Fixation device for clamping tissue

Abstract

The fixing device for clamping tissue includes a support mechanism (2000) including a connection unit (2100) and a drive unit (2200) movable relative to the fixed connection unit (2100), a pair of closing members (1100) and a pair of capture members (1200) provided corresponding to the closing members (1100), respectively, the closing member (1100) includes a clamping mechanism (1000) including a closing connection portion (1120) provided in a groove (1121) and a closing clamping portion (1110), and the fixed connection unit (21 The fixed connection unit (2100) is provided with a groove driving member (850) at least a part of which is located in the guide groove (1121), the guide groove (1121) including at least one non-linear portion, the driving unit (2200) connects the two closing connection parts (1120), and is configured to drive the two closing clamping parts (1110) to relatively approach or move apart by the groove driving member (850) sliding relatively in the guide groove (1121) when the driving unit (2200) moves relative to the fixed connection unit (2100). By improving the driving method to drive in combination with the guide groove (1121) having a non-linear portion, the deployment angle and capture distance of the closing member (1100) are increased, the valve leaflet is captured more easily, the contact area with the valve leaflet is increased, and the valve leaflet is captured more reliably.

Description

[Technical field]

[0001] FIELD OF THEINVENTION The present invention relates to medical instruments, and more particularly to fixation devices for clamping tissue. [Background technology]

[0002] The mitral valve functions as a check valve to prevent oxygenated blood from leaking back into the left atrium during normal heart contractions, while abnormal leakage of blood from the left ventricle into the left atrium is called mitral regurgitation. Severe regurgitation can affect the efficiency of the heart's pumping function and put patients at risk for severe and progressive heart failure.

[0003] The most common treatments for mitral regurgitation rely on prosthetic valve replacement and valve repair techniques such as rectangular resection of the posterior leaflet, chordae shortening, edge-to-edge repair, and artificial chordae implantation techniques; techniques such as replacement and repair typically rely on open-chest surgery, which involves opening the patient's chest through a sternotomy and placing the patient on cardiopulmonary bypass.

[0004] However, with the advancement of medical technology, traditional high-risk surgical procedures are being replaced by minimally invasive catheter procedures. The minimally invasive interventional techniques that are mainly developed and applied in the market include indirect annuloplasty, direct annuloplasty, edge-to-edge repair, and chordae tendineae repair.

[0005] The edge-to-edge repair technique has gradually matured in the clinical practice of surgical treatment of mitral regurgitation and has shown good therapeutic effects. The edge-to-edge repair technique brings the normal chordae on both sides of the lesion closer to each other by suturing the valve edges of the prolapsed part of the valve, thereby restoring the normal coaptation between the valve leaflets and restoring the normal coaptation function of the mitral valve. Its advantages are: 1. the treatment is reliable because the lesion site is directly treated; 2. the valve edges are reliably joined; 3. the reproducibility of the shaping is high, which can optimally ensure the coaptation of the valve leaflets and the relationship between the valve leaflets and the remaining tissues; 4. the leaflet tissue is sufficiently preserved and tension is reduced; and 5. the posterior leaflet can be effectively prevented from moving forward due to excess longitudinal folding tissue, which can cause complications.

[0006] The valve clip device, which was researched and developed based on the principle of surgical edge-to-edge suturing of the valve, is currently the most popular due to its high safety, simple technical principle, and high feasibility.

[0007] In conventional surgery, a valve leaflet clip is carried to the mitral valve by a delivery device, and the clip opens and closes relative to one another to simultaneously clamp the anterior and posterior leaflets of the mitral valve, thereby fixing the anterior and posterior leaflets of the mitral valve, thereby achieving the goal of reducing mitral valve regurgitation. However, in conventional surgery, the clip must pass through a narrow passage before bending, which places a certain limit on the length of the clip and limits the capturing distance. In addition, the link mechanism that drives the clip in conventional surgery usually also limits the rotation angle of the clip, making it more difficult to capture the valve leaflets. Summary of the Invention [Problem to be solved by the invention]

[0008] In order to solve the above technical problems, the present invention provides a fixation device for clamping tissue that increases the deployment angle and capture distance of the closure member by improving the driving method, making it easier to capture the valve leaflet, increasing the contact area with the valve leaflet, and more securely capturing the valve leaflet. [Means for solving the problem]

[0009] Specifically, the following aspects are included.

