CN113768660A - Prosthetic Heart Valves and Prosthetic Heart Valve Systems - Google Patents

Abstract

Translated fromChinese

本发明涉及一种人工心脏瓣膜和人工心脏瓣膜系统，人工心脏瓣膜包括瓣架和至少一个凸起结构，凸起结构包括凸出部，凸出部设于瓣架上，且凸出部向瓣架的外侧凸出，凸出部被构造成受径向压缩时可形成褶皱。本发明的人工心脏瓣膜植入人体后，凸起结构中的凸出部与自体瓣环对应接触，凸出部会受到自体瓣环对其产生径向压缩作用，凸出部形成的褶皱与自体瓣环接触，可以增加凸出部与自体瓣环内壁的接触点，可以提高贴壁性，并且减小凸出部与自体瓣环之间形成的间隙的大小，可降低血液流过该间隙的流速，血液中的蛋白质在间隙处沉积并形成血栓可对间隙进行封堵，进而防止瓣周漏。

The invention relates to an artificial heart valve and an artificial heart valve system. The artificial heart valve comprises a valve holder and at least one protruding structure, the protruding structure comprises a protruding part, the protruding part is arranged on the valve holder, and the protruding part faces the valve The outer side of the frame protrudes, and the protuberances are configured to form folds when compressed radially. After the artificial heart valve of the present invention is implanted into the human body, the protruding part in the protruding structure is in corresponding contact with the native valve annulus. Ring contact can increase the contact point between the protruding part and the inner wall of the native valve annulus, which can improve the adherence, and reduce the size of the gap formed between the protruding part and the native valve annulus, which can reduce the flow rate of blood flowing through the gap. , the protein in the blood deposits at the gap and forms a thrombus to seal the gap, thereby preventing paravalvular leakage.

Description

Prosthetic heart valve and prosthetic heart valve system

Technical Field

The invention relates to the field of interventional medical devices, in particular to a prosthetic heart valve and a prosthetic heart valve system.

Background

Heart valve disease has become one of the most common cardiovascular diseases today, and while thousands of patients worldwide can benefit from surgical valve replacement surgery every year, a large number of patients are still not amenable to surgical treatment due to advanced, and numerous complications of valve disease.

The above disadvantages can be overcome by intervention of artificial valve operation. In 2002, the Cribier et al implant the stent with the artificial valve into the diseased aortic valve position of the human body, so that the hemodynamics of the postoperative patient is obviously improved, and the life quality is improved. In recent years, with the continuous improvement of interventional instruments and the accumulation of related experience, interventional heart valve stents are beginning to be applied to cases where surgery is not appropriate, such as aortic valves, pulmonary valves, mitral valves, tricuspid valves, and the like.

As shown in fig. 1, the conventionalprosthetic heart valve 10 includes avalve frame 11 and anouter skirt 13 covering thevalve frame 11. In order to adapt to the physiological shape of the native valve annulus (the native valve annulus is approximately circular), the portion of thevalve frame 11 contacting the native valve annulus is set in a cylindrical state. Thevalve frame 11 is made of a material with shape memory, so that thevalve frame 11 has self-expansion property, and thevalve frame 11 is self-expanded and unfolded after being released from the sheath. Thevalve frame 11 has a plurality of meshes for easy packing into the sheath after compression.

After theartificial heart valve 10 is implanted into a human body, thevalve frame 11 is unfolded under the self-expansion force, due to the mesh openings on thevalve frame 11, the material of thevalve frame 11 is not continuous in the 360-degree circumferential direction, further, only a plurality of supportingpoints 111 of thevalve frame 11 are used for radially supporting theouter skirt 13, and the unfoldedouter skirt 13 is only contacted with the inner wall of the autologous valve annulus at the positions of the supportingpoints 111. Since the native valve annulus is substantially circular in shape, theouter skirt 13 forms a chord of the circle, and very severe paravalvular leakage exists between theouter skirt 13 and the native valve annulus.

Disclosure of Invention

Based on this, there is a need for a prosthetic heart valve, which at least solves the problem of perivalvular leakage easily occurring after the prosthetic heart valve is implanted in the prior art.

In one embodiment, a prosthetic heart valve is provided, including a valve frame and at least one protruding structure, the protruding structure including a protrusion, the protrusion being disposed on the valve frame and protruding outward of the valve frame, the protrusion being configured to form a pleat when radially compressed.

