CN117769403A

CN117769403A - Prosthetic heart valve devices, stents, delivery systems, interventional systems, and related methods

Info

Publication number: CN117769403A
Application number: CN202280053134.2A
Authority: CN
Inventors: 查理·克拉普; 吉尔伯特·马德里
Original assignee: Laguna Technology Usa
Current assignee: Laguna Technology Usa
Priority date: 2021-08-04
Filing date: 2022-08-03
Publication date: 2024-03-26

Abstract

A prosthetic heart valve device is provided having a stent and a leaflet assembly having a plurality of leaflets secured to the stent. The stent is defined by an annular body and has three spaced apart commissure regions, each commissure region having commissure posts extending from a proximal outflow end of the stent. First and second clamping arms extend from opposite sides of each commissure post, each clamping arm extending from each commissure post at an obtuse angle relative to each commissure post. Each gripping arm has a free end and is provided with a tip at the free end. The body has a first diameter at a location where the tip of the clamping arm is located, and the tip of the clamping arm extends outwardly defining a second diameter, wherein the second diameter is greater than the first diameter.

Description

Prosthetic heart valve devices, stents, delivery systems, interventional systems, and related methods

Technical Field

The present invention relates to a prosthetic heart valve device, and more particularly to a prosthetic heart valve for treating aortic insufficiency.

Background

Aortic insufficiency (aortic valve insufficiency, AI), also known as aortic regurgitation (aortic regurgitation, AR), is a serious and potentially fatal structural heart disease that afflicts millions of patients worldwide. Aortic insufficiency is characterized by excessive volume loading and centrifugal hypertrophy, associated with structural changes (cavity structural modifications) and progressive dysfunction (progressive dysfunction) of the Left Ventricle (LV) lumen. This causes the aortic root/annulus to dilate, resulting in aortic valve regurgitation. If not treated in time, the disease may gradually worsen, eventually leading to death of the patient.

To date, only two known minimally invasive transcatheter aortic valve implantation devices are available for treating aortic valve insufficiency disorders. The first device is manufactured by JenaValve, and uses a stent design with "antenna" arches to align with the native anatomy and clamp the native valve leaflets during release. However, the JenaValve design is difficult to deliver and release due to its open cell design, and does not have any structure to prevent the native leaflet from interacting with the prosthetic leaflet. The JenaValve device also has a pronounced asymmetry that includes different cell sizes, as well as a notch design for leaflet attachment. All these features make the device press-grip very challenging and thus release also becomes difficult to control.

The second device is manufactured by JC Medical, in a split design, with a U-shaped anchoring ring released in the native cusp, and a self-expanding valve endoprosthesis thereafter. The two separate components are anchored together with sutures/wires, which may lead to failure during or after implantation, which may lead to displacement and/or device embolization. The main disadvantage of this device is the metal-on-metal design, which increases the size (profile) of the valve and affects the long-term durability of the valve.

The transcatheter aortic valve implant device for treating aortic valve insufficiency disorders is compared to conventional transcatheter valve designs for treating aortic stenosis. Conventional stenotic valves provide a retaining ring to release and anchor the native valve. However, in a purely aortic insufficiency condition, no fixation ring can be anchored inside. Thus, in non-stenotic valves used to treat aortic insufficiency, it is more difficult to anchor the valve using the native anatomy.

Thus, there remains a need for a prosthetic heart valve that can be used to treat aortic insufficiency and that overcomes the shortcomings of prior devices.

Disclosure of Invention

The present invention provides a prosthetic heart valve that can be effectively used to treat aortic insufficiency while avoiding the drawbacks of prior devices.

To achieve the objects of the invention, the present invention provides a prosthetic heart valve device having a stent and a leaflet assembly having a plurality of leaflets secured to the stent. The support is defined by an annular body defined by an arrangement of cells. The stent has three spaced apart commissure regions, each commissure region having commissure posts extending from a proximal outflow end of the stent. First and second clamping arms extend from opposite sides of each commissure post, each clamping arm extending from each commissure post at an angle of 90 to 180 degrees relative to each commissure post. Each gripping arm has a free end and is provided with a tip at the free end. The body has a first diameter at a location where the tip of the clamping arm is located, and the tip of the clamping arm extends outwardly defining a second diameter, wherein the second diameter is greater than the first diameter.

The present invention also provides a method of securing a prosthetic heart valve device at an aortic annulus comprising a plurality of native leaflets. The method comprises the following steps: pressing the heart valve device within the delivery system, delivering the heart valve device to the annulus, and releasing the heart valve device at the annulus, wherein at least some of the native leaflets are positioned between the clamping arms and the body.

According to another embodiment, some native leaflets may also be positioned around the outer surface of some of the gripping arms.

The method of the present invention may further comprise the steps of:

advancing a delivery system through an aortic arch and an ascending aorta of the patient, wherein a distal portion of the delivery system passes through an aortic annulus into a ventricle;

retracting a portion of the delivery system such that the gripper arms are exposed within the chamber;

retracting the delivery system and the heart valve device such that the clamping arms are completely clear of the aortic annulus and now positioned within the aortic fixed end;

positioning the distal end of the gripping arms over the native aortic valve, distally advancing the heart valve device until the gripping arms fall into the cusps of the native leaflets; and

the remainder of the delivery system is retracted to release the stent body at the aortic annulus.

The present invention provides a prosthetic heart valve device and method of release thereof that can be effectively released at the aortic annulus in a manner that minimizes post-release displacement or movement of the released heart valve device.

A stent for a prosthetic heart valve device, comprising:

the inner frame is of a net barrel structure, has opposite compression states and expansion states according to radial deformation, and allows a supporting device for driving the inner frame to switch to the expansion states to be placed in the inner frame;

the clamping arms are arranged at the periphery of the inner frame and are circumferentially arranged at intervals along the support, each clamping arm is provided with a fixed end and a free end which are opposite, the fixed ends are directly or indirectly connected with the inner frame, the fixed ends of the clamping arms in the same group are mutually adjacent, and the clamping arms adopt memory materials and have the following states:

the loading state, wherein the inner frame is in a compression state, and the clamping arms are attached to the inner frame;

the inner frame is in an expansion state, the free ends of the clamping arms extend radially outwards and form a space with the inner frame to allow the primary valve leaflet to enter, the free ends of at least two clamping arms in the same group have a divergent trend, and the free ends of at least two clamping arms in two adjacent groups have a converging trend.

A stent for a prosthetic heart valve device, comprising:

the connecting ring is fixed at the outflow end of the inner frame and is provided with a plurality of connecting areas at intervals; and

the clamping arms are arranged at the periphery of the inner frame and are circumferentially arranged at intervals along the bracket, and each clamping arm is provided with a fixed end and a free end which are opposite; the fixed ends of the clamping arms in the same group are positioned in the same connecting area.

The clamping arm is made of a memory material and has the following states:

and a released state in which the inner frame is in an expanded state, the free ends of the clamping arms extending radially outwardly and forming a space with the inner frame to allow access to the native leaflets.

A stent for a prosthetic heart valve device, comprising:

Each clamping arm is provided with a fixed end and a free end which are opposite, the fixed end is connected with the inner frame, the fixed end extends in the circumferential direction of the bracket, and the clamping arms at least meet the following condition compared with the axis of the inner frame:

the central angle of the circumferential distribution area M1 of the fixed end is larger than 15 degrees compared with the central angle of the axis;

the clamping arm has a length of more than 5mm compared to the axially distributed area M3 of the axis.

The clamping arm is made of a memory material and has the following states:

A prosthetic heart valve device includes a stent and leaflets; the stent is a stent for a prosthetic heart valve device as described herein; the valve blades are connected to the bracket and positioned in the blood flow channel, and the valve blades are mutually matched multiple pieces for controlling the opening or closing of the blood flow channel.

A delivery system for a prosthetic heart valve device, comprising:

A support device switchable under the action of a fluid between an inflated state and a contracted state;

an outer sheath slidably fitted around the outer periphery of the support device, the radial gap between the outer sheath and the support device being a loading zone;

the prosthetic heart valve device described herein is placed in the loading zone in a compressed state.

A positioning method of a prosthetic heart valve device for positioning the prosthetic heart valve device described herein in an aortic valve, the positioning method comprising:

the artificial heart valve device is conveyed to a preset position, the inner frame is in a compressed state in the conveying process, the clamping arms are in a loading state, and the supporting device is in a contracted state;

driving the outer sheath to release the free end of the clamping arm and extend the free end of the clamping arm;

adjusting the position of the inner frame to enable the free end of at least one clamping arm to be positioned on the primary valve She Waice;

the supporting device is driven to a swelling state, the inner frame and the fixed end of the clamping arm are released, the inner frame is enabled to enter the swelling state, and the clamping arm is enabled to enter the releasing state.

A prosthetic aortic valve device having opposite inflow and outflow ends, the prosthetic aortic valve device comprising:

The inner frame is of a net barrel structure capable of radially deforming and is provided with a compression state and an expansion state which are opposite, and the inner frame is internally provided with a blood flow channel which is axially communicated;

the valve blades are connected to the inner frame, are multiple and are matched with each other to control the opening and closing of the blood flow channel;

the guide piece, the guide piece is arranged in proper order along the inner frame circumference and circumference position respectively aligns with each valve leaflet, each guide piece include connect in the root of inner frame and by root is further to inflow end extended wing portion, the guide piece adopts memory material and is configured to can switch in following state:

a loading state in which portions of the guide are radially proximate the inner frame in a compressed state;

a transitional state in which the root parts of the guide members remain gathered to adapt to the inner frame in a compressed state, and the wing parts self-extend in the peripheral area of the inner frame and form a containing space for receiving the native valve leaflet with the outer wall of the inner frame;

a released state in which the root portions of the respective guides are relatively far apart to accommodate the inner frame in the expanded state.

A delivery system for loading, delivering a prosthetic aortic valve device described herein, the delivery system having opposite distal and proximal ends and comprising:

A balloon device switchable under fluid action between an inflated state and a contracted state;

an outer sheath slidably fitted over the outer periphery of the balloon device, the radial clearance between the outer sheath and the balloon device being a loading zone for receiving the prosthetic aortic valve device in a compressed state;

a control handle to which the proximal ends of both the balloon apparatus and the outer sheath extend, wherein the outer sheath is a slip fit relative to the control handle.

An interventional system comprising a prosthetic aortic valve device as described herein; and a delivery system for a prosthetic aortic valve device as described herein.

The application describes a method of using an interventional system, comprising:

delivering the prosthetic aortic valve device to a predetermined location, wherein the inner frame is in a compressed state, the guide member is in a loading state, and the balloon device is in a contracted state during delivery;

proximally retracting the outer sheath to expose the wings of the guide member, bringing the guide member into a transitional state;

acquiring the relative position of the guide piece and the valve sinus, rotating the supporting device and driving the inner frame to synchronously move when the guide piece and the valve sinus are dislocated, so that the wing parts of the guide piece are aligned and enter the valve sinus; and

The balloon apparatus is driven to an inflated state, releasing the inner frame and the root of the guide member, causing the inner frame to enter an inflated state, and the guide member to enter a released state.

An artificial aortic valve apparatus having opposite inflow and outflow ends, the artificial aortic valve apparatus comprising:

the inner frame is provided with a net barrel structure capable of radially deforming, and is provided with a compression state and an expansion state which are opposite, and the inner frame is internally provided with a blood flow channel which is axially communicated;

a plurality of leaflets, the plurality of leaflets being connected to the inner frame, the plurality of leaflets cooperatively controlling the blood flow passage, wherein adjacent leaflets are joined at respective commissure regions of the inner frame; and

the plurality of positioning members are sequentially arranged along the circumferential direction of the inner frame, one end of each positioning member is connected with the inner frame, the other end of each positioning member extends towards the inflow end, and a peripheral area of the inner frame between two adjacent commissure regions defines a spacing area, and the positioning members avoid the spacing area.

Drawings

Fig. 1 is a side perspective view of a stent of a prosthetic heart valve device in accordance with a first embodiment of the present invention.

Fig. 2 is a flattened view of a portion of the stent of fig. 1.

Fig. 3 is a flattened view of the entire stent of fig. 1.

Fig. 4 is a top perspective view of the bracket of fig. 1.

Fig. 5 is a side perspective view of a prosthetic heart valve device of a first embodiment of the present invention.

Fig. 6 is a top perspective view of the device of fig. 5.

Fig. 7 is a top view of the device of fig. 5.

Fig. 8 is a side perspective view illustrating the device of fig. 5 gripping a native valve leaflet.

Fig. 9 is a bottom perspective view illustrating the device of fig. 5 gripping a native valve leaflet.

Fig. 10A shows the device of fig. 5 held in a compressed state within a delivery system.

Fig. 10B shows the various components of the delivery system of fig. 10A in a fully released configuration without the device of fig. 5.

Fig. 10C shows the various components of the delivery system of fig. 10A in a fully released configuration, with the device of fig. 5 compressed onto the inner tube.

Fig. 11A-11G illustrate how the device of fig. 5 is delivered to and released at the aortic annulus of a patient's heart.

Fig. 12 is a side perspective view of a stent of a prosthetic heart valve device in accordance with a second embodiment of the present invention.

Fig. 13 is a flattened view of a portion of the stent of fig. 12.

Fig. 14 is a side perspective view of a stent of a prosthetic heart valve device in accordance with a third embodiment of the present invention.

Fig. 15 is a side perspective view of a stent of a prosthetic heart valve device in accordance with a fourth embodiment of the present invention.

Fig. 16 is a side perspective view of a stent of a prosthetic heart valve device in accordance with a fifth embodiment of the present invention.

Fig. 17A shows a modification that can be made to the stent of fig. 1.

Fig. 17B shows the stent of fig. 17A secured at the native annulus.

Fig. 18A shows another modification that may be made to the stent of fig. 1.

Fig. 18B shows the stent of fig. 18A secured at the native annulus.

FIG. 19 is a schematic view of a holder of an artificial heart valve device in an embodiment;

FIGS. 20 a-20 d are schematic views of the structure of the clamping arm in different embodiments in front view;

FIG. 20e is a schematic illustration of an asymmetric arrangement of clamp arms;

FIG. 21a is a schematic diagram showing the relationship of the clamping arm and the inner frame in a side view;

FIG. 21b is a schematic view of the clamping arm and native leaflet cooperation;

FIGS. 22 a-22 d are schematic diagrams illustrating the structure of the clamping arm in different embodiments from a side view;

FIGS. 23a and 23b are schematic diagrams illustrating the mating relationship of the clamping arms and the inner frame in different embodiments, respectively, from a top view;

FIG. 24a is a schematic view of the mating relationship between the fixed end of the clamping arm and the commissure zones;

FIGS. 24 b-24 d are schematic diagrams showing the assembly relationship between the fastening end and the fastening region in various embodiments;

FIG. 25 is a schematic view of a stent of an artificial heart valve device in another embodiment;

FIGS. 26 to 29 are schematic views showing different fitting modes of the fixed end of the clamping arm and the commissure posts, respectively;

FIGS. 30 a-30 d are schematic views of the bracket of FIG. 25 mated with a different form of clamping arm;

FIG. 31 is a schematic view of the clamp arm inside the inner frame;

FIG. 32 is a schematic view of a stent in a flattened state of an artificial heart valve device in an embodiment;

FIG. 33a is a schematic view of a connecting ring according to an embodiment;

FIG. 33b is a schematic view of the coupling ring and bracket of FIG. 33 a;

FIG. 33c is a schematic view of a connecting ring in another embodiment;

FIG. 33d is a schematic view of the coupling ring and bracket engagement of FIG. 33 c;

FIG. 33e is a schematic view of a connecting ring according to yet another embodiment;

FIG. 33f is a schematic view of the coupling ring and bracket of FIG. 33 e;

FIGS. 34a and 34b are schematic views of various embodiments of the integrated attachment ring and clamp arm structures, respectively;

FIG. 35 is a schematic view of a stent of an artificial heart valve device in yet another embodiment;

FIGS. 36a and 36b are schematic views of the attachment ring and the inner frame, respectively, as connected by a flexible member;

FIGS. 36c and 36d are schematic views of the various views of FIGS. 36a and 36b, respectively;

FIG. 37a is a schematic view of a support structure of a clamping arm strengthening arrangement according to an embodiment;

FIG. 37b is a schematic view showing a bracket flattening of a clamping arm strengthening arrangement in an embodiment;

FIG. 37c is a schematic top view of the bracket of FIG. 37 b;

FIG. 37d is a schematic view showing a bracket flattening of a clamping arm strengthening arrangement in another embodiment;

FIG. 37e is a schematic view of a gripper arm configured as a web;

FIG. 37f is a schematic view of edge thickening of a gripper arm;

FIG. 37g is a schematic view of a free end setting positioning structure of the clamp arm;

FIG. 37h is a schematic view of a plurality of positioning structures provided on a clamping arm;

FIG. 37i is a schematic view of the structure of the clamp arm mating fitting;

FIG. 37j is a schematic view of the simultaneous placement of the adapter sleeve and positioning structure on the clamp arm;

FIG. 37k is a schematic view of an integrally formed clamping arm with reinforcement;

FIG. 37l is a schematic view of different extension paths of integrally formed clamping arms with strengthening arrangements;

FIG. 37m is a schematic illustration of an asymmetric arrangement of integrally formed strengthening arranged clamp arms;

FIG. 38a is a schematic side view of a bracket with a clamp arm strengthening arrangement in another embodiment;

FIG. 38b is a schematic view of the stent of FIG. 38a mated with a native leaflet;

FIG. 38c is a schematic view of a prosthetic heart valve device with enhanced placement of the clamping arms according to one embodiment;

FIG. 38d is a schematic view of the prosthetic heart valve device of FIG. 38c mated with a native leaflet;

FIGS. 38e and 38f are schematic views showing different ways of engaging the fixed end of the clamping arm;

FIG. 38g is a schematic view of a clamping arm of a further embodiment of the reinforcement arrangement;

FIG. 38h is a schematic view of the engagement of the clamping arm and the inner frame of FIG. 38 g;

FIG. 38i is a schematic diagram comparing the loaded and released states of the clamp arm of FIG. 38 g;

FIG. 38j is a schematic view of different extension paths of the clamping arms of the reinforcement arrangement;

FIG. 38k is a schematic illustration of an asymmetric arrangement of clamping arms in a reinforced arrangement;

FIG. 39a is a schematic view of an artificial heart valve device in another embodiment;

FIG. 39b is a schematic view of the prosthetic heart valve device of FIG. 39a mated with a native leaflet;

FIG. 40 is a schematic view of a slot in an embodiment;

FIGS. 41 a-41 c are schematic diagrams illustrating different operation of the conveying system according to one embodiment;

42 a-42 g are schematic diagrams illustrating operation of the conveyor system in one embodiment;

fig. 43a to 43d are schematic views of a pre-inflation process of the conveying system.

FIG. 44 is a schematic illustration of aortic and coronary locations in the heart;

FIG. 45 is a schematic illustration of a circumferential relationship between an artificial aortic valve apparatus and an aortic valve;

FIG. 46a is a schematic diagram of an embodiment of an artificial aortic valve assembly;

FIG. 46b is a schematic view of the artificial aortic valve assembly of FIG. 46a from another perspective;

FIG. 47a is a front view of the prosthetic aortic valve assembly of FIG. 46b with the inner frame in a straight tubular shape in a released state (with the leaflets omitted);

FIG. 47b is a left side view of the artificial aortic valve apparatus of FIG. 47 a;

FIG. 48 is a front view of an example artificial aortic valve assembly in a loaded state;

FIG. 49 is a front view of an artificial aortic valve assembly in a transitional state according to one embodiment;

FIG. 50 is a perspective view of the artificial aortic valve apparatus of FIG. 48;

FIG. 51 is a perspective view of the artificial aortic valve apparatus of FIG. 49;

FIG. 52a is a front view of an artificial aortic valve assembly in a released state according to one embodiment;

FIG. 52b is a left side view of the artificial aortic valve assembly of FIG. 52 a;

FIG. 52c is a perspective view of the artificial aortic valve apparatus of FIG. 52 a;

FIG. 53 is a schematic illustration of the relationship of the position of the cover and the inner frame in an artificial aortic valve unit;

FIG. 54a is a front view of an eversion of an inner frame of an artificial aortic valve unit according to one embodiment;

FIG. 54b is a left side view of the artificial aortic valve assembly of FIG. 54 a;

FIG. 54c is a perspective view of the artificial aortic valve apparatus of FIG. 54 b;

FIGS. 55 a-55 d are front, left, perspective and top views, respectively, of an inner frame of an artificial aortic valve assembly in a compressed state;

FIGS. 56 a-56 d are front, left, perspective and top views, respectively, of an inner frame of an artificial aortic valve assembly in an expanded state;

FIGS. 57 a-57 d are front, left, perspective and top views, respectively, of an everting inner frame of an artificial aortic valve assembly in an expanded state;

FIG. 58a is a top view of an artificial aortic valve assembly in a released state according to one embodiment;

FIG. 58b is a schematic view of an artificial aortic valve apparatus prior to circumferential positioning with the aortic valve;

FIG. 58c is a schematic view of the artificial aortic valve apparatus after circumferential positioning with the aortic valve;

FIG. 58d is a schematic view of the artificial aortic valve assembly after engagement with the aortic valve;

FIG. 59a is a schematic view of the guide after placement in the sinus region and prior to mating;

FIG. 59b is a schematic representation of deformation of the guide at an initial release stage;

FIG. 59c is a schematic view of the placement of the guide into the valve sinus after release is completed;

fig. 60a to 60c are front, perspective and right views, respectively, of the guide in the loaded state;

fig. 61a to 61c are front, perspective and right views, respectively, of the guide in the transitional state;

fig. 62 is a front view of the guide in a released state (root eversion);

FIG. 63 is a perspective view of the guide of FIG. 62;

FIG. 64 is an enlarged view of portion C of FIG. 62 b;

FIG. 65 is an enlarged view of portion B of FIG. 60B;

FIG. 66 is a top view of FIG. 47 a;

FIG. 67 is a schematic view of the intersecting frame bars of the root portion;

FIG. 68 is a schematic view of parallel bars of the root portion;

FIG. 69 is an enlarged view of portion A of FIG. 52 a;

FIG. 70a is a schematic view of an embodiment of an artificial aortic valve apparatus prior to pre-shaping a guide;

FIG. 70b is a schematic view of the strips of the root portion of the guide of FIG. 70a being drawn toward each other (transitional state);

FIG. 70c is a schematic view of the root section of FIG. 70b with the frame strips away from each other (released);

FIG. 71 is a schematic representation of the distribution of the visualization markers in an artificial aortic valve apparatus;

FIG. 72 is a schematic diagram of a conveying system according to an embodiment of the present application;

FIG. 73 is a schematic view of the distal end of the delivery system of FIG. 72 loaded with a prosthetic aortic valve apparatus;

FIG. 74 is a schematic view of the structure of a tube in an artificial aortic valve apparatus;

FIG. 75 is a schematic view of another tubular body in an artificial aortic valve apparatus;

FIG. 76 is a partial schematic view of another manner of control handle in the delivery system;

FIG. 77 is a partial schematic view of another mode of control handle in the delivery system;

FIG. 78 is a partial schematic view of another mode of control handle in the delivery system;

FIGS. 79 a-80 b are schematic illustrations of a release process for an artificial aortic valve assembly;

FIG. 81 is a flowchart illustrating a method for using an access system according to an embodiment of the present application.

