Tissue clamping device and tissue clamping system

Abstract

The application relates to a tissue clamping device and a tissue clamping system, the tissue clamping device comprising a clamping mechanism and an expansion mechanism; the clamping mechanism comprises at least two clamping arms which can be relatively expanded and closed, the clamping arms comprise a connecting end which is movably connected with other clamping arms and a free end, and the clamping arms extend along a first direction from the connecting end to the free end; the expansion mechanism comprises an elastic member and at least one expansion assembly which is connected with the elastic member, the elastic member is arranged to be elastically compressed or elastically recovered along a second direction, a part of the expansion assembly is movably connected with the clamping arms, and another part of the expansion assembly is arranged to be elastically driven by the elastic member to be retracted or expanded along the second direction relative to the clamping arms, and the included angle between the first direction and the second direction is greater than 0 degrees and less than 180 degrees. By elastically driving the expansion assembly to be retracted or expanded relative to the clamping arms through the elastic member, the clamping width of the tissue can be significantly increased, so that the clamping effect is enhanced.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to a tissue clamping device and tissue clamping system. Background Technology

[0002] The mitral valve is a one-way valve located between the left atrium and left ventricle of the heart. A normal, healthy mitral valve 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. The mitral valve consists of a pair of leaflets, called the anterior and posterior leaflets. When the edges of the anterior and posterior leaflets align, the mitral valve should be completely closed, 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, resulting in a series of pathophysiological changes known as "mitral regurgitation."

[0003] Currently, minimally invasive interventional treatments can be used for edge-to-edge repair of mitral valves. For example, valve clips are delivered to the mitral valve via an interventional catheter, and the relative opening and closing of the clips clamps the anterior and posterior leaflets of the mitral valve, thereby fixing the leaflets and reducing mitral regurgitation. During this interventional procedure, the valve clips need to be inserted into the interventional catheter and delivered to the lesion site. Due to catheter size limitations, the width of the valve clips is limited, thus the clamping range of the leaflets is also relatively limited. For patients with a wide regurgitation jet, if the clamping range of a single valve clip is small, it cannot effectively eliminate regurgitation, often requiring the implantation of two or more valve clips to achieve a better regurgitation reduction effect. Implanting multiple valve clips at the mitral valve can easily cause orifice stenosis and restrict leaflet mobility, resulting in poor postoperative outcomes. Summary of the Invention

[0004] This application provides a tissue clamping device and a tissue clamping system to solve the technical problem of poor postoperative results due to insufficient clamping width.

[0005] The tissue clamping device provided in this application includes a clamping mechanism and an expansion mechanism;

[0006] The clamping mechanism includes at least two clamping arms that can be opened and closed relative to each other. Each clamping arm includes a connecting end that is movably connected to other clamping arms and a suspended end. The clamping arm extends in a first direction from the connecting end to the suspended end.

[0007] The expansion mechanism includes an elastic element and at least one expansion component connected to the elastic element. The elastic element is configured to elastically compress or elastically recover along a second direction. A portion of the expansion component is movably connected to a clamping arm, and another portion of the expansion component is configured to retract or expand relative to the clamping arm along the second direction under the elastic drive of the elastic element. The angle between the first direction and the second direction is greater than 0 degrees and less than 180 degrees.

[0008] The tissue clamping system provided in this application includes the aforementioned tissue clamping device and a delivery device, wherein the clamping mechanism is detachably connected to the distal end of the delivery device.

[0009] In the tissue clamping device of this application, the expansion assembly is elastically driven by an elastic element to retract or expand relative to the clamping arm, which can increase the clamping width of the tissue clamping device on the tissue, or in other words, it is equivalent to widening the clamping arm, thereby increasing the clamping range and enhancing the clamping effect. When the tissue clamping device is used to clamp the leaflets, the same size instrument can clamp a larger range of leaflets, which can more significantly reduce or eliminate regurgitation. Especially for patients with a wide regurgitation jet, the ideal regurgitation reduction effect can be achieved by using fewer tissue clamping devices, avoiding valve stenosis caused by using multiple tissue clamping devices, avoiding restriction of leaflet mobility, and improving surgical results. Attached Figure Description

[0010] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0011] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0012] Figure 1 This is a schematic diagram of the unfolded structure of a tissue clamping device according to the first embodiment of this application;

[0013] Figure 2 for Figure 1 A schematic diagram of the tissue clamping device after it is closed;

[0014] Figure 3 for Figure 1 A schematic diagram of the tissue clamping device from another perspective;

[0015] Figure 4 for Figure 1 Top view;

[0016] Figure 5 for Figure 1 A simplified diagram illustrating the state of the tissue clamping device holding the leaflet.

[0017] Figure 6 for Figure 1 A schematic diagram of the clamping arm in the middle;

[0018] Figure 7 for Figure 6 Top view;

[0019] Figure 8 for Figure 1 Exploded view of the clamping arm and expansion unit in the middle;

[0020] Figure 9 for Figure 1 A schematic diagram showing the expansion unit retracting into the clamping arm;

[0021] Figure 10 for Figure 1 A schematic diagram showing the expansion unit extending out of the clamping arm;

[0022] Figure 11 for Figure 1 A schematic diagram of a structural form of the elastic element in the process;

[0023] Figure 12 for Figure 1 A schematic diagram of another structural form of the elastic element in the diagram;

[0024] Figure 13 This is a schematic diagram of two expansion units;

[0025] Figure 14 This is a schematic diagram of the structure of a tissue clamping device according to a second embodiment of the present application, showing a clamping arm cooperating with an expansion unit;

[0026] Figure 15 This is a schematic diagram of the structure of another clamping arm of a tissue clamping device according to the second embodiment of this application cooperating with another expansion unit;

[0027] Figure 16 This is a schematic diagram of the structure of a tissue clamping device according to a third embodiment of this application;

[0028] Figure 17 This is a schematic diagram of the structure of a tissue clamping device after closure according to the fourth embodiment of this application;

[0029] Figure 18 for Figure 17 A schematic diagram of the tissue clamping device after it has been deployed;

[0030] Figure 19 for Figure 17 A schematic diagram showing the expansion unit extending out of the clamping arm;

[0031] Figure 20 for Figure 17 A schematic diagram showing the expansion unit retracting into the clamping arm;

[0032] Figure 21 for Figure 17 A schematic diagram of the structure of the expander in the image. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0034] In the description of this invention, it should be noted that, in the field of interventional medical devices, "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator; "straight line" refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; "radial" refers to a direction perpendicular to or approximately perpendicular to the straight line; and "circumferential" refers to a direction surrounding the straight line. It is worth noting that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "terminal end," "both ends," "free end," "upper end," and "lower end" is not limited to a tip, endpoint, or end face, but also includes a portion extending a straight line distance and / or radial distance 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.

[0035] See Figures 1 to 5 According to a first embodiment of this application, a tissue clamping device 00 includes a clamping mechanism 1 and an expansion mechanism 2. The clamping mechanism 1 includes at least two clamping arms 11 that can be relatively unfolded and closed, as indicated by arrow A1. Each clamping arm 11 includes a connecting end 11b movably connected to the other clamping arms 11 and a suspended end 11a, and the clamping arms 11 extend along a first direction H1 from the connecting end 11b to the suspended end 11a. The expansion mechanism 2 includes an elastic element 21 and at least one expansion component 22 connected to the elastic element 21. The elastic element 21 is configured to elastically compress or elastically recover along a second direction H2. A portion of the expansion component 22 is movably connected to the clamping arms 11, and another portion of the expansion component 22 is configured to retract or expand relative to the clamping arms 11 along the second direction H2 under the elastic drive of the elastic element 21. The angle θ between the first direction H1 and the second direction H2 is greater than 0 degrees and less than 180 degrees.

[0036] In the tissue clamping device 00 of this application, the elastic element 21 elastically drives the expansion assembly 22 to retract or expand relative to the clamping arm 11, which is equivalent to widening the clamping arm 11. This increases the clamping width of the tissue clamping device 00 on the tissue, thereby increasing the clamping range and enhancing the tissue clamping effect. When using this tissue clamping device 00 to clamp the leaflets, instruments of the same size can clamp a larger range of leaflets, which can more significantly reduce or eliminate regurgitation. Especially for patients with a wide regurgitation jet, a smaller number of tissue clamping devices 00 can achieve the ideal regurgitation reduction effect, avoiding the valve stenosis caused by using multiple tissue clamping devices 00, avoiding restriction of the leaflet 01's mobility, and improving the surgical outcome.