In one embodiment, the number of the convex structures is multiple, and the convex parts of the convex structures can move independently under the action of external radial force.

In one embodiment, the valve frame is provided with meshes, the bulges protrude out of the meshes, and the bulges cover the outer sides of the meshes protruded by the bulges.

In one embodiment, the prosthetic heart valve further comprises an outer skirt, the outer skirt covers the outer side surface of the valve frame, and at least part of the outer skirt protrudes out of the outer side surface of the valve frame to form a protruding part.

In one embodiment, the outer skirt is at least partially connected with the valve frame, the part of the outer skirt connected with the valve frame is a connecting part, and two adjacent bulges are connected through the connecting part.

In one embodiment, the valve frame comprises a plurality of circles of annular grid structures which are axially connected, the protruding structure comprises an elastic part, one end of the elastic part is connected with the annular grid structures, the other end of the elastic part extends to the outer side of the valve frame to abut against the inner side face of the protruding part, the elastic part is connected with the protruding part, and the elastic part can elastically deform inwards when being compressed in the radial direction.

In one embodiment, the annular grid structure comprises a plurality of unit cells, the unit cells are annularly connected to form the annular grid structure, the elastic element is connected with the axial end parts of the unit cells, and the orthographic projection of the unit cells surrounds the orthographic projection of the elastic element in a projection plane parallel to the central axis plane of the annular grid structure.

In one embodiment, the number of the protruding structures is multiple, wherein at least one protruding structure comprises a plurality of elastic members, one part of the elastic members is connected with the near end of the unit cell, the other part of the elastic members is connected with the far end of the unit cell, and when the elastic members are in a compressed state, the axial distance is reserved between the elastic members connected with the near end of the unit cell and the elastic members connected with the far end of the unit cell.

In one embodiment, the number of the protruding structures is multiple, wherein at least one protruding structure comprises a plurality of elastic members, one part of the elastic members is connected with the near end of the unit cell, the other part of the elastic members is connected with the far end of the unit cell, and when the unit cell is in a compressed state, the elastic members connected with the near end of the unit cell and the elastic members connected with the far end of the unit cell have circumferential spacing and do not have axial spacing.

In one embodiment, a prosthetic heart valve system is also provided, the prosthetic heart valve system including a delivery apparatus releasably coupled to the prosthetic heart valve, and the prosthetic heart valve described above.

The bulge of foretell artificial heart valve implantation outwards bulges in the lateral surface of valve frame, the bulge is constructed and can forms the fold when receiving radial compression, after artificial heart valve implantation human body, bulge and autologous valve ring in the bulge structure correspond the contact, because the external diameter of bulge is greater than the internal diameter of autologous valve ring in the artificial heart valve, the bulge can receive autologous valve ring to its radial compression effect that produces, the fold that the bulge formed contacts with autologous valve ring, can increase the contact point of bulge and autologous valve ring inner wall, adherence can improve, and reduce the size of the clearance that forms between bulge and the autologous valve ring, can reduce the velocity of flow that blood flows through this clearance, protein in the blood deposits and forms the thrombus in clearance department can carry out the shutoff to the clearance, and then prevent the valve periphery and leak.

Drawings

Fig. 1 is a state diagram of a prior art prosthetic heart valve implantation.

Fig. 2 is a perspective view of a prosthetic heart valve according to a first embodiment of the present invention.

FIG. 3 is a schematic cross-sectional view of a heart valve prosthesis according to a first embodiment of the present invention

Fig. 4 is a perspective view of the flap frame and the elastic member in the first embodiment of the present invention.

Fig. 5 is a perspective view of the annular lattice structure and the elastic member in the first embodiment of the present invention.

Fig. 6 is a schematic structural view of the projection structure and the unit cell in a compressed state according to the first embodiment of the present invention.

Fig. 7 is a schematic sectional view along a-a of fig. 6.

FIG. 8 is a perspective view of a leaflet of the first embodiment of the invention

Fig. 9 is a schematic view of a second embodiment of the present invention showing a structure in which the projection structure and the unit cell are in a compressed state.

Fig. 10 is a schematic sectional structure view along B-B of fig. 9.

