CN113208776A

CN113208776A - Prosthetic heart valve and delivery device

Info

Publication number: CN113208776A
Application number: CN202110449975.2A
Authority: CN
Inventors: 傅国胜; 俞飞成
Original assignee: Zhejiang University ZJU
Current assignee: Zhejiang University ZJU
Priority date: 2021-04-25
Filing date: 2021-04-25
Publication date: 2021-08-06

Abstract

The application discloses prosthetic heart valve and conveyor, wherein prosthetic heart valve includes support and valve, the support is the tube-shape, and has relative compression state and release state according to the radial deformation of self, the inside of support is the blood flow passageway, the valve connect in order to open or seal in the support the blood flow passageway, its characterized in that, be connected with on the support and be used for the anchor arm that acts on with the primary tissue of focus, the anchor arm under the compression state is attached at the support periphery wall, the anchor arm under the release state turns over the perk towards the radial outside of support; the support is characterized in that two ends of the support in the axial direction of the support are an initial release end and a rear release end which are opposite, a connecting structure matched with the conveying device is arranged at the initial release end of the support, and the connecting structure is used for restraining the release of the initial release end to be later than that of the anchoring arm. The application further optimizes the stent structure and considers delivery and release positioning.

Description

Prosthetic heart valve and delivery device

Technical Field

The present application relates to the field of medical devices, in particular to prosthetic heart valves for use in interventional procedures and corresponding delivery devices.

Background

The artificial heart valve replacement technology is a revolutionary breakthrough of the heart valve treatment technology and has wide prospect. With economic development and aging population, the incidence of senile Calcified Aortic Valve Disease (CAVD) is on the rise, second to coronary heart disease and hypertension.

At present, the implantation of a biological valve through a catheter is a main method for treating heart valve diseases, firstly, a prosthetic heart valve is compressed into a delivery device, the delivery device delivers the valve to a heart lesion through a blood vessel, and then the prosthetic heart valve is released to replace a diseased autologous valve. The heart valve developed at present is a balloon-type expansion valve or a self-expansion valve, and the artificial heart valve replacement device generally comprises a reticular support made of a memory metal material and a valve sewn in the support and capable of opening in a single direction, the expansion force of the support is matched with the lesion position as much as possible, but perivalvular leakage and peripheral reflux of different degrees still occur.

In order to further reduce paravalvular leakage and peripheral backflow and facilitate accurate positioning when an interventional instrument is released, in some prior arts, an acuate convex anchoring arm capable of clamping native tissues (such as an aortic valve or a mitral valve) is arranged on the periphery of a stent, the anchoring arm is released in advance to be in place before the stent is completely released, then the stent is completely released, the anchoring arm is arranged to play a role in pre-positioning, and in addition, the stent can be better attached to the peripheral native tissues to reduce the paravalvular leakage.

Because the anchoring arm needs to be released before the stent, the delivery device is relatively complicated, for example, a double-layer sheath tube is used for releasing layer by layer, or a two-section sheath tube is used, namely, the proximal end and the distal end are released respectively, but because the anchoring arm is positioned at the periphery of the stent when the stent is loaded, one section of the stent is inevitably in a half-release state when the stent is released, the positioning and the posture of the anchoring arm are adversely affected, and a serious person has the risk of dislocation or even failure of the anchoring arm.

Disclosure of Invention

In view of the problems of the prior art, the present application provides a prosthetic heart valve with anchoring clip arms, and corresponding delivery device, that is improved for loading and release of the stent and anchoring arms.

The artificial heart valve comprises a support and a valve, wherein the support is cylindrical and has a relative compression state and a release state according to the radial deformation of the support, a blood flow channel is formed in the support, the valve is connected with the support to open or close the blood flow channel, an anchoring arm used for acting with a focus native tissue is connected to the support, the anchoring arm in the compression state is attached to the peripheral wall of the support, and the anchoring arm in the release state is tilted towards the radial outer side of the support;

the support is characterized in that two ends of the support in the axial direction of the support are an initial release end and a rear release end which are opposite, a connecting structure matched with the conveying device is arranged at the initial release end of the support, and the connecting structure is used for restraining the release of the initial release end to be later than that of the anchoring arm.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the first release end of the bracket includes a plurality of pointed portions distributed along the circumferential direction, the connection structure is a plurality of wire passing holes distributed along the circumferential direction of the bracket, and each pointed portion is provided with the wire passing hole.