[0037] Furthermore, the elastic element 21 elastically compresses or elastically recovers along the second direction H2, which is a straight line, and the first direction H1 is not parallel to the second direction H2. Therefore, during the linear retraction or expansion of the expansion component 22 along the second direction H2, it does not need to bend or flip relative to the clamping arm 11, thus not increasing the overall size of the compressed device and not imposing higher requirements on the size of the delivery conduit. At the same time, compared with existing devices where the expansion component retracts by bending or flipping, or devices where the elastic expansion component is directly fixed to the clamping arm, the stress direction of the expansion component after expansion is consistent with the direction of bending or flipping retraction from the tissue at the clamping point. If the stress at the tissue is large enough, it will also push the expansion component to bend or flip and retract during clamping, thus failing to stably maintain the expansion width and failing to effectively and reliably achieve the effect of widening the clamping arm. In this application, the expansion component 22 retracts or expands along the second direction H2 under the action of the elastic element 21. While the expansion component 22 is easy to expand or retract, the direction of the pressure it receives from the tissue is not related to the direction of retraction, so it will not affect the effect of the expansion component 22 on increasing the clamping width after expansion. The width of the expansion component 22 after expansion can be maintained stably, which improves the clamping reliability and effectively widens the clamping width of the clamping arm 11.

[0038] See Figure 5 When the expansion component 22 is not expanded, the clamping width of the tissue clamping device 00 on the leaflet 01 is not greater than the maximum width W1 of the clamping arm 11. If the expansion component 22 expands relative to the clamping arm 11, the extended expansion component 22 widens the clamping width of the device. This clamping width is usually the sum of the clamping width of the clamping arm 11 and the extended length of the expansion component 22, for example, W2, where W2 > W1, thereby achieving the effect of increasing the clamping width.

[0039] In addition, during clamping, the device will be subjected to pressure from the leaflet 01 along the compression direction H3, which is basically perpendicular to the second direction H2. Therefore, the pressure of the leaflet 01 on the device will not affect the elastic expansion or retraction of the elastic member 21, ensuring that the width of the expansion component 22 after expansion can be stably maintained, and effectively increasing the clamping width of the leaflet 01.

[0040] See Figures 6 to 8 The clamping arm 11 has a clamping surface, which is typically referred to as the area of ​​the clamping arm 11 that contacts the tissue the most. For example, the clamping arm 11 in the figure includes a bottom 111 and a side portion 112 vertically connected to the bottom 111. During clamping, both the side portion 112 and the bottom 111 contact and clamp the tissue, but the bottom 111 has a relatively large contact area. Therefore, in this example, the clamping surface of the clamping arm 11 is the plane containing the bottom 111. See also... Figure 8 The second direction H2 of the elastic element 21's retraction or expansion is parallel to the plane where the bottom 111 is located, that is, the second direction H2 is parallel to the clamping surface. With the above configuration, the elastic element 21 retracts or expands linearly along the second direction H2 parallel to the clamping surface. Therefore, during the clamping process, even if the elastic element 21 is squeezed between the clamping surface and the tissue, the squeezing force is usually perpendicular to the clamping surface. Thus, the squeezing effect of the tissue will not affect the elastic retraction or expansion of the elastic element 21, ensuring the reliability of increasing the clamping width.

[0041] To ensure that the expansion assembly 22 can expand to widen under the action of the elastic member 21, the second direction H2 of the expansion assembly 22 is not parallel to the first direction H1 of the clamping arm 11. The angle θ between the two directions only needs to be greater than 0° and less than 180°. Preferably, the angle θ between the first direction H1 and the second direction H2 is in the range of [45°, 135°]. More preferably, as in this embodiment, the first direction H1 is perpendicular to the second direction H2, and θ is 90°.

[0042] With the aforementioned angle settings, the portion of the expansion assembly 22 that can retract or expand relative to the clamping arm 11 along the second direction H2 under the elastic drive of the elastic element 21 includes a part parallel to the first direction H1. This part, after the expansion assembly 22 expands relative to the clamping arm 11, effectively widens the clamping arm 11. When the included angle θ is 90°, the overall length of the expansion assembly 22 extending relative to the clamping arm 11 is the increased clamping width, resulting in the best widening effect. When θ is at other angles, the increased clamping width is less than the overall length of the expansion assembly 22 extending relative to the clamping arm 11, and the widening effect is relatively weakened. For example, see... Figure 9 and Figure 10In this specific embodiment, the first direction H1 and the second direction H2 are perpendicular, that is, the included angle θ is 90°. The part of the expansion component 22 that is parallel to the first direction H1 extends outward relative to the clamping arm 11 by a length of L1. The clamping width of the tissue clamping device will increase from the width L2 of the clamping arm 11 along the second direction H2 to at least L1+L2.

