Valve stent and valve device

Abstract

The invention relates to a valve stent and a valve device. The valve stent comprises a stent body and a positioning part, the two ends of the positioning part are provided with a connecting end and a clamping end respectively in the extending direction of the positioning part, the connecting end is connected with the stent body, and a positioning and clamping area used for containing a native valve leaflet is formed between the positioning part and the stent body; in the radial direction of the support body, the positioning piece has a first state position and a second state position relative to the support body, when the positioning piece is located at the first state position, a first radial distance D1 is formed between the clamping end and the center axis of the support body, and when the positioning piece is located at the second state position, a second radial distance D1 is formed between the clamping end and the center axis of the support body. And a second radial distance D2 is formed between the central axis of the clamping end and the central axis of the bracket main body and meets the relational expression that D1 is greater than D2. According to the valve support, the native valve leaflet can be rapidly captured, the displacement resistance is high, and a valve device adopting the valve support can rapidly capture the native valve leaflet and improve the reliability after implantation.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve stent and a valve device having the valve stent. Background Art

[0002] Aortic valve disease refers to a type of heart disease in which the aortic valve has structural or functional abnormalities, leading to obstruction or reverse flow of blood. Common aortic valve diseases include aortic stenosis and aortic regurgitation.

[0003] Among them, transcatheter aortic valve replacement (TAVR) is a minimally invasive surgery widely used in the world for the treatment of aortic valve disease. Through interventional catheter technology, the valve device is delivered to the position of the aortic valve, thereby completing the implantation of the valve device and restoring the valve function. TAVR has the advantages of less trauma, faster recovery, and higher quality of life for patients after surgery, and has become the current trend in the treatment of aortic valve disease.

[0004] For regurgitant aortic valve disease, current TAVR products mostly use a valve device with a valve stent and a positioning piece. The positioning piece is inserted into the valve sinus to position the valve device, so that the leaflets of the valve device coincide with the native leaflets of the human body, ensuring better postoperative hemodynamics of the valve device.

[0005] However, the valve device has the problem of being difficult to capture the native leaflets and being easily detached from the native leaflets. Summary of the invention

[0006] Based on this, it is necessary to provide a valve stent to address the above problems.

[0007] A valve stent, the valve stent comprising:

[0008] The stent body and the positioning piece, along the extension direction of the positioning piece, the two ends of the positioning piece respectively have a connecting end and a clamping end, the connecting end is connected to the stent body, and a positioning clamping area for accommodating the native valve leaflet is formed between the positioning piece and the stent body;

[0009] In which, in the radial direction of the bracket body, the positioning member has a first state position and a second state position relative to the bracket body, wherein when the positioning member is in the first state position, there is a first radial spacing D1 between the clamping end and the central axis of the bracket body, and when the positioning member is in the second state position, there is a second radial spacing D2 between the clamping end and the central axis of the bracket body, satisfying the relationship: D1>D2.

[0010] In one embodiment, the valve stent further includes: a lifting member connected between the positioning member and the stent body, and the lifting member is configured to drive the positioning member to be located in the first state position.

[0011] In one embodiment, the lifting member includes at least two longitudinal lifting portions, and the at least two longitudinal lifting portions are cross-connected, so that the lifting member is a planar structure; or,

[0012] The lifting member comprises at least two longitudinal lifting parts arranged in parallel and at least one transverse connecting part, wherein the transverse connecting part is connected with the at least two longitudinal lifting parts, so that the lifting member is a planar structure.

[0013] In one embodiment, when the positioning member is in the second state position, a portion of the surface of the lifting member facing the stent body is configured to contact the native valve leaflet.

[0014] In one embodiment, the lifting member is an elastic member.

[0015] In one embodiment, along the axial direction of the stent body, the connection between the lifting member and the stent body and the positioning member are spaced apart, and the distance between the connection between the lifting member and the stent body and the connection end is smaller than the distance between the connection between the lifting member and the stent body and the clamping end.

[0016] In one embodiment, the valve stent further includes: a pre-tightening member connected between the positioning member and the stent body, and the pre-tightening member is configured to drive the positioning member to move from the first state position toward the second state position.

[0017] In one embodiment, the pre-tightening element is extended along the peripheral wall of the bracket body.

[0018] In one embodiment, the valve stent further includes: a sleeve member, the sleeve member is suitable for being assembled on the stent body, and the pre-tightening member is suitable for passing through the sleeve member so that the pre-tightening member is extended along the peripheral wall of the stent body.

[0019] In one embodiment, the positioning member includes a curved portion and a clamping and positioning portion, and the curved portion is connected between the clamping and positioning portion and the bracket body;

[0020] The clamping and positioning portion includes a first clamping section and a second clamping section, the first clamping section is connected between the second clamping section and the curved portion, the first clamping section and the central plane of the bracket body form a first angle θ1, and the second clamping section and the central plane of the bracket body form a second angle θ2;

[0021] The relationship is satisfied: 0°≤θ1≤45°; 0°≤θ2≤45°.