[0010] 1. A fixation device for clamping tissue, comprising: A support mechanism including a fixed connection unit and a drive unit that is movable relative to the fixed connection unit; A pair of closing members and a pair of capturing members provided corresponding to the closing members, the closing members including a clamping mechanism including a closing connection portion provided with a guide groove and a closing clamping portion that cooperates with the capturing members to clamp tissue, The fixed connection unit is provided with a groove driving member at least a portion of which is located within the guide groove, and the guide groove includes at least one non-linear portion. The drive unit is configured to connect the two closing connection parts and drive the two closing clamping parts to move closer to or farther apart relative to each other by the groove driving member sliding relatively within the guide groove when the drive unit moves relative to the fixed connection unit.

[0011] Furthermore, the closure connection is rotatably connected to the drive unit, with a connection site on the side proximate to the distal end of the closure connection.

[0012] Furthermore, the connection portion between the closing connection portion and the drive unit is located on the centripetal side of the guide groove in the closing connection portion.

[0013] Furthermore, the guide groove includes at least two guide grooves that communicate with each other, and the curvature of the first guide groove is greater than the curvature of the second guide groove.

[0014] The guide groove further includes a third guide groove communicating with the second guide groove and having a curvature larger than that of the second guide groove, and the second guide groove is located between the first guide groove and the third guide groove.

[0015] The drive unit further includes a drive connection block having a first mounting surface and a second mounting surface on a side thereof, the first mounting surface and the second mounting surface being perpendicular to each other; the drive connection block is connected to the closure connection portion by a closure member fitting provided on the first mounting surface; The capture member includes a rigid capture portion, a flexible connection portion, and a capture connection portion, the flexible connection portion being located between the rigid capture portion and the capture connection portion, and the second mounting surface being fixedly connected to the capture connection portion.

[0016] Furthermore, the rigid capture portion includes a rigid surface and a capture protrusion provided on the outer side of the rigid surface, and the rigid surface has a uniform thickness and is formed in a curved shape.

[0017] Furthermore, the closing clamping portion has a free end and a connecting end connected to the closing connection portion, and an outer surface of the closing clamping portion tends to narrow inward at least in part in a direction from the connecting end to the free end.

[0018] Furthermore, the fixed connection unit includes a base casing having a base cavity therein, a base screw portion provided inside the base cavity, and the drive unit includes a drive shaft having a drive screw portion that engages with the base screw portion, and the base screw portion has a lead angle of a screw that engages with the drive screw portion that is smaller than the friction angle.

[0019] Furthermore, the base casing further includes a base leg provided at a distal end thereof, and the groove driving member is provided on the outer side of the base leg. Effect of the Invention

[0020] As mentioned above, the present invention has the following beneficial effects:

[0021] 1) By improving the drive method so that it is driven in combination with a guide groove having a non-linear portion, the deployment angle and capture distance of the closure member are increased, making it easier to capture the valve leaflets, making the contact area with the valve leaflets larger, and more securely capturing the valve leaflets.

[0022] 2) By arranging the arc-shaped first guide groove, the linear second guide groove and the arc-shaped third guide groove in that order, the torque required when the closure member opens from the initial position and when it reaches the maximum deployment angle position is smaller than the torque required in the intermediate capture process, making the change speed faster, while improving the reliability of the system in the capture section and slowing down the angle change, facilitating fine operation by the operator.

[0023] 3) The closing jaws have a pulling effect towards the distal end, imparting a "meshing"-like action to the closure process, providing a "pulling" effect on the leaflets held by the closing jaws while keeping the tissue tightly clamped, bringing the leaflets into more secure contact with the closing jaws.

[0024] 4) By adding a friction-enhancing structure or protrusion structure, such as the capture protrusion of the present embodiment, to the rigid portion of the capture member, the "pulling" effect on the valve leaflet becomes more pronounced, and the present invention provides a stronger bond between the valve leaflet and the fixation device compared to the proximal element described in the background art, which can only perform an inversion movement. [Brief description of the drawings]

[0025] In order to more clearly describe the technical solutions of the present invention, the following briefly describes the drawings used in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without creative efforts.