FIG. 82 is a schematic view of the artificial aortic valve assembly in a loaded state (valve leaflets omitted from the drawing);

FIG. 83 is a schematic view of the prosthetic aortic valve apparatus of FIG. 82 in a transitional state;

FIG. 84 is a schematic view of the artificial aortic valve apparatus of FIG. 83 in a released state;

FIG. 85a is a schematic view of a prosthetic aortic valve apparatus according to one embodiment;

FIGS. 85b-85c are schematic illustrations of an artificial aortic valve apparatus according to one embodiment;

FIG. 85d is a perspective view of an artificial aortic valve apparatus according to one embodiment;

FIG. 86 is a schematic view of an alternative embodiment of an artificial aortic valve assembly;

FIGS. 87 a-87 c are different structural schematic views of an artificial aortic valve assembly guide;

FIG. 88a is a schematic view of an artificial aortic valve apparatus prior to circumferential positioning with an aortic valve;

FIG. 88b is a schematic view of the artificial aortic valve apparatus after circumferential positioning with the aortic valve;

FIG. 89a is a schematic diagram of a guide in an embodiment;

FIG. 89b is an enlarged view of portion C of FIG. 89 a;

FIG. 89c is a schematic view of the prosthetic aortic valve apparatus in a transitional state;

FIG. 89d is a flattened schematic of an artificial aortic valve assembly;

FIG. 90 is a schematic view of the mating relationship after placement of the guide in the sinus region;

FIG. 91a is a schematic view of a wing space configuration in a guide;

FIG. 91b is a schematic view of another manner of spatial configuration of the wings in the guide;

FIG. 92a is a flattened schematic of an integrated guide;

FIG. 92b is a flattened schematic of another version of an integrated guide;

FIG. 92c is a flattened schematic of another version of an integrated guide;

FIG. 93a is a schematic illustration of the distribution of the visualization markers in an artificial aortic valve apparatus;

FIG. 93b is a schematic view of another manner of developing markers in an artificial aortic valve apparatus;

FIG. 94 is a perspective view of another embodiment of an artificial aortic valve apparatus;

fig. 95 and 96 are perspective views showing the spaced-apart regions of the artificial aortic valve apparatus in different configurations.

Reference numerals in the drawings are described as follows:

100. a prosthetic heart valve device; 1000. a prosthetic aortic valve device; 101. an inflow end; 102. an outflow end; 103. an inner frame; 104. a connecting column; 1041. a fifth frame bar; 1042. a sixth frame bar; 110. a bracket; 111. a spacing region; 1112. an eyelet; 114. a commissure zone; 115. a first collar; 116. a cell; 117. a second collar; 120. a clamping arm; 121. a fixed end; 1221. a smooth structure; 123. a free end; 127. a joint; 129. a projection area; 132. a commissure column; 141. a leg portion; 142. a second support arm; 146. a vertex; 160. a first inclined space; 168. a slot; 173. developing points;

200. Valve leaves; 201. native valve leaflets; 204. the valve sinus; 211. a junction region; 220. coating a film; 221. an inner coating film; 223. an outer coating film;

301. a blood flow channel; 310. a connection part; 3101. a developing hole; 311. a positioning structure; 3120. adapting the set; 313. a rigid portion; 314. a flexible portion; 315. a connecting piece; 321. a unit; 330. a wave structure; 340. a connecting ring; 341. a connection region; 342. a second inclined space; 343. a first position; 344. a second position; 345. a flexible member;

400. a conveying system; 404. a support device; 405. an outer sheath; 406. a loading area; 407. a control handle; 410. a support body; 411. a chute; 420. a movable seat; 430. a drive sleeve; 440. a rotating seat; 441. a planet carrier; 442. a planet wheel; 443. a gear ring; 444. a planetary input shaft; 445. a planetary output shaft; 451. a worm wheel; 452. a worm; 453. a transmission sleeve; 454. a support base; 461. a first gear; 462. a second gear; 463. a transmission sleeve; 464. a support base;

530. a guide; 531. a wing portion; 531a, wings; 531b, wings; 531c, wings; 531d, wings; 531e, wings; 531f, wings; 532. root part; 532a, root; 532b, root; 5321. a first frame bar; 5322. a second frame strip; 5323. a first binding-wire hole; 5324. a first connection point; 5325. a second connection point; 5326. a third connection point; 5327. a first plane; 5311. a first wing; 5312. a second wing; 534. a free end; 5341. a wave undulating structure; 535. a bifurcated structure; 5351. a third frame bar; 5352. a fourth frame bar; 5353. fork openings; 5354. a second binding-wire hole; 5355. a fourth connection point; 5356. a second plane; 536. a free end; 5361. a seventh frame bar; 5362. an eighth frame bar; 537. a constraining structure; 538. a first portion; 539. a second portion; 550. developing the mark; 550a, developing the mark; 550b, developing the mark; 550c, developing the mark; 551. an eyelet;

600. A balloon device; 610. a tube body; 6101. an outermost layer; 6102. an intermediate layer; 6103. an innermost layer; 620. a guide head; 630. a balloon; 900. a human heart; 910. an aorta; 911. a right coronary artery trunk; 912. the left coronary artery trunk.

Detailed Description

The following detailed description is of the best modes presently contemplated for carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of embodiments of the invention. The scope of the invention is best defined by the appended claims.

Fig. 1-9 illustrate a prosthetic heart valve device 100 in accordance with the present invention. The device 100 has a stent 110 defined by an annular body 112, the stent 110 including three commissure regions 114. The body 112 is defined by an arrangement of cells 116. Each cell 116 may be defined by four struts 118 to form any desired shape. Fig. 1-9 illustrate the struts 118 being bent to form teardrop shaped cells, but any other configuration may be employed (e.g., four straight struts to form a diamond shaped cell).

Referring first to fig. 1 to 4, the body 112 may be configured with three cell regions 120a, 120b, and 120c forming an endless belt. Each cell region 120a, 120b, and 120c is made up of a plurality of cells, with a first row 122 of cells 116, a second row 124 of cells 116, a third row 126 of cells 116, a fourth row 128 of cells 116, and a fifth row 130 of cells. The first row 122 defines the distal (or inflow) end of the stent 110 and has a maximum number (e.g., five in this embodiment) of cells 116. The second row 124 is immediately proximal to the first row 122 and is staggered from the first row 122 by the same or a second (e.g., five in this embodiment) number of cells 116 as the first row 122. The third row 126 is immediately proximal to the second row 124 and is staggered from the second row 124 by a number of cells 116 that is less than the number of cells 116 of the second row 124 (e.g., three in this embodiment). The fourth row 128 is immediately proximal to the third row 126 and is staggered from the third row 126 by a number of cells 116 that is less than the number of cells of the third row 126 (e.g., two in this embodiment). The fifth row 130 is immediately proximal to the fourth row 124 and is staggered from the fourth row 124 by a number of cells 116 that is less than the number of cells 116 of the fourth row 124 (e.g., one in this embodiment). The fifth row 130 is also the most proximal (outflow end) row of cells 116, and each cell 116 in the fifth row 130 supports a respective commissure post 132.

As shown in fig. 1, the distal end (inflow end) of the body 112 may be slightly flared such that an increased diameter at the distal end (inflow end) may be used to better secure the stent 110 at the native annulus. Specifically, the cells 116 in a first row 122 may be shaped to be flared and define a larger diameter than the cells 116 of a next row 124.

Each commissure region 114 includes a connection, and in this embodiment, the connection is configured as a commissure post 132 extending from the most distal row of cells 116. Each commissure post 132 includes at least one eyelet 134 extending from the top (proximal end) of the post 132, and in this embodiment, there is also a second eyelet 136. When the plurality of apertures 136 are configured, the plurality of apertures 136 may be aligned sequentially along the length of the respective commissure posts 132, or in other directions.

A first bracket arm 140 and a second bracket arm 142 extend from opposite sides of each post 132. Each first arm 140 from one post 132 is connected at a distally facing apex 146 to a second arm 142 from an adjacent post 132. Each vertex 146 engages or connects with a vertex of a cell 116x in row 124 at a connection location 158. Each arm 140 and 142 may be straight or contoured (as shown, with different bending regions along the arm) or curved. The first bracket arm 140 is connected to the bracket 110 at a connection location closer to the distal (or inflow) end than the eyelet 134. Each arm 140 and 142 is a single rod structure or a deformable webbing. As shown in fig. 3, the angle between each arm 140 and 142 and the axis of the bracket ranges from 30 degrees to 85 degrees.

In addition, a first inclined space 160 is defined by each first arm 140 and the corresponding cell region 120a, 120b, or 120c, and a second inclined space 162 is defined by each second arm 142 and the corresponding cell region 120a, 120b, or 120 c. The first angled spaces 160 are angled distally (or inflow) away from the respective posts 132. The first and second arms 140, 142 between two adjacent posts 132 are generally V-shaped, and the first and second arms 140, 142 are symmetrically disposed on opposite sides of the apex of the V-shape.

First and second clamping arms 164, 166 extend from opposite sides of each connection for connecting the clamping arms 164, 166 and the bracket (here, the post 132) from a position between the first and second arms 140, 142 and the respective most distal row of cells 116, respectively. Alternatively, the first clamping arm 164 and the second clamping arm 166 may extend from opposite sides of the same row of cells 116. Preferably, the circumferential span between the first clamping arm 164 and the second clamping arm 166 is small. More preferably, the axial span between the first clamping arm 164 and the second clamping arm 166 is also small. In this embodiment, the connection between the first clamping arm 164 and the column is adjacent to the connection between the second clamping arm 166 and the same column. Preferably, the first and second clamping arms 164, 166 may be symmetrically disposed on opposite sides of the respective post 132. The connection of the first arm 140 and the corresponding post is closer to the proximal (or outflow) end than the connection of the first clamping arm 164 and the second clamping arm 166 and the corresponding post. In other embodiments, more clamping arms 164, 166 may be provided on any post 132, in which case all clamping arms 164, 166 on the same side of post 132 act as a set of clamping arms. The ends of the clamping arms in the same group, which are connected with the column, can be positioned at the same position or adjacent to each other, and the free ends of the clamping arms in the same group can be converged and connected. In some embodiments, a single gripping arm may be formed as a deformable web structure.

The first inclined space 160 may be regarded as a hollowed-out region of the bracket 110. Before the clamp arms 164 and 166 are released and extended, the clamp arms 164 and 166 are positioned within the respective hollowed-out areas, which avoids an increase in the overall outer diameter of the stent 100 caused by radial stacking during loading of the device 100. Each clamp arm 164, 166 defines an angle X between the respective clamp arm 164, 166 and the respective commissure post 132. Referring to fig. 2, the angle X ranges from 90 degrees to 180 degrees, preferably about 120 degrees. The clamp arms 164 and 166 function as beams, so the term "beam" is also used interchangeably herein with the term "clamp arm" and has the same meaning. Each clamp arm 164 and 166 may include one or more slots 168 in the body of the arm 164 or 166, and each arm 164 and 166 has a first end 170 connected to the respective post 132 and a second end having an aperture 172, the aperture 172 slightly expanding the second end. Each of the first and second clamping arms 164, 166 extends to the vicinity of the first and second inclined spaces 160, 162, respectively, and serves to clamp a portion of a native valve leaflet (see fig. 8 and 9) to the body 112. The clamping arms 164, 166 may be formed as a single piece, cut from the same tubular structure as the body 112, or connected by various methods (e.g., suture connection or laser welding) after cutting.

Each slot 168 may be an open space in the body of the arm 164 or 166, and the open space may have any desired shape, including diamond (as shown). Thus, these slots 168 may be considered elongated cells. The purpose of these extension cells 168 is to extend the arms 164 or 166 after the initial stent cut. The extension cells 168 are designed in such a way that: before setting they are in the open configuration (i.e. the struts are further apart), but after setting they are in the closed configuration. By changing from the open configuration to the closed configuration, the extension cells 168 shorten and cause the beam to elongate. This allows the stent 110 to be designed to be constructed of a single tube and achieves a design that allows the heart valve device 100 to be positioned high enough in the aortic annulus to minimize the length required to protrude into the Left Ventricular Outflow Tract (LVOT) and thereby minimize the risk of conduction system interference. Each arm 164 and 166 may have a plurality of elongated cells 168 spaced along the length of each arm 164, 166. As a further alternative, the dimensions of the slot 168 may vary depending on the use, application, and clinical requirements.

Each clamp arm 164 and 166 may have a length of about 18mm, but the length may be adjusted based on clinical needs. As shown, each arm 164 and 166 extends across a majority of the area of the respective space 160 and 162. Arms 164 and 166 serve two purposes. First, each arm is located behind a native leaflet and retains the native leaflet between the arm and the stent body. This allows the use of native leaflets to improve the seal between the native anatomy and the prosthesis. In addition, a secondary gripping mechanism may be obtained by capturing the leaflet between adjacent arms. Second, the arm limits protrude to the LVOT, thereby minimizing the impact of the conduction system. Arms 164, 166 are first released and placed such that tips 172 are within the cusps. The tip position can be adjusted by changing the length or angle of the arms 164, 166 and commissure posts. Thus, the tip 172 can be designed to be positioned at an optimal location relative to the inflow end of the heart valve, approximately 4-8mm from the most distal end of the stent 110, thereby limiting protrusion into the LVOT. In addition, the stiffness of the arms 164, 166 can be adjusted by varying the thickness of the arms 164, 166 such that there is more or less bending (flexing) when contacting the native leaflet. The desired embodiment positions the valve prosthesis within the native anatomy such that stent 110 protrusion into the LVOT is minimized and reduces the instances of PPI (permanent pacemaker implantation ). For improved safety, the tips 172 may be provided in a rounded structure and/or wrapped with a protective layer, preferably made of a biocompatible synthetic or biological material.

Each arm 164, 166 in the current embodiment is shaped to be approximately 4mm in diameter than the body 112 of the bracket 110. In other words, the outer diameter formed by tracking the tips 172 of all arms 164, 166 may be equal to or greater than the outer diameter of the body 112 at the circumferential location of the tips 172. This may be shown or represented by space S in fig. 1. This shaped configuration (except that arms 164, 166 are free at one end) allows arms 164, 166 to expand to a larger diameter during delivery. The larger diameter expansion increases the opportunity to capture native leaflets between the arms 164, 166 and the body 112 of the stent 110, thereby increasing the likelihood of proper anatomical placement (anatomical placement) of the prosthetic device 100. As a non-limiting alternative, each of the clamping arms 164 and 166 may extend outwardly in a wave-like fashion to further enhance the clamping positioning of the arms against the native valve leaflet portion of the body 112 without affecting in vivo seating.

An alternative is to provide a varying spacing S of the tips 172 along the circumference of the stent 112. For example, the spacing S may be 4mm at some tips 172 and 3mm at other tips 172.

The stent 110 may be made of nitinol or any other known self-expanding material having superelastic memory properties.

Although the bracket 110 is described above with particular reference to a specific embodiment, this is not intended to limit the invention, and the invention may be configured with different brackets 110.

Referring now to fig. 5-7, the device 100 also has a set of prosthetic leaflets 200a, 200b, and 200c configured as a conventional tricuspid (tri-leaflet) valve. The leaflets 200a, 200b, and 200c can be of any known desired prosthetic material, including processed animal tissue such as porcine tissue and bovine tissue, or synthetic material.

The three leaflets are attached together using sutures and the commissure tabs 206 are created by folding the leaflet tabs back and attaching to the cloth. The commissure tab cloths may be made of synthetic material (e.g., polyester) and help to maintain the sutures when attaching the tissue member (tissue subassembly) to the stent 110. Once formed, the leaflet member (leaflet subassembly) is sewn to the skirt material 205. The skirt is similarly formed from three separate pieces and sewn together. The skirt material 205 may be made of porcine or bovine tissue or a synthetic material. Once the component is formed, the commissure tabs 206 are connected to the stent 110 at the most proximal row (row 130) of cells 116 at locations 208 to form commissures. In one embodiment, the suture between each leaflet 200a, 200b, 200c and skirt material 205 is attached to the stent 110 at the appropriate location using stitches (see attachment points 202), although other attachment methods are possible. In addition, additional stitching is used to secure the skirt material to the stent 110 (between the bottom of the stent 110 and the leaflet attachment). One example of a connection point 202 is a point or location where the leaflet edge connects to the cell 116. The cells 116 in the row 130 will be used for commissure connections and the leaflets will be connected along a curved path that follows the shape of the leaflets through the plurality of cells as shown in fig. 6, the curved path being defined by a plurality of connection points 202. The skirt material 205 is attached across the space from the leaflet attachment to the bottom of the stent.

The device 100 of the present invention provides a number of benefits over existing transcatheter aortic valve implantation devices for treating aortic valve insufficiency disorders.

First, the stent 110 has a plurality of beams or gripping arms 164 and 166 that act as cantilevered beams-like structures designed to securely and easily clasp onto the native aortic valve leaflet. Specifically, during device implantation, the clamping arms 164, 166 are first exposed from the delivery catheter and positioned behind and/or around the native leaflets. Once the device 100 is fully released, the clamping arms 164, 166 will mechanically clasp onto the native leaflets, thereby holding the device 100 in place. The mechanical fastening force may be enhanced by shaping the gripping arms in a configuration where the gripping arms mate with the clip.

Unlike existing JenaValve or J-Valve devices that position three large parabolic or "U" -shaped arches behind three native leaflets, the device 100 of the present invention uses six cantilever beams 164, 166 to clip onto the native leaflets. This provides two main benefits. First, the additional gripping arms or beams increase the likelihood of successful capture of one or more native leaflets, thereby making the procedure easier and safer. Secondly, the primary valve leaflet can be successfully buckled in various modes, so that the anchoring mechanism is safer and more reliable. For example, the leaflets can be fastened by placing all arms 164, 166 behind the native leaflets and securing the native leaflets between the arms 164, 166 and the body 112; or by placing the plurality of arms 164, 166 behind the native leaflet and the plurality of arms 164, 166 in front of the native leaflet, thereby placing the native valve She Koujin between adjacent arms 164, 166. A potential benefit of having tightly positioned gripping arms is that they are designed so that if all arms 164, 166 are located behind the native leaflet, they can be used as a clip against the leaflet back liner (leaf back). In some cases, when some of the arms 164, 166 are not behind the native leaflets, the offset shape allows the closely positioned arms to also clasp the native leaflets and provide better anchoring. For example, there may be clinical situations in which: a plurality of gripping arms 164, 166 are located in front of the native leaflets. This positioning of the gripping arms in front of and behind the native leaflet provides better fastening of the native leaflet than prior devices where the arches must be positioned behind the native leaflet.

Second, the clamping arms 164, 166 also have atraumatic tips (eyelets 172) that may be loaded with radiopaque markers 212 to facilitate visualization during implantation. Additional radiopaque markers 214 (see fig. 16) in the commissure regions 114 may also be provided to allow for comparison of movement between the eyelet 172 and the commissures. Based on the movement of the markers 212, 214 during release, these markers can help identify which gripping arm is behind the leaflet and which gripping arm is in front of the leaflet. For example, a marker that moves in a heart beat rhythm typically helps to indicate that it is touching the lowest point of the native leaflet. By providing radiopaque markers on the gripping arms and commissure regions, the physician can readily ascertain that the gripping arms are behind the native leaflets before the device 100 is fully released. This will make the procedure faster and safer.

Third, the stent 110 provides leaflet retainer or petals She Beichen, and leaflet retainer or petals She Beichen are long struts (i.e., arms 140 and 142) emanating from the post 132. These leaflet retainer structures further clasp the native leaflet to the scaffold 110 while maintaining the native leaflet trapped between the clamping arms 164, 166. These leaflet limiting structures prevent the native leaflet from interfering with the prosthetic leaflet and may also work with the clamping arms to clamp onto the native leaflet.

Fourth, the rack 110 provides a closed cell design, meaning that all of the struts 118 are connected to one another. Such a design allows for recoating of the device 100 because there are no open cells (since any struts of the open cells seize the outer sheath 306) that would inhibit the catheter sheath from retrieving the entire stent 110.

Figures 8-11G illustrate how the device 100 is delivered to and released at the aortic annulus. First, fig. 8 and 9 illustrate the native leaflets 201 clamped or sandwiched between the clamping arms 164, 166 and the body 112 of the stent 110 after the device 100 has been released at the aortic annulus.