Optionally, the stent is woven by metal wires, and one section of at least one strand of metal wire extends out of the periphery of the stent and forms the anchoring portion by winding; or

The bracket and the anchoring arm are integrally cut by adopting a metal pipe; or

The support is cut by adopting a metal pipe, and the anchoring arm is welded and fixed to the support.

Optionally, the anchoring arm is of a frame structure, and includes a root connected to the bracket and a head far from the bracket in a release state, the shape of the head gradually converges from the root, and the outer edge of the head is of an arc structure.

The application still provides a conveyor for loading and carry this application prosthetic heart valve, conveyor has relative distal end and near-end, conveyor includes the sheath core and slides and establish the outer sheath pipe in sheath core periphery, the sheath core and the near-end of outer sheath pipe both is connected with the handle of the relative motion of drive both, be fixed with on the sheath core with prosthetic heart valve's back release end looks complex installation head, the inside of sheath core is equipped with first acting as go-between, the one end of first acting as go-between is worn out the sheath core and with prosthetic heart valve's connection structure cooperation, the other end of first acting as go-between extends to the near-end in the sheath core and is controlled by the handle.

Optionally, a fixing sleeve is disposed on the periphery of the distal end of the sheath core, a guide hole for extending the first pull wire penetrates through the space between the inner wall of the sheath core and the outer wall of the fixing sleeve, and the extending direction of the guide hole is inclined relative to the sheath core axis;

the inner wall of the sheath core of the guide hole is provided with a hole inner edge, the outer wall of the fixed sleeve is provided with a hole outer edge, and the hole outer edge is provided with a smooth flaring structure.

Optionally, the conveying device further comprises a first wire ring sequentially passing through each wire passing hole along the circumferential direction of the stent, and the first pull wire is connected to the first wire ring and mutually pulled with at least two positions of the first wire ring;

the first pull wire is connected to the handle directly or via a first tube slidably mounted within the sheath core.

Optionally, the fitting manner of the rear release end of the artificial heart valve and the mounting head is as follows:

the rear release end of the artificial heart valve is mutually clamped with the mounting head through a positioning structure with matched shape, the positioning structure limits the axial position of the bracket in a compressed state, and the positioning structure is disengaged in a released state; or

The mounting head is provided with a through hole, the conveying device further comprises a second pull wire connected with the rear release end of the artificial heart valve, and the proximal end of the second pull wire is coupled to the handle through the through hole.

Optionally, a second tube at the proximal end side of the mounting head is slidably mounted in the radial gap between the sheath core and the outer sheath, the proximal end of the second pull wire is connected to the distal end of the second tube through the through hole, and the proximal end of the second tube is connected to the handle.

Optionally, the delivery device further comprises a second wire loop passing through the rear release end of the stent along the circumferential direction of the stent, and the second pull wire is connected to the second wire loop and pulls at least two portions of the second wire loop with each other.

The artificial heart valve and the conveying device improve the support structure with the anchoring arms, and the single-layer and single-section outer sheath tubes are adopted for loading and releasing, so that the overall radial size of the device is prevented from being too large as much as possible, the flexibility is ensured, the support can be kept in a compressed state after the anchoring arms are released, and the posture and the accurate positioning of the anchoring arms are conveniently controlled.