[0043] To ensure that the elastic element 21 can elastically retract or expand along the second direction H2, the elastic element 21 includes at least one spring extending along the second direction H2. See also Figure 11 In one specific embodiment, the elastic element 21 may be a single spring. See also Figure 12 The elastic element 21 may further include a spring 210 and sleeves 2101, 2102, and 2103 sleeved outside the spring 210. When the elastic element 21 is compressed, sleeves 2101 and 2103 can be respectively inserted into sleeve 2102 from both sides. The arrangement of each sleeve helps the spring 210 to compress or expand only along its axial direction. It is understood that the elastic element 21 may also include two or more springs arranged in parallel along the second direction H2.

[0044] See Figures 8 to 10 ,as well as Figure 13 The expansion component 22 includes at least one expansion unit 221 or 222. Each expansion unit includes a connector 2211 or 2221 and an expansion member 2212 or 2222. The connector 2211 or 2221 is slidably connected to the clamping arm 11. The expansion member 2212 or 2222 is connected to the elastic member 21 and the connector 2211 or 2221, so that the expansion member 2212 or 2222 can slide and retract or expand relative to the clamping arm 11 through the elastic compression or elastic recovery of the elastic member 21. For example, in this embodiment, a first expansion unit 221 and a second expansion unit 222 are correspondingly provided on each clamping arm 11. These two expansion units are located on opposite sides of the clamping arm 11 along the second direction H2. The expansion of the two expansion units is superimposed, and the expansion member 2212 or 2222 clamps the leaflet together with the clamping arm 11, which can further enhance the widening effect on the clamping arm 11.

[0045] It is worth noting that the expansion member 2212 or 2222, like the clamping arm 11, is made of rigid material, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or polyetheretherketone (PEEK).

[0046] See details Figure 8 and Figure 13The first connector 2211 of the first expansion unit 221 includes a first pin, and the first expansion member 2212 includes a first base plate 2212b and a first side plate 2212a vertically connected to the first base plate 2212b on one side. The clamping arm 11 is provided with a plurality of sliding grooves 113 extending along the second direction H2. The first base plate 2212b is slidably connected to the clamping arm 11 through the first pin 2211 provided in the first sliding groove 1131. The first side plate 2212a is connected to one end of the elastic member 21. For example, a first connecting post 2214 is radially protruding inward on the first side plate 2212a. One end of the elastic member 21 is sleeved on the first connecting post 2214 and fixedly connected to the first side plate 2212a.

[0047] Correspondingly, the second connector 2221 of the second expansion unit 222 includes a second pin, and the second expansion member 2222 includes a second base plate 2222b and a second side plate 2222a vertically connected to the second base plate 2222b on one side. The second base plate 2222b is slidably connected to the clamping arm 11 through the second pin 2221 provided in the second slide groove 1132. The second side plate 2222a is connected to one end of the elastic member 21. For example, a second connecting post 2224 is radially protruding inward on the second side plate 2222a. The other end of the elastic member 21 is sleeved on the second connecting post 2224 and fixedly connected to the second side plate 2222a.

[0048] Preferably, the first base plate 2212b of the first expansion unit 221 and the second base plate 2222b of the second expansion unit 222 are offset from each other on the inner or outer side of the clamping arm 11, such as... Figure 3 and Figure 5 As shown, both the first base plate 2212b and the second base plate 2222b are located on the outer side of the clamping arm 11. It is understood that in other embodiments, the first base plate 2212b and the second base plate 2222b may also be located on the inner side of the clamping arm 11. After the expansion assembly 22 retracts, the first base plate 2212b and the second base plate 2222b can be nested together, reducing space occupation. The clamping arm 11 is correspondingly provided with a first groove 1131 and a second groove 1132 extending along the second direction H2 and relatively offset. For example, Figure 8The clamping arm 11 shown includes two parallel first sliding grooves 1131, and two parallel second sliding grooves 1132 are disposed between these two first sliding grooves 1131. The sliding grooves are equally spaced from each other. The first base plate 2212b and the second base plate 2222b are nested alternately, and the lengths of both the first base plate 2212b and the second base plate 2222b are at least greater than half the length of the clamping arm 11 along the second direction H2. Correspondingly, the lengths of the first sliding grooves 1131 and the second sliding grooves 1132 are also at least greater than half the length of the clamping arm 11 along the second direction H2. Therefore, the total width widened by the combination of the two expansion units can be greater than the length of the clamping arm 11 itself along the second direction H2, further enhancing the widening effect. The length of the base plate and the length of the sliding groove mentioned here refer to their respective lengths along the second direction H2. The length by which the expansion unit can move along the sliding groove determines the length by which the expansion unit can extend in the second direction H2, thereby determining the degree to which the clamping arm 11 can be widened.