Fig. 11 is a schematic structural view of a third embodiment of the present invention with a projection structure and a unit cell in a compressed state.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. 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. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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 invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The axial direction refers to the direction parallel to the connecting line of the center of the far end and the center of the near end of the medical instrument; the radial direction means a direction perpendicular to the axial direction.

After the prosthetic heart valve is implanted in a human body, blood flow flows along the axial direction of the prosthetic heart valve, defining a flow of blood from the proximal end of the prosthetic heart valve to the distal end of the prosthetic heart valve.

First embodiment

Referring to fig. 2 and 3, an embodiment of the invention provides aprosthetic heart valve 30, which includes avalve frame 31, at least oneprotrusion structure 33, aninner skirt 35, and avalve leaflet 37.

Theinner skirt 35 is fixed to the frame of thecell 312 by sewing, and theinner skirt 35 is located inside thevalve frame 31, and theinner skirt 35 may be a flow blocking member made of flow blocking materials such as PET (Polyethylene Terephthalate), PTFE (polytetrafluoroethylene), and the like.

The profile of the distal end of theinner skirt 35 is trimmed according to the profile of the distal end of thevalve frame 31, and the profile of the proximal end of theinner skirt 35 may be trimmed according to the profile of the proximal end of thevalve frame 31 or may be a plain end.

Referring to fig. 4 and 5, thevalve frame 31 is made of a material with shape memory, thevalve frame 31 includes a plurality of circles of axially connectedannular grid structures 311, and a plurality ofmeshes 313 are formed on theannular grid structures 311 of thevalve frame 31. When thevalve frame 31 is subjected to radial compression force, the valve frame can contract inwards and deform to a compression state; after the radial compression force is removed, thevalve frame 31 can be restored to its natural state under the action of its own expansion force. Thevalve frame 31 has an outer diameter larger than the inner diameter of thenative valve annulus 21 in the natural state.

Theannular grid structure 311 includes a plurality ofunit cells 312, theunit cells 312 are connected in an annular manner (i.e., connected in a circumferential direction) to form a completeannular grid structure 311, theunit cells 312 may be rhombus, rectangle, or other closed polygonal frames, and the through holes surrounded by the frames of theunit cells 312 are the above-mentionedmesh holes 313. The number of theunit cells 312 in theannular grid structure 311 may be 6 to 18, the number of theunit cells 312 in theannular grid structure 311 of the present embodiment is 12, and the shape of theunit cells 312 is a diamond shape. When thevalve frame 31 is manufactured, thevalve frame 31 can be processed by performing laser cutting on the shape memory alloy tube (such as a nickel-titanium alloy tube) and then performing heat setting and other processes, so that the structure of thevalve frame 31 meets expectations.

Theconvex structure 33 is arranged on thevalve frame 31, theconvex structure 33 is arranged at the proximal end of thevalve frame 31, and after theartificial heart valve 30 is implanted, theconvex structure 33 is abutted against thenative valve annulus 21. Of course, in other embodiments, theprotruding structure 33 may be disposed at other positions of thevalve frame 31, such as the middle or the distal end of thevalve frame 31, as long as theprotruding structure 33 abuts against thenative annulus 21 after theprosthetic heart valve 30 is implanted.

In one embodiment, the number of theprotruding structures 33 is multiple, eachprotruding structure 33 is arranged along the circumferential direction, and the number of theprotruding structures 33 may be 6-18. In this embodiment, the number of theprotruding structures 33 is the same as the number of thecells 312 in a singleannular grid structure 311, theprotruding structures 33 are connected to thecells 312 in a one-to-one correspondence, the number of theprotruding structures 33 is 12, and eachprotruding structure 33 is disposed on the same annular grid structure 311 (i.e., on the same circumference). Of course, in other embodiments, the number of theconvex structures 33 may be only one.

The protrudingstructure 33 in this embodiment is substantially in the shape of a quadrangular pyramid, the protrudingstructure 33 includes a protrudingportion 331 and anelastic member 335, the protrudingportion 331 is located outside theelastic member 335, and the protrudingportion 331 forms an outer contour of the protrudingstructure 33.

The protrudingportion 331 is disposed on thevalve frame 31, the protrudingportion 331 can be disposed on the outer side surface or the inner side surface of thevalve frame 31, the protrudingportion 331 protrudes toward the outer side of thevalve frame 31, and the protrudingportion 331 in this embodiment is disposed on the outer side surface of thevalve frame 31. Referring to fig. 6 and 7, theprotrusions 331 are configured to formpleats 332 when radially compressed. When theprosthetic heart valve 30 is implanted in a human body, theprotrusion 33 abuts against thenative valve annulus 21, and theprotrusion 331 of theprotrusion 33 abuts against thenative valve annulus 21. Because the outer diameter of theconvex part 331 of theartificial heart valve 30 is larger than the inner diameter of theautologous valve annulus 21, theconvex part 331 can be compressed radially by theautologous valve annulus 21, thefolds 332 formed by theconvex part 331 are contacted with theautologous valve annulus 21, the contact point of theconvex part 331 and the inner wall of theautologous valve annulus 21 can be increased, and the adherence can be improved. Compared with the prior art, the size of the gap formed between theconvex part 331 and theautologous valve ring 21 can be reduced, so that the flow velocity of blood at the gap can be reduced, and the gap can be blocked by depositing nutrient substances such as protein in the blood and forming thrombus at the gap, thereby preventing paravalvular leakage.

When the radial external force acts, theprotrusions 331 of theprotrusion structures 33 can move independently, so that theadjacent protrusions 331 can be prevented from being linked with each other, even if acertain protrusion 331 is not radially compressed, theprotrusion 331 cannot be linked with theadjacent protrusion 331, and further theprotrusion 331 which is not radially compressed drives theadjacent protrusion 331 to radially expand relative to the outer surface of thevalve frame 31, so that theprotrusion 331 is better attached to the tissue wall of theautologous valve annulus 21.

The number of the protrudingportions 331 may be 6-18, in this embodiment, each protrudingstructure 33 includes one protrudingportion 331, the number of the protrudingportions 331 is the same as the number of theunit cells 312, and the number of the protrudingportions 331 is 12.

Thebulge 331 protrudes out of themesh 313, thebulge 331 covers the outside of themesh 313 protruded by the bulge, when thebulge 33 is pressed inward in the radial direction, thefold 332 formed by compressing thebulge 331 is accommodated in themesh 313, so that the outer side surface of thebulge 331 after compression deformation is consistent with the outer side surface of thevalve frame 31, a gap between theartificial heart valve 30 and the tissue wall of theautologous valve annulus 21 can be avoided, and further the perivalvular leakage is prevented. In contrast, when theprosthetic heart valve 30 is implanted, the tissue wall of thenative valve annulus 21 compresses theprotrusion 331 in the radial direction, and if the outer side surface of theprotrusion 331 protrudes outward from the outer side surface of thevalve frame 31, a gap is formed between thevalve frame 31 and the tissue wall of thenative valve annulus 21, which may result in perivalvular leakage. Note that the outer side surface of thewrinkle 332 is an arc surface where the outermost portion (e.g., the portion indicated by the outer tip in fig. 7) is located. Note also that the outer side surface of the substance attached to the substrate has the same outer surface as the substrate, for example, if a film structure is attached to the outer surface of thevalve frame 31, the film structure has an attachment portion attached to thevalve frame 31, and the outer surface of the attachment portion can be regarded as the same as the outer surface of thevalve frame 31.

Theprosthetic heart valve 30 also includes anouter skirt 34, and theouter skirt 34 may be a flow blocking member made of a flow blocking material such as PET, PTFE, or the like. In this embodiment, theouter skirt 34 is made of PET, theouter skirt 34 covers the outer side of thevalve frame 31, and at least a portion of theouter skirt 34 protrudes out of the outer side of thevalve frame 31 to form the protrudingportion 331. Theouter skirt 34 is at least partially connected to thevalve frame 31, the connectingportion 341 of theouter skirt 34 to thevalve frame 31, and any twoadjacent protrusions 331 are connected by the connectingportion 341. Theconnection portion 341 may be connected to thevalve frame 31 by asuture 336 so that theconnection portion 341 is attached to thevalve frame 31. Theconnection portion 341 may space the twoadjacent protrusions 331 so that radial movements of the twoadjacent protrusions 331 do not interlock with each other. It is to be noted that the suture in this embodiment is not shown in fig. 2 and 3, but only in fig. 6.