[0026] [Figure 1] FIG. 2 is a structural schematic diagram of the clamping mechanism of the present application in the mitral valve. [Diagram 2] FIG. 1 is a schematic diagram of the overall structure of the present application. [Diagram 3] FIG. 2 is a partial cross-sectional view of the overall structure of the present application. [Figure 4] 1A-1D are schematic diagrams showing the principle of the capture member of the present application in various positions. [Diagram 5] Fig. 5(a) is a side view of the closure member of the present application, and Fig. 5(b) is a structural schematic diagram of the closure member of the present application. [Figure 6] 6(a) to (d) are schematic diagrams illustrating the principle of the closing member of the present application. [Figure 7] Fig. 7(a) is a structural schematic diagram of a capture member of the present application, Fig. 7(b) is a cross-sectional view of a capture member of one embodiment of the present application, and Fig. 7(c) is a cross-sectional view of a capture member of another embodiment of the present application. [Figure 8] 8(a) to (e) are component drawings of the support mechanism of the present application. [Figure 9] 9(a) to 9(c) are schematic diagrams showing the movement of the closing member and the capturing member in the clamping process of the present application. [Figure 10] 10(a) to (d) are component drawings of the clutch mechanism of the present application. [Figure 11] FIG. 13 is a partial enlarged view of the detached position of the operating wire. [Figure 12] 12(a) to 12(d) are diagrams showing a movement process in which the clamping mechanism of the present invention releases the closing member. [Figure 13] 13(a) to (d) are diagrams showing the movement process by which the clamping mechanism of the present invention achieves capture and fixation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The following clearly and completely describes the technical solutions of the embodiments of the present invention with reference to the drawings in the embodiments of the present invention, and obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. In this embodiment, "near end" means the direction approaching the operator, and "far end" means the direction away from the operator. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts shall belong to the patent scope of the present invention. Example 1

[0028] As shown in Figures 2 to 4, the fixation device for clamping tissue of the present application specifically comprises a support mechanism 2000 including a fixed connection unit 2100 and a drive unit 2200 that is movable relative to the fixed connection unit 2100, and the fixed connection unit 2100 in the support mechanism 2000 is used to connect the clamping mechanism 1000 at its distal end and to detachably connect to a delivery control device at a proximal end via a clutch mechanism 3000.

[0029] In this embodiment, specifically, the clamping mechanism 1000 includes a pair of closure members 1100 and a pair of capture members 1200 provided corresponding to the closure members 1100, respectively. The closure members 1100 are opened and closed by a drive unit 2200, and the capture members 1200 are opened and closed by an operation wire 610. When clamping tissue, the inside of the closure member 1100 and the outside of the capture member 1200 cooperate to clamp the tissue. In this embodiment, the specific principle of use of the fixation device for clamping tissue of the present application will be described using the clamping of a heart valve as an operation scenario. As shown in FIG. 1, the fixation device of the present application is delivered to a predetermined position of the heart by a delivery control unit, and specifically, the delivery control unit includes a push shaft 600 for delivering the fixation device to a predetermined position and a clutch mechanism 3000 for detachably joining the push shaft 600 to the fixation device. In one embodiment of the present invention, the push shaft 600 is a rod-like body or a hollow tubular body having a cavity, and is made of a biocompatible material. In this embodiment, the fastening shaft is a round rod-like body or a circular tube-like body, and the push shaft 600 has a smooth surface, which avoids damaging the valve leaflets or getting caught on the chordae tendineae. Here, the push shaft 600 first enters the surgical path together with the catheter 500, and after reaching the vicinity of the lesion, extends from the catheter 500 to deliver the fixation device to the mitral valve. The distal end of the clamping mechanism 1000, which is the distal end of the fixation device, is preferably covered with a protective coating layer, which is made of a biocompatible material and completely covers the outer circumference of the clamping mechanism 1000, so that the instrument can avoid damaging the tissue, and when the fixation device is placed in the heart as an implant, the outer surface of the fixation device can be completely protected by the protective coating layer.

[0030] After the fixation device reaches the lesion location, the closing member 1100 and the capturing member 1200 of the clamping mechanism 1000 in this embodiment cooperate to clamp the area where the anterior and posterior leaflets of the heart valve cannot normally coapt, thereby aligning the position of the areas that cannot normally coapt, thereby completely closing the mitral valve or reducing the area of ​​deployment, thus alleviating or treating "mitral regurgitation."