[0049] In some specific embodiments, the thickness of the portion of the bottom 111 of the clamping arm 11 that overlaps with the base plate of the expander is less than the thickness of the other portions of the bottom 111. More preferably, the sum of the thickness of the portion of the bottom 111 that overlaps with the base plate of the expander and the thickness of the base plate of the expander is equal to the thickness of the other portions of the bottom 111, to ensure that the overall thickness of the device does not increase when the expansion assembly 22 retracts, thus eliminating the need to increase the inner diameter of the delivery conduit. Specifically, the base plate of the expander is slidably connected to the bottom 111 of the clamping arm 11, and the side portion 112 of the clamping arm extends vertically in the same direction as the side plate of the expander. When the expansion assembly 22 retracts, the side portion 112 and the side plate are aligned, so that no irregular parts appear when the device is compressed. More preferably, the side portion 112 is flush with the side plate, so as not to affect the device's insertion into the delivery conduit, and after release in the body, the side portion 112 and the side plate can clamp the tissue together.

[0050] Combination Figure 2 , Figure 3 , Figures 6 to 10 ,and Figure 13The clamping arm 11, along the first direction H1, includes: a connecting section 11e with a connecting end 11b, a suspended section 11c with a suspended end 11a, and an intermediate section 11d connecting the connecting section 11e and the suspended section 11c. The suspended section 11c includes a suspended bottom 11c1 and a suspended side portion 11c2 vertically connected to the suspended bottom 11c1. The connecting section 11e includes a connecting bottom 11e1 and a connecting side portion 11e2 vertically connected to the connecting bottom 11e1. The intermediate section 11d includes only the intermediate bottom 11d1. The base plates 2212b and 222b of the expansion member are slidably connected to the intermediate bottom 11d1, and the side plates 2212a and 2222a of the expansion member are disposed between the suspended side portion 11c2 and the connecting side portion 11e2. The grooves 1131 and 1132 are located on the middle bottom 11d1 and extend along the second direction H2. The thickness of the middle bottom 11d1 is less than the thickness of the connecting bottom 11e1 and the thickness of the suspended bottom 11c1, respectively. No side portion is provided at the middle section 11d, but a notch is formed relative to the suspended side portion 11c2 and the connecting side portion 11e2. After the expansion assembly retracts, the side plates 2212a and 2222a of the expansion member are accommodated in the notch to save the space occupied by the expansion assembly and not increase the volume of the tissue clamping device 00.

[0051] Of course, the thickness of the middle bottom 11d1 of the intermediate section 11d can also remain unchanged, maintaining the same thickness as the suspended bottom 11c1 and the connecting bottom 11e1. This can improve the connection strength and help the clamping arm 11 and the expansion assembly 22 to provide more stable support and clamping for the leaflets. Those skilled in the art can adopt a suitable method according to actual needs. It is understood that, without reducing the thickness of the middle bottom 11d1 of the intermediate section 11d, it is preferable to place the bottom plate of the expansion member inside the middle bottom 11d1. This way, the overall thickness of the device is not increased, while the connection strength is improved.

[0052] After the expander is extended and clamps the leaflet together with the clamping arm 11, the force direction is mainly distributed from the inside to the outside (that is, in the direction that is basically perpendicular to the expansion direction of the elastic member 21), and this direction is not in the extension and retraction direction of the expander, i.e., the second direction H2. The expander relies on the rigid base plate and side plate connected to the clamping arm 11 to provide stable support or clamping force. Once the expander is extended, the base plate and side plate will not bend or deform in the direction away from the leaflet due to the force of the leaflet, so as to maintain a stable clamping width and effectively increase the effective clamping width of the leaflet.

