CN115624415A

CN115624415A - Artificial heart valve stent, artificial heart valve and implantation system

Info

Publication number: CN115624415A
Application number: CN202211233455.9A
Authority: CN
Inventors: 王海山; 朱洪旺; 许阳; 詹航敏; 虞奇峰
Original assignee: Shanghai Newpulse Medical Technology Co ltd
Current assignee: Shanghai Newpulse Medical Technology Co ltd
Priority date: 2022-10-10
Filing date: 2022-10-10
Publication date: 2023-01-20

Abstract

The application provides a prosthetic heart valve stent, a prosthetic heart valve and an implantation system. The stent comprises a positioning piece, a valve piece and a connecting piece, wherein after the positioning piece is positioned to the aortic sinus floor, the valve piece expands to press the native valve leaflets to the positioning piece, and the stent positioning is completed. Wherein the positioning piece is provided with a turnover section and an inward barb, so that the barb pierces the native valve leaflet during pressing. The connecting piece comprises a chain structure which is formed by sequentially and fixedly connecting a plurality of chain rings; the connecting piece also comprises a rigidity weakening section, and when the rigidity weakening section is positioned at the bending part of the S-shaped bend, the connecting piece is in a stable bending state, so that the reliable positioning of the valve piece is ensured. The artificial heart valve comprises the stent and the artificial valve leaflet sewed to the valve component, and the implantation system comprises the artificial heart valve and the delivery mechanism. The folding and the barb of the positioning piece, the rigidity weakening section of the connecting piece and the like are arranged to ensure the reliable positioning of the valve.

Description

Artificial heart valve stent, artificial heart valve and implantation system

Technical Field

The application relates to the technical field of artificial heart valves and implantation systems thereof, in particular to an artificial heart valve stent, an artificial heart valve and an implantation system.

Background

The dilation of the aortic annulus caused by the lesion may cause a poor seal when the leaflets close, thereby creating a regurgitation lesion that affects the pumping function of the heart. Through minimally invasive surgery, the artificial heart valve is implanted through the femoral artery to replace the native valve leaflet, and the regurgitation lesion caused by the expansion of the aortic valve annulus can be effectively treated.

Generally, both the valve leaflet and the valve annulus are soft and may be further expanded continuously, which cannot provide enough supporting force to fix the artificial valve leaflet implant, so that the artificial valve leaflet is usually required to be sewn on the artificial heart valve support to form the artificial heart valve and integrally implanted to the sinus floor of the aorta, and the artificial valve leaflet structure which can be reliably positioned and works for a long time is realized.

The invention with the publication number of CN114886615A provides a prosthetic valve, which comprises a positioning frame and a valve bracket, wherein the valve bracket is further released after the positioning frame is positioned to the sinus floor of the aorta by utilizing a conveying mechanism, so that the implantation and positioning of the prosthetic valve are realized. However, the technical scheme still has the following needs to be improved: barbs are arranged on the elastic arms of the positioning frame, but the barbs extend towards the near end and cannot well penetrate into native valve leaflets, so that the positioning piece is easy to move in a staggered manner in a body; in addition, in the relative positioning process of the positioning frame and the valve support, due to the fact that the structure of the connecting piece is unstable, the connecting piece is easy to stretch and deform under the action of force and even deflect, and therefore accurate positioning between the positioning frame and the valve support is affected.

Disclosure of Invention

Aiming at the defects existing in the prior art, the artificial heart valve stent which can more reliably position the artificial heart valve to the target position and has lower manufacturing cost and better stability, the artificial heart valve based on the artificial heart valve stent and the artificial heart valve implantation system are provided.

In order to achieve the above object, the present application provides the following technical solutions.

