Clamping device and clamping system
By designing a clamping device with anchors of different extension lengths, the problem of the existing clamping device requiring a greater force when clamping and releasing the leaflets is solved, and the stability and safety are improved.
Patent Information
- Application Number
- CN202420987046.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-08
- Publication Date
- 2025-04-18
- Estimated Expiration
- 2034-05-08
AI Technical Summary
Existing clamping devices require a greater force when clamping and releasing the leaflets, and the anchor piercing is prone to damage the leaflets when they are disengaged, affecting stability and safety.
A clamping device is designed, wherein the clamping assembly includes a relatively arranged first clamping arm and a second clamping arm, and a plurality of anchors are provided on the clamping arm, and the extension lengths of which are not completely equal. This design ensures stability during clamping and can be disengaged with a smaller force when released, reducing damage to the leaflets.
While ensuring the clamping effect, it is achieved to reduce the force required during the clamping process, and reduce the damage to the petal leaflets by the anchor, improving the stability and safety of the device.
Smart Images
Figure CN222765316U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of interventional medical devices, in particular to a clamping device and a clamping system. Background Art
[0002] Atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can 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 is a one-way valve located between the left atrium and the left ventricle of the heart. It can control 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 includes a pair of leaflets, namely the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are aligned, the mitral valve can be completely closed, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or its related structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve are not aligned properly. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, causing blood to flow back from the left ventricle to the left atrium, thereby causing a series of pathophysiological changes known as "mitral regurgitation."
[0003] Currently, minimally invasive interventional treatments are available to repair the valve edge to edge. The mainstream approach is to use a clip to clamp and pull the two valves together to reduce the regurgitant gap and width. Figure A1 As shown, the clip is usually implanted into the atrioventricular valve via a catheter delivery system ( Figure A1 The clip shown in the figure is in an open state. When it is delivered, it is closed and placed in the catheter delivery system. During the implantation of the clip, the leaflet m' is captured by the unfolded clamp arm 11', and then the adjustment line 30' is released to make the clip 12' approach the clamp arm 11', thereby clamping the leaflet m' between the clip 12' and the clamp arm 11'. At this time, the anchor barb 121' on the clip 12' penetrates into the leaflet m' (refer to Figure A1 and Figure A2 However, the existing clamp has a problem in that the lengths of the existing anchoring spikes 121' are the same (see Figure A1 ), and are generally long, which results in all anchor spikes penetrating the leaflets to a relatively deep depth. When the leaflets are not properly clamped and the adjustment line 30 needs to be pulled to lift the clip 12' to re-clamp, a large force is required to pull the clip 12', and this large force is not conducive to the stability of the holding device. In addition, during the process of lifting the clip 12', the anchor spike 121' at the root of the elastic clip 12' cannot be smoothly separated from the leaflet. At this time, a larger force is required to lift the clip 12' to achieve separation. Figure A3 and Figure A4As shown, when lifted to the first raised position A', the anchor 121' at the root of the clip 12' is still in an anchored state and cannot be completely separated from the leaflet. At this time, it is necessary to continue to increase the pulling force so that the clip 12' is lifted to the second raised position B', so that the anchor 121' at the root is gradually separated. This process not only requires a large adjustment force but also the anchor 121' at the root is prone to damage the leaflet. Utility Model Content
[0004] The purpose of the embodiments of the present invention is to at least solve one of the problems mentioned in the background art.
[0005] In order to solve the above technical problems, the present invention provides an embodiment that adopts the following technical solutions:
[0006] The utility model provides a clamping device, including a clamping member, the clamping member including at least a clamping assembly, the clamping assembly including a first clamping arm and a second clamping arm arranged opposite to each other, the first clamping arm and the second clamping arm each having a connecting end and a free end opposite to the connecting end, the connecting end of the first clamping arm and the connecting end of the second clamping arm are coupled and the free end of the first clamping arm and the free end of the second clamping arm can be close to or away from each other, and tissue can be clamped between the two clamping arms when the two clamping arms are close to each other, at least one of the first clamping arm and the second clamping arm is provided with an anchor extending toward the side of the other clamping arm, and a plurality of the anchors are provided, and the extension lengths of the plurality of anchors are not all equal.
