Patent ID: 12226313

LIST OF REFERENCE NUMERALS

100, prosthetic heart valve device;1000, prosthetic aortic valve device;101, inflow end;102, outflow end;103, inner frame;104, connecting post;1041, fifth bar;1042, sixth bar;110, frame;111, spacing region;1112, eyelet;114, commissure region;115, first collar;116, cell;117, second collar;120, clipping arm;121, fixed end;1221, rounded structure;123, free end;127, commissure region;129, projection area;132, commissure post,141, leg,142, pulling arm,146, apex,160, first avoidance space,168, deformable slot,173, radiopaque point;200, leaflet;201, native leaflet;204, valvular sinus;211, joining region;220, covering film;221, inner covering film;223, outer covering film;301, blood flow passage;310, connecting portion;3101, radiopaque hole;311, positioning structure;3120, sleeve;313, rigid portion;314, flexible portion;315, connecting member;321, unit;330, wave structure;340, connecting ring;341, a connecting region,342, a second avoidance space,343, a first position,344, a second position,345, a flexible member;400, delivery system;404, support device;405, outer sheath;406, loading zone;407, control handle;410, support;411, sliding groove;420, movable base;430, driving sleeve;440, rotatable seat;441, planetary carrier;442, planetary gear;443, ring gear;444, planetary input shaft;445, planetary output shaft;451, worm wheel;452, worm;453, transmission sleeve;454, support base;461, first gear;462, second gear;463, transmission sleeve;464, support base;530, guiding member;531, wing;531a, wing;531b, wing;531c, wing;531d, wing;531e, wing;531f, wing;532, root;532a, root;532b, root;5321, first bar;5322, second bar;5323, first binding eyelet;5324, first connection point;5325, second connection point;5326, third connection point;5327, first plane;5311, first wing;5312, second wing;534, free end;5341, wave structure;535, branched structure;5351, third bar;5352, fourth bar;5353, slot;5354, second binding eyelet;5355, fourth connection point;5356, second plane;536, free end;5361, seventh bar;5362, eighth bar;537, restricting structures;538, first portion;539, second portion;550, radiopaque marker;550a, radiopaque marker;550b, radiopaque marker;550c, radiopaque marker;551, eyelet;600, balloon device;610, tube;6101, outermost layer;6102, middle layer;6103, innermost layer;620, guiding head;630, balloon;900, human heart;910, aorta;911, right coronary artery trunk;912, left coronary artery trunk.

DESCRIPTION OF THE EMBODIMENTS

The technical solutions according to the embodiments of the present disclosure will be described clearly and fully in combination with the drawings according to the embodiments of the present disclosure. Obviously, the described embodiments are not all embodiments of the present disclosure, but only part of the embodiments of the present disclosure. Based on the disclosed embodiments, all other embodiments obtained by those skilled in the art without creative work fall into the scope of this invention.

It should be noted that, when a component is “connected” with another component, it may be directly connected to another component or may be indirectly connected to another component through a further component. When a component is “provided” on another component, it may be directly provided on another component or may be provided on another component through a further component.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art. The terms in the description of the present disclosure are used to describe specific embodiments, and not to limit the present disclosure. The term “and/or” used herein includes one or more of the listed options in any combinations, or the combination of all of the listed options.

In the present application, the terms “first”, “second” and the like are used for descriptive purposes only and are not to be understood as indicating or implying the relative importance or the number or order of the technical features referred. Thus, features defined with “first”, “second” can explicitly or implicitly include one or more of such features. In the description of the present invention, “plurality” means at least two, such as two, three, etc., unless explicitly and specifically defined otherwise.

In this application, the terms “corresponding”, “matched”, “adapted” and the like, for example, “B corresponding to A,” “A corresponding to B,” indicate that B corresponds to A in shape, position or function, and B can be determined from A. However, determining B from A does not mean determining B from A alone, but can also be determined from A and/or other information.

Referring toFIGS.1a-1b, the aorta910of the human heart900has native tricuspid leaflets201. Valvular sinuses204are located between the leaflets and the vessel wall, with two of the valvular sinuses communicating the right coronary artery trunk911and the left coronary artery trunk912, respectively. The prosthetic aortic valve device1000should be placed to ensure that blood flowing out through the orifice of the leaflets200enters one of the coronary artery trunks in the direction M. Therefore, if there is a position deviation for the prosthetic aortic valve device1000in the circumferential direction, the prosthetic aortic valve device1000should be adjusted. For example, as shown inFIG.1b, the prosthetic aortic valve device1000can be rotated in direction W such that blood can enter the left coronary artery trunk912in direction M.

The frame of the prosthetic heart valve device and the prosthetic heart valve device hereinafter have different configurations in different applications. The frame mainly includes an inner frame and a positioning mechanism such as clipping arms or guiding members, wherein the inner frame has relative compressed and expanded configurations, and the positioning mechanism has loaded configuration, transition configuration and released configuration. Unless otherwise specified, the description related to the proportional relationship of the parts of the frame and the structure of the frame refers to the free condition of the frame outside the human body without force from surrounding tissue, for example, the expanded configuration for the inner frame, and the released configuration for the positioning mechanism.

Referring toFIGS.1cto13, the present application discloses a prosthetic heart valve device, including a frame110and leaflets although the figures only show the frame. The frame110includes an inner frame103having a meshed cylindrical structure that is radially deformable and has an axis, a circumferential direction around the axis, and two axial ends being an inflow end101and an outflow end102, the inner frame103has relative compressed and expanded configurations depending on the radial deformation, with a blood flow passage extending axially through the inner frame103, and a support device (e.g., a balloon device) for driving the inner frame103to transform into the expanded configuration can be placed within the inner frame103.

When leaflets are arranged, the leaflets are connected to the inner frame and cooperate with each other to control opening and closing of the blood flow passage. The meshed cylindrical structure of the inner frame103is provided with a positioning mechanism. In this embodiment, the positioning mechanism is configured as clipping arms12. A plurality of groups of clipping arms120are located at an outer periphery of the inner frame103and spaced apart from each other in the circumference of the frame110, each clipping arm120having opposite fixed end121and free end123, the fixed end121being directly or indirectly connected with the inner frame103, the other end extending towards the inflow end to the free end123. During the use of the prosthetic heart valve device, the clipping arm120can transform among various configurations of:a loaded configuration, in which the inner frame103assumes the compressed configuration, and the clipping arms120contact or are adjacent to the inner frame103in the compressed configuration;during release, the clipping arms120are located outside the inner frame103, and thus can be released prior to the inner frame103, thereby transforming into the transition configuration;in the transition configuration, the inner frame103is in the compressed configuration, and the ends of the clipping arms120as the positioning mechanism connected to the inner frame103remain compressed along with the inner frame103to adapt to the inner frame103in the compressed configuration. That is, the fixed ends of the clipping arms120are gathered together and remain in contact with or close to the inner frame103, while the free ends of the clipping arms120extending towards the inflow end are stretched in the outer peripheral region of the inner frame103, with a first receiving space defined between the clipping arms120and the outer wall of the inner frame for allowing the native leaflets to enter therein. As the inner frame103is released, the clipping arms120transform into the released configuration; andin the released configuration, the inner frame103is in the expanded configuration, the ends of the clipping arms120connected to the inner frame103move away from each other to adapt to the inner frame103in the expanded configuration, and the free ends123of the clipping arms120expand radially outward, with a second receiving space defined between the free ends123and the outer wall of the inner frame for clipping the native leaflets. In general, at least one native leaflet201is clipped between the clipping arm120and the inner frame103in vivo.

In the present application, the frame110for the prosthetic heart valve device is structurally improved. When applied to the aortic valve as a prosthetic aortic valve device, the positioning effect in case of aortic valve insufficiency diseases is improved, with the advantage of high assembly efficiency, convenient deployment and positioning, long-term stability and high durability, and having positive impact on the application of minimally invasive transcatheter aortic valve implantation devices for treating aortic valve insufficiency.

The positioning mechanism can be located at the respective valvular sinuses so that the prosthetic heart valve device can be aligned in the circumferential direction. The positioning mechanism and the inner frame103clipping the native leaflets or the positioning mechanism abutting against the sinus floors of the valvular sinuses allows am axial positioning so that the prosthetic heart valve device can be prevented from displacement under the influence of blood flow.

Spatially, both the first and second receiving spaces are radial gap between the outer wall of the inner frame and the positioning mechanism, and merely refer to different configurations. Therefore, unless otherwise specified, the receiving spaces are not strictly distinguished below. In some embodiments below, by changing the shape of the inner frame103or the deformation of the positioning mechanism, it is possible to make the second receiving space be smaller than the first receiving space in the radial direction of the inner frame. That is, the positioning mechanism in the released configuration tends to further clip the native leaflets relative to the transition configuration.

In the expanded configuration, the overall configuration of the inner frame103can be straight cylindrical, although in other implements, the outflow end of the inner frame can be flared outwards, which is also adapted to the changes in the size of the first and second receiving spaces.

In order to engage with the valvular sinuses, the fixed ends121of the clipping arms120in each group are adjacent to each other, the free ends123of at least two clipping arms120in each group tend to extend away from each other, and the free ends123of at least two clipping arms120in adjacent groups tend to extend close to each other. The clipping arms120are provided separately so as to avoid the positioning failure caused by an individual clipping arm(s)120which cannot be located in the valvular sinus. Taking the tricuspid valve as an example, three groups of clipping arms120are provided. The free ends123of at least two clipping arms120in each group tend to extend away from each other, which greatly increases the available anchor points, while the free ends123of at least two clipping arms120in the adjacent two groups tend to extend close to each, which conforms the anatomic structure of the valvular sinus.

In order to control the release sequence of the positioning mechanism and the inner frame103in the human body, the positioning mechanism is released by self-expanding and made of a suitable material, for example, a memory material such as a nickel-titanium alloy, and are preset to shape of the released configuration by heat treatment. The positioning mechanism can be automatically released prior to the inner frame103after being released from the radial constrain. The inner frame103is released by ball expanding and made of a suitable material. As the inner frame needs to be released and expanded by means of the balloon device, it can be released later than the positioning mechanism.

In the case where the inner frame103and the clipping arms120are both self-expanded, the delivery device would be more complicated and needs two sheaths connected in series or one surrounded by another so as to release the inner frame103and the clipping arms120in different steps, respectively, having more movable components and further reducing the compliance.

A specific portion can be provided by the inner frame103for connecting with the fixed end121of the clipping arm120. Referring toFIG.1, the inner frame103is provided with at least two commissure regions114spaced apart in the circumferential direction, with the coaptation portion of adjacent leaflets corresponding to the respective commissure region114, and the fixed ends121of the clipping arms120in each group are connected to a corresponding commissure region114. Specifically, the inner frame103is provided with a plurality of commissure regions114adjacent to the outflow end102, and the fixed ends121of the clipping arms120in each group are connected to the corresponding commissure region114. As shown in the figures, the number of the commissure regions114is preferably n, where n is the number of the leaflets200configured to be loaded in the frame110. For example, in case of aorta valve, n is generally3. More specifically, the edge of the inner frame103at the outflow end102has a structure with peaks and valleys, and the commissure regions114are located at the peaks (which protrude towards the outflow end102). In another aspect, the axial length of the inner frame103varies in the circumferential direction of the inner frame103, and gradually shortens as far away from the commissure region114. Further, in the axial direction of the inner frame103, the inner frame103has a plurality of rows of cells, including N rows of cells that respectively extend continuously in the circumferential direction adjacent the inflow end101, and the remaining rows of cells respectively extend discontinuously in the circumferential direction, where N is 1, 2 or 3. As can be seen from the figure, in the circumferentially discontinuously extending rows of cells, the distance between the cells spaced from each other in the same row is larger as it is closer to the outflow end102.

Referring toFIG.8, the commissure region114is configured as a commissure post132. InFIG.10, each commissure post132extends from the outflow end102of the inner frame103. Alternatively, the commissure posts132can extend from the interior of the inner frame103. Specifically, the commissure post132can be configured as a bar, which extends along the axis of the inner frame103or the free end123of which is inclined radially inward. As shown in the figures, the commissure post132is configured as a solid rod. Alternatively, the commissure post132can be configured as a bar frame.

Referring toFIG.8, the commissure post132is provided with a plurality of eyelets1112. Alternatively, one eyelet1112can be provided. As shown in the figure, the plurality of eyelets1112on the commissure post132are arranged in sequence in the axial direction of the main body of the commissure post132to facilitate the processing and assembly.

The plurality of commissure posts132can be provided separately. As shown inFIG.8, a pulling arm142is connected between adjacent commissure posts132, and a first avoidance space160is defined between the pulling arm142and the outflow end102of the inner frame103. In the loaded configuration, the clipping arms120can be located within the respective first avoidance spaces160. The first avoidance space160provides motion space and receiving space for the clipping arm120, thereby improving the engagement of the clipping arm120with the inner frame. For example, in the loaded configuration, all the clipping arms120do not radially overlap on the inner frame103, which improves the loaded configuration of the inner frame103, optimizing the profile of the inner frame103and facilitating assembly of the system as well as the treatment, wherein the small profile improves the compliance for in vivo delivery. The pulling arm142can extend straightly. Alternatively, as shown in the figure, the pulling arm142between two adjacent commissure posts132has a bent portion, i.e., an apex146, and is generally V-shaped. InFIG.7, the apex of the V-shape is fixedly connected with the edge of the inner frame103at the outflow end102. Alternatively, in other embodiments, the apex of the V-shape can be free from the edge of the inner frame103at the outflow end102.