[0022] The present application further proposes a valve device, which includes a valve stent and an artificial valve component as described in some of the above embodiments, wherein the artificial valve component is assembled on the valve stent.

[0023] In the above-mentioned valve stent, the positioning member in the valve stent is configured to have a first state position and a second state position relative to the stent body, wherein when the positioning member is in the first state position, it is convenient for the valve stent to quickly capture the native leaflets, and when the positioning member is in the second state position, the positioning member and the stent body cooperate to firmly clamp the native leaflets, so that the valve stent is reliably clamped and fixed to the native leaflets. Therefore, the valve stent according to the present application can not only quickly capture the native leaflets, but also has a strong anti-displacement ability. For the valve device using the valve stent of the present application, the valve device can quickly capture the native leaflets, and ensure the reliability of the valve device using the valve stent of the present application after implantation, and solve the problem of the valve device being separated from the native leaflets. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic structural diagram of a valve stent according to one embodiment of the present application.

[0025] Figure 2 It is a structural schematic diagram of a positioning member in a first state relative to a bracket body according to an embodiment of the present application.

[0026] Figure 3 It is a structural schematic diagram of a positioning member in a second state relative to a bracket body according to an embodiment of the present application.

[0027] Figure 4 It is a schematic structural diagram of a single lifting member connected between a positioning member and a bracket body according to an embodiment of the present application.

[0028] Figure 5 It is a schematic structural diagram of two pulling members connected between a positioning member and a bracket body according to an embodiment of the present application.

[0029] Figure 6 It is a schematic structural diagram of a single lifting member connected between a positioning member and a bracket body according to another embodiment of the present application.

[0030] Figure 7 Schematic diagram of the structure of a positioning member according to an embodiment of the present application.

[0031] Figure 8 FIG. 4 is a force diagram of a positioning member according to an embodiment of the present application.

[0032] Reference numerals:

[0033] 100. Valve stent; 101. Positioning and clamping area; 1. Stent body; 11. Fixing part; 110. Assembly hole; 2. Positioning piece; 2a. Connecting end; 2b. Clamping end; 21. Arch part; 22. Clamping and positioning part; 221. First clamping section; 222. Second clamping section; 3. Lifting piece; 31. Longitudinal lifting part; 4. Pre-tightening piece; 5. Sleeve piece; 200. Medical operating equipment. DETAILED DESCRIPTION

[0034] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0035] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0036] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0037] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0038] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0039] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0040] See also Figures 1 to 3 As shown, according to some embodiments of the present application, the valve stent 100 can be used to be assembled with an artificial valve component (not shown in the figure) to form a valve device (not shown in the figure). The valve device can be used to treat aortic valve disease.

[0041] Aortic valve disease refers to a type of heart disease in which the aortic valve has structural or functional abnormalities, leading to obstruction or reverse flow of blood. Common aortic valve diseases include aortic stenosis and aortic regurgitation.

[0042] Among them, transcatheter aortic valve replacement (TAVR) is a minimally invasive surgery widely used in the world for the treatment of aortic valve disease. Through interventional catheter technology, the valve device is delivered to the position of the aortic valve, thereby completing the implantation of the valve device and restoring the valve function. TAVR has the advantages of less trauma, faster recovery, and higher quality of life for patients after surgery, and has become the current trend in the treatment of aortic valve disease.

[0043] For regurgitant aortic valve disease, current TAVR products mostly use a valve device with a valve stent and a positioning piece. The positioning piece is inserted into the valve sinus to position the valve device so that the valve leaflets of the valve device coincide with the native valve leaflets of the human body, ensuring better postoperative hemodynamics of the valve device. At the same time, the clamping force of the positioning piece and the valve stent on the native valve leaflets ensures the support of the valve device after implantation, which is suitable for regurgitant aortic valve disease.

[0044] The valve device of the regurgitant TAVR relies on the positioning parts of the valve stent to clamp the native leaflets and the radial support force of the valve stent to fix the valve. When the patient's valve sinus is large, it is difficult for the positioning parts of the valve stent to smoothly capture the native leaflets to enter the sinus. In order to ensure that the positioning parts can capture the native leaflets, the opening angle of the positioning parts can be increased to facilitate the positioning parts to capture the native leaflets. However, the increase in the opening angle of the positioning parts reduces the fatigue performance of the connection between the positioning parts and the stent body and the clamping performance of the native leaflets. The positioning parts cannot reliably clamp the native leaflets, causing the valve stent (i.e., the valve device) to be separated from the native leaflets.