Referring now to fig. 10 and 11A-11G, the device 100 is first compressed and held in the delivery system 300. The delivery system 300 shown in fig. 10 is but one non-limiting example and has an outer sheath 306, an inner tube 308 having a dock 310 at its distal end, a distal sheath 302 and distal tip 316 mounted at the distal end of a shaft 312, and a proximal sheath 304. Proximal sheath 304 is mounted at the distal end of outer sheath 306, and inner tube 308 extends within the lumen of outer sheath 306. The interface 310 has a protrusion 320, the protrusion 320 being adapted to be clamped within the aperture 134/136 to retain the stent 110 within the delivery system 300. Shaft 312 is slidably retained within the bore of inner tube 308.

When the device 100 is squeezed or compressed within the delivery system 300 (see fig. 10A and 10C), the commissures 114 are adjacent to the docking portion 310 and the apertures 134/136 are connected to the protrusions 320. The compressed device 100 surrounds the shaft 312 and the proximal sheath 304 covers a majority of the length of the device 100. Distal sheath 302 covers a small length of the distal end of device 100, with the distal end of proximal sheath 304 overlying and covering the proximal end of distal sheath 302. In particular, proximal sheath 304 may have a band 322 at its distal-most end and distal sheath 302 may have a band 324 at its proximal-most end. Bands 322 and 324 may contain radiopaque markers to allow the clinician to visualize during the release process. The device 100 is contained entirely within a capsule (capsule) defined by a distal sheath 302 and a proximal sheath 304.

Referring to fig. 11A, a catheter 300 with the device 100 held therein is introduced through the femoral artery via a puncture wound at the upper thigh region and advanced through the aortic arch and ascending aorta to the location of the aortic annulus 920, and a portion of the capsule passes through the aortic annulus into the ventricle. Next, in fig. 11B, the proximal sheath 304 is retracted such that the distal ends (eyelets 172) of the clamp arms 164, 166 are exposed in the ventricle. In the next step (see fig. 11C), the device 100 is retracted by retracting the delivery system 300 such that the distal ends (eyelets 172) of the clamp arms 164, 166 have left the aortic annulus and are now positioned inside the aortic fixed end. When the distal ends of the clamp arms 172 are positioned over the native aortic valve, the device 100 is advanced distally until the clamp arms 164, 166 fall into the cusps of the native leaflets. See fig. 11D. Due to the three sets of gripping arms 164, 166, there are a total of six gripping arms, which allow the six gripping arms to be spaced apart within the native valve leaflet within the aortic annulus. Next, distal sheath 302 is advanced to expose the distal end of device 100 so that the distal end of device 100 can be released. This is shown in fig. 11E, where the body 112 of the stent 110 is expanding. At this point, the device 100 is secured at the aortic annulus. The proximal sheath 304 is then retracted further to release the commissure regions 114. See fig. 11F. Finally, the distal tip sheath 302 is retracted into the proximal tip sheath 304 and the entire delivery system 300 is withdrawn from the body. See fig. 11G.

The method steps described in connection with fig. 11A-11G provide an advantageous way of adjusting the position of the body 112 of the bracket 110. In particular, a distal sheath 302 is provided to retain the body 112 in its compressed state while the clamping arms 164, 166 are released and positioned within the cusps of the native leaflets. After the clamping arms 164, 166 have been properly positioned, the clinician may then manipulate the stent 110 in its compressed state so that the body 112 may be accurately positioned in the aortic annulus before it is released. The straps 322, 324 may assist the clinician during this positioning step.

Fig. 12-13 illustrate a second embodiment of the bracket 110 of the present invention. The stent 110a in fig. 12 and 13 is very similar to the stent 110 in fig. 1-9, and therefore the same reference numerals as in fig. 1-9 are used in fig. 12 to denote the same elements (except that "a" is added before the reference numerals in fig. 12). The bracket 110a differs from the bracket 110 in three ways.

First, the vertex 146a is not connected to or engaged with the cell 116x of the body 112 a. Thus, a space 158a (rather than a connection site 158) is defined between vertex 146a and the vertices of cells 116x in row 124 a. Breaking the apex 146a and cell 116x and creating space 158a allows the struts 140a and 142a of the flap She Beichen to set more naturally and reduces the stress on the stent 110a during the setting of the stent 110 a.

Second, each clamp arm 164a and 166a may have more than one slot 168a, with the slots 168a being spaced along the length of each clamp arm 164a and 166 a. The inclusion of additional slots 168a allows additional length to be obtained in the clamp arms 164a, 166 a. The length of each clamping arm 164a, 166a is one factor in determining the position of the tip 172a and thus the placement of the device 100 in the native anatomy. In other words, by adding additional slots 168a, the length of each clamping arm 164a, 166a is extended, allowing the device 100 to be in a higher position in the native anatomy. In addition, each gripping arm may be angled more obtuse to allow the tip 172a to be closer to the inflow (distal) end of the stent 110. The reduced distance from the tip 172a to the inflow end (distal end) of the stent 110 allows the device 100 to be in a higher position in the native anatomy, thereby reducing the chance of conductive system interference and thus PPI.

Third, only one eyelet 134a is provided at the commissure post 132a, and the second eyelet 136 is omitted. The device 100 may be provided with a single eyelet or a double eyelet depending on the interface 310. The dual aperture (134+136) configuration may provide a more secure lock with the interface 310 in the delivery system 300, while the single aperture 134a may reduce the overall height of the device 100. Additionally, the dual eyelet configuration may provide a mechanism for additional adjustment of the in vivo position of the arm.

In addition, while the present invention shows the use of an eyelet to clamp the boss 320 within the interface 310, other alternatives to an eyelet may be provided in the post 132 to achieve the same function. As one example, a key structure (key structure) may be used.

Fig. 14 shows a third embodiment of the bracket 110 of the present invention. The bracket 110b in fig. 14 is very similar to the bracket 110a in fig. 12-13, and therefore like reference numerals are used in fig. 14 to refer to like elements in fig. 12-13 (except that "b" is added in the reference numerals in fig. 14). Bracket 110b differs from bracket 110a primarily in that cell 116x is omitted entirely, such that space or distance 158b is greater than space 158a, and the length of arms 164b and 166b is also slightly greater. Eliminating the cells 116x allows additional beam length to be added to the bracket 110. This additional beam length allows the device 100 to be in a higher position in the native anatomy and reduces the risk of PPI. This can be seen in fig. 14, where the tip 172b is positioned lower on the stent 110b than in other embodiments.

Fig. 15 shows a fourth embodiment of the bracket 110 of the present invention. The bracket 110c in fig. 15 is very similar to the bracket 110 in fig. 1-9, so the same reference numerals as in fig. 1-9 are used in fig. 15 to denote the same elements (except that "c" is added before the reference numerals in fig. 15).

A curved bridge 148 may connect each set of first and second arms 140c, 142c at a substantially central location of each set of first and second arms 140c, 142c. Each bridge 148 has a first leg 150 extending from the first arm 140c and a second leg 152 extending from the second arm 142c, and the two legs 150 and 152 are connected at a proximally facing vertex 154. Each set of first and second arms 140c, 142c, and legs 150 and 152 define a generally diamond-shaped space 156. Instead of curved bridges 148, a deformable mesh structure defined by an arrangement of cells may also be provided to connect each set of first and second arms 140c and 142c at a substantially central position thereof.

Fig. 16 shows a fifth embodiment of the bracket 110 of the present invention. The bracket 110d in fig. 16 is very similar to the brackets 110 and 110c in fig. 1-9 and 15, and therefore the same reference numerals as those of fig. 1-9 and 15 are used in fig. 16 to denote the same elements (except that "d" is added in the reference numerals of fig. 16). In this embodiment, additional marking elements are added to the connection ends of the clamping arms 164d, 166 d. This allows additional visualisation to be obtained under fluoroscopy in a clinical situation to better achieve a correct anatomical placement of the device. Based on the movement of the markers 212d, 214 during release, the two markers can help identify which of the clamping arms 164d, 166d is behind the leaflet and which of the clamping arms is in front of the leaflet. For example, a marker that moves in a heart beat rhythm typically helps to indicate that it is touching the lowest point of the native leaflet. By providing radiopaque markers on the clamping arms and commissure regions 114d, the physician can readily ascertain that the clamping arms 164d, 166d are behind the native leaflets before the device 100 is fully released. This will make the procedure faster and safer.

Reviewing and comparing the embodiments of fig. 1 and 12-15, one important aspect of the present invention is shown: the free end (i.e., tip 172) of each clamp arm 164, 166 is positioned along a circumferential line (see, e.g., 222 in fig. 16) of the stent 110 that is closer to the inflow end (distal end) of the stent 110 than the outflow end (proximal end) of the stent 110. The inflow end may be defined by a circumferential line defined by distally facing vertices of the cells 116 in the first row 122, while the outflow end may be defined by a circumferential line defined by proximally facing vertices of the cells 116 in the fifth row 130.

As described in connection with fig. 1, the distal (inflow) end of the body 112 may be flared to provide a mechanism for securing the stent 110 at the native annulus. Fig. 17A, 17B, 18A and 18B illustrate two other embodiments of securing the stent 110 at the native annulus using different mechanisms.

Fig. 17A shows the same stent 110 as fig. 1, but with everting struts 190 extending from the most distal apices of some cells 116 in the row 122. The everting struts 190 may be shaped so as to have one end connected to the most distal apices of some cells 116 in the row 122 and an opposite free end extending at an angle away from the body 112. Fig. 17B shows the position of the struts 110 when the stent 110 is secured at the native annulus.

Fig. 17B shows the same stent 110 as fig. 1, but with everting cells 192 extending from the most distal apices of some cells 116 in the row 122. Each valgus cell 192 has two struts 194 and 196, which struts 194 and 196 connect to form an valgus apex 198. The everting cells 192 may be shaped such that one end of each strut 194, 196 is connected to an adjacent distal-most vertex of some cells 116 in the row 122, and the opposing everting vertex 198 extends at an angle away from the body 112. The cells 192 may even be formed by removing some of the cells 116 from the far-most cell row 120. Fig. 18B shows the position of the cells 192 when the stent 110 is secured at the native annulus.

The size and location of the everting cells 192 may be adjusted depending on the desired application. For example, the length of the struts 190, 194, 196 may vary, and the struts 190, 194, 196 may even be curved. As another example, the everting struts 190 may be disposed on any number of vertices, or in any arrangement. For example, the everting struts 190 may be disposed on alternating vertices. Moreover, the struts 194, 196 of the everting cells 192 need not extend from adjacent vertices, but may extend from two separate vertices separated by one vertex.

While the above description relates to specific embodiments of the invention, it will be understood that many modifications may be made without departing from the spirit thereof. The appended claims are intended to cover such modifications as fall within the true scope and spirit of the invention.

In the following, the stent of the prosthetic heart valve device and the prosthetic heart valve device have different states in different usage scenarios, mainly comprising an inner frame and a clamping arm, wherein the inner frame has a relatively compressed state and an expanded state, and the clamping arm has a corresponding loading state and a release state, wherein the description of the proportional relation of each part of the stent and the spatial structure in the release state refers to the free state of the stent outside the human body without being subjected to the force of surrounding tissues without special emphasis.

With reference to fig. 19-31, the present application discloses a stent 110 for a prosthetic heart valve device, comprising:

the inner frame 103, the inner frame 103 is of a net drum structure, the inner frame 103 has a compression state and an expansion state which are opposite according to radial deformation, and a supporting device (such as a balloon) for driving the inner frame 103 to switch to the expansion state is allowed to be placed in the inner frame 103;

The clamping arms 120, the clamping arms 120 are arranged at the periphery of the inner frame 103 at intervals along the circumferential direction of the bracket 110, each clamping arm 120 is provided with a fixed end 121 and a free end 123 which are opposite, the fixed ends 121 are directly or indirectly connected with the inner frame 103, the fixed ends 121 of the clamping arms 120 of the same group are adjacent to each other, and the clamping arms 120 adopt memory materials and have the following states:

a loading state in which the inner frame 103 is in a compressed state, the clamp arm 120 being attached to the inner frame 103;

a released state, wherein the inner frame 103 is in an expanded state, the free ends 123 of each clamping arm 120 extend radially outward and form a space with the inner frame 103 to allow the native leaflets 201 to enter, the free ends 123 of at least two clamping arms 120 in the same set have a diverging tendency, and the free ends 123 of at least two clamping arms 120 in adjacent sets have a converging tendency.

The net barrel structure of the inner frame 103 is provided with a spatial axis and a circumferential direction distributed around the axis, two axial ends of the net barrel structure are respectively an inflow end 101 and an outflow end 102, the inside of the net barrel structure is a blood flow channel 301, and a supporting device which is allowed to be placed in the inner frame 103 is positioned in the blood flow channel 301.

The artificial heart valve device positioning effect for treating the pure aortic valve insufficiency disease is improved through the structural optimization of the bracket 110 for the artificial heart valve device, and meanwhile, the artificial heart valve device positioning device has the advantages of high production and assembly efficiency, convenient deployment and positioning, good long-term use stability and high durability, and has positive significance for realizing the application of the minimally invasive transcatheter aortic valve implantation device in treating the aortic valve insufficiency treatment scene.

The clamping arms 120 are configured in a relatively independent manner, so that positioning failure caused by incapability of positioning the individual clamping arms 120 in the valve sinus can be avoided, three groups of tricuspid valves are taken as an example, the free ends 123 of at least two clamping arms 120 in each group have a divergent trend, thus greatly increasing available anchor points, and the free ends 123 of at least two clamping arms 120 in two adjacent groups have a closing trend and cater for the anatomical characteristics of the valve sinus. Moreover, the clamping arms 120 can realize self-expansion release by adopting a memory material, the inner frames 103 are released by adopting a supporting device (such as a balloon), and different release modes can be more suitable for two stages of integral release, namely the clamping arms 120 are mainly released in the first stage, and after the clamping arms 120 are in place, the inner frames 103 are released in the second stage, so that the inner frames 103 positioned on the inner side and the outer side of the valve leaflet 200 are mutually matched with the clamping arms 120. Whereas taking the self-expansion as an example for both the inner frame 103 and the clamping arm 120, the configuration of the conveying device is more complicated, two sections of butted or nested inner and outer sheath pipes are needed, the inner frame 103 and the clamping arm 120 are released respectively at different stages, the moving parts of the whole system are increased, and the flexibility is further reduced.

A specific portion may be provided on the inner frame 103 to connect with the fixed end 121 of the clamping arm 120. Referring to fig. 19, the inner frame 103 is provided with at least two coupling regions 114 at intervals in the circumferential direction, and the fixed ends 121 of the clamping arms 120 of the same group are connected to the corresponding coupling regions 114. Specifically, the inner frame 103 is provided with a plurality of connecting areas 114 adjacent to the outflow end 102, and the fixed ends 121 of the clamping arms 120 of the same group are connected to the corresponding connecting areas 114. In the figures, the number of commissure regions 114 is preferably n, where n is the number of leaflets 200 for loading in the stent 110. More specifically, the edge of the outflow end 102 of the inner frame 103 has a peak-to-valley structure, and the commissure regions 114 are located at peak positions (the convex portions toward the outflow end 102 are regarded as peaks). From another perspective, the axial length of the inner frame 103 has a tendency to vary in the circumferential direction of the inner frame 103 and becomes progressively shorter as it moves away from the commissure regions 114. Further, as shown in fig. 25, in the axial direction of the inner frame 103, the inner frame 103 includes a plurality of rows of cells, wherein N rows of cells adjacent to the inflow end 101 respectively extend continuously in the circumferential direction, and the cells of the remaining rows respectively extend discontinuously in the circumferential direction. N is 1, 2 or 3. As can be seen from the figures, the closer the outflow end 102 is to the circumferentially discontinuous rows of cells, the greater the distance between cells in the same row that are spaced apart from each other.

Referring to fig. 26, the commissure regions 114 are commissure posts 132. In fig. 28, each commissure post 132 extends from the outflow end 102 of the inner frame 103. Alternatively, each commissure post 132 can also be configured to extend from the interior of the inner frame 103. In a specific form, the commissure posts 132 are stripe-shaped, extending in a direction coincident with the axis of the inner frame 103 or with the free ends 123 being inclined radially inward. As shown in the figures, commissure posts 132 are solid bars. Alternatively, the commissure posts 132 may also be provided as a bar frame.

Referring to fig. 26, the commissure posts 132 have a plurality of eyelets 1112 thereon. Alternatively, a eyelet 1112 may be provided. In the drawing, a plurality of holes 1112 on the same commissure post 132 are sequentially arranged along the axial direction of the body of the same commissure post 132 to facilitate processing and assembly.

The plurality of commissure posts 132 may be independently disposed, as shown in fig. 26, a second support arm 142 is connected between two adjacent commissure posts 132, a first inclined space 160 is defined between the second support arm 142 and the outflow end 102 of the inner frame 103, and each clamping arm 120 is located in the corresponding first inclined space 160 in the loading state. The first inclined space 160 can provide a moving space and a receiving space for the clamping arm 120, thereby improving the cooperation of the clamping arm 120 with the inner frame. For example: in the loaded state, the inner frame 103 and all the clamping arms 120 do not overlap each other in the radial direction. The fit relationship between the inner frame 103 and the clamping arm 120, which are not overlapped with each other, can optimize the loading state of the inner frame 103, thereby providing more excellent volume performance of the inner frame 103, facilitating the assembly of the system and the development of the treatment process, and the smaller outer diameter can improve the flexibility and facilitate the transportation in vivo. The second support arm 142 may be disposed in a straight line. Alternatively, referring to the drawings, the second support arms 142 between two adjacent commissure posts 132 have a bent portion, i.e., an apex 146, and are generally V-shaped. In fig. 25, the V-shaped apex is fixedly attached to the edge of the outflow end 102 of the inner frame 103. Alternatively, in other embodiments, the V-shaped apex and the outflow end 102 edge of the inner frame 103 may be free.

The second bracket arm 142 may be provided independently. Alternatively, referring to fig. 25, a leg 141 is connected to the inner corner side of the V-shape, and the middle of the leg 141 is bent to form a vertex 154, and the vertex 154 protrudes in the direction of the dotted arrow in the figure.

The second bracket arm 142 is V-shaped with its apex 146 projecting in a direction opposite the apex 154 and secured to a corresponding portion of the bracket 110 at the outflow end 102. The second support arm 142 is of a single bar construction or a deformable mesh belt construction.

Similar to the peak-and-trough structure above, in the present embodiment, the axial length of the inner frame 103 has a tendency to vary in the circumferential direction of the inner frame 103, and becomes gradually shorter as it is farther from the commissure regions 114. In the axial direction of the inner frame 103, the inner frame 103 includes a plurality of rows of cells, wherein N rows of cells adjacent to the inflow end 101 extend continuously in the circumferential direction, respectively, and the remaining rows of cells extend discontinuously in the circumferential direction, respectively. N is 1, 2 or 3. In each row of circumferentially discontinuous cells, the closer to the outflow end 102, the greater the distance between cells in the same row that are spaced apart from each other.

Referring to fig. 19 to 23b, one end of the clamping arm 120 is a fixed end 121 connected to the corresponding commissure region 114, and the other end is a free end 123 distant from the commissure region 114, and the free ends 123 of the clamping arms 120 of two adjacent commissure regions 114 are adjacent to each other in the circumferential direction.

In order to better observe the position state of the clamping arm 120 during treatment, a developing point 173 is provided on the clamping arm 120. There are one or more developing points 173, and at least one developing point 173 is adjacent to the free end 123 of the holding arm 120. Further, the developing points 173 have a plurality of positions, at least one developing point 173 is adjacent to the free end 123 of the holding arm 120, and at least one developing point 173 is adjacent to the fixed end 121 of the holding arm 120. The developing points may be provided separately or may share the hole sites with other structures. For example, in fig. 20c, the free end 123 of the clamping arm 120 is provided with an eyelet 551. Wherein the perforations 551 may be used to configure the development dots 173, or may be used to form rounded structures.

In order to reduce damage to the native tissue and surrounding tissue by the clamping arm 120, the free end 123 of the clamping arm 120 is rounded 1221 as shown in the drawings. Likewise, the free ends 123 of the clamping arms 120 may be provided with a protective coating. The shield and the rounded structures 1221 may be provided in combination.

Further, the clamping arm 120 has a deformed configuration. The deformed structure may have a variety of arrangements. For example, in fig. 25, the clamping arm 120 is provided with a slot 168. The number of slots 168 may be provided as one or more. The slot 168 can allow the clamp arm 120 to gain additional length in the released state. The length of the clamp arm 120 is one factor in determining the position of the fixed end 121 of the clamp arm 120 and thus the position of the bracket 110 in the as-manufactured anatomical structure. Thus, by adjusting the number, location, and size of the slots 168, length adjustment of the clamp arms 120 can be achieved, thereby enabling a greater range of adaptation of the prosthetic valve relative to physiological structures. The slot 168 may also embed a developing mark when smaller.

With respect to the same commissure zone 114, the number of clamping arms 120 located on the same side of the commissure zone 114 along the circumferential direction of the inner frame 103 is one or more. Referring to the embodiment shown in fig. 19, the clamping arms 120 on the same side of the commissure regions 114 are single, the free ends 123 of the single clamping arms 120 are bifurcated or the middle of the single clamping arms 120 are bifurcated and the free ends 123 are integrated (e.g., as shown in fig. 25). Alternatively, the plurality of gripping arms 120 on the same side of the commissure regions 114 (e.g., as shown in fig. 23 b), the plurality of gripping arms 120 being independently configured or integrated at the free ends 123.

In the drawings, the clamping arm 120 has a single-rod structure. It will be appreciated that the clamping arms 120 may also be provided as deformable webbing.