[0053] See Figures 1 to 3The tissue clamping device 00 further includes: a support mechanism 4, which includes an axially opposite mounting end and a free end; a clamping mechanism 1 located outside the support mechanism 4, with its clamping arm 11 rotatably connected to the mounting end; and a drive mechanism 3 connected to the clamping arm 11 of the clamping mechanism 1 to drive the clamping arm 11 to open or close. The tissue clamping device 00 may also include an elastic mesh adjustment mechanism (not shown), with at least a portion of the support mechanism 4 passing through the adjustment mechanism. For example, one end of the adjustment mechanism is sleeved outside the mounting end of the support mechanism and fixedly connected to it, while the other end of the adjustment mechanism is freely suspended. The tissue clamping device 00 also includes a gripping mechanism 5 located between the support mechanism 4 and the clamping arm 11. The gripping mechanism 5 cooperates with the clamping arm 11 to capture the leaflets. After the two clamping arms 11 clamp the leaflets, the deformation of the adjustment mechanism can adapt to the spacing of the leaflets, thereby adjusting the degree of traction exerted by the clamping arms 11 on the leaflets.

[0054] See Figure 14 and Figure 15 Compared with the first embodiment, the tissue clamping device 00 according to the second embodiment of this application differs in that the expansion assembly 22 includes a third expansion unit 223 and a fourth expansion unit 224, and the clamping mechanism 1 includes a first clamping arm 1101 and a second clamping arm 1102 that can be relatively unfolded and closed; the third expansion unit 223 is disposed on the first clamping arm 1101. One end of the first elastic member 21a on the first clamping arm 1101 is fixedly connected to the side of the first clamping arm 1101, and the other end is connected to the side plate of the third expansion unit 223; one end of the second elastic member 21b on the second clamping arm 1102 is fixedly connected to the side of the second clamping arm 1102, and the other end is connected to the side plate of the fourth expansion unit 224. The third expansion unit 223 and the fourth expansion unit 224 can be disposed on the same side or opposite sides of the tissue clamping device 00 along the second direction H2, which can also widen the clamping width of the two clamping arms 1101 and 1102 on the leaflets and increase the clamping range.

[0055] See Figure 16 Based on the first embodiment, the expansion unit of the tissue clamping device 00 according to the third embodiment of this application further includes at least one adjusting wire 23. The adjusting wire 23 is detachably connected to the expansion member 22a. The adjusting wire 23 is configured to control the elastic member 21 to elastically compress or elastically recover along the second direction H2 through the expansion member 22a. By controlling the adjusting wire 23, the expansion member 22a can also retract into the clamping arm 11 after being expanded. If it is found that the implantation is not appropriate during the operation, the tissue clamping device 00 can be retracted into the delivery catheter, adjusted, and then released or withdrawn from the body, thereby improving the safety of product use.

[0056] Specifically, the adjusting wire 23 passes through the side plate 22a1 of the expander 22a and the side portion 112 of the clamping arm 11. When the adjusting wire 23 is in the loose state, the expander 22a unfolds under the action of the elastic member 21, which increases the clamping width of the leaflets. When the adjusting wire 23 is in the tensioned state, the side plate 22a1 of the expander 22a retracts inward under the action of the adjusting wire 23, overcoming the thrust of the elastic member 21, until the side plate of the expander 22 re-embeds into the clamping arm 11. The wire-threading holes provided on the side portion 112 of the clamping arm 11 and the side plate 22a1 of the expander 22a need to be smooth and burr-free to ensure the smooth operation of the adjusting wire 23.

[0057] For example, an adjustment wire 23 is provided on the side 112 of a clamping arm 11. The adjustment wire 23 is folded into a U-shape, and the U-shaped part is positioned on the inner side of the side 112 of the clamping arm 11. Along the extension direction H1 of the clamping arm 11 from top to bottom, the two ends of the adjustment wire 23 successively pass outward from the side 112 of the clamping arm 11, pass inward into the side plate 22a1 of the expansion member 22a, pass outward from the side plate 22a1 of the expansion member 22a, and then pass inward into the side 112 of the clamping arm 11. Afterward, it extends along the support mechanism 4 to the delivery conduit and connects to the control handle. When the tissue clamping device 00 is implanted and it is necessary to separate the tissue clamping device 00 from the delivery system, the adjustment wire 23 should be removed first.

[0058] The adjusting wire 23 can be made of materials such as nickel-titanium wire, stainless steel wire, or high-strength suture. In this embodiment, nickel-titanium multi-strand wire is used as the adjusting wire 23. To further reduce the resistance of the adjusting wire 23 during operation, a lubricating layer, such as a polytetrafluoroethylene (PTFE) coating, can be provided on its outer surface.