[0045] See also Figures 1 to 3 As shown, the valve stent 100 according to some embodiments of the present application includes a stent body 1 and a positioning member 2. The main body shape of the stent body 1 is a hollow annular column, and the stent body 1 can be made of a metal material (for example, nickel-titanium alloy) to form a "cage-type" structure, so that a number of prismatic grid-shaped through-hole structures are formed in the stent body 1. In this way, when the stent body 1 is subjected to an external force, the stent body 1 is compressed and deformed to reduce the radial size of the stent body 1, and when the external force releases the compression of the stent body 1, the stent body 1 can be restored to the original radial size. It can also be understood that the stent body 1 can be elastically deformed so that the stent body 1 reduces its radial size under the action of an external force, and when the compression of the external force is released, the stent body 1 expands outward to restore its original radial size. It should be supplemented that, since the stent body 1 itself has the ability to expand outward, the valve device equipped with the valve stent 100 of the present application can provide a certain radial support force through the valve stent 100 after implantation, thereby improving the stability of the valve device.

[0046] Along the extension direction of the positioning member 2, the two ends of the positioning member 2 respectively have a connecting end 2a and a clamping end 2b, wherein the connecting end 2a is connected to the stent body 1, so that the positioning member 2 is assembled to the stent body 1, so that the overall structure of the positioning member 2 is relatively static relative to the overall structure of the stent body 1. In addition, in the radial direction of the stent body 1, the positioning member 2 is spaced apart from the outer peripheral wall of the stent body 1, so that a positioning clamping area 101 for accommodating the native valve leaflet is formed between the positioning member 2 and the stent body 1.

[0047] In addition, the positioning member 2 has a first state position and a second state position relative to the bracket body 1, such as Figure 2 As shown, Figure 2 The positioning member 2 is shown in the first state relative to the bracket body 1, and Figure 3 As shown, Figure 3 It is shown that the positioning member 2 is located in the second state relative to the bracket body 1. When the positioning member 2 is in the first state, there is a first radial spacing D1 between the clamping end 2b and the central axis of the bracket body 1, and when the positioning member 2 is in the second state, there is a second radial spacing D2 between the clamping end 2b and the central axis of the bracket body 1, satisfying the relationship: D1>D2.

[0048] It is worth noting that in some embodiments of the present application, the clamping end 2b is configured to be movable, thereby making it possible to change the size of the positioning clamping area 101. It can also be understood that the opening angle of the positioning member 2 is adjustable.

[0049] Combination Figure 1 and Figure 2 As shown, the positioning member 2 is configured to be applied with a first force, and the positioning member 2 is under the action of the first force so that the positioning member 2 is expanded relative to the stent body 1, that is, the clamping end 2b moves along the radial direction of the stent body 1 away from the central axis of the stent body 1, so that the positioning member 2 is located in the first state position relative to the stent body 1. And the first force can also maintain the positioning member 2 in the first state position. When the positioning member 2 is in the first state position, the clamping end 2b of the positioning member 2 has a larger radial spacing with the central axis of the stent body 1 than when the first force is not applied to the positioning member 2, that is, there is a first radial spacing D1 between the clamping end 2b and the central axis of the stent body 1. It can also be understood that when the positioning member 2 is configured to be applied with the first force to be located in the first state position, the opening angle of the positioning member 2 is increased, so that a larger positioning clamping area 101 is formed between the positioning member 2 and the stent body 1, thereby facilitating the valve stent 100 to capture the native leaflet to enter the sinus. It should be noted that, in some embodiments of the present application, the power source for applying the first force may be a medical operating device 200 and / or a component in the valve stent 100 belonging to some embodiments of the present application (for example: a lifting member 3, for details about the lifting member 3, please refer to the following content, which will not be described in detail here).

[0050] Therefore, according to the valve stent 100 of the present application, when the positioning member 2 is driven to the first state position, the positioning clamping area 101 of the valve stent 100 is enlarged to facilitate the valve stent 100 to capture the native leaflet.

[0051] Next, please combine Figure 3As shown, when the positioning member 2 is in the first state position and the native leaflet is in the positioning clamping area 101. The positioning member 2 can be configured to be applied with a second force, and the positioning member 2 is under the action of the second force, so that the positioning member 2 is closed relative to the stent body 1, that is, the clamping end 2b moves along the radial direction of the stent body 1 toward the central axis of the stent body 1, so that the positioning member 2 moves from the first state position to the second state position relative to the stent body 1. And the second force can also maintain the positioning member 2 in the second state position. In the process of the positioning member 2 moving from the first state position to the second state position, the opening angle of the positioning member 2 gradually decreases, so that the positioning member 2 will capture the native leaflet toward the stent body 1, so that the positioning member 2 and the stent body 1 together clamp the native leaflet in the positioning clamping area 101. When the native leaflet is clamped between the stent body 1 and the positioning member 2 and the positioning member 2 cannot move further toward the stent body 1, the positioning member 2 stops moving, and the position of the positioning member 2 relative to the stent body 1 can be understood as the second state position. The valve stent 100 firmly clamps the native valve leaflet. It is worth noting that when the positioning member 2 is in the second state, there is a second radial distance D2 between the clamping end 2b and the central axis of the stent body 1, and the relationship D1>D2 is satisfied.