A prosthetic heart valve stent, comprising: the positioning piece is suitable for radially contracting under the action of radial force to form a conveying state and expanding to a working state after the radial force is removed, and a positioning space is formed around the native valve leaflets of a patient; the valve component is suitable for radially contracting under the action of radial force to form a conveying state and expanding to a working state after the radial force is removed so as to press the native valve leaflets to the positioning component in the positioning space; the connecting piece is connected with the positioning piece and the valve piece and has a straightened state and an S-shaped bent state; wherein, the setting element is equipped with the barb the operating condition of setting element, the barb sets up inwards, makes the valve spare will primary valve leaflet pressfitting in during the setting element, the barb pierces primary valve leaflet.

In some embodiments, the retainer comprises a plurality of resilient arms forming a unitary structure in the shape of a cylinder; the far end of the elastic arm is turned inwards or outwards to form a set acute angle to form a turning section, and the barb is arranged on the turning section.

In some embodiments, the folded section occupies 20% to 40% of the axial length of the resilient arm, and the set acute angle is between 40 ° and 60 °; the barb and the proximally directed axis of the positioning member form an angle of between 40 ° and 140 °.

In some embodiments, the barb is located at a distal end of the folded section; when the folding section is folded inwards, the barb points to the far end before folding; when the turnover section is turned outwards, the barb points to the near end before the turnover.

In some embodiments, the valve component is generally cylindrical in shape, and includes a first-increasing and a second-decreasing bulge portion from the distal end to the proximal end, for pressing-fit to the native valve leaflet after implantation; the valve piece also comprises an inner concave part and a skirt part, wherein the diameter of the inner concave part is reduced from the far end to the near end and then is increased, and the skirt part is positioned at the far end and the diameter of the skirt part is monotonically increased from the far end to the far end; the concave portion is located between the rising portion and the skirt portion in the axial direction.

In some embodiments, the connecting member comprises a chain structure in which a plurality of chain rings are sequentially and fixedly connected; the dimension of the chain ring in the length direction of the connector is smaller than the dimension of the chain ring in the width direction of the connector; adjacent said links are connected by a connecting arm; the size of the connecting arm is smaller than that of the chain ring in the length direction of the connecting piece.

In some embodiments, the connector comprises at least 1 weakened section with a set length, and the average bending stiffness of the weakened section is smaller than that of the structures on two sides of the weakened section over the set length; the set length is not less than the length of the unfolded bending part in the S-shaped bending state.

In some embodiments, the stiffness weakened sections are formed by reducing the cross-sectional size of the chain link and/or by changing the shape of the chain link.

In some embodiments, the stiffness weakened section is a folded-back structure formed by bending the elongated structure back and forth in a direction crossing the axial direction; the structures on two sides of the rigidity weakening section are chain-shaped structures fixedly connected with a plurality of chain rings in sequence.

In some embodiments, the proximal end of the positioning member is provided with a proximal hook, the distal end of the valve member is provided with a distal hook, and the proximal hook and the distal hook are used for connecting to a delivery mechanism of a prosthetic heart valve implantation system; the positioning piece, the valve piece and the connecting piece are integrally formed.

The application also provides a prosthetic heart valve, which comprises any one of the prosthetic heart valve stents; still include artificial valve leaflet, artificial valve leaflet sets up in the valve member.

The application also provides a prosthetic heart valve implantation system, which comprises the prosthetic heart valve and a conveying mechanism, wherein the conveying mechanism is used for releasing and positioning the prosthetic heart valve after the prosthetic heart valve in a conveying state is conveyed to a target position.

Various embodiments of the present application have at least one of the following technical effects:

1. the positioning piece is provided with the inward barbs, so that when the valve piece presses the native valve leaflets to the positioning piece, the barbs can penetrate the native valve leaflets to the maximum extent, and the positioning reliability of the positioning piece is ensured;

2. the turnover section is arranged on the elastic arm of the positioning piece, so that the positioning function of the positioning piece is further improved; the folding section has two functions, one function is to enable the far end of the positioning piece to form a proper folding structure so as to increase the pressing force with the inner wall of the aorta or the native valve leaflet and increase the axial positioning reliability; the barb and the elastic arm can be produced according to a plane structure without specially matching the direction of the barb, so that the production cost of the positioning piece is hardly increased due to the arrangement of the barb;

3. through the arrangement of the rigidity weakening section, the connecting piece is easy to bend and not easy to break, and the stable operation of the whole implantation process is ensured;

4. through setting up stable connecting piece structure for in the motion process of setting element and valve spare relative positioning, be difficult to take place to deflect, thereby realize the accurate location between the two.