[0031] The clamping mechanism 1000 in another embodiment of the present invention is also useful for alleviating or treating "tricuspid regurgitation", i.e., in addition to the original pair of closure members 1100 and capture members 1200, one more member is added to treat "tricuspid regurgitation". Its principle and structure are similar to those for solving mitral regurgitation in the embodiment of the present invention, so detailed description is omitted here. It should be understood that the other embodiment of the present invention can also be applied to other minimally invasive surgeries that require clamping multiple pieces of tissue, and the number of closure members 1100 and capture members 1200 may be changed according to actual needs.

[0032] After clamping the mitral valve, the fixation device is separated from the delivery control unit by a clutch mechanism 3000, thereby leaving the fixation device in place at the lesion and maintaining fixation of the leaflets.

[0033] Further, with regard to the clamping mechanism 1000, as shown in Figures 4 to 9 and Figures 12 to 13, in this embodiment, the closing member 1100 of the clamping mechanism 1000 includes a closing connection portion 1120 and a closing clamping portion 1110, which cooperates with the capturing member 1200 to clamp tissue.

[0034] The closing connection part 1120 is provided with a guide groove 1121. The fixed connection unit 2100 is provided with a groove driving member 850, at least a part of which is located in the non-linear guide groove 1121. The guide groove 1121 includes at least one non-linear portion. The driving unit 2200 is connected to the two closing connection parts 1120, and is configured to drive the two closing clamping parts 1110 to move closer to or farther away from each other by the groove driving member 850 sliding relatively in the guide groove 1121 when the driving unit 2200 moves relative to the fixed connection unit 2100.

[0035] Specifically, the distal end of the closing connection part 1120 is rotatably connected to the drive unit 2200, and in particular, is rotatably connected to the distal end of the drive unit 2200. In this embodiment, the closing connection part 1120 is provided with a connection part shaft hole 1122 and is connected to the drive unit 2200 via a rotation shaft, but in other embodiments, other hinge connection methods are also possible. Before the fixation device is delivered to a predetermined position, as shown in FIG. 12(a), the closing clamp 1110 is in its initial position and the groove driving member 850 is at the proximal end of the guide groove 1121. At this time, the closing clamp 1110 is in a closed state and the groove driving member 850 is fitted into the guide groove 1121. Therefore, when the driving unit 2200 drives the part of the driving unit 2200 that is rotatably connected to the closing connection part 1120, the part moves to the proximal end, that is, when the connection part axial hole 1122 moves to the proximal end, the guide groove 1121 also moves synchronously to the proximal end. Since the groove driving member 850 does not move, the groove driving member 850 moves to the distal end relative to the guide groove 1121. In order to accommodate such a change in distance, the groove driving member 850 adaptively rotates the groove 1121 relative to the connection part axial hole 1122, so that the closing clamp 1110 rotates around the connection part axial hole 1122 as its center. When the closing clamping portion 1110 is inverted outward around the connection portion axial hole 1122 as the axis, it reaches the state shown in Figures 12(b) and (c), and when it is further driven so that the connection portion axial hole 1122 moves toward the near end, the closing clamping portion 1110 can reach the state shown in Figure 12(d), where the angle between the two closing clamping portions 1110 is 180° and the distance between the ends is the maximum capture distance.

[0036] Due to the design of the guide groove 1121, even if the angle between the two closed clamping parts 1110 is 180°, they can be further inverted and deployed to an obtuse angle as shown in FIG. 13(a), which can be applied when the positioning is not accurate or the fixation device needs to be pulled out from the heart due to some other circumstances. Since the angle between the two closed clamping parts 1110 is an obtuse angle, the contact surface with the tissue tends to be inclined outward during the pulling process, and the tissue is not caught, so that the pulling can be performed smoothly and safely. The specific principle of the closing clamping parts 1110 being deployed at the above angle by the engagement of the groove driving member 850 and the guide groove 1121 will be described in detail later.