[0052] The positioning member 2 moves from the first state position to the second state position under the action of the second force to ensure that the positioning member 2 can move to the second state position, thereby ensuring that the positioning member 2 and the stent body 1 cooperate to firmly clamp the native leaflets. Therefore, according to the positioning member 2 of the present application, since it is configured to move from the first state position to the second state position, it can also be understood that: the positioning member 2 moves from the first state position to the second state position under the action of the second force. In this way, even if there is a situation where fatigue performance of the connection between the positioning member 2 and the stent body 1 is caused by the opening of the positioning member 2, the second force can still ensure that the positioning member 2 moves to the second state position, so that the positioning member 2 and the stent body 1 cooperate to firmly clamp the native leaflets, thereby improving the anti-displacement ability of the valve stent 100.

[0053] It should be noted that, in some embodiments of the present application, the power source for applying the second force may be the medical operating device 200 and / or components in the valve stent 100 belonging to some embodiments of the present application (for example: the preload 4, for details about the preload 4, please refer to the following content, which will not be described in detail here).

[0054] It should be supplemented that, since the stent body 1 can be compressed under the action of external force (i.e., the radial dimension of the stent body 1 is reduced). In one embodiment, in the process of driving the positioning member 2 from the first state position to the second state position by the second force, the compression effect of the external force on the stent body 1 is released at the same time, so that the radial dimension of the stent body 1 gradually increases. Therefore, in this process, the radial spacing between the clamping end 2b of the positioning member 2 and the central axis of the stent body 1 gradually decreases (i.e., with reference to the positioning member 2, the clamping end 2b of the positioning member 2 is getting closer and closer to the outer peripheral wall of the stent body 1), and the radial dimension of the stent body 1 gradually increases (i.e., with reference to the stent body 1, the outer peripheral wall of the stent body 1 is getting closer and closer to the clamping end 2b of the positioning member 2). That is, the direction of the force generated by the outward expansion of the stent body 1 itself is opposite to the direction of the second force, thereby effectively reducing the size of the positioning clamping area 101, so that the stent body 1 and the positioning member 2 cooperate to reliably clamp the native valve leaflet, so that the valve stent 100 is reliably clamped and fixed to the native valve leaflet. And because the radial dimension of the stent body 1 gradually increases, the valve stent 100 provides a certain radial support force, so as to further improve the anti-displacement capability of the valve stent 100, and at the same time, the valve device using the valve stent 100 of the present application has a strong anti-displacement capability, thereby ensuring the stability of the valve device. The reliability of the valve device using the valve stent 100 of the present application after implantation is effectively guaranteed, and the problem of the valve device being separated from the native leaflet is solved.

[0055] For example, see Figures 1 to 3 As shown, the application of the valve device using the valve stent 100 of the present application in the treatment of aortic valve disease is taken as an example for explanation, wherein the lifting member 3 of the valve stent 100 applies a first force to the positioning member 2 and the pre-tightening member 4 applies a second force to the positioning member 2 as an example.

[0056] In preparation for the treatment operation, the operator uses the medical operation device 200 to compress part of the structure of the stent body 1, thereby reducing the radial size of the part of the structure in the stent body 1, so as to facilitate the delivery of the valve device to the preset position through the medical operation device 200, and then complete the implantation of the valve device. During the implantation process, the lifting member 3 applies a first force to the positioning member 2 to keep the positioning member 2 in the first state position. Figure 2 As shown, Figure 2The figure shows that the positioning member 2 is in the first position relative to the stent body 1. When the positioning member 2 is in the first position, the opening angle of the positioning member 2 is increased, and the native leaflets are more likely to enter the positioning clamping area 101 formed by the positioning member 2 and the stent body 1, thereby improving the ability of the valve device to capture the native leaflets. When the operator implants the valve device, the valve device can quickly capture the native leaflets, which is conducive to shortening the time required for the treatment operation.

[0057] After the valve device successfully captures the leaflets (it can also be understood as: there are enough native leaflets in the positioning and clamping area 101), the force applied by the medical operation device 200 to compress the stent body 1 is released, so that the radial size of the stent body 1 gradually increases. At the same time, the preload member 4 applies a second force to the positioning member 2, so that the positioning member 2 moves from the first state position to the second state position, so that the positioning member 2 and the stent body 1 cooperate to firmly clamp the native leaflets, and the stent body 1 provides a certain radial support force, so as to further improve the stability of the valve device.

[0058] Based on the above content, it can be known that the positioning member 2 in the valve stent 100 according to the present application is configured to have a first state position and a second state position relative to the stent body 1, wherein when the positioning member 2 is in the first state position, it is convenient for the valve stent 100 to quickly capture the native leaflets, and when the positioning member 2 is in the second state position, the positioning member 2 and the stent body 1 cooperate to firmly clamp the native leaflets, so that the valve stent 100 is reliably clamped and fixed to the native leaflets. Therefore, the valve stent 100 according to the present application can not only quickly capture the native leaflets, but also has a strong anti-displacement ability. For the valve device using the valve stent 100 of the present application, the valve device can quickly capture the native leaflets, and ensure the reliability of the valve device using the valve stent 100 of the present application after implantation, and solve the problem of the valve device being separated from the native leaflets.