[0059] See Figures 17 to 21 Compared with the first embodiment, the expansion component of the tissue clamping device 00 according to the fourth embodiment of this application includes at least one expansion unit 220, and one or more expansion units 220 may be provided on each clamping arm 11. For example, the expansion component 22 includes two expansion units 220.

[0060] The connector of any expansion unit 220 includes two first pins 2201a and two second pins 2201b. The expansion member includes two connecting rods 2202a and an expansion body 2202b. The expansion body 2202b is provided with two guide grooves 2202c extending along the first direction H1, and the clamping arm 11 is provided with at least one sliding groove 1101 extending along the first direction H1. One end of a connecting rod 2202a is slidably connected to the expansion body 2202b along the first direction H1 via one of the first pins 2201a provided in one of the guide grooves 2202c. The other end of 202a is slidably connected to the clamping arm 11 along the first direction H1 via a second pin 2201b provided in the slide groove 1101; one end of another connecting rod 2202a is slidably connected to the expander 2202b along the first direction H1 via another first pin 2201a provided in another guide groove 2202c, and the other end of the connecting rod 2202a is slidably connected to the clamping arm 11 along the first direction H1 via another second pin 2201b provided in the slide groove 1101; the expander 2202b is connected to one end of the elastic member 21. Of course, the clamping arm 11 may also be provided with a notch to accommodate the expander 2202b, so that the volume of the clamping arm 11 will not increase when the expander unit 220 retracts.

[0061] The two expansion bodies 2202b of the two expansion units 220 are respectively located on opposite sides of the clamping arm 11; one end of the elastic member 21 is connected to the expansion body 2202b of one expansion unit 220, and the other end of the elastic member 21 is connected to the expansion body 2202b of the other expansion unit 220. The two oppositely arranged expansion units 220 can widen the clamping arm 11 together.

[0062] In this embodiment, the two connecting rods 2202a cooperate with the guide groove 2202c and the sliding groove 1101, and under the drive of the elastic element 21, they drive the expander 2202b to expand or retract. This structure is equivalent to a three-bar linkage, which can stably increase the clamping width or clamping range of the leaflet 01, and also provide stable support or clamping force. At the same time, by making full use of the sliding groove 1101 and the guide groove 2202c structure, the size of the expansion component can be reduced, and the overall weight of the tissue clamping device can be reduced.

[0063] This application also provides a tissue clamping system, including any of the tissue clamping devices 00 described above, and a conveying device. The clamping mechanism 1 is detachably connected to the distal end of the conveying device. The conveying device includes a push shaft with a certain axial length and a spindle movably inserted in the push shaft. The push shaft is detachably connected to the support mechanism 4, and the spindle is detachably connected to the drive mechanism 3, used to drive the two clamping arms to open and close relative to each other.

[0064] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0065] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0066] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A tissue clamping device, characterized by, The clamping mechanism comprises at least two clamping arms which are relatively expandable and closable, and the clamping arms comprise a connecting end and a free end which are movably connected with other clamping arms, and the clamping arms extend along a first direction from the connecting end to the free end. The expansion mechanism comprises an elastic member and at least one expansion component connected with the elastic member, the elastic member is configured to be elastically compressed or elastically recovered along a second direction, a part of the expansion component is movably connected with the clamping arm, and another part of the expansion component is configured to be retracted or expanded along the second direction relative to the clamping arm under the elastic driving of the elastic member, and the included angle between the first direction and the second direction is greater than 0 degrees and less than 180 degrees. The clamping arm has a clamping surface, and the second direction is parallel to the clamping surface.

2. The tissue clamping device of claim 1, wherein, The included angle between the first direction and the second direction ranges from 45 degrees to 135 degrees.

3. The tissue clamping device of claim 1, wherein, The first direction is perpendicular to the second direction.

4. The tissue clamping device of claim 3, wherein, The other part of the expansion component comprises a part parallel to the first direction.

5. The tissue clamping device of claim 4, wherein, The elastic member comprises at least one spring extending along the second direction.

6. The tissue clamping device of claim 1, wherein, The expansion component comprises at least one expansion unit, and the expansion unit comprises a connecting member and an expansion member; the connecting member is slidably connected with the clamping arm, and the expansion member is connected with the elastic member and the connecting member respectively, so as to drive the expansion member to slide and retract or expand relative to the clamping arm under the elastic compression or elastic recovery of the elastic member.

