Valve clamping device and clamping system
By designing a deformable auxiliary clamping component and an asymmetrically staggered valve clamping device, the problem of regurgitation and leakage in existing clamps was solved, achieving more efficient valve clamping and lower surgical risks.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHENZHEN LIFEVALVE MEDICAL SCI CO LTD
- Filing Date
- 2024-05-08
- Publication Date
- 2026-06-26
Smart Images
Figure CN118402892B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of interventional medical device technology, and in particular to a valve clamping device and clamping system. Background Technology
[0002] The atrioventricular valves, such as the mitral and tricuspid valves, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. Specifically, the mitral valve consists of a pair of leaflets, an anterior leaflet and a posterior leaflet. When the edges of the anterior and posterior leaflets align, the mitral valve closes completely, preventing blood from flowing from the left ventricle to the left atrium. When organic or functional changes occur in the leaflets of the mitral valve or its related structures, the anterior and posterior leaflets may not align properly. Consequently, when the left ventricle contracts, the mitral valve cannot close completely, causing blood to flow back from the left ventricle to the left atrium, leading to a series of pathophysiological changes known as "mitral regurgitation."
[0003] A minimally invasive surgical procedure involves delivering a leaflet clamp to the mitral valve via a delivery device. The clamp then simultaneously clamps the anterior and posterior leaflets of the mitral valve through relative opening and closing, thus fixing the leaflets together and reducing mitral regurgitation. However, the clamping range of the existing clamp is limited. Even after clamping the mitral valve, regurgitation leakage still occurs on both sides and at the top of the clamp. This often necessitates the use of multiple clamps to achieve a good anti-regurgitation effect, increasing the difficulty and risk of the surgery, as well as medical costs. Summary of the Invention
[0004] In order to solve the above-mentioned technical problems, or at least partially solve the above-mentioned technical problems, the present invention provides a valve clamping device and clamping system.
[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution:
[0006] This invention provides a valve clamping device, including a main clamping member for clamping and an auxiliary clamping member connected to the main clamping member for auxiliary clamping; the main clamping member includes a pair of clamping assemblies that can be opened or closed relative to the central axis of the valve clamping device; the auxiliary clamping member is deformable and has an expanded state in its natural state and a contracted state after being squeezed; the auxiliary clamping member includes a first expansion assembly and a second expansion assembly, the first expansion assembly and the second expansion assembly are respectively connected to one of the clamping assemblies, and the first expansion assembly and the second expansion assembly connected to the clamping assembly extend from the width direction of the clamping assembly connected to them, and the extended portions tend to extend toward the opposite side.
[0007] In some embodiments, in the extended state, the first extended component and the second extended component are arranged symmetrically or asymmetrically with respect to the central axis.
[0008] In some embodiments, the extended end edges of the first extension component and the second extension component are symmetrically or asymmetrically arranged and are opposite to each other, with the opposite end edges spaced apart from each other or abutting each other.
[0009] In some embodiments, when the opposite two end edges are spaced apart, the minimum spacing is less than a preset distance; when the opposite two end edges abut, there is a preset tension between the abutting first extension component and the second extension component.
[0010] In some embodiments, the extended end edges of the first extension component and the extended end edges of the second extension component are mutually cooperating bevels, and the first extension component and the second extension component can be misaligned based on the guidance of the bevels after being compressed.
[0011] In some embodiments, in the extended state, the first extension component and the second extension component are asymmetrically arranged relative to the central axis, and the extended end edges of the asymmetrically arranged first extension component and the extended end edges of the second extension component are offset in the width direction of the clamping component.
[0012] In some embodiments, the extended end edge of the first extension component is spaced apart from or overlaps with the extended end edge of the second extension component.
[0013] In some embodiments, both the first extension component and the second extension component include at least one extension arm, wherein;
[0014] The first extension component includes a first front extension arm and / or a first rear extension arm, and the second extension component includes a second front extension arm and / or a second rear extension arm adapted to the first front extension arm and / or the first rear extension arm of the first extension component; the first front extension arm and the second front extension arm are used together for auxiliary clamping, and the first rear extension arm and the second rear extension arm are used together for auxiliary clamping.
[0015] In some embodiments, the extension arm has a frame structure, and the extension arm includes an upper connecting section, an upper support section, a clamping section, a lower support section, and a lower connecting section that are sequentially connected. The upper connecting section and the lower connecting section extend substantially along the width direction of the second clamping arm. One end of the upper connecting section and the lower connecting section is connected to the same side of the second clamping arm, and the other end is connected to one end of the upper support section and the lower support section, respectively. The clamping section extends substantially along the central axis direction of the valve clamping device. The other end of the upper support section and the lower support section is connected to both ends of the clamping section, respectively. The upper support section and the lower support section gradually expand outward from the upper connecting section and the lower connecting section to the clamping section.
[0016] In some embodiments, the first extension component and / or the second extension component includes a support portion on which an extension anchor is provided.
[0017] In some embodiments, the first extension component and the second extension component have different support strengths, resulting in different degrees of deformation of the first extension component and the second extension component under the same force; and / or,
[0018] The support strength of the first extension component and the second extension component is not uniformly set, so that the first extension component and the second extension component deform to different degrees under the same force.
[0019] In some embodiments, each of the clamping components includes a first clamping arm and a second clamping arm that cooperates with the first clamping arm, a pair of first clamping arms located inside a pair of second clamping arms, a pair of second clamping arms that can be opened or closed relative to the central axis, and the first extension component and the second extension component are respectively connected to a second clamping arm.
[0020] In some embodiments, the second clamping arm includes a clamping bottom for engaging tissue and a sidewall disposed on the side of the clamping bottom, wherein the first extension component and the second extension component are respectively connected to the sidewall of the second clamping arm on the corresponding side.
[0021] In some embodiments, a drive assembly is further included, the drive assembly including a pair of drive arms, one of the drive arms being hinged to a second clamping arm, the pair of drive arms driving the pair of second clamping arms to open or close relative to the central axis; when the extension assembly includes a front extension arm and a rear extension arm, and the extension arm includes an upper connecting section, an upper support section, a clamping section, a lower support section and a lower connecting section that are sequentially connected, the lower connecting sections of the front extension arm and the rear extension arm are connected, and the connected lower connecting sections pass through both a drive arm and a second clamping arm, such that the drive arm is hinged to the second clamping arm.
[0022] In some embodiments, the main clamping member and / or the auxiliary clamping member are covered with an outer membrane, and the main clamping member and / or the auxiliary clamping member are movably disposed within the outer membrane.
[0023] In some embodiments, a partial inner membrane is provided on one side of the free end of the main clamping member and / or the auxiliary clamping member, and the partial inner membrane is located inside the outer membrane.
[0024] The present invention also provides a clamping system, including the valve clamping device and the delivery assembly described above, wherein the delivery assembly is detachably connected to the valve clamping device.