In the released state, the angle between the clamping arm 120 and the inner frame 103 in the axial direction is in the range of 30 to 85 degrees. Where reference is made to the line between the ends of the clamping arm 120 when measuring the angle.

In the form of the distribution of the clamping arms 120, the clamping arms 120 on opposite sides of the same commissure zone 114 are symmetrically distributed. The clamping arms 120 are symmetrically distributed between two adjacent commissure regions 114 in the circumferential direction of the inner frame 03.

Fig. 30a to 31 show the fitting relationship of the clamping arms 120 and the inner frame, wherein each clamping arm is connected to the inner frame by riveting, and in fig. 30a to 30d, the connection position of the clamping arm is located on the outer peripheral surface of the inner frame, and in fig. 31, the connection position of the clamping arm is located on the inner peripheral surface of the inner frame. It will be appreciated that the clamping arms shown in fig. 30a to 30d may also be attached to the inner peripheral surface of the inner frame.

The fixing ends 121 of the clamping arms 120 may be connected to the inner frame 103 independently or after intersecting each other, and in the embodiment shown in fig. 26 to 29, the fixing ends 121 of the clamping arms 120 of the same group are converged to the connecting portion 310 and fixed to the inner frame 103 by the connecting portion 310. The connection portion 310 and the clamping arm 120 joined to the connection portion 310 may be integrally formed, for example, by cutting or braiding. Further, the clamping arms 120 of the same group are distributed on both sides of the connecting portion 310 along the circumferential direction of the inner frame 103. In a specific product, the inner frame 103 is circumferentially provided with at least two commissure regions 114 at intervals, and the connecting portions 310 are respectively fixed to the commissure regions 114 on the inner frame 103 by welding or fixing through connecting members 315.

The connection portion 310 has an advantage in that it enables the connection of the clamp arm 120 and the inner frame 103 to be better achieved while achieving different expansion characteristics of the two. Further, the fit of the connecting portion 310 and the union region 114 may vary. For example, referring to fig. 24a, the connection portion 310 is overlapped outside the commissure regions 114 in the radial direction of the inner frame 103. Referring to fig. 31, the connection portion 310 is overlapped on the inner side of the commissure regions 114 in the radial direction of the inner frame 103. Referring to fig. 26, the connection 310 is circumferentially laterally, i.e., radially, non-overlapping, to the commissure regions 114 along the circumference of the stent 110. Referring to fig. 28 and 129, the connecting portion 310 covers the top of the commissure regions 114. The bonding sites in the manner of fig. 26, 28 and 29 are more hidden than the manner of fig. 24a and 31 and are not easily represented in the actual drawings, so that the specific bonding sites are indicated by the bold line L in the drawings. The different ways described above have different advantages in terms of assembly difficulty, bulk in the loaded state.

When the fixing manner is fixing by the connection member 315, a specific implementation of the connection member 315 may be provided as shown in fig. 24b to 24 d. The connecting member 315 is a fixing member penetrating through the connecting portion 310 and the connecting region 114, and specifically referring to fig. 24b, bolts, rivets, binding wires, etc. are used as the connecting member 315; referring to fig. 24c, an intermediate layer such as an adhesive layer may be used; reference is also made to fig. 24d, which illustrates various ways of coating the structure.

Referring to fig. 28, the connection portions 310 corresponding to the clamping arms 120 of the same group are integrally formed. Referring to fig. 29, the connection portions 310 corresponding to the same group of clamping arms 120 may be separate structures adjacent to each other. Further, the split structure includes a plurality of units 321, each of which is relatively independent and is connected to the connecting region 114 of the inner frame 103, or the plurality of units 321 are fixed to each other, and at least one of the units 321 is connected to the connecting region 114 of the inner frame 103.

The connection portion 310 may also be provided with a developing hole 3101 for mounting a developing element in order to provide a finer viewing effect, in the same manner as the developing arrangement on the chucking arm 120.

The clamping arm 120 can also be correspondingly optimally arranged in its own form. The different arrangements of the gripping arms can be seen from different perspectives in connection with fig. 20a to 20d, fig. 22a to 22d, and fig. 23a to 23 b.

The view angles in fig. 20a to 20d are front view angles in fig. 19, and can be understood as a state in which the clamp arm projects on the paper surface in this direction. When the clamp arm is not disposed in a configuration relative to the paper surface, it can be understood as a flattened state of the clamp arm.

Fig. 22a to 22d are released states of the clamp arm in a cylindrical coordinate system, wherein a broken line is shown as a reference of the cylindrical coordinate system. For better understanding of the three-dimensional configuration of the clamping arm in a two-dimensional picture, the cylinder of the cylindrical coordinate system in the figure is also drawn to approximate the size of the bracket, which can be approximately understood as the spatial relationship of the bracket and the clamping arm.

Fig. 23a to 23b are plan views of fig. 19, which can be understood as a state in which the clamp arm is projected on the paper surface in this direction. When the clamp arm is not disposed in a configuration relative to the paper surface, it can be understood as a flattened state of the clamp arm.

Referring to fig. 20d, 22c and 22d, the clamp arm 120 is a wave structure 330 adjacent the free end 123. In the figures, the undulation of the wave structure 330 is mainly reflected in the axial direction of the support 110. It will be appreciated that the clamping arm 120 can have undulations in multiple dimensions in three-dimensional space. Referring to fig. 23a and 23b, the clamping arms 120 have a radial undulating configuration as viewed axially of the inner frame 103. The undulations of the multiple dimensions can be independently arranged or superimposed on one another to form a complex three-dimensional configuration.

The clamping arms 120 may be divided into a plurality of groups according to the location of the fixed end 121. Each set of clamping arms 120 may include one or more pairs of clamping arms 120. In the embodiment shown in fig. 23b, the same pair of clamping arms is formed by a plurality of pairs, and the clamping arms 120 of the same pair are located at two sides of the connecting portion 310 along the circumferential direction of the inner frame 103, and the lengths of the extending clamping arms 120 of different pairs are different.

From another perspective, the same pair of clamping arms 120 are multiple pairs, and the clamping arms 120 of the same pair are located at two sides of the connecting portion 310 along the circumferential direction of the inner frame 103, and in the released state, the extending trends of the clamping arms 120 of different pairs are different at the same side of the connecting portion 310.

The different arrangements described above are mainly for achieving a three-dimensional spatial posture of the clamp arm 120 in the released state. Further, referring to fig. 23a, in the released state, the free ends 123 of the same set of gripping arms 120 are positioned at the same radial position of the inner frame 103. Referring to fig. 23b, in the released state, the free ends 123 of the clamping arms 120 of the same group are staggered in position in the radial direction of the inner frame 103. But in the released state, in its entirety, the free ends 123 of all the clamping arms 120 are axially located between the two ends of the inner frame 103. The space between the two ends of the inner frame 103 is understood in this embodiment to be the space between the inflow end 101 and the outflow end 102 of the inner frame 103, so as not to affect the release and positioning of the bracket 110 by the clamping arms 120.

In the case where the plurality of holding arms 120 are fitted to each other, the above-mentioned uniform arrangement may be referred to, and the differential arrangement may be referred to in the embodiment shown in fig. 20 e. Embodied in different sets, adjacent clamp arms 120 have different lengths. Further, the clamping arms 120 of the same group may be arranged differently. It is mainly shown that the two clamping arms 120 have different lengths in the same group. In addition to the difference in the extension length of the clamping arms 120, the free ends of adjacent two clamping arms are staggered in different groups in the circumferential direction of the inner frame. In the drawings, the gripping arm 120 has a turning point adjacent to its free end to effect adjustment of the direction of extension of itself. In the released state, in different groups, the turning part of one of the two adjacent clamping arms semi-surrounds the other free end, and the positioning effect of the clamping arms 120 on the native valve leaflets can be further optimized.

Referring to fig. 32-37 j, the present application discloses a stent 110 for a prosthetic heart valve device, comprising:

A connecting ring 340 fixed to the outflow end 102 of the inner frame 103 and provided with a plurality of connecting areas 341 at intervals; and

the clamping arms 120, the clamping arms 120 are arranged at the periphery of the inner frame 103 at intervals along the circumferential direction of the bracket 110, and each clamping arm 120 is provided with a fixed end 121 and a free end 123 which are opposite; the fixed ends 121 of the clamping arms 120 of the same set are in the same connection region 341.

The clamping arm 120 is made of a memory material and has the following states:

a released state, wherein the inner frame 103 is in an expanded state, the free ends 123 of the respective clamping arms 120 extend radially outward and form a space with the inner frame 103 to allow access to the native leaflets 201.

In this embodiment, the plurality of groups of the clamping arms 120 are connected through the connection ring 340, so that a more flexible arrangement mode is realized, and a structural basis is provided for independent arrangement of the clamping arms 120 and the inner frame 103. As a whole, the free ends 123 of at least two clamping arms 120 in the same group have a divergent tendency, and the free ends 123 of at least two clamping arms 120 in adjacent groups have a convergent tendency. Each of the clamping arms 120 forms a deformable space release structure around the periphery of the inner frame 103. In a specific connection form of the clamping arm 120, the connection with the inner frame can be achieved by means of a connection 310. In particular, reference may be made to an embodiment in which the connecting portion 310 is superimposed on the outside of the commissure regions 114 in the radial direction of the inner frame 103. Or with reference to another embodiment, the connecting portion 310 is overlapped on the inner side of the commissure regions 114 in the radial direction of the inner frame 103. Or with reference to yet another embodiment, the connection 310 is circumferentially laterally, i.e., radially, non-overlapping, of the commissure regions 114 along the circumference of the stent 110. The bonding sites in the modes shown in fig. 38e and 38f are hidden and are not easy to be represented in practical drawings, so that the specific bonding sites are shown with thicker thickness. The different ways described above have different advantages in terms of assembly difficulty, bulk in the loaded state.

In a specific manner of attachment of the clamping arms 120, reference is made to fig. 33a, in which the fixed ends 121 of the clamping arms 120 of different groups are located at different attachment areas 341. In the detail of the arrangement of the connection ring 340, referring to fig. 36a, the connection ring 340 is coupled around the outer circumference of the inner frame 103. Or as shown with reference to fig. 35, the connecting ring 340 is connected to one side of the inner frame 103 in the axial direction. Further, the connecting ring 340 is a radially deformable structure. In a particular product, the attachment ring 340 may be provided as a mesh belt structure. Referring to fig. 34a and 34a, the connection ring 340 is in the shape of a single strand bar, extends along the circumference of the inner frame 103, and has a wave structure 330 that undulates axially of the inner frame 103.

In the released state, the connecting ring 340 and the clamping arm 120 form a separate spatial structure. The mating relationship between the attachment ring 340 and the inner frame 103 thus has more free design space. Referring to fig. 35, the inflow end 101 of the connecting ring 340 interfaces with the outflow end 102 of the inner housing 103. This arrangement enables mutual displacement of the connecting ring 340 and the inner frame 103 in the axial direction. Further, a second inclined space 342 is defined between the inflow end 101 of the connecting ring 340 and the outflow end 102 of the inner frame 103, and each clamping arm 120 is located in the corresponding second inclined space 342 in the loading state. In a specific connection position, the connection ring 340 is connected to the inner frame 103 via the first position 343 and/or the second position 344, and the different connection positions and numbers can adjust the mechanical performance of the connection ring 340, thereby affecting the athletic performance of the clamping arm 120. The clamping arm 120 is connected to the connecting ring 340 by a second position 344, and the first position 343 and the second position 344 are offset from each other in the circumferential direction of the inner frame 103 by 360/2n, where n is the number of leaflets 200 to be loaded in the stent 110. In the figures, the stent 110 is shown as tricuspid valve, so that the first position 343 and the second position 344 are angularly displaced by 60 degrees.

Independent of the arrangement described above, the interface between the connecting ring 340 and the inner frame 103 is radially non-overlapping. The connecting ring 340 and the inner frame 103, which are not overlapped with each other, can achieve better compression volume performance, thereby providing a more excellent structural basis for the treatment process.

The connecting ring 340 and the inner frame 103 can be arranged separately and independently in an axial dislocation and a radial dislocation, and can also be arranged cooperatively with each other as shown in the accompanying drawings.

In a specific connection relationship between each set of clamping arms 120 and the inner frame 103, see fig. 35, the fixed ends 121 of the same set of clamping arms 120 converge into a connecting ring 340, the connecting ring 340 being adjacent the outflow end 102 of the inner frame 103. As shown in fig. 35, the attachment ring 340 is rigidly secured to the union region 114. As shown in fig. 36a and 36b, the attachment ring 340 and the commissure regions 114 are free of play with respect to each other. In order to achieve the constraining effect of the clamping arms 120 on the inner frame 103, it will be appreciated that axial spacing between the attachment ring 340 and the union region 114 needs to be met. In a specific implementation form, the method can be set as follows: the connecting ring 340 is movably matched with the commissure zone 114 along the circumferential direction of the bracket 110 and is limited axially; or (b)

The connecting ring 340 is movably matched with the commissure zone 114 along the radial direction of the bracket 110, and is limited in the axial direction.

In addition to the usual rigid connection, the connection ring 340 can also be connected to the union region 114 by a flexible element 345, as shown in fig. 36a to 36 d. In a specific implementation, the flexible member 345 is movably threaded through the inner frame 103 and changes the allowable axial movement travel between the inner frame 103 and the clamping arms 120 when the inner frame 103 is switched state. The flexible member 345 may be implemented by using a binding wire made of a polymer material, a deformable member made of metal or plastic, or the like. In a specific construction, the pliable component 345 may be a monofilament as shown in fig. 36a or a mesh belt as shown with reference to fig. 36 b.

The connection between the connection ring 340 and the clamping arms 120 may be made by, in addition to the alternatives mentioned above, referring to fig. 34a and 34b, the connection ring 340 being integrally formed with each clamping arm 120. Further, the connection ring 340 and each of the clamping arms 120 are formed by winding a wire. In a particular product, the wire is a single continuous piece. The metal wire can be made of alloy material with memory effect.

Referring to fig. 37a, the present application also discloses a stent 110 for a prosthetic heart valve device, comprising:

the inner frame 103, the inner frame 103 is of a net drum structure, and has a compression state and an expansion state which are opposite according to radial deformation, and a supporting device for driving the inner frame 103 to switch to the expansion state is allowed to be placed in the inner frame 103;

Clamping arms 120, each clamping arm 120 having opposite fixed and free ends 121, 123, wherein the fixed ends 121 are connected to the inner frame 103, and the clamping arms 120 satisfy at least one of the following conditions compared to the axis of the inner frame 103:

the central angle of the circumferential distribution area M1 of the fixed end 121 is larger than 15 degrees compared with the axis; and

the length of the axially distributed area M3 of the fixed end 121 is greater than 5mm.

The clamping arm 120 is made of a memory material and has the following states:

An implementation of a set of gripping arms 120 in a reinforced arrangement is shown in fig. 37 a. The present embodiment adopts a manner of combining a supporting device (e.g., a balloon) with self-expansion, and optimizes the shape characteristics or the size of the independently configured clamping arms 120 to realize the strengthening arrangement of the self-strengthening device, so that the positioning effect of the self-strengthening device on the native valve leaflet 201 can be improved. The clamping arm 120 of the present embodiment has a more stable positioning effect than the clamping arm 120 of a single rod or the like.

In particular, an improved way is proposed for the circumferentially distributed area M1 and the axially distributed area M3 of the fixed end 121 of the single clamping arm 120, guaranteeing the strength of the connection of the single clamping arm 120 to the inner frame 103 and the ability to remain shaped spatially.

In the connection form of the clamping arm 120 and the inner frame 103, the connection can be realized by adopting an independent connection ring as shown in fig. 37b to 37m, and then the connection ring and the inner frame 103 are connected to form a split bracket, or the clamping arm 120 can be directly connected with the inner frame 103 to form an integrated bracket as shown in fig. 28a to 38 f. In fig. 37k, 37l, and 37m, the connecting ring and each of the clamp arms 120 are formed by winding a wire, and of course, the shape of each of the clamp arms 120 in fig. 37k, 37l, and 37m is different. In fig. 37l, the clamping arms 120 extend mainly in the axial direction of the inner frame 103, and then the steering direction extends mainly in the circumferential direction of the inner frame 103, and as shown in fig. 37m, the clamping arms 120 of the same group may be asymmetrically arranged.

Referring to fig. 37a to 38f, the clamping arms 120 are arranged in groups, and the fixed ends 121 of the clamping arms 120 of the same group are adjacent to each other. As can be seen from a comparison of fig. 37b and 37d, the free ends 123 of the clamping arms 120 can be moved apart or closer together to achieve different positioning effects. In order to avoid interference of the plurality of clamping arms 120 in the circumferential direction, in the sizing of the clamping arms 120, a circumferential distribution area M4 of the fixed ends 121 of each group of clamping arms 120 is 360/n or less compared to the central angle of the axis, where n is the number of leaflets 200 for loading in the holder 110. In the embodiment shown in the drawings, the bracket 110 is a tricuspid valve, so that the central angle of the circumferentially distributed area M3 of the fixed end 121 of each set of clamping arms 120 is less than or equal to 120 degrees compared with the axis.

The circumferential distribution area M1 of the fixed ends 121 of the single clamping arms 120 has a central angle of 360/2n or less with respect to the axis, where n is the number of leaflets 200 for loading in the holder 110. Similarly, in the technical solution shown in the drawings, the central angle of the circumferentially distributed area M1 of the fixed end 121 of the single clamping arm 120 is less than or equal to 60 degrees compared with the axis.

The above-described parameter setting has an advantage in that the problem of a decrease in the degree of freedom of movement of the clamp arm 120 due to an increase in the size of the clamp arm 120 can be avoided, thereby ensuring the positioning effect.

Referring to fig. 37b, 37c and 38f, the circumferential distribution area M1 is shown as a projection size of the fixed end 121 of the clamping arm 120 in the circumferential direction of the inner frame 103, and similarly, the axial distribution area M3 is shown as a projection size of the fixed end 121 of the clamping arm 120 in the axial direction of the inner frame 103. As can be seen from fig. 38e and fig. 28f, the circumferential distribution area M1 and the axial distribution area M3 are adjusted according to different arrangements of the fixing ends 121. Meanwhile, the specific joint (shown by the bold solid line) between the clamping arm 120 and the inner frame 103 will also vary accordingly.

Overall, the clamp arm 120 is represented as a sheet-like structure having a certain projected area on the peripheral surface of the inner frame 103. As can be seen from fig. 37a, 37d and 38a, the clamping arms 120 have a curved path as a whole when extending from the fixed end 121 to the free end 123, and the two clamping arms 120 of adjacent groups cooperate with each other to further adapt to the shape of the valve sinus 204, for example, the two clamping arms 120 of adjacent groups gradually converge in shape from the outflow end 102 to the inflow end 101 as a whole, i.e., the span in the circumferential direction of the inner frame 103 gradually decreases until the free ends 123 approach each other. In a curved specific path, as shown in fig. 37a, the gripping arms 120 extend uniformly in the circumferential and axial directions of the inner frame 103; as shown in fig. 38d, the clamp arm 120 extends mainly in the circumferential direction of the inner frame 103, and then turns to extend mainly in the axial direction of the inner frame 103; reference may also be made to fig. 38j.

Between the fixed ends 121 of the two adjacent clamping arms 120, at least a space area M2 is provided in the circumferential direction of the inner frame 103, and the space area M2 is greater than 30 degrees, for example, 60-120 degrees, compared with the central angle of the axis, so that the space area M2 can reduce the interference of the clamping arms 120 of the adjacent clamping arms and reduce the risk of simultaneous failure.

In the specific form of the clamping arms 120, each clamping arm 120 has a multi-rod structure from a fixed end 121 to a free end 123. Any of which is a multi-bar structure is understood to mean that in a selected direction there are at least two bars of the gripping arms 120 extending through the direction. The particular direction may be one or more of axial, radial, and circumferential to the stent 110. Or referring to fig. 37e, each clamping arm 120 is in a mesh belt structure, the mesh belt structure is formed by surrounding rods, at least two rods are arranged at each position of the extending direction of the clamping arm 120, if a single rod extending structure exists, the strength of the position is reduced, and the overall strength and the positioning effect are affected. The web structure is generally considered a sheet-like structure, and the web of this form of clamping arm 120 may extend in a single layer or may traverse in double layers from the fixed end 121 to the free end 123. Further, the clamping arms 120 of the mesh belt structure may be formed into an integral sheet structure through filling the hollow areas, and the specific material for filling may be selected from a polymer material or a metal material, that is, a sheet structure that is relatively closed in space. When the material of the filling is the same as that of the rod of the clamping arm 120, the clamping arm 120 is integrally formed as a leaf-shaped metal sheet.

Accordingly, the clamping arm, which is entirely of sheet metal, may have a problem in switching between the loading state and the release state. Referring to the embodiment shown in fig. 38g, the portion of the clamping arm 120 adjacent the free end 123 is a non-deformable rigid portion 313. The non-deformability of the rigid portion 313 is understood to mean that in the design concept, deformation of the portion is not desired, but rather an absolute rigid body in terms of mechanics. Referring to fig. 38i, in the loaded state and the released state, the rigid portion 313 maintains the same or similar shape and form. The resistance to deformation of the rigid portion 313 is significantly higher than that of other portions of the clamping arm 120, particularly the flexible portion 314, which is described below. In a specific implementation form, the rigid portion 313 may be implemented by different arrangements of materials, or may be implemented by a structure, as shown in the drawings, in which the rigid portion 313 is a sheet-like solid structure.

The rigid portion 313 is configured to concentrate the self-deformation of the clamping arm 120 on the fixed end 121, which can be achieved by weakening the mechanical property of the fixed end, and in an embodiment, the fixed end 121 of the clamping arm 120 is a flexible portion 314 capable of deforming; or with reference to another embodiment, the same set of clamping arms 120 are interconnected by a deformable flexible portion 314. The two embodiments described above differ in that the flexible portion 120 is provided on the clamping arm 120 or provided separately from the clamping arm 120. The flexible portion 314 may be implemented by different materials or by structural arrangements, such as a mesh belt in the drawings.

