Valve stent and prosthetic valve having the same

Abstract

The application provides a valve support and an artificial valve with the same, and belongs to the technical field of heart valves. The valve support comprises a support body, a positioning ring and an elastic connecting wire. The positioning ring is arranged in a compressed state and is adapted to be sequentially and serially arranged along an axis with the support body. When the positioning ring is elastically deformed from the compressed state to an expanded state, the positioning ring can be coaxially sleeved on the support body through the traction of the elastic connecting wire. After the valve support is implanted, the positioning ring can be self-expanded to the expanded state through elastic deformation and can be coaxially sleeved on the support body according to the traction of the elastic connecting wire. Therefore, the positioning ring and the support body can be simultaneously positioned during the implantation operation. Due to the traction of the connecting wire, the support body can be self-positioned according to the positioning ring, thereby saving the separate positioning operation of the positioning ring and the support body and making the operation more convenient.

Description

Technical Field

[0001] This invention relates to the field of cardiac valve technology, and more specifically to a valve stent and an artificial valve having the same. Background Technology

[0002] Aortic valve disease is one of the most common cardiovascular diseases, classified into aortic stenosis and aortic regurgitation. Patients with severe aortic stenosis and severe aortic regurgitation have a poor prognosis; once they develop symptoms such as heart failure, the mortality rate is high, and medical treatment is ineffective, with an average survival rate of only 2-3 years. Currently, the most effective and widely accepted treatment for severe aortic stenosis or aortic regurgitation is surgical aortic valve replacement. However, this surgery requires open-chest surgery, which is highly invasive, and many elderly or frail patients cannot tolerate traditional open-chest valve replacement surgery.

[0003] In recent years, transcatheter aortic valve implantation (TAVI) has become an alternative to surgical procedures for the treatment of severe aortic stenosis due to its advantages such as safety, minimal invasiveness, and rapid recovery. TAVI involves inserting an interventional catheter through the femoral artery to deliver an artificial heart valve to the aortic valve area, thereby restoring valve function. The most widely used products in clinical TAVI procedures are the balloon-expandable Sapien valve stent series from Edwards Corporation and the self-expanding CoreValve valve from Medtronic Corporation. These two valves are primarily designed for treating patients with aortic stenosis. Currently, TAVI is limited to patients with severe aortic stenosis; aortic regurgitation remains a contraindication for TAVI. Researchers attempted to use the CoreValve self-expanding stent and Sapien valve stent in patients with isolated aortic regurgitation, but found that the incidence of inaccurate stent positioning and incomplete implantation was as high as 20%. These two types of stents are now basically no longer used in patients with aortic regurgitation.

[0004] Currently, there are two main types of products used for isolated aortic valve regurgitation. One type uses a valve stent with three self-designed anchoring points (e.g., Jenavallve, Acurate TA). However, due to structural limitations, the opening range of the anchoring points is relatively small, resulting in poor ease of operation. Furthermore, during valve loading, the anchoring points overlap with the valve, which increases the valve's overall size and reduces the product's application range. The other type uses an outer anchoring point (e.g., J-valve). During loading, the anchoring points do not overlap with the valve, reducing valve size. However, the suture connection method is flexible, making it difficult to maintain the correct distance between the bottom of the anchoring point and the bottom of the valve. Additionally, the anchoring points need to be manually pulled to the valve, increasing operational complexity. Summary of the Invention

[0005] Therefore, in order to overcome the above problems, the present invention provides a valve stent that can be used for aortic valve insufficiency.

[0006] The present invention also provides an artificial valve having the above-described valve stent.

[0007] To solve the above-mentioned technical problems, the present invention provides a valve stent comprising:

[0008] The support body is a radially expandable annular structure, with an interior suitable for accommodating artificial leaflets;

[0009] The positioning ring is a radially compressible annular structure, and its interior is adapted to accommodate the support body;

[0010] The elastic connecting wire is fixedly connected at one end to the upper end of the positioning ring and at the other end to the middle or lower part of the bracket body.

[0011] When the positioning ring is in a compressed state, it is suitable to be connected in series with the support body along the axis; when the positioning ring is elastically deformed from the compressed state to the open state, it can be coaxially sleeved on the support body by the traction of the elastic connecting wire.

[0012] As a preferred embodiment, the positioning ring, when in the open state, is a straight cylindrical ring.

[0013] As a preferred embodiment, the lower end of the positioning ring is provided with a dumbbell structure suitable for connecting the developing mark.