[0037] In this embodiment, the opening and closing of the closure clamping part 1110 is realized by the driving unit 2200 moving relative to the groove driving member 850, but the groove driving member 850 and the fixed connection unit 2100 connected thereto not moving, so that in the process of the closure clamping part 1110 of the closure member 1100 from the initial position to the deployed position, the closure connection part 1120 at the distal end moves to the proximal end, and compared with the clamping element of the prior art that only has the movement of deployment reversal, in the present invention, the closure member 1100 at this time has two combined movements, so that the deployment distance in the radial direction of the closure member 1100 can be made larger. Furthermore, when in the initial position, the closure connection part 1120 is not provided with any other mechanism, so that the height of the entire fixing device is reduced, which makes it easier to bend during delivery, and the length of the closure member 1100 can be increased accordingly, and the capture distance is also made larger.

[0038] After the closure clamp 1110 has clamped the tissue in cooperation with the capturing member 1200, it is necessary to further close the closure clamp 1110, and as it closes, the closure connection portion 1120 at the distal end of the closure clamp 1110 moves toward the distal end, causing the closure clamp 1110 to have the effect of pulling something toward the distal end, giving the closure process an "interlocking" like operating characteristic, firmly clamping the tissue and also providing a "pulling" effect on the valve leaflets clamped by the closure clamp 1110, thereby bringing the valve leaflets into more secure contact with the closure clamp 1110.

[0039] The guide groove 1121 includes at least two guide grooves, a first guide groove and a second guide groove, which are at least mutually connected, and the curvature of the first guide groove is larger than that of the second guide groove. FIG. 6(a) is a diagram showing an embodiment of the guide groove according to the first embodiment of the present application, in which the guide groove is divided into a first guide groove, a second guide groove, and a third guide groove from the far end to the near end, respectively, the first guide groove and the third guide groove are arc portions, and the second guide groove is a straight portion. Here, when the guide groove is formed in an arc shape, the change in the rotation angle is larger, but the torque is smaller, the torque changes nonlinearly, the change range is small, and there is also a dead point where the torque becomes zero. On the other hand, when the guide groove is formed in a straight line, the torque is larger, the torque changes linearly and stably, the change range is large, there is no dead point of the torque, but the change in the rotation angle is small. Therefore, by configuring guide groove 1121 to have an arc-shaped first guide groove, a linear second guide groove, and an arc-shaped third guide groove in this order, the torque required when the closure member deploys from the initial position or when it reaches the maximum deployment angle position is smaller than the torque required for the intermediate capture process, and the rate of change of the closure member becomes faster, while at the same time improving the reliability of the system in the capture section, and facilitating fine operation by the operator since the angle changes at a relatively slow speed.

[0040] As shown in Fig. 6(a), 6(c) and 6(d), the groove driving member 850 is a round bar and is located in the guide groove 1121, and the outer diameter of the groove driving member 850 is equal to the width of the guide groove 1121. When the groove driving member 850 is in the initial position, not opened, as shown in Fig. 6(c), it is at the nearest end, that is, the nearest end of the third guide groove, and at this time, the distance between the groove driving member 850 and the closing member fitting portion 2320 is h1. During the process of expanding the closing clamping portion 1110, the groove driving member 850 slides to the far end in the third guide groove and enters the second guide groove from the farthest end of the third guide groove, and at this time, the angle already rotated by the closing clamping portion 1110 is α1. When the groove driving member 850 slides further to the far end and reaches the farthest end of the second guide groove, i.e., the end of the straight portion, the angle through which the closing clamping portion 1110 has already rotated is set to α2 and the distance between the groove driving member 850 and the closing member fitting portion 2320 is set to h2, as shown in Fig. 6(d). When the groove driving member 850 slides further to the far end in the first guide groove and reaches the farthest end of the guide groove 1121, the angle through which the closing clamping portion 1110 has already rotated is set to α3. Here, the range of values ​​of α1, α2, α3, h1, and h2 may be determined as necessary. In this embodiment, the range of α1 is preferably 30° to 45°, more preferably 35° to 40°, and even more preferably 40°, the range of α2 is preferably 55° to 70°, more preferably 60° to 70°, and even more preferably 65°, and the range of α3 is preferably 120° to 150°, more preferably 125° to 135°, and even more preferably 130°. Preferably, the range of h1 is 15 to 16 mm, more preferably 15.5 mm, and the distance of h2 is 5 to 7 mm, and even more preferably 6 mm. From the above description, it can be seen that in order for the closing clamping part 1110 to rotate by the angle α2, it is necessary to drive the closing member fitting part 2320 to move by the movement distance "h2-h1" relative to the driving groove driving member 850. When α2 is 65°, h1 is 15.5 mm, and h2 is 6 mm, ie when the two closure jaws 1110 are deployed at 130° relative to each other, the travel distance of the closure member fitting portion 2320 is 9.5 mm.By combining the arc-shaped first guide groove, the linear second guide groove and the arc-shaped third guide groove, the closure member changes at a faster rate when deployed from the initial position or when reaching the maximum deployment angle position than during the intermediate capture process, while the rate of angle change in the capture section is slower, enabling more stable capture; and compared with a normal linear groove, the driving distance required to obtain a preset capture angle is shorter in this application, and it is safer and more reliable than the curved groove in positions requiring fine operation.