The cooperation between the rigid portion 313 and the flexible portion 314 is expressed as a distribution ratio of the two on the clamp arm. In principle, the rigid portion represents at least 50% of the total length of the clamping arm in the direction of extension of the clamping arm. Further, referring to fig. 38g, the ratio may be adjusted to 65% or more.

The main function of the flexible portion 314 is to achieve a deformation of the rigid portion 313 relative to the inner frame, i.e. a switching between a loading state, in which the clamping arms of the same group are brought close to each other and around the outer periphery of the inner frame, as shown in fig. 38i, and a release state. Wherein with reference to fig. 38h, the clamping arms do not overlap each other in the radial direction of the inner frame, thereby improving the overall volumetric performance of the stent in the loaded state. From another angle, the sum of the projection lengths of the clamping arms in the axial direction of the bracket is smaller than or equal to the circumferential length of the bracket. In the illustrated embodiment, the projected lengths of the respective clamp arms in the axial direction of the bracket are equal.

In the case where the plurality of holding arms 120 are fitted to each other, the above-mentioned uniform arrangement may be referred to, and the differential arrangement may be referred to in the embodiment shown in fig. 20 e. Embodied in different sets, adjacent clamp arms 120 have different lengths. Further, the clamping arms 120 of the same group may be arranged differently. It is mainly shown that the two clamping arms 120 have different lengths in the same group. In addition to the difference in the extension length of the clamping arms 120, the free ends of adjacent two clamping arms are staggered in different groups in the circumferential direction of the inner frame. In the drawings, the gripping arm 120 has a turning point adjacent to its free end to effect adjustment of the direction of extension of itself. In the released state, in different groups, the turning part of one of the two adjacent clamping arms semi-surrounds the other free end, and the positioning effect of the clamping arms 120 on the native valve leaflets can be further optimized. This asymmetric arrangement is also applicable to the embodiment shown in fig. 37 m.

Attachment members may also be provided on the clamping arms 120, and referring to fig. 37f and 37g, each clamping arm 120 includes a spatially enlarged locating feature 311. The positioning structure 311 can help the clamping arm 120 better achieve positioning of the native leaflet 201, avoiding separation of the clamping arm 120 from the valve sinus 204. In particular, in fig. 37g, the positioning structure 311 is located in correspondence of the free end 123 of the gripping arm 120 and forms a spatially enlarged condition by extension of the material of the gripping arm 120 itself. Further, the positioning structure 311 is in a sphere shape that expands in space. In fig. 37f, the locating feature 311 is a thickened region on the clamping arm 120. Embodied as edge thickening. The positioning structure 311 is located on a side edge of the clamping arm 120 extending from the fixed end 121 to the free end 123. I.e., where the positioning mechanism is located where the clamping arm 120 contacts the bottom or edge of the valve sinus of the native leaflet 201. The positioning structure 311 may be in the form of a positioning ball, a positioning flange, a positioning bump, etc. Alternatively, referring to fig. 37h, different positioning structures 311 can be provided on the same clamping arm 120 to cooperate with each other.

In addition to the positioning structure 311, referring to fig. 37i and 37j, each clamping arm 120 may be further covered with an adapting member 3120, where the adapting member 3120 is a woven structure or integrally formed. The adaptation set 3120 can provide a richer function for the clamp arm 120. For example, the fitting 3120 is made of a polymer material having biocompatibility. In this approach, the adaptation set 3120 enables the attachment and fixation of surrounding tissue to the clamp arm 120, thereby further enhancing the positioning effect. For example, a medicine carrying space is provided on the fitting sleeve 3120. The drug delivery space may be a separate space structure or may be a braided gap on the adaptation sleeve 3120 of the braided structure mentioned above. In this scenario, the adaptation group 3120 may be through a drug assisted treatment process. As can be seen with reference to fig. 37j, the fitting pin 3120 and the positioning structure 311 described above can be provided on the same clamping arm 120 to fit each other.

Similar to the other clamping arms 120, referring to fig. 38a, the line between the center P1 of the fixed end 121 and the center P2 of the free end 123 of each clamping arm 120 is a clamping path, which is not coplanar with the axis of the inner bracket 110. In the process of cooperating with the native valve leaflet 201, referring to fig. 38b, the overall size of the clamping arm 120 is increased to better adapt to the shape of the valve sinus 204, thereby achieving a better positioning effect.

With reference to fig. 38c to 38f, the present application discloses a prosthetic heart valve device based on a clamping arm 120 with reinforcement, which includes a stent 110 and a leaflet 200 in the above-mentioned technical solution, wherein the leaflet 200 is connected to the stent 110 and is located in a blood flow channel 301, and the leaflet 200 is a plurality of pieces that cooperate with each other to change the opening or closing trend of the blood flow channel 301.

The inner and/or outer side of the inner frame 103 may also be provided with a cover 220. The two circumferentially adjacent leaflets 200 are joined to the inner frame 103 at a joint region 211 therebetween, and each of the commissure regions 114 corresponds to a corresponding one of the joint regions 211 in the circumferential direction of the inner frame 103.

The specific operation of the prosthetic heart valve device 100 is known from the above description of the stent, and will not be described in detail herein. The delivery process for the prosthetic heart valve device 100 will be described in more detail below with respect to a delivery system.

In conjunction with the foregoing, it will be appreciated that the present application further discloses a prosthetic heart valve device 100, including a stent 110 and a leaflet 200, where the stent 110 is any stent 110 in the foregoing technical solution, the leaflet 200 is connected to the stent 110 and is located in a blood flow channel 301, and the leaflet 200 is a plurality of pieces that cooperate with each other to change the opening or closing trend of the blood flow channel 301.

The specific operation of the prosthetic heart valve device 100 is known from the description of the stent and the description of the stent in connection with fig. 39 a-39 b, and is not repeated here. The delivery process for the prosthetic heart valve device 100 will be described in more detail below with respect to a delivery system.

The leaflet 200 and cover film 220 can be provided by any known prosthetic material, including processed animal tissue, such as porcine tissue and bovine tissue, or synthetic materials. The leaflet 200 and cover 220 can be attached to the stent 110 by existing suturing means.

Referring to fig. 41 a-41 c, the present application also discloses a delivery system 400 for a prosthetic heart valve device 100, comprising:

A support 404 that is fluid-switchable between inflated and deflated conditions;

an outer sheath 405 is slidably fitted over the outer periphery of the support device 404, and the radial clearance between the outer sheath 405 and the support device 404 is a loading area 406 for placement of the prosthetic heart valve device 100 in a compressed state.

42 a-43 d, the present application further discloses a positioning method of the prosthetic heart valve device 100, for positioning the prosthetic heart valve device 100 according to any one of the above technical solutions, where the positioning method includes:

delivering the prosthetic heart valve device 100 to a predetermined location using the delivery system 400, wherein the inner frame 103 is in a compressed state, the clamping arms 120 are in a loaded state, and the support device 404 is in a contracted state during delivery;

actuating the outer sheath 405 releases the free end 123 of the clamping arm 120, releasing the free end 123 of the clamping arm 120 to extend;

adjusting the position of the inner frame 103 so that the free end 123 of the at least one clamping arm 120 is located outside the native leaflet 201;

the support device 404 is driven to an inflated state, the inner frame 103 and the fixed end 121 of the clamping arm 120 are released, the inner frame 103 is brought into an inflated state, and the clamping arm 120 is brought into a released state.

Optionally, before adjusting the position of the inner frame 103, the support device 404 is driven to a pre-inflated state, so that the inner frame 103 is in an intermediate state between the compressed state and the inflated state, and the clamping arm 120 is in an intermediate state between the loaded state and the released state, so as to achieve accurate adjustment of the position of the inner frame 103.

The following operations of the positioning method are specifically explained with reference to the specific drawings:

referring to fig. 42a and 42b, the conveying means conveys the inner frame 103 to a predetermined position in a compressed state while the clamp arm 120 is in a loaded state; in the figures, the delivery device passes through the native leaflet 201 site first after entering the target site from the aortic arch; the particular puncture path may be via the carotid or femoral artery or other feasible location.

Referring to fig. 42 c-42 d, the delivery device releases the clamp arm 120, releasing the free end 123 of the clamp arm 120 from extension; in this embodiment, the clamping arms 120 are released to extend over the inflow end 101 of the native leaflet 201;

referring to fig. 42e, the holder 110 is positioned such that the free ends 123 of the clamping arms 120 are positioned outside the native leaflets 201, holding the inner frame 103 inside the native leaflets 201; in this embodiment, the manner of adjusting the position of the stent 110 is achieved by retracting the delivery assembly, thereby improving the mating effect of the gripping arms 120 and the native leaflets 201;

referring to fig. 42f, the support device 404 is driven to an inflated state, releasing the inner frame 103 and the fixed end 121 of the clamping arm 120, bringing the inner frame 103 into an inflated state, the clamping arm 120 into a released state, and the inner frame 103 interacts with at least one clamping arm 120 to clamp the native leaflet 201;

Referring to fig. 42g, the support device 404 is retracted and the delivery device is retracted to complete the transcatheter therapeutic procedure.

During a particular operation, because expansion of the inner frame affects the positioning of the clamping arms, certain operations can be performed to reduce the impact of the problem on the positioning effect.

Referring to fig. 43a to 43d, before adjusting the position of the inner frame 103, the supporting device 404 is driven to a pre-inflated state, so that the inner frame 103 is in an intermediate state between the compressed state and the inflated state, and the clamping arm 120 is in an intermediate state between the loaded state and the released state, so as to achieve accurate adjustment of the position of the inner frame 103; the intermediate inner frame 103 can release the stroke of the clamping arm 120 to a greater extent, so that the clamping arm 120 is closer to the final form before the position of the inner frame 103 is adjusted, and the effect of adjusting the position of the bracket 110 is improved.

Referring to fig. 44-45, the aorta 910 of the human heart 900 carries three native leaflets 201, each between a leaflet and a vessel wall, being a valve sinus 204, wherein two valve sinus locations communicate with a right coronary artery trunk 911 and a left coronary artery trunk 912, respectively. The prosthetic aortic valve device 1000 should be in place to ensure that blood flowing out through the openings of the leaflets 200 enters one of the coronary stems in direction M, and thus the prosthetic aortic valve device 1000 should be adapted when there is a deviation in circumferential position, e.g., the prosthetic aortic valve device 1000 can be rotated in direction W in fig. 45 so that blood enters just the left coronary stem 912 in direction M.

Referring to fig. 46 a-52 c, an embodiment of the present application provides a prosthetic aortic valve apparatus 1000 having opposite inflow and outflow ends 101, 102, the prosthetic aortic valve apparatus 1000 comprising:

the inner frame 103, the inner frame 103 is of a net barrel structure capable of radial deformation, and has a relative compression state and an expansion state after being acted by external force, and the inner frame 103 is internally provided with a blood flow channel 301 which is axially penetrated; in the figure, the countercurrent blood flows in the direction H.

The valve leaflet 200 (artificial valve leaflet, in fig. 45, in an open state) is connected to the inner frame 103, and the valve leaflet 200 has three pieces and controls the opening and closing of the blood flow channel 301 in cooperation with each other; and

the guides 530 are sequentially arranged in the circumferential direction of the inner frame 103 in three (corresponding in number to the aortic valve sinus) and the circumferential positions are aligned with the respective valve leaflets 200, and each guide 530 includes a root 532 fixedly connected to the inner frame 103 and a wing 531 extending from the root 532 further toward the inflow end 101, and the guides 530 are made of a memory material and configured to be switchable among a loading state, a transition state, and a release state.

In the loaded state, as shown in fig. 48 and 50, the inner frame 103 is maintained in a compressed state, and each part of the guide 530 is radially adjacent to the inner frame 103 in the compressed state along the inner frame 103, so that the inner frame is conveniently wrapped by a pipe fitting and is in-vivo inserted and conveyed.

As shown in fig. 49 and 51, in the transitional state, the inner frame 103 is still kept in the compressed state, the root 532 of each guide 530 is kept gathered to adapt to the inner frame 103 in the compressed state, the wing 531 is deformed by itself to extend in the peripheral area of the inner frame 103 and forms a containing space for the native valve leaflet 201 to enter between the outer wall of the inner frame 103, and the containing space is used for containing the native valve leaflet. To perform the circumferential positioning of the inner frame 103, the wings 531 are extended to gain access to the corresponding sinus region by positional adjustment, with the inner frame 103 at the native valve She Nace and the wings 531 at the outer side of the native valve leaflets.

In the released state, as shown in fig. 52 a-52 c, the inner frame 103 has been brought into the expanded state by the application of an external force, the root 532 of each guide 530 being relatively far away to accommodate the inner frame 103 in the expanded state.

When not specifically stated, the present application refers to the released state by default with respect to the description of the shape and position of the guide 530, and refers to the expanded state by default with respect to the shape and position of the inner frame 103.

The inner frame 103 adopts a net barrel structure, which can be radially deformed to facilitate intervention after compression and re-expansion and release, and the axial dimension change can be accompanied in the process, so that the net barrel structure expands after being subjected to external force, namely, a self-expansion material is not adopted, and a ball expansion mode can be generally utilized. The guide member 530 is made of a memory material (for example, nickel-titanium alloy is pre-heat-set), the wing parts 531 can be released in advance in the body, the root parts 532 are understood as the adjacent joint parts of the guide member 530 and the inner frame 103, the specific shape is not strictly limited, the root parts 532 and the wing parts 531 can be made of an integrated structure more convenient to process, the wing parts 531 extend outwards relative to the inner frame 103 after being released, the wing parts 531 can enter the valve sinus 204 by adjusting the posture of the inner frame 103, the circumferential position of the inner frame 103 is pre-registered, and then the inner frame 103 is released by expanding the ball, and the guide member 530 is aligned with each valve leaflet 200, so that the joint parts of the adjacent valve leaflets 200 avoid coronary artery openings, blood flow is prevented from being blocked, the wing parts 531 are propped against the bottom of the valve sinus 204, the positioning of the inner frame 103 in the axial direction can be realized, and the left ventricle side is prevented from sliding under the effect of reverse bleeding.

In connection with fig. 53, to construct a blood flow passageway and better fit with surrounding tissue, the prosthetic aortic valve apparatus 1000 further comprises a covering film 220, which covering film 220 may be one or both of an inner covering film 221 and an outer covering film 223, wherein the inner covering film 221 is secured to the inner wall of the inner frame 103 and interfaces with the edge of the inflow end 101 of the leaflet 200; the outer coating 223 is fixed to the outer wall of the inner frame 103, and the coating 220 avoids the projection area 129 of each leaflet 200 on the side wall of the inner frame.

Fig. 48 to 54c show the overall posture of the guide 530 in the radial direction of the inner frame 103 in different states, and in the loaded state, the guide 530 has an equal diameter in the axial direction from the root 532 to the wing 531; in the transitional state, the radial position of the root 532 of the guide 530 is unchanged, while the wing 531 is turned radially outwards; in the released state, the guide 530 extends outwardly from the root 532 with the expansion of the inner frame 103, and the guide 530 extends radially outwardly and then bends inwardly in the overall posture.

Each guide 530 is made of a memory alloy (for example, nickel-titanium alloy material) and is shaped by heat treatment in advance, and the shape corresponding to the release state after heat treatment shaping has internal stress (at normal temperature or in-vivo temperature) when the guide 530 is in the loading state and the transition state relative to the release state. This internal stress may assist the inner frame 103 and guide 530 in switching to the final state within the body and may gradually dissipate as the inner frame 103 expands, allowing the inner frame 103 and guide 530 to better remain in the final state. In the released state, the guide 530 axially occupies 40% to 80% of the entire length of the inner frame 103, for example, 50%.

The bracket 110 integrally includes an inner frame 103 and a guide 530. The end of the guide 530 remote from the inner frame 103 is a free end 536 and the root 532 is a fixed end opposite the free end 536.

In the loaded state, the wing 531 is attached to the outer side of the inner frame 103; in the transitional state, the wing 531 (e.g., with the connection line between the two ends as a reference) has an angle P1 with the inner frame axis.

In the released state, the free ends of the wing parts are further close to the outer wall of the inner frame, at this time, the included angle between the wing parts 531 and the axis of the inner frame is P2, and P1 is more than P2. For example, P1 satisfies 30 to 60 degrees, and P2 satisfies 5 to 30 degrees. The free ends of the wing parts are close to the outer wall of the inner frame, which can be caused by the outward turning of the outflow end of the inner frame, can be also caused by the shape characteristics of the guide piece, or can be the cooperation of two factors.

As shown in fig. 47a and 47b, the inner frame 103 is still in a straight cylinder shape after being released, and the included angle between the wing 531 and the axis of the inner frame is P3, so that P3< P1 is satisfied. The posture of the wing 531 is shown only schematically, and does not express the absolute size of the included angle.

As shown in fig. 55a to 55d, the inner frame 103 is formed by cutting a tube, and the material is suitable for ball expansion release (for example, nickel-titanium alloy material). The inner frame 103 has a straight tubular shape in the loaded state.

In another embodiment, as shown in fig. 57 a-57 d, the outflow end 120 of the inner housing 103 is everted about an axis. Wherein the everting angle is P4 as shown in FIG. 57b, and P4 satisfies 0 degrees < P4.ltoreq.45 degrees, for example 5 to 25 degrees.

The outflow end 120 is slightly turned outwards, so that the free ends of the wing parts 531 can be further closed towards the inner frame 103 to clamp the native valve leaflet, and the positioning effect is improved. The everting of the outflow end 120 may utilize the self compliance of the balloon, and since the outer periphery of the balloon is unbound beyond the outflow end of the inner frame 103, the everting of the outflow end 120 is driven correspondingly with a more obvious tendency to evert, and if the axial length or everting angle of the everting portion is further increased, the balloon with an enlarged end portion may also be utilized to directly shape the stent 110.

To secure the guide 530, as shown in fig. 58a, the mating position of adjacent leaflets 200 on the inner frame 103 is the joint 127 of the inner frame 103, with the root 532 of the guide 530 between the adjacent two joints 127, but this is not required to be centered.

The guide 530 is generally a frame strip structure. Wherein each guide 530 is itself of unitary construction and switches states based on its elastic deformation. For adopting the hinge structure to realize deformation, the guide piece of this application can be in the deformation process with the internal stress conversion that accumulates driving force of deformation. 58b and 58c, after the guide 530 is released, there may be a deviation between the circumferential position of the guide 530 and the position of the valve sinus 204, for example, the area separated by the three radially extending solid lines may be regarded as the approximately distributed area of the three guides, and the three radially extending dashed lines may be regarded as the approximately distributed area of the three valve sinuses, where the inner frame 103 may be rotated and driven by the guide 530 in the direction of the solid arrow in the figure until the three radially extending solid lines coincide with the dashed lines, i.e. the circumferential registration as shown in FIG. 58c is achieved.

After circumferential registration, the inner frame 103 is moved toward the inflow end until the guide 530 abuts against the bottom of the valve sinus 204, or the native leaflet has filled the receiving space between the inner frame 103 and the guide 530 to achieve positioning, in an axial position as shown in fig. 58d, and in a radial position, as shown in fig. 59 a-59 c, the native leaflet 201 is between the guide 530 and the inner frame 103. The inner frame 103 can then be released in a ball-expanding manner, ensuring that the coronary artery is avoided.

Referring to fig. 59b, when the balloon 630 is used for expanding, the two ends of the inner frame 103 first have a tendency to evert, during which the free ends of the guide members 530 will be folded inwards and begin to grip the native valve leaflets 201, and in the later stage of the balloon expansion, the inner frame 103 is completely released radially, as shown in fig. 59c, since the root of the guide members 530 will deform circumferentially along with the inner frame, the free ends of the guide members 530 will be further folded towards the inner frame 103 to grip the native valve leaflets. The mechanism of deformation of the guide 530 is further described below.

Referring to fig. 60 a-62 c, wing 531 is bifurcated structure 535 adjacent root 532, wing 531 is free end 536 remote from root 532, and prongs 5353 of bifurcated structure 535 are directed toward outflow end 102. Furcation structure 535 converges and extends toward free end 536.

As shown in fig. 60 a-61 c, the two opposite portions of the furcation structure 535 are themselves constrained to the root 532 in the stowed and transitional states and are drawn towards each other, as shown in fig. 62 a-62 c, in the released state the two opposite portions of the furcation structure 535 are urged away from each other by deformation of the root 532 and the inner frame 103, e.g. in the stowed, transitional and released states the two opposite portions of the furcation structure 535 have a circumferential span G1, G2 and G3, respectively, satisfying g1=g2 < G3.

The root 532 of the furcation structure 535 forms a triangle, trapezoid, rectangle, or the like. Two opposing portions of the furcation structure 535 converge and extend toward the free end 536 and are circumferentially distributed in radiation adjacent the free end 536. Wherein the circumferential radiation is distributed in such a way as to be divided into at least two strands. The two frame strips 5361 and 5362 are respectively connected at the ends of each frame strip to form an included angle M of about 45 degrees or more, for example, 45-120 degrees (as shown in fig. 64). Along the axial direction of the inner frame 103, the free end 536 is adjacent to the edge of the inflow end 101 of the inner frame 103 and the root 532 is adjacent to the edge of the outflow end 102 of the inner frame 103, so that the wing 531 has a sufficient extension to ensure a positioning effect. To improve safety, the free end 536 has a rounded structure, and further, a protective layer is wrapped around the free end 536. Or the free end 536 is looped, and further wrapped with a protective coating or surface smoothing over the looped free end.

As shown in fig. 65, the wing 531 has opposite length and width directions, and the width of the looped free end is greater than the width of the wing frame strip. The width D2 of the annular free end is 2-6 times of the width D1 of the wing frame strip.