Drawings

FIG. 1 is a schematic illustration of a prosthetic heart valve according to an embodiment of the present application applied to a mitral valve position;

FIG. 2 is a schematic view of a prosthetic heart valve of an embodiment of the present application applied to an aortic valve position;

FIG. 3 is a schematic structural view of a prosthetic heart valve according to another embodiment of the present application applied to an aortic valve site;

FIG. 4 is a schematic view of a prosthetic heart valve according to an embodiment of the present application;

FIG. 5 is a schematic illustration of the stent of FIG. 4 in a compressed state with only the anchoring arms released;

FIG. 6 is a schematic illustration of the stent of FIG. 5 after release of the first release end;

FIG. 7 is a schematic representation of a prosthetic heart valve according to another embodiment of the present application;

FIG. 8 is a schematic representation of a prosthetic heart valve according to another embodiment of the present application;

FIG. 9 is a schematic view of a prosthetic heart valve according to another embodiment of the present application;

fig. 10 is a schematic view of the stent of fig. 9 in a compressed state with only the anchoring arms released.

FIG. 11 is a schematic illustration of the stent of FIG. 10 after release of the first release end;

FIG. 12 is a schematic view of the prosthetic heart valve of FIG. 5 in an aortic valve position;

FIG. 13 is a schematic view of the prosthetic heart valve of FIG. 10 in a mitral position;

FIG. 14 is a schematic view of a prosthetic heart valve of one embodiment of the present application in a compressed state loaded onto a delivery device;

FIG. 15 is a schematic illustration of the prosthetic heart valve of FIG. 14 with only the anchoring arms released;

FIG. 16 is a schematic view of the prosthetic heart valve stent of FIG. 15 after further release of the first released end;

FIG. 17 is a schematic view of the prosthetic heart valve of FIG. 16 after complete release;

FIG. 18 is a schematic view of the rear release end configuration of the alternate stent of FIG. 17;

fig. 19 is a schematic view of the engagement of the stent ends with the wire loops.

The reference numerals in the figures are illustrated as follows:

100. the mitral valve;

200. an aortic valve;

300. a prosthetic heart valve; 310. a support; 320. an anchoring arm; 330. a wire passing hole; 340. connecting lugs; 350. releasing the end first; 360. a rear release end; 370. a wire passing hole; 380. a valve;

400. a conveying device; 410. a sheath core; 411. fixing a sleeve; 412. a guide hole; 413. the outer edge of the hole; 414. an inner edge of the hole; 420. an outer sheath tube; 430. a guide head; 440. a first pull wire; 441. a first wire loop; 450. a first pipe member; 460. a mounting head; 461. a card slot; 462. penetrating a lead hole; 470. a second pull wire; 480. a second pipe.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 to 13, an embodiment of the present application provides a prosthetic heart valve 300, including a stent 310 and a valve 380, where the stent 310 is cylindrical and has a compressed state and a released state opposite to each other according to its radial deformation, the interior of the stent 310 is a blood flow channel, the valve 380 is connected to the interior of the stent 310 to open or close the blood flow channel, the stent 310 is connected to an anchoring arm 320 for interacting with a lesion native tissue, the anchoring arm 320 in the compressed state is attached to the outer circumferential wall of the stent 310, and the anchoring arm 320 in the released state is tilted toward the outer side of the stent 310 in the radial direction;

the stent 310 has opposite first and second release ends 350 and 360 at its axial ends, and the first release end 350 of the stent 310 is provided with a connection structure for engaging with the delivery device 400, the connection structure being used for restraining the first release end 350 to release later than the release of the anchoring arms 320.

The stent 310 may have matching shape characteristics according to different lesion sites, for example, it may be implanted in the mitral valve 100 or the aortic valve 200, and the first release end 350 and the second release end 360 may be interchanged according to different access routes and release modes, for example, in the aortic valve 200 of fig. 3, the first release end 350 is generally the lower end of the stent (according to the orientation of fig. 3) when the aortic arch is accessed, the first release end 350 is generally the upper end of the stent (according to the orientation of fig. 3) when the aortic arch is accessed, and generally, the end away from the operator along the access route is the distal end and the end toward the operator is the proximal end.