Referring toFIG.14, the pulling arms142can be provided separately. Alternatively, referring toFIG.7, the inner side of the V-shape is connected with a leg141, and the middle portion of the leg141is bent, with the apex146protruding towards the outflow end102. As shown in the figures, the inner side of the V-shape is configured as the outflow end102of the frame110, and the pulling arm142is configured as a single rod. It can be conceived that the pulling arm142can be provided as a deformable meshed strip.

Similar to the above structure with peaks and valleys, in the present embodiment, the axial length of the inner frame103varies in the circumferential direction of the inner frame103, and gradually shortens as far away from the commissure region114. In the axial direction of the inner frame103, the inner frame103has a plurality of rows of cells, including N rows of cells that respectively extend continuously in the circumferential direction adjacent the inflow end101, and the remaining rows of cells respectively extend discontinuously in the circumferential direction, where N is 1, 2 or 3. In the circumferentially discontinuously extending rows of cells, the distance between the cells spaced from each other in the same row is larger as it is closer to the outflow end102.

Referring toFIGS.1cto5b, one end of the clipping arm120is a fixed end121connected with the respective commissure region114, and the other end is a free end123away from the commissure region114. In the circumferential direction, the free ends123of the clipping arms120corresponding to adjacent two commissure regions114are adjacent to each other.

In order to better observe the position of the clipping arms120during the treatment, the clipping arms120are provided with one or more radiopaque points173, and at least one radiopaque point173is adjacent the free end123of the clipping arm120. Further, in the case of a plurality of radiopaque points173, at least one radiopaque point173is adjacent to the free end123of the clipping arm120, and at least one radiopaque point173is adjacent to the fixed end121of the clipping arm120. The radiopaque point can be provided separately or share the same hole with other structure. For example, inFIG.2c, the free end123of the clipping arm120is provided with an eyelet551. The eyelet551can be used for providing the radiopaque point173and also for providing a rounded structure.

In order to reduce the damage of the clipping arm120to the native and surrounding tissues, as shown in the figures, the free end123of the clipping arm120is configured as a rounded structure1221. Similarly, the free end123of the clipping arm120can be provided with a protective layer. The protective layer and the rounded structure1221can be provided in combination.

Further, the clipping arm120can have a deformable structure. The deformable structure can use various forms. For example, inFIG.7, the clipping arm120is provided with one or more deformable slots168. The deformable slot168can additionally extend the length of the clipping arm120in the released configuration. The length of the clipping arm120is one of the factors that determine the position of the fixed end121of the clipping arm120, and thus determines the position of the frame110in the physiological anatomy. Therefore, by adjusting the number, position, and size of the deformable slots168, the length of the clipping arm120can be adjusted, thereby extending the application of the prosthetic valve in the physiological anatomy. In the case where the deformable slot168is small, the radiopaque marker can be accommodated therein.

In the circumferential direction of the inner frame103, various clipping arms120can be provided at one side where the individual commissure region114is located. In the embodiment shown inFIG.1c, one single clipping arm120is provided at one side where the commissure region114is located. Alternatively, as shown inFIG.7, the single clipping arm120can have a branched structure at the middle thereof that converges at the free end123. The free end123of the clipping arm120can also have a branched structure. Alternatively, a plurality of clipping arms120can be provided at one side where the commissure region114is located as shown inFIG.5b. The clipping arms120can be configured as a single bar or configured as a deformable meshed strip.

In the deployed state, the angle between the clipping arm120and the axis of the inner frame103ranges from 30 to 85 degrees, where the angle is measured referring to the line connecting the two ends of the clipping arm120.

Regarding the distribution of the clipping arms120, the clipping arms120on two opposite sides of the commissure region114are symmetrically distributed, and in the circumferential direction of the inner frame103, the clipping arms120between the adjacent commissure regions114are symmetrically distributed.

FIGS.12ato13show the engagement between the clipping arms120and the inner frame, wherein the clipping arms120are all connected to the inner frame by riveting. As shown inFIGS.12ato12d, the clipping arm is connected with the outer peripheral surface of the inner frame, while inFIG.13, the clipping arm is connected with the inner peripheral surface of the inner frame. It can be conceived that the clipping arms shown inFIGS.12ato12dcan be connected with the inner peripheral surface of the inner frame.

The fixed ends121of the clipping arms120can be connected with the inner frame103separately or in combination. In the embodiment shown inFIG.8to11, the fixed ends121of the clipping arms120in each group converge to a connecting portion310and are fixed to the inner frame103by the connecting portion310. The connecting portion310and the clipping arms120joined to the connecting portion310can be formed in one piece, for example, by cutting or knitting. Further, in the circumferential direction of the inner frame103, the clipping arms120in each group are distributed on two sides of the connecting portion310. In practice, the inner frame103is provided with at least two commissure regions114at intervals in the circumferential direction, and the connecting portions310are respectively fixed to the commissure regions114on the inner frame103by welding or by connecting members315.

The connecting portion310can connect the clipping arms120and the inner frame103better while adapting different expansion characteristics of the two. Further, the engagement between the connecting portion310and the commissure region114can be various. For example, referring toFIG.3a, the connecting portion310is overlapped on the outer side of the commissure region114in the radial direction of the inner frame103. Referring toFIG.13, the connecting portion310is overlapped on the inner side of the commissure region114in the radial direction of the inner frame103. Referring toFIG.8, in the circumferential direction of the frame110, the connecting portion310is located on one circumferential side of the commissure region114, that is, the connecting portion310does not radially overlap on the commissure region114. Referring toFIGS.10and11, the connecting portion310covers the top of the commissure region114. Compared withFIG.3aandFIG.13, the junction inFIG.8,FIG.10andFIG.11is more invisible and cannot be clearly shown in the figures, and thus is represented by a thick line L. The above-mentioned various configurations have different advantages in terms of assembly difficulty and volume in the loaded configuration.

In the case where the connecting member315is used for fixing, the specific implementation of the connecting member315can refer toFIGS.6bto6c. In the figures, the connecting member315is configured as a fixing member passing through the connecting portion310and the commissure region114. Specifically, with reference toFIG.6a, the connecting member315can be configured as a screw, a rivet, a binding wire, or the like. Alternatively, as shown inFIG.6b, the connecting member315can be configured as a sandwiched adhesive lay. Alternatively, as shown inFIG.6c, the connecting member315can be configured as a covering structure.

As shown inFIG.28, the connecting portions310corresponding to the clipping arms120in each group are formed in one piece. Referring toFIG.11, the connecting portions310corresponding to the clipping arms120in each group can be separated and adjacent to each other. Further, the separated structure includes a plurality of units321, which are separated and respectively connected to the commissure region114of the inner frame103, or the plurality of units321can be fixed to each other, with at least one unit321connected to the commissure region114of the inner frame103.

Similarly to the radiopaque configuration in the clipping arm120, the connecting portion310can also be provided with a radiopaque hole(s)3101for mounting the radiopaque element(s), in order to provide a more clear observation.

The clipping arm120can use various forms.FIGS.2ato2d,4ato4d, and 5a to5bshows different perspectives of the clipping arms with different arrangements.

FIGS.2ato2dshow front view ofFIG.1, which can be considered as showing the clipping arm projected on the paper in the front view; in the case where the clipping arm, when projected on the paper, has no configuration as shown in the figures, the shown clipping arm can be considered as the configuration being flattened.

FIGS.4ato4dshow the released configuration of the clipping arm in a cylindrical coordinate, wherein the dotted line shows the cylindrical coordinate. In order to better show the three-dimensional configuration of the clipping arm in the two-dimensional figures, the cylinder of the cylindrical coordinate in the figure is depicted referring to the profile of the frame, so these figures can be approximately understood as showing the spatial relationship between the frame and the clipping arm.

FIGS.5ato5bshow top views ofFIG.1, and can be understood as showing the clipping arm projected on the paper in the top view; in the case where the clipping arm, when projected on the paper, has no configuration as shown in the figures, the shown clipping arm can be considered as the configuration being flattened.

Referring toFIG.2d,FIG.4c, andFIG.4d, the clipping arm120has a wave structure330adjacent to the free end123. In the figures, the wave structure330mainly undulates in the axial direction of the frame110. It can be conceived that the clipping arm120can have undulations in multiple directions in space. Referring toFIGS.5aand5b, the clipping arm120has a radially undulating structure as viewed in the axis of the inner frame103. The undulations in multiple directions can be provided separately or overlapped with each other to form a complex three-dimensional configuration.

The clipping arms120can be divided into a plurality of groups, depending on the position of the fixed ends121. Each group of clipping arms120can include one or more pairs of clipping arms120. In the embodiment shown inFIG.5b, each group includes multiple pairs of clipping arms120. In the circumferential direction of the inner frame103, the clipping arms120in each pair are respectively located on two sides of the connecting portion310, and the clipping arms120in different pairs have different lengths after being released.

In another aspect, in the circumferential direction of the inner frame103, the clipping arms120in each group are divided into pairs of clipping arms120, and the clipping arms120in each pair are respectively located on two sides of the connecting portion310. In the released configuration, the clipping arms120on the same side of the connecting portion310while in different pairs have different extensions as shown inFIG.4d.

The different configurations described above represent the three-dimensional configurations of the clipping arm120in the released configuration. Further, referring toFIG.5a, in the released configuration, the free ends123of the clipping arms120in each group are located at the same radial position relative to the inner frame103. Referring toFIG.5b, in the released configuration, the free ends123of the clipping arms120in each group are offset from each in the radial direction relative to the inner frame103. However, the free ends123of all the clipping arms120in the afore-mentioned two cases are both located between the two ends of the inner frame103in the axial direction of the inner frame103in the released configuration, wherein the two ends of the inner frame103in the present embodiment refer to the inflow end101and the outflow end102of the inner frame103, so as to prevent the clipping arms120from affecting the release and positioning of the frame110.

The plurality of clipping arms120can use the same configuration as describe above. Alternatively, the plurality of clipping arms120can use different configurations in one embodiment as shown inFIG.2e. Specifically, two adjacent clipping arms120in different groups have different lengths. Further, the clipping arms120in each group can be different. For example, the two clipping arms120in each group can have different lengths. Besides the difference in the extension length of the clipping arms120, the free ends of adjacent two clipping arms in different groups can be offset from each other in the circumferential direction of the inner frame. As shown in the figure, the clipping arm120has a bent portion adjacent to the free end thereof so as to change the extension path thereof. In the deployed state, the bent portion of one of the adjacent clipping arms surrounds the free end of the other in half, which further improves the positioning of the clipping arms120on the native leaflet.

Referring toFIGS.14to19m, the present application discloses a prosthetic heart valve device, including leaflets and a frame110. Different from the above embodiments, the frame110in this embodiment further includes:a connecting ring340fixed with the outflow end102of the inner frame103and provided with a plurality of connecting regions341at intervals; and the fixed ends121of clipping arms120in each group are located at the same connecting region341.

In this embodiment, the plurality of groups of the clipping arms120are connected by the connecting ring340, so that the clipping arms120and the inner frame103can be separately provided with more flexibility. In general, the free ends123of at least two clipping arms120in each group tend to extend away from each other, and the free ends123of at least two clipping arms120in adjacent two groups tend to extend close to each other. The clipping arms120forms a deformable deployed structure on the outer periphery of the inner frame103. The clipping arm120can be connected with the inner frame by the connecting portion310. Specifically, in one embodiment, the connecting portion310can be overlapped on the outer side of the commissure region114in the radial direction of the inner frame103. Alternatively, in another embodiment, the connecting portion310can be overlapped on the inner side of the commissure region114in the radial direction of the inner frame103. Alternatively, in a further embodiment, the connecting portion310can be connected at one circumferential side of the commissure region114in the circumferential direction of the frame110, that is, the connecting portion310does not radially overlap on the commissure region114. InFIGS.20eand20f, the junction is more invisible and cannot be clearly shown in the figures, and thus is represented in a bold in the figures. The above-mentioned various configurations have different advantages in terms of assembly difficulty and volume in the loaded configuration.

Referring toFIG.15a, the fixed ends121of the clipping arms120in different groups are located at different connecting regions341. Referring toFIG.18a, the connecting ring340surrounds and is connected with the outer periphery of the inner frame103. Alternatively, referring toFIG.17, the connecting ring340is connected with one axial end of the inner frame103. Further, the connecting ring340is configured as a radially deformable structure. In practice, the connecting ring340can be configured as a meshed strip. Referring toFIGS.16aand16b, the connecting ring340is configured as a single-strand strip, which extends along the circumferential direction of the inner frame103, and has a wave structure330undulating in the axial direction of the inner frame103.

In the released configuration, an independent space is defined between the connecting ring340and the clipping arms120, so that the connecting ring340can be more flexibly engaged with the inner frame103. Referring toFIG.18, the inflow end101of the coupling ring340is connected with the outflow end102of the inner frame103, which allows the connecting ring340and the inner frame103to be offset from each other in the axial direction. Further, a second avoidance space342is defined between the inflow end101of the connecting ring340and the outflow end102of the inner frame103, and the clipping arms120are located within the respective second avoidance space342in the loaded configuration. Specifically, the connecting ring340is connected with the inner frame103at a first position343and/or a second position344. Different connection positions and numbers affect the mechanical performance of the connecting ring340, thereby affecting the movement of the clipping arms120. The clipping arm120is connected with the connecting ring340at the second position344. The first position343and the second position344are offset from each other in the circumferential direction of the inner frame103, and the offset angle is 360/2n, where n is the number of leaflets200configured to be loaded in the frame110. As shown in the figure, the frame110shown is used for a tricuspid valve, so the first position343and the second position344are offset by an angle of 60 degrees.

