Valve stent and valve prosthesis
By using a valve stent design that clamps the native valve leaflet, the anchoring and implantation displacement problems in patients with simple aortic valve regurgitation are solved, achieving stability and safety of the valve stent and cardiac tissue, and making it suitable for thin delivery systems.
Patent Information
- Application Number
- CN202422444652.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-09
- Publication Date
- 2025-11-07
- Estimated Expiration
- 2034-10-09
AI Technical Summary
For patients with isolated aortic valve regurgitation, the native valve is relatively soft and cannot provide sufficient radial support, making it difficult for the artificial valve to be accurately fixed at the native valve annulus, resulting in anchoring and implantation displacement problems.
The valve stent design increases stability by clamping the original valve leaflet. The clamping support and the main support form a frame structure. The bending angle of the clamping support is controlled by the traction line through the cooperation of the elastic folding section and the clampable section, reducing the dependence on radial support force.
It improves the stability between the valve stent and the heart tissue, reduces the difficulty of positioning, reduces the risk of wear and implantation displacement, is suitable for thinner delivery systems, and enhances the operational safety of valve prostheses.
Smart Images

Figure CN223516495U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to medical instrument technical field, specifically, an intervention type artificial valve stent and valve prosthesis. BACKGROUND
[0002] Aortic regurgitation (AR) is aortic valve insufficiency leading to diastolic blood flow from the aorta into the left ventricle. Its causes include valve degeneration and aortic valve root expansion leading to poor coaptation of the leaflets.
[0003] Currently, domestic and foreign scholars explore the use of transarterial aortic valve implantation to treat AR patients in a super-indication manner. However, for patients with simple aortic valve regurgitation (aortic valve without stenosis and calcification), the annulus tissue of the native aortic valve is usually soft, thus unable to provide sufficient radial support. In this case, the difficulty of using an artificial valve delivery system to accurately fix the artificial valve at the native annulus by radial support will increase. SUMMARY
[0004] The technical problem to be solved by the utility model is to provide a valve stent and prosthesis that can increase the anchoring points of the valve stent by clamping the native leaflets, without relying on increasing radial support to improve the stability between the valve stent and the heart tissue, thereby solving the anchoring problem of the valve stent and the implantation displacement problem.
[0005] To solve the above technical problems, the utility model adopts the following technical solutions:
[0006] In a first aspect, the utility model provides a valve stent, comprising: a support body and at least one clamping valve body connected to the support body, a gap for accommodating native leaflets is formed between the clamping valve body and the support body; the clamping valve body includes a connection segment connected to the support body, a clippable segment located radially outside the support body, and an elastic folding segment connecting the connection segment and the clippable segment; the clippable segment is provided with a first threading hole.
[0007] In the implementation process of the above technical solution, the valve stent comprises a support main body and at least one clamping leaf support connected with the support main body, and a gap capable of accommodating a native leaflet is formed between the clamping leaf support and the support main body, so that the native leaflet can be clamped, and the stability between the valve stent and the native leaflet is improved; the clamping leaf support comprises a connecting section connected with the support main body, a clamping section located on the radial outer side of the support main body, and an elastic folding section connecting the connecting section and the clamping section, so that the clamping leaf support forms a frame structure, the contact area with the native leaflet is increased, and the stability is improved; the clamping section is provided with a first threading hole, and the traction line can control the bending angle of the clamping leaf support by passing through the first threading hole, so as to facilitate the clamping of the clamping leaf support and the support main body on the native leaflet.
[0008] In addition, the clamping leaf support is located on the radial outer side of the support main body, and the clamping leaf support and the support main body clamp the native leaflet, so that when the valve prosthesis is intervened, the support main body does not need to find a specific positioning position, and the positioning difficulty of the valve prosthesis is reduced.
[0009] As an implementation manner, the extension direction of the connecting section is the axial direction of the support main body.
[0010] In the implementation process of the above technical solution, the connecting section extends in the axial direction of the support main body, which can improve the elastic force of the clamping leaf support on the one hand, and can increase the axial length of the clamping leaf support on the other hand, so that the clamping leaf support can clamp more native leaflets, and the stability between the valve stent and the heart tissue is improved.