[0007] In a preferred solution of some embodiments, at least one column of anchoring units is included, and one column of the anchoring units includes a plurality of the anchoring members; the plurality of the anchoring members in one column of the anchoring units are arranged in sequence along the arm length direction of the clamping arm, and the extension lengths of the plurality of the anchoring members arranged in sequence are not all equal.
[0008] In a preferred solution of some embodiments, the plurality of anchors in a column of the anchoring units have multiple groups of different extension lengths, the number of groups is less than the number of anchors in the column of the anchoring units, the extension lengths of the anchors in the same group are the same, and the extension lengths of the anchors in different groups are different.
[0009] In a preferred solution of some embodiments, the anchoring members in a column of anchoring units close to the connecting end have a first extension length, and the remaining anchoring members in the column of anchoring units have a second extension length, and the first extension length is smaller than the second extension length.
[0010] In a preferred solution of some embodiments, a column of the anchoring units includes 4 to 8 anchoring members, and 1 to 3 of the anchoring members close to the connecting end have a first extension length.
[0011] In a preferred solution of some embodiments, the extension lengths of the plurality of anchors gradually increase from the connecting end to the free end.
[0012] In a preferred solution of some embodiments, the clamping member includes a pair of clamping assemblies arranged opposite to each other, and the pair of clamping assemblies can be opened or closed relative to each other; in a pair of clamping assemblies, a pair of first clamping arms are located on the inner side of a pair of second clamping arms, and the pair of first clamping arms and the pair of second clamping arms are coupled at the connecting end.
[0013] In a preferred solution of some embodiments, a driving component is further included, which is engaged with a pair of second clamp arms to drive the pair of second clamp arms to open or close; the pair of first clamp arms are elastic, and the pair of first clamp arms can move away from each other and approach the second clamp arms opposite to them under the action of their own elastic force, and can move away from the second clamp arms opposite to them and approach each other under the action of external force.
[0014] In some preferred embodiments, the surface of the second clamp arm is covered with a first outer film, the free end of the second clamp arm can move within the first outer film during the process of opening or closing the pair of second clamp arms, and a first partial inner film is further provided on a portion of the free end of the second clamp arm, and the first partial inner film is located between the second clamp arm and the first outer film; and / or,
[0015] The driving assembly includes a base, a driving shaft connected to the proximal end of the base and a pair of connecting arms connected to both sides of the base, one end of the pair of connecting arms is rotatably hinged on the base, and the other end is hinged to the corresponding second clamping arms on the same side, and the axial movement of the driving shaft can drive the pair of second clamping arms to open or close relative to each other, the surfaces of the pair of connecting arms and the base are covered with a second outer film, and the pair of connecting arms can move in the second outer film during rotation, and a second local inner film is also provided at the connection between the pair of connecting arms and the base, and the second local inner film is located between the driving assembly and the second outer film.
[0016] In a preferred solution of some embodiments, the anchor is provided on the first clamp arm and extends toward the second clamp arm opposite thereto. When the angle between the openings of a pair of second clamp arms is between 110° and 170°, and the distance between the clamping surface of the first clamp arm and the edge of the second clamp arm opposite thereto is not greater than 4 mm, the angle between the extension direction of at least some of the multiple anchors provided on the first clamp arm and the length direction of the second clamp arm opposite thereto tends to 90°.
[0017] The utility model also provides a clamping system, comprising the clamping device and a conveying assembly as described above, wherein the conveying assembly is detachably connected to the clamping device.
[0018] The lengths of the multiple anchors in the clamping device and clamping system of the present invention are not all equal, allowing the anchors on the clamping arms to be pulled out of the tissue with minimal force while maintaining a clamping effect, thereby facilitating the stability of the entire device during the clamping process. Furthermore, when the anchors at the free end are longer and the anchors at the root are shorter, not only can minimal force be achieved for detachment, but the clamping arms can also be fully and quickly detached without requiring a large angle of expansion, facilitating rapid re-clamping. In particular, when multiple anchors of varying specifications are arranged within a row of anchor units, for example, multiple anchors at the free end have a longer second extension length, while anchors at the root have a shorter first extension length, this arrangement not only ensures the clamping effect of the clamping device, but also enables rapid detachment of the root anchors, reduces pulling force and lifting amplitude, and minimizes tearing damage to the root tissue caused by the anchors, but also significantly reduces manufacturing difficulty and production costs. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In order to more clearly illustrate the solutions in the present invention, the following briefly introduces the drawings required for the description of the embodiments. Obviously, the drawings described below are some embodiments of the present invention or corresponding prior art. For those skilled in the art, other drawings can be obtained based on these drawings without inventive work. Among them:
[0020] Figure A1 It is a structural schematic diagram of an existing clamp;
[0021] Figure A2 This is a schematic diagram of the structure of an existing clip clamping valve leaflet;
[0022] Figure A3 Yes, lift Figure A2 Schematic diagram of the structure of the clip in;
[0023] Figure A4 yes Figure A3 A local enlarged schematic diagram in FIG.