[0059] See also Figures 1 to 3 As shown, in some embodiments of the present application, the valve stent 100 may also include a lifting member 3, which is connected between the positioning member 2 and the stent body 1. The lifting member 3 is configured to drive the positioning member 2 to be located in the first state position. It can also be understood that the first force is applied to the positioning member 2 by the lifting member 3, so that the positioning member 2 moves and is maintained in the first state position. This increases the opening angle of the positioning member 2, that is, increases the positioning clamping area 101, so that the native leaflets are easier to enter the positioning clamping area 101, thereby improving the ability of the valve device to capture the native leaflets. In the process of implanting the valve device, the valve device can quickly capture the native leaflets, which is conducive to shortening the time required for the treatment operation.

[0060] In some embodiments, the lifting member 3 may be an elastic member, so that when the lifting member 3 applies a second force to the positioning member 2 to make the positioning member 2 move from the first state position to the second state position, the lifting member 3 is prevented from restricting the positioning member 2, and the positioning member 2 can be ensured to move from the first state position to the second state position under the action of the second force. It is also worth noting that by selecting the lifting member 3 as an elastic member, the problem of the lifting member 3 breaking due to the movement of the lifting member 3 to the second state position can be effectively avoided. It should be understood that since the valve stent 100 can be applied to transcatheter aortic valve replacement, that is, the valve stent 100 is implanted in the human body, if the lifting member 3 breaks, the lifting member 3 will form a linear structure with at least two free states, and the lifting member 3 is uncontrollable. According to the present application, the lifting member 3 is an elastic member, that is, the lifting member 3 can be elastically deformed, which not only avoids the problem of the lifting member 3 limiting the positioning member 2, but also the state of the lifting member 3 is controllable, so that the valve device using the valve stent 100 of the present application has higher reliability. It should be added that the lifting member 3 can be made of polymer elastic material and / or metal elastic material.

[0061] In some of the embodiments, along the extension direction of the lifting member 3 (which can also be understood as the length direction of the lifting member 3), one end of the lifting member 3 can be connected to the bracket body 1 by welding, riveting, sewing, etc., and the other end of the lifting member 3 can be connected to the positioning member 2 by welding, riveting, sewing, etc.

[0062] In some of these embodiments, see Figure 1 As shown, along the axial direction of the bracket body 1, the connection between the lifting member 3 and the bracket body 1 and the positioning member 2 are spaced apart, and the distance between the connection between the lifting member 3 and the bracket body 1 and the connection end 2a is smaller than the distance between the connection between the lifting member 3 and the bracket body 1 and the clamping end 2b.

[0063] For example, see Figure 1 As shown, the valve stent 100 is Figure 1 When placed in the middle direction, Figure 1 The Z direction is the axial direction of the bracket body 1. Figure 1As shown, the connection between the lifting member 3 and the bracket body 1 has a first axial spacing with the connection end 2a in the axial direction of the bracket body 1, and the connection between the lifting member 3 and the bracket body 1 has a second axial spacing with the clamping end 2b in the axial direction of the bracket body 1, and satisfies the relationship: the first axial spacing is smaller than the second axial spacing, so it can be seen that in the axial direction of the bracket body 1, the connection between the lifting member 3 and the bracket body 1 is close to the connection end 2a. In addition, since the connection between the lifting member 3 and the bracket body 1 is located on one side of the positioning member 2 in the axial direction of the bracket body 1, it can be seen that the connection between the lifting member 3 and the bracket body 1 is located on the upper side of the positioning member 2, which can also be understood as: the connection between the lifting member 3 and the bracket body 1 is higher than the positioning member 2 in the axial direction of the bracket body 1.

[0064] Since the connection between the lifting member 3 and the bracket body 1 is higher than the positioning member 2, the effectiveness of the first force applied by the lifting member 3 to the positioning member 2 is ensured, ensuring that the positioning member 2 moves toward the first state position under the action of the lifting member 3 and can be maintained in the first state position.

[0065] In some of these embodiments, see Figure 1 As shown, when the positioning member 2 is in the second state position, the partial surface of the lifting member 3 facing the stent body 1 is configured to contact the native leaflets. It should be understood that when the native leaflets are located in the positioning clamping area 101 and the positioning member 2 is in the second state position, in the radial direction of the stent body 1, the positioning member 2 is located on the side of the native leaflets away from the stent body 1, and because the lifting member 3 is connected between the positioning member 2 and the stent body 1, the lifting member 3 is also located on the side of the native leaflets away from the stent body 1. Configuring the partial surface of the lifting member 3 facing the stent body 1 to contact the native leaflets increases the contact area between the valve stent 100 and the native leaflets, thereby improving the anti-displacement ability of the valve stent 100.