[0011] As an implementation manner, the elastic folding section comprises a first inclined section, two first inclined sections in the same clamping leaf support extend in opposite directions; the elastic folding section further comprises a first bending section, the first bending section bends radially outward away from the support main body, and two ends of the first bending section are connected with the first inclined section and the clamping section, respectively.
[0012] In the implementation process of the above technical solution, the elastic return bending section comprises a first inclined section, two first inclined sections are arranged in the same clamping leaf support body, and the two first inclined sections extend in opposite directions, so that the unfolding width of the clippable section along the circumferential direction of the valve stent is increased, more areas of the native leaflets can be clamped by the clamping leaf support body, and the stability between the valve stent and the native leaflets is improved; the first bending section is bent radially outward away from the support main body, the two ends of the first bending section are connected with the first inclined section and the clippable section respectively, the clamping leaf support body is bent toward the upstream direction after extending in the downstream direction for a distance, a bent clamp structure is formed to clamp the native leaflets, and therefore the support main body does not need to provide additional radial support force, that is, the support main body does not need to be positioned by increasing the radial size, and therefore the radial size of the valve stent in the contracted state is smaller, and the valve stent can be applied to a thinner delivery system.
[0013] As an implementation form, the clippable section comprises an extension section and a second inclined section connected with the connection section, two second inclined sections in the same clamping leaf support body are connected to form a connection point, and the first threading hole is formed on the connection point.
[0014] In the implementation process of the above technical solution, the clippable section comprises an extension section and a second inclined section connected with the connection section, two second inclined sections in the same clamping leaf support body are connected to form a connection point, and the first threading hole is formed on the connection point.
[0015] As an implementation form, the distance between the two connection sections in the same clamping leaf support body is equal to the distance between the two clippable sections.
[0016] In the implementation process of the above technical solution, the distance between the two connection sections in the same clamping leaf support body is equal to the distance between the two clippable sections, so that the width of the clamping leaf support body unfolded along the circumferential direction of the valve stent in the present application is smaller than that in the above implementation form, and therefore the axial length of the clamping leaf support body is shortened during the contraction and loading process, which is beneficial to the delivery catheter crossing the aortic arch; and the clamping leaf support body with a short axial length is easier to release during the release process in the positioning stage.
[0017] As an implementation form, the clippable section comprises an extension section and a second bending section, one end of the extension section is connected with the elastic return bending section, the other end is connected with the second bending section, the second bending section is bent radially outward away from the valve stent, two second bending sections in the same clamping leaf support body are connected to form a connection point, and the first threading hole is formed on the connection point.
[0018] In the implementation process of the above technical solution, the clamping section includes an extension section and a second bending section, one end of the extension section is connected with the elastic bending section, the other end is connected with the second bending section, two second bending sections in the same clamping petal support body are connected to form a connection point, so that the clamping petal support body forms a closed structure, improving the stability of the clamping petal support body; in addition, the second bending section is bent outward from the radial direction of the valve support, this structure not only reduces the wear or penetration of the clamping petal support body to the native valve leaflet during the pulsation of the valve prosthesis, but also increases the contact area between the clamping petal support body and the heart tissue, increases the working safety of the valve prosthesis, and the first threading hole is arranged on the connection point, which is equivalent to the end of the clamping section controlled by the traction line, so that the traction line can more easily control the bending angle of the clamping section, to facilitate clamping the native valve leaflet.
[0019] As an implementation form, the support body is a hollow structure formed by cutting metal.
[0020] In the implementation process of the above technical solution, the support body is a hollow structure formed by cutting metal, which can reduce weight under the condition of meeting the structural strength, reduce the burden on the patient, and also increase the recovery compliance, facilitate recovery compression and release.
[0021] As an implementation form, the upstream and downstream directions are defined along the direction of blood flow, and the support body is provided with a second threading hole at the downstream end.
[0022] In the implementation process of the above technical solution, the support body is provided with a second threading hole at the downstream end, and the traction line can control the contraction and expansion of the support body by passing through the second threading hole, so as to realize the recovery and release of the valve prosthesis.
[0023] As an implementation form, the downstream end of the support body is further provided with a reinforcing hole for enhancing the connection force of the skirt, and the reinforcing hole is located on one side of the second threading hole toward the upstream direction.