[0024] Figure 1a This is a schematic diagram of an implementation of the clamping device of the utility model;
[0025] Figure 1b yes Figure 1a Schematic diagram of the clamping device clamping the tissue;
[0026] Figure 2a This is another schematic diagram of the clamping device of the utility model;
[0027] Figure 2b yes Figure 2a Schematic diagram of the clamping device clamping the tissue;
[0028] Figure 3 This is another schematic diagram of the implementation of the clamping device of the utility model;
[0029] Figure 4 yes Figure 3 Schematic diagram of the clamping device clamping the tissue;
[0030] Figure 5 Yes, lift Figure 4 A schematic structural diagram of the first clamping arm in FIG.
[0031] Figure 6 yes Figure 5 A local enlarged schematic diagram in FIG.
[0032] Figure 7 yes Figure 3 A schematic structural diagram of the first clamping arm;
[0033] Figure 8 yes Figure 3 Schematic diagram of the three-dimensional structure of the first clamping arm;
[0034] Figure 9 yes Figure 8 A local enlarged schematic diagram in FIG.
[0035] Figure 10 yes Figure 3 A schematic diagram of the structure of the clamping device wrapping the film;
[0036] Figure 11 yes Figure 10 A local enlarged schematic diagram in FIG.
[0037] Figure 12 yes Figure 10 Another partial enlarged schematic diagram in;
[0038] Figure 13 yes Figure 3 A schematic structural diagram of a clamping device in which a pair of clamping components are opened. DETAILED DESCRIPTION
[0039] The following will be combined with the accompanying drawings to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0040] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description. They do 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 limiting the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. When an element is referred to as being "fixed to" or "disposed on" another element, the element can 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 can be directly connected to the other element, or connected to the other element through one or more connecting elements.
[0041] 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 central axis of rotation of objects such as cylinders and tubes is defined as the axial direction; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (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 worth noting that the "end" that appears in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes the part extending an axial distance and / or radial distance from the end, endpoint, or end face on the component to which the end, endpoint, or end face belongs. The above definitions are only for convenience of expression and should not be understood as limitations on the present invention.
[0042] The clamping device and clamping system provided by the present invention are used for clamping tissues, for example, to repair heart valves, especially mitral valves and tricuspid valves, so as to reduce the gap between valve leaflets and tissues and alleviate mitral valve or tricuspid valve regurgitation.
[0043] See also Figure 1a 、 Figure 1b 、 Figure 2a 、 Figure 2b as well as Figure 3 and Figure 4As shown, the present invention exemplarily provides a clamping device 100, which includes a clamping member 1, and the clamping member 1 includes at least a clamping assembly 10, and the clamping assembly 10 includes a first clamping arm 11 and a second clamping arm 12 arranged opposite to each other, and the first clamping arm 11 and the second clamping arm 12 cooperate to clamp the tissue m. In the clamping assembly 10, the first clamp arm 11 and the second clamp arm 12 each have a connecting end and a free end opposite to the connecting end along the length direction of each arm. The connecting end of the first clamp arm 11 is coupled to the connecting end of the second clamp arm 12, and the free ends can move closer to or farther away from each other. The first clamp arm 11 and the second clamp arm 12 that are close to each other can move their free ends farther away from each other in response to a separation force. The tissue m can be clamped between the first clamp arm 11 and the second clamp arm 12 when they are close to each other. At least one of the first clamp arm 11 and the second clamp arm 12 is provided with an anchor 13 extending toward the side of the other clamp arm. The anchor 13 can be anchored into the tissue m between the two. There are multiple anchors 13, and the extension lengths of the multiple anchors 13 are not all equal. Preferably, the anchor 13 has a tapered tip extending toward the tissue bonding surface. The anchor 13 includes but is not limited to anchor barbs, barbs, bumps, etc. or a combination thereof. In this embodiment, the extension toward the opposite side refers to the extension toward the side opposite thereto, i.e., toward the side of the tissue binding surface, but is not limited to the extension perpendicular to the opposite side. The angle of the extension may be any angle at which the anchor 13 is anchored.