7. The tissue clipping device according to any one of claims 1 to 6, wherein The connecting member comprises a pin, and the expansion member comprises a bottom plate and a side plate vertically connected with the bottom plate at one end of the bottom plate; the clamping arm is provided with at least one sliding groove extending along the second direction, the bottom plate is slidably connected with the clamping arm through the pin arranged in the sliding groove, and the side plate is connected with one end of the elastic member.

8. The tissue clamping device of claim 7, wherein, The thickness of the part of the clamping arm overlapping with the bottom plate is less than the thickness of other parts of the clamping arm.

9. The tissue clamping device of claim 8, wherein, The clamping arm comprises a bottom part and a side part vertically connected with the bottom part; the bottom plate is slidably connected with the bottom part, and the side part vertically extends in the same direction as the side plate.

10. The tissue clamping device of claim 8, wherein, 11. The tissue clamping device according to claim 10, wherein The clamping arm comprises a connecting section having the connecting end, a free section having the free end, and an intermediate section connected between the connecting section and the free section along the first direction; The free section comprises a free bottom part and a free side part vertically connected with the free bottom part, the connecting section comprises a connecting bottom part and a connecting side part vertically connected with the connecting bottom part, and the intermediate section comprises an intermediate bottom part; The bottom plate is slidably connected with the intermediate bottom part, and the side plate is arranged between the free side part and the connecting side part. ​ 12. The tissue clamping device of claim 8, wherein, The expansion assembly comprises two expansion units, two side plates of the two expansion units are separately arranged on opposite sides of the clamping arm, one end of the elastic member is connected with the side plate of one expansion unit, and the other end of the elastic member is connected with the side plate of the other expansion unit; the two side plates are retracted or expanded away from each other along the second direction relative to the clamping arm under the elastic driving of the elastic member.

13. The tissue clamping device of claim 12, wherein, The bottom plate of one expansion unit is oppositely arranged with the bottom plate of the other expansion unit on the inner side or the outer side of the clamping arm; a first sliding groove and a second sliding groove which extend along the second direction and are oppositely arranged are correspondingly arranged on the clamping arm, and the length of the first sliding groove and the length of the second sliding groove are both greater than half of the length of the clamping arm along the second direction.

14. The tissue clamping device of claim 7, wherein, The expansion unit further comprises at least one adjusting wire, the adjusting wire is detachably connected with the expansion member, and the adjusting wire is arranged to control the elastic member to be elastically compressed or elastically recovered along the second direction through the expansion member.

15. The tissue clamping device according to claim 7, wherein The connecting member comprises two first pins and two second pins, the expansion member comprises two connecting rods and an expansion body, the expansion body is provided with two guide grooves extending along the first direction, and the clamping arm is provided with at least one sliding groove extending along the first direction; One end of one connecting rod is connected with the expansion body in the first direction through one first pin arranged in one guide groove, and the other end of the connecting rod is connected with the clamping arm in the first direction through one second pin arranged in the sliding groove; One end of the other connecting rod is connected with the expansion body in the first direction through the other first pin arranged in the other guide groove, and the other end of the connecting rod is connected with the clamping arm in the first direction through the other second pin arranged in the sliding groove; The expansion body is connected with one end of the elastic member.

16. The tissue clamping device of claim 15, wherein, The expansion assembly comprises two expansion units, two expansion bodies of the two expansion units are separately arranged on opposite sides of the clamping arm, one end of the elastic member is connected with the expansion body of one expansion unit, and the other end of the elastic member is connected with the expansion body of the other expansion unit.

17. The tissue clipping device according to claim 1, wherein, The tissue clamping device further comprises: A support mechanism, the support mechanism comprises an installation end and a free end which are arranged in an axial direction, the clamping mechanism is arranged on the outer side of the support mechanism, and the clamping arm of the clamping mechanism is connected with the installation end; A driving mechanism, the driving mechanism is connected with the clamping arm of the clamping mechanism to drive the clamping arm to be unfolded or closed.

18. The tissue clamping device of claim 17, wherein, The tissue clamping device further comprises an elastic net-shaped adjusting mechanism, at least a part of the support mechanism is arranged in the adjusting mechanism.

19. A tissue clamping system, characterized by The tissue clamping device according to any one of claims 1 to 18 and a delivery device, the clamping mechanism is detachably connected with the distal end of the delivery device.

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