[0041] 6(b) is a diagram showing an embodiment of the guide groove 1121 of another embodiment of the present application, the guide groove 1121 is divided into a first guide groove and a second guide groove from its distal end to its proximal end, the first guide groove is an arcuate portion, and the second guide groove is a straight portion, in this case, it can be quickly closed from the maximum deployment angle to the capture position, while in the process of capturing tissue, the straight portion slows down the speed of the angle change in the capture portion, allowing for more stable capture. Specifically, the change in angle from the proximal end of the guide groove 1121 to the boundary between the first guide groove and the second guide groove is θ1, the change in angle in the straight portion in the guide groove 1121 of the groove driving member 850 is θ1, and when the groove driving member 850 moves further to the distal end, the deployment angle of the closed clamping portion 1110 on one side is θ2, where preferably, the value of θ1 ranges from 40° to 60°, and the value of θ2 ranges from 120° to 140°.

[0042] Here, as shown in Figures 3 and 8, the drive unit 2200 includes a moving base 2300, specifically, a drive connection block 2310, the side of which includes a first mounting surface and a second mounting surface perpendicular to each other, and the drive connection block 2310 is hingedly connected to the closure connection portion 1120 via the closure member fitting portion 2320 provided on the first mounting surface, thereby driving the closure member fitting portion 2320 to move, and further realizing the relative movement between the guide groove 1121 and the groove driving member 850.

[0043] Further, as shown in FIG. 7, in the present application, the capture member 1200 includes a rigid capture portion 1210, a flexible connection portion 1220, and a capture connection portion 1230 connected in sequence, the flexible connection portion 1220 being located between the rigid capture portion 1210 and the capture connection portion 1230, and the second mounting surface being fixedly connected to the capture connection portion 1230.

[0044] In this example, the capture member cooperates with the closure member to capture the movable leaflet, and the captured leaflet is located between the closure member and the capture member. The capture connection part of the capture member is connected to the second mounting surface. The capture member has the shape of an open bird's wing in a natural state, and the flexible connection part is specifically a deformable member having a predetermined recovery force, and when an inversion external force is applied to the rigid part of the capture member, the flexible connection part elastically deforms, changing the angle between the rigid part of the capture member and the axial direction, and the capture member inverts. When the movable leaflet to be captured is located above the closure member on one side of the capture member, the elastic flexible part instantly recovers to its shape in the natural state when the inversion external force is released, and at this time, the leaflet is captured between the closure member and the rigid part of the capture member. When capturing the valve leaflet, the rigid part mainly plays a role of fixing the movable valve, so that the structure is required to have a predetermined rigidity to prevent the captured leaflet from pushing aside the capture part and escaping.

[0045] More preferably, the rigid capture portion 1210 includes a rigid surface 1211 and a capture protrusion 1212 provided on the outer side of the rigid surface, and the rigid surface 1211 has a uniform thickness and is formed in a curved shape.

[0046] The rigid surface 1211 of the capture clip has the characteristics of a rigid cross-section, and its cross-sectional shape is curved as shown in Figure 7(b) or folded as shown in Figure 7(c). The provision of the curved or folded portion of such a structure is equivalent to adding a reinforcing rib to the main body, so that the cross-section of the thin-walled strip has a high bending-resistant section modulus, and the rigidity of the rigid portion of the capture clip can be improved without adding a member that improves rigidity. In this embodiment, by pushing or pulling the operating wire in the delivery control unit, a force is applied to the capture clