly, the outer tube 101 can be manipulated to retrieve a portion of the anchor 203 back into the outer tube 101 and reposition the anchor 203. Therefore, the recyclable function of the whole artificial heart valve is improved, and the operation safety is improved. Furthermore, movably connecting the connector 232 with both the anchor 203 and the ventricular side frame section 240 also reduces the difficulty of compressing the ventricular side frame section 240, the anchor 203, and the connector 232 together into the delivery device 100.

Specifically, the inflow row grid of ventricular side valve frame sections 240 is provided with a plurality of first connecting portions 241 circumferentially spaced apart for corresponding connection with the respective connecting members 232. In this embodiment, each first connecting portion 241 includes two second through holes 243 for penetrating the corresponding connecting member 232 so that the connecting member 232 can enter the radially inner side of the ventricular side valve frame section 240 along the second through holes 243, thereby maintaining the natural form of the connecting member 232 during the swinging. The two second through holes 243 are preferably circumferentially horizontal and axially spaced apart to allow the connector 232 to rotate relative to the ventricular side frame section 240. It is also preferred that the two second through holes 243 are formed directly on the branches of the ventricular side valve frame section 240, i.e. the first connection 241 is provided by the ventricular side valve frame section 240 itself, although in other embodiments the first connection may be formed separately and additionally connected to the ventricular side valve frame section 240.

The connecting piece 232 has a substantially 8-shaped structure with two closed loop structures, and includes two first linear sections 321, a linear first limiting portion 320 connected to one end of the two first linear sections 321, two second linear sections 322, a linear second limiting portion 323 connected to one end of the two second linear sections 322, and a second connecting portion 324 connected to the other end of the two first linear sections 321 and the other end of the two second linear sections 322, wherein the second connecting portion 324 is closer to the second limiting portion 323 than the first limiting portion 320. The two first linear sections 321 respectively pass through the corresponding first through holes 252. The first limiting portions 320 are limited to the radially outer sides of the two first through holes 252 by the solid material of the corresponding base portion 250 located between the two first through holes 252, thereby limiting the axial limiting position of the anchor 203 while preventing the anchor 203 from being separated from the connecting member 232. The two second linear sections 322 respectively pass through the corresponding second through holes 243. The second limiting portion 323 is limited radially inward of the two second through holes 243 by the solid material of the first connecting portion 241 between the two second through holes 243, thereby providing a base point for the connecting piece 232 to swing around the ventricular side frame section 240 while preventing the ventricular side frame section 240 from being separated from the connecting piece 232. Optionally, the remaining portion of the connection member 232 excluding the second connection portion 324 is formed by bending one connection wire. The connection wire is preferably made of a metal material such as nickel-titanium alloy or stainless steel, or a polymer material such as nylon, PTFE or PET. Preferably, in order to ensure smooth sliding of the connection wire within the first through hole 252 and the second through hole 243, a gap between the connection wire and the wall of the first through hole 252 and/or the second through hole 243 is preferably in the range of 0.05mm to 1 mm. It will be appreciated that the connection may comprise only one first linear section and/or one second linear section; or the connecting piece can also adopt other structures such as a spherical first limit part and/or a second limit part which are not linear; so long as the connector 232 is movably connected with the anchor 30 and the ventricular side valve frame section 240.

For example, another variation of the connector 332 shown in fig. 5A is substantially identical to the connector 232 shown in fig. 4A, and also has a substantially 8-shaped configuration, including two first linear sections 321 passing through the respective first through holes 252, one linear first stopper 320 connecting one ends of the two first linear sections 321, two second linear sections 322 passing through the respective second through holes 243, one linear second stopper 323 connecting one ends of the two second linear sections 322, and a second connector 324 connecting the other ends of the two first linear sections 321 and the other ends of the two second linear sections 322. The second connecting portion 324 in this example is closer to the first limiting portion 320 than the second limiting portion 323.

As another example, the connection 432 of yet another variation shown in fig. 5B, while also including two first linear sections 321 passing through the respective first through holes 252, one linear first stopper 320 connecting one ends of the two first linear sections 321, two second linear sections 322 passing through the respective second through holes 243, and one linear second stopper 323 connecting one ends of the two second linear sections 322, the other end of one of the first linear sections 321 is directly connected with the other end of one of the second linear sections 322, and the other end of the other first linear section 321 is connected with the other end of the other second linear section 322 through the second connection 324, such that the connection 432 is substantially in a closed loop configuration.

The first and second stop portions of each of the connectors of the example described above with reference to fig. 4A-5B are both linear, although one stop portion of each of the connectors shown in fig. 5C-5F is linear, but the other stop portion or portions are spherical.

For example, as shown in fig. 5C, the connection piece 532 also includes two first linear sections 321 passing through the corresponding first through holes 252, two second linear sections 322 passing through the corresponding second through holes 243, a linear second limiting portion 323 connecting one ends of the two second linear sections 322, and a second connection portion 324 connecting the two first linear sections 321 and the two second linear sections 322. However, the connection piece 532 in this example no longer includes the linear first stopper 320 described above, but includes two spherical first stoppers 1320. Each first stopper 1320 is connected to one end of a corresponding first linear section 321, and the diameter of the first stopper 1320 is larger than the diameter of the corresponding first through hole 252 to be limited to the radially outer side of the first through hole 252. It can be seen that in this variant example, the connection 532 has only one closed loop structure. In addition, the spherical limiting part can be formed by welding or extruding after the corresponding linear section passes through the corresponding through hole, or can be connected with the corresponding linear section after being independently formed.

As another example, in the example shown in fig. 5D, the connection 632 also includes two first linear sections 321 passing through the respective first through holes 252, a linear first stopper 320 connecting one ends of the two first linear sections 321, two second linear sections 322 passing through the respective second through holes 243, and a second connection 324 connecting the two first linear sections 321 and the two second linear sections 322. However, the connection piece 532 in this example no longer includes the aforementioned linear second stop 323, but includes two spherical second stops 1323. Each second limiting portion 1323 is connected to one end of a corresponding second linear section 322, and the diameter of the second limiting portion 1323 is larger than the diameter of the corresponding second through hole 243 to be limited to the radial inner side of the second through hole 243. It can be seen that in this variant example, the connection 632 also has only one closed-loop structure.

As further shown in fig. 5E, the connecting member 732 also includes two first linear sections 321 passing through the corresponding first through holes 252, and a linear first limiting portion 320 connecting one ends of the two first linear sections 321, but the connecting member 732 in this example includes only one second linear section 322, and accordingly, the ventricular side frame section 240 may also be designed with only one second through hole 243. Further, a second stopper 1323 connected to one end of the second linear section 322 is not linear any more, but is spherical. Therefore, the second connecting portion 324 only needs to connect the two first linear sections 321 and the second linear section 322. It can be seen that in this variant example, the connection 732 also has only one closed loop structure.

While the connector 832 shown in fig. 5F includes two first linear sections 321 passing through the corresponding first through holes 252, one linear first limiting portion 320 connecting one ends of the two first linear sections 321, two second linear sections 322 passing through the corresponding second through holes 243, and two spherical second limiting portions 1323 respectively connected to one ends of the two second linear sections 322 as the connector 632 shown in fig. 5D, the connector 832 in this example no longer includes the second connecting portions 324. In contrast, the two first linear sections 321 and the two second linear sections 322 in the present example are directly connected one to one, respectively, such that the connecting member 832 has a substantially U-shaped or inverted U-shaped structure.

Each of the connectors of the example described above with reference to fig. 5C-5F includes a linear stop portion and one or more spherical stop portions, but each of the connectors shown in fig. 6A-7D, which will be described below, does not include a linear stop portion, but instead uses spherical stop portions.

For example, the connector 932 shown in fig. 6A and 6B includes two first linear sections 321 passing through the corresponding first through holes 252, one second linear section 322, a spherical second stopper 1323 connected to one end of the second linear section 322, and a second connector 324 connecting the two first linear sections 321 and one second linear section 322, similarly to the connector 732 shown in fig. 5E, but the connector 932 in this example no longer includes one linear first stopper 320 but includes two spherical first stoppers 1320. Each first stopper 1320 is connected to one end of a corresponding first linear section 321, and the diameter of the first stopper 1320 is larger than the diameter of the corresponding first through hole 252 to be limited to the radially outer side of the first through hole 252.

As another example, in the connector 1032 shown in fig. 7A, as compared to the connector 932 shown in fig. 6A-6B, although the connector 1032 also includes one second linear section 322 and one spherical second stopper 1323 connected to one end of the second linear section 322, the connector 1032 no longer includes two first linear sections 321 and two first stoppers 1320, but includes only one first linear section 321 and one spherical first stopper 1320 connected to one end of the first linear section 321, and the first linear section 321 is directly connected to the second linear section 322, with the second connector 324 omitted. In other words, in this variant embodiment, only one through hole may be designed on each of the base portion 250 and the ventricular side valve frame section 240.

Also shown in fig. 7B is a connector 1132 that includes two connectors 1032 as shown in fig. 7A, with the two connectors 1032 being independent of each other.

The connector 1232 shown in fig. 7C omits the second connector 324 as compared to the connector 932 shown in fig. 6A-6B. In other words, the two first linear sections 321 and one second linear section 322 are directly connected.

The connector 1332 shown in fig. 7D is an inverted connector 1232 shown in fig. 7C, and includes a first linear section 321, a first spherical stopper 1320 connected to one end of the first linear section 321, two second linear sections 322, and two second spherical stoppers 1323 connected to the two second linear sections 322 respectively, wherein the two second linear sections 322 and the first linear section 321 are directly connected.

Referring to fig. 8A-8F, a process for delivering/implanting a prosthetic heart valve 300 to replace a native mitral valve using a delivery device 100 is shown.

Specifically, as shown in fig. 8A, the delivery device 100 loaded with the prosthetic heart valve 200 reaches the right atrium via the inferior vena cava, then the left atrium via the atrial septum, and is maneuvered into alignment with the patient's native mitral valve to deliver the prosthetic heart valve 300 thereto. Next, as shown in fig. 8B, by manipulating the outer tube 101 of the delivery device 100 (refer to the method of manipulating the delivery device 100 described above with reference to fig. 1A-1E, which will not be described herein), the anchor 203 of the prosthetic heart valve 300 is first partially released over the native mitral valve annulus, while the valve frame body 202 is still retracted within the inner tube 102 of the delivery device 100. Then, as shown in fig. 8C, the two anchoring segments 211 of the anchor 203 are aligned with the anterior leaflet A2 and the posterior leaflet P2 of the native mitral valve, respectively, and the prosthetic heart valve 300 is moved entirely to the ventricular side after alignment. Next, the outer tube 101 of the delivery device 100 may be continued to be maneuvered to fully release the anchor 203 and the connection mechanism 306, the anchor 203 being fully expanded, the connection mechanism 306 expanding into a rib-like shape following the expansion of the anchor 203. Then, as shown in fig. 8D, the anterior and posterior leaflets of the native mitral valve are captured between the anchor 203 and the valve frame body 202 while the valve frame body 202 remains retracted within the inner tube 102 of the delivery device 100. As further shown in fig. 8E, the inner tube 102 is moved to move the valve frame body 202 entirely toward the atrial side, during which the connection mechanism 306 slides relative to the anchor 203, the anchor 203 is aligned to the ventricular side valve frame section 240 of the valve frame body 202, and the anchor 203 is located at the root of the native annulus. Finally, as shown in fig. 8F, the valve frame body 202 is fully released, expanded by distally pushing the rear section 106 of the inner tube 102 and proximally withdrawing the front section 104 of the inner tube 102. After the prosthetic heart valve 300 is fully expanded, the anterior and posterior leaflets of the native mitral valve are clamped by the valve frame body 202 and the anchor 203, the hollowed out grooves 270 are aligned at the junction of the anterior and posterior leaflets, and chordae tendineae fall into the hollowed out grooves 270, thereby realizing firm anchoring of the prosthetic heart valve 300 at the native mitral valve.

The above description is given by way of example only of replacement of a native mitral valve with a prosthetic heart valve 300, it being understood that the prosthetic heart valve 300 can also be applied to replacement of a native tricuspid valve or a native aortic valve with the native valve sandwiched between the anchor 203 in the expanded configuration and the valve frame body 202 in the expanded configuration to position the prosthetic heart valve 300.

Fig. 9A shows a prosthetic heart valve 400 according to a second embodiment of the invention, which differs from the prosthetic heart valve 300 according to the first embodiment described above mainly in that: in this embodiment, the ventricular side-valve frame section 440 is provided with at least one radial cutout 441, said radial cutout 441 communicating the interior and the exterior of said ventricular side-valve frame section 440. When the prosthetic heart valve 400 is implanted in the native mitral valve of the patient, the hollowed-out portion 441 faces the left ventricular outflow tract direction, so that the problem of left ventricular outflow tract obstruction can be effectively solved.

Specifically, as shown in fig. 9B, the hollow portion 441 of the present embodiment is configured as an arch hole. When the number of the hollowed-out portions 441 is plural, the plural hollowed-out portions 441 may be uniformly distributed along the circumferential direction of the ventricular side valve frame section 440, or may be unevenly arranged. Taking this embodiment as an example, 3 hollowed-out portions 441 are uniformly arranged in the circumferential direction of the ventricular side valve frame section 440. As shown in fig. 9C, after the prosthetic heart valve 400 is implanted in the native mitral valve of the patient, one of the hollowed out portions 441 is circumferentially coincident with the portion of the anchoring segment 211 corresponding to the anterior leaflet A2 region such that the hollowed out portion 441 faces in the left ventricular outflow tract direction.

The foregoing is merely a preferred embodiment of the present invention, and the scope of the present invention is not limited to the above-listed examples, and any simple modification or equivalent substitution of the technical solution that can be obviously obtained by those skilled in the art within the technical scope of the present invention disclosed in the present invention falls within the scope of the present invention.

Claims

1. A valve frame assembly, comprising:

A valve frame body for receiving a prosthetic valve leaflet and having a compressed configuration and an expanded configuration;

An anchor having a compressed configuration and an expanded configuration, wherein the anchor is configured to receive the valve frame body in its expanded configuration and retain a native leaflet therebetween; and

A connection mechanism connecting the valve frame body and the anchor and configured to be at least partially swingable therebetween upon relative axial movement of the anchor in an expanded configuration and the valve frame body in a compressed configuration, wherein the connection mechanism is movably connected with the anchor such that at least a portion of the connection mechanism is slidable radially outward of the anchor relative to the anchor.

2. The valve frame assembly according to claim 1, wherein the connection mechanism is movably connected with the valve frame body such that the connection mechanism is capable of adaptively maintaining its natural configuration during oscillation.

3. The valve frame assembly of claim 1, wherein when the valve frame body in the expanded configuration is positioned within the anchor in the expanded configuration, the two form an interference fit, thereby clamping the native leaflet therebetween.

4. The valve frame assembly of claim 1, wherein the anchor comprises an anchoring mechanism, a plurality of extensions, and at least two base portions; the anchoring mechanism is positioned on the radial outer side of the valve frame body and comprises at least two anchoring sections which are circumferentially arranged at intervals; two ends of each anchoring section are respectively connected with one extending part, and a substrate part is connected between two adjacent extending parts between two adjacent anchoring sections; the anchor is generally annular in circumferential direction when in the expanded configuration.

5. The valve frame assembly of claim 4, wherein the valve frame body comprises an atrial side valve frame section and a ventricular side valve frame section that are connected to each other; in the expanded configuration of the valve frame body, the atrial side valve frame section protrudes at least radially outward relative to the ventricular side valve frame section;

When the valve frame body and the anchoring member are both in the expanded configuration, each location of the anchoring mechanism is located below the atrial side valve frame section.

6. The valve frame assembly of claim 4, wherein the anchor is in a compressed configuration: each of the anchor segments is compressed and folded between two of the extensions connected to both ends thereof, and the anchors are at least partially enclosed radially outward of the valve frame body in a compressed configuration.

7. The valve frame assembly according to claim 5, wherein the connection mechanism is movably connected with the base portion, at least a portion of the connection mechanism being slidable relative to the base portion radially outward of the base portion;

In the compressed configuration of the valve frame body and the compressed configuration of the anchor, an end of the connection mechanism connected to the ventricular side valve frame section is distal to an end of the connection mechanism connected to the base portion; in the expanded configuration of the valve frame body and the expanded configuration of the anchor, the valve frame body is positioned within the anchor and an end of the connection mechanism connected to the ventricular side valve frame section is positioned proximal to an end of the connection mechanism connected to the base.

8. The valve frame assembly of claim 7, wherein in the compressed configuration of the valve frame body and the expanded configuration of the anchor, and when the connection mechanism has not been swung, an end of the connection mechanism connected to the ventricular side valve frame section is located distal to an end of the connection mechanism connected to the base portion, and an angle between the connection mechanism and a central axis of the valve frame body is in a range of 30 ° to 60 °; and/or

In the compressed configuration of the valve frame body and the expanded configuration of the anchor, the connection mechanism performs the oscillation with an angle in the range of 90 ° to 120 ° when the anchor and the valve frame body are relatively moved in the axial direction; and/or

In the compressed configuration of the valve frame body and the expanded configuration of the anchor, and after the connection mechanism completes the oscillation, an end of the connection mechanism connected with the ventricular side valve frame section is located proximal to an end of the connection mechanism connected with the base portion, and an included angle between the connection mechanism and a central axis of the valve frame body is in a range of 140 ° to 170 °.

9. The valve frame assembly according to claim 1, wherein said anchor is provided with at least one first through hole extending radially therethrough, said attachment mechanism including at least one attachment member, a respective one of said attachment members being movably disposed through said at least one first through hole such that at least a portion of said attachment member is slidable relative to said anchor along said at least one first through hole to said radially outer side of said anchor.

10. The valve frame assembly according to claim 9, wherein the connector comprises at least one first linear section and at least one first stop, the first linear section being connected to the first stop, wherein the first linear section is movably threaded through the respective first through hole, and the respective first stop is located radially outward of the respective first through hole.

11. The valve frame assembly according to claim 2, wherein said valve frame body includes at least one connecting portion, each of said connecting portions having at least one second through hole radially extending therethrough, said connecting mechanism including at least one connecting member, a respective one of said connecting members being movably disposed through said at least one second through hole so that said connecting member is adapted to maintain its natural configuration during oscillation.

12. The valve frame assembly according to claim 11, wherein the connecting piece comprises at least one second linear section and at least one second limiting portion, the second linear section being connected to the corresponding second limiting portion, wherein the second linear section movably passes through the corresponding second through hole, and the corresponding second limiting portion is located radially inward of the corresponding second through hole.

13. A prosthetic heart valve comprising the valve frame assembly of any one of claims 1-12, and the prosthetic leaflet housed within the frame body.