Independent from the above configuration, the coupling ring340and the inner frame103do not overlap each other, so that they are allowed to be compressed into a desired volume, which facilitates the treatment.

The axial offset and the radial offset between the connecting ring340and the inner frame103can be achieved separately and independently, or in combination as shown in the figures.

Regarding the connection between the groups of clipping arms120and the inner frame103, seeFIG.18, the fixed ends121of the clipping arms120in each group converge to the connecting ring340adjacent the outflow end102of the inner frame103. As shown inFIG.18, the connecting ring340is rigidly fixed with the commissure region114.

Besides the above-mentioned connection methods for the connecting ring340and the clipping arms120, as shown inFIGS.16and17, the connecting ring340and the clipping arms120can be formed in one piece. Further, the connecting ring340and the clipping arms120are formed by winding a wire(s). In practice, the wire is configured as a single wire without a break. The wire can be made of an alloy material having a memory effect.

Referring toFIG.19a, the present application further discloses a prosthetic heart valve device, including leaflets and a frame110. The difference of this embodiment from the above embodiments is that the circumferential distribution region M1 of the fixed end121of the clipping arm120has a central angle greater than 15 degrees with respect to the axis of the inner frame103.

FIG.19ashows a group of reinforced clipping arms120. In this embodiment, on the one hand, the frame is self-expanded by means of a support device (such as a balloon), on the other hand, the separate clipping arms120are reinforced by optimizing the shape or size thereof, thereby improving the positioning effect of the clipping arms120on the native leaflet201. Compared with the clipping arm120configured as a single rod or the like, the reinforced clipping arm120according to this embodiment has a more stable positioning effect.

Specifically, the circumferential distribution region M1 and the axial distribution region M3 of the fixed end121of the individual clipping arm120are improved, to ensure the connection strength of the single clipping arm120with the inner frame103as well as the spatial shaping performance thereof.

Regarding the connection between the clipping arms120and the inner frame103, as shown inFIGS.19bto19m, the clipping arms120are connected with a separate connecting ring, and then connected to the inner frame103by the connecting ring to form a frame with separate pieces. Alternatively, as shown inFIGS.10ato20f, the clipping arms120are directly connected to the inner frame103to form a frame with a one piece. InFIGS.19k,19l, and19m, the connecting ring and the clipping arms120are formed by winding a wire, but the clipping arms120inFIGS.19k,19l, and19mhave different shapes. As shown inFIG.19l, the clipping arm120extends approximately in the axial direction of the inner frame103, and then turns to extending approximately in the circumferential direction of the inner frame103. As shown inFIG.19m, the clipping arms120in each group can be asymmetrically arranged.

Referring toFIGS.19ato20f, the clipping arms120are arranged in groups, and the fixed ends121of the clipping arms120in each group are adjacent to each other. ComparingFIGS.19band19d, it can be seen that the free ends123of the clipping arms120can be moved away from or closer to each other to achieve different positioning effects. In order to avoid interference between the clipping arms120in the circumferential direction, the clipping arm120is sized so that the central angle of the circumferential distribution region M4 of the fixed ends121of the clipping arms120in each group with respect to the axis is equal to or less than 360/n, where n is the number of leaflets200configured to be loaded in the frame110. As shown in the figures, the frame110is used for a tricuspid valve, and thus the central angle of the circumferential distribution region M1 of the fixed ends121of the clipping arms120in each group with respect to the axis is less than or equal to 120 degrees.

The central angle of the circumferential distribution region M1 of the fixed end121of the clipping arm120with respect to the axis is equal to or less than 360/2n, where n is the number of leaflets200configured to be loaded in the frame110. Similarly, as shown in the figures, the central angle of the circumferential distribution region M1 of the fixed end121of the clipping arm120with respect to the axis is smaller than or equal to 60 degrees.

The above-described parameters can avoid a reduced freedom of motion of the clipping arm120caused by the increased size, thereby ensuring the positioning effect.

Referring toFIG.19b,FIG.19candFIG.20f, it can be seen that the circumferential distribution region M1 shown in the figures represents the projection dimension of the fixed end121of the clipping arm120in the circumferential direction of the inner frame103. In another embodiment, the length of the axial distribution region M3 of the fixed end121of the clipping arm120relative to the inner frame103is greater than 5 mm. The axial distribution region M3 represents the projection dimension of the fixed end121of the clipping arm120in the axial direction of the inner frame103. Alternatively, the circumferential distribution region M1 and the axial distribution region M3 can be combined.

Referring toFIGS.20eand20f, depending on the different configurations of the fixed end121, the circumferential distribution region M1 and the axial distribution region M3 are adjusted correspondingly, and the specific junction (shown by a thick solid line in the figures) between the clipping arm120and the inner frame103is also changed correspondingly.

In general, when projected onto the peripheral surface of the inner frame103, the clipping arm120assumes a sheet-like structure having a certain area. Referring toFIG.19a,FIG.19dandFIG.20a, the clipping arm120generally has a curved extension from the fixed end121to the free end123, and two clipping arms120in adjacent groups cooperate with each other to conform to the anatomic structure of the valvular sinus204. Specifically, and for example, within two clipping arms120in adjacent two groups, the overall structure gradually converges from the outflow end102to the inflow end101, that is, the span between the two clipping arms120in the circumferential direction of the inner frame103gradually decreases until the free ends123thereof are close to each other. With regard to the specific extension path, the clipping arm120can extend uniformly in the circumferential and axial directions of the inner frame103as shown inFIG.19a, or first extends approximately in the circumferential direction of the inner frame103and then turns to extending approximately in the axial direction of the inner frame103as shown inFIG.20d, or refer toFIG.20j.

At least a spacing region M2 is defined between the fixed ends121of the two clipping arms120in adjacent groups in the circumferential direction of the inner frame103, wherein the spacing region M2 has a center angle relative to the axis greater than 30 degrees, for example, 60 to 120 degrees. The spacing region M2 can reduce interference between clipping arms120in adjacent groups and low the risk of simultaneous failure.

With regard to the specific structure of the clipping arm120, each of the clipping arms120has a multi-bar structure from the fixed end121to the free end123. The multi-bar structure is configured so that there are at least two bars of the clipping arm120at any portion in any direction which can be one or more of the axial direction, the radial direction, and the circumferential direction of the frame110. Alternatively, referring toFIG.19e, each of the clipping arms120is configured as a meshed strip consisting of bars, and there are at least two bars at any position in the extension direction of the clipping arm120. In the case where the clipping arm120is configured as a single bar, the strength there will be inevitably decreased, affecting the overall strength and positioning effect. The meshed strip is generally configured as a sheet-like structure, where the clipping arm120extends in a single layer or in double layers from the fixed end121to the free end123. Further, a solid sheet-like structure, i.e., a relatively closed sheet-like structure in space, can be formed by filling the hollowed-out regions of the meshed strip of the clipping arm120, and the specific filter can be a polymer material or a metal material. In the case where the filter chooses the same material as the bars of the clipping arm120, the clipping arm120is generally formed as a leaf-shaped metal sheet.

However, the clipping arm, which is generally formed as a metal sheet, results in problems in switching between the loaded configuration and the released configuration. In the embodiment shown with reference toFIG.20g, the portion of the clipping arm120adjacent to the free end123is configured as an undeformable rigid portion313. The undeformable rigid portion313should be understood as a portion which is designed to be undeformable, rather than being a rigid body in strict mechanical meaning. Referring toFIG.20i, the rigid portion313maintains the same or similar shape and form both in the loaded configuration and the released configuration. In terms of mechanical properties, the deformation resistance of the rigid portion313is significantly higher than that of other portions of the clipping arm120, particularly the flexible portion314mentioned below. Specifically, the rigid portion313can be implemented by a specific rigid material, or by a specific rigid structure. As shown in the figures, the rigid portion313is configured as a solid sheet-like structure.

The rigid portion313is provided so that the self-deformation of the clipping arm120is concentrated on the fixed end121, which can be implemented by weakening the mechanical properties of the fixed end121. Alternatively, referring to one embodiment, the fixed end121of the clipping arm120is configured as a deformable flexible portion314. Alternatively, referring to another embodiment, the clipping arms120in each group are connected to each other through a deformable flexible portion314. The difference between the two embodiments is that the flexible portion314is provided by the clipping arm120or independent from the clipping arm120. The flexible portion314can be implemented by a flexible material, or can be implemented by a flexible structure. For example, as shown in the figures, the flexible portion314is configured as a meshed strip.

The rigid portion313and the flexible portion314fit with each other depending on the respective distribution proportions thereof on the clipping arm. In principle, the rigid portion is at least 50% of the total length of the clipping arm in the extension direction of the clipping arm. Further, referring toFIG.20g, the proportion can be adjusted to 65% or more.

The flexible portion314mainly functions to realize the deformation of the rigid portion313with respect to the inner frame, that is, switching between the loaded configuration and the released configuration. Referring toFIG.20i, in the loaded configuration, the clipping arms in each group are close to each other and surround the outer periphery of the inner frame. Referring toFIG.20h, the clipping arms do not overlap each other in the radial direction of the inner frame, thereby improving the overall profile of the frame in the loaded configuration. From another perspective, the sum of the projection lengths of the clipping arms in the axial direction of the frame is less than or equal to the circumferential length of the frame. In the illustrated embodiment, the projection lengths of the clipping arms in the axial direction of the frame are the same.

The plurality of clipping arms120can use the same configuration as describe above. Alternatively, the plurality of clipping arms120can use different configurations in one embodiment as shown inFIG.20k. Specifically, two adjacent clipping arms120in different groups have different lengths. Further, the clipping arms120in each group can be different. For example, the two clipping arms120in each group can have different lengths. Besides the difference in the extension length of the clipping arms120, the free ends of adjacent two clipping arms in different groups can be offset from each other in the circumferential direction of the inner frame. As shown in the figure, the clipping arm120has a bent portion adjacent to the free end thereof so as to change the extension path thereof. In the deployed state, the bent portion of one of the adjacent clipping arms surrounds the free end of the other in half, which further improves the positioning of the clipping arms120on the native leaflet. This asymmetric arrangement can also be applied to the embodiment shown inFIG.19m.

An additional part can be further provided on the clipping arm120. With reference toFIGS.19fand19g, each clipping arm120is provided with an enlarged positioning structure311. The positioning structure311can facilitate the positioning of the clipping arm120on the native valve leaflet201and prevent the clipping arm120from falling off the valvular sinus204. Specifically, as shown inFIG.19g, the positioning structure311is provided at the free end123of the respective clipping arm120and is enlarged by extension of the material of the clipping arm120itself. Further, the positioning structure311is configured as an enlarged sphere. As shown inFIG.19f, the positioning structure311is configured as a thickened region on the clipping arm120, specifically at the edge. The positioning structure311is provided at a side edge of the clipping arm120extending from the fixed end121to the free end123thereof. In other words, the positioning structure can be provided at the portion of the clipping arm120which is configured to contact the floor or edge of the sinus of the native leaflet201. The specific form of the positioning structure311can be a positioning sphere, a positioning flange, a positioning bump, or the like. Alternatively, referring toFIG.19h, different positioning structures311can be provided on the same clipping arm120, which cooperate with each other.

In addition to the positioning structure311, referring toFIG.19iandFIG.19j, each of the clipping arms120can be covered with a sleeve3120, which can use a braided structure or be formed in one piece. The sleeve3120can provide more functions for the clipping arm120. For example, the sleeve3120can be made of a biocompatible polymer material. In this embodiment, the sleeve3120enables the surrounding tissue to be attached and fixed to the clipping arm120, thereby further improving the positioning effect. For another example, the sleeve3120can be provided with a drug-loading space. The drug-loading space can be a separate space, or can be a gap(s) in the sleeve3120of the braided structure as mentioned above. In this embodiment, the sleeve3120can facilitate the treatment by applying drug. Referring toFIG.19j, the sleeve3120and the positioning structure311as described above can be provided on the same clipping arm120, which cooperate with each other.

Similar to the other clipping arms120, referring toFIG.20a, the line connecting the center P1 of the fixed end121and the center P2 of the free end123of each clipping arm120is defined as the clipping path which is not coplanar with the axis of the inner frame110. When fitting the native valve leaflet201, as shown inFIG.20b, the increased size of the clipping arm120can better fit the anatomic structure of the valvular sinus204, thereby achieving a better positioning effect.

Referring toFIGS.20cto20f, the present application discloses a prosthetic heart valve device with reinforced clipping arms120, including a frame110as described above and valve leaflets200, wherein the leaflets200are connected with the frame110and configured to be located within the blood flow passage301. The leaflets200cooperate with each other for opening or closing the blood flow passage301.

The inner and/or outer sides of the inner frame103can be further provided with a covering film220. The two leaflets200adjacent in the circumferential direction are connected to a joining region211on the inner frame103, and the commissure region114corresponds to a corresponding joining region211in the circumferential direction of the inner frame103.

The leaflets200and the covering film220can be any known repair material including processed animal tissue, such as pig tissue and bovine tissue, or synthetic material. The leaflets200and the covering film220can be attached to the frame110by conventional stitching.