Drawings

The above features, technical features, advantages and modes of realisation of the present invention will be further described in the following detailed description of preferred embodiments thereof, which is to be read in connection with the accompanying drawings.

FIG. 1 is a schematic view of one embodiment of a prosthetic heart valve stent;

FIG. 2 is a schematic view of the embodiment of FIG. 1 in use after implantation;

FIG. 3 is a schematic illustration of the embodiment of FIG. 1 with the valve member 200 in a delivery state;

FIG. 4 is a detailed structural schematic diagram of the positioning member 100 of the embodiment of FIG. 1;

FIG. 5 is a schematic view of another embodiment of the positioning member 100;

fig. 6 is a schematic view of a stable bending state of the bending portion 320 of the connector 300;

FIG. 7 is a side view of FIG. 6;

fig. 8 is a schematic view of a structure of the folded-back structure 321 of the bending portion 320;

FIG. 9 is a schematic structural diagram of an embodiment of the bending portion 320;

fig. 10 is a schematic structural diagram of another embodiment of the bending part 320;

FIG. 11 is a detailed structural schematic of one embodiment of valve member 200;

FIG. 12 is a schematic view of the body 210 of the valve member 200 in use after implantation;

FIG. 13 is a schematic illustration of the embodiment of FIG. 1 during a released position after delivery of a delivery mechanism of the prosthetic heart valve implant system to a target location;

FIG. 14 is a schematic illustration of another state of the release positioning process of the embodiment of FIG. 1 after delivery of the delivery mechanism of the prosthetic heart valve implant system to the target location;

FIG. 15 is a variation of the embodiment of FIG. 10;

the reference numbers illustrate:

10. aorta, 11, aortic sinus floor, 20, native valve leaflet, 30, delivery mechanism, 100, positioning element, 110, elastic arm, 111, folded section, 120, proximal hook, 130, barb, 200, valve element, 210, body, 211, bulge, 212, internal recess, 213, skirt rod, 214, skirt portion, 220, distal hook, 300, connecting element, 310, connecting rod, 320, bent portion, 321, folded structure, 322, stiffness weakened section, 400, artificial valve leaflet.

Detailed Description

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following will describe the specific embodiments of the present application with reference to the accompanying drawings. The drawings in the following description are only some examples of the application, and it is obvious to a person skilled in the art that other drawings and other embodiments can be obtained from these drawings without inventive effort.

For the sake of simplicity, the drawings only schematically show the parts relevant to the present application, and they do not represent the actual structure of the product. In some of the figures, elements having the same structure or function are shown only schematically or only indicated. In this document, "one" means not only "only one" but also a case of "more than one". The term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items. The terms "first," "second," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

Unless expressly stated or limited otherwise, the terms "mounted," "connected," and "connected" are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in this application will be understood to be a specific case for those of ordinary skill in the art.

The first embodiment. As shown in fig. 1 and 12, the present embodiment is a prosthetic heart valve stent. This embodiment is used to construct a prosthetic heart valve after the prosthetic valve leaflet 400 is placed, and provides an implant for a patient with aortic regurgitation lesions to replace the diseased native leaflet 20. As shown in fig. 13 and 14, the implantation process can be completed by a minimally invasive femoral approach, and after the prosthetic heart valve is delivered to the position of the sinus floor 11 of the aorta of the patient by the delivery mechanism 30 of the prosthetic heart valve implantation system, the positioning member 100 is released and positioned as shown in fig. 13; then, as shown in fig. 14, the valve member 200 provided with the artificial valve leaflet 400 is positioned to the positioning space inside the positioning member 100, and the positioning is released, completing the implantation process. The detailed delivery and implantation procedures can be found in the applicant's previously filed patent application for implantation system invention with publication number CN 114767334A.

The artificial heart valve support provided by the application can be produced and sold as an independent product, and various artificial heart valve products are formed after the artificial valve leaflets 400 with different models and sealing films and other structures are arranged. But at the end of use, all perform their function in the form of an implant product for a prosthetic heart valve. For the sake of brevity and convenience, when the function of the artificial heart valve stent is described in the present specification, the function of the artificial heart valve stent in the artificial heart valve should be understood and is not annotated one by one.

As shown in fig. 1, the artificial heart valve stent of the present embodiment includes a positioning member 100, a valve member 200, and a connecting member 300 integrally made of nitinol. As shown in fig. 13 and 14, the positioning member 100 is adapted to be radially contracted by a radial force of the delivery mechanism 30 to form a delivery state, and expanded to an operative state after the radial force is removed, so as to be radially compressed to the inner wall of the aorta 10 in the sinus floor 11 of the patient and form a positioning space around the native valve leaflets 20 of the patient. The valve component 200 is adapted to contract radially under the action of the radial force of the delivery mechanism 30 to form a delivery state, and expand to an operating state after the radial force is removed, so as to press-fit the native valve leaflets 20 to the positioning component 100 in the positioning space formed by the positioning component 10; the native leaflets 20, which are compressed between the positioning member 100 and the valve member 200, serve as an aid in positioning the prosthetic heart valve, and provide a one-way valve for the heart, which is replaced by the prosthetic leaflets 400 provided within the valve member 200, thereby enabling treatment of the regurgitation lesion.

The two ends of the connecting member 300 are connected to the positioning member 100 and the valve member 200, respectively, and the connecting member 300 has a straightened state as shown in fig. 1 and an S-shaped bent state as shown in fig. 2.

In this application, axial direction refers to the axial direction of the aorta 10 at the sinus floor 11, and also to the axial direction of the elongated tubular member of the delivery mechanism 30 and the positioning member 100 and the valve member 200, which are generally cylindrical. As used herein, reference is also made to the delivery mechanism 30 as being proximal and distal, with the proximal end being proximal to the access location and the distal end being distal to the access location in the direction of delivery. As shown in fig. 1 and 13, the positioning member 100 is located at the proximal end and the valve member 200 is located at the distal end.

The positioning member 100 and the valve member 200 shown in fig. 1 are both in a fully expanded state, wherein the outer diameters of the positioning member 100 and the valve member 200, which are cylindrical, are substantially the same. While the connector 300 is in a straightened state. As shown in figure 3, prior to the actual implantation procedure, the valve member 200 is radially compressed and placed within the radial restraining structure of the delivery mechanism 30. Similarly, the positioning member 100 is radially compressed and held in a compressed state (not shown) for delivery through the elongated femoral artery to the site of the aortic sinus floor 11. As shown in fig. 4 and 11, the proximal end of the positioning member 100 is provided with a proximal latch 120, and the distal end of the valve member 200 is provided with a distal latch 220 for latching to the proximal release mechanism and the distal release mechanism of the delivery mechanism 30, respectively. The connector 300 remains straightened and can withstand a tensile force without significant deformation during delivery and release of the spacer 100, such that the spacer 100 does not undergo significant positional movement during release.

The positioning member 100 and the valve member 200 are shown in FIG. 2 in an actual post-implantation operative configuration, and the connecting member 300 is also shown in an actual post-implantation S-bend configuration. As shown in fig. 13 and 14, the positioning member 100 after releasing the positioning is pressed onto the inner wall of the aorta 10, so that the position thereof is not easy to move, and the valve element 200 presses the native valve leaflet 20 onto the positioning member 100, thereby positioning the whole artificial heart valve. At this time, the positioning member 100 and the valve member 200 do not reach the fully expanded state, so the elastic expansion force thereof can maintain the continuous pressing state between the structures, thereby realizing reliable positioning.