[0044] Specifically, such as Figure 1a 、 Figure 2a as well as Figure 3 As shown, the first clamp arm 11 includes a first connecting end 11a and a first free end 11b, and the second clamp arm 12 includes a second connecting end 12a and a second free end 12b. The first connecting end 11a of the first clamp arm 11 is coupled to the second connecting end 12a of the second clamp arm 12. The first free end 11b of the first clamp arm 11 and the second free end 12b of the second clamp arm 12 can approach each other and move away from each other in response to a separation force. During the process of moving away from each other and then approaching each other, the tissue m can be clamped between the first and second clamp arms 11 and 12. At the same time, the anchor 13 is anchored into the tissue m to form a stable grip as the first and second free ends 11b and 12b approach each other. The coupling method of the first connecting end 11a and the second connecting end 12a includes, but is not limited to, direct connection (hinged connection) or connection via one or more connecting members (rotational connection). For example, the first connecting end 11a and the second connecting end 12a can be connected to each other through a torsion spring or an elastic clamping member so that the two remain in a closed state, and the free ends of the first clamping arm 11 and the second clamping arm 12 can be connected to each other through an actuator such as an adjustment line, and the actuator is pulled so that the first free end 11b of the first clamping arm 11 and the second free end 12b of the second clamping arm 12 move away from each other in response to the separation force.
[0045] See also Figure 1a and Figure 1b The clamping assembly 10 in the clamping device 100 of this embodiment includes one, and one clamping assembly 10 is used to close and clamp the tissue m. In this embodiment, to ensure the clamping effect, the anchor 13 is provided on both the first clamping arm 11 and the second clamping arm 12, and the anchors 13 on the two clamping arms are opposite each other. It should be understood that the anchors 13 can be provided on only one of them. The anchors 13 in this embodiment are arranged in sequence along the length of the clamping arms, and the extension lengths of all anchors 13 are not all equal. As shown in the figure, the extension length of the anchor 13 located at the root, i.e., near the connection end, is shorter, while the extension lengths of the remaining anchors are longer.
[0046] See also Figure 2a and Figure 2b The clamping assembly 10 in the clamping device 100 of this embodiment also includes a Figure 1a and Figure 1b The difference between the illustrated clamping device 100 and the illustrated clamping device 100 is that the clamping device 100 of this embodiment further includes a spacer 4. Preferably, the spacer 4 is elastically adjustable. The first clamping arm 11 and the second clamping arm 12 are respectively arranged on the outer side of the spacer 4 and opposite to each other. Anchors 13 are provided on the opposite surfaces of the first clamping arm 11 and the second clamping arm 12. The first clamping arm 11 and the second clamping arm 12 can be opened or closed relative to the spacer 4. When closed, the first clamping arm 11 and the second clamping arm 12 can simultaneously cooperate with the spacer 4 to clamp the tissue m, so that one tissue m can be clamped between the adjusting member 4 and the first clamping arm 11, and the other tissue m can be clamped between the adjusting member 4 and the second clamping arm 12. At this time, the anchors 13 can be anchored into the tissue to achieve stable clamping. The anchors 13 in this embodiment are arranged in sequence along the length of the clamping arm, and the extension lengths of all anchors 13 are not all equal. As shown in the figure, the extension length of the anchors 13 located at the root, i.e., near the connection end, is shorter, while the extension lengths of the others are longer.
[0047] Reference Figure 3 and Figure 4 As shown, the clamping member 1 in the clamping device 100 of this embodiment includes a pair, that is, two, of clamping components 10, and the two clamping components 10 are arranged opposite to each other. Figure 3As shown, the two clamping assemblies 10 can be arranged opposite each other on the left and right sides. Preferably, the pair of clamping assemblies 10 are arranged substantially symmetrically along an axis of symmetry X. The pair of oppositely arranged clamping assemblies 10 can be opened or closed relative to the axis of symmetry X. The pair of first clamping arms 11 in the pair of clamping assemblies 10 are respectively located oppositely on the inner sides of 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 ends. It is understood that the connecting ends of the two first clamping arms 11 and the two second clamping arms 12 can be directly coupled or connected via one or more connecting members. Exemplarily, the clamping device 100 includes a base 3, and 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, the first connecting ends 11a of the two first clamping arms 11 are connected, and then 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 arms 11 and the second clamping arms 12 is not limited to this.
[0048] Among them, the multiple anchors in the clamping device 100 of the present invention include at least one column of anchor units, and a column of anchor units includes multiple anchors 13. The multiple anchors 13 in a column of anchor units are arranged in sequence along the arm length direction of the clamp arm, and the extension lengths of the multiple anchors 13 arranged in sequence are not all equal. Furthermore, the multiple anchors in a column of anchor units have multiple groups of different extension lengths, and the number of groups is less than the number of anchors in the column of anchor units. The extension lengths of anchors in the same group are the same, and the extension lengths of anchors in different groups are different. The multiple groups here can be understood as multiple specifications, that is, the extension lengths of the multiple specifications are different. For example, from the connection end to the free end, the extension lengths of the multiple anchors 13 arranged in sequence gradually increase. Alternatively, the multiple anchors 13 arranged in sequence have extension lengths of multiple specifications. For example, among the multiple anchors 13 arranged in sequence, some anchors 13 near the connection end are grouped together, and the group has a first specification of extension length, and the remaining anchors 13 are grouped together, and the group has a second specification of extension length. It should be understood that there may also be a third specification, a fourth specification, and so on. Preferably, among the multiple specifications of extension length, the multiple specifications of extension length increase in sequence from the connection end to the free end. For example, referring to Figures 5 to 7 As shown, the extension length of the anchor member with the first extension length L1 near the connection end is shorter than the extension length of the anchor member with the second extension length L2. This multi-specification arrangement not only allows the extension lengths of the multiple anchor members 13 at the free end to be set longer, thereby ensuring effective anchoring depth, anchoring effect, and clamping stability, but also the extension length of the anchor member 13 near the root connection end is shorter, reducing tearing damage to the tissue m when the elastic arm clamping arm is pulled, facilitating quick and easy detachment of the anchor member 13 from the tissue m, and significantly reducing the difficulty of manufacturing and production costs.
[0049] For example, a row of anchor units includes 4 to 8 anchors 13, 1 to 3 of which near the connection end have a first extension length, and the remaining anchors 13 have a second extension length. The first extension length is less than the second extension length. Figure 1a 、 1b as well as Figure 3 and Figure 7 As shown, a column of anchoring units includes 5 anchors 13, which have two groups of different extension lengths. Two first anchors 13b close to the connection end are in one group, both of which have a first extension length L1, and the remaining three second anchors 13a are in another group, both of which have a second extension length L2, and the first extension length L1 is smaller than the second extension length L2.
[0050] Reference Figure 8 and Figure 9 As shown, a plurality of anchors 13 in a row of anchor units A are sequentially spaced along the side edges of the clamp arm. Preferably, a row of anchor units A is provided on each side edge of the anchor 13. As a forming method, the anchor 13 can be formed by cutting the clamp arm, for example, cutting the clamp arm along the direction of the inclined clamp arm axis, and then bending it in a direction away from the clamping surface of the clamp arm to form the anchor. Control of different extension lengths can be achieved by controlling the inclination angle of the cutting or the cutting length. For anchors with shorter roots, the support strength and clamping strength of the clamp arm at the root are well guaranteed due to the shorter length of the cut extension.
[0051] The multiple anchors in the clamping device of the present invention are of unequal length, enabling the anchors on the clamping arms to be pulled out of the tissue with minimal force while maintaining effective clamping, thus facilitating the stability of the entire device during the clamping process. Furthermore, when the anchors at the free ends are longer and those at the base are shorter, not only can detachment be achieved with minimal force, but the clamping arms can also be fully and quickly detached without requiring a large angle of expansion, facilitating rapid re-clamping. In particular, when multiple anchors of varying sizes are arranged within a row of anchor units—for example, multiple anchors at the free ends have a longer second extension length, while anchors at the base have a shorter first extension length—this arrangement not only ensures effective clamping, allows for rapid detachment of the root anchors, reduces pulling force and lifting amplitude, and minimizes tearing damage to the root tissue caused by the anchors, but also significantly reduces manufacturing complexity and production costs. Therefore, this approach is the result of a comprehensive consideration of clamping effectiveness, stability, detachment, damage, and manufacturing complexity and cost.
[0052] Based on any of the above embodiments, the anchors 13 with unequal extension lengths can be provided on the first clamp arm 11 or the second clamp arm 12 , or can be provided on both the first clamp arm 11 and the second clamp arm 12 , provided that there is no structural conflict.
[0053] The following will be Figure 3 The embodiment shown is used as an example to illustrate other structures of the clamping device. In this embodiment, the anchor 13 is set on the first clamping arm 11 as an example. It can be understood that it can be set to the second clamping arm 12 or set on the first clamping arm 11 and the second clamping arm 12 at the same time according to selection.
[0054] Reference Figures 3 to 5 As shown, the clamping device 100 of this embodiment also includes a driving component 2, which is engaged with a pair of second clamping arms 12 to drive the pair of second clamping arms 12 to open or close; the pair of first clamping arms 11 are both elastic, and the pair of first clamping arms 11 can move away from each other and approach the second clamping arms 12 opposite to them under the action of their own elastic force, and at the same time, they can move away from the second clamping arms 12 opposite to them and approach each other under the actuation of the actuator 70.
[0055] As an implementation method, continue to refer to Figure 3 The driving assembly 2 of this embodiment includes a base 21, a driving shaft 22 connected to the proximal end of the base 21, and a pair of connecting arms 23 connected to both sides of the base 21. One end of the pair of connecting arms 23 is rotatably hinged on the base 21, and the other end is hinged to the corresponding second clamping arms 12 on the same side. The axial movement of the driving shaft 22 can drive the pair of second clamping arms 12 to open or close relative to each other.
[0056] The first clamp arm 11 is formed of a shape memory material configured to exhibit superelasticity in a physiological environment. The shape memory material comprises 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. Furthermore, 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)diol, oligo(p-dioxanone)diol, polynorbornene, polyisoprene, styrene-butadiene, polyurethane-based materials, and vinyl acetate polyester-based compounds.
[0057] Combine Figure 3 、 Figure 10 and Figure 11As shown, the clamping device 100 of this embodiment can be covered with a coating. In one embodiment, the surface of the second clamping arm 12 is covered with a first outer film 51a. The second free end 12b of the second clamping arm 12 can move within the first outer film 51a during the process of opening or closing the pair of second clamping arms 12. A first local inner film 51b is also provided on a part of the second free end 12b of the second clamping arm 12. The first local inner film 51b is located between the second clamping arm 12 and the first outer film 51a.
[0058] Combine Figure 3 、 Figure 10 and Figure 12 As shown, in one embodiment, the surfaces of the pair of connecting arms 23 and the base 21 are covered with a second outer membrane 52a. The pair of connecting 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 connecting arms 23 and the base 21. The second partial inner membrane 52b is located between the drive assembly 2 and the second outer membrane 52a. The first partial inner membrane 51b and / or the second partial inner membrane 52b can be fixed to the outer membrane based on their local location, or can be unfixed and simply located inside the outer membrane. Alternatively, the partial inner membrane can be fixed relative to the second clamping arm and the connecting arm, for example, by directly attaching them. It should be understood that the method of fixing the partial inner membrane can be customized. The outer membrane and / or the partial inner membrane are made of at least one layer of a biocompatible polymer material that is biocompatible, antioxidant, and dissolution-resistant. The polymer material is selected from at least one of PET, polyester, PTFE, silicone, silica gel, or urethane. Furthermore, the materials of the outer membrane and the partial inner membrane can be the same or different. Preferably, the local inner membrane has a higher density than the outer membrane and has better anti-wear performance.