As shown in fig. 66, the guides 530 need to have a sufficient circumferential span in order to properly guide the spatial position of the inner frame 103 and reduce the offset after seating. The circumferential span of a single guide 530 corresponds to a central angle Σ of 30-60 degrees, the root 532 of the same guide being 15-45 degrees with respect to the circumferential span β of the inner frame 103.

The wings 531 extend radially outward and then bend inward during extension to the inflow end to provide a greater clamping force, allowing for a greater amount of radial deflection.

The root 532 and the inner frame 103 are fixed to the radially inner side, the radially outer side, or the radially aligned inner frame 103 by welding, caulking, binding, or the like, so that the root 532 is always abutted against the inner frame 103 in each state, and deformation in the circumferential direction (deformation amount is the same as the corresponding portion of the inner frame) occurs between the transition state and the release state as the inner frame 103 is changed.

The root 532 is secured to the outside of the inner frame 103 by strapping to facilitate the assembly operation and also to provide the possibility of twisting the frame strip of the root 532 about its longitudinal axis. The root 532 includes a first frame strip 5321 and a second frame strip 5322 connected to the wing 531 (i.e., bifurcated structure). With respect to the inner frame 103. The root 532 further extends toward the outflow end 102 relative to the inner frame 103, so that enough accommodation space can be reserved, the inner frame 103 is allowed to further sink when in place, and the free ends of the wings are ensured to extend into the bottom of the valve sinus. As shown in fig. 67 to 69, the ends of the first frame strip 5321 and the second frame strip 5322 remote from the wing 531 meet, are parallel or diverge from each other.

For example, the ends of the first frame strip 5321 and the second frame strip 5322 far from the wing 531 meet each other, and are fixed to the inner frame 103 by a binding wire (binding wire is omitted in the drawing) penetrating through the first binding wire hole 5323, and similar eyelet structures can be arranged at the corresponding positions of the inner frame as required.

The other ends of the first frame 5321 and the second frame 5322 radiate at intervals and are connected to the wing 531 (i.e., a bifurcated structure) to form a closed quadrilateral. To facilitate positioning and threading, the end of the first and second frame strips connected to the wing 531 is provided with a second binding-wire hole 5354. Similar eyelet structures can be arranged at corresponding positions of the inner frame according to the requirements.

In some embodiments, the inner frame 103 has a connecting post 104 extending outwardly in an axial direction toward the outflow end 102, the connecting post 104 being the same shape as the root 532 and radially overlapping one another along the inner frame. The same-shape finger connecting post 104 also includes two fifth and sixth frame strips 1041, 1042 similar to the first and second frame strips 5321, 5322, respectively, with the fifth and sixth frame strips 1041, 1042 conforming to the shape of the root 532, e.g., meeting one another near the outflow end 102 such that the tip of the connecting post 104 forms a V-shape toward the outflow end 102, or is parallel or diverged. The first frame bar 5321 and the fifth frame bar 1041 may be stacked on each other, and the second frame bar 5322 and the sixth frame bar 1042 may be stacked on each other.

Wherein the inner frame 11 has a plurality of diamond-shaped cells 116 arranged in an axial direction, the root 532 of the same guide 530 being one or two cells with respect to the circumferential span of the inner frame 103. As shown in fig. 56a, a fifth frame bar 1041 and a sixth frame bar 1042 are obtained by extending from the end of the inner frame 103. While the inner frame is half-open at the cell of the outflow end 102, one end of each of the fifth frame strip 1041 and the sixth frame strip 1042 is connected to two adjacent cells 116.

The wing 531 includes a third frame strip 5351 and a fourth frame strip 5352 which constitute a bifurcated structure; wherein one end of the third frame strip 5351 is connected to the first frame strip 5321 and the other end extends toward the inflow end 101; one end of the fourth frame strip 5352 is connected to the second frame strip 5322, and the other end extends toward the inflow end 101 and meets the third frame strip 5351.

The first frame strip 5321, the second frame strip 5322, the third frame strip 5351 and the fourth frame strip 5352 enclose a closed area, and the shape of the closed area is a quadrilateral structure in radial projection, for example, four frame strips enclose a parallelogram.

When the ends of the first and second frame strips 5321, 5322 distal from the wing 531 are parallel or divergent from each other, the first and second frame strips 5321, 5322 and the wing form a semi-enclosed region that opens toward the outflow end 102.

The frame strip is not strictly limited to a straight frame strip, but may be slightly curved. The fourth frame bar 5352 and the third frame bar 5351 may be directly connected to each other or indirectly connected through other frame bars. As shown, the fourth frame bar 5352 and the third frame bar 5351 are directly connected to each other. After the strips are connected to each other, the strips may extend a distance and then diverge to the free end, or diverge directly to the free end, or may diverge first and then converge again to form a loop-like structure, which may reduce interference with the coronary ostium and the risk of puncturing tissue.

The joint between two adjacent frame strips, for example, the joint between the fourth frame strip 5352 and the second frame strip 5322, is not too sharp, but can be smoothly shaped. For example, the third and fourth frame strips 5351, 5352 may be formed as a unitary piece having an arcuate structure, wherein the third and fourth frame strips 5351, 5352 represent different portions of the arcuate structure. Thus, it is contemplated that the above first through fourth frame bars may not only form a parallelogram, but may also be a closed circle, oval, even hexagon, etc.

But at least ensures that the third frame strip 5351 is not collinear with the first frame strip 5321 and that the fourth frame strip 5352 is not collinear with the second frame strip 5322, which would otherwise affect or impair the intended deformation of the guide.

The morphological changes of the guide when switching between the transitional state and the released state are further analyzed below, wherein the first and second frame bars 5321, 5322 spatially define the first portion 538, and the third and fourth frame bars 5351, 5352 spatially define the second portion 539.

The third frame strip 5351 and the first frame strip 5321 meet at a first connection point 5324, the fourth frame strip 5352 and the second frame strip 5322 meet at a second connection point 5325, the first frame strip 5321 and the second frame strip 5322 meet at a third connection point 5326, the third frame strip 5351 and the fourth frame strip 5352 meet at a fourth connection point 5355, and the first connection point 5324, the second connection point 5325 and the third connection point 5326 form a first plane 5327 (only the plane is taken as a schematic analysis, and in fact, the first plane may be slightly curved or nearly the plane) in which the first portion is located; the first connection point 5324, the second connection point 5325 and the fourth connection point 5355 form a second plane 5356 in which the second portion lies.

The structures surrounded by the first to fourth frame bars described above do not need to correspond to the cells of the inner frame. For example, the first and second connection points 5324, 5325 may each be aligned with a node of the inner frame or may be offset from a node of the inner frame to reduce interference with the inner frame during deformation.

In fig. 70a, the frame strips are in the same plane (q=180 degrees) when fully extended, and the distance between the first connection point 5324 and the second connection point 5325 is the largest.

In fig. 70b, in the transitional state, the inner frame 103 is in a compressed state, so that the first connection point 5324 and the second connection point 5325 are close to each other, the wing 531 is warped relative to the root 532, and the first plane 5327 and the second plane 5356 form an included angle Q1 with each other. It should be noted that during the approaching of the first 5324 and second 5325 connection points, the frame strips may twist about their own axes to accommodate the buckling of the wing 531, otherwise only the in-plane deformation, i.e. the elongation of the length of the guide, is coordinated with the attachment of the root to the inner frame 103 by means of lashing. As can be seen from the figure, in a different configuration, the first to fourth frame strips have been twisted and the first 5324 and second 5325 connection points are no longer coplanar with the third 5326 and fourth 5355 connection points.

In fig. 70c, when the transition state is switched to the release state, the first connection point 5324 and the second connection point 5325 are far away from each other, the degree of turning of the wing 531 is reduced, and at this time, the first portion 538 and the second portion 539 form an overall included angle of Q2, and Q1 is smaller than Q2, which means that the free end of the wing is further close to the inner frame, so as to facilitate clamping the native valve leaflet.

It can be seen that the angle M1 between the axes of the third frame 5351 and the first frame 5321 (and the angle M2 between the second frame 5322 and the fourth frame 5352) is substantially unchanged when switching between the transition state and the release state. For example m1=m2=120 degrees, which also illustrates from another angle that the guide is not a deformation in a plane, but a deformation in three dimensions.

As described above, it can be seen that the root portion 532 and the portion of the wing portion 531 connected to the root portion 532 constitute a frame structure, for example, including first to fourth frame bars. Both ends of the frame structure in the circumferential direction, for example, the first connection point 5324 and the second connection point 5325, are turned relatively as the inner frame is compressed and expanded, so that both ends of the frame structure in the axial direction of the inner frame (for example, the third connection point 5326 and the fourth connection point 5355) are driven to be turned relatively.

In the frame structure, when the axial both ends of the inner frame are turned relative to each other, one end such as the third connection point 5326 is fixed relative to the inner frame, and the other end such as the fourth connection point 5355 is turned relative to the outer wall of the inner frame.

In the frame structure, when both ends in the circumferential direction of the inner frame are flipped with respect to each other, both ends such as the first connection point 5324 and the second connection point 5325 are flipped with respect to the outer wall of the inner frame.

In order to guide the deformation, the shaping posture after the heat treatment is completed may be that the wing 531 is slightly warped with respect to the root 532 at the time of the guide processing.

The guide 530 has a restraining structure 537 formed on the first and second connection points 5324 and 5325, and the first and second connection points 5324 and 5325 are bound to the inner frame 103 by the restraining structure 537. The constraint structure 537 is an eyelet (i.e., the second binding-wire hole 5354), or other local abrupt shape such as a circumferentially convex eyelet-equipped lug. The constraint structure 537 rotates as a stress point relative to the axis of the frame strip, so as to drive the adjacent part of the frame strip and the constraint structure to start torsion.

In order to reduce the constraint on the torsion of the frame strip and obtain a larger wing rotation angle, only one side of the inner frame with the eyelet in the axial direction is bound during binding, because if two sides of the inner frame in the axial direction are bound, the torsion of the frame strip may be constrained.

To assist in the procedure in conjunction with imaging equipment, the prosthetic aortic valve apparatus 1000 can be provided with a visualization marker 550, such as a partial inlay or including a noble metal that can be differentially displayed at other locations under X-ray or other detection.

The developing mark 550 may be dot-shaped or stripe-shaped or enclosed in a ring shape (closed or non-closed, but at least half-ring shape), and the developing mark 550 may be provided on at least one of the inner frame 103 and the guide 530. The corresponding inner frame 103 or guide 530 is provided with an aperture for mounting the developing mark 550.

Alternatively, the development marks may be provided at the respective binding-wire holes, or the development marks may be provided at the middle section of the wing portion, or the free end.

For example, as shown in fig. 71, free end 536 carries a development mark 550. Free end 536 carries an aperture 551 where the developing indicia is located. For another example, wing 531 may have perforations 551 at a location prior to bifurcation, and may have a development mark at perforations 551.

Referring to 72 and 73, in an embodiment, a delivery system for a prosthetic aortic valve apparatus 1000 is provided, which may be used to load and deliver the prosthetic aortic valve apparatus 1000 of the previous embodiments, the delivery system having opposite distal and proximal ends, the delivery system comprising:

balloon apparatus 600 is switchable under fluid action between an inflated state and a deflated state;

an outer sheath 405 slidably fitted around the balloon apparatus 600, the radial gap between the outer sheath 405 and the balloon apparatus 600 being a loading area 406 for placement of the prosthetic aortic valve apparatus 1000; and

the proximal ends of both the control handle 407, balloon apparatus 600 and outer sheath 405 extend to the control handle 407, with the outer sheath 405 being a slip fit relative to the control handle 407.

Sliding of the outer sheath 405 may wrap around or expose the prosthetic aortic valve apparatus 1000 to effect switching between loading delivery and release. In the whole conveying system, the outer sheath 405 and the balloon device 600 are in running fit, namely, the circumferential position of the artificial aortic valve device 1000 can be adjusted by rotating the balloon device 600, so that the valve leaflet 200 can be aligned to the position of the valve sinus, furthermore, the artificial aortic valve device 1000 of the embodiment is provided with the guide 530, one of the inner frame 103 and the guide 530 is provided with the developing mark 550, and the operation can be monitored and guided in real time through the image equipment when the position of the artificial aortic valve device 1000 is adjusted. In these embodiments, the placement of the guide 530 and the visualization mark 550, in combination with the rotational engagement of the sheath 405 and the balloon apparatus 600, further cooperate to ensure accurate positioning of the prosthetic aortic valve apparatus 1000.

In some cases, for example, the balloon apparatus 600 cannot rotate relative to the outer sheath 405, and although the balloon apparatus 600 and the outer sheath 405 may be integrally rotated for circumferential registration, the outer sheath 405 may have turn portions in a long insertion path, which are difficult to directly twist around its own axis, and tend to generate a large force with surrounding tissues, resulting in a safe operation resistance, in which the outer sheath 405 is used to maintain a stable channel in which the relatively rotatable balloon apparatus 600 (a tube member inside the outer sheath 405) is twisted around its own axis, so that the above hidden troubles can be solved to the greatest extent.

The outer sheath 405 is not excessively twisted at least in the circumferential direction when the balloon apparatus 600 is rotated, and the tube body can be reinforced as needed, for example, by embedding ribs, a reinforcing mesh, a hypotube, or the like.

The prosthetic aortic valve assembly 1000 is radially compressed and placed in the loading area 406, and is wrapped distally with the outer sheath 405, and the guide 530 is gradually exposed by sliding the outer sheath 405 proximally during release, at which time the inner frame 103, although exposed, is not self-expanding due to the choice of material, and the circumferential position of the inner frame 103 is registered by the rotatable feature of the balloon assembly 600, and the inner frame 103 is driven to expand by the balloon assembly 600 after registration. The outer sheath 405 can be held relatively stationary during registration, reducing safety concerns and co-registration.

Referring to fig. 72 and 73 to 76, balloon apparatus 600 includes:

a tube 610, wherein at least a guide wire channel and a perfusion channel are provided in the tube 610, and the proximal end of the tube 610 is rotatably mounted on the control handle 407;

the guide head 620 is fixed at the distal end of the tube body 610, the distal end of the guide wire channel is opened at the guide head 620, the guide wire can be inserted in advance when the conveying system conveys in the body, and then the conveying system is sleeved on the guide wire in a sliding way through the guide wire channel as a whole and is pushed along the guide wire; and

a balloon 630 fixed to the tube body 610 at a proximal end side of the guide head 620, and an inside of the balloon 630 communicating with the perfusion channel.

The guide wire channel and the perfusion channel can be provided with pipe fittings independently or by a multi-cavity tube or the like, and the guide wire channel and the perfusion channel can be provided with pipeline joints (such as a three-way structure on the right side in fig. 72) at the proximal end respectively, such as luer joints and the like. In use, fluid is delivered using the perfusion channel to inflate balloon 630.

Because the balloon apparatus 600 needs to rotate, the tube 610 should be capable of ensuring torque transmission in the circumferential direction, and minimizing the angular deviation between the distal end and the proximal end, so that the tube body can be reinforced, for example, the tube 610 includes a multi-layer structure from inside to outside, at least one layer in the middle adopts the manner of embedded ribs, reinforcing mesh, hypotube, steel cable tube, etc., so as to ensure synchronization between the proximal end and the distal end, and of course, correction and real-time adjustment can be further performed according to the development mark when there is deviation.

For example, as shown in fig. 74, in an embodiment, the tube body 610 adopts a three-layer structure, the middle layer 6102 adopts a hypotube and is located between the outermost layer 6101 and the innermost layer 6103, the outermost layer 6101 and the innermost layer 6103 can adopt conventional materials such as Pebax and TUP, and each layer is fixed to the hypotube by thermal fusion, etc., and the cutting mode of the hypotube is not strictly limited, for example, the cutting process is alternately performed at different circumferential positions, so that the hypotube has compliance, and thus a curved insertion path can be passed.

For example, as shown in fig. 75, in another embodiment, the middle layer 6102 is formed by two layers of steel cable tubes, and the winding directions are opposite, and the steel cable tubes have a certain compliance and can ensure the transmission of torque in the circumferential direction.

The control handle 407 includes:

a support body 410;

a movable base 420 movably mounted to the support body 410, the proximal end of the outer sheath 405 being fixed to the movable base 420;

the driving sleeve 430 is rotatably installed on the outer periphery of the support body 410 and is in transmission fit with the moving seat 420, so as to drive the outer sheath 405 to slide relative to the balloon device 600; and

the rotating seat 440 is rotatably mounted on the outer periphery of the support body 410 and is in transmission fit with the tube body 610 of the balloon apparatus 600, so as to drive the balloon apparatus 600 to rotate relative to the outer sheath 405.

Wherein the driving sleeve 430 and the movable base 420 are screwed. The rotation of the driving sleeve 430 can drive the movable seat 420 to slide, in order to prevent the movable seat 420 from rotating along with the rotation, the supporting body 410 is provided with a guiding structure, such as a sliding slot 411 or a guiding rod, for limiting the movement path of the movable seat 420, and the outer periphery of the supporting body 410 can be fixedly covered with a housing, so as to play a role in protection and aesthetic appearance.

As shown in fig. 72, the rotation seat 440 and the tube 610 of the balloon apparatus 600 may be directly fixed. In use, the rotating base 440 is directly operated, and marks may be provided on the rotating base 440 and the supporting body 410 to show the direction and magnitude of rotation of the rotating base 440.

The rotating seat 440 and the balloon apparatus 600 can also be indirectly driven by a driving mechanism. The speed reducing mechanism can improve the adjustment accuracy and the hand feeling.

Referring to fig. 76, the present embodiment employs a planetary reduction mechanism, specifically including a carrier 441, a planetary gear 442, a ring gear 443, a planetary input shaft 444, and a planetary output shaft 445. The planetary input shaft 444 has external teeth and is fixed on the rotating seat 440, and the planetary input shaft 444 and the rotating seat 440 can adopt an integral or split structure and are rotationally driven by the rotating seat 440.

The gear ring 443 has internal teeth and is fixed on the support body 410, the gear ring 443 can be in an integral or split structure with the support body 410, and the planetary gears 442 are generally three, meshed between the planetary input shaft 444 and the gear ring 443, and driven by the planetary carrier 441; the planet carrier 441 is fixed to the planet output shaft 445, and each planet wheel 442 can induce the planet carrier 441 to rotate when revolving, so that the planet output shaft 445 drives the tube 610 fixed thereto to rotate, and the balloon apparatus 600 is induced to rotate the inner carrier.

Referring to fig. 77, in another embodiment, the rotary base 440 and the tube body 610 are driven by a worm wheel 451 and a worm 452 that are engaged with each other. The rotary seat 440 is rotatably mounted on the support body 410 by using a dial wheel, and the rotation axis of the rotary seat 440 is perpendicular to the length direction of the support body 410 (i.e. the extending direction of the tube body 610). The rotary seat 440 is coaxially fixed with the worm 452, and the worm wheel 451 is fixed to the tube 610 and cooperates with the worm 452. The outside of the tube body 610 can be fixed with a transmission sleeve 453 for reinforcing the structure of the tube body, the transmission sleeve 453 is in running fit with a supporting seat 454 fixed on the supporting body 410, and the transmission sleeve 453 and the worm gear 451 are integrally or separately arranged to realize transmission. The rotation of the rotary seat 440 is transmitted to the tube 610 through the worm and gear mechanism.

Referring to fig. 78, in another embodiment, the rotating base 440 and the tube 610 may also be driven by a gear set. The gear set includes a first gear 461 and a second gear 462 that intermesh. The rotary base 440 may be, for example, a dial rotatably mounted on the support body 410, and the rotation axis of the rotary base 440 is parallel to the extending direction of the tube body 610. The rotary seat 440 is coaxially fixed with the first gear 461 to realize transmission, the outside of the tube body 610 is fixed with a transmission sleeve 463 for reinforcing the structure of the tube body, the transmission sleeve 463 is in rotary fit with a supporting seat 464 fixed on the supporting body 410, and the transmission sleeve 463 is coaxially fixed with the second gear 462 to realize transmission.

In the embodiments where the rotating base 440 and the pipe body 610 are driven, a locking mechanism for limiting the rotation of the rotating base 440 may be further provided according to needs, for example, a pin slidably mounted on the supporting body 410 is adopted, and the rotating base 440 is provided with a slot or a jack matched with the pin, so that the position of the rotating base 440 is locked. In addition, a scale mark indicating the rotation angle may be provided on the rotation seat 440 to compare the rotation amplitude of the tube 610.

An embodiment of the present application further provides an interventional system, including: the delivery system of the above embodiments, and the prosthetic aortic valve apparatus 1000, wherein the prosthetic aortic valve apparatus 1000 is disposed within a loading zone 406 of the delivery system.

Referring to fig. 79 a-81, an embodiment of the present application provides a method of using the above interventional system, which is also a method of securing a prosthetic heart valve device at an aortic annulus comprising a plurality of native valve leaflets, which can be accomplished using the above interventional system.

The method comprises the following steps:

in step S10, as shown in fig. 79a, the prosthetic aortic valve apparatus 1000 is delivered to a predetermined position, the inner frame 103 is in a compressed state during the delivery, the guide 530 is in a loaded state, the balloon apparatus 600 is in a contracted state, and each developing mark can be detected and displayed in combination with an imaging device during the delivery, and the spatial position of the prosthetic aortic valve apparatus 1000 relative to the aortic valve can be comprehensively determined in combination with the effect of the contrast medium.

At step S20, as shown in fig. 79b, after the prosthetic aortic valve apparatus 1000 is brought into the native annulus position (aortic annulus), the outer sheath 405 is retracted proximally to expose the wings 531 of the guide 530, such that the guide 530 made of a memory material transitions in the in vivo environment toward a preformed configuration, wherein the wings extend outwardly into a transitional state, while the inner frame made of a non-memory material is still in a compressed state such that the root of the guide does not extend significantly outwardly.