The stent 310 and the valve 380 may be made of any material known in the art, for example, the stent 310 may be made of woven wire or cut tubing, and may be formed of a plurality of hollow-out lattice structures for easy compression loading, but the shape or arrangement of the lattice structures is not critical. The valve 380 is sewn inside the stent 310 and used for controlling the unidirectional opening of a blood flow channel, two lobes or three lobes can be selected according to the physiological characteristics of a lesion site, and in addition, the inner peripheral wall or the outer peripheral wall of the stent 310 can be coated according to the requirement.

The anchoring arms 320 can be in a strip, sheet or frame structure, and can be made of a pre-setting elastic material, the anchoring arms 320 are released before the stent 310, the native tissue at the periphery can be firstly released, and the anchoring arms 320 are matched with the stent 310 after the stent 310 is released to further clamp or clamp the native tissue, so that the accuracy of the overall posture of the artificial heart valve 300 is ensured, and the occurrence of perivalvular leakage is reduced.

Generally, the rear release end 360 of the stent 310 is finally separated from the constraint of the delivery device 400, before the release of the anchoring arm 320 is completed, the application focuses on the connection structure matched with the delivery device 400 arranged on the front release end 350 of the stent 310, so that the front release end 350 can be ensured to be in a compressed state before and during the release of the anchoring arm 320, and the rear release end 360 is naturally also in a compressed state.

Some prior art adopt two segmentation sheath pipes, release anchor arm and few part support earlier, and then release the support of the rest part, but even the release of few part support also can cause the change of anchor arm angle, be unfavorable for accurate taking one's place. This application can guarantee that each end of support all keeps the compression state when the anchoring arm releases, has improved the location effect.

The following embodiments provide different solutions for the specific form of the anchoring arms 320 and the connection relationship with the stent 310.

In one embodiment, the stent 310 is woven from metal wires, and at least one of the wires extends out of the outer circumference of the stent 310 and is routed to form an anchoring portion.

In one embodiment, the stent 310, along with the anchoring arms 320, are integrally cut from metal tubing.

In one embodiment, the stent 310 is cut from metal tubing and the anchor arms 320 are welded to the stent 310.

When an integral cutting mode is adopted, continuous hollow parts can be generated at the anchoring arms 320, the overall strength of the bracket 310 can be slightly influenced, the problem can be avoided due to the weaving structure, and the number of the anchoring arms 320 can be 2, 3 or 4 and the anchoring arms are uniformly arranged along the circumferential direction.

In one embodiment, the anchoring arm 320 is a frame structure, and includes a root portion connected to the bracket 310 and a head portion away from the bracket 310 in a release state, wherein the shape of the head portion gradually converges from the root portion to the head portion, and the outer edge of the head portion has an arc structure.

The span of the root of the anchoring arm 320 in the circumferential direction, namely the corresponding central angle, can be 5-180 degrees, the smaller the degree is, the more obvious the trend of the shape gradual convergence is, preferably 30-90 degrees, and in addition, the positioning and the safety can be considered in combination with the outer edge shape of the head.

In order to ensure the operation effect of the first release end 350, in an embodiment, the first release end 350 of the bracket 310 includes a plurality of pointed portions distributed along the circumferential direction, the connection structure is a plurality of wire passing holes 330 distributed along the circumferential direction of the bracket 310, and each pointed portion is provided with a wire passing hole 330.

When the bracket 310 adopts a grid structure, the sharp corner part is the vertex part of the grid at the first release end 350, and each sharp corner part is provided with the wire passing hole 330, so that the pulling wire in the conveying device can be used for synchronously controlling each part of the first release end 350, the balanced change of the postures of each part is facilitated, and the adverse effect of the individual sharp corner on positioning after being turned outwards and tilted is avoided.