Referring toFIGS.22ato22c, the present application further discloses a delivery system400for a prosthetic heart valve device100, including:a support device404that is switchable between the inflated and deflated configurations under fluid; andan outer sheath405that is slidably engaged with the periphery of the support device404, the radial gap between the outer sheath405and the support device404being a loading zone406for receiving the prosthetic heart valve device100in the compressed configuration.

Referring toFIG.23atoFIG.24d, the present application further discloses a positioning method for the prosthetic heart valve device100for positioning any of the prosthetic heart valve devices100as described above, and the positioning method includes:delivering the prosthetic heart valve device100to a predetermined site by a delivery system400, in which the inner frame103is in a compressed configuration, the clipping arms120are in a loaded configuration, and the support device404is in a deflated configuration;driving the outer sheath405to release the free ends123of the clipping arms120, thereby expanding the free ends123of the clipping arms120and thus transforming into the transition configuration;adjusting the position of the inner frame103such that the free end123of the at least one clipping arm120is located outside the native leaflet201; anddriving the support device404to the inflated configuration and releasing the inner frame103and the fixed ends121of the clipping arms120, so that the inner frame103transforms into the expanded configuration and the clipping arms120transform into the released configuration.

Optionally, before adjusting the position of the inner frame103, the support device404is driven to a pre-inflated configuration, so that the inner frame103transforms into an intermediate configuration between the compressed configuration and the expanded configuration, and the clipping arms120transform into an intermediate configuration between the loaded configuration and the released configuration so as to achieve precise adjustment of the position of the inner frame103.

The specific positioning method is explained in detail below with reference to the drawings.

Referring toFIGS.23aand23b, the delivery device delivers the inner frame103in a compressed configuration and the clipping arms120in a loaded configuration to a predetermined site. As shown in the figures, the delivery device passes through the native leaflets201after entering the target from the aortic arch. The specific puncture path can include the aortic or femoral artery or other feasible location.

Referring toFIGS.23c-23d, the delivery device releases the clipping arms120, causing the free ends123of the clipping arms120to expand and thus transforming into the transition configuration. In this embodiment, the clipping arms120extend at the inflow end101of the native leaflets201.

Referring toFIG.23e, the position of the frame110is adjusted such that the free ends123of the clipping arms120are located just outside the native leaflets201while the inner frame103is located inside the native leaflet201. In this embodiment, the position of the frame110is adjusted by withdrawing the delivery assembly, so as to improve the engagement of the clipping arms120and the native leaflets201.

Referring toFIG.23f, the support device404is driven to the inflated configuration, the inner frame103and the fixed ends121of the clipping arms120are released, so that the inner frame103transforms into the expanded configuration, and the clipping arms120transforms into the released configuration, wherein the inner frame103cooperates with at least one clipping arm120to hold the native leaflets201.

Referring toFIG.23g, the support device404is withdrawn and the delivery device is withdrawn. The transcatheter surgery is finished.

During the surgery, the expansion of the inner frame may affect the positioning of the clipping arms, which can be alleviated through specific operations.

Referring toFIGS.24ato24d, prior to adjusting the position of the inner frame103, the support device404is driven to a pre-inflated configuration so that the inner frame103transforms into an intermediate configuration between the compressed configuration and the expanded configuration, and the clipping arms120transform into an intermediate configuration between the loaded configuration and the released configuration so as to achieve precise adjustment of the position of the inner frame103. The inner frame103in the intermediate configuration allows to release the clipping arm120to a great extent, so that the intermediate configuration of the clipping arms120prior to adjusting the position of the inner frame103are closer to the completely released configuration thereof, thereby improving the positioning effect of the frame110.

Referring toFIGS.25a-33c, an embodiment of the present application provides a prosthetic aortic valve device1000having opposite inflow end101and outflow end102, the prosthetic aortic valve device1000including:an inner frame103having a meshed cylindrical structure, which is radially deformable and has relative compressed and expanded configurations after being subjected to an external force, wherein the interior of the inner frame103is configured as an axially through blood flow passage301, and the countercurrent blood flows in the direction H as shown in the figure;leaflets200(prosthetic leaflets, in an opened state inFIG.26) connected to the inner frame103, wherein the leaflets200include three leaflets and cooperate with each other to control the opening and closing of the blood flow passage301; andthree guiding members530as the positioning mechanism arranged in sequence in the circumferential direction of the inner frame103(the number of which corresponds to that of the aortic valvular sinuses), and the position thereof respectively aligned with the area where the leaflets200are located in the circumferential direction, wherein each guiding member530includes a root532fixedly connected with the inner frame103and a wing531extending from the root532further towards the inflow end101, the guiding member530is made of a memory material and is configured to be switchable between a loaded configuration, a transition configuration, and a released configuration.

As shown inFIG.29andFIG.31, in the loaded configuration, the inner frame103assumes the compressed configuration and the guiding members are radially pressed to contact or be close to the inner frame103in the compressed configuration, so that the inner frame103and the guiding members can be easily surrounded by the sheath and delivered in vivo.

As shown inFIGS.30and32, in the transition configuration, the inner frame103remains in the compressed configuration, and the roots532of the guiding members530remain gathered to adapt the compressed configuration of the inner frame103. The wings531are self-deformed and thus extend outside of the inner frame103, with a first receiving space formed between the outer wall of the inner frame103and the wings531for receiving the native leaflets201. As the circumferential position of the guiding members530are respectively aligned with the area where the leaflets200are located (i.e., located within the one-third circumferential area where the corresponding leaflet is located), the extended wings531can be adjusted in position to enter the corresponding valvular sinuses, thereby achieving the circumferential positioning of the inner frame103, with the inner frame103inside the native leaflets and the wings531outside the native leaflets.

As shown inFIGS.33ato33c, in the released configuration, the inner frame103is already transformed into the expanded configuration after being subjected to an external force, and the roots532of the guiding members530move away from each other to adapt the expanded configuration of the inner frame103. A second receiving space is formed between the wings531and the outer wall of the inner frame103, and the at least one native leaflet is clipped in the second receiving space when the positioning is accurate.

In the present application, unless otherwise specified, the shape and position of the guiding member530are described referring to its released configuration, and the shape and position of the inner frame103are described referring to its expanded configuration.

The inner frame103has a meshed cylindrical structure, which can be radially deformed to facilitate the intervention after compression and the subsequent expansion and release. The axial length of the inner frame103may change when the inner frame103is radially deformed. The meshed cylindrical structure is configured to be expanded by external force, i.e., the meshed cylindrical structure is not made of self-expandable material. In general, the inner frame can be expanded by balloon. However, the guiding member530is made of a memory material (e.g., pre-heat-set nickel-titanium alloy), the wing531of which can be released in the human body first, the root532of which can be considered as a portion where the guiding member530and the inner frame103are adjacent and connected to each other. The specific shape is not strictly limited. The root532and the wing531can be formed in one piece to facilitate processing. The wing531extends outward relative to the inner frame103after release, and by adjusting the posture of the inner frame103, the wing531can enter into the valvular sinus204to pre-position the inner frame103in the circumferential direction, and then the inner frame103can be released and expanded by balloon. Because the guiding members530are aligned with the area where the valve leaflets200are located, the junction of adjacent valve leaflets200avoids the coronary artery orifice and prevents the blood flow from being obstructed. In addition, the wings531abut against the sinus floors of the valvular sinuses204, which positions the inner frame103in the axial direction to avoid slipping to the left ventricle side under the action of the reverse flow of blood.

Referring toFIGS.33a-33cand39a-39d, based on the circumferential positional relationship between the guiding members530and the region where the leaflets200are located, it can be considered that an embodiment of the present application provides a prosthetic heart valve device having opposite inflow and outflow ends. The prosthetic heart valve device includes an inner frame103and leaflets200, wherein the inner frame and the leaflets can use conventional techniques or embodiments described herein. The prosthetic heart valve device further includes a positioning mechanism. The positioning mechanism includes a root connected to the inner frame and a wing extending from the root towards the inflow end. The wing is extendable in the peripheral region of the inner frame, with a receiving space defined between the wing and the outer wall of the inner frame for allowing the entry of the native leaflet. The positioning mechanism is used to be placed at the corresponding valvular sinus in the human body to perform positioning. In other embodiment, various guiding members can be employed, without strictly limiting the various configurations and the transformations.

In this embodiment, the focus is that the positioning mechanism is arranged along the circumferential direction of the inner frame, and connected with the inner frame at a plurality of connections, each of which is located between two adjacent commissure regions in the circumferential direction of the inner frame. For example, in the case where the positioning mechanism includes a plurality of guiding members, the guiding member includes a root connected to the inner frame and a wing extending from the root towards the inflow end, and the root of each guiding member is located between two adjacent commissure regions in the circumferential direction of the inner frame.

In order to position the inner frame103in space correctly and reduce the displacement after the inner frame103is positioned in place, the guiding member530needs to have a suitable circumferential span (referring to the description ofFIG.47herein).

As one of the functions of the positioning mechanism is to clip the native leaflet, the position of the root affects the clipping strength to a certain extent. In this embodiment, the root is located between two adjacent commissure regions in the circumferential direction of the inner frame, and generally corresponding to the middle of the sinus or native leaflet. Compared to the embodiments with clipping arms extending from the commissure regions and provided with the same clipping force, the present embodiment has a low structural strength requirement.

Further, the guiding member can extend from the root to the free end over the shortest path to reduce the overall extension length, which is beneficial to control the radial dimension after compression to ensure the necessary compliance during intervention.

Referring toFIG.34, in order to construct the blood flow passage and better fit with the surrounding tissue, the prosthetic aortic valve device1000further includes a covering film220, which can include one or both of an inner covering film221and an outer covering film223. The inner covering film221is fixed to the inner wall of the inner frame103and connected with the edge of the leaflets200at the inflow end101, and the outer covering film223is fixed to the outer wall of the inner frame103. Furthermore, the covering film220avoids the projection areas129of the leaflets200on the side wall of the inner frame.

FIGS.29to35cshow the postures of the guiding members530in different configurations in the radial direction of the inner frame103. In the loaded configuration, the guiding member530has the same diameter in the axial direction from the root532to the wing531. In the transition configuration, the radial position of the root532of the guiding member530is unchanged, while the wing531is turned radially outward. In the released configuration, the guiding member530extends outwardly from the root532as the inner frame103expands, wherein the guiding member530extends radially outwardly and then is bent inwardly.

The guiding members530are made of a memory alloy, such as a pre-heat-set nickel-titanium alloy the shape of which corresponds to the released. The guiding member530, at room or in-vivo temperature, has an internal stress in both the loaded configuration and the transition configuration relative to the released configuration. This internal stress urges the inner frame103and the guiding member530to switch to the final configuration in the body, and can be gradually eliminated as the inner frame103expands, so that the inner frame103and the guiding member530are better maintained in the final configuration. In the released configuration, the axial length of the guiding member530is 40% to 80%, for example, 50%, of the entire length of the inner frame103.

The frame110generally includes the inner frame103and the guiding members530. One end of the guiding member530away from the inner frame103is configured as the free end536, and the root532can be regarded as a fixed end opposite to the free end536.

In the loaded configuration, the wing531contacts the outer side of the inner frame103. In the transition configuration, an angle P1 is defined between the wing531(referring to the line connecting the two ends of the wing) and the axis of the inner frame.

In the released configuration, the free end of the wing is closer to the out wall of the inner frame, with an angle P2 defined between the wing531and the axis of the inner frame, where P1 is great than p2. For example, P1 satisfies 30 to 60 degrees, and P2 satisfies 5 to 30 degrees. The free end of the wing closer to the outer wall of the inner frame can be caused by the outflow end of the inner frame turning outward, and by the shaping of the guiding member itself, separately or in combination. That is, the second receiving space would become smaller relative to the first receiving space.

As shown inFIG.28aandFIG.28b, after the inner frame103is released, the inner frame103is still in a straight cylindrical shape, and an angle P3 is defined between the wing531and the axis of the inner frame, where P3<P1. The posture of the wing531shown in the figure is only for illustration, which does not strictly limit the angle.

As shown inFIGS.36ato36d, the inner frame103is formed by cutting a pipe material, and the material (for example, stainless steel) is suitable for balloon expansion release. The inner frame103has a straight cylindrical shape in the loaded configuration.

As shown inFIGS.38ato38d, in another embodiment, the outflow end102of the inner frame103is flared outward with respect to the axis, wherein the turning angle is P4 as shown inFIG.38b, and P4 satisfies 0 degree<P4<45 degrees, such as 5 to 25 degrees.

The outflow end102slightly turning outward causes the free ends of the wings531to be closer to the inner frame103to clip the native leaflets and thus improve the positioning. The outflow end102can be flared by the balloon. For example, when the balloon extends beyond the outflow end of the inner frame103, the balloon is released and thus tends to expand outward, thereby driving the outflow end102to turn outward. In the case where the axial length or the turning angle for the turning portion is further increased, the frame110can be shaped to turn outward directly using the expanded end portion of the balloon.

In order to fix the guiding member530, as shown inFIG.39a, two adjacent leaflets200are connected on the inner frame103at the commissure region127of the inner frame103, and the root532of the guiding member530is located between two adjacent commissure regions127, but is not limited to being strictly centered therebetween.