[0014] As a preferred embodiment, the upper part of the support body is provided with a fixing ear for connecting the leaflets, and the fixing ear has at least one elongated hole.

[0015] As a preferred option, it also includes:

[0016] Fasteners are fastened to the connection end between the positioning ring and the elastic connecting wire, and / or fastened to the connection end between the bracket body and the elastic connecting wire.

[0017] As a preferred embodiment, the positioning ring and / or the bracket body have a slot for accommodating one end of the elastic connecting wire.

[0018] As a preferred embodiment, the outer sides of the first slot on both sides of the bracket body have snap-fit ​​areas for connecting the fasteners.

[0019] As a preferred embodiment, the elastic connecting wire is connected to the second slot on the positioning ring by a snap-fit ​​connection.

[0020] As a preferred embodiment, the fastener is securely connected to the positioning ring and the elastic connecting wire by wrapping, and / or the fastener is securely connected to the bracket body and the elastic connecting wire by wrapping.

[0021] As a preferred embodiment, the fastener has an insertion hole for connecting the elastic connecting wire and a snap-fit ​​body for connecting the bracket body; the bracket body has a slot for snapping the snap-fit ​​body of the fastener.

[0022] As a preferred embodiment, the connecting wire is a single filament or multiple filaments, and its cross-section is circular or flat.

[0023] As a preferred embodiment, the connecting wire is a double wire, with one end connected and the other ends far apart.

[0024] The artificial valve provided by the present invention includes, as described in any one of the above embodiments, a valve stent, and further includes:

[0025] Artificial leaflets are connected to the inner side of the support body;

[0026] The developing mark is fixedly connected to the lower end of the positioning ring.

[0027] As a preferred embodiment, the upper sides of the leaflet have suture ears within elongated holes for inserting the fixing ears of the support body.

[0028] As a preferred embodiment, the developing mark is a sheet-like structure or a filament, suitable for wrapping around the middle of the dumbbell structure at the lower end of the positioning ring.

[0029] The technical solution of this invention has the following advantages:

[0030] 1. The valve stent provided by this invention, after implantation, allows the positioning ring to expand to an open state through elastic deformation and coaxially mount onto the support body under the traction of the elastic connecting wire. Therefore, during the implantation surgery, the positioning ring and the support body can be positioned simultaneously. Due to the traction of the connecting wire, the support body can self-position itself based on the positioning ring, thus saving the need for separate positioning operations for the positioning ring and the support body, making the surgical procedure simpler.

[0031] Furthermore, the positioning ring of this application, when compressed, can be sequentially connected in series with the stent body along the axis. This non-overlapping design can reduce the overall outer diameter of the loading when the valve is delivered in the blood vessel, reduce conduction blockage, and improve the valve's permeability.

[0032] Furthermore, the positioning ring is always connected to the stent body via an elastic connecting wire, eliminating the need to reconnect the positioning ring to the stent body during the implantation procedure, thus simplifying the surgical operation. The elastic connecting wire used to connect the positioning ring and the stent body provides a more stable and rigid connection because both ends are fixed, ensuring the distance between the stent body and the positioning ring and keeping them concentric.

[0033] 2. The valve stent provided by the present invention has a cylindrical structure after the positioning ring expands to the open state, so it can be fully unfolded and can more easily grasp the moving human valve leaflets, making the positioning ring easier to position. Attached Figure Description

[0034] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0035] Figure 1 This is a three-dimensional structural diagram of a specific embodiment of the valve stent provided by the present invention.

[0036] Figure 2 This is a schematic diagram of the unfolded support body.

[0037] Figure 3 This is a schematic diagram of the unfolded hem.

[0038] Figure 4 This is a front view of the fixing ear on the upper part of the bracket body.

[0039] Figure 5 This is a schematic diagram showing the cross-sectional direction of the fixation ear when connecting the artificial flap to the fixation ear.

[0040] Figure 6 This is a front view of the first slot on the bracket body.

[0041] Figure 7 This is a schematic diagram of the three-dimensional structure of the elastic connecting wire.

[0042] Figure 8 This is a schematic diagram of the unfolded positioning ring.

[0043] Figure 9 This is a schematic diagram of the three-dimensional structure of the fastener.

[0044] Figure 10 This is a schematic diagram showing an alternative implementation of the support body.

[0045] Figure 11 This is an unfolded schematic diagram of another alternative embodiment of the support body.

[0046] Figure 12 A front view of an alternative embodiment of the mounting ears on the support body.

[0047] Figure 13 A front view of another alternative embodiment of the fixing ear.

[0048] Figure 14 A front view of another alternative embodiment of the fixing ear.

[0049] Figure 15 A front view of another alternative embodiment of the fixing ear.

[0050] Figure 16 A front view of an alternative embodiment of the first slot on the bracket body.

[0051] Figure 17 This is a front view of an alternative embodiment of the first slot on the support body.

[0052] Figure 18 This is a front view of an alternative embodiment of the first slot on the support body.

[0053] Figure 19 This is a front view of an alternative embodiment of the first slot on the support body.

[0054] Figure 20 This is a front view of an alternative embodiment of the first slot on the support body.

[0055] Figure 21 This is a front view of an alternative embodiment of the first slot on the support body.

[0056] Figure 22This is a front view of an alternative embodiment of the first slot on the support body.

[0057] Figure 23 This is a front view of an alternative embodiment of the first slot on the support body.

[0058] Figure 24 This is a front view of an alternative embodiment of the first slot on the support body.

[0059] Figure 25 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0060] Figure 26 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0061] Figure 27 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0062] Figure 28 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0063] Figure 29 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0064] Figure 30 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0065] Figure 31 This is a three-dimensional structural diagram of an alternative embodiment of the elastic connecting wire.

[0066] Figure 32 This is a schematic diagram showing an alternative implementation of the positioning ring.

[0067] Figure 33 A front view of an alternative implementation of the second slot on the positioning ring.

[0068] Figure 34 A front view of another alternative implementation of the second slot on the positioning ring.

[0069] Figure 35 A front view of another alternative implementation of the second slot on the positioning ring.

[0070] Figure 36 A front view of another alternative implementation of the second slot on the positioning ring.

[0071] Figure 37 A front view of another alternative implementation of the second slot on the positioning ring.

[0072] Figure 38 A front view of another alternative implementation of the second slot on the positioning ring.

[0073] Figure 39 A front view of another alternative implementation of the second slot on the positioning ring.

[0074] Figure 40 This is a three-dimensional structural diagram of an alternative embodiment of a fastener.

[0075] Figure 41 This is a three-dimensional structural diagram of an alternative embodiment of the fastener.

[0076] Figure 42 This is a three-dimensional structural diagram of an alternative embodiment of the fastener.

[0077] Figure 43 This is a three-dimensional structural diagram of an alternative embodiment of the fastener.

[0078] Figure 44 This is a front view of the positioning ring and the stent body inside the delivery catheter during the implantation process.

[0079] Figure 45 A front view of the catheter reaching the lesion site.

[0080] Figure 46 Front view of the valve stent being deployed at the lesion site.

[0081] Figure 47 Front view of adjusting the valve stent to the positioning position.

[0082] Figure 48 A front view showing the valve stent fixed in place at the lesion site.

[0083] Figure 49 This is a front view of the artificial leaflet.

[0084] Explanation of reference numerals in the attached figures:

[0085] 1. Support body; 101. Serrated rod; 102. Vertical rod; 103. Fixing ear; 104. Elongated hole; 2. Skirt; 3. Suture thread; 4. First slot; 401. Snap-fit ​​area; 5. Elastic connecting wire; 501. Fastening ring; 6. Positioning ring; 601. Dumbbell structure; 7. Second slot; 8. Fastener; 9. Artificial valve leaflet; 901. Connecting ear. Detailed Implementation

[0086] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0087] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0088] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0089] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0090] Example 1

[0091] This embodiment provides a specific implementation of a valve stent, such as... Figure 1 As shown, it includes: a stent body 1, a positioning ring 6, and an elastic connecting wire 5. The stent body 1 is an annular structure that can be further radially expanded. When the stent body 1 is fully expanded, it can clamp the human valve together with the positioning ring 6, thereby completing the positioning of the valve stent.

[0092] The stent body 1 is adapted to accommodate an artificial valve leaflet 9, thereby replacing the human autologous valve to prevent blood backflow.

[0093] The positioning ring 6 is connected to the bracket body 1 via an elastic connecting wire 5. One end of the elastic connecting wire 5 is fixedly connected to the upper end of the positioning ring 6, and the other end is fixedly connected to the middle or lower part of the bracket body 1.

[0094] The positioning ring 6 is currently in an open state, but should be in a compressed state during delivery. During delivery, the compressed positioning ring 6 is sequentially connected in series with the stent body 1 along the axis; this non-overlapping design reduces the overall outer diameter of the loading when the valve is delivered within the blood vessel, lowers conduction blockage, and improves valve permeability. When released upon reaching the desired position, the positioning ring 6 expands from its compressed state to an open state through elastic deformation, and can be coaxially fitted onto the stent body 1 under the traction of the elastic connecting wire 5; therefore, during the implantation procedure, the positioning ring 6 and the stent body can be positioned simultaneously. Due to the traction of the connecting wire, the stent body can self-position itself based on the positioning ring 6, thus saving the need for separate positioning operations for the positioning ring 6 and the stent body, making the surgical procedure simpler.

[0095] The positioning ring 6 has a cylindrical structure when fully extended. This cylindrical structure means that the upper and lower ends of the positioning ring 6 have the same diameter, i.e., the same width at both ends. This cylindrical structure allows the positioning ring 6 to fully unfold, making it easier to grasp moving human body flaps and thus facilitating positioning.

[0096] like Figure 2 The diagram shows the structure of the support body 1 after it has been unfolded. The support body 1 is a frame formed by connecting multiple horizontally arranged serrated rods 101 and multiple vertically arranged vertical rods 102. On the first layer of vertical rods 102 at the top of the support body 1, there are fixing ears 103 for connecting leaflets. Each fixing ear 103 has an elongated hole 104, through which it is bound to the connecting ear 901 of the artificial leaflet 9. The second layer of vertical rods in the middle of the support body 1 is reinforced with thicker vertical rods 102, which improves the overall strength of the support body 1. The lower part of the support body 1 is directly connected by serrated rods 101.

[0097] like Figure 3 As shown, the skirt 2 is flexible and can be made of polymer materials or biological tissue. It is used to wrap around the lower edge of the lower part of the stent body 1 to adaptively seal the artificial valve leaflet 9, minimizing the occurrence of reflux in patients with complex structural lesions or when applied to patients with calcified lesions.

[0098] like Figure 4 As shown, this is one embodiment of the fixing ear 103 on the upper part of the bracket body 1. The fixing ear 103 has a regular rectangle around its perimeter and an elongated hole 104 in the middle.

[0099] like Figure 5 As shown, Figure 4A cross-sectional schematic diagram of the fixing ear 103. The fixing ear 103 is used to connect with the connecting ears 901 at both ends of the artificial leaflet 9. When one of the connecting ears 901 at both ends of the artificial leaflet 9 is tied to the fixing ear 103, the connecting ear 901 of the artificial leaflet 9 is first passed through the elongated hole, and then forked at the end. The forked connecting ear 901 is then wrapped around from both sides of the fixing ear 103 back to the tail of the connecting ear 901. Finally, the ends of the connecting ear 901 are tied and fixed with suture 3.

[0100] like Figure 6 As shown, this is one embodiment of a first slot 4 provided on a reinforcing rod on the bracket body 1. This first slot 4 is used to connect one end of an elastic connecting wire 5. The outer sides of both sides of the first slot 4 have inwardly recessed locking areas 401 for connecting fasteners 8. When connecting the elastic connecting wire 5 to the bracket body 1, one end of the elastic connecting wire 5 is inserted into the first slot 4, and then the fastener 8 is wrapped around the locking area 401, thereby securing the elastic connecting wire 5 to the bracket body 1.

[0101] like Figure 7 The diagram illustrates one embodiment of the elastic connecting wire 5. This elastic connecting wire 5 has a double-wire structure, with the double wires giving it a flat cross-section. The elastic connecting wire 5 is made of metal wire with shape memory effect, and each elastic connecting wire 5 is heat-treated and shaped into an S-shape with two opposing arcs. Fastening rings 501 are provided at both ends of the elastic connecting wire 5, and the fastening rings 501 are connected to the connecting wire by welding, riveting, or bonding.

[0102] like Figure 8 The diagram shows an unfolded view of one embodiment of the positioning ring 6. The unfolded structure of the positioning ring 6 is a sinusoidal curve. At its upper end, it has a second slot 7 for connecting the elastic connecting wire 5. The end of the elastic connecting wire 5 can be inserted into the second slot 7, and then the fastener 8 is wrapped around its exterior for further fixation. At the lower end of the positioning ring 6, there is a dumbbell structure 601 for connecting a contrast marker. The dumbbell structure 601 is a structure that is small in the middle and large at both ends. A sheet-like contrast marker can be wrapped around the middle of the dumbbell structure 601 to facilitate the positioning of the valve stent during surgery. Furthermore, the contrast marker can be fixed with sutures 3.

[0103] like Figure 9As shown, one embodiment of the fastener 8 is illustrated. The fastener 8 can be used to connect the bracket body 1 and the elastic connecting wire 5 by wrapping around the positioning ring 6 and the elastic connecting wire 5. The elastic connecting wire 5 is inserted into the second slot 7 on the positioning ring 6, and the fastener 8 is wrapped around the second slot 7 on the positioning ring 6 to securely connect the positioning ring 6 and the elastic connecting wire 5. Similarly, the elastic connecting wire 5 can be inserted into the first slot 4 on the bracket body 1, and the fastener 8 is wrapped around the first slot 4 on the bracket body 1 to securely connect the bracket body 1 and the elastic connecting wire 5. The fastener 8 can be made of a rigid, deformable material.

[0104] How to use

[0105] In the valve stent of the above embodiment, during use, one end of the elastic connecting wire 5 is inserted into the first slot 4 in the middle of the stent body 1, and the other end is inserted into the second slot 7 at the upper end of the positioning ring 6. Fasteners 8 are used to secure the connection between the positioning ring 6 and the elastic connecting wire 5, as well as the connection between the stent body 1 and the elastic connecting wire 5. The upper part of the stent body 1 has a fixing lug 103 for connecting the valve leaflets, which employs a method such as... Figure 5 The winding method shown connects the three leaflets inside the annular structure of the support body 1. The dumbbell structure 601 at the lower end of the positioning ring 6 is used to wind sheet-like or filamentous contrast markers, thereby enabling accurate positioning of the valve during surgery.

[0106] like Figure 10 As shown, this is an alternative embodiment of the support body 1. In this embodiment, the support body 1 has a four-layer structure. The fixing ear 103 for connecting the leaflets is still set in the first layer. The second layer is directly connected by a serrated rod 101. The first slot 4 for connecting the elastic connecting wire 5 is set in the third layer. The fourth layer is still directly connected by a serrated rod 101.

[0107] like Figure 11 As shown, another alternative embodiment of the support body 1 is provided. In this embodiment, the support body 1 has three layers, while the structure of the upper and middle layers remains basically unchanged. The vertical rod of the lower layer is a reinforcing rod, and the first slot 4 for connecting the elastic connecting wire 5 is provided in the lower layer.

[0108] like Figure 12 As shown, this is an alternative embodiment of the fixing ear 103 on the support body 1 for connecting the leaflet. In this embodiment, there are multiple parallel through holes on both sides of the elongated hole 104 of the fixing ear 103 for the suture 3 to pass through, thereby better connecting the fixing ear 103 and the artificial leaflet 9.

[0109] like Figure 13As shown, this is another alternative embodiment of the fixing ear 103 on the support body 1 for connecting the leaflets. In this embodiment, there are wavy sides on both sides of the elongated hole 104 in the middle of the fixing ear 103. The wavy side has a trough, which can be used to better connect the suture 3 and prevent the suture 3 from shifting.

[0110] like Figure 14 As shown, this is another alternative embodiment of the fixing ear 103 on the support body 1 for connecting the leaflets. In this embodiment, the structure of the fixing ear 103 is similar to that in the previous embodiment, except that there are two troughs on the wavy side of the elongated hole 104, which can be used to fix more sutures 3.

[0111] like Figure 15 As shown, this is another alternative embodiment of the fixing ear 103 on the support body 1 for connecting the leaflets. In this embodiment, there are two other symmetrical elongated holes on both sides of the elongated hole 104 of the fixing ear, which are used to fold the fixing ear 103 securely, making the fixing ear 103 more durable and the stitching more reliable.

[0112] like Figure 16 As shown, this is an alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the outer sides of both sides of the first slot 4 have inwardly recessed snap-fit ​​areas 401 for connecting fasteners 8. The first slot 4 has a groove in the middle for inserting one end of the elastic connecting wire 5, and the groove is shaped as a vertical strip with an elliptical expansion at the top.

[0113] like Figure 17 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference lies in the shape of the slot, which is a vertically elongated strip with a horizontal bend at the top facing one side.

[0114] like Figure 18 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference lies in the shape of the slot, which is a vertical elongated strip with an arc-shaped bend at the top facing one side.

[0115] like Figure 19As shown, this is another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference is that the shape of the slot is a vertical strip with an inclined bend at the top that slopes upwards to both sides.

[0116] like Figure 20 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference lies in the shape of the slot, which is a vertically elongated strip with an inverted triangular expansion at the top.

[0117] like Figure 21 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference lies in the shape of the slot, which is a vertically elongated strip with a lateral bend at the top towards both sides.

[0118] like Figure 22 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference lies in the shape of the slot, which is a vertical elongated strip with an arc-shaped bend at the top towards both sides.

[0119] like Figure 23 The diagram shows an alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference is that the slot is shaped as a horizontal bar at the top.

[0120] like Figure 24 The diagram shows another alternative embodiment of the first slot 4 on the bracket body 1 for connecting one end of the elastic connecting wire 5. In this embodiment, the snap-fit ​​areas 401 on both sides of the first slot 4 remain unchanged. The difference is that the slot is shaped as a circular groove at the top.

[0121] like Figure 25As shown, this is an alternative embodiment of the elastic connecting wire 5. In this embodiment, the elastic connecting wire 5 is a double wire, with one end connected and the other end separate. The connected end is used to connect to the positioning ring 6, while the separate end is used to connect to the bracket body 1, and is respectively connected to the first slot 4 at two different positions on the bracket body 1. At the top of the elastic connecting wire 5, there is a sphere with a slightly larger diameter. When the elastic connecting wire 5 is inserted into the first slot 4 on the bracket body 1, its sphere can block the bend on the first slot 4, thereby making the connection between the elastic connecting wire 5 and the bracket body 1 more secure.

[0122] like Figure 26 As shown, another alternative embodiment of the elastic connecting wire 5 is provided. In this embodiment, the elastic connecting wire 5 is also a double wire, with one end connected and the other end separate. The difference is that the end used for connecting with the positioning ring 6 has a rectangular strip with a slightly larger diameter. This rectangular strip can be snapped into the second slot 7 of the positioning ring 6, thereby connecting the positioning ring 6 and the elastic connecting wire 5.

[0123] like Figure 27 As shown, another alternative embodiment of the elastic connecting wire 5 is provided. In this embodiment, the elastic connecting wire 5 is also a double wire, with one end connected and the other end separate. The difference is that rectangular strips with slightly larger diameters are provided at all three free ends. Except for the end used to connect with the positioning ring 6, the other two pairs of rectangular strips can be snapped into the first slot 4 on the bracket body 1, thereby realizing the connection between the elastic connecting wire 5 and the bracket body 1.

[0124] like Figure 28 The diagram shows another alternative embodiment of the elastic connecting wire 5. In this embodiment, the elastic connecting wire 5 is also a double wire, with one end connected and the other end separate. The difference is that the end used to connect to the positioning ring 6 is bent upwards, so it can be connected to the positioning ring 6 from bottom to top to meet different practical needs.

[0125] like Figure 29 The diagram shows another alternative embodiment of the elastic connecting wire 5, in which the elastic connecting wire 5 is also a double wire. The difference is that the elastic connecting wire 5 does not have a split end, and the end used to connect to the bracket body 1 extends upwards by a longer distance, so that it can connect to different positions of the bracket body 1 according to actual needs.

[0126] like Figure 30As shown, another alternative embodiment of the elastic connecting wire 5 is provided. In this embodiment, the elastic connecting wire 5 is made of a sheet structure, with wrapping structures at both ends for connecting the bracket body 1 and the positioning ring 6. When the elastic connecting wire 5 is connected to the bracket body 1 and the positioning ring 6, the wrapping structure can be unfolded and inserted into the first slot 4 of the bracket body 1 and the second slot 7 of the positioning ring, respectively. The wrapping structure can automatically spring back to its original state due to the elasticity of the elastic connecting wire 5, thereby completing the connection between the elastic connecting wire 5 and the bracket body 1 and the positioning ring.

[0127] like Figure 31 As shown, another alternative embodiment of the elastic connecting wire 5 is provided. In this embodiment, the elastic connecting wire 5 is composed of two parallel wires arranged at intervals, and then the two ends are connected. At both ends of the elastic connecting wire 5, there are also blocks for connecting with the bracket body 1 and the positioning ring 6. The blocks have through holes in the middle, which can be further fixedly connected with the bracket body 1 and the positioning ring 6.

[0128] like Figure 32 The figure shown is an unfolded view of an alternative embodiment of the positioning ring 6. The unfolded structure of the positioning ring 6 is also a sinusoidal structure. The difference is that there are two second slots 7 at the upper end for connecting the elastic connecting wire 5. The ends of the elastic connecting wire 5 can be inserted into the two second slots 7 in sequence, thereby deforming the elastic connecting wire 5 and forming a snap-fit ​​with the elastic connecting wire 5.

[0129] like Figure 33 As shown, this is an alternative embodiment of the second slot 7 at the upper end of the positioning ring 6 for connecting the elastic connecting wire 5. The connection between the second slot 7 and the positioning ring 6 is located on both sides closer to the upper end of the second slot 7, and has two downward slots, into which the elastic connecting wire 5 can be inserted in sequence, thereby forming a snap-fit ​​with the elastic connecting wire 5.

[0130] like Figure 34 As shown, another alternative embodiment of the second slot 7 is provided. The connection points of the second slot 7 and the positioning ring 6 are also located on both sides closer to the upper end of the second slot 7. The difference is that this second slot 7 is a groove with an opening at the lower end and a barb on one side of the opening, which allows for a better connection with the fastener 8. The groove of the second slot 7 provides greater deformation capacity, enabling a better engagement between the second slot 7 and the fastener 8.

[0131] like Figure 35As shown, another alternative embodiment of the second slot 7 is provided. The connection between the second slot 7 and the positioning ring 6 is also located on both sides closer to the upper end of the second slot 7, and there is also an opening at the lower end of the second slot 7. The difference is that the opening of the second slot 7 is larger, and there are barbs on both sides of the opening, which can be used for better engagement with the fastener 8.

[0132] like Figure 36 As shown, another alternative embodiment of the second slot 7 is provided. The lower end of the second slot 7 also has an opening, and both sides of the opening have barbs. The difference is that the connection between the second slot 7 and the positioning ring 6 is located in the upper middle part of the second slot 7. The upper end of the second slot 7 has a locking hole, which can be used to lock the elastic connecting wire 5 by accommodating it, thereby improving the connection stability of the elastic connecting wire 5.

[0133] like Figure 37 As shown, another alternative embodiment of the second slot 7 is provided. The lower end of this second slot 7 also has an opening, with barbs on both sides of the opening, and the connection point with the positioning ring 6 is also located in the upper middle part of the second slot 7. The difference is that the opening at the lower end of this second slot 7 is smaller and located in the middle, and the upper end of this second slot 7 has a insertion hole for the elastic connecting wire 5 to pass through, thereby allowing the elastic connecting wire 5 to undergo elastic deformation for better stability within the second slot 7.

[0134] like Figure 38 As shown, another alternative embodiment of the second slot 7 is provided, wherein the connection between the second slot 7 and the positioning ring 6 is located on both sides of the upper end of the second slot 7, and has a horizontal slot.

[0135] like Figure 39 As shown, another alternative embodiment of the second slot 7 is provided. The connection between the second slot 7 and the positioning ring 6 is located on both sides of the upper part of the middle of the second slot 7. It has a wider slot at the top and a longer slot at the bottom connected thereto.

[0136] like Figure 40 As shown, this is an alternative embodiment of the fastener 8. The structure of the fastener 8 is also suitable for wrapping connection. The difference is that the fastener 8 is a non-deployable closed ring structure, which can be made of shape memory alloy. It can wrap the connected body through its own elastic deformation.

[0137] like Figure 41 As shown, another alternative embodiment of the fastener 8 is provided. The fastener 8 has snap-fit ​​grooves on both sides, which can be inserted into the slot to form a snap-fit ​​connection with the slot. The fastener 8 also has two through holes that pass through the upper and lower ends for connecting the elastic connecting wire 5.

[0138] like Figure 42 As shown, another alternative embodiment of the fastener 8 is provided. The fastener 8 has a groove structure in the middle that is suitable for wrapping, and a through hole on the wall of the groove structure, through which the cylindrical fastener 8 can be further connected to the connected unit. The fastener 8 also has two through holes on both sides that pass through the upper and lower ends for connecting the elastic connecting wire 5.

[0139] like Figure 43 As shown, another alternative embodiment of the fastener 8 is shown. The structure of the fastener 8 is similar to that of the fastener 8 described above, except that the wrapping structure in the middle of the fastener 8 is a closed annular column, which can wrap and connect the connected units through elastic deformation.

[0140] like Figures 44-48 The diagram shown illustrates the implantation process of a valve stent.

[0141] like Figure 44 As shown, the positioning ring 6 is arranged sequentially inside the delivery conduit while maintaining a compressed state with the support body 1, and the positioning ring 6 is located in front of the support body 1 and is connected to the support body 1 by the elastic connecting wire 5.

[0142] like Figure 45 As shown, after the catheter is inserted into the lesion site through the guidewire and vascular sheath, the tip of the catheter is passed through the diseased autologous valve.

[0143] At the same time, such as Figure 46 As shown, the valve stent is released from the end of the catheter, causing the positioning ring 6 to automatically and elastically return to the open state. At the same time, under the traction of the elastic connecting wire 5, the positioning ring 6 moves axially backward to be coaxially sleeved on the stent body 1.

[0144] like Figure 47 As shown, the drive valve stent moves toward the diseased autologous valve, so that the fully expanded positioning ring 6 is engaged on the outside of all autologous leaflets and reaches the root of the autologous leaflet; and the stent body 1 passes through the autologous valve from the middle.

[0145] like Figure 48 As shown, the stent body 1 is expanded by balloon dilation, and the autologous leaflet is clamped between the stent body 1 and the positioning ring 6, thereby completing the positioning and fixation of the valve stent.

[0146] Example 2

[0147] This embodiment provides an artificial valve, including: the valve stent described in Embodiment 1, an artificial leaflet 9 connected to the inner side of the stent body 1, and a radiopaque marker fixedly connected to the lower end of the positioning ring 6.

[0148] like Figure 49 The diagram shows a front view of the artificial valve leaflet 9. In this embodiment, three leaflets are provided, all connected to the interior of the support body 1. The artificial valve leaflet 9 has connecting ears 901 on both its left and right sides for connection with the fixing ears 103. The ends of the connecting ears 901 have two forks. The bottom of the artificial valve leaflet 9 has a downward protrusion to prevent blood backflow, and this protrusion is arc-shaped, allowing the three sets of artificial valve leaflets 9 to fit together completely. The top of the artificial valve leaflet 9 also has an upward protrusion to effectively prevent blood from flowing back from the side.

[0149] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A valve stent, characterized in that, include: The support body (1) is a radially expandable annular structure, and its interior is suitable for accommodating artificial leaflets (9). The positioning ring (6) is a radially compressible annular structure, and its interior is adapted to accommodate the support body (1). The elastic connecting wire (5) is fixedly connected at one end to the upper end of the positioning ring (6) and at the other end to the middle or lower part of the support body (1); the positioning ring (6) is in a compressed state and is suitable to be connected in series with the support body (1) along the axis; when the positioning ring (6) is elastically deformed from the compressed state to the open state, it can be coaxially sleeved on the support body (1) by the traction of the elastic connecting wire (5); when the positioning ring (6) is in the open state, it is a straight cylindrical ring structure. Fastener (8) is fastened to the connection end of the positioning ring (6) and the elastic connecting wire (5), and / or fastened to the connection end of the bracket body (1) and the elastic connecting wire (5); The fastener (8) is fastened to the positioning ring (6) and the elastic connecting wire (5) by wrapping, and / or the fastener (8) is fastened to the bracket body (1) and the elastic connecting wire (5) by wrapping; Alternatively, the fastener (8) has an insertion hole for connecting the elastic connecting wire (5) and a snap-fit ​​body for connecting the bracket body (1); the bracket body (1) has a slot for snapping the snap-fit ​​body of the fastener (8).

2. The valve stent according to claim 1, characterized in that, The lower end of the positioning ring (6) is provided with a dumbbell structure (601) suitable for connecting the developing mark.

3. The valve stent according to claim 1, characterized in that, The upper part of the support body (1) is provided with a fixing ear (103) for connecting the leaflets, and the fixing ear (103) has at least one elongated hole (104).

4. The valve stent according to claim 1, characterized in that, The positioning ring (6) and / or the bracket body (1) have slots for accommodating one end of the elastic connecting wire (5).

5. The valve stent according to claim 4, characterized in that, The outer sides of the first slot (4) on the bracket body (1) have snap-fit ​​areas (401) for connecting the fastener (8).

6. The valve stent according to claim 4, characterized in that, The elastic connecting wire (5) is connected to the second slot (7) on the positioning ring (6) by a snap-fit ​​connection.

7. The valve stent according to claim 1, characterized in that, The connecting wire is a single filament or multiple filaments, and its cross-section is circular or flat.

8. The valve stent according to claim 7, characterized in that, The connecting wire is a double wire, with one end connected and the other ends far apart.

9. An artificial valve, characterized in that, The valve stent according to any one of claims 1 to 8 further comprises: Artificial leaflet (9) is connected to the inner side of the support body (1); The developing mark is fixedly connected to the lower end of the positioning ring (6).

10. The artificial valve according to claim 9, characterized in that, The upper sides of the leaflet have suture ears in the elongated holes (104) for inserting the fixing ears (103) of the support body (1).

11. The artificial valve according to claim 9, characterized in that, The developing mark is a sheet-like structure or a filament, suitable for wrapping around the middle of the dumbbell structure (601) at the lower end of the positioning ring (6).

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