Fig. 4 to 6 illustrate the release change of the anchoring arm 320 and the first release end 350, and fig. 9 to 11 are similar only in application scenarios and the detailed construction of the stent. The anchoring arms 320 are released when the stent 310 is kept compressed, and may be pre-positioned to surrounding native tissue as shown in fig. 12 and 13. in order to control the posterior release end, the stent 310 may be generally constrained by an external sheath of a delivery device, and the stent 310 may have engaging lugs 340 for engaging with the delivery device or may be provided with wire-passing holes 370, i.e., in a wire-controlled manner similar to the anterior release end 350.

Referring to fig. 14-19, in some embodiments of the present application, a delivery device 400 is further provided for loading and delivering the prosthetic heart valve 300 of the above embodiments, the delivery device 400 has opposite distal and proximal ends, the delivery device 400 includes a sheath core 410 and an outer sheath 420 slidably disposed on the outer circumference of the sheath core 410, the proximal ends of the sheath core 410 and the outer sheath 420 are connected to a handle (not shown) for driving the relative movement of the two, a mounting head 460 is fixed on the sheath core 410 and is coupled to the rear release end 360 of the prosthetic heart valve 300, a first pull wire 440 is disposed inside the sheath core 410, one end of the first pull wire 440 penetrates through the sheath core 410 and is coupled to the connecting structure of the prosthetic heart valve 300, and the other end of the first pull wire 440 extends proximally in the sheath core 410 and is controlled by the handle.

The sheath core 410 is tubular, and may be in one-piece or multi-segment connection, the distal end of the sheath core 410 has a guiding head 430 for passing through the body, the proximal ends of the sheath core 410 and the sheath tube 420 are connected to a handle, and the handle may be driven by gears, electric push rod, etc. for each relative motion component, which may also be implemented in combination with many existing technologies.

One end of the first pulling wire 440 directly or indirectly pulls each wire passing hole 330 on the stent 310, and the other end is directly or indirectly connected to a corresponding driving part in the handle, the releasing time of the first releasing end 350 of the stent 310 can be controlled by the handle through the pulling wire, the first pulling wire 440 can be one or a plurality of parallel wires, the proper material and wire diameter can be selected by using synthetic fibers or metal wires on the premise of ensuring the pulling strength, and when a guide wire needs to be threaded inside the sheath core 410, the wire diameter of the first pulling wire 440 at least leaves a gap in the sheath core 410 for the guide wire to pass through.

In order to avoid excessive stress of the first pull wire 440 at the turning part penetrating out of the sheath core 410, in one embodiment, the outer periphery of the distal part of the sheath core 410 is provided with a fixing sleeve 411, a guide hole 412 for extending the first pull wire 440 is arranged between the inner wall of the sheath core 410 and the outer wall of the fixing sleeve 411 in a penetrating way, and the extending direction of the guide hole 412 is obliquely arranged relative to the axis of the sheath core 410;

the guiding hole 412 is a hole inner edge 414 at the inner wall of the sheath core 410, and a hole outer edge 413 at the outer wall of the fixing sleeve 411, and the hole outer edge 413 has a smooth flaring structure.

The stress concentration part of the turn of the first pulling wire 440 is mainly at the outer edge 413 of the hole, and the smooth flaring structure is provided in the embodiment to protect the first pulling wire 440, so as to facilitate the release of the first pulling wire 440, and the first pulling wire 440 can be pulled, recovered and released again when the position of the stent 310 is not good.

The direction of extension of the guide hole 412 determines the direction of extension of the first pull wire 440, and the closer to the distal end, the more outwardly the guide hole 412 is, in combination with the orientation in fig. 14.

In order to facilitate the first pulling wire 440 to control the release and the recovery of the stent 310, in one embodiment, the delivery device 400 further includes a first wire loop 441 sequentially passing through each of the wire passing holes 330 along the circumferential direction of the stent 310, and the first pulling wire 440 is connected to the first wire loop 441 and is pulled by at least two portions of the first wire loop 441.

The first wire loop 441 can drive all sharp corner parts of the first releasing end 350 to be synchronously retracted, and at least two parts of the first pull wire 440 and the first wire loop 441 are mutually pulled to form a pulling mode similar to a parachute, so that the action is more stable, and the pre-positioning effect of the anchoring arm 320 cannot be damaged.