[0024] In the implementation process of the above technical solution, by arranging a reinforcing hole at the downstream end of the support body, when the skirt is connected with the support body, the bonding area between the support body and the skirt is increased, and the connection force of the support body and the skirt is improved; at the same time, the skirt is made of high molecular synthetic material, which can also reduce the problem of paravalvular leakage.
[0025] As an implementation form, the support body includes a plurality of support units, and the plurality of support units surround a channel for blood flow; wherein each support unit includes two first support sections for connecting different artificial valve leaflets respectively, and two first support sections in the same support unit are connected with first support sections in two adjacent support units respectively.
[0026] In the implementation process of the above technical solution, the support body comprises a plurality of support units, the plurality of support units surround a channel for blood flow, so that blood can flow through the middle; each support unit comprises two first support sections, the two first support sections in the same support unit are connected with the first support sections in the adjacent two support units respectively, thereby surrounding an annular structure which can be adapted to the heart tissue, and at the same time, the two first support sections in each support unit are respectively used to connect different artificial valve leaves, so that the artificial valve leaves on the valve prosthesis can replace the native valve leaflets to realize the opening and closing function.
[0027] As an embodiment, the support unit further comprises a first arc section, one end of the first arc section is connected with the first support section, and the other end extends towards the upstream direction, the two first arc sections in the same support unit are transitionally connected with the first arc sections in the adjacent two support units respectively; the support unit further comprises two second support sections which are arranged at intervals, one end of each of the two second support sections is connected with the corresponding first support section, and the other end extends towards the upstream direction and converges; the support unit further comprises two third support sections, one end of each of the two third support sections is connected with the corresponding second support section, and the other end is connected with the first arc section; the support unit further comprises a second arc section, both ends of the second arc section are connected with the two third support sections respectively, and the second arc section is locally convexly arranged towards the upstream direction; the support unit further comprises two fourth support sections, each of the two fourth support sections is provided with a bending portion, one end of the fourth support section is convergently connected with the second support section, and the other end is connected with the second arc section.
[0028] In the implementation process of the above technical solution, the support unit further comprises a first arc segment, one end of the first arc segment is connected with the first support segment, and the other end extends towards the upstream direction, thereby lengthening the axial length of the valve stent and meeting the axial length of the valve stent; the two first arc segments in the same support unit are respectively transitionally connected with the first arc segments in the two adjacent support units, the structural stability of the valve stent is improved, and the two first arc segments form a ring after being connected, which facilitates connection with the skirt cloth and improves the recovery compliance of the valve stent. The support unit further comprises two second support segments arranged at intervals, one end of each of the two second support segments is connected with the corresponding first support segment, and the other end extends towards the upstream direction and converges, thereby meeting the structural stability of the valve stent and making the valve stent have a hollow structure, which facilitates connection with the skirt cloth and improves the stability between the skirt cloth and the support main body; the support unit further comprises two third support segments, one end of each of the two third support segments is connected with the corresponding second support segment, and the other end is connected with the first arc segment, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, and increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; the support unit further comprises a second arc segment, both ends of the second arc segment are connected with the two third support segments, and the second arc segment is locally protrudingly arranged towards the upstream direction, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; and the support unit further comprises two fourth support segments, each of the two fourth support segments is provided with a bending portion, and the structural strength of the valve stent is improved; one end of each of the fourth support segments is connected with the second support segment, and the other end is connected with the second arc segment, thereby improving the structural stability of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body.
[0029] In the implementation process of the above technical solution, the support unit further comprises a first arc segment, one end of the first arc segment is connected with the first support segment, and the other end extends towards the upstream direction, thereby lengthening the axial length of the valve stent and meeting the axial length of the valve stent; the two first arc segments in the same support unit are respectively transitionally connected with the first arc segments in the two adjacent support units, the structural stability of the valve stent is improved, and the two first arc segments form a ring after being connected, which facilitates connection with the skirt cloth and improves the recovery compliance of the valve stent. The support unit further comprises two second support segments arranged at intervals, one end of each of the two second support segments is connected with the corresponding first support segment, and the other end extends towards the upstream direction and converges, thereby meeting the structural stability of the valve stent and making the valve stent have a hollow structure, which facilitates connection with the skirt cloth and improves the stability between the skirt cloth and the support main body; the support unit further comprises two third support segments, one end of each of the two third support segments is connected with the corresponding second support segment, and the other end is connected with the first arc segment, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, and increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; the support unit further comprises a second arc segment, both ends of the second arc segment are connected with the two third support segments, and the second arc segment is locally protrudingly arranged towards the upstream direction, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; and the support unit further comprises two fourth support segments, each of the two fourth support segments is provided with a bending portion, and the structural strength of the valve stent is improved; one end of each of the fourth support segments is connected with the second support segment, and the other end is connected with the second arc segment, thereby improving the structural stability of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body.
[0030] In the implementation process of the above technical solution, the support unit further comprises a first arc segment, one end of the first arc segment is connected with the first support segment, and the other end extends towards the upstream direction, thereby lengthening the axial length of the valve stent and meeting the axial length of the valve stent; the two first arc segments in the same support unit are respectively transitionally connected with the first arc segments in the two adjacent support units, the structural stability of the valve stent is improved, and the two first arc segments form a ring after being connected, which facilitates connection with the skirt cloth and improves the recovery compliance of the valve stent. The support unit further comprises two second support segments arranged at intervals, one end of each of the two second support segments is connected with the corresponding first support segment, and the other end extends towards the upstream direction and converges, thereby meeting the structural stability of the valve stent and making the valve stent have a hollow structure, which facilitates connection with the skirt cloth and improves the stability between the skirt cloth and the support main body; the support unit further comprises two third support segments, one end of each of the two third support segments is connected with the corresponding second support segment, and the other end is connected with the first arc segment, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, and increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; the support unit further comprises a second arc segment, both ends of the second arc segment are connected with the two third support segments, and the second arc segment is locally protrudingly arranged towards the upstream direction, thereby meeting the structural stability of the valve stent, making the valve stent have a hollow structure, increasing the compliance of the valve stent, facilitating recovery of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body; and the support unit further comprises two fourth support segments, each of the two fourth support segments is provided with a bending portion, and the structural strength of the valve stent is improved; one end of each of the fourth support segments is connected with the second support segment, and the other end is connected with the second arc segment, thereby improving the structural stability of the valve stent, facilitating connection with the skirt cloth, and improving the stability between the skirt cloth and the support main body. Attached Figure Description
[0031] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments of this utility model will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.
[0032] Figure 1 This is a schematic diagram of the structure of the valve stent provided in an embodiment of the present invention;
[0033] Figure 2 This is a schematic diagram of the structure of the valve prosthesis provided in an embodiment of the present invention;
[0034] Figure 3 Schematic diagrams of the valve prostheses provided in different embodiments of this utility model;
[0035] Figure 4 This is a schematic diagram of the structure of a valve prosthesis provided in another embodiment of the present invention;
[0036] Figure 5 This is a schematic diagram illustrating an application scenario of a valve prosthesis provided in one embodiment of the present invention.
[0037] Icons: 1-Support body; 11-First threading hole; 12-Reinforcing hole; 13-First support segment; 14-First arc segment; 15-Second support segment; 16-Second arc segment; 17-Third support segment; 18-Fourth support segment; 2-Clamping valve support; 21-Connecting segment; 22-Clampable segment; 221-Extension segment; 222-Second inclined segment; 223-Second bending segment; 23-Elastic folding segment; 231-First inclined segment; 232-First bending segment; 24-Second threading hole; 3-Capsule; 4-Artificial valve leaflet; 5-Skirt fabric. Detailed Implementation
[0038] The technical solutions of the present invention will now be described with reference to the accompanying drawings in the embodiments of the present invention.
[0039] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this utility model, the term "distal" refers to the end of the component in the delivery system closer to the heart tissue, and "proximal" refers to the end of the delivery system closer to the operator. The terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.
[0040] In a first aspect, the utility model discloses a valve stent, which can improve the stability between the valve stent and the heart tissue by clamping the native valve leaflet, and does not rely on increasing the radial support force to improve the stability between the valve stent and the heart tissue, thereby solving the anchoring problem and the implant displacement problem of the valve stent.