[0066] In some of these embodiments, see Figure 4 and Figure 5 As shown, the lifting member 3 is a linear structure, or refer to Figure 6 As shown, the lifting member 3 is a planar structure. Figure 4 and Figure 6 As shown, in some embodiments of the present application, a single lifting member 3 is connected to the positioning member 2, but the present application is not limited thereto. A single positioning member 2 can also be connected to the bracket body 1 through multiple lifting members 3, as shown in FIG. Figure 5As shown, in this embodiment, two lifting members 3 are connected between a single positioning member 2 and the stent body 1, and the single positioning member 2 is lifted by the two lifting members 3, so that the positioning member 2 is subjected to a more uniform force, and the contact area between the valve stent 100 and the native leaflet can be further increased. It should also be noted that in some embodiments of the present application, at least one lifting member 3 with a linear structure and at least one lifting member 3 with a planar structure can be connected between the single positioning member 2 and the stent body 1.

[0067] In some embodiments, the lifting member 3 includes at least two longitudinal lifting portions 31, and the at least two longitudinal lifting portions 31 are cross-connected, so that the lifting member 3 forms a planar structure. Figure 6 As shown, the lifting member 3 has two longitudinal lifting portions 31, and the two longitudinal lifting portions 31 are cross-connected to form a wave crest area or a wave trough area, thereby ensuring that the lifting member 3 with a planar structure has higher stability.

[0068] Alternatively, in some other embodiments, the lifting member 3 includes at least two parallel longitudinal lifting parts 31 and at least one transverse connecting part, and the transverse connecting part is connected to at least two longitudinal lifting parts 31, so that the lifting member 3 has a planar structure. It can also be understood that the lifting member 3 has a mesh structure.

[0069] It should be noted that, in some embodiments of the present application, the lifting member 3 is a planar structure, so that the lifting member 3 has a larger area, thereby further increasing the contact area between the valve stent 100 and the native leaflet, so as to further enhance the anti-displacement ability of the valve stent 100.

[0070] See also Figure 1 As shown, in some embodiments of the present application, the valve stent 100 may further include a preload 4, which is connected between the positioning member 2 and the stent body 1, and the preload 4 is configured to drive the positioning member 2 to move from the first state position toward the second state position. It should be understood that: since the stent body 1 can be elastically deformed, the stent body 1 reduces its radial size under the action of external force, and when the compression of the external force is released, the stent body 1 expands outward to restore its original radial size. Thus, the preload 4 is connected between the positioning member 2 and the stent body 1, so that during the process of the stent body 1 expanding outward, the distance between the connection between the preload 4 and the stent body 1 and the connection between the preload 4 and the positioning member 2 gradually increases, so that when the stent body 1 is in the state of expansion, the stent body 1 pulls the positioning member 2 toward the stent body 1 through the preload 4 (that is, drives the positioning member 2 to move toward the second state position). Therefore, when the radial dimension of the stent body 1 increases, the preload member 4 applies a second force to the positioning member 2 to move to the second state position, so that the valve stent 100 can quickly and reliably clamp the native leaflet.

[0071] It is also worth noting that, since the valve stent 100 according to the present application utilizes the self-expansion characteristics of the stent body 1 (i.e., the stent body 1 expands outward after being released from compression), the preload member 4 pulls the positioning member 2 from the first state position to the second state position under the action of the stent body 1. In this way, the valve stent 100 does not need to be additionally provided with a component for pulling the preload member 4, that is, the valve stent 100 according to the present application is a passive component, which can also be understood as that, when the valve stent 100 has no external energy supply, the preload member 4 can still pull the positioning member 2 from the first state position to the second state position.

[0072] It is necessary to add that, see Figure 1 As shown, in some embodiments of the present application, a single positioning member 2 is connected to the bracket body 1 through a single pre-tightening member 4, but the present application is not limited thereto, and a single positioning member 2 can also be connected to the bracket body 1 through multiple pre-tightening members 4. For example, a single positioning member 2 is connected to the bracket body 1 through two pre-tightening members 4, and the two pre-tightening members 4 are symmetrically arranged, so that the positioning member 2 is subjected to more uniform force.

[0073] In some embodiments, the pre-tightening member 4 may be a filamentary structure, for example, the pre-tightening member 4 may be a medical metal wire, a suture, a wire made of a polymer, etc. The pre-tightening member 4 may be a non-elastic member or an elastic member.

[0074] In some of the embodiments, along the extension direction of the preload member 4 (which can also be understood as the length direction of the preload member 4), one end of the preload member 4 and the bracket body 1 can be connected by welding, riveting, sewing, etc., and the other end of the preload member 4 and the positioning member 2 can be connected by welding, riveting, sewing, etc.