The first pull wire 440 and the first wire ring 441 can be tied or movably wound with each other, preferably movably wound, so as to release the pulling force between the first pull wire 440 and the first wire ring 441, and the first wire ring 441 is made of a biocompatible material, and can be left in the body along with the stent, or can be recovered after the prosthetic heart valve 300 is stable in operation.

To control the first puller wire at the handle, the first puller wire 440 is connected to the handle directly or via a first tube 450 slidably mounted within the sheath core 410.

To facilitate the retrieval of the pull wires, it is also possible that one end of the first pull wire 440 passes through the sheath core 410 and is intertwined with the first wire loop 441, and the other end of the first pull wire 440 is two strands, one strand is connected to the fixation sleeve 411 (not extending into the sheath core 410), and the other strand extends proximally in the sheath core 410 to the handle or is connected to the handle via the first tube 450.

When the first pulling wire 440 is retracted, one of the first pulling wires is cut off, and then the first pulling wire is pulled again, so that the first pulling wire and the first wire loop 441 can be released from each other until the first pulling wire is separated out of the body.

During operation, release of the anchoring arms 320 may be accomplished by retracting the outer sheath 420, but the outer sheath is generally retracted to a degree that it remains constrained to the posterior release end 360. after release of the first release end 350 is accomplished, the outer sheath 420 is further retracted to expose and release the posterior release end 360. in some embodiments, the engagement of the posterior release end 360 of the prosthetic heart valve 300 with the mounting head 460 is disclosed.

In one embodiment, the rear release end 360 of the prosthetic heart valve 300 and the mounting head 460 are engaged with each other by a shape-matching detent structure that limits the axial position of the stent 310 in the compressed state and disengages from the detent structure in the released state.

As seen in fig. 17, the positioning structure includes a T-shaped slot 461 at the outer periphery of the mounting head 460 and a T-shaped engaging lug 340 at the bracket 310, and the slot 461 and the engaging lug 340 are engaged, and only when the sheath 420 is retracted to expose the engaging lug 340, the slot 461 is disengaged to allow the rear releasing end 360 to release. While the engaging lug 340 in fig. 7, for example, has a ring shape, the corresponding mounting head 460 has a positioning column projection on the periphery thereof, which is engaged with the ring shape.

In one embodiment, the mounting head 460 defines a through-hole 462, and the delivery device 400 further includes a second pull wire 470 connected to the rear delivery end 360 of the prosthetic heart valve 300, a proximal end of the second pull wire 470 being coupled to the handle via the through-hole 462.

For example, as shown in fig. 17, the mounting head 460 is provided with a through hole 462 along the axial direction, the rear releasing end 360 is similar to the first releasing end 350, a wire passing hole is provided at the sharp corner, and the second pulling wire 470 is applied to each wire passing hole to control the retraction of the rear releasing end 360.

For ease of control, a second tube 480 is slidably mounted in the radial gap between the sheath core 410 and the outer sheath 420 on the proximal side of the mounting head 460, the proximal end of the second pull wire 470 is connected to the distal end of the second tube 480 via the through-going hole 462, and the proximal end of the second tube 480 is connected to the handle.

The thread-passing hole of the rear releasing end 360 may also be threaded through a thread loop, for example, the delivery device 400 further includes a second thread loop (omitted in the figure) passing through the rear releasing end 360 of the stent 310 along the circumferential direction of the stent 310, and the second pulling thread 470 is connected to the second thread loop and pulls at least two portions of the second thread loop with each other. The matching manner of the second pulling wire 470 and the second wire loop and the arrangement manner of the second wire loop are the same as the first releasing end 350, as shown in fig. 19, taking the first releasing end 350 as an example, the first wire loop 441 sequentially passes through each wire passing hole 330, the number of the first pulling wires 440 is two, one end of each wire loop movably winds around the first wire loop 441, the winding positions of the two first pulling wires 440 and the first wire loop 441 are approximately symmetrical, six sharp corners are provided in the drawing, and the winding positions of the two first pulling wires 440 and the first wire loop 441 are spaced by three sharp corners.