The basic structure of the artificial heart valve stent of the present application can be referred to the invention patent application with publication number CN114886615A previously filed by the applicant, and the present embodiment is improved on the basic structure. As shown in FIG. 4, the positioning member 100 is provided with a plurality of barbs 130; as shown in fig. 2, in the working state of the positioning member 100, all the barbs 130 are disposed radially inward, so that when the valve member 200 presses the native valve leaflets 20 into the positioning member 100, the barbs 130 penetrate the native valve leaflets 20, thereby achieving more reliable positioning of the heart valve prosthesis. The barbs 130 of the applicant's prior application are all directed proximally, i.e., parallel to the axis of the positioning member 100, and do not effectively penetrate the native leaflets 20, and thus the present application achieves better positioning.

Specifically, as shown in fig. 4, the positioning member 100 includes a plurality of elastic arms 110, constituting an integral structure in a cylindrical shape. The preferred arrangement of the resilient arms 110 is 3 to match the sinus floor structure of the three leaflets of the native leaflet 20. The distal end of the elastic arm 110 is folded outward in the radial direction by a set acute angle α to form a folded section 111, and the barb 130 is disposed on the folded section 111. The folded section 111 occupies 20% to 40% of the axial length of the elastic arm 110, and the set acute angle α is between 40 ° and 60 °; the angle β between the barbs 130 and the proximally directed axis of the positioning member 100 is between 40 ° and 140 ° so that the barbs 130 can penetrate the native leaflets 20 to a maximum extent. The acute angle alpha is set at 50 deg. in figure 4 and the angle beta between the barb 130 and the proximally directed axis of the positioning member 100 is 130 deg.. After implantation, the folded section 111 is located at the sinus floor 11 of the aorta, and the folded section 111 can increase the pressure of the positioning member 100 on the inner wall of the aorta 10, thereby further improving the positioning reliability of the positioning member 100.

As a variation of the present embodiment, as shown in fig. 5, the foldable sections 111 can also be folded inward, and the foldable sections 111 at this time can increase the pressure on the root of the native leaflet 20 in the pressed state, and can also improve the positioning reliability of the positioning element 100.

Example two. On the basis of the first embodiment, as shown in fig. 4, the barbs 130 of the present embodiment are disposed at the distal end of the folded section 111; and as shown in figure 5, when the folded sections 111 are folded inwardly, the barbs 130 are directed toward the distal end of the positioning member 100 prior to folding; as shown in figure 4, when the folded sections 111 are folded outwardly, the barbs 130 are directed toward the proximal end of the positioning member 100 prior to folding. "before folding" refers to the state of the positioning member 100 before the folding process is performed on the folding section 111 during the production process, and the barbs 130 are directed to the proximal end or the distal end, i.e. parallel to the axis of the positioning member 100; and then angled inwardly from the axis after the folding process. This provides the advantage that the barbs 130 and resilient arms 110 and proximal hooks 120, as well as the connecting element 300 and valve element 200, all prior to final shaping, are part of a regular cylindrical surface of a predetermined thickness, which is partially equivalent to a planar structure, and thus are easier to manufacture and can save substantially more cost than a three-dimensional structure. The present application, through the provision of the folded sections 111, creates an easily machined planar structure with barbs 130 that approximate a three-dimensional structure that can penetrate inwardly into the native leaflets 20.

As a variation of this embodiment, the barbs 130 may be disposed at other positions on the resilient arms 110, and may be disposed in a three-dimensional configuration as in the prior art, so as to achieve any penetration angle of the barbs 130. However, as previously discussed, the three-dimensional structure increases manufacturing costs.