[0025] The valve clamping device and clamping system of the present invention, by providing deformable auxiliary clamping components for auxiliary clamping, can increase the effective clamping width of the valve clamping device without increasing or excessively increasing the overall outer diameter of the clamps, thereby reducing the number of clamps used, improving the anti-reflux effect, shortening the operation time, and reducing the surgical risk. Furthermore, the asymmetrical and limited end-staggered manner of the present invention, on the one hand, ensures that the ends of the staggered first and second extension components do not abut against each other when subjected to a contraction force, but rather move inward in an orderly manner to contract, making the valve clamping device easier to retract and avoiding the need for excessive contraction force and damage to the auxiliary clamping components; on the other hand, and more importantly, because the edges of the two extended ends in contact with the leaflet tissue are staggered along the width direction of the clamping components, the effective clamping width is further increased to a certain extent. Specifically, the first expansion component forms an abutment position when it contacts the leaflet tissue, and the second expansion component forms another abutment position when it contacts the leaflet assembly. The two abutment positions are not directly opposite each other in the X direction, but are spaced apart along the width direction of the clamping component, i.e., in the Y direction, and are set one in front of the other. The pair of leaflets are pushed against each other from two directions by the two expansion components, so that the leaflets within this interval range S are clamped and constrained, reducing the leaflet gap. Compared with the method of directly facing each other, this method not only significantly increases the effective width of the auxiliary clamping component, which can further reduce the amount of valve clamp used and improve the anti-reflux effect, but also avoids the problem of leaflet perforation caused by relative abutment during the cardiac cycle because the two abutment positions are not directly opposite each other in the X direction. Attached Figure Description
[0026] To more clearly illustrate the solutions in this invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention or corresponding prior art. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein:
[0027] Figure 1 This is a perspective view of an exemplary valve clamping device of the present invention, wherein the auxiliary clamping member is in a constricted state;
[0028] Figure 2 yes Figure 1 A top view of the valve clamping device;
[0029] Figure 3 yes Figure 2 A top view of the extended state of the auxiliary clamping component in its natural unfolded state;
[0030] Figure 4 This is a schematic diagram of an exemplary valve clamping device of the present invention housed in a delivery system;
[0031] Figure 5 This is a schematic diagram of a pair of clamping components of an exemplary valve clamping device of the present invention in operation.
[0032] Figure 6 yes Figure 5 A top view of the valve clamping device;
[0033] Figure 6 (a) is Figure 6 A partial schematic diagram;
[0034] Figure 7 yes Figure 5 A side view of the valve clamping device;
[0035] Figure 8 yes Figure 5 A three-dimensional schematic diagram of the valve clamping device;
[0036] Figure 8 (a) is Figure 8 A partial schematic diagram;
[0037] Figures 9(a) to 9(c) These are schematic diagrams of different embodiments of the exemplary valve clamping device of the present invention when the extended components are facing each other.
[0038] Figure 9(d) is a partial schematic diagram of the inclined surface at the end of the expansion component in the exemplary valve clamping device of the present invention;
[0039] Figures 10(a) to 10(c) These are schematic diagrams of different embodiments of the exemplary valve clamping device of the present invention when the extended components are asymmetrically arranged;
[0040] Figure 10(d) is a schematic diagram of the valve leaflet clamping when the extended components of the exemplary valve clamping device of the present invention are asymmetrically arranged;
[0041] Figure 10(e) is a partial schematic diagram of Figure 10(d);
[0042] Figure 11 These are schematic diagrams of another embodiment of the exemplary valve clamping device of the present invention when the extended components are asymmetrically arranged;
[0043] Figure 12(a) is a partial schematic diagram of an extension anchor provided at the end of the extension component in an exemplary valve clamping device of the present invention;
[0044] Figure 12(b) is a schematic diagram of the extended anchoring member of Figure 12 being anchored into the leaf;
[0045] Figure 13 This is a schematic diagram of the structure of the valve clamping device of the present invention, which is wrapped with a membrane. The auxiliary clamping components are not shown in this schematic diagram.
[0046] Figure 14 yes Figure 13 A magnified view of a portion of the image;
[0047] Figure 15 yes Figure 13 Another enlarged view of a part;
[0048] Figure 16 This is a schematic diagram of the structure of a pair of clamping components of an exemplary valve clamping device of the present invention when they are opened, wherein the auxiliary clamping components are not shown in this schematic diagram. Detailed Implementation
[0049] The technical solutions in the embodiments of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0050] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. When an element is referred to as being "fixed to" or "set on" another element, the element may be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or connected to the other element through one or more connecting elements.
[0051] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is important to note that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end point," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, endpoint, or end face, but also includes a portion extending axially and / or radially from the tip, endpoint, or end face on the element to which the tip, endpoint, or end face belongs. The above definitions are for convenience only and should not be construed as limiting the invention.
[0052] The valve clamping device and clamping system provided by the present invention are used to repair heart valves, especially mitral and tricuspid valves, to reduce leaflet gap and alleviate mitral or tricuspid regurgitation.
[0053] Please refer to Figure 1 and Figure 5 As shown, the present invention provides an exemplary valve clamping device 100, which includes a main clamping member 1 for clamping the valve leaflets and an auxiliary clamping member 6 connected to the main clamping member 1 for assisting in clamping the valve leaflets. The valve clamping device 100 has a central axis oo, and the main clamping member 1 includes a pair of clamping assemblies 10 that can be opened or closed relative to the central axis oo. Figure 2 and Figure 3 As shown, the auxiliary clamping member 6 can deform, and the auxiliary clamping member 6 has an extended state in its natural state. Figure 3 (as shown) and the contracted state that converges towards the central axis oo after being compressed ( Figure 2 (As shown). The auxiliary clamping member 6 includes a first extension component 61 and a second extension component 62. The first extension component 61 and the second extension component 62 are respectively connected to a clamping component 10. The first extension component 61 and the second extension component 62 connected to the clamping component 10 extend outward from the width direction of the clamping component 10 connected to them, and the extended portions tend to extend towards the opposite side, so that the adjacent side of the leaflet clamped by the main clamping member 1 can be auxiliaryly clamped between the first extension component 61 and the second extension component 62 in the extended state.
[0054] As shown in Figure 10(d), the leaflet m is clamped by the main clamping member 1 with a clamping width of L1. The adjacent sides of the leaflet m after being clamped by the main clamping member 1 are clamped by auxiliary clamping members 6. That is, the leaflets m on both sides are clamped between the first extension component 61 and the second extension component 62. The effective clamping width of the entire clamping device after being clamped by the auxiliary clamping members 6 is L2. Obviously, L2 is greater than, or even much greater than, L1. The setting of the auxiliary clamping members 6 in this invention can increase the effective clamping width of the valve clamping device 100, reduce the number of clamps used, improve the anti-reflux effect, shorten the operation time, and reduce the surgical risk. At the same time, the deformable auxiliary clamping members 6 are compressed and deformed under external force constraints, so that the outer diameter of the valve clamping device 100 after overall constraint will not increase or will not increase excessively, and will not cause or minimize the increase in the inner diameter of the delivery system, facilitating sheathing and delivery.