The other end of each first pulling wire 440 is divided into two strands, and both strands are connected to the first pipe 450, or one strand is connected to the first pipe 450 and the other strand is connected to the fixing sleeve 411.

Referring to fig. 14-17, when the prosthetic heart valve 300 is released, the imaging device is used to confirm proper positioning, and then the outer sheath 420 is withdrawn proximally relative to the sheath core 410 until the anchoring arms 320 are fully exposed and released for deployment, while the stent 310 itself is kept in a compressed state, wherein the first released end is only controlled by the first pull wire 440, and the second released end is still covered by the outer sheath 420.

After the posture is adjusted to determine that the anchoring arm 320 is matched with the peripheral tissue position, the first pull wire 440 is released to release the constraint of the first release end 350, as can be seen in fig. 16, the first release end 350 is unfolded, the outer sheath 420 is further retracted until the second release end 360 is released, and finally the first pull wire 440 is released in a shearing or releasing manner and is withdrawn out of the body along with the delivery device 400.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims

1. The artificial heart valve comprises a support and a valve, wherein the support is cylindrical and has a relative compression state and a release state according to the radial deformation of the support, a blood flow channel is arranged in the support, and the valve is connected in the support to open or close the blood flow channel;

2. The prosthetic heart valve of claim 1, wherein the pre-release end of the stent includes a plurality of cusp portions circumferentially distributed about the stent, and the connection structure is a plurality of wire-passing holes circumferentially distributed about the stent, each of the cusp portions being provided with the wire-passing hole.

3. The prosthetic heart valve of claim 1, wherein the stent is woven from wire, and wherein a length of at least one strand of wire extends beyond a periphery of the stent and is routed to form the anchoring portion; or

4. The prosthetic heart valve of claim 1, wherein the anchoring arms are frame-like structures including a root portion connected to the stent and a head portion spaced apart from the stent in a released state, the shape of the head portion gradually converging from the root portion to the head portion, and the outer edge of the head portion is an arc-shaped structure.

5. A delivery device for carrying and delivering the heart valve prosthesis of any one of claims 1 to 4, the delivery device having opposite distal and proximal ends, the delivery device comprising a sheath core and an outer sheath tube slidably disposed around the sheath core, the proximal ends of the sheath core and the outer sheath tube being connected to a handle for driving the sheath core and the outer sheath tube to move relatively, the sheath core being fixed with a mounting head for engaging with the rear release end of the heart valve prosthesis, wherein a first pull wire is disposed inside the sheath core, one end of the first pull wire extends out of the sheath core and engages with a connecting structure of the heart valve prosthesis, and the other end of the first pull wire extends proximally in the sheath core and is controlled by the handle.

6. The delivery device according to claim 5, wherein the outer periphery of the distal end portion of the sheath core is provided with a fixing sleeve, a guide hole for extending the first pull wire penetrates from the inner wall of the sheath core to the outer wall of the fixing sleeve, and the extending direction of the guide hole is obliquely arranged relative to the sheath core axis;

7. The delivery device of claim 5, further comprising a first loop of wire passing through each of the wire passing holes in sequence circumferentially of the stent, the first pull wire being connected to the first loop of wire and drawing at least two portions of the first loop of wire in relation to each other;

8. The delivery device of claim 5, wherein the rear release end of the prosthetic heart valve is mated to the mounting head by:

9. The delivery device of claim 8, wherein a second tube at a proximal side of the mounting head is slidably mounted in the radial gap between the sheath core and the outer sheath, a proximal end of the second pull wire being connected to a distal end of the second tube via the through-going hole, a proximal end of the second tube being connected to the handle.

10. The delivery device of claim 9, further comprising a second wire loop circumferentially threaded through the rear release end of the stent, the second pull wire being connected to the second wire loop and drawing at least two portions of the second wire loop.