As can be seen from the embodiment, the positioning function of the positioning element 100 can be further improved by providing the folding section 111 on the elastic arm 110; the folded section 111 has two functions, one is to form a proper eversion or inversion structure at the distal end of the positioning member 100 to increase the pressure on the inner wall of the aorta 10 at the sinus floor 11 or the pressure on the root of the native valve leaflet 20 with higher strength, thereby improving the axial positioning reliability of the positioning member 100; another function is to provide the barbs 130 at the distal end of the positioning member 100 with an appropriate angle to better penetrate the native leaflets and prevent the positioning member 100 from moving out of position in vivo; while allowing the barbs 130 and the spring arms 110 to be produced in a planar configuration without the need to specially adapt the orientation of the barbs 130 to the spring arms 110 in a three-dimensional configuration, thereby allowing the barbs 130 to be provided with little or no increase in the production cost of the positioning member 100.

Example three. On the basis of the above embodiment, as shown in fig. 11, the valve member 200 of the present embodiment has an overall cylindrical surface shape, and the body 210 thereof has the ridge portion 211, and the distal end of the body 210 is provided with the distal end hook 220. The diameter of the bulge 211 increases from the distal end to the proximal end and then decreases to form a structure with a local bulge, which is used to press the native valve leaflet 20 after implantation and further press the native valve leaflet 20 to the positioning member 100.

The mating relationship between the native leaflet 20 and the body 210 of the valve element 200 of the present embodiment is schematically illustrated in fig. 12. As can be seen, the outwardly convex configuration of the raised portions 211 increases the positioning of the valve member 200 and positioning member 100 after the native leaflets 20 have been compressed. As further shown in fig. 11, the distal end of the valve member 200 is a skirt portion 214 with a diameter monotonically increasing toward the distal end, the skirt portion 214 is provided with a skirt rod 213, the skirt rod 213 extends axially and has an outwardly protruding structure, and the structural design of the skirt portion 214 and the arrangement of the skirt rod 213 can reduce the risk of blood leakage. Meanwhile, an inner concave portion 212 whose diameter is first reduced and then increased is provided between the ridge portion 211 and the skirt portion 214.

Example four. On the basis of the above embodiments, the present embodiment illustrates the improvement of the connector 300 of the present application. As mentioned above, one function of the connector 300 is to apply the necessary pulling force to the retainer 100 when the retainer 100 is released, with the connector 300 in a straightened state. After the positioning member 100 and the valve member 200 are implanted, the connecting member 300 is in the S-shaped bent state. Although the artificial heart valve can be positioned by means of the pressing force of the positioning member 100 on the inner wall of the aorta 10, the pressing force of the valve member 200 on the positioning member 100 and the auxiliary positioning function of the native valve leaflet 20, the valve member 200 is not easily moved relative to the positioning member 100. However, in order to more reliably maintain the axial relative positions of the positioning member 100 and the valve member 200 after implantation, the connecting member 300 of the present embodiment has at least one stable bending state, in which the bending resistance of the connecting member 300 needs to be overcome when the positioning member 100 and the valve member 200 are relatively close to each other or relatively far from each other in the axial direction, so that the connecting member 300 tends to return to the stable bending state, and the relative positioning between the positioning member 100 and the valve member 200 is further ensured.

When the positioning member 100, the valve member 200, and the connecting member 300 are integrally formed of memory metal, the stable bending state may be formed by performing a molding process on the connecting member 300. Or, the connecting element 300 is made to remember the stable bending state, and under the action of the body temperature of the patient after implantation, the connecting element 300 tends to restore the memory state to return to the stable bending state, i.e. has the function of automatically returning to the stable bending state after a small deformation occurs, thereby ensuring the positioning reliability.

While the present embodiment provides another method of achieving a stable bending state through the structural arrangement of the connecting member 300. Specifically, as shown in fig. 1, the connecting member 300 includes a connecting rod 310 and a bending part 320; as shown in fig. 6 and 7, the bending portion 320 forms an S-shaped bending structure in the implanted state of fig. 2. As shown in fig. 9, the bending portion 320 has at least 1 stiffness weakened section 322, and the bending stiffness of the stiffness weakened section 322 is smaller than the bending stiffness of the structures on both sides, so that the bending portion 320 is easy to bend when being bent at the stiffness weakened section 322. This is because, in this case, even when the bent portion 320 is continuously bent in any direction, a larger bending resistance needs to be overcome. At least one bending position of the bending part 320 in the stable bending state is a rigidity weakening section 322.