Referring to fig. 6 to 7 again, in the present embodiment, each of theprotrusion structures 33 includes a plurality ofelastic members 335, and theelastic members 335 and the protrudingportions 331 are disposed in a one-to-one correspondence. Of course, in other embodiments, the number of theelastic members 335 in each of the protrudingstructures 33 may be multiple, for example, the number of theelastic members 335 in each of the protrudingstructures 33 is two, three or more. In addition, in other embodiments, the number of theelastic members 335 in one part of the protrudingstructure 33 may be one, and the number of theelastic members 335 in another part of the protrudingstructure 33 may be multiple, and the "multiple" may be two or more.

One end of theelastic member 335 is connected to theannular mesh structure 311, the other end of theelastic member 335 extends to the outside of thevalve frame 31 and abuts against the inner side surface of theprotrusion 331, theelastic member 335 can be connected to theprotrusion 331 through asuture 337, theelastic member 335 can elastically deform inward when being radially compressed, theelastic member 335 can provide elastic force, when theprotrusion 331 is radially compressed and deformed inward and forms awrinkle 332, theelastic member 335 elastically deforms in the radial direction, so that theelastic member 335 guides theprotrusion 331 to be radially compressed, theprotrusion 331 is prevented from greatly swinging in the circumferential direction during deformation, theprotrusion 331 is ensured to deform in the radial direction, theprotrusion 331 is further enabled to form auniform wrinkle 332 in the circumferential direction, and a large gap between a local area of theouter skirt 332 and a tissue wall due tonon-uniform wrinkle 332 can be avoided. And, the elastic force provided by theelastic member 335 can also make theprotrusion 331 closely fit with the tissue wall of thenative valve annulus 21.

Theelastic member 335 is connected to an axial end (i.e., a proximal end or a distal end) of theunit cell 312, in this embodiment, theelastic member 335 is connected to the distal end of theunit cell 312, and in other embodiments, theelastic member 335 may be connected to the proximal end of theunit cell 312. In a projection plane parallel to a central axis plane of theannular grid structure 311, an orthographic projection of theunit cell 312 surrounds an orthographic projection of theelastic member 335, so that when theelastic member 335 is subjected to a radial compressive force, the elastic member can be elastically deformed to be located in amesh 313 surrounded by theannular grid structure 311, and then awrinkle 332 formed by thebulge 331 can be brought into themesh 313 of theunit cell 312, a frame of theunit cell 312 presses thewrinkle 332, so that thewrinkle 332 is more compact, and the function of preventing the leakage around the valve is achieved. Under the co-extrusion action of theelastic element 335 and the tissue wall of thenative valve annulus 21, the outer side surface of thewrinkle 332 and the outer side surface of thevalve frame 31 can be located on the same peripheral surface, that is, thewrinkle 332 and thevalve frame 31 have the same outer side surface, so that a gap between the tissue wall of thenative valve annulus 21 and thevalve frame 31 or thewrinkle 332 can be avoided, and the valve periphery leakage can be prevented.

Referring to fig. 8, the number of theleaflets 37 is 3, the structure and shape of eachleaflet 37 are the same, and theleaflets 37 are connected end to end and uniformly distributed on the inner side of thevalve frame 31. Theleaflet 37 has a fixededge 371 and afree edge 373, wherein the fixededge 371 is fixed to the distal ends of theinner skirt 35 and thevalve frame 31 by sewing, thefree edge 373 is not fixed by sewing and can be opened and closed angularly, and theleaflet 37 mainly functions as a one-way valve to allow blood to flow from the proximal end to the distal end and prevent blood from flowing from the distal end to the proximal end. The material of thevalve leaflet 37 is a biological tissue material, such as porcine pericardium, bovine pericardium, equine pericardium, ovine pericardium, porcine heart valve, etc., and may also be a polymer material and a tissue engineering material.

Second embodiment

The number of theprojection structures 43 in the second embodiment is plural, wherein at least oneprojection structure 43 includes pluralelastic members 435, and a part of the pluralelastic members 435 of theprojection structure 43 is connected to the proximal end of the unit cell, and another part of the pluralelastic members 435 is connected to the distal end of the unit cell. In the compressed state, theresilient members 435 associated with the proximal ends of the cells are axially spaced from theresilient members 435 associated with the distal ends of the cells such that the raisedstructures 43 are radially compressed and may create circumferentially extending corrugations.