[0041] As shown in Figure 1 , 3 and 4, the valve stent comprises a support body 1 and at least one clamping valve body 2 connected with the support body 1, and a gap for accommodating the native valve leaflet is formed between the clamping valve body 2 and the support body 1, so that the native valve leaflet can be clamped to improve the stability between the valve stent and the native valve leaflet; the clamping valve body 2 comprises a connecting section 21 connected with the support body 1, a clamping section 22 located on the radial outer side of the support body 1, and an elastic folding section 23 connecting the connecting section 21 and the clamping section 22, so that the clamping valve body 2 forms a frame structure, which can improve the contact area with the native valve leaflet and improve the stability; the clamping section 22 is provided with a first threading hole 11, and the traction line can control the bending angle of the clamping valve body 2 by passing through the first threading hole 11, so as to facilitate the clamping of the native valve leaflet by the clamping valve body 2 and the support body 1.
[0042] In addition, the clamping valve body 2 is located on the radial outer side of the support body 1, and the clamping valve body 2 and the support body 1 clamp the native valve leaflet, so that the support body 1 does not need to find a specific positioning position when the valve prosthesis is intervened, and the positioning difficulty of the valve prosthesis is reduced.
[0043] Optionally, the clamping valve body 2 is provided with three, so that the native valve leaflet can be clamped from multiple angles.
[0044] Optionally, the support body 1 and the clamping valve body 2 can be manufactured by cutting, forming, sandblasting and polishing processes of a nickel-titanium tube.
[0045] As shown in Figure 1 , 3 and 4, as an embodiment, the extension direction of the connecting section 21 is the axial direction of the support body 1, which can improve the elastic force of the clamping valve body 2 on the one hand, and can increase the axial length of the clamping valve body 2 on the other hand, so that the clamping valve body can clamp more native valve leaflets to improve the stability between the valve stent and the heart tissue.
[0046] Optionally, each clamping valve body 2 comprises two connecting sections 21, and the two connecting sections 21 extend in parallel to facilitate the clamping valve body 2 to be arranged in a frame structure.
[0047] As shown in Figure 1As shown, as an embodiment, the elastic return bending section 23 comprises a first inclined section 231, and two first inclined sections 231 are arranged in the same clamping leaf support body 2, and the two first inclined sections 231 extend in opposite directions, so as to increase the unfolding width of the clamping section 22 along the circumferential direction of the valve stent, increase the area of the clamping leaf support body 2 clamping the native leaflet, and improve the stability between the valve stent and the native leaflet; the elastic return bending section 23 further comprises a first bending section 232, which is bent radially outward away from the support main body 1, and the two ends of the first bending section 232 are connected with the first inclined section 231 and the clamping section 22 respectively, so that the clamping leaf support body 2 is bent towards the upstream direction after extending a distance in the downstream direction, forming a bent clamp structure to clamp the native leaflet, so that the support main body 1 does not need to provide additional radial support force, that is, the support main body 1 does not need to realize positioning by increasing the radial size, and therefore, the radial size of the valve stent in the contracted state is smaller, and the valve stent can be applied to a thinner delivery system.
[0048] As shown in Figure 1 , as an embodiment, the clamping section 22 comprises an extension section 221 and a second inclined section 222 connected with the connecting section 21, and two second inclined sections 222 in the same clamping leaf support body 2 are connected to form a connecting point, so that the clamping leaf support body 2 forms a closed structure, improves the stability of the clamping leaf support body 2, and the first threading hole 11 is arranged on the connecting point, and when the traction line passes through the first threading hole 11, the end of the clamping section 22 can be controlled by the traction line, so that the traction line can more easily control the bending angle of the clamping section 22, so as to facilitate clamping the native leaflet.
[0049] As shown in Figure 3 and 4 , as a parallel embodiment, the distance between the two connecting sections in the same clamping leaf support body is equal to the distance between the two clamping sections, so that the width of the clamping leaf support body 2 in the embodiment of the utility model along the circumferential direction of the valve stent is smaller than the width of the clamping leaf support body 2 in the above-mentioned embodiment, and therefore, in the process of contraction and loading, the axial length of the clamping leaf support body 2 in the embodiment of the utility model is shortened, which is beneficial to the delivery catheter crossing the aortic arch; in the positioning stage, the clamping leaf support body 2 with short axial length is also easier to release in the release process.