Specifically, as shown in fig. 9, the connector 300 includes a planar chain structure in which a plurality of chain rings are sequentially fixedly connected. The dimension of the link in the length direction of the link 300 is smaller than the dimension in the width direction of the link 300; adjacent links are connected by a connecting arm; the dimension of the connecting arm is smaller than the dimension of the link in the length direction of the connecting member 300. Since the chain link is a stable structure that is closed and not easily deformed, the chain link is not easily stretched in the longitudinal direction of the connector 300 and is structurally stable as compared with the folded structure 321 shown in fig. 8, and thus the stability of the connector 300 in the longitudinal direction can be achieved; meanwhile, the chain structure formed by connecting the chain links in series through the connecting arms with shorter sizes is bilaterally symmetrical, so that deflection is not easy to occur in the bending process; in combination with its stability in the length direction, the connector 300 allows for precise positioning between the positioning member 100 and the valve member 200.

The stiffness weakened sections 322 may be achieved by reducing the cross-sectional size of the links, or by changing the shape of the links, such as increasing the width of the links in fig. 9 and changing the shape of the links from a flat kidney round to a flat diamond shape with transition fillets; in addition, rigidity weakening can be realized by combining the technical means. Meanwhile, when the connecting piece is made of memory metal such as nickel-titanium alloy and the rigidity weakening section is adopted, a stable bending state with better positioning performance can be obtained.

As a variation of this embodiment, as shown in fig. 8 and 10, the stiffness weakening section 322 is a folded structure 321 formed by bending an elongated structure back and forth in a direction intersecting with the axial direction, and the structures on both sides of the stiffness weakening section 322 are chain-like structures in which a plurality of chain rings are sequentially and fixedly connected, so that the bending stiffness of the stiffness weakening section 322 is smaller than the bending stiffness of the structures on both sides thereof. In addition, as shown in fig. 15, the single S-shaped structure formed by the single folded-back structure 321 in fig. 10 and the chain-shaped structure formed by the chain links may also be alternately arranged, so that the bending portion 320 may have a plurality of stiffness weakening sections 322, and the connecting member 320 may have a plurality of stable bending states, so that a plurality of selectable stable positioning states may be provided between the positioning member 100 and the valve member 200, and may be selectively set as required. The stiffness weakening portion 322 is not only easily bent but also not easily broken, so the stiffness weakening portion 322 also improves the reliability of the connector 300 and the entire prosthetic heart valve stent.

Example six. As shown in fig. 12, the present embodiment is a heart valve prosthesis, which comprises a heart valve prosthesis support of any one of the foregoing embodiments, wherein a sealing membrane (shown as a shaded portion in the figure) and a prosthetic leaflet 400 are sewn to the valve component 200, and the prosthetic leaflet 400 is shown in a closed state.

Example seven. The present embodiment is a prosthetic heart valve implantation system, as shown in fig. 13 and 14, for implanting the prosthetic heart valve of the sixth embodiment into a target position in a patient, i.e. the position of the sinus floor 11 of the aorta, by a delivery mechanism 30 to replace the diseased native valve leaflet 20 of the patient to realize a one-way valve function. The delivery mechanism 30 is used to deliver the prosthetic heart valve in a delivery state to a target location via a femoral approach and then release the prosthetic heart valve into position.

The foregoing is only a preferred embodiment of the present application and the technical principles employed, and various obvious changes, rearrangements and substitutions may be made without departing from the spirit of the application. Other advantages and effects of the present application will be readily apparent to those skilled in the art from the disclosure herein. The present application is capable of other and different embodiments and its several details are capable of modifications and variations in various respects, all without departing from the spirit of the present application. The features in the above embodiments and embodiments may be combined with each other without conflict.

Claims

1. A prosthetic heart valve stent, comprising:

the positioning piece is suitable for radially contracting under the action of radial force to form a conveying state and expanding to a working state after the radial force is removed, and a positioning space is formed around the native valve leaflets of a patient;

the valve component is suitable for radially contracting under the action of radial force to form a conveying state and expanding to a working state after the radial force is removed so as to press the native valve leaflets to the positioning component in the positioning space;

the connecting piece is connected with the positioning piece and the valve piece and has a straightening state and an S-shaped bending state;

wherein, the setting element is equipped with the barb the operating condition of setting element, the barb sets up inwards, makes the valve spare will primary valve leaf pressfitting in during the setting element, the barb pierces primary valve leaf.

2. The prosthetic heart valve stent of claim 1,

the positioning piece comprises a plurality of elastic arms which form an integral structure in a cylindrical surface shape;

the far end of the elastic arm is turned inwards or outwards to form a set acute angle to form a turning section, and the barb is arranged on the turning section.

3. The prosthetic heart valve stent of claim 2,

the turnover section accounts for 20-40% of the axial length of the elastic arm, and the set acute angle is 40-60 degrees; the barb may be angled between 40 ° and 140 ° from the proximally directed axis of the positioning member.

4. The prosthetic heart valve stent of claim 3,

the barb is positioned at the far end of the turnover section;

when the folding section is folded inwards, the barb points to the far end before folding;

when the turnover section is turned outwards, the barb points to the near end before the turnover.

5. The prosthetic heart valve stent of claim 2,

the valve component is integrally in a cylindrical surface shape, comprises a bulge part with the diameter increasing from the far end to the near end and then reducing, and is used for being pressed to the native valve leaflet after being implanted;

the valve piece also comprises an inner concave part and a skirt part, wherein the diameter of the inner concave part is reduced from the far end to the near end and then is increased, and the skirt part is positioned at the far end and the diameter of the skirt part is monotonically increased from the far end to the far end;

the concave portion is located between the rising portion and the skirt portion in the axial direction.

6. The prosthetic heart valve stent of any one of claims 1-5,

the connecting piece comprises a chain structure which is formed by sequentially and fixedly connecting a plurality of chain rings; the dimension of the chain ring in the length direction of the connector is smaller than the dimension of the chain ring in the width direction of the connector; adjacent said links are connected by a connecting arm; the connecting arm is smaller in size than the link in a length direction of the connecting member.

7. The prosthetic heart valve stent of claim 6,

the connecting piece comprises at least 1 stiffness weakened section with a set length, and the average bending stiffness of the stiffness weakened section is smaller than that of structures on two sides of the stiffness weakened section over the set length;

the set length is not less than the length of the unfolded bending part in the S-shaped bending state.

8. The prosthetic heart valve stent of claim 7,

the weakened section of stiffness is formed by reducing the cross-sectional size of the link and/or by changing the shape of the link.

9. The prosthetic heart valve stent of claim 7,

the rigidity weakening section is a folded structure formed by bending a slender structure back and forth in a direction crossed with the axial direction; the structures on two sides of the rigidity weakening section are chain-shaped structures fixedly connected with a plurality of chain rings in sequence.

10. The prosthetic heart valve stent of claim 1,

the proximal end of the positioning piece is provided with a proximal end hook, the distal end of the valve piece is provided with a distal end hook, and the proximal end hook and the distal end hook are used for being connected to a conveying mechanism of the artificial heart valve implantation system;

the positioning piece, the valve piece and the connecting piece are integrally formed.

11. A prosthetic heart valve, characterized in that,

comprising the prosthetic heart valve stent of any one of claims 1-11;

still include artificial valve leaflet, artificial valve leaflet sets up in the valve member.

12. A prosthetic heart valve implantation system,

comprising the prosthetic heart valve of claim 12,

the delivery mechanism is used for releasing and positioning the artificial heart valve after the artificial heart valve in a delivery state is delivered to a target position.