[0075] See also Figure 1As shown, in some embodiments of the present application, the preload 4 is extended along the peripheral wall of the stent body 1, so that in the process of the stent body 1 expanding outward, the distance between the connection between the preload 4 and the stent body 1 and the connection between the preload 4 and the positioning member 2 gradually increases, so that when the stent body 1 is in the state of expansion, the stent body 1 pulls the positioning member 2 toward the stent body 1 through the preload 4 (that is, drives the positioning member 2 to move toward the second state position). At the same time, avoiding the preload 4 from crossing the stent body 1 can also be understood as avoiding the preload 4 from crossing the hollow area of ​​the stent body 1 horizontally. It should be understood that: the valve stent 100 is applied to a valve device, which is used to be implanted in the human body, wherein the hollow area of ​​the stent body 1 is mainly used for circulating blood. Based on this, according to the present application, the preload 4 is extended along the peripheral wall of the stent body 1 to avoid the preload 4 from crossing the hollow area of ​​the stent body 1 horizontally, thereby avoiding the preload 4 from causing obstruction to the blood and ensuring the smooth flow of blood.

[0076] It should be noted that, in some embodiments of the present application, the preload member 4 may be extended along the inner circumferential wall and / or the outer inner circumferential wall of the bracket body 1. It can be understood that, in one embodiment, Figure 1 As shown, the preload member 4 is extended along the inner circumferential wall of the bracket body 1; or, in another embodiment, the preload member 4 is extended along the outer circumferential wall of the bracket body 1; or, in yet another embodiment, a portion of the preload member 4 is extended along the outer circumferential wall of the bracket body 1, and another portion of the preload member 4 is extended along the inner circumferential wall of the bracket body 1.

[0077] See also Figure 1 As shown, in some embodiments of the present application, the valve stent 100 may further include a sleeve 5, which is suitable for being assembled on the stent body 1, and the preload member 4 is suitable for passing through the sleeve 5, so that the preload member 4 is extended along the peripheral wall of the stent body 1. Therefore, according to the valve stent 100 of the present application, the sleeve 5 is provided to limit the preload member 4 to a certain extent, which is conducive to avoiding the compression and expansion of the stent body 1 by the preload member 4, as well as the influence on blood flow after surgery.

[0078] The structure of the sleeve 5 can be a cylindrical structure or an annular structure. The sleeve 5 can be made of a polymer material or a metal material. The sleeve 5 can be sleeved on a rod used to surround a grid forming the stent body 1. The sleeve 5 can be integrally formed with the stent body 1 by cutting, or it can be a separate component and set on the stent body 1 by bonding or suturing.

[0079] The sleeve 5 is provided with a guide hole, and the preloaded member 4 is passed through the guide hole, so that the preloaded member 4 can be arranged along the outer wall and / or inner wall of the bracket body 1. At this time, the preloaded member 4 is in a curve. Specifically, in order to facilitate the arrangement of the preloaded member 4 along the outer wall and / or inner wall of the bracket body 1, the number of sleeves 5 applied to a single preloaded member 4 can be configured as multiple, and two adjacent multiple sleeves 5 are distributed at intervals. The specific distribution method can be set according to actual needs and will not be repeated here. Figure 1 As shown, in one embodiment of the present application, the preload member 4 is arranged along the inner circumferential wall of the stent body 1 (ie, the preload member 4 is arranged on the inner side of the stent body 1) through the sleeve member 5 to reduce the interference of the preload member 4 on the native leaflet.

[0080] Combination Figure 1 and Figure 7 As shown, in some embodiments of the present application, the positioning member 2 includes a curved portion 21 and a clamping and positioning portion 22, the curved portion 21 is connected between the clamping and positioning portion 22 and the bracket body 1, and along the axial direction of the bracket body 1, the arc formed by the curved portion 21 faces the extension direction of the clamping and positioning portion 22. The clamping and positioning portion 22 may also include a first clamping section 221 and a second clamping section 222, the first clamping section 221 is connected between the second clamping section 222 and the curved portion 21, the first clamping section 221 forms a first angle θ1 with the center plane of the bracket body 1, and the second clamping section 222 forms a second angle θ2 with the center plane of the bracket body 1, and the relationship is satisfied: 0°≤θ1≤45°; 0°≤θ2≤45°. This not only ensures the good fatigue performance of the root of the positioning member 2, but also ensures that the lifting member 3 can pull the positioning member 2 up to a certain angle.

[0081] For example, see Figure 7 and Figure 8 As shown, the positioning member 2 is in a U-shaped structure as a whole, and the positioning member 2 includes two curved portions 21 and a clamping and positioning portion 22, wherein along the extension direction of the clamping and positioning portion 22, the two curved portions 21 are respectively connected to the two ends of the clamping and positioning portion 22. Further, the clamping and positioning portion 22 includes two first clamping segments 221 and a second clamping segment 222, the second clamping segment 222 is in a U-shaped structure, and the two first clamping segments 221 are respectively connected to the two ends of the second clamping segment 222.