The number of theelastic members 435 of eachprojection structure 43 is illustrated as two. Specifically, referring to fig. 9 and 10, in the present embodiment, the number of theelastic members 435 of each protrudingstructure 43 is two. Of course, in other embodiments, the number of theelastic members 435 of only the partially protrudingstructure 43 may be two. In addition, in other embodiments, the number of "plurality ofelastic members 435" may be 3, 4, or more.

In this embodiment, in one of theconvex structures 43, one of theelastic members 435 is connected to the proximal end of the cell, the otherelastic member 435 is connected to the distal end of the cell, the twoelastic members 435 are axially opposite, and in a compressed state, there is an axial gap between the twoelastic members 435, the convex structure can not only form anaxial fold 432a, but also form acircumferentially extending fold 432b at the axial gap, and the extending direction of thefold 432b is perpendicular to the blood flow direction, which is beneficial for preventing the paravalvular leakage of theheart valve prosthesis 30. In addition, theextra folds 432a and 432b added on the outer side surface of thevalve frame 31 can also increase the stress points of theprosthetic heart valve 30, so as to increase the radial supporting force and stability of theprosthetic heart valve 30.

In the natural state, the opening angle formed by the tangent of theelastic member 435 and the axis of the valve frame ranges from 15 ° to 60 °, and the opening angle in this embodiment is 30 °.

Third embodiment

The third embodiment differs from the second embodiment in that the raisedstructures 53 may create curved, extendingcorrugations 532 in the compressed state with circumferential spacing between theresilient members 535 associated with the proximal ends of thecells 312 and theresilient members 535 associated with the distal ends of thecells 312 and no axial gap between theresilient members 535. It should be noted that the twoelastic members 535 do not have axial clearance, which means that the free end of oneelastic member 535 is located within the axial length of the otherelastic member 535.

Referring to fig. 11, in the present embodiment, the sum of the lengths of the twoelastic members 535 is greater than the axial length of themesh 313, so that the twoelastic members 535 have no axial gap, the ends of the twoelastic members 535 are disposed away from each other, and when in a compressed state, theconvex structures 53 can form a curve-extendingfold 532 between the twoelastic members 535, and the curve-extendingfold 532 is beneficial to theprosthetic heart valve 30 to prevent paravalvular leakage.

Fourth embodiment

The present embodiment also provides a prosthetic heart valve system including a transporter (not shown) releasably coupled to theprosthetic heart valve 30, and theprosthetic heart valve 30 described above.

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.

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

Claims (10)

Translated fromChinese

1.一种人工心脏瓣膜，其特征在于，包括瓣架和至少一个凸起结构，所述凸起结构包括凸出部，所述凸出部设于所述瓣架上，且所述凸出部向所述瓣架的外侧凸出，所述凸出部被构造成受径向压缩时可形成褶皱。1. An artificial heart valve, characterized in that, comprising a valve holder and at least one protruding structure, and the protruding structure comprises a protruding portion, and the protruding portion is provided on the valve holder, and the protruding portion is The protruding portion protrudes toward the outside of the valve holder, the protruding portion being configured to form folds when compressed radially.2.如权利要求1所述的人工心脏瓣膜，其特征在于，所述凸起结构的数量为多个，受径向外力作用时，各所述凸起结构的所述凸出部可独立地运动。2 . The artificial heart valve according to claim 1 , wherein the number of the protruding structures is plural, and the protruding portions of the protruding structures can be independently acted upon by a radial external force. 3 . sports.3.如权利要求1所述的人工心脏瓣膜，其特征在于，所述瓣架上形成有网孔，所述凸出部凸出于所述网孔的外侧，且所述凸出部覆盖在被其凸出的所述网孔的外侧。3. The artificial heart valve according to claim 1, wherein a mesh hole is formed on the valve holder, the protruding portion protrudes from the outside of the mesh hole, and the protruding portion covers the The outside of the mesh that is protruded by it.4.如权利要求1所述的人工心脏瓣膜，其特征在于，所述人工心脏瓣膜还包括外裙围，所述外裙围覆盖于所述瓣架的外侧面，所述外裙围至少部分凸出于所述瓣架的外侧面形成所述凸出部。4. The artificial heart valve according to claim 1, wherein the artificial heart valve further comprises an outer skirt, the outer skirt covers the outer side of the valve frame, and the outer skirt is at least partially The protruding portion is formed protruding from the outer side surface of the petal holder.5.如权利要求4所述的人工心脏瓣膜，其特征在于，所述外裙围至少部分与所述瓣架相连，所述外裙围与所述瓣架相连的部分为连接部，相邻两所述凸出部通过所述连接部相连。5. The artificial heart valve according to claim 4, wherein the outer skirt is at least partially connected with the valve holder, and the part where the outer skirt is connected with the valve holder is a connecting portion, adjacent to The two protruding parts are connected through the connecting part.6.如权利要求1所述的人工心脏瓣膜，其特征在于，所述瓣架包括多圈轴向相连的环状网格结构，所述凸起结构还包括弹性件，所述弹性件的一端与所述环状网格结构相连，所述弹性件的另一端延伸至所述瓣架的外侧与所述凸出部的内侧面相抵，所述弹性件与所述凸出部相连，所述弹性件受径向压缩时可向内弹性变形。6 . The artificial heart valve according to claim 1 , wherein the valve holder comprises a plurality of rings of axially connected annular grid structures, the protruding structure further comprises an elastic member, and one end of the elastic member Connected with the annular grid structure, the other end of the elastic piece extends to the outside of the valve frame and abuts against the inner side of the protruding portion, the elastic piece is connected to the protruding portion, and the The elastic member can be elastically deformed inward when compressed radially.7.如权利要求6所述的人工心脏瓣膜，其特征在于，所述环状网格结构包括多个单元格，所述多个单元格环形相连形成所述环状网格结构，所述弹性件与所述单元格的轴向端部相连，在与所述环状网格结构的中心轴平面平行的投影面内，所述单元格的正投影包围所述弹性件的正投影。7. The artificial heart valve according to claim 6, wherein the annular grid structure comprises a plurality of cells, and the plurality of cells are annularly connected to form the annular lattice structure, and the elastic The element is connected to the axial end of the unit cell, and the orthographic projection of the unit cell surrounds the orthographic projection of the elastic element in a projection plane parallel to the plane of the central axis of the annular grid structure.8.如权利要求6所述的人工心脏瓣膜，其特征在于，所述凸起结构的数量为多个，其中至少一个所述凸起结构包括多个弹性件，所述多个弹性件中一部分所述弹性件与所述单元格的近端相连，另一部分弹性件与所述单元格的远端相连，在压缩状态时，与所述单元格的近端相连的弹性件与与所述单元格的远端相连的弹性之间具有轴向间距。8 . The artificial heart valve according to claim 6 , wherein the number of the protruding structures is plural, wherein at least one of the protruding structures comprises a plurality of elastic members, and a part of the plurality of elastic members The elastic piece is connected with the proximal end of the cell, and another part of the elastic piece is connected with the distal end of the cell. In a compressed state, the elastic piece connected with the proximal end of the cell is connected with the cell. There is an axial spacing between the elastics connected at the distal ends of the cells.9.如权利要求6所述的人工心脏瓣膜，其特征在于，所述凸起结构的数量为多个，其中至少一个所述凸起结构包括多个弹性件，所述多个弹性件中一部分所述弹性件与所述单元格的近端相连，另一部分弹性件与所述单元格的远端相连，在压缩状态时，与所述单元格的近端相连的弹性件与与所述单元格的远端相连的弹性之间具有周向间距，且不具有轴向间距。9 . The artificial heart valve according to claim 6 , wherein the number of the protruding structures is multiple, wherein at least one of the protruding structures comprises a plurality of elastic members, and a part of the plurality of elastic members The elastic piece is connected with the proximal end of the cell, and another part of the elastic piece is connected with the distal end of the cell. In a compressed state, the elastic piece connected with the proximal end of the cell is connected with the cell. The elastics connected at the distal ends of the cells have a circumferential spacing and no axial spacing.10.一种人工心脏瓣膜系统，其特征在于，所述人工心脏瓣膜系统包括输送器和权利要求1至9中任意一项所述的人工心脏瓣膜，所述输送器与所述人工心脏瓣膜可解脱相连。10. An artificial heart valve system, characterized in that the artificial heart valve system comprises a conveyor and the artificial heart valve according to any one of claims 1 to 9, the conveyor and the artificial heart valve can be Free to connect.

Images