[0050] As shown in Figure 4As shown, as an embodiment, the clamping section 22 comprises an extension section 221 and a second bending section 223, one end of the extension section 221 is connected with the elastic return section 23, the other end is connected with the second bending section 223, and the two second bending sections 223 in the same clamping limb body 2 are connected to form a connection point, so that the clamping limb body 2 forms a closed structure, improving the stability of the clamping limb body 2; in addition, the second bending section 223 is bent outward from the radial direction of the valve stent, this structure not only can reduce the wear or penetration of the clamping limb body 2 to the native valve leaflet during the pulsation of the valve prosthesis, but also increases the contact area between the clamping limb body 2 and the heart tissue, increases the working safety of the valve prosthesis, and the first threading hole 11 is arranged on the connection point, when the traction line passes through the first threading hole 11, it is equivalent that the traction line can control the end of the clamping section 22, so that the traction line can more easily control the bending angle of the clamping section 22, to facilitate clamping the native valve leaflet.
[0051] As shown in Figure 1 , 3 and 4, as an embodiment, the support body 1 is a hollow structure formed by cutting metal, which can reduce weight and reduce the burden on the patient while meeting the structural strength, and also increase the recovery compliance, facilitating recovery compression and release.
[0052] As shown in Figure 1 , as an embodiment, the upstream and downstream directions are defined along the direction of blood flow, the support body 1 is provided with a second threading hole 24 at the downstream section, and the traction line can control the contraction and expansion of the support body 1 by passing through the second threading hole 24, so as to realize the recovery and release of the valve prosthesis.
[0053] As shown in Figure 1 , as an embodiment, the downstream end of the support body 1 is also provided with a reinforcing hole 12 for enhancing the connection force of the skirt 5, and the reinforcing hole 12 is located on the side of the second threading hole 24 towards the upstream direction. By providing the reinforcing hole 12 at the downstream end of the support body 1, when the skirt 5 is connected with the support body 1, the bonding area between the support body 1 and the skirt 5 is increased, improving the connection force of the support body 1 and the skirt 5; at the same time, the skirt 5 is made of high molecular synthetic material, which can also reduce the problem of paravalvular leakage.
[0054] Optionally, the upstream direction is the blood inflow end.
[0055] As shown in Figure 1 and 3As shown, as an embodiment, the support body 1 comprises a plurality of support units, the plurality of support units surround a channel for blood flow, so that the blood can flow through the middle; each support unit comprises two first support sections 13, the two first support sections 13 in the same support unit are connected with the first support sections 13 in the adjacent two support units respectively, so as to surround an annular structure, which can be adapted to the heart tissue, and meanwhile, the two first support sections 13 in each support unit are used to connect different artificial valve leaflets 4 respectively, so that the artificial valve leaflets 4 on the valve prosthesis can replace the native valve leaflets to realize the opening and closing function.
[0056] Optionally, the first support section 13 is arranged obliquely, and the two first support sections 13 of the adjacent two support units are connected to form a V-shaped opening structure, so as to fix the edge of the artificial valve leaflet 4, and meanwhile, the valve stent is convenient to recycle, and the risk of blocking the coronary artery is reduced.
[0057] Optionally, three support units can be arranged, and the three support units surround to form a cylindrical structure, so that the blood can flow; the adjacent two support units can be welded to realize the connection.
[0058] As shown in Figure 1 and 3 As an embodiment, the support unit further comprises a first arc section 14, one end of the first arc section 14 is connected with the first support section 13, and the other end extends towards the upstream direction, so as to lengthen the axial length of the valve stent to meet the axial length of the valve stent; the two first arc sections 14 in the same support unit are transitionally connected with the first arc sections 14 in the adjacent two support units respectively, so as to improve the structural stability of the valve stent, and also form a ring after the connection of the two first arc sections 14, which is convenient for connection with the skirt 5, and also improves the recycling compliance of the valve stent.
[0059] The support unit further comprises two second support sections 15 arranged at intervals, one end of each of the two second support sections 15 is connected with the corresponding first support section 13, and the other end extends towards the upstream direction to converge, so as to meet the structural stability of the valve stent, and also make the valve stent a hollow structure, which is convenient for connection with the skirt 5 and improves the stability between the skirt 5 and the support body 1;
[0060] The support unit further comprises two third support sections 17, one end of each of the two third support sections 17 is connected with the corresponding second support section 15, and the other end is connected with the first arc section 14, so as to meet the structural stability of the valve stent, make the valve stent a hollow structure, and also increase the compliance of the valve stent, so that the valve stent is convenient to recycle, and also convenient for connection with the skirt 5, which improves the stability between the skirt 5 and the support body 1;
[0061] The support unit further comprises a second arc segment 16, two ends of the second arc segment 16 are connected with two third support segments 17 respectively, the second arc segment 16 is arranged locally protruding towards the upstream direction, so that the structural stability of the valve stent can be met, the valve stent is a hollow structure, the compliance of the valve stent is increased, the valve stent is convenient to recycle, meanwhile, the valve stent is convenient to connect with the skirt 5, and the stability between the skirt 5 and the support main body 1 is improved.
[0062] The support unit further comprises two fourth support segments 18, the two fourth support segments 18 are respectively provided with a bending part, so that the structural strength of the valve stent is improved; one end of the fourth support segment 18 is connected with the second support segment 15, and the other end is connected with the second arc segment 16, so that the structural stability of the valve stent is improved, meanwhile, the valve stent is convenient to connect with the skirt 5, and the stability between the skirt 5 and the support main body 1 is improved.
[0063] Optionally, the two first arc segments 14 in the same support unit are respectively arranged on two sides of the support unit, so that the first arc segments 14 in the two adjacent support units can be welded conveniently.
[0064] Optionally, the third support segment 17 is a circular arc segment, so that the valve stent is convenient to contract.
[0065] As shown in Figure 2 and 5 In the second aspect, the utility model provides a valve stent, including the valve stent provided by the first aspect further includes artificial valve leaflet 4, artificial valve leaflet 4 is connected with support main body 1, so as to replace the original valve leaflet and realize the function of opening and closing, skirt 5 is covered in the circumferential surface of support main body 1, can reduce the problem of valve prosthesis paravalvular leakage, capsule 3 is connected with support main body 1, and the capsule 3 is located in the gap, and is provided with the hole for the blood to enter, and the capsule 3 is arranged in the gap between the clamping valve body 2 and the support main body 1, blood can enter the capsule 3 through the hole, and the capsule 3 can be inflated, when the clamping valve body 2 and the support main body 1 clamp the original valve leaflet, the inflated capsule 3 can be filled to the position of the original valve ring, to improve the stability between the valve prosthesis and the heart tissue.
[0066] Optionally, the capsule 3 and the skirt 5 can be made of high molecular synthetic material.
[0067] Optionally, the valve prosthesis of the utility model embodiment can be implanted according to the following steps:
[0068] Loading stage: a plurality of traction lines are used to make the valve prosthesis in a contracted state, and the proximal end of the valve prosthesis is loaded into the proximal end capsule cavity of the delivery catheter, and the distal end is loaded into the distal end capsule cavity.
[0069] Positioning stage: after the delivery system reaches the position of the aortic root, the bending angle of the clamping leaflet support 2 can be controlled by winding and unwinding the traction line. At the same time, the relative position of the valve prosthesis and the aortic valve ring is adjusted by pushing and pulling the delivery catheter, so that the clamping leaflet support 2 reaches the predetermined position of the aortic valve sinus bottom.
[0070] Anchoring stage: the distal end of the valve prosthesis is released from the distal end capsule cavity of the delivery catheter, and the distal end is attached to the native valve ring. At this time, the capsule 3 plays a role in sealing the native valve ring, and the native valve leaflet is in the gap formed by the support body 1 and the clamping leaflet support 2. After the distal end of the valve prosthesis is released and stabilized, the support body 1 is released from the proximal end capsule cavity of the delivery catheter, and then the support body 1 is fully unfolded by using the traction line.
[0071] Recycling and releasing stage: if the working position of the valve prosthesis is not ideal, the support body 1 and the clamping leaflet support 2 can be recycled into the proximal end capsule cavity, and the distal end of the valve prosthesis is recycled into the distal end capsule cavity, so as to deploy the valve again or withdraw the delivery catheter.
[0072] Delivery catheter withdrawal stage: when the implantation state of the valve prosthesis reaches the appropriate position, the traction line and the valve prosthesis are disconnected, and the delivery catheter is withdrawn from the aorta, and the valve prosthesis works normally in the implantation position.
[0073] The above only describes the embodiments of the present application and is not used to limit the protection scope of the present application. For those skilled in the art, the present application can be variously changed and modified. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
[0074] The above only describes the embodiments of the present application and is not used to limit the protection scope of the present application. For those skilled in the art, the present application can be variously changed and modified. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
[0075] It is to be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a component" can include a combination of two or more components. Additionally, the terms "comprise," "comprises," and "comprising," or any variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to those elements, but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. Furthermore, unless otherwise indicated herein, the terms "first," "second," "third," etc., are used herein merely as labels, and are not intended to impose ordinal import.
Claims
1. A valve stent, characterized by, The application relates to a valve support, which comprises a support body and at least one clamping branch connected to the support body, and a gap between the support body and the clamping branch for accommodating a native valve leaflet. The clamping branch comprises a connecting section connected to the support body, a clamping section located radially outside the support body, and an elastic folding section connecting the connecting section and the clamping section; and the clamping section is provided with a first threading hole. The extending direction of the connecting section is the axial direction of the support body.
2. The valve support of claim 1, wherein, The elastic folding section comprises a first inclined section, and two first inclined sections in the same clamping branch extend in opposite directions.
3. The valve support of claim 2, wherein, The elastic folding section further comprises a first bending section, which bends radially outward away from the support body, and the two ends of the first bending section are connected to the first inclined section and the clamping section respectively. The clamping section comprises an extending section connected to the connecting section and a second inclined section, and two second inclined sections in the same clamping branch are connected to form a connecting point, and the first threading hole is formed on the connecting point.
4. The valve support of claim 3, wherein, The distance between the two connecting sections in the same clamping branch is equal to the distance between the two clamping sections.
5. The valve support of claim 1 or 2, wherein, The clamping section comprises an extending section and a second bending section, one end of the extending section is connected to the elastic folding section, and the other end is connected to the second bending section, the second bending section bends outward from the radial direction of the valve support, and two second bending sections in the same clamping branch are connected to form a connecting point, and the first threading hole is formed on the connecting point.
6. The valve support of claim 5, wherein, The support body is a hollow structure formed by cutting a metal.
7. The valve support of any of claims 1 to 4, wherein, The upstream and downstream directions are defined along the direction of blood flow, and the support body is provided with a second threading hole at the downstream end.
8. The valve support of any of claims 1 to 4, wherein, The downstream end of the support body is further provided with a reinforcing hole for enhancing the connection force of the skirt, and the reinforcing hole is located on one side of the second threading hole in the upstream direction.
9. The valve support of claim 8, wherein, The support body comprises a plurality of support units, and the plurality of support units surround a channel for blood flow.
10. The valve support of any of claims 1 to 4, wherein, Each support unit comprises two first support sections for connecting different artificial valve leaves respectively, and the two first support sections in the same support unit are connected to the first support sections in two adjacent support units respectively. The support unit further comprises a first arc section, one end of the first arc section is connected to the first support section, and the other end extends in the upstream direction, and the two first arc sections in the same support unit are transitionally connected to the first arc sections in two adjacent support units respectively.
11. The valve support of claim 10, wherein, The support unit further comprises two second support sections arranged at intervals, one end of each second support section is connected to the corresponding first support section, and the other end extends in the upstream direction and converges. The support unit further comprises two third support sections, one end of each third support section is connected to the corresponding second support section, and the other end is connected to the first arc section. The support unit further comprises a second arc section, two ends of the second arc section are connected to the two third support sections respectively, and the second arc section is locally convex in the upstream direction. The support unit further comprises two fourth support segments, each of which is provided with a bent portion, one end of the fourth support segment is connected with the second support segment, and the other end is connected with the second arc segment.
12. A valve prosthesis comprising the valve support of any one of claims 1 to 11, characterized in that The valve prosthesis further comprises an artificial valve leaflet connected with the support body. A skirt is covered on the circumferential surface of the support body. A capsule is connected with the support body, the capsule is located in the gap, and a hole for blood to enter is arranged.