[0082] Further, illustratively, see Figure 8As shown, the positioning member 2 and the lifting member 3 are subjected to a pulling force F2 along the direction of the positioning member 2 and a pulling force F1 along the direction of lifting the positioning member 2, wherein F1 can be decomposed into a pulling force F12 along the axial direction of the stent body 1 and a pulling force F11 away from the radial direction of the stent body 1, ensuring that F11 < F0, wherein F0 is the pulling force given by the preload member 4 to the positioning member 2 along the radial direction of the stent body 1. It is assumed here that the total pulling force given by the lifting member 3 is F, and F11 = Fcosθ, wherein the range of θ is specified to be (30°~90°), thereby ensuring that F0 > 1 / 2F. It should be understood that θ is the angle between the positioning member 2 and the side wall of the stent body 1.

[0083] Combination Figure 3 and Figure 8 As shown, in some embodiments of the present application, the stent body 1 is provided with a fixing portion 11, and the fixing portion 11 is provided with an assembly hole 110, and the assembly hole 110 is suitable for being installed into the clamp of the medical operating device 200, thereby achieving an effect that the stent body 1 can be assembled on the medical operating device 200, so that the medical operating device 200 can transport the valve device using the valve stent 100 of the present application to a preset position.

[0084] The valve device according to some embodiments of the present application includes the valve stent and the artificial valve component in some embodiments described above, and the artificial valve component is assembled on the valve stent. Since the valve stent 100 has a strong anti-displacement ability, the valve device according to the present application has a high anti-displacement ability, thereby ensuring the stability of the valve device. The reliability of the valve device after implantation is effectively guaranteed, and the problem of the valve device being separated from the native leaflet is solved.

[0085] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0086] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A valve stent, characterized in that: include: A stent body and a positioning member, wherein along the extension direction of the positioning member, two ends of the positioning member respectively have a connecting end and a clamping end, the connecting end is connected to the stent body, and a positioning clamping area for accommodating the native valve leaflet is formed between the positioning member and the stent body; Wherein, in the radial direction of the bracket body, the positioning member has a first state position and a second state position relative to the bracket body, wherein when the positioning member is in the first state position, there is a first radial spacing D1 between the clamping end and the central axis of the bracket body, and when the positioning member is in the second state position, there is a second radial spacing D2 between the clamping end and the central axis of the bracket body, satisfying the relationship: D1>D2.

2. The valve stent according to claim 1, characterized in that: Also includes: A lifting member is connected between the positioning member and the bracket body, and the lifting member is configured to drive the positioning member to be located in the first state position.

3. The valve stent according to claim 2, characterized in that: The lifting member comprises at least two longitudinal lifting parts, and at least two of the longitudinal lifting parts are cross-connected, so that the lifting member is a planar structure; or, The lifting member includes at least two longitudinal lifting parts arranged in parallel and at least one transverse connecting part, wherein the transverse connecting part is connected to at least two longitudinal lifting parts, so that the lifting member has a planar structure.

4. The valve stent according to claim 2, characterized in that: When the positioning member is located in the second state position, a portion of the surface of the lifting member facing the stent body is configured to contact the native leaflet.

5. The valve stent according to claim 2, characterized in that: The lifting member is an elastic member.

6. The valve stent according to claim 2, characterized in that: Along the axial direction of the bracket body, the connection between the lifting member and the bracket body and the positioning member are spaced apart, and the distance between the connection between the lifting member and the bracket body and the connecting end is smaller than the distance between the connection between the lifting member and the bracket body and the clamping end.

7. The valve stent according to claim 1, characterized in that: Also includes: A pre-tightening member is connected between the positioning member and the bracket body, and the pre-tightening member is configured to drive the positioning member to move from the first state position toward the second state position.

8. The valve stent according to claim 7, characterized in that: The pre-tightening member is extended along the peripheral wall of the bracket body.

9. The valve stent according to claim 8, characterized in that: Also includes: The sleeve member is suitable for being assembled on the bracket body, and the pre-tightening member is suitable for passing through the sleeve member so that the pre-tightening member is extended along the peripheral wall of the bracket body.

10. The valve stent according to any one of claims 1 to 9, characterized in that: The positioning member includes a curved portion and a clamping and positioning portion, and the curved portion is connected between the clamping and positioning portion and the bracket body; The clamping and positioning portion includes a first clamping section and a second clamping section, the first clamping section is connected between the second clamping section and the curved portion, the first clamping section and the central plane of the bracket body form a first angle θ1, and the second clamping section and the central plane of the bracket body form a second angle θ2; The relationship is satisfied: 0°≤θ1≤45°; 0°≤θ2≤45°.

11. A valve device, characterized in that: include: The valve stent according to any one of claims 1 to 10; An artificial valve component is assembled on the valve stent.

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