[0055] like Figure 4 As shown, Figure 2 The valve clamping device 100 in its contracted state can be housed in the delivery sheath 200 of the delivery system. After being delivered to a preset position (e.g., inside the human atrium) by the delivery system, it can be further pushed out of the delivery sheath 200 by operating the delivery system. The auxiliary clamping member 6 of the pushed-out valve clamping device 100 will automatically unfold. Figure 3 The valve clamping device 100, which is in an expanded state within the atrium, can be further opened by the operation of the delivery system (e.g., in an open state as shown). Figure 5 As shown, the first extension component 61 and the second extension component 6261, which are connected to a pair of clamping components 10, move away from each other as the clamping components 10 are opened.
[0056] In the deformable auxiliary clamping member 6 of the present invention, the entire auxiliary clamping member 6 or at least its unfolded portion is formed of a shape memory material, the shape memory material being configured to exhibit superelasticity in a physiological environment. Exemplarily, the shape memory material includes one or more shape memory alloys or shape memory polymers. The shape memory material is a shape memory alloy selected from the group consisting of copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, nickel-titanium alloys, nickel-titanium-platinum alloys, and nickel-titanium-palladium alloys. Further, the shape memory material is a nickel-titanium alloy. The shape memory material is a shape memory polymer selected from the group consisting of oligo(ε-caprolactone) glycol, oligo(p-dioxane) glycol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and compounds based on vinyl acetate polyesters.
[0057] To clearly illustrate the structure of the valve clamping device 100 of the present invention, the following directions are defined: the Z-direction is defined as the central axis oo of the valve clamping device 100, and the Z-direction is defined as the direction parallel to the width W of the clamping assembly 10 (e.g., ...). Figure 2 The direction perpendicular to the Z direction (as shown in the diagram) is the Y direction, and the direction perpendicular to both the Z and Y directions is the X direction. The XY plane is a plane perpendicular to the Z direction, defined by a straight line extending along the X direction and a straight line extending along the Y direction intersecting that line. It is understood that there can be multiple XY planes, and these multiple XY planes can be arranged parallel to each other along the Z direction. The XZ plane is a plane perpendicular to the Y direction, defined by a straight line extending along the X direction and a straight line extending along the Z direction intersecting that line. It is understood that there can be multiple XZ planes, and these multiple XZ planes can be arranged parallel to each other along the Y direction. The YZ plane is a plane perpendicular to the X direction, defined by a straight line extending along the Y direction and a straight line extending along the Z direction intersecting that line. It is understood that there can be multiple YZ planes, and these multiple YZ planes can be arranged parallel to each other along the X direction. The valve clamping device 100 has a certain axial length, i.e., a Z-direction length. The clamping assembly 10 has a certain X-direction width.
[0058] Please continue to refer to Figure 1 and Figure 5 A pair of clamping assemblies 10 may be symmetrically arranged based on the central axis oo of the valve clamping device 100, and the pair of clamping assemblies 10 may be opened or closed relative to the central axis oo. For example, each clamping assembly 10 may include a first clamping arm 11 and a second clamping arm 12 arranged opposite each other, the first clamping arm 11 and the second clamping arm 12 cooperating to clamp a leaflet m. Both the first clamping arm 11 and the second clamping arm 12 have a connecting end and a free end opposite to the connecting end along their respective arm length direction. The connecting end of the first clamping arm 11 is coupled to the connecting end of the second clamping arm 12, and the free ends may approach each other. The first clamping arm 11 and the second clamping arm 12 approaching each other may move their free ends away from each other in response to a separation force, and the leaflet may be clamped between the first clamping arm 11 and the second clamping arm 12 when they are close together. The pair of first clamping arms 11 in the pair of clamping assemblies 10 are respectively located inside the pair of second clamping arms 12, and the pair of first clamping arms 11 and the pair of second clamping arms 12 are coupled at the connecting end. Understandably, the connecting ends of the two first clamping arms 11 and the two second clamping arms 12 can be directly coupled or connected through one or more connectors. For example... Figure 1 and Figure 5As shown, the valve clamping device 100 further includes a base 3. The first clamping arm 11 includes a first connecting end 11a and a first free end 11b opposite to the first connecting end 11a along its arm length direction. The second clamping arm 12 includes a second connecting end 12a and a second free end 12b opposite to the second connecting end 12a along its arm length direction. The first connecting end 11a of the first clamping arm 11 and the second connecting end 12a of the second clamping arm 12 are respectively connected to the base 3 to achieve coupling. Preferably, after the first connecting ends 11a of the two first clamping arms 11 are connected, they are further coupled to the base 3 and the second connecting ends 12a of the two second clamping arms 12. It should be noted that the coupling method of the first clamping arm 11 and the second clamping arm 12 is not limited to this; their coupling connection method can also refer to existing technology, which will not be elaborated here.
[0059] For example, both of the first clamping arms 11 of the present invention are elastic. The pair of first clamping arms 11 can move away from each other and move closer to their respective opposing second clamping arms 12 under their own elastic force, and simultaneously move away from their respective opposing second clamping arms 12 and closer to each other under the actuation of the actuator 70 (see...). Figure 8 The elastic first clamping arm 11 may be formed of a shape memory material configured to exhibit superelasticity in a physiological environment. Exemplarily, the shape memory material includes one or more shape memory alloys or shape memory polymers. The shape memory material is a shape memory alloy selected from the group consisting of copper-zinc-aluminum alloys, copper-aluminum-nickel alloys, nickel-titanium alloys, nickel-titanium-platinum alloys, and nickel-titanium-palladium alloys. Further, the shape memory material is a nickel-titanium alloy. The shape memory material is a shape memory polymer selected from the group consisting of oligo(ε-caprolactone) glycol, oligo(p-dioxane) glycol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and compounds based on vinyl acetate polyesters.
[0060] In this invention, the first extension component 61 and the second extension component 62 are respectively connected to a clamping component 10, for example, as shown below. Figure 1 and Figure 5As shown, the first extension component 61 and the second extension component 62 of the present invention are respectively connected to two second clamping arms 12 that are opposite to each other on the left and right. That is, the first extension component 61 is connected to one of the second clamping arms 12, and the second extension component 62 is connected to the other second clamping arm 12. The first extension component 61 and the second extension component 62 are located on the same side. The "same side" in the present invention means that they are simultaneously located on the same side in the X direction. For example, when the first extension component 61 and the second extension component 62 extend only on one side along the width direction of the clamping component 10, that is, when the first extension component 61 and the second extension component 62 only include the front part or the rear part, the first extension component 61 and the second extension component 62 are simultaneously located on the front side or the rear side in the X direction. Or when the first extension component 61 and the second extension component 62 extend on both sides along the width direction of the clamping component 10, that is, when the first extension component 61 and the second extension component 62 simultaneously include the front and rear parts, the two front sides are located on the same side, and the two rear sides are located on the same side.
[0061] Reference Figures 1 to 8 Both the first extension component 61 and the second extension component 62 include at least one extension arm. Understandably, in order to achieve auxiliary clamping, the extension arm of the first extension component 61 and the extension arm of the second extension component 62 are always adapted to be located on the same side, as mentioned above, including at least a single-sided extension or a double-sided extension on the same side.
[0062] For example, such as Figures 1 to 8 As shown, the first extension component 61 includes a first front extension arm 61a, and the second extension component 62 includes a second front extension arm 62a adapted to the first front extension arm 61a of the first extension component 61; the first front extension arm 61a and the second front extension arm 62a extend on the same side, and the first front extension arm 61a and the second front extension arm 62a together are used to assist in clamping the leaflet on one adjacent side of the main clamping member 1. Alternatively, the first extension component 61 includes a first rear extension arm 61b, and the second extension component 62 includes a second rear extension arm 62b adapted to the first rear extension arm 61b of the first extension component 61; the first rear extension arm 61b and the second rear extension arm 62b extend on the same side, and the first rear extension arm 61b and the second rear extension arm 62b together are used to assist in clamping the leaflet on one adjacent side of the main clamping member 1. Alternatively, as shown in the figure, the first extension component 61 includes a first front extension arm 61a and a first rear extension arm 61b, and the second extension component 62 includes a second front extension arm 62a and a second rear extension arm 62b adapted to the first front extension arm 61a and the first rear extension arm 61b of the first extension component 61; the first front extension arm 61a and the second front extension arm 62a extend on the same side, the first rear extension arm 61b and the second rear extension arm 62b extend on the same side, the first front extension arm 61a and the second front extension arm 62a are used together to assist in clamping the leaflet on one adjacent side of the main clamping member 1, and the first rear extension arm 61b and the second rear extension arm 62b are used together to assist in clamping the leaflet on the other adjacent side of the main clamping member 1.
[0063] For example, continue to refer to Figures 1 to 7 as well as Figure 8 and Figure 8 (a) The extension arm of the present invention has a frame structure. The extension arm includes an upper connecting section 6a, an upper support section 6b, a clamping section 6c, a lower support section 6d, and a lower connecting section 6e that are sequentially connected. The upper connecting section 6a and the lower connecting section 6e extend substantially along the width direction of the second clamping arm 12, i.e., in the X direction. One end of the upper connecting section 6a and the lower connecting section 6e is connected to the same side of a second clamping arm 12, and the other end is connected to one end of the upper support section 6b and the lower support section 6d, respectively. The clamping section 6c extends substantially along the central axis oo of the valve clamping device 100 (in the contracted state), or the clamping section 6c extends substantially along the arm length direction of the second clamping arm 12. The other end of the upper support section 6b and the lower support section 6d is connected to both ends of the clamping section 6c, respectively. The upper support section 6b and the lower support section 6d gradually expand outward from the upper connecting section 6a and the lower connecting section 6e to the clamping section 6c. In this embodiment, the outer contour of the extended end of the frame structure's extension arm can be freely unfolded without constraint. When the implantation position is unsuitable and the valve clamping device 100 needs to be retracted, the outer contour can quickly deform and enter the sheath upon receiving the resistance force from the delivery sheath. Simultaneously, the frame structure does not significantly increase the overall weight of the valve clamping device 100. Furthermore, this embodiment uses a clamping section 6c with a certain extension length to clamp the leaflet, effectively increasing the clamping range and stability. Preferably, in this embodiment, the ends of the upper support section 6b and the lower support section 6d that are furthest from the connecting section gradually approach each other, causing the upper support section 6b and the lower support section 6d to tilt relative to each other in the X direction. This tilting allows for a smooth transition against the edge of the delivery sheath, facilitating the re-entry of the auxiliary clamping member into the sheath. The transition connection in this embodiment refers to the connection between the two sections achieved through a curved transition portion. The "basic" value in this embodiment is a relative deviation angle of less than ±10° or more preferably less than ±5°. It should be noted that the structures of the extension arms of the first extension component 61 and the second extension component 62 may be the same or different, and are not limited thereto. Where there is no structural conflict, the structure of the extension arms may be set as needed.
[0064] In the extended state, the auxiliary clamping member 6 of the valve clamping device 100 of the present invention has a first extension component 61 and a second extension component 62 arranged symmetrically or asymmetrically with respect to the central axis oo, that is, symmetrically or asymmetrically with respect to the Y direction passing through the central axis oo. Preferably, the first extension component 61 and the second extension component 62 are arranged asymmetrically with respect to the central axis oo.
[0065] As one implementation method, please refer to Figures 9(a) to 9(c)In this embodiment, when the auxiliary clamping member 6 of the valve clamping device 100 is in the extended state, the first extension component 61 and the second extension component 62 are symmetrically or asymmetrically arranged relative to the central axis oo, that is, symmetrically or asymmetrically arranged relative to the Y direction passing through the central axis oo. In this embodiment, the first extension component 61 and the second extension component 62, which are symmetrically or asymmetrically arranged, are opposite each other at their extended end edges after unconstrained extension. Here, "opposite" means directly opposite, and the extended end edge refers to the edge contour. It can be understood that the edge opposite includes at least the extended end edges being spaced apart or abutting each other, that is, the edge contours being spaced apart or abutting each other.
[0066] As shown in Figure 9(a), the first extension component 61 and the second extension component 62 are symmetrically arranged. The extended end edges of the symmetrically arranged first extension component 61 and the second extension component 62 are spaced apart from each other. At this time, there is a gap between the extended end edges of the first extension component 61 and the second extension component 62. This gap is greater than zero, and the minimum gap is less than a preset distance. The preset distance can be set as needed. For example, the preset distance can be set with reference to the thickness of the leaflets. The preset distance can be the sum of the thicknesses of the two leaflets. When the minimum gap is less than the sum of the thicknesses of the two leaflets, it can be ensured that the two extended components can effectively assist in clamping the leaflets to ensure clamping stability. It should be noted that the preset distance can be set according to actual needs and is not limited to the above setting method. In this embodiment, the minimum gap refers to the minimum distance between the edge contours of the two spaced-apart extension components in the X-direction of the XY plane, as shown by the minimum gap W0 in Figure 9(a). In the embodiment shown in FIG9(a), the extended end edge of the first front extended arm 61a of the first extended component 61 and the extended end edge of the second front extended arm 62a of the second extended component 62 are spaced apart from each other; the extended end edge of the first rear extended arm 61b of the first extended component 61 and the extended end edge of the second rear extended arm 62b of the second extended component 62 are spaced apart from each other; of course, it is also possible to set only on one side.
[0067] As shown in Figure 9(b), the first extension component 61 and the second extension component 62 are symmetrically arranged. The extended end edges of the symmetrically arranged first extension component 61 and the second extension component 62 abut against each other. At this time, there may be no force between the two abutting components. That is, the first extension component 61 and the second extension component 62 are only in contact with each other, but there is no force between them. It can be understood that the distance between their end edges is zero. Further, the extended end edges of the symmetrically arranged first extension component 61 and the second extension component 62 abut against each other. At this time, there is a force between the two abutting components. That is, there is a preset tension between the abutting first extension component 61 and the second extension component 62. After the first extension component 61 and the second extension component 62 move from the open position to the closed position with the clamping component 10, the unfolded first extension component 61 and the second extension component 62 abut against each other and exert relative forces on each other. When a pair of petals are clamped between the first extension component 61 and the second extension component 62, this preset tension can enable the extension components to provide better clamping force to the petals, thereby further improving the clamping effect. In the embodiment shown in FIG9(b), the extended end edge of the first front extended arm 61a of the first extended component 61 abuts against the extended end edge of the second front extended arm 62a of the second extended component 62; the extended end edge of the first rear extended arm 61b of the first extended component 61 abuts against the extended end edge of the second rear extended arm 62b of the second extended component 62 at intervals; of course, it can also be provided on only one side.
[0068] As shown in Figure 9(c), the first extension component 61 and the second extension component 62 are asymmetrically arranged. In this embodiment, the first extension component 61 and the second extension component 62 are not only not symmetrically arranged in the Y direction passing through the central axis oo (i.e., asymmetrically arranged), but their shape contours are also different. This difference in shape contour also falls within the scope of asymmetrical arrangement. It should be understood that an asymmetrical scheme can be reconstructed based on any of the above asymmetrical arrangement methods. In the embodiment shown in Figure 9(c), the extended end edges of the asymmetrically arranged first extension component 61 and the second extension component 62 are spaced apart from each other. The limitation of the spacing can be referred to the aforementioned description of the spacing setting in Figure 9(a), and will not be repeated here. Of course, the extended end edges of the asymmetrically arranged first extension component 61 and the second extension component 62 can also abut against each other. The abutting arrangement of the extended end edges can be referred to the aforementioned description of the abutting arrangement in Figure 9(b), and will not be repeated here. In the embodiment shown in FIG9(c), the extended end edge of the first front extended arm 61a of the first extended component 61 and the extended end edge of the second front extended arm 62a of the second extended component 62 are spaced apart from each other. The first front extended arm 61a is close to the Y direction passing through the central axis oo, and the second front extended arm 62a is slightly away from the Y direction passing through the central axis oo. The extended end edge of the first rear extended arm 61b of the first extended component 61 and the extended end edge of the second rear extended arm 62b of the second extended component 62 are spaced apart from each other. The first rear extended arm 61b is close to the Y direction passing through the central axis oo, and the second rear extended arm 61b is away from the Y direction passing through the central axis oo. Of course, it is also possible to set it on only one side.
[0069] Referring to Figure 9(d), based on the aforementioned arrangement of the first extension component 61 and the second extension component 62, in order to facilitate the compression and tightening of the auxiliary clamping member 6 and avoid excessive tightening force and bending damage to the auxiliary clamping member 6 caused by the opposite ends continuously abutting each other during tightening, the opposite extended end edges of the first extension component 61 and the second extension component 62 are mutually cooperating inclined surfaces p. That is, the opposite end edges of the first extension component 61 are provided with a first inclined surface, and the opposite end edges of the second extension component 62 are provided with a second inclined surface in the same inclination direction as the first inclined surface. After being compressed, the first extension component 61 and the second extension component 62 can quickly separate based on the guidance of the inclined surface p. The quick separation avoids the two continuously abutting each other at their ends, reducing the tightening force and bending damage to the auxiliary clamping member 6. Meanwhile, the inclined surface increases the contact area between the ends of the first extension component 61 and the second extension component 62 and the leaflet tissue, improving the stability of clamping and avoiding damage (such as perforation) to the leaflet caused by continuous contact due to a small contact area.
[0070] As another implementation method, please refer to Figure 10(a)~10(e) as well as Figure 11 In this embodiment, in the extended state, the auxiliary clamping member 6 of the valve clamping device 100 has the first extension component 61 and the second extension component 62 asymmetrically arranged relative to the central axis oo of the valve clamping device 100, that is, symmetrical or asymmetrical relative to the Y direction passing through the central axis oo. Furthermore, the extended end edges of the first extension component 61 and the second extension component 62 are offset in the width direction of the clamping component 10. This asymmetrical arrangement and the defined end offset in this embodiment, on the one hand, ensures that when the first extension component 61 and the second extension component 62 are subjected to a constricting force, their ends will not abut against each other, but will orderly converge inwards, making it easier for the valve clamping device 100 to retract, avoiding the need for excessive constricting force and damage to the auxiliary clamping member 6; on the other hand, and more importantly, because the two extended end edges that contact the leaflet tissue are offset along the width direction of the clamping component 10, the effective clamping width of the auxiliary clamping member 6 is increased to a certain extent. Referring to Figures 10(d) and 10(e), in this embodiment, the first extension component 61 forms an abutment position D1 when it contacts the leaflet tissue, and the second extension component 62 forms another abutment position D2 when it contacts the leaflet assembly. The two abutment positions are not directly opposite each other in the X direction, but are spaced apart along the width direction of the clamping component 10, i.e., in the Y direction, and are arranged one in front of the other. The pair of leaflet tissues are pushed towards each other from two directions by the two extension components, so that the leaflet tissues within this interval range S are clamped and constrained, reducing the leaflet gap. Compared with the method of the two abutting directly opposite each other, this embodiment not only significantly increases the effective width of the auxiliary clamping component 6, which can further reduce the amount of valve clamp used and improve the anti-reflux effect, but also avoids the problem of leaflet perforation caused by relative abutment during the cardiac cycle because the two abutment positions are not directly opposite each other in the X direction.
[0071] In this embodiment, the asymmetrical arrangement of the extended end edge of the first extension component 61 and the extended end edge of the second extension component 62 being offset in the width direction of the clamping component 10 includes at least the following arrangements: the extended end edge of the first extension component 61 and the extended end edge of the second extension component 62 being spaced apart or overlapping.
[0072] like Figures 10(a) to 10(c) as well as Figure 11 As shown, the first expansion component 61 and the second expansion component 62 are asymmetrically arranged. In this embodiment, the asymmetrical arrangement refers to the asymmetrical arrangement of the first expansion component 61 and the second expansion component 62 relative to the central axis oo of the valve clamping device 100, that is, the asymmetrical arrangement in the Y direction passing through the central axis oo.
[0073] In one embodiment, the extended end edge of the first extension component 61 shown in FIG10(a) overlaps with the extended end edge of the second extension component 62. At this time, one of the end edges of the first extension component 61 and the second extension component 62 is located on the inner side and the other is located on the outer side, and they overlap in the X direction. The overlapping ends can form a relatively strong push against the leaflet tissue, which can make the two leaflets between the two abutment positions fit tightly and prevent backflow. In another embodiment, the extended end edge of the first extension component 61 shown in Figure 10(b) is spaced apart from the extended end edge of the second extension component 62, that is, there is an X-direction gap between the extended end edges of the first extension component 61 and the extended end edges of the second extension component 62. Specifically, this gap is greater than or equal to zero, and the minimum gap is less than a preset distance. The preset distance can be set as needed; for example, it can be set with reference to the leaf thickness. The preset distance can be the sum of the thicknesses of the two leaflets. When the minimum gap is less than the sum of the thicknesses of the two leaflets, it can ensure that the two opposite extension components after expansion can effectively assist in clamping the leaflets, thus ensuring clamping stability. It should be noted that the preset gap can be set according to actual needs and is not limited to the above setting method. In this embodiment, the minimum gap refers to the minimum distance in the X-direction gap of the edge contours of the two oppositely spaced extension components in the XY plane. As shown in Figure 10(b), the minimum gap W2 is greater than zero. As shown in Figure 10(c), the minimum gap is equal to zero. Figure 11 The minimum spacing in the text is also equal to zero, which is understandable. Figure 11 The interval between items can also be greater than zero. Or Figure 11 The first extension component 11 and the second extension component 12 can also be set to overlap in the X direction.
[0074] The difference is that, in Figures 10(a) to 10(c) In the illustrated embodiment, the first front extension arm 61a of the first extension component 61 is located inside the second front extension arm 62a of the second extension component 62, and the first rear extension arm 61b of the first extension component 61 is located outside the second rear extension arm 62b of the second extension component 62. Of course, the inner and outer sides can also be reversed. Figure 11 In the illustrated embodiment, the first front extension arm 61a and the first rear extension arm 61b of the first extension component 61 are both located outside the second front extension arm 62a and the second rear extension arm 62b of the second extension component 62. Of course, their inner and outer sides can also be reversed. It should be noted that the above-described asymmetrical arrangement is merely illustrative and not limiting; other alternative solutions made in the art based on the above embodiments are all within the scope of protection of this invention.
[0075] Referring to Figures 12(a) and 12(b), based on any of the above embodiments, the first extension component 61 and / or the second extension component 62 in the valve clamping device 100 of this embodiment include a retaining portion 60 that abuts against the valve leaflet when clamping it. The retaining portion 60 is provided with an extension anchoring member 601 that can be anchored into the valve leaflet. The extension anchoring member 601 can be provided on the retaining portion 60 of the first extension component 61, or on the retaining portion 60 of the second extension component 62, or simultaneously on the retaining portions 60 of both the first and second extension components 61. Exemplarily, the extension anchoring member 601 has a tapered tip extending toward the valve leaflet mating surface. The extension anchoring member includes, but is not limited to, anchor spikes, barbs, protrusions, or combinations thereof. In other embodiments, to improve the clamping effect, the extended anchor 601 extends from the root to the free end toward the inside of the valve clamping device 100. The extended anchor 601 can more compliantly and reliably penetrate into the leaflet m, while avoiding tearing damage to other tissues by the tip of the extended anchor when the valve clamping device 100 in the extended state enters the ventricle from the atrium.
[0076] In other embodiments, to avoid excessive local stress and difficulty in deformation and compression due to continuous contact between the ends of the first extension component 61 and the second extension component 62 under compression, the support strengths of the first extension component 61 and the second extension component 62 can be set differently. This results in different degrees of deformation between the first extension component 61 and the second extension component 62 under the same force. During compression, when subjected to the compression force, the extension component with weaker support strength on the same side will deform first, allowing the extension components on the same side to quickly form misalignment, thereby avoiding continuous contact and difficulty in compression. Alternatively, the support strengths of the first extension component 61 and the second extension component 62 can be set unevenly, similarly achieving different degrees of deformation under the same force, thus achieving the same effect. Of course, the above two methods can be combined to form new solutions that achieve the above effects, all of which fall within the scope of protection of this invention. The different support strengths can be achieved, for example, by using different rod diameters or by partial cutting, and should be understood as not being limited to these methods.
[0077] For example, refer to Figure 8 and Figure 8As shown in (a), the second clamping arm 12 of this embodiment includes a clamping bottom 121 for joining tissues and a sidewall 122 disposed on the side of the clamping bottom 121. The first extension component 61 and the second extension component 62 are respectively connected to the sidewall 122 on the corresponding side. Exemplarily, the connecting ends of the first extension component 61 and the second extension component 62 away from the extension end can be directly connected to the sidewall 122 by welding, or indirectly connected by other connectors. The connection method is not limited to this.
[0078] Reference Figure 5 , Figure 8 and Figure 8 (a) The valve clamping device 100 of the present invention further includes a drive assembly 2, which includes a pair of drive arms 23. One drive arm 23 is hinged to a second clamping arm 12, and the pair of drive arms 23 drives the pair of second clamping arms 12 to open or close. Further, the drive assembly 2 of this embodiment also includes a base 21 and a drive shaft 22 connected to the proximal end of the base 21. One end of the pair of drive arms 23 is rotatably hinged to the base 21, and the other end is respectively hinged to the corresponding second clamping arm 12 on the same side. Axial movement of the drive shaft 22 can drive the pair of second clamping arms 12 to open or close relative to each other.
[0079] In other embodiments, combined with Figure 8 and Figure 8 (a) When the extension assembly includes both a front extension arm and a rear extension arm, the lower connecting segments 6e of the front and rear extension arms are connected, and the connected lower connecting segments 6e pass through both a drive arm 23 and a second clamping arm 12, so that the drive arm 23 and the second clamping arm 12 are hinged. This method achieves hinged connection without requiring additional fixing processes to fix the extension assembly, and the process and overall structure are simple. In addition, the upper connecting segments 6a on both sides can also be fixed in the same way as described above, for example, by providing through holes in the side wall 122 for the ends of the upper connecting segments 6a to pass through to achieve connection. It should be understood that the connection method between the extension arm and the second clamping arm 12 is not limited to this.
[0080] See Figure 6 and Figure 6 (a) and Figures 13-15The main clamping member 1 and / or the auxiliary clamping member 6 are covered with an outer membrane, which is movably disposed within the outer membrane. The outer membrane prevents the metal surface of the valve clamping device from directly contacting the valve tissue, thereby reducing or avoiding tissue allergies and inflammatory reactions, preventing damage to the clamped valve tissue, and facilitating tissue migration. The outer membrane loosely covers the outer surface of the main clamping member 1 and / or the auxiliary clamping member 6, preventing excessive constraint on the main clamping member 1 and / or the auxiliary clamping member 6 and affecting their movement. Here, "loosely" means that the outer membrane is not completely directly attached after covering, but there is some movement or deformation between the two. Furthermore, a local inner membrane is provided on one side of the free end of the main clamping member 1 and / or the auxiliary clamping member 6, and the local inner membrane is located within the outer membrane. In this embodiment, the inner membrane is only partially installed. This avoids direct contact between the main clamping member 1 and the auxiliary clamping member 6 and the outer membrane during rotation, preventing damage (e.g., abrasion) and improving safety. Furthermore, compared to a fully double-layered design, this avoids the constraint and tension imposed by the inner layer on the main and auxiliary clamping members, ensuring flexible rotation of the main clamping member 1 and the auxiliary clamping member 6. It also avoids the problem of increased overall outer diameter of the clamping device caused by a fully double-layered design. Additionally, the partial installation significantly reduces coating costs and simplifies the abrasion prevention process (e.g., eliminating the need for partial treatment of the outer membrane for abrasion prevention).
[0081] Combination Figures 13-15 As shown, in this embodiment, the second clamping arm 12 of the main clamping member 1 is covered with an outer membrane. In one embodiment, the surface of the second clamping arm 12 is covered with a first outer membrane 51a. The second free end 12b of the second clamping arm 12 can move within the first outer membrane 51a during the opening or closing of the pair of second clamping arms 12. A first partial inner membrane 51b is also provided on a portion of the second free end 12b of the second clamping arm 12, and the first partial inner membrane 51b is located between the second clamping arm 12 and the first outer membrane 51a. In one embodiment, the surfaces of the pair of driving arms 23 and the base 21 are covered with a second outer membrane 52a. The pair of driving arms 23 can move within the second outer membrane 52a during rotation. A second partial inner membrane 52b is also provided at the connection between the pair of driving arms 23 and the base 21, and the second partial inner membrane 52b is located between the driving assembly 2 and the second outer membrane 52a. For example, see [link to example]. Figure 6(a) In this embodiment, the auxiliary clamping member 6 is covered with a third outer membrane 53a. The auxiliary clamping member 6 can move within the third outer membrane 53a during the opening or closing process of the main clamping member 1, as well as during its own unfolding and retraction. A third partial inner membrane 53b is also provided on a portion of the extended end of the auxiliary clamping member 6, located between the auxiliary clamping member 6 and the third partial inner membrane 53b. The first outer membrane 51a, the second outer membrane 52a, and the third outer membrane 53a can be an integral structure or a separate structure. The range of partial configurations in this invention can be adaptively configured by those skilled in the art based on the range of motion of the moving parts, aiming to achieve an anti-wear effect.
[0082] The first outer membrane 51a, the second outer membrane 52a, and the third outer membrane 53a of the present invention loosely cover the exterior of the second clamping arm 12, the drive arm 23, the base 21, and the auxiliary clamping member 6, respectively. Here, "loosely" means that the outer membranes are not completely directly attached after covering, but rather allow for some movement or deformation. The outer membranes prevent the metal surface of the valve clamping device from directly contacting the valve tissue, thereby reducing or avoiding tissue allergies and inflammatory reactions, preventing damage to the clamped valve tissue, and facilitating tissue migration. Furthermore, the loose covering allows the second clamping arm 12, the drive arm 23, and the auxiliary clamping member a certain amount of movement within the first outer membrane 51a, the second outer membrane 52a, and the third outer membrane 53a, preventing excessive constraint and traction on the second clamping arm 12, the drive arm 23, and the auxiliary clamping member 6, thus affecting their respective rotation and the opening and closing of the clamping device. The first partial inner membrane 51b, the second partial inner membrane 52b, and the third partial inner membrane 53b are partially disposed and located inside the outer membrane. This design avoids direct contact between the second clamping arm 12, the driving arm 23, and the auxiliary clamping component 6 and the outer membrane during movement, thus preventing damage (e.g., abrasion) and improving safety. Furthermore, compared to a fully integrated double-layer design, this method avoids the constraint and tension imposed by the inner layer on the clamping arm, driving arm, and auxiliary clamping component, ensuring their flexible rotation. It also avoids the problem of increased overall outer diameter of the clamping device caused by a fully integrated design. Additionally, the partial design significantly reduces coating costs and simplifies the wear-resistant process (e.g., eliminating the need for partial treatment of the outer membrane for wear resistance).
[0083] The local inner membrane of the present invention can be fixed to the outer membrane based on a local location, or it can be unfixed and simply located inside the outer membrane, or the local inner membrane can be locally fixed relative to the main clamping member 1 and the auxiliary clamping member 6, for example, by directly attaching them. It should be understood that the fixing method of the local inner membrane can be set as needed. The outer membrane and / or the local inner membrane are made of at least one layer of biocompatible polymer material with biocompatibility, antioxidant properties, and solvent resistance. The polymer material is selected from at least one of PET, polyester, PTFE, silicone resin, silicone, or urethane. Furthermore, the materials of the outer membrane and the local inner membrane can be the same or different. Preferably, the local inner membrane has better density than the outer membrane, resulting in better wear resistance.
[0084] Reference Figure 5 and Figure 16 In other embodiments, the first clamping arm 11 is provided with an anchoring member 13 extending toward the opposite second clamping arm 12. The anchoring member 13 can be anchored into the leaflet m between the two. Multiple anchoring members 13 are provided. The anchoring member 13 may have a tapered tip extending toward the leaflet mating surface. The anchoring member 13 includes, but is not limited to, anchor spikes, barbs, protrusions, or combinations thereof. In this embodiment, "extending toward the opposite side" refers to extending toward the opposite side, i.e., toward the leaflet mating surface, but is not limited to an extension perpendicular to the opposite side. The angle of this extension can be any angle at which the anchoring member 13 anchors.
[0085] When the angle α between the two second clamping arms 12 is between 110° and 170°, preferably between 115° and 125°, and the distance h1 from the clamping surface of the first clamping arm 11 to the edge of the opposite second clamping arm 12 is not greater than 4 mm, preferably between 0.3 mm and 3 mm, that is, the distance h1 from the clamping surface at the first free end 11b of the first clamping arm 11 to the edge of the opposite second clamping arm 12 is h1. At least some of the anchoring members 13 on the first clamping arm 11 have an angle β between their extension direction b and the length direction a of the opposite second clamping arm 12 that tends towards 90°, such that at least some of the anchoring members 13 can be anchored substantially perpendicularly into the leaflet m captured on the second clamping arm 12. In this embodiment, "tending towards 90°" means close to 90°; preferably, the angle β is in the range of 80° to 100°. This design ensures the length of the anchor on the first clamping arm when it is inserted into the leaflet, enhancing the anchoring strength. At the same time, when the elastic first clamping arm is pulled up, the 90° angle facilitates the anchor's withdrawal from the leaflet and reduces damage to the leaflet.
[0086] See Figure 5 and Figure 16Preferably, the extension lengths of the multiple anchoring elements 13 are not all equal. For example, the valve clamping device of the present invention includes at least one row of anchoring units among the multiple anchoring elements, and each row of anchoring units includes multiple anchoring elements 13. The multiple anchoring elements 13 in the row of anchoring units are arranged sequentially at intervals along the arm length direction of the clamping arm, and the extension lengths of the sequentially arranged anchoring elements 13 are not all equal. Further, the multiple anchoring elements in a row of anchoring units have multiple sets of different extension lengths, the number of sets being less than the number of anchoring elements. The anchoring elements in the same set have the same extension length, while the anchoring elements in different sets have different extension lengths. Here, "multiple sets" can be understood as multiple specifications, i.e., multiple specifications with different extension lengths. The multi-specification setting not only allows for a longer extension length of the multiple anchoring parts 13 at the free end, thus ensuring an effective anchoring depth, anchoring effect, and clamping stability, but also reduces the extension length of the anchoring parts 13 near the root connection end, thereby reducing tearing damage to the leaf m when lifting the elastic arm clamp and facilitating the quick and easy detachment of the anchoring parts 13 from the leaf m. Furthermore, it significantly reduces the difficulty of manufacturing and production costs.
[0087] In other embodiments, see Figure 1 As shown, the valve clamping device 100 also includes a spacer 4, which is elastically adjustable. The first clamping arm 11 and the second clamping arm 12 are respectively disposed on the outer side of the spacer 4 and face each other. During the closure process of the valve clamping device 100, the spacer 4 can cooperate with the first clamping arm 11 and the second clamping arm 12 to deform into any shape, as shown in Figure 10(d). In order to improve the occlusion effect, the spacer 4 can fill the space enclosed by the auxiliary clamping member 6 and the main clamping member 1 as much as possible. Furthermore, the valve clamping device 100 also includes a support member. The spacer 4 is sleeved on the support member, and at least one end of the spacer 4 is fixed relative to the support member in the axial direction. This part can be referred to in the prior art and will not be described in detail here.
[0088] The present invention also provides an exemplary clamping system for clamping a valve, the clamping system including any of the valve clamping devices 100 described above and a delivery assembly, the delivery assembly being detachably connected to the valve clamping device 100. The valve clamping device has a first connector at its proximal end, and the delivery assembly has a second connector at its distal end that is detachably connected to the first connector. The delivery assembly further includes a delivery sheath and a push tube, the push tube driving a drive assembly to open or close the clamping assembly 10.
[0089] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of the claims of the present invention.
Claims
1. A valve clamping device, characterized in that, The device includes a main clamping member for clamping and an auxiliary clamping member connected to the main clamping member for auxiliary clamping. The main clamping member includes a pair of clamping assemblies that can be opened or closed relative to the central axis of the valve clamping device. The auxiliary clamping member is deformable and has an expanded state in its natural state and a contracted state after being squeezed. The auxiliary clamping member includes a first expansion assembly and a second expansion assembly. The first expansion assembly and the second expansion assembly are respectively connected to a clamping assembly. The first expansion assembly and the second expansion assembly connected to the clamping assembly extend from the width direction of the clamping assembly connected to them, and the extended portions tend to extend towards the opposite side. In the extended state, the first extension component and the second extension component are symmetrically or asymmetrically arranged relative to the central axis. The extended end edges of the first extension component and the second extension component are opposite to each other, and the two opposite end edges are spaced apart or abut against each other. The extended end edges of the first extension component and the second extension component are mutually cooperating inclined surfaces. The first extension component and the second extension component can be misaligned based on the guidance of the inclined surfaces after being compressed.
2. The valve clamping device according to claim 1, characterized in that, When the two opposite end edges are spaced apart, the minimum spacing is less than a preset distance; when the two opposite end edges abut, there is a preset tension between the abutting first extension component and the second extension component.
3. The valve clamping device according to claim 1, characterized in that, In the extended state, the first extension component and the second extension component are asymmetrically arranged relative to the central axis, and the extended end edges of the asymmetrically arranged first extension component and the extended end edges of the second extension component are offset in the width direction of the clamping component.
4. The valve clamping device according to claim 3, characterized in that, The extended end edge of the first extension component is spaced apart from or overlaps with the extended end edge of the second extension component.
5. The valve clamping device according to claim 1, characterized in that, Both the first extension component and the second extension component include at least one extension arm, wherein; The first extension component includes a first front extension arm and / or a first rear extension arm, and the second extension component includes a second front extension arm and / or a second rear extension arm adapted to the first front extension arm and / or the first rear extension arm of the first extension component; the first front extension arm and the second front extension arm are used together for auxiliary clamping, and the first rear extension arm and the second rear extension arm are used together for auxiliary clamping.
6. The valve clamping device according to claim 5, characterized in that, The extension arm has a frame structure and includes an upper connecting section, an upper support section, a clamping section, a lower support section, and a lower connecting section that are sequentially connected. Each clamping component includes a second clamping arm. The upper connecting section and the lower connecting section extend substantially along the width direction of the second clamping arm. One end of the upper connecting section and the lower connecting section is connected to the same side of a second clamping arm, and the other end is connected to one end of the upper support section and the lower support section, respectively. The clamping section extends substantially along the central axis direction of the valve clamping device. The other end of the upper support section and the lower support section is connected to both ends of the clamping section, respectively. The upper support section and the lower support section gradually expand outward from the upper connecting section and the lower connecting section to the clamping section. The width direction of the second clamping arm, the width direction of the clamping component, and the central axis are perpendicular to each other.
7. The valve clamping device according to any one of claims 1 to 6, characterized in that, The first extension component and / or the second extension component include a supporting portion, on which an extension anchor is provided.
8. The valve clamping device according to any one of claims 1 to 6, characterized in that, The first extension component and the second extension component have different support strengths, resulting in different degrees of deformation of the first extension component and the second extension component under the same force; and / or, The support strength of the first extension component and the second extension component is not uniformly set, so that the first extension component and the second extension component deform to different degrees under the same force.
9. The valve clamping device according to any one of claims 1 to 5, characterized in that, Each of the clamping components includes a first clamping arm and a second clamping arm that cooperates with the first clamping arm. A pair of first clamping arms are located inside a pair of second clamping arms. The pair of second clamping arms can be opened or closed relative to the central axis. The first extension component and the second extension component are respectively connected to a second clamping arm.
10. The valve clamping device according to claim 9, characterized in that, The second clamping arm includes a clamping bottom for engaging tissue and a sidewall located on the side of the clamping bottom, wherein the first extension component and the second extension component are respectively connected to the sidewall of the second clamping arm on the corresponding side.
11. The valve clamping device according to claim 10, characterized in that, It also includes a drive assembly, which includes a pair of drive arms, one of which is hinged to a second clamping arm. The pair of drive arms drive the pair of second clamping arms to open or close relative to the central axis. When the extension assembly includes a front extension arm and a rear extension arm, and the extension arm includes an upper connecting section, an upper support section, a clamping section, a lower support section, and a lower connecting section that are sequentially connected, the lower connecting sections of the front extension arm and the rear extension arm are connected, and the connected lower connecting sections pass through both a drive arm and a second clamping arm, so that the drive arm and the second clamping arm are hinged.
12. The valve clamping device according to claim 1, characterized in that, The main clamping member and / or the auxiliary clamping member are covered with an outer membrane, and the main clamping member and / or the auxiliary clamping member are movably disposed within the outer membrane.
13. The valve clamping device according to claim 12, characterized in that, A partial inner membrane is provided on one side of the free end of the main clamping member and / or the auxiliary clamping member, and the partial inner membrane is located inside the outer membrane.
14. A clamping system, characterized in that, It includes the valve clamping device and delivery assembly as described in any one of claims 1 to 13, wherein the delivery assembly is detachably connected to the valve clamping device.