In step S30, the position of the guide 530 in the body, in particular with respect to the native annulus and the valve sinus 204, may be obtained by using an imaging device in combination with the visualization mark. At this time, it may be predicted whether the circumferential position of the guide 530 is aligned with each valve sinus, and in some cases, for example, the criterion may be just that the artificial aortic valve device 1000 is further pushed distally, so that the free ends of the wings of the guide 530 are approximately abutted against the bottom of the valve sinus, and if the positions are dislocated, the balloon device is rotated and the inner frame 103 is driven to move synchronously, so that the wings 531 of the guide 530 are approximately aligned circumferentially and enter the valve sinus 204, and then the artificial aortic valve device 1000 is pushed distally, so that the free ends of the wings of the guide 530 are approximately abutted against the bottom of the valve sinus.

Since the guide is in a transitional state with its wings extending outwardly relative to the inner frame, the at least one native valve leaflet enters the radial gap between the inner frame and the guide. At this point, the axial position of the artificial aortic valve unit may be considered desirable. Preferably, all three native leaflets enter the respective radial gaps.

Otherwise, the entire device needs to be withdrawn proximally to readjust the position to ensure stability of the grasping native valve leaflets and post-release axial position.

In step S40, as shown in fig. 80a, the prosthetic aortic valve assembly 1000 is completely released into place by injecting fluid to drive the balloon assembly 600 to an inflated state, i.e., to drive release the inner frame 103 and the root 532 of the guide 530, bringing the inner frame 103 into an inflated state, and the guide 530 into a released state.

In the process of inflation and deformation of the balloon device, the two axial ends of the balloon are subjected to relatively small radial constraint force, so that deformation can be firstly generated, particularly, the outflow end of the inner frame can drive the end part of the inner frame to turn over together with the root part, and the free ends of the wing parts are closer to the inner frame to clamp the native valve leaflets.

After the inner frame 103 is brought into the inflated state, the outflow section of the inner frame 103 may be substantially in a straight cylindrical state or turned outwards, and the roots are radially distant from each other, depending on the balloon pressure or the balloon itself. In combination with the deformation principle of the guide member 530, the root and the joint portion between the root and the wing portion deform, so that the free end of the wing portion of the guide member 530 can further approach the outer wall of the inner frame 103 to clamp the native valve leaflet in a transitional state, thereby ensuring the positioning effect.

Step S50, as shown in fig. 80b, after release, the balloon device 600 is switched to a contracted state, the entire delivery system is retracted, while the prosthetic heart valve device is positioned and held at the aortic annulus to replace diseased native tissue.

The present application, through structural modification of the prosthetic aortic valve device 1000, more facilitates adjustment of circumferential position, aligns the leaflets 200 to the coronary orifice, reduces blood flow interference, and also further avoids positional offset during long-term use.

Referring to fig. 82-84, in another embodiment of the prosthetic aortic valve apparatus, two separate wings 531 are provided, i.e., two wings in the same guide 530.

In the stowed condition, the guide 530 (shown in phantom) is radially proximate the inner frame 103 in the compressed condition along the inner frame 103, facilitating the use of tubing to encase the inner frame 103 and guide and provide for in vivo interventional delivery.

In the transitional state, the root 532 of each guide 530 is kept gathered to adapt to the inner frame 103 in the compressed state, the wing 531 is self-deformed and extends to the peripheral area of the inner frame 103 and forms a containing space with the outer wall of the inner frame 103, the containing space is used for containing the native valve leaflet, in order to realize the circumferential positioning of the inner frame 103, the wing 531 can enter the corresponding valve sinus area through position adjustment after extending, at this time, the inner frame 103 is positioned on the native valve She Nace, and the wing 531 is positioned on the outer side of the native valve leaflet.

In the released state, the root 532 of each guide 530 is relatively far away from the inner frame 103 to accommodate the expanded state, at which point the inner frame 103 and each guide 530 are completely released from the delivery system and enter the working state.

Fig. 82-84 are merely illustrative of spatial poses and relative relationships or features in different states. When not specifically stated in the present embodiment, the description of the shape and position of the guide 530 refers to the released state thereof by default, and the description of the shape and position of the inner frame 103 refers to the expanded state thereof by default.

Radial deformation of the mesh tube structure is convenient for intervention after compression and subsequent expansion and release, axial dimensional change is possible in the process, the mesh tube structure is expanded after external force action, namely, instead of adopting a self-expanding material, a ball expanding mode is generally utilized, the guide piece 530 adopts a memory material (for example, nickel-titanium alloy is subjected to pre-heat setting) and can be released in the body in advance, the root 532 is understood as a part of the guide piece 530, which is adjacent to and connected with the inner frame 103, the specific shape is not strictly limited, the root 532 and the wing 531 can be of an integral structure, the wing 531 extends outwards relative to the inner frame 103 after release, the wing 531 enters the valve sinus 204 through adjusting the posture of the inner frame 103, the inner frame 103 is preregistered at the circumferential position, and then the inner frame 103 is expanded again, and as the guide piece 530 is aligned with each valve leaflet 200, the joint of the adjacent valve leaflet 200 is guaranteed to avoid blood flow obstruction, the wing 531 is abutted against the bottom of the valve sinus 204, positioning of the inner frame 103 in the axial direction is also avoided, and the left ventricular sliding action is avoided.

In order to fix the guide 530, as shown in fig. 85a and 85d, the joint of two adjacent leaflets 200 on the inner frame 103 is a commissure zone of the inner frame 103, and the root 532 of the guide 530 is fixed to the joint at the corresponding position; or the root 532 of the guide 530 in the circumferential direction of the inner frame 103 is between two adjacent joints.

Referring to fig. 85d, in the released state, the free ends 534 of the two wings 531 of the same guide member 530 are spaced apart from each other, and the span of the spaced region in the circumferential direction of the inner frame 103 corresponds to a central angle β, which is greater than 30 degrees.

In terms of its shape, the commissure regions may be stripe-shaped, i.e., commissure posts 132, and each commissure post 132 is provided as follows:

extending from the end of the outflow end 102 of the inner frame 103 or within the inner frame 103. The commissure posts 132 extend in a direction coincident with the axis of the inner frame 103 or are inclined radially inward. For example, the outflow end 102 of the inner frame 103 has a peak-to-valley configuration with the commissure regions at the peak locations, i.e., the commissure regions at the furthest outflow end of the inner frame 103.

Referring to fig. 85d, the commissure posts 132 have a first collar 114 at their ends and the inner frame 103 has a second collar 117 at the inflow end 101 that is aligned with the first collar 115. The first and second collars 115, 117 may be used as developing mark positions as needed, or may be coupled to a conveying system.

Referring to fig. 86, each guide 530 may include two wings 531a and 531b having free ends 534 that are independent of each other at ends of the wings remote from the inner frame 103. Failure of one of the free ends 534 in the same guide does not necessarily affect the other free end when it fails to enter the valve sinus, thus avoiding to some extent the risk of overall guide failure.

In the axial direction of the inner frame 103, the free end 534 is located near the inflow end 101 of the inner frame 103 and the root 532 is located near the outflow end 102 of the inner frame 103, so that the wings 531 have a sufficient extension to ensure positioning. To improve safety, the free end 536 has a rounded structure and may be further covered with a protective layer.

Taking fig. 86 as an example, in two adjacent guides, the wing 531b and the wing 531c close to each other are formed as one piece from the common root 532, and the common root 534, the wing 531b and the wing 531c form a bifurcated structure, with the bifurcated bifurcation toward the inflow end 101. The bifurcated structure facilitates riding over adjacent portions of the two native leaflets through its bifurcation, with each guide in position in a corresponding valve sinus.

Referring to fig. 87 a-c, three alternative configurations of the guide 530 are illustrated in the released state. Comprising the following steps: in a first manner, shown in fig. 87a, the guide 530 extends radially from the root 532 and is bent inwardly. In a second embodiment shown in fig. 87b, the guide 530 extends from the root 532 toward the outflow end 102 and is bent toward the inflow end 101 in the axial direction of the inner frame 103. As shown in fig. 87c, the second embodiment adopts the structures of both the first embodiment and the second embodiment.

Referring to fig. 88a and 88b, in order to properly guide the spatial position of the inner frame 103 and reduce the offset after seating, the guide 530 needs to have a sufficient circumferential span, and the circumferential span of the guide 530 may be a span of different locations, such as the root 532 or the wing 531, wherein having the largest circumferential span of the root 532 is more advantageous for stabilizing the position of the inner frame 103. Taking root 532 span as an example: each guide 530 spans at least 1/6 of a circumference in the circumferential direction of the inner frame 103, that is, the central angle α in fig. 92b is 60 degrees or more. Also for example, along the circumference of the inner frame 103, each guide 530 spans 1/3 of a circumference, i.e., the central angle α is equal to 120 degrees.

In the case where the root 532 has a large span, in order to facilitate smooth entry of the guide into the valve sinus, the guide has opposite outer and inner sides in the circumferential direction of the inner frame, and the edges of the wings on the outer side of the guide have a smooth profile. Further, the profile curve extends from the root to the inflow end and is offset inboard. The smooth profile and curve extension helps to locate the guide itself in the valve sinus, reduces the difficulty of adjusting and locating the inner frame, and in addition reduces the potential safety hazard, avoiding puncturing surrounding tissue.

After the guide 530 is released, there may be a deviation between the circumferential position of the guide 530 and the position of the valve sinus 204, for example, the area separated by the three solid lines extending in radial direction may be regarded as the approximately distributed area of the three guide, while the three dashed lines extending in radial direction may be regarded as the approximately distributed area of the three valve sinus, and the inner frame 103 may be rotated and driven by each guide 530 along the direction of the solid arrow in the figure until the three solid lines extending in radial direction coincide with the dashed lines, i.e. the circumferential registration as shown in fig. 92b is achieved.

After circumferential registration, the inner frame 103 is moved toward the inflow end until the guide 530 abuts against the bottom of the valve sinus 204, achieving a positioning, in which the native leaflets 201 are between the guide 530 and the inner frame 103 in a radial position. The inner frame 103 can then be released in a ball-expanding manner, ensuring that the coronary artery is avoided.

In the released state, the guide 530 axially occupies 40% to 80% of the entire length of the inner frame 103, for example, 50%.

Referring to fig. 89a and 89b, the guide free end 534 in one embodiment is an annular structure of the outer Zhou Guanghua, the wing 531 being generally strip-shaped and having opposite length and width directions, the width of the annular structure being greater than the width of the wing 531. The width D2 of the annular structure is 2 to 6 times the width D1 of the wing 531.

Referring to fig. 89c, the free end 534 itself defines a reference surface, and in the transitional state, the free ends 534 of the two wings 531 of the same guide member define a first reference surface and a second reference surface, respectively, and an included angle γ between the first reference surface and the second reference surface is less than or equal to 90 degrees. Preferably less than 45 degrees, for example, the included angle gamma is selected to be 45 degrees.

Referring to fig. 89d, each guide 530 includes two wings 531, wherein, in two adjacent guides 530, a first wing 5311 belonging to one guide 530 and a second wing 5312 belonging to the other guide 530 are adjacent to each other along the circumferential direction of the inner frame 103, the outflow end 102 of the inner frame is provided with a commissure post 132, and the root portions of the first wing 5311 and the second wing 5312 are connected in an integrated structure and are stacked and fixed on the outer side of the commissure post 132.

In connection with the above embodiments, the first wing 5311 and the second wing 5312 are connected to a common root 532, which may be considered to constitute a set of clamping arms. The artificial aortic valve unit as a whole has three sets of clamping arms, each set of clamping arms being connected to the inner frame, respectively.

In the released state, both the first wing 5311 and the second wing 5312 are approaching a coplanar surface.

The root portions 532 corresponding to the two wing portions 531 in the same guide 530 are each independently or integrally configured. The free ends 534 are independent of each other so as not to pull one another when the other fails, since the root 532 is already close to the inner frame 103, and thus the two wing parts 531 will not pull one another, taking the root 532 independent of each other as an example, the span of the guide 530 in the circumferential direction of the inner frame 103 can be understood as the central angle corresponding to the central line of the two root parts 532 and the inner frame 103, i.e. the central angle α shown in fig. 92 b.

Each wing 531 is generally a flat bar configuration. The flat bar structure itself may be solid or entirely hollowed (only the edge frame is reserved) or partially hollowed (for example, a grid structure), for example, a braid or cut is adopted, and the flat bar structure may have a certain width, but does not require equal width extension. The flat shape is more beneficial to reducing the whole radial dimension during loading, ensuring the compliance during insertion, and the strip shape is more beneficial to space shaping.

Referring to fig. 90 to 91b, two wing parts 531 extend from both outer sides of the guide member 530 toward the inflow end 101 while also approaching each other.

The wing 531 may have an overall arcuate configuration, or may have an undulating configuration 5341 adjacent the free end 534, with the undulating direction being along the radial and/or axial direction of the inner frame 103. Or circumferentially along the inner frame 103 at a section adjacent the free end 534. In the figures, the undulations of the undulating structure 5341 are primarily embodied in the axial direction of the prosthetic aortic valve device. It is to be appreciated that the guide 530 can have undulations in multiple dimensions in three-dimensional space. Referring to the drawings, the guide 530 has a radial undulating structure as viewed axially of the inner frame 103. The undulations of the multiple dimensions can be independently arranged or superimposed on one another to form a complex three-dimensional configuration.

In the transitional state, the two wings 531 of the same guide member 530 have been extended outwards, but the root portions 532 of the two wings 531 are limited by the shape of the inner frame 103 and still located adjacent to each other, and the free ends 534 of the two wings 531 should be prevented from interfering with each other. Based on this, in the circumferential direction of the inner frame 103, the guide 530 is in a transitional state, the free ends 534 of the two wings 531 in the same guide 530 are staggered with each other; in the released state, the free ends 534 of the two wings 531 in the same guide 530 are spaced apart from each other.

The free ends 534 of the two wings 531 in the same guide 530 in the transitional state are staggered in the following manner: in the transitional state of the guide 530, the free ends 534 of the two wings 531 in the same guide 530 are radially spaced along the inner frame 103 or axially spaced along the inner frame 103.

For ease of processing, referring to fig. 92 a-92 c, all guides 530 are integrally constructed. For example, by a strip-shaped metal piece being bent around. Each wing 531 extends from opposite outer sides of the guide 530. This ensures the circumferential span of the guide 530 as a whole. The shape of each guide 530 in the figures varies. In fig. 92b, the guides 530 extend primarily in the axial direction of the inner frame 103, and the rear turns extend primarily in the circumferential direction of the inner frame 103, and in fig. 92c, the same set of guides 530 may be arranged asymmetrically.

Referring to fig. 93 a-93 b, to assist in the procedure in conjunction with imaging equipment, the prosthetic aortic valve apparatus 1000 may be provided with a visualization mark 550, such as a partial inlay or including a noble metal that may be differentially displayed at other locations under X-ray or other detection.

The developing mark 550 itself may be dot-shaped or stripe-shaped or may be looped (closed or non-closed, but at least semi-looped), and the developing mark 550 may be disposed on the inner frame 103 and/or the guide 530. For example, the inner frame 103 or the guide 530 is provided with an aperture 551 for mounting the developing mark 550.

The specific manner in which the development mark 550 is mounted is not limited to one or more of the following combinations: the wing 531 in at least two guides 530 carries a developing mark 550; preferably, the wings 531 of all guides 530 are provided with a developing mark. The root 532 in at least two guides 530 carries a development mark 550; preferably, the root 532 of all guides 530 are provided with a developing mark.

The visible developed indicia 550 is at least three in view along the axial direction of the inner frame 103 and is distributed in different areas in the circumferential direction of the inner frame 103. Based on the shape (effect shown in the developing device) surrounded by the plurality of developing marks 550, the angle of the axis of the inner frame 103 can be known, and whether or not there is an excessive inclination or the like can be determined.

The visible developed indicia 550 is at least three places and at least two places are distributed at radially different areas of the inner frame 103 as seen in an axial view of the inner frame 103. The plurality of developing marks 550 are located at different areas in the radial direction, which can assist in determining the posture of the inner frame 103 in the circumferential direction.

The visible developing marks 550 are distributed in different areas of the inner frame 103 along the axial direction along the radial direction of the inner frame 103, so that the axial direction angle of the inner frame 103 can be known along the radial direction.

At least one developing mark is disposed on the inner frame 103 or the root 532 of the guide 530, and at least one developing mark is disposed on the wing 531 of the guide 530 and adjacent to the free end 534 of the wing 531, so as to determine the extension condition of a certain wing 531.

In combination, as shown in fig. 93b, for example, a first developing mark 550a is disposed on the inner frame 103, and a second developing mark 550b and a third developing mark 550c are disposed at the free ends 534 of the two wing parts 531, and these developing marks 550 are distributed in different areas in the circumferential direction of the inner frame 103 along the axial direction view of the inner frame 103, and the first developing mark 550a and the other two are distributed in different areas in the radial direction of the inner frame 103, and the first developing mark 550a and the other two are also distributed in different areas in the axial direction of the inner frame 103. The incorporation of contrast agent further facilitates expression of the pose of the prosthetic aortic valve apparatus 1000 in the aorta and the registration of each guide 530 with the valve sinus 204.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

For example, fig. 94 may be considered to show another embodiment combining fig. 70a to 70c with fig. 86, 89a, 19 or 37a, etc., fig. 70a to 70c show shape features and spatial deformations of the joint between root and airfoil, fig. 86, 89a, 19 or 37a, etc. show a specific configuration of the airfoil.

A connecting post 104 extends from the outflow end of the inner frame 103. The connecting post 104 is V-shaped and the sharp corners of the V-shape are axially convex and the junction of two adjacent leaflets 200 on the inner frame 103 is the commissure zone of the inner frame 103. The connecting posts 104 are located in the circumferential direction in the respective commissure regions, unlike that shown in fig. 46a, wherein the connecting posts are located between two adjacent commissure regions.

The positioning structure of the artificial heart valve (which can also be regarded as an artificial aortic valve when applied to the aorta) in this embodiment will be described from different angles.

From the guide's perspective, there are three circumferentially arranged guides, corresponding to three valve sinuses in the human body, respectively, and the guides include two separate roots, such as root 532a and root 532b. The root portions 532a and 532b are respectively connected to different connection posts 104, the root portion 532a further extends to form a wing portion 531d, the root portion 532b further extends to form a wing portion 531f, and the free ends 534 of the wing portions 531d and 531f are separated from each other.

From the viewpoint of the clamp arms, three groups of clamp arms are arranged in the circumferential direction. Each set of clamping arms comprises two clamping arms. For example, one of the clamping arms has a root 532a, the root 532a further extending into a bifurcation forming two wings: wings 531d and 531e, wherein the free ends of wings 531d and 531f in the other set of clamping arms are adjacent to each other and correspond to the same valve sinus in the body, which is more advantageous in avoiding coronary arteries.

The different angles mentioned above refer to the same structure. In this embodiment, the connection of the root and the wing is referred to in figures 70a to 70c (where the reference numerals are applied hereinafter). From the angle of the clamping arm, the root part is fixed to the outer side of the inner frame by binding and comprises a first frame strip and a second frame strip, the wing part comprises a third frame strip and a fourth frame strip which are adjacent to the root part, one end of the third frame strip is connected to the first frame strip, and the other end of the third frame strip extends towards the inflow end; one end of the fourth frame strip is connected to the second frame strip, and the other end of the fourth frame strip extends toward the inflow end and meets the third frame strip. The third and fourth frame strips meet and then diverge from each other until they extend to the free end, with different branches (e.g., wing 531d and wing 531e, respectively, in fig. 94) corresponding to different valve sinuses. The first frame strip 5321, the second frame strip 5322, the third frame strip 5351 and the fourth frame strip 5352 form a quadrilateral, the principle and deformation of which are referred to above and will not be repeated here.

According to the above-described embodiments, the clip arms or guides located at the periphery of the inner frame can be regarded as positioning members that play an important role in circumferential alignment with the valve sinus and in displacement restriction of the frame in the axial direction. The positioning member is not directly connected with the two commissure regions in the circumferential direction, also ensuring the positioning effect.

In general, the present application provides an artificial aortic valve apparatus having opposite inflow and outflow ends, the artificial aortic valve comprising:

the inner frame 103, the inner frame 103 is of a net barrel structure capable of radial deformation, and has a relative compression state and an expansion state after being acted by external force, and the inner frame 103 is internally provided with a blood flow channel 301 which is axially penetrated;

a plurality of leaflets 200 connected to the inner frame 103 and cooperating with each other to control a blood flow path, wherein the junction of two adjacent leaflets 200 on the inner frame 103 is the commissure zone 114; and

a plurality of positioning members (the above-described clamp arms 120 or the guides 530) arranged in order in the circumferential direction of the inner frame 103, one end of each of the plurality of positioning members being connected to the inner frame 103 and the other end extending toward the inflow end, wherein a spacing region 111 is formed at a peripheral region of the inner frame between two adjacent commissure regions 114, and the positioning members avoid the spacing region 111.

Because of the spacer region 111, no positioning member directly connects the two commissure regions 114. For example, in fig. 95, the positioning member may be considered as a guide 530 located between two adjacent commissure regions 114, rather than being connected to the commissure regions in the circumferential direction. Thus, in addition to the guides 530, there are two spacer regions 111 between two adjacent commissure regions 114. The circumferential span of the guide 530 is limited in order to achieve circumferential alignment with the valve sinus.

As another example, in fig. 96, the free ends of the wings (from different clamping arms 120) on either side of the spacing region 111 are separated from each other and do not connect directly, thereby providing more anchor points for the valve sinus, thereby reducing the risk of anchor failure.

In combination with the foregoing, the positioning member is made of a memory material and is configured to be switchable in:

a loading state in which the positioning member is radially pressed to attach the inner frame 103 in a compressed state;

a transitional state in which ends of the positioning members connected to the inner frame 103 remain gathered to accommodate the inner frame 103 in a compressed state, ends of the positioning members extending toward the inflow end self-expanding at a peripheral region of the inner frame 103, wherein a receiving space is formed between the positioning members and an outer wall of the inner frame for receiving the native leaflets; and

In the released state, the ends of the positioning members connected to the inner frame 103 are distanced from each other to accommodate the expanded state of the inner frame 103.

The positioning members connected to one commissure zone 114 are not directly connected to the other commissure zones, i.e. each positioning member is a member configured independently of the other. The positioning member is at most directly connected to one commissure zone 114 (in the case where the guide 530 is connected between two commissure zones 114, it can be considered that it is not directly connected to any commissure zone).

The inner frame 103 is released in a ball-expanding manner to allow the positioning member to switch to the transitional state. Reference is made to the foregoing embodiments for additional structural details and in vivo methods of use of the artificial aortic valve apparatus.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the claims. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application.

Claims

1. A prosthetic heart valve device, comprising:

a stent defined by an annular body defined by an arrangement of cells, the body having a distal inflow end and a proximal outflow end, the stent further having:

Three spaced apart connections;

a first clamping arm and a second clamping arm extending from opposite sides of each connecting portion, each clamping arm having a free end with a tip;

wherein the body has a first diameter at a circumferential location where the tip of the gripping arm is located and the tip of the gripping arm extends outwardly defining a circumferential line having a second diameter, wherein the second diameter is greater than the first diameter; and

a leaflet assembly having a plurality of leaflets secured to the scaffold.

2. The device of claim 1, wherein the stent has three spaced apart commissure regions, and wherein the connection is a commissure post extending from a proximal outflow end of the respective commissure region.

3. The device of claim 2, wherein each clamping arm extends from each commissure post at an obtuse angle relative to each commissure post.

4. The device of claim 2, wherein the stent further comprises a first stent arm and a second stent arm extending from opposite sides of each commissure post, the first stent arm from one commissure post being connected to the second stent arm of an adjacent commissure post at a distally facing apex.

5. The device of claim 4, wherein the first and second clamp arms extend from opposite sides of each commissure post from a location between the first and second support arms, respectively.

6. The device of claim 4, wherein each distally facing vertex is connected to a vertex of a cell within the body at a connection location.

7. The device of claim 1, wherein each clamping arm has at least one slot.

8. The device of claim 1, wherein a radiopaque marker is provided at the tip of each gripping arm.

9. The device of claim 4, wherein the bridge connects each set of first and second support arms from adjacent commissure posts.

10. The device of claim 2, wherein each commissure post has at least one aperture.

11. The device of claim 2, wherein a radiopaque marker is provided at the location where each clamp arm is connected to the commissure posts.

12. The device of claim 1, wherein the body has a plurality of rows of cells, the number of cells in each row decreasing from the distal inflow end toward the proximal outflow end.

13. The device of claim 1, wherein the body is flared such that the distal inflow end has a larger diameter than a remainder of the body.

14. The device of claim 1, further comprising a securing mechanism disposed at the distal inflow end of the body.

15. A method of securing a prosthetic heart valve device at an aortic annulus comprising a plurality of native leaflets, comprising the steps of:

provided is a prosthetic heart valve device, comprising:

a stent defined by an annular body defined by an arrangement of cells, the stent further having:

three spaced apart commissure regions, each commissure region having a commissure post;

first and second clamping arms extending from opposite sides of each commissure post, each clamping arm extending from each commissure post at an angle of 90 to 180 degrees relative to each commissure post, and each clamping arm having a free end with a tip at the free end;

wherein the body has a first diameter at the point of the gripping arm and the tip of the gripping arm extends outwardly defining a second diameter, the second diameter being greater than the first diameter; and

A leaflet assembly having a plurality of leaflets secured to the scaffold;

pressing the heart valve device within a delivery system;

delivering the heart valve device to the annulus; and

releasing the heart valve device at the annulus, wherein at least some of the native leaflets are positioned between the clamping arms and the body.

16. The method of claim 15, wherein the releasing step further comprises positioning some of the native leaflets around an outer surface of some of the gripping arms.

17. The method of claim 15, wherein the step of delivering comprises the steps of:

advancing the delivery system through an aortic arch and an ascending aorta of the patient, wherein a distal portion of the delivery system passes through the aortic annulus into a ventricle;

retracting a portion of the delivery system such that the gripping arms are exposed within the chamber;

positioning a distal end of the gripping arm over a native aortic valve, distally advancing the heart valve device until the gripping arm falls into a cusp of a native leaflet;

Releasing the body of the stent at the aortic annulus; and

the remainder of the delivery system is retracted outside the patient.

18. A prosthetic heart valve device, comprising:

three spaced-apart commissure regions, each commissure region having a commissure post extending from the proximal outflow end;

first and second clamping arms extending from opposite sides of each commissure post, each clamping arm extending from each commissure post at an obtuse angle relative to each commissure post, and each clamping arm having a free end with a tip positioned along a circumferential line of the stent, the circumferential line being closer to the distal inflow end relative to the proximal outflow section; and

a leaflet assembly having a plurality of leaflets secured to the scaffold.

19. The device of claim 18, wherein the body has a first diameter at a circumferential location where the tip of the gripping arm is located, and the tip of the gripping arm extends outwardly defining a circumferential line having a second diameter, wherein the second diameter is greater than the first diameter.

20. The device of claim 18, wherein each commissure post has a bottom end that engages a proximally facing vertex of a cell of the stent at the proximal outflow end, and wherein each clamp arm has an end that is connected to the stent at the bottom end of a commissure post.

21. The device of claim 18, wherein the first and second clamp arms extend from opposite sides of each commissure post from a location between the first and second support arms, respectively.

22. The device of claim 18, further comprising a securing mechanism disposed at the distal inflow end of the body.

23. A stent for a prosthetic heart valve device, comprising:

24. The stent for a prosthetic heart valve device of claim 23, wherein the inner frame is circumferentially spaced apart with at least two commissure regions, the fixed ends of the same set of clamping arms being connected to corresponding commissure regions; in the loading state, the inner frame and all the clamping arms are not overlapped in the radial direction.

25. The stent for a prosthetic heart valve device of claim 24, wherein the commissure regions comprise commissure posts, wherein a stent arm is connected between adjacent commissure posts, wherein a first oblique space is defined between the stent arm and the outflow end of the inner stent, and wherein each of the gripping arms is positioned in the corresponding first oblique space in the loaded state;

the support arm is of a single-rod structure or a deformable net belt.

26. The stent for a prosthetic heart valve device of claim 23, wherein the fixed end is configured as a root and is secured to an outer side of the inner frame by a tie-down, and the clamp arm has a wing extending from the fixed end to the free end;

The root portion includes a first frame bar and a second frame bar, and the wing portion includes a third frame bar and a fourth frame bar adjacent to the root portion, wherein the first frame bar, the second frame bar, the third frame bar, and the fourth frame bar form a quadrilateral; and

the ends of the third and fourth frame strips distal from the root meet and then diverge away from each other to respective free ends, wherein the diverging branches are configured to correspond to different valve sinuses.

27. The stent for a prosthetic heart valve device of claim 23, wherein the number of gripping arms connected on the same side of the commissure zone is one or more along the circumference of the inner frame; wherein:

the free end of the single clamping arm is of a bifurcation structure or the middle part of the single clamping arm is of a bifurcation structure, and the free ends are converged into a whole;

the plurality of clamping arms are arranged independently of each other or are integrated together at the free ends.

28. The stent for a prosthetic heart valve device of claim 23, wherein the gripping arms are single-bar structures or deformable mesh bands; the mesh belt is of a deformation structure in the extending direction of the clamping arm.

29. The stent for a prosthetic heart valve device of claim 23, wherein the gripping arms extend from the fixed end gradually toward the inflow end of the inner stent; the free ends of at least two clamping arms in the same group have a divergent trend, and the free ends of at least two clamping arms in adjacent two groups have a converging trend.

30. The stent for a prosthetic heart valve device of claim 23, wherein the gripping arms are wave-like structures adjacent the free ends.

31. The stent for a prosthetic heart valve device of claim 23, wherein the fixed ends of the same set of clip arms converge to a connection and are secured to the inner frame by the connection;

the connecting parts corresponding to the clamping arms in the same group are of an integral structure or a split structure adjacent to each other;

the same group of clamping arms are in a plurality of pairs, the same pairs of clamping arms are positioned at two sides of the connecting part along the circumferential direction of the inner frame, and the lengths of the different pairs of clamping arms after extension are different.

32. The stent for a prosthetic heart valve device of claim 23, wherein the fixed ends of the same set of clip arms converge to a connection and are secured to the inner frame by the connection;

the same group of clamping arms are in a plurality of pairs, the same pair of clamping arms are positioned at two sides of the connecting part along the circumferential direction of the inner frame, and the clamping arms which are positioned at the same side of the connecting part in a release state but are in different pairs have different extending trends.

33. The stent for a prosthetic heart valve device of claim 23, wherein in the released state, the free ends of the same set of gripping arms are in the same radial position as the inner stent or staggered;

In the released state, the free ends of all the clamping arms are located axially of the inner frame between the ends of the inner frame and adjacent the inflow end of the inner frame.

34. The stent for a prosthetic heart valve device of claim 23, wherein the fixed ends of the same set of clip arms converge to a connection and are secured to the inner frame by the connection; the inner frame is provided with at least two connecting areas at intervals in the circumferential direction, and the connecting parts are fixed on the connecting areas on the inner frame in a welding mode or through connecting pieces;

the connecting part is overlapped on the outer side of the commissure zone along the radial direction of the inner frame or is positioned at the circumferential side of the commissure zone along the circumferential direction of the bracket.

35. A stent for a prosthetic heart valve device, comprising:

the connecting ring is fixed at the outflow end of the inner frame and is provided with a plurality of connecting areas at intervals;

the clamping arms are arranged at the periphery of the inner frame and are circumferentially arranged at intervals along the bracket, and each clamping arm is provided with a fixed end and a free end which are opposite; the fixed ends of the clamping arms in the same group are positioned in the same connecting area;

The clamping arm is made of a memory material and has the following states:

36. The stent for a prosthetic heart valve device of claim 35, wherein the attachment ring and each clip arm are formed from a wire that is coiled around.

37. A stent for a prosthetic heart valve device, comprising:

The length of the clamping arm is greater than 5mm compared with the axial distribution area M3 of the axis;

the clamping arm is made of a memory material and has the following states:

38. The stent for a prosthetic heart valve device of claim 37, wherein the clamping arms are arranged in groups with the fixed ends of the clamping arms of the same group being adjacent to each other, the circumferentially distributed area M4 of the fixed ends of each group of clamping arms being 360/n or less compared to the central angle of the axis, where n is the number of leaflets for loading in the stent.

39. The stent for a prosthetic heart valve device of claim 37, wherein a circumferential distribution area M1 of a fixed end of a single clamping arm is 360/2n or less compared to a central angle of the axis, where n is a number of leaflets for loading in the stent.

40. The stent for a prosthetic heart valve device of claim 37, wherein each clip arm includes a spatially enlarged positioning structure; the positioning structure is positioned at the free end of the corresponding clamping arm and forms a space expansion state through the extension of the self material of the clamping arm; or the positioning structure is positioned on a side edge of the clamping arm extending from the fixed end to the free end.

41. The stent for a prosthetic heart valve device of claim 37, wherein each gripping arm is covered with a fitting sleeve, the fitting sleeve being of woven construction or integrally formed.

42. The holder for a prosthetic heart valve device of claim 37, wherein in the stowed condition, the same set of gripping arms are drawn toward each other and around the periphery of the inner frame;

the clamping arms are not overlapped with each other in the radial direction of the inner frame.

43. A prosthetic heart valve device comprising a stent and leaflets;

the stent is a stent for a prosthetic heart valve device according to any one of claims 23 to 42;

the valve blades are connected to the bracket and positioned in the blood flow channel, and the valve blades are mutually matched multiple pieces for controlling the opening or closing of the blood flow channel.

44. A delivery system for a prosthetic heart valve device, comprising:

an outer sheath slidably fitted around the outer periphery of the support device, the radial gap between the outer sheath and the support device being a loading zone; and

The prosthetic heart valve device of claim 43, disposed in the loading zone in a compressed state.

45. A method of positioning a prosthetic heart valve device in accordance with claim 43, wherein the method comprises:

releasing the free end of the clamping arm and enabling the free end of the clamping arm to be released and stretched;

46. A prosthetic aortic valve apparatus having opposite inflow and outflow ends, the prosthetic aortic valve apparatus comprising: the inner frame is of a net barrel structure capable of radially deforming and is provided with a compression state and an expansion state which are opposite, and the inner frame is internally provided with a blood flow channel which is axially communicated;

The valve blades are connected to the inner frame, are multiple and are matched with each other to control the blood flow channel;

a transitional state in which the root portions of the respective guides remain bunched to accommodate the inner frame in a compressed state, the wings self-extending in the peripheral region of the inner frame and forming a space with the outer wall of the inner frame for accommodating the native leaflets;

47. The prosthetic aortic valve device according to claim 46, wherein the inner frame has commissure regions corresponding to the commissures of adjacent leaflets, the circumferential location of each guide root being between the commissure regions;

in the released state, the guide member extends from the root portion to the outside in the radial direction of the inner frame and is bent inward.

48. The prosthetic aortic valve device according to claim 46, wherein each guide is itself of unitary construction and switches states based on its elastic deformation;

and each guide piece adopts a memory alloy and is subjected to heat treatment shaping in advance, the shape of the guide piece corresponds to the shape of the release state after the heat treatment shaping, and the guide piece has internal stress in the release state under the loading state and the transition state.

49. The prosthetic aortic valve device according to claim 46, wherein the wings are bifurcated structures adjacent the root portion, the wings being free ends remote from the root portion, the bifurcated structures converging to extend toward or directly to the free ends.

50. The prosthetic aortic valve device according to claim 49, wherein the bifurcated structure extends posteriorly to the free end and is circumferentially radiating along the inner frame at a location adjacent the free end;

the radiation is distributed in such a way that it is split into at least two strands.

51. The prosthetic aortic valve device according to claim 49, wherein the free end is annular and wrapped with a protective layer;

The free end is provided with a first eyelet, the wing part is provided with a second eyelet at a position before bifurcation, and developing marks are arranged at the first eyelet and the first eyelet.

52. The prosthetic aortic valve device according to claim 49, wherein in the released state, the wings extend radially outward and then flex inward during extension toward the inflow end;

the free ends of the wings are adjacent to or abut against the outer wall of the inner frame.

53. The prosthetic aortic valve device of claim 49, wherein the free end span of each wing corresponds to a central angle of 30-60 degrees along the circumference of the inner frame.

54. The prosthetic aortic valve device of claim 46, wherein in the transitional state, the wings collectively form an angle P1 with the inner frame axis; in the release state, the included angle between the wing part and the axis of the inner frame is P2; and P1 is satisfied to be greater than P2.

55. The prosthetic aortic valve device according to claim 46, wherein the root of the same guide is 15-45 degrees in circumferential span relative to the inner frame;

the inner frame has a plurality of cells arranged in an axial direction, and the root of the same guide is one or two cells with respect to the circumferential span of the inner frame.

56. The prosthetic aortic valve device according to claim 46, wherein the root portion is always in abutment with the inner frame in each state of the guide;

the root portion is in abutment with the inner frame in a manner that it is radially inward, outward or radially aligned with the inner frame.

57. The prosthetic aortic valve device according to claim 46, wherein the root has a circumferential deformation between the transitional state and the released state.

58. The prosthetic aortic valve device according to claim 46, wherein the root portion comprises a first frame strip and a second frame strip, both of which are rotatable about their longitudinal axes relative to the inner frame;

the first frame strip and the second frame strip are bound to the inner frame, one ends of the first frame strip and the second frame strip are mutually spaced and connected with the wing parts, the other ends of the first frame strip and the second frame strip are fixed to the inner frame, and the fixed positions are outflow ends of the inner frame.

59. The prosthetic aortic valve device of claim 58, wherein the ends of the first and second frame strips distal from the wings meet, are parallel or diverge from each other;

the first frame strip and the second frame strip are provided with binding wire holes at the intersection positions.

60. The prosthetic aortic valve device according to claim 46, wherein the outflow end of the inner frame extends to form an axially outwardly convex connecting post, the root portion being secured to a corresponding connecting post, the connecting posts being identical in shape to the root portion and radially overlapping each other along the inner frame.

61. The prosthetic aortic valve device of claim 60, wherein the connecting post is V-shaped with a tip of the V facing the outflow end.

62. The prosthetic aortic valve device of claim 58, wherein the wings comprise:

one end of the third frame strip is connected with the first frame strip, and the other end extends to the inflow end;

one end of the fourth frame strip is connected with the second frame strip, and the other end extends to the inflow end and is intersected with the third frame strip;

the first frame strip, the second frame strip, the third frame strip and the fourth frame strip enclose a closed area or a semi-closed area which is opened towards the outflow end; when switching from the transition state to the release state, at least one of the four frame strips is twisted around its own longitudinal axis.

63. The prosthetic aortic valve device of claim 62, wherein the first and second frame strips define a first portion, the third and fourth frame strips define a second portion,

In the transition state, the included angle between the first part and the second part is Q1;

in the release state, the included angle between the first part and the second part is Q2;

and Q1 is smaller than Q2, and the included angle is formed outside the inner frame.

64. The prosthetic aortic valve device of claim 62, wherein a first connection point is provided between the third frame strip and the first frame strip, a second connection point is provided between the fourth frame strip and the second frame strip, the first connection point and the second connection point being spaced apart from one another when the guide is switched from the transitional state to the released state, and an angle between the third frame strip and the first frame strip and an angle between the second frame strip and the fourth frame strip being substantially constant.

65. The prosthetic aortic valve apparatus of claim 64, wherein the guide has a constraining structure thereon open at the first and second connection points, and the first and second connection points are tethered to the inner frame by the constraining structure.

66. A prosthetic aortic valve apparatus having opposite inflow and outflow ends, the prosthetic aortic valve apparatus comprising: the inner frame is of a net barrel structure capable of radially deforming, and has a compression state and an expansion state after being acted by external force, and the inner frame is internally provided with an axially-communicated blood flow channel;

The valve blades are connected to the inner frame, three valve blades are arranged and are matched with each other to control the opening and closing of the blood flow channel;

the guide pieces are sequentially arranged along the circumferential direction of the inner frame, the circumferential positions of the guide pieces are respectively aligned with the valve leaflets, each guide piece comprises a root fixedly connected with the inner frame and a wing part extending from the root to the inflow end, the splicing positions of two adjacent valve leaflets on the inner frame are the connecting areas of the inner frame, the root of the guide piece is fixed with the connecting areas corresponding to the positions, or the root of the guide piece is positioned between the two adjacent connecting areas in the circumferential direction of the inner frame;

the guide employs a memory material and is configured to be switchable between:

a released state in which the root portion of each guide member is relatively far away from the inner frame to accommodate the expanded state, the guide member has opposite outer and inner sides along the circumference of the inner frame, the edge portion of the wing portion located outside the guide member has a smooth profile, and the profile line extends from the root portion toward the inflow end while also being offset toward the inner side.

67. The prosthetic aortic valve assembly of claim 66, wherein in the released state, the free ends of the two wings of the same guide are spaced apart from one another, and the spaced apart region spans the circumferential direction of the inner frame at a central angle β that is greater than 30 degrees.

68. The prosthetic aortic valve assembly of claim 66, wherein the free ends themselves define a reference surface, the free ends of the two wings of the same guide member defining a first reference surface and a second reference surface, respectively, in the transitional state, and wherein the angle between the first reference surface and the second reference surface is less than or equal to 90 degrees, preferably less than 45 degrees.

69. A delivery system for loading and delivering a prosthetic aortic valve device according to any one of claims 46 to 68, wherein the delivery system has opposite distal and proximal ends and comprises:

an outer sheath slidably fitted over the outer periphery of the balloon device, the radial clearance between the outer sheath and the balloon device being a loading zone for receiving the prosthetic aortic valve device in a compressed state; and

70. The delivery system of a prosthetic aortic valve device of claim 69, wherein the balloon device comprises:

the catheter body is internally provided with at least a guide wire channel and a perfusion channel, and the proximal end of the catheter body is rotatably arranged on the control handle;

a guide head fixed to a distal tip of the tube body, a distal end of the guidewire channel being open to the guide head;

and the balloon is fixed on the tube body and is positioned at the proximal end side of the guide head, and the interior of the balloon is communicated with the perfusion channel.

71. The delivery system of a prosthetic aortic valve device of claim 70, wherein the tube body comprises a multi-layer structure from inside to outside, and the centered layer is a hypotube or a wirerope tube; the steel cable pipe is multi-layered, and the winding directions of two layers are opposite.

72. The prosthetic aortic valve device delivery system of claim 70, wherein the control handle comprises:

a support body;

A movable seat movably mounted on the support body, the proximal end of the sheath tube being fixed to the movable seat;

the driving sleeve is rotatably arranged on the periphery of the supporting body and is in transmission fit with the movable seat so as to drive the outer sheath tube to slide relative to the balloon device;

the rotating seat is rotatably arranged on the periphery of the supporting body and is in transmission fit with the tube body of the balloon device so as to drive the balloon device to rotate relative to the outer sheath tube.

73. An interventional system, comprising:

the prosthetic aortic valve apparatus of any one of claims 46-68; and

the delivery system of any of claims 69 to 72.

74. A method of using an interventional system of claim 73, comprising:

75. An artificial aortic valve apparatus having opposite inflow and outflow ends, the apparatus comprising:

76. The artificial aortic valve apparatus according to claim 75, wherein the plurality of positioning members are separated from each other, and a single positioning member is directly connected to at least one commissure zone.