[0059] The first outer membrane 51a and the second outer membrane 52a of the present invention are loosely wrapped around the outside of the second clamp arm 12, the connecting arm 23, and the outside of the base 21, respectively. Loose here means that the outer membrane is not completely directly attached to the second clamp arm and the connecting arm after wrapping, but rather that the second clamp arm and the connecting arm will move or deform to a certain extent during rotation. The outer membrane can prevent the metal surface of the clamping device from directly contacting the valve tissue, thereby reducing or avoiding tissue allergies and inflammatory reactions, avoiding damage to the clamped valve tissue, and facilitating tissue crawling. The loose wrapping allows the second clamp arm 12 and the connecting arm 23 to have a certain amount of movement within the first outer membrane 51a and the second outer membrane 52a, preventing the first outer membrane 51a and the second outer membrane 52a from causing excessive restraint and traction on the second clamp arm 12 and the connecting arm 23, thereby affecting the rotation of the two and the opening and closing of the clamping device. Furthermore, the first partial inner membrane 51b and the second partial inner membrane 52b are locally arranged and located inside the outer membrane. On the one hand, this prevents the second clamping arm 12 and the connecting arm 23 from directly contacting the outer membrane during rotation and causing damage to the outer membrane (e.g., wearing through the outer membrane), thereby improving safety. On the other hand, compared with the overall double-layer arrangement, this arrangement avoids the problem of the inner layer constraining and pulling the clamping arm and the connecting arm in the overall double-layer arrangement, thereby ensuring the flexible rotation of the clamping arm and the connecting arm. On the other hand, it avoids the problem of the overall outer diameter of the clamping device being increased due to the overall arrangement. Another aspect is that the local arrangement greatly reduces the cost of the coating and reduces the difficulty of the anti-wear process (e.g., there is no need to perform local treatment on the outer membrane for anti-wear considerations).
[0060] Reference Figure 13 In other embodiments, the anchor 13 is disposed on the first clamp arm 11 and extends toward the opposing second clamp arm 12. When the angle α formed by the pair of second clamp arms 12 is between 110° and 170°, preferably between 115° and 125°, and the axial distance h1 between the clamping surface of the first clamp arm 11 and the edge of the opposing second clamp arm 12 is no greater than 4 mm, preferably between 0.3 mm and 3 mm, i.e., the distance h1 between the clamping surface at the first free end 11b of the first clamp arm 11 and the edge of the opposing second clamp arm 12 is h1, at least some of the plurality of anchors 13 disposed on the first clamp arm 11 have an angle β between the extension direction b and the length direction a of the opposing second clamp arm 12 approaching 90°, so that at least some of the anchors 13 can be substantially vertically anchored into the tissue m captured on the second clamp arm 12. In this embodiment, the angle β of 90° is close to 90°. Preferably, the angle β is within the range of 80° to 100°. This arrangement ensures that the anchor member on the first clamp arm has a sufficient length when inserted into the tissue, thereby enhancing the anchoring strength. At the same time, when the elastic first clamp arm is pulled up and retracted, the angle β of 90° facilitates the anchor member to exit the tissue and reduces tissue damage.
[0061] Based on any of the above exemplary clamping devices 100 , the present invention further provides a clamping system, which includes the clamping device 100 and a conveying assembly, wherein the conveying assembly is detachably connected to the clamping device 100 .
[0062] The lengths of the multiple anchors in the clamping device and clamping system of the present invention are not all equal, allowing the anchors on the clamping arms to be pulled out of the tissue with minimal force while maintaining a clamping effect, thereby facilitating the stability of the entire device during the clamping process. Furthermore, when the anchors at the free end are longer and the anchors at the root are shorter, not only can minimal force be achieved for detachment, but the clamping arms can also be fully and quickly detached without requiring a large angle of expansion, facilitating rapid re-clamping. In particular, when multiple anchors of varying specifications are arranged within a row of anchor units, for example, multiple anchors at the free end have a longer second extension length, while anchors at the root have a shorter first extension length, this arrangement not only ensures the clamping effect of the clamping device, but also enables rapid detachment of the root anchors, reduces pulling force and lifting amplitude, and minimizes tearing damage to the root tissue caused by the anchors, but also significantly reduces manufacturing difficulty and production costs.
[0063] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of the claims of the present invention.
Claims
1. A clamping device, characterized in that: The invention comprises a clamping member, wherein the clamping member comprises at least one clamping assembly, wherein the clamping assembly comprises a first clamping arm and a second clamping arm arranged opposite to each other, wherein the first clamping arm and the second clamping arm each have a connecting end and a free end opposite to the connecting end, wherein the connecting end of the first clamping arm and the connecting end of the second clamping arm are coupled and the free end of the first clamping arm and the free end of the second clamping arm can be close to or away from each other, and tissue can be clamped between the two clamping arms when the two clamping arms are close to each other, and an anchor extending toward the side of the other clamping arm is provided on at least one of the first clamping arm and the second clamping arm, and the anchoring member is provided in plurality, and the extension lengths of the plurality of anchoring members are not all equal.
2. The clamping device according to claim 1, characterized in that: At least one column of anchoring units is included, and one column of the anchoring units includes a plurality of the anchoring members; the plurality of the anchoring members in one column of the anchoring units are sequentially spaced apart along the arm length direction of the clamping arm, and the extension lengths of the plurality of the sequentially spaced apart anchoring members are not all equal.
3. The clamping device according to claim 2, characterized in that: The plurality of anchors in a column of the anchoring units have a plurality of groups of different extension lengths, the number of groups being less than the number of anchors in the column of the anchoring units, the extension lengths of anchors in the same group being the same, and the extension lengths of anchors in different groups being different.
4. The clamping device according to claim 3, characterized in that: The anchoring members in a column of the anchoring units close to the connecting end have a first extension length, and the remaining anchoring members in the column of the anchoring units have a second extension length, and the first extension length is smaller than the second extension length.
5. The clamping device according to claim 4, characterized in that: A column of the anchoring units includes 4 to 8 anchoring members, and 1 to 3 of the anchoring members close to the connecting end have a first extension length.
6. The clamping device according to claim 2, characterized in that: From the connecting end to the free end, the extension lengths of the plurality of anchoring elements gradually increase.
7. The clamping device according to any one of claims 1 to 6, characterized in that: The clamping member includes a pair of clamping assemblies arranged opposite to each other, and the pair of clamping assemblies can be opened or closed relative to each other; in the pair of clamping assemblies, the pair of first clamping arms are located on the inner side of the pair of second clamping arms, and the pair of first clamping arms are coupled with the pair of second clamping arms at the connecting end.
8. The clamping device according to claim 7, characterized in that: It also includes a driving component, which is engaged with a pair of second clamp arms to drive the pair of second clamp arms to open or close; the pair of first clamp arms are both elastic, and the pair of first clamp arms can move away from each other and approach the second clamp arms opposite to them under the action of their own elastic force, and can move away from the second clamp arms opposite to them and approach each other under the action of external force.
9. The clamping device according to claim 8, characterized in that: The surface of the second clamp arm is covered with a first outer film, the free end of the second clamp arm can move in the first outer film during the process of opening or closing a pair of the second clamp arms, and a first local inner film is also provided on a part of the free end of the second clamp arm, and the first local inner film is located between the second clamp arm and the first outer film; and / or, The driving assembly includes a base, a driving shaft connected to the proximal end of the base, and a pair of connecting arms connected to both sides of the base. One end of the pair of connecting arms is rotatably hinged on the base, and the other end is respectively hinged to the corresponding second clamping arms on the same side. The axial movement of the driving shaft can drive the pair of second clamping arms to open or close relative to each other. The surfaces of the pair of connecting arms and the base are covered with a second outer film. The pair of connecting arms can move in the second outer film during rotation. A second partial inner film is also provided at the connection between the pair of connecting arms and the base. The second partial inner film is located between the driving assembly and the second outer film.
10. The clamping device according to claim 7, characterized in that: The anchor is arranged on the first clamp arm and extends toward the second clamp arm opposite thereto. When the angle between the opening of a pair of the second clamp arms is between 110° and 170°, and the distance between the clamping surface of the first clamp arm and the edge of the second clamp arm opposite thereto is not greater than 4 mm, the angle between the extension direction of at least some of the multiple anchors arranged on the first clamp arm and the length direction of the second clamp arm opposite thereto tends to be 90°.
11. A clamping system, characterized in that: It comprises the clamping device and the conveying assembly as described in any one of claims 1 to 10, wherein the conveying assembly is detachably connected to the clamping device.