The guiding member530is generally configured as a bar. Each guiding member530is formed in one piece and switches the configurations thereof based on its own elastic deformation. Compared with a hinge structure, the internal stress of the guiding member of the present application can be used as the driving force for deformation. Referring toFIGS.39band39c, after release of the guiding members530, there may be deviations in the circumferential positions of the guiding members530from the positions of the valvular sinuses204. For example, the areas represented by the three radially extending solid lines can be regarded as the approximate distribution regions of the three guiding members, while the areas represented by the three radially extending dotted lines can be regarded as the approximate distribution regions of the three valvular sinuses, which are not aligned with each other as shown inFIG.39b, in which case, the inner frame103can be rotated in the direction of the solid arrow shown in the figure to drive the guiding members530until the three radially extending solid lines coincide with the dashed lines, so as to achieve circumferential alignment as shown inFIG.39c.

After circumferential alignment, the inner frame103is moved towards the inflow end until the guiding members530abut against the sinus floors of the valvular sinuses204or the native leaflets have filled the receiving space between the inner frame103and the guiding members530to achieve positioning.FIG.39dshow the axial position, andFIGS.40ato40cshow the radial position, wherein the native leaflet201is located between the guiding member530and the inner frame103. The inner frame103can be then released and expanded by balloon, thereby avoiding the coronary artery.

Referring toFIG.40b, when the balloon630is expanded, the ends of the inner frame103first tend to turn over, during which process, the free ends of the guiding members530will tend to move inward and begin to clip the native leaflets201. The inner frame103is completely released radially at the later stage of the balloon expansion. As shown inFIG.40c, since the root of the guiding member530deforms circumferentially with the deformation of the inner frame, the free end of the guiding member530is further moved towards the inner frame103to clip the native leaflet. The mechanism of deformation of the guiding member530is further described below.

Referring toFIGS.41a-44, the wing531is a branched structure535adjacent to the root532, the end of the wing531away from the root532is configured as a free end536, and the slot5353of the branched structure535is towards the outflow end102. The wing531further extends from the convergence point of the branched structure535towards the free end536.

As shown inFIGS.41a-42c, the two opposite parts of the branched structure535are constrained by the root532to move towards each other in the loaded configuration and in the transition configuration. As shown inFIGS.43-44, the two opposite parts of the branched structure535move away from each other with the deformation of the root532and the inner frame103in the released configuration. For example, in the loaded, transition, and released configurations, the circumferential spans of the two opposite parts of the branched structure535are G1, G2, and G3, respectively, satisfying G1=G2<G3.

The root532and the branched structure535enclose a triangle, a trapezoid, or a rectangle, or the like. The two opposite parts of the branched structure535converge and extend towards the free end536, and then split circumferentially adjacent the free end536.

With regard to the shape of the wing531, an embodiment of the present application further provides a prosthetic heart valve device having an inflow end and an outflow end opposite to each other, including an inner frame103, leaflets200and positioning mechanism. The inner frame103and the leaflets200can refer to the other embodiments. The difference between the present embodiment and the other embodiments is that the present embodiment does not strictly limit the transition configuration of the positioning mechanism. For example and specifically, the prosthetic heart valve device includes:the inner frame103, which has a radially deformable meshed cylindrical structure and has relative compressed and expanded configurations, and the interior of the inner frame103is configured as a blood flow passage axially passing therethrough;leaflets200, connected to the inner frame103, wherein the leaflets200cooperate with each other to control opening and closing of the blood flow passage; anda positioning mechanism arranged in the circumferential direction of the inner frame, the positioning mechanism including a root532connected to the inner frame103and a wing531extending from the root532towards the inflow end; the wing is extendable in the peripheral region of the inner frame, with a receiving space defined between the wing and the outer wall of the inner frame for allowing the entry of the native leaflet; the inner frame103has commissure regions each of which corresponds to the coaptation portion of adjacent leaflets, and the root532is located between two adjacent commissure regions in the circumferential direction; the end of the wing531away from the root is a free end, and the portions of the wings531adjacent to the free ends extend along the circumferential direction of the inner frame in a radiation pattern. Of course, the positioning mechanism of the prosthetic heart valve device of the present embodiment can also have the guiding members with various configurations as described above.

The radiation distribution can reduce the safety risk and also ensure the positioning effect. The wing531is divided into at least two parts at the portion adjacent to the free end536, i.e., the seventh bar5361and the eighth bar5362, respectively, and the angle M between the connecting lines of the respective ends of the two bars is about 45 degrees or more, for example, 45 to 120 degrees as shown inFIG.45. In the axial direction of the inner frame103, the free end536is located adjacent to the inflow end101of the inner frame103, and the root532is located adjacent to the outflow end102of the inner frame103, so that the wing531has a sufficient extension to ensure positioning. In order to improve safety, the free end536has a rounded structure. For example, the seventh bar5361and the eighth bar5362can have rounded structure at the ends thereof. The free end536can be further surrounded with a protective layer. Alternatively, the free end536can be ring-shaped, and can be further covered with protective layer or can be suffered from a surface smoothness treatment.

As shown inFIG.46, the wing531has opposite length and width directions, and the width of the ring-shaped free end is larger than the width of the wing bar. The width DH2 of the ring-shaped free end is 2 to 6 times the width D1 of the wing bar.

As shown inFIG.47, in order to better position the inner frame103and reduce the offset after positioning, the guiding members530need to have a sufficient circumferential span. The circumferential span of the single guiding member530has a center angle Σ of 30 to 60 degrees, and the circumferential span β of the root532of the single guiding member with respect to the inner frame103is 15 to 45 degrees.

The wing531expands radially outward and then bends inward during the extension to the inflow end, providing greater clipping force and allowing greater radial deformation.

The root532is fixed to the radially inner, or outer side of the inner frame103or radially aligned with the inner frame103by means of welding, riveting or binding, so that the root532is always attached to the inner frame103in any configuration, and deforms in the circumferential direction as the inner frame103deforms in the circumferential direction in the transition configuration and the released configuration, wherein the deformation amount of the root532is the same as the corresponding portion of the inner frame.

The root532can be secured to the outside of the inner frame103by binding to facilitate assembly and allow the bars of the root532to twist about its own longitudinal axis. The root532includes a first bar5321and a second bar5322connected to the wing531(i.e., a branched structure). The root532further extends towards the outflow end102relative to inner frame103to provide sufficient space to allow the inner frame103to be lowered further in position, ensuring that the free end of the wing extends into the sinus floor of the valvular sinus. As shown inFIGS.48to50, the ends of the first bar5321and the second bar5322away from the wing531are connected with, parallel to or away from each other.

For example, the ends of the first bar5321and the second bar5322away from the wing531are connected with each other, and are fixed to the inner frame103through a binding line (not shown) passing through the first binding eyelet5323. Similarly, the corresponding portion of the inner frame can also be provided with a similar eyelet as required.

The other ends of the first bar5321and the second bar5322are spaced apart from each other and are connected to the wing531(i.e., the branched structure) to form a closed quadrangle. In order to facilitate the positioning and threading, one end of the first and second bars connecting with the wing531is respectively provided with a second binding eyelet5354. Similarly, the corresponding portion of the inner frame can also be provided with a similar eyelet as required.

In some embodiment, the inner frame103has a connecting post104extending axially and outwardly towards the outflow end102. The connecting post104can use the same shape as the root532and radially overlap on the inner frame. The same shape means that the connecting post104also includes fifth bar1041and sixth bar1042similar to the first bar5321and the second bar5322(in combination withFIG.37a). The fifth and sixth bars1041,1042conform to the shape of the root532, for example, the ends thereof adjacent the outflow end102meet each other such that the tip of the connecting post104is V-shaped towards the outflow end102, or parallel, or are parallel to or away from each other. The first bar5321and the fifth bar1041can be overlap with each other, and the second bar5322and the sixth bar1042can be overlap with each other.

The inner frame11has a plurality of diamond shaped cells116distributed in the axial direction, the root532of the single guiding member530corresponds to one or more, for example, two or more cells with respect to the circumferential span of the inner frame103. As shown inFIG.37a, the fifth bar1041and the sixth bar1042extend from the end nodes of the inner frame103. The cells of the inner frame at the outflow end102are cut in half and thus opened, and the ends of the fifth bar1041and the sixth bar1042are connected with two adjacent cells116.

The wing531includes a third bar5351and a fourth bar5352adjacent the root and thus forms a branched structure, wherein one end of the third bar5351is connected with the first bar5321, one end of the fourth bar5352is connected with the second bar5322, and the other ends of the third bar5351and the fourth bar5352extend towards the inflow end101and intersects with the third bar5351.

The first bar5321, the second bar5322, the third bar5351, and the fourth bar5352form a closed region, and the radially projected shape of which is quadrangular. For example, the four bars form a parallelogram.

In the case where the ends of the first bar5321and the second bar5322away from the wing531are parallel to or away from each other, the first bar5321and the second bar5322as well as the wing form a semi-closed area opened towards the outflow end102.

The above bars are not strictly limited to be straight bars, but can be slightly curved or bent. The fourth bar5352and the third bar5351can be directly connected with each other or indirectly connected by other bar(s). As shown in the figure, the fourth bar5352and the third bar5351are directly connected with each other. After the bars are connected with each other, the bar can extend a certain distance and then be branched to the free ends, or be directly branched to the free ends, or can be branched and then meet again to form a ring structure, which can reduce the interference on the coronary orifice and the risk of puncturing the tissue.

The junction between two adjacent bars, for example, between the fourth bar5352and the second bar5322, does not need a sharp turning, but can be shaped smoothly. For example, the third bar5351and the fourth bar5352can be formed in one piece having an arc structure, wherein the third bar5351and the fourth bar5352represent different portions of the arc structure. Therefore, it can be conceived that the first to fourth bars above can not only form as a parallelogram, but also can be an enclosed circle, ellipse, or even hexagon or the like.

At least the third bar5351is not collinear with the first bar5321, and the fourth bar5352is not collinear with the second bar5322, otherwise, the expected deformation of the guiding member would be affected or weakened.

In the following, the deformation of the guiding member when it is switched between the transition configuration and the released configuration will be explained, wherein the first bar5321and the second bar5322define a first portion538, and the third bar5351and the fourth bar5352define a second portion539.

The third bar5351and the first bar5321meet at a first connection point5324; the fourth bar5352and the second bar5322meet at a second connection point5325; the first bar5321and the second bar5322meet at a third connection point5326; and the third bar5351and the fourth bar5352meet at a fourth connection point5355, wherein the first connection point5324, the second connection point5325, and the third connection point5326form a first plane5327in which the first portion is located, and the first connection point5324, the second connection point5325and the fourth connection point5355form a second plane5356in which the second portion is located. It should be noted that the first plan and the second plane are for illustration, and they may be slighted curved or approximate planes.

The structure enclosed by the first to fourth bars above does not need to correspond to the cell of the inner frame. For example, the first connection point5324and the second connection point5325can be respectively aligned with the nodes of the inner frame, or can be offset from the nodes of the inner frame to reduce the interference with the inner frame during deformation.

InFIG.51a, when the bars are fully extended, they lie in the same plane (Q=180 degrees), and the distance between the first connection point5324and the second connection point5325is at the largest.

InFIG.51b, in the transition configuration, the inner frame103is in the compressed configuration, so that the first connection point5324and the second connection point5325are close to each other, the wing531is warped with respect to the root532, and the first plane5327and the second plane5356form an angle Q1 therebetween. It should be noted that, when the first connection point5324and the second connection point5325moves towards each other, each bar may twist about its own axis in order to adapt the warpage of the wing531, otherwise, the deformation only occurs in a plane, i.e., only the length of the guiding member is stretched, which is in cooperation with the binding of the root to the inner frame103. It can be seen from the figures that, in different configurations, the first to fourth bars have already twisted, and the first connection point5324and the second connection point5325are no longer coplanar with the third connection point5326and the fourth connection point5355.

InFIG.51c, when transforming from the transition configuration to the released configuration, the first connection point5324and the second connection point5325move away from each other, and the warpage degree of the wing531is reduced, in which case, the angle between the first portion538and the second portion539is Q2, and Q1 is less than Q2, which means that the free end of the wing is closer to the inner frame, facilitating clipping the native leaflets.

It can be seen from the figures that the angle M1 between the axis of the third bar5351and the axis of the first bar5321and the angle M2 between the second bar5322and the fourth bar5352are substantially unchanged when switching between the transition configuration and the released configuration. For example, M1=M2=120 degrees. In other words, the guiding member is not deformed in a plane, but in three dimensions.

As described above, it can be seen that the root532and the portion of the wing531connected with the root532constitute a frame structure, for example, including the first to fourth bars. Two ends of the frame structure in the circumferential direction, for example, the first connection point5324and the second connection point5325, are relatively turned over as the inner frame is compressed and expanded, thereby driving the two ends of the frame structure in the axial direction of the inner frame, such as the third connection point5326and the fourth connection point5355, to be relatively turned over.

In the frame structure, when the two ends in the axial direction of the inner frame are turned over relative to each other, one end such as the third connection point5326is fixed relative to the inner frame, and the other end such as the fourth connection point5355is turned over relative to the outer wall of the inner frame.

During the compression of the inner frame, within the frame structure, two end in the circumferential direction of the inner frame, for example, the first connection point5324and the second connection point5325, have relative movement, and the first connection point5324and the second connection point5325are close to each other when the inner frame is radially contracted, while the first connection point5324and the second connection point5325are away from each other when the inner frame is radially expanded.

The first connection point5324and the second connection point5325are also turned over with respect to the outer peripheral wall of the inner frame when moving away from or close to each other, where the turning directions are opposite to each other with respect to the axis of the inner frame.

In order to facilitate the deformation, during processing the guiding member, the wing531can be slightly warped with respect to the root532in the shaping configuration after the heat treatment.

The guiding member530has restricting structures537opened at the first connection point5324and the second connection point5325, and the first connection point5324and the second connection point5325are bound to the inner frame103through the restricting structures537. The restricting structure537can be configured as an eyelet (i.e., the second binding eyelet5354) or other protrusions extending circumferentially outwardly with an eyelet. The restricting structure537, as a force point, rotates relative to the axis of the bar, thereby driving the portions of the bars adjacent to the restricting structure to twist.

In order to reduce the restraint on the twist of the bars and obtain a larger turning angle of the wing, when binding, only one side with the eyelet in the axial direction of the inner frame is bound, as the bars may be restrained to twist if two sides in the axial direction of the inner frame are bound.

In cooperation with an imaging equipment, the prosthetic aortic valve device1000can be provide with a radiopaque marker550, which can be embedded or include a precious metal that can be displayed differentiating from other portions under X-ray or other means of detection.

The radiopaque marker550can be in the form of a dot or a strip or a ring (closed or non-closed, but at least in half ring), and the radiopaque marker550can be disposed on at least one of the inner frame103and the guiding members530. Accordingly, the inner frame103or the guiding members530are provided with eyelets for receiving the radiopaque marker550.

Optionally, each of the above binding eyelets can be provided with a radiopaque marker, or the radiopaque marker can be provided at the middle portion or the free end of the wing.

For example, as shown inFIG.52, the free end536carries radiopaque markers550. The free end536has eyelets551at which the radiopaque markers are located. As another example, the wing531is provided with an eyelet551at a position before being branched and can be provided with a radiopaque marker at the eyelet551.

Referring toFIGS.53and54, in one embodiment, a delivery system for a prosthetic aortic valve device1000is provided that can be used to load and deliver the prosthetic aortic valve devices1000of the above embodiments. The delivery system has opposite distal and proximal ends, the delivery system including:a balloon device600switchable between an inflated configuration and a deflated state under the action of a fluid;an outer sheath405which is slidably fitted on the outer periphery of the balloon device600, and a radial gap between the outer sheath405and the balloon device600is a loading zone406for placing the prosthetic aortic valve device1000; anda control handle407, wherein both the proximal ends of the balloon device600and the outer sheath405extend to the control handle407with the outer sheath405slidably fit with the control handle407.

The outer sheath405can be moved to cover or expose the prosthetic aortic valve device1000to effect switching between the loading and delivery configuration and release configuration. In the delivery system, the outer sheath405and the balloon device600are rotatably fitted with each, that is, the circumferential position of the prosthetic aortic valve device1000can be adjusted by rotating the balloon device600so that the valve leaflets200can be aligned with the valvular sinues. In addition, the prosthetic aortic valve device1000of the present embodiment is provide with guiding members530, a radiopaque marker(s)550is provided on one of the inner frame103and the guiding members530, so that the prosthetic aortic valve device1000can be monitored in real time by mean of an imaging equipment when the position thereof is adjusted, so as to guide the surgery. In this embodiment, the arrangement of the guiding member530and the radiopaque marker550in cooperation with the rotation of the outer sheath405and the balloon device600ensures accurate positioning of the prosthetic aortic valve device1000.

In some case, for example, where the balloon device600cannot be rotated relative to the outer sheath405, although the balloon device600and the outer sheath405can be rotated together for circumferential alignment, the outer sheath405will twist itself due to a relatively long intervention length, and it is difficult for the outer sheath405to recover to its untwist configuration around its own axis, so that a large force would inevitably occur between the outer sheath405and the surrounding tissues. However, in this embodiment, the outer sheath405is used for provide a stable passage, the rotatable balloon device600(the tube inside the outer sheath405) can be twisted around its own axis in the passage so as to reduce the risk to the maximum extent.

When the balloon device600is rotated, the outer sheath405can be kept at least from being excessively twisted in the circumferential direction, and can be reinforced as needed, for example, by means of an inner rib, a reinforcing mesh, a hypotube, or the like.

The prosthetic aortic valve device1000as a whole is radially compressed and placed in the loading zone406and surrounded within the distal section of the outer sheath405. In the release process, the guiding members530are progressively exposed by sliding the outer sheath405proximally. At this time, although the inner frame103is exposed, the inner frame103cannot automatically transform into the expanded configuration due to its material thereof, and the circumferential position of the inner frame103can be aligned by rotating the balloon device600. After alignment, the inner frame103is driven to expand using the balloon device600. During the alignment, the outer sheath405can be kept relatively stationary, reducing safety hazards and improving the alignment.

Referring toFIG.53andFIGS.54to57, the balloon device600includes:a tube610having at least a guidewire channel and an injection channel provided therein, the proximal end of the tube610being rotatably mounted to the control handle407;a guiding head620which is fixed to the distal end of the tube610, the distal end of the guidewire channel is opened into the guiding head620, and wherein during the delivery of the delivery system in vivo, the guide wire can be first intervened into the human body, and then the entire delivery system can be surrounded around the guide wire through the guidewire channel and is advanced along the guide wire; anda balloon630fixed to the tube610at the proximal side of the guiding head620, the interior of the balloon630communicating with the injection channel.

The guidewire channel and the injection channel can be provided with additional tubes, or by a multi-lumen tube, and the guidewire channel and the injection channel can be respectively provided with a tube connector (for example, a three-way structure on the right side shown inFIG.53, such as a luer connector or the like) at the proximal ends thereof. In practice, the injection channel can be used to deliver fluid to inflate the balloon630.

In order to allow rotation of that balloon device600, the tube610should be capable of ensuring circumferential torque transmission and minimizing angular deviation between the distal and proximal end. For example, the tube610can include a multi-layer structure from the inside to the outside, and at least one layer in the middle is provided with embedded ribs, reinforcing mesh, hypotubes, steel cables and the like to ensure the synchronization of the proximal and distal ends. Of course, when there is a deviation, correction and real-time adjustment can be further carried out by means of the radiopaque marker.

For example, as shown inFIG.55, in one embodiment, the tube610has a three-layer structure, the middle layer6102is a hypotube and is between the outermost layer6101and the innermost layer6103, and the outermost layer6101and the innermost layer6103can be made of conventional materials such as Pebax and TUP, which are respectively fixed to the hypotube by means of thermal fusion or the like. The cutting method of the hypotube is not strictly limited, for example, alternate slits at different circumferential positions can be provided to provide the compliance for passing through a curved intervention path.

For example, as shown inFIG.56, in another embodiment, the middle layer6102is made of two layers of steel cable tubes coiled in opposite directions, which have compliance and can ensure the transmission of torque in the circumferential direction.

The control handle407includes:a support410;a movable base420movably mounted on the support410, to which the proximal end of the outer sheath405is fixed;a driving sleeve430rotatably mounted on the outer periphery of the support410and engaged with the movable base420to drive the outer sheath405to slide relative to the balloon device600; anda rotatable seat440rotatably mounted on the outer periphery of the support410and engaged with the tube610of the balloon device600to drive the balloon device600to rotate relative to the outer sheath405.

The driving sleeve430and the movable base420are threadably engaged with each other. The rotation of the driving sleeve430can drive the movable base420to slide. In order to prevent free rotation of the movable base420, the support410is provided with a guiding structure, such as a sliding groove411or a guiding rod, for restricting the movement of the movable420. The outer periphery of the support410can be fixedly covered with a shell, so as to play a protective and aesthetic role.

The rotatable seat440can be directly fixed to the tube610of the balloon device600as shown inFIG.53. In operation, the rotatable seat440is directly operated, and a marker can be arranged on the rotatable seat440and the support410to show the direction and magnitude of rotation of the rotatable seat440.

The rotatable seat440and the balloon device600can be indirectly connected by a transmission mechanism. A speed reduction mechanism can be used to improve the accuracy of adjustment and improve the feel.

Referring toFIG.57, this embodiment employs a planetary reduction mechanism, specifically including a planetary carrier441, planetary gears442, a ring gear443, a planetary input shaft444, and a planetary output shaft445. The planetary input shaft444has external teeth and is fixed to the rotatable seat440and configured to be driven by the rotatable seat440. The planetary input shaft444and the rotatable seat440can be formed in one or separate pieces.

The ring gear443has internal teeth and is fixed to the support410. The ring gear443and the support410can be formed in one or separate pieces. The planetary gears442generally include three planetary gears442, meshing between the planetary input shaft444and the ring gear443and configured for driving the planetary carrier441. The planetary carrier441is fixed to the planetary output shaft445. When the planetary gears442revolve, the planetary carrier441rotates, and then the planetary output shaft445drives the fixed tube610to rotate, thereby driving the balloon device600to rotate the inner frame.

Referring toFIG.58, in another embodiment, the rotatable seat440and the tube610are driven by a worm wheel451and a worm452engaging with each other. The rotatable seat440is configured as a wheel and rotatably mounted on the support410, and the rotating axis of the rotatable seat440is perpendicular to the longitudinal direction of the support410(i.e., the extension direction of the tube610). The rotatable seat440is coaxially fixed to the worm452, and the worm wheel451is fixed to the tube610and engaged with the worm452. A transmission sleeve453for reinforcing the tube610can be fixed to the outside of the tube610, which is rotatably engaged with a support base454fixed on the support410. The transmission sleeve453and the worm wheel451can be formed in one or separate pieces for transmission. When the rotatable seat440rotates, the torque is transmitted to the tube610through the worm gear mechanism for rotation.

Referring toFIG.59, in another embodiment, the rotatable seat440and the tube610can be driven through a gear set. The gear set includes a first gear461and a second gear462that mesh with each other. For example, the rotatable seat440can be a wheel rotatably mounted on the support410, and the rotating axis of the rotatable seat440is parallel to the extension direction of the tube610. The rotatable seat440is coaxially fixed with the first gear461for transmission, and a transmission sleeve463is fixed to the outside of the tube610to reinforce its structure, and the transmission sleeve463is rotatably engaged with the support base464fixed on the support410. The transmission sleeve463is coaxially fixed with the second gear462for transmission.

In the above embodiments that the tube610is driven by the rotatable base440, a locking mechanism for limit the rotation of the rotatable seat440can be provided as required, for example, a pin slidably mounted on the support410. The rotatable seat440is provided with an engagement slot or an insertion hole engaged with the pin to realize the position locking of the rotatable seat440. In addition, a scale mark indicating a rotation angle can be provided on the rotatable base440to adjust the rotation angle of the tube610.

For alignment with the valvular sinuses in vivo and circumferential adjustment of the interventional device, an embodiment of the present application further provides an interventional system including a prosthetic heart valve device and a delivery system. For example, the prosthetic heart valve device can be the prosthetic aortic valve device1000, and specifically includes an inner frame and a positioning mechanism and leaflets respectively connected to the inner frame.

The delivery system includes a balloon device, an outer sheath slidably fitted around the periphery of the balloon device, a control handle connected to the balloon device and the outer sheath. The prosthetic heart valve can be loaded in the radial gap between the balloon device and the outer sheath. The control handle is provided with a rotatable seat for controlling the rotation of the balloon device such that the positioning mechanism is aligned with the valvular sinuses.

Both the prosthetic heart valve and the delivery system can employ the above embodiments, wherein the prosthetic aortic valve device1000is disposed within the loading zone406of the delivery system.

Referring toFIGS.60a-62, an embodiment of the present application provides a method for using the above interventional system, which is also a method for securing the prosthetic heart valve device at an aortic annulus including a plurality of native valve leaflets, which can be implemented using the interventional system described above.

The delivery system enters the human body via the femoral artery. The balloon device600and outer sheath405should be configured with sufficient length, for example, at least 80 or more, to adapt to the long interventional path. The prosthetic aortic valve device1000is typically positioned against the blood flow after passing through the aortic arch, so that the inflow end for the inner frame is the opposite distal end (away from the operator along the interventional path), and the outflow end is the opposite proximal end. According to the normal release method over the path, the inflow end of the inner frame is the end to be released first, and the outflow end is the end to be released later.

The method includes the following steps.

In step S10, as shown inFIG.60a, the prosthetic aortic valve device1000is delivered to a predetermined site, wherein the inner frame103is in a compressed configuration, the guiding members530are in a loaded configuration, and the balloon device600is in a deflated configuration. In the delivery process, an imaging equipment can be used to detect and display the radiopaque markers, and the spatial position of the prosthetic aortic valve device1000relative to the aortic valve can be determined by means of the contrast medium.

In step S20, as shown inFIG.60b, after the prosthetic aortic valve device1000enters the native annulus (aortic annulus), the outer sheath405is retracted proximally to expose the wings531of the guiding members530, which is also related to the manner in which the delivery system of this embodiment enters the human body via the femoral artery, so that the guiding members530made of the memory material tends to the preset configuration in the in vivo environment, with the wings expanding outward into the transition configuration, while the inner frame made of non-memory material is still in the compressed configuration, so that the roots of the guiding members do not obviously extend outward.

In step S30, the positions of the guiding members530in vivo, especially relative to the native annulus and valvular sinuses204can be obtained by using the imaging equipment in combination with the radiopaque marker. Now, whether the circumferential positions of the guiding members530are aligned with the respective valvular sinuses can be initially determined. In some cases, for example, if the guiding members530are exactly aligned with the respective valvular sinuses, the prosthetic aortic valve device1000can be pushed further distally so that the free ends of the wings of the guiding members530generally abut the sinus floors of the valvular sinuses. If misaligned, the balloon device is rotated and the inner frame103is moved synchronously so that the wings531of the guiding members530are approximately aligned in the circumferential direction and then enter the valvular sinuses204, and then the prosthetic aortic valve device1000is pushed distally, so that the free ends of the wings of the guiding members530further abut against the sinus floors of the valvular sinuses.

Since the guiding members are in the transition configuration, the wings thereof extend outward relative to the inner frame, so that at least one native valve leaflet enters the radial gap between the inner frame and the guiding member. At this time, it can be considered that the axial position of the prosthetic aortic valve device is desired. Preferably, all three native leaflets enter the respective radial gaps.

Otherwise, the whole device needs to be withdrawn proximally to readjust the position for ensuring clipping the native valve leaflets and the stability of the axial position after release.

In step S40, as shown inFIG.61a, the balloon device600is driven to the inflated configuration by injecting fluid, that is, the inner frame103and the roots532of the guiding members530are released, so that the inner frame103transforms into the expanded configuration, and the guiding members530transform into the released configuration. Now, the prosthetic aortic valve device1000is released into position.

In the process of inflation and deformation of the balloon device, the two ends of the balloon in the axial direction suffer from relatively small radial restraint force, and thus will be first deformed, especially at the outflow end of the inner frame, which can drive the end of the inner frame together with the roots to move outwardly, so that the free ends of the wings tend to move closer to the inner frame to clip the native leaflets.

After the inner frame103transforms into the expanded configuration, the outflow section of the inner frame103can be substantially in a straight cylindrical configuration or flared, depending on the pressure of the balloon or the shape of the balloon, and the roots radially move away from each other. Referring to the above deformation mechanism of the guiding members530, the roots and the junctions with the wings deform so that the free ends of the wings of the guiding member530will further move closer to the outer wall of the inner frame103relative to the transition configuration to clip the native leaflets to ensure the positioning effect.

In step S50, as shown inFIG.61b, after release, the balloon device600is switched to the deflated configuration, and the entire delivery system is retracted, while the prosthetic heart valve device is positioned and remained at the aortic annulus to replace the diseased native tissue.

In the present application, the prosthetic aortic valve device1000is improved in structure to facilitate circumferential position adjustment, aligning the valve leaflets200with the coronary orifice to reduce blood flow interference, and further avoiding positional deviation during long-term use.

Another embodiment of a prosthetic heart valve device according to the present application has opposite inflow and outflow ends, including an inner frame103, leaflets200and a positioning mechanism, wherein the inner frame103and leaflets200can refer to the other embodiments. The difference between this embodiment and the other embodiments is that the present embodiment does not strictly limit the transition configuration of the positioning mechanism. For example, the prosthetic heart valve device specifically includes:the inner frame103, which has a radially deformable meshed cylindrical structure and has relative compressed and expanded configurations, and the interior of the inner frame103is configured as a blood flow passage axially passing therethrough;leaflets200, connected to the inner frame103, wherein the leaflets200cooperate with each other to control opening and closing of the blood flow passage; anda positioning mechanism arranged in the circumferential direction of the inner frame, the positioning mechanism including a root532connected to the inner frame103and a wing531extending from the root532towards the inflow end; the wing531is extendable in the peripheral region of the inner frame, with a receiving space defined between the wing and the outer wall of the inner frame for allowing the entry of the native leaflet; and the positioning mechanism corresponding to the same leaflet in the circumferential direction of the inner frame is formed by separate positioning members.

The positioning mechanism formed by separate positioning members can refer toFIG.1c. That is, the positioning mechanism corresponding to the same leaflet in the circumferential direction of the inner frame are two clipping arms, and one end of each clipping arm connected to the inner frame is a fixed end, the other end is the opposite free end, and the free ends of the two clipping arms are spaced apart from each other and tend to close to each other.

The positioning mechanism formed by separate positioning members can also refer toFIGS.63to65. That is, the positioning mechanism corresponding to the same leaflet in the circumferential direction of the inner frame includes guiding members, and the guiding member has two wings. The wing has a free end away from the root, and the free ends of the two wings of the guiding member are spaced apart from each other. Of course, the positioning mechanism, that is, the guiding members in this embodiment can further have:

In the loaded configuration, the guiding members530(shown in dashed lines) are radially pressed against the inner frame103in the compressed configuration, so that the inner frame103and the guiding members can be easily surrounded by the sheath and delivered in vivo.

In the transition configuration, the roots532of the guiding members530remain gathered to adapt the compressed configuration of the inner frame103. The wings531are self-deformed and thus extend outside of the inner frame103, with a receiving space formed between the outer wall of the inner frame103and the wings531for receiving the native leaflets201. In order to circumferentially position the inner frame103, the extended wings531can be adjusted in position to enter the corresponding valvular sinuses, with the inner frame103inside the native leaflets and the wings531outside the native leaflets.

In the released configuration, the roots532of the guiding members530move away to adapt the expanded configuration of the inner frame103, at which time both the inner frame103and the guiding members530are fully released from the delivery system into the work state.

FIGS.63-65are only for illustration of the spatial posture and relative relationship or characteristics in different configurations. Unless otherwise specified, the shape and position of the guiding member530are described referring to the released configuration, and the shape and position of the inner frame103are described referring to its expanded configuration.

The meshed cylindrical structure can be radially deformed to facilitate the intervention after compression and the subsequent expansion and release. The axial length of the meshed cylindrical structure may change when the meshed cylindrical structure is radially deformed. The meshed cylindrical structure is configured to be expanded by external force, i.e., the meshed cylindrical structure is not made of self-expandable material. In general, the meshed cylindrical structure can be expanded by balloon. However, the guiding member530is made of a memory material (e.g., pre-heat-set nickel-titanium alloy), which can be released in the human body first, the root532of which can be considered as a portion where the guiding member530and the inner frame103are adjacent and connected to each other. The specific shape is not strictly limited. The root532and the wing531can be formed in one piece to facilitate processing. The wing531extends outward relative to the inner frame103after release, and by adjusting the posture of the inner frame103, the wing531can enter into the valvular sinus204to pre-position the inner frame103in the circumferential direction, and then the inner frame103can be released and expanded by balloon. Because the guiding members530are aligned with the valve leaflets200, the junction of adjacent valve leaflets200avoids the coronary artery orifice and prevents the blood flow from being obstructed. In addition, the wings531abut against the sinus floors of the valvular sinuses204, which positions the inner frame103in the axial direction to avoid slipping to the left ventricle side under the action of the reverse flow of blood.

In order to fix the guiding member530, as shown inFIGS.66aand66d, the junction of two adjacent leaflets200on the inner frame103is the commissure region of the inner frame103, and the root532of the guiding member530is fixed to a corresponding junction. Alternatively, the root532of the guiding member530can be located between two adjacent junctions in the circumferential direction of the inner frame103.

Referring toFIG.66d, in the released configuration, the free ends534of the two wings531of the individual guiding member530are spaced apart from each other, and the spacing region has a central angle β, in the circumferential direction of the inner frame103, greater than 30 degrees.

The commissure region can be a strip-shaped, i.e., commissure post132, and each commissure post132can be provided as follows.

The commissure post132can extend from the end node of the outflow end102of the inner frame103or be located within the inner frame103. The commissure post132extends along the axis of the inner frame103or is inclined radially inward. For example, the outflow end102of the inner frame103can have a structure with peaks and valleys, and the commissure region is located at the peak, that is, at the most-distal end of the outflow end of the inner frame103.

Referring toFIGS.66ato66d, the end of the commissure post132is provided with a first collar115, and the inner frame103is provided at the inflow end101with a second collar117in alignment with the first collar115. The first collar115and the second collar117can be used for providing radiopaque marker or can be used to connect with the delivery system as required.

Referring toFIG.67, each guiding member530can include two wings531aand531b, the ends of which facing away from the inner frame103are separate free ends534. In one guiding member, failure of one of the free ends534to enter the valvular sinus does not necessarily affect the other free end, thus avoiding to some extent the risk of failure of the guiding member as a whole.

In the axial direction of the inner frame103, the free end534is located adjacent to the inflow end101of the inner frame103, and the root532is located adjacent to the outflow end102of the inner frame103, so that the wing531has a sufficient extension to ensure positioning. In order to improve safety, the free end536has a rounded structure, and can be further covered with a protective layer.

TakingFIG.67as an example, in two adjacent guiding members, the wing531band the wing531c, which are close to each other, are formed in one piece by a common root532, and the common root532, the wing531band the wing531cform a branched structure, the opening of which faces towards the inflow end101. This branched structure facilitates crossing the junction of the two native leaflets by virtue of its opening such that the guiding members can be respectively positioned in the respective sinuses.

FIGS.68a-68cshow three alternative configurations of the guiding member530in the released configuration, including: a first example, in which the guiding member530extends outward from the root532in the radial direction of the inner frame103, and then is bent inward, as shown inFIG.72a; a second example, in which the guiding member530extends from the root532in the axial direction of the inner frame103towards the outflow end102and is bent towards the inflow end101, as shown inFIG.72b; and a third example incorporating the first and the second examples, as shown inFIG.72c.

Referring toFIGS.69aand69b, in order to exactly guide the inner frame103to position and reduce the offset once in place, the guiding member530needs to have a sufficient circumferential span, which can be a span of different portions, for example, a portion of the root532or the wing531, wherein the root532having the largest circumferential span is more advantageous for stabilizing the position of the inner frame103. For example, take the root532as an example: in the circumferential direction of the inner frame103, each guiding member530spans at least ⅙ circumference, i.e., the center angle α inFIG.73bis greater than or equal to 60 degrees. Further, for example, each guiding member530spans ⅓ circumference in the circumferential direction of the inner frame103, that is, the central angle α is equal to 120 degrees.

In order to facilitate smooth entry of the guiding member into the valvular sinus in the case where the root532has a large span, the guiding member has opposite outer and inner sides in the circumferential direction of the inner frame, and the edge of the wing on the outer side of the guiding member has a smooth contour. In addition, the curve of the contour extends from the root to the inflow end and is offset towards the inner side. The smooth contour and the extension of the curve facilitate the positioning of the guiding member itself in the valvular sinus, reducing the difficulty of adjusting and positioning the inner frame, and additionally reducing the potential safety hazard and avoiding puncturing the surrounding tissue.

After release of the guiding members530, there may be deviations in the circumferential positions of the guiding members530from the positions of the valvular sinuses204. For example, the areas represented by the three radially extending solid lines can be regarded as the approximate distribution regions of the three guiding members, while the areas represented by the three radially extending dotted lines can be regarded as the approximate distribution regions of the three valvular sinuses, which are not aligned with each other as shown in the figure, in which case, the inner frame103can be rotated in the direction of the solid arrow shown in the figure to drive the guiding members530until the three radially extending solid lines coincide with the dashed lines, so as to achieve circumferential alignment as shown inFIG.73b.

After circumferential alignment, the inner frame103is moved towards the inflow end until the guiding members530abut against the sinus floors of the valvular sinuses204to achieve positioning. In the radial position, the native leaflet201is located between the guiding member530and the inner frame103. The inner frame103can be then released and expanded by balloon, thereby avoiding the coronary artery.

In the released configuration, the ratio of the axial length of the guiding members530to the entire length of the inner frame103is 40% to 80%, for example, 50%.

Referring toFIGS.70aand70b, in one embodiment, the free end534of the guiding member is configured as a ring structure with a smoothed outer periphery, the wing531is generally strip-shaped and has opposite length and width directions, and the width of the ring structure is larger than that of the wing531. The width D2 of the ring structure is 2 to 6 times the width D1 of the wing531.

Referring toFIG.70c, the free end534has a planar structure without considering the thickness of the material thereof, i.e., defines a reference plane, and in the transition configuration, the free ends534of the two wings531of the individual guiding member define a first reference plane and a second reference plane, respectively, and the angle γ between the first reference plane and the second reference plane is less than or equal to 90 degrees, preferably less than 45 degrees, for example 45 degrees.

Referring toFIG.70d, each guiding member530includes two wings531. In two adjacent guiding members530, a first wing5311of one of the guiding members530and a second wing5312of the other guiding member530are adjacent to each other in the circumferential direction of the inner frame103. The outflow end102of the inner frame is provided with commissure posts132, and the roots of the first wing5311and the second wing5312are connected to each other to form one piece which is overlapped and fixed to the outer side of the respective commissure post132.

In connection with the above embodiments, the first wing5311and the second we5312are connected to a common root532, which three can be considered to constitute one group of clipping arms. The prosthetic aortic valve device as a whole has three groups of clipping arms, and each group of clipping arms is separately connected to the inner frame.

In the released configuration, the first wing5311and the second wing5312are almost coplanar.

The roots532corresponding to the two wings531of the individual guiding member530are formed in one or separate pieces. In the case where the free ends534are separate from each other, if one of the wings were worked out, it would not pull the other, and since the roots532are close to the inner frame103, the two wings531would not be pulled by each other. Taking the separate roots532as an example, the span of the guiding member530in the circumferential direction of the inner frame103can be understood as the central angle between the lines connecting the two roots532and the center of the inner frame103, i.e., the central angle α shown inFIG.73b.

Each wing531has a flat strip structure as a whole. The flat strip structure can be solid or totally hollowed out (leaving only the edge bars) or partially hollowed out (e.g. a meshed structure), for example by weaving or cutting. The flat strip structure can have a certain width, but does not necessarily extend with an equal width. The “flat” shape is more favorable for reducing the overall radial dimension during loading and ensuring compliance during intervention, while the “strip” shape is more favorable for space shaping.

Referring toFIG.71toFIG.72b, the two wings531extend towards the inflow end101respectively from two outer sides of the respective guiding member530, and approach each other.

The wing531generally has an arc configuration, and a wave structure5341can be provided adjacent to the free end534thereof, which can undulate in the radial and/or axial direction of the inner frame103, or extend in the circumferential direction of the inner frame103at a section adjacent the free end534. In the figure, the wave structure5341mainly undulates in the axial direction of the prosthetic aortic valve device. It will be conceived that the guiding member530can have undulations in multiple dimensions in three dimensions. Referring to the drawings, the guiding member530has a radially undulating structure in an axial view of the inner frame103. The undulations in multiple directions can be provided separately or overlapped with each other to form a complex three-dimensional configuration.

In the transition configuration, the two wings531of the individual guiding member530have expanded outward, but the roots532of the two wings are restrained by the configuration of the inner frame103and are still adjacent to each other, in which case, the free ends534of the two wings531should not interfere with each other. Therefore, in the circumferential direction of the inner frame103, the free ends534of the two wings531of the individual guiding member530are staggered with each other in the transition configuration of the guiding member530, and in the released configuration, the free ends534of the two wings531in the individual guiding member530are spaced from each other.

The free ends534of the two wings531in the individual guiding member530are staggered with each other in the transition configuration of the guiding member530in such a way that the free ends534of the two wings531in the individual guiding member530are spaced in the radial or axial direction of the inner frame103.

For ease of processing, referring toFIGS.73a-73c, all of the guiding members530are formed in one piece, for example, by bending a strip of metal. Each of the wings531extends from opposite outer sides of the guiding member530, which ensures the overall circumferential span of the guiding member530. In the figure, the guiding members530have different shapes. InFIG.73b, the guiding members530extend approximately in the axial direction of the inner frame103, and then turn to extend approximately in the circumferential direction of the inner frame103. As shown inFIG.73c, the guiding members530in each group can be provided asymmetrically.

Referring toFIGS.74a-74b, in cooperation with an imaging equipment, the prosthetic aortic valve device1000can be provide with a radiopaque marker550, which can be embedded or include a precious metal that can be displayed differentiating from other portions under X-ray or other means of detection.

The radiopaque marker550can be in the form of a dot or a strip or a ring (closed or non-closed, but at least in half ring), and the radiopaque marker550can be disposed in at least one of the inner frame103and the guiding members530. For example, the inner frame103or the guiding members530are provided with eyelets for receiving the radiopaque marker550.

The radiopaque marker550is installed, but not limited to one or more of the following methods: the wings531of the at least two guiding members530are provided with the radiopaque markers550, and preferably, the wings531of all the guiding members530are provided with the radiopaque markers; the roots532of at least two of the guiding members530are provided with the radiopaque markers550, and preferably the roots532of all the guiding members530are provided with the radiopaque markers.

In the axial view of the inner frame103, at least three radiopaque markers550are visible and are distributed in different regions in the circumference of the inner frame103. The position of the axis of the inner frame103can be determined according to the shape formed by the radiopaque markers550(displayed in the imaging equipment), so as to determine whether there is excessive tilt or the like.

In that axial view of the inner frame103, at least three radiopaque markers550are visible and at least two are distributed in different regions in the radial direction of the inner frame103. The radiopaque markers550in different regions in the radial direction can assist in determining the posture of the inner frame103in the circumferential direction.

In a radial view of that inner frame103, at least three radiopaque markers550are visible and are distributed in different regions in the axial direction of the inner frame103, in order to determine the position of the axis of the inner frame103from the radial view.

At least one radiopaque marker is disposed in the inner frame103or the root532of the guiding member530, and at least one radiopaque marker is disposed in the wing531of the guiding member530and adjacent to the free end534of the wing531, in order to determine the extension of the respective wing531.

In combination of the above methods, as shown inFIG.74b, for example, a first radiopaque marker550ais arranged in the inner frame103, a second radiopaque marker550band a third radiopaque marker550care arranged in the free ends534of the two wings531. All these radiopaque markers550are distributed in different regions in the circumferential direction of the inner frame103from the axial view of the inner frame103, and the first radiopaque markers550aand the other two radiopaque markers are distributed in different regions in the radial direction of the inner frame103, and the first radiopaque marker550aand the other two radiopaque markers are also distributed in different regions in the axial direction of the inner frame103. By means of the contrast medium, the posture of the prosthetic aortic valve device1000in the aorta and the alignment of the guiding members530with the valvular sinuses204can be easily determined.

For example,FIG.75can be considered as showing another embodiment which combinesFIGS.51ato51cwhich shows the shape characteristics and the spatial deformations of the joint between the root and the wing withFIG.67,70a,1, or19aor the like which shows the specific configurations of the wing.

Connecting posts104extend from the outflow end of the inner frame103. The connecting post104is V-shaped and the sharp corner of the V-shape is axially convex, and the junction of the two adjacent leaflets200on the inner frame103is the commissure region of the inner frame103. The connecting posts104are located at the respective commissure region in the circumferential direction, which is different from what shown inFIG.27a, where the connecting post is located between adjacent two commissure regions.

In the following, the positioning structure for the prosthetic heart valve (which can also be regarded as the prosthetic aortic valve when applied to the aorta) in this embodiment will be described from different perspectives.

For the guiding member, there are three circumferentially arranged guiding members respectively corresponding to three valvular sinuses in the human body, and the guiding member includes two separate roots, for example a root532aand a root532b. The roots532aand532bare respectively connected to different connecting posts104, the roots532afurther extends to form a wing531d, the roots532bfurther extends to form a wing531f, and the free ends534of the wings531dand531fare separate of each other.

For the clipping arm, there are three groups of clipping arms arranged in circumferential direction, each group including two clipping arms. For example, one of the clipping arms has a root532awhich further extends to form two branched wings, wing531dand wing531e, respectively, wherein the free ends534of the wing531dand the wing531fin the other group of clipping arms are adjacent to each other and correspond to the same valvular sinus in vivo, which is more advantageous for avoiding coronary arteries.

The above different perspectives refer to the same structure. In this embodiment, the connection of the root and the wing refers toFIGS.51ato51c(the reference numerals in which are applied in the following). From the clipping arm, the root is fixed to the outer side of the inner frame by binding, including a first bar and a second bar, the wing includes, adjacent to the root, a third bar and a fourth bar, wherein one end of the third bar is connected to the first bar, and the other end of the third bar extends towards the inflow end; one end of the fourth bar is connected to the second bar, and the other end of the fourth bar extends towards the inflow end and intersects with the third bar. The third and fourth bars meet and then diverge away from each other until they extend to the free ends, with the different branches (such as the wing531dand the wing53lerespectively inFIG.75) corresponding to different valvular sinuses. The first bar5321, the second bar5322, the third bar5351, and the fourth bar5352form a quadrangle, and the principle and deformation of the quadrangle, i.e., the frame, refer to the above, and would not be repeated herein.

Regarding the frame structure of the above embodiments, an embodiment of the present application further provides a prosthetic heart valve device having opposite inflow and outflow ends, including an inner frame103, leaflets200and a positioning mechanism, wherein the inner frame103and the leaflets200can refer to the other embodiments. The difference between this embodiment and the other embodiments is that the present embodiment does not strictly limit the transition configuration of the positioning mechanism. For example, the prosthetic heart valve device specifically includes:the inner frame103, which has a radially deformable meshed cylindrical structure and has relative compressed and expanded configurations, and the interior of the inner frame103is configured as a blood flow passage axially passing therethrough;leaflets200, connected to the inner frame103, wherein the leaflets200cooperate with each other to control opening and closing of the blood flow passage; anda positioning mechanism arranged in the circumferential direction of the inner frame, the positioning mechanism including a root532connected to the inner frame103and a wing531extending from the root532towards the inflow end; the wing is extendable in the peripheral region of the inner frame, with a receiving space defined between the wing and the outer wall of the inner frame for allowing the entry of the native leaflet; the roots532and the connection portions of the wings531with the roots532form as a frame structure; the two ends of the frame structure in the circumferential direction move relative to each other as the inner frame is compressed, and the two ends of the frame structure in the axial direction of the inner frame turn over relative to each other.

In this embodiment, the focus is that a frame structure (for example, enclosed by the first to fourth frame bars) is formed at the connection portion between the positioning mechanism and the inner frame, and the angle between the wing and the inner frame changes when the shape of the frame structure changes. Based on this, the native leaflets are clipped and positioned. The released structural configurations can also refer toFIG.76andFIG.77.

Regarding the embodiments described above, the clipping arms or guiding members at the periphery of the inner frame can be regarded as the positioning mechanism, which allow the circumferential alignment with the valvular sinuses, and axial limitation of frame displacement. The positioning mechanism not directly connected to the two commissure regions in the circumferential direction also ensures the positioning effect.

In order to reduce the pulling effect among different portions and to ensure the accuracy and reliability of positioning into the respective valvular sinuses, a spacing region111is formed at the outer peripheral region of the inner frame between two adjacent commissure regions114, and the positioning mechanism, as a whole, avoid the spacing region111.

Due to the spacing region111, any positioning member would not directly connect the two commissure regions114. For example, inFIG.76, the positioning mechanism can be considered as including a plurality of guiding members530located between adjacent two commissure regions114, without being connected to the commissure regions114in the circumferential direction. Therefore, there are two spacing regions111between two adjacent commissure regions114in addition to the guiding member530. The circumferential span of the guiding member530is limited, in order to realize circumferential alignment with valvular sinus.

As another example, inFIG.77, the free ends of the wings (from different clipping arms120) on either side of the spacing region111are separate of each other and are not directly connected, providing more anchor points with the valvular sinus, reducing the risk of anchor failure.

Similarly, when the positioning mechanism includes a plurality of separate positioning members, the individual positioning member connected to the individual commissure region114is not directly connected to the other commissure regions. In other words, in the case where the positioning mechanism includes a plurality of separate positioning members, the individual positioning member is at most directly connected to one commissure region114(in the case where the guiding member530is connected between the two commissure regions114, it can be considered not to be directly connected to any commissure region).

Based on the spaced distribution of the separate positioning members of the positioning mechanism, one embodiment of the present application further provides a prosthetic heart valve device having opposite inflow and outflow end. The prosthesis heart valve device includes an inner frame103and leaflets200, wherein the inner frame and the leaflets can use conventional technique or the above embodiments. The prosthesis heart valve device further includes a positioning mechanism. The positioning mechanism includes a root connected to the inner frame and a wing extending from the root to the inflow end. The wing is extendable in the peripheral region of the inner frame, with a receiving space defined between the wing and the outer wall of the inner frame for allowing the entry of the native leaflet. The positioning mechanism is used to be placed at the corresponding valvular sinus in the human body to perform positioning. The clipping arms or guiding members can refer to the above embodiments, without strictly limiting the various configurations and the transformations.

The focus of this embodiment is that the positioning mechanism includes a plurality of separate positioning members arranged sequentially in the circumferential direction of the inner frame, and the separate positioning members are indirectly connected to each other only by the inner frame103. The positioning member can be a group of clipping arms (the configuration as shown inFIG.74a), or guiding members with the roots between the two commissure regions (the configuration as shown inFIG.76). Considering the structure of the native aortic valve, three separate positioning members are taken as example, which are not directly connected, but are respectively fixed to the inner frame, i.e., indirectly connected with each other through the inner frame. The free ends of the separate positioning members are not connected with each other, so that even if one of the leaflets is not positioned in place, such as being located outside of the positioning mechanism, the leaflets can also be positioned into the valvular sinuses, with a better fault tolerance.

In addition, the roots of the three separate positioning members are far away from each other in the circumferential direction, with a span therebetween corresponding to a central angle of approximately 120 degrees, so that after the inner frame103is released into the expanded configuration, the configurations of the separate positioning members are relatively independent from each other, in order to adapt to the more complex and even abnormal valvular sinuses.

Preferably, the inner frame is released and expanded by means of a balloon device and the positioning mechanism is released by self-expanding so that the positioning mechanism can have the above mentioned loaded, transition and released configurations. Taking the clipping arms shown inFIG.74aandFIG.75as an example, each positioning member is a group of clipping arms, and one end of each clipping arm connected to the inner frame is a fixed end, while the other end is an opposite free end. Each group of clipping arms includes two clipping arms, wherein the fixed ends are adjacent to each other, and the free ends of the two clipping arms in each group are far away from each other. For example, the wings531dand531eextend away from each other. The connection portion between the respective group of clipping arms and the inner frame is aligned with the corresponding commissure region in the circumferential direction. Two clipping arms corresponding to the same leaflet belong to different groups in the circumferential direction, and the free ends thereof are spaced from each other and tend to close to each other. For example, the free end534of the wing531dand the free end534of the wing531fin the other group of clipping arms are adjacent to each other and correspond to the same valvular sinus in the human body.

The technical features of the above embodiments can be arbitrarily combined, and not all possible combinations of the technical features of the above embodiments have been described for the sake of brevity of description. However, as long as there is no contradiction in the combination of these technical features, it should be regarded as falling in the scope of this specification. When the technical features in different embodiments are shown in the same figure, it can be considered that the drawing also discloses a combination example of various embodiments involved.

The above-described embodiments only represent several embodiments of the present application, and the description therefor is specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that a number of modifications and developments can be made to those of ordinary skill in the art without departing from the spirit of the present application, all of which are within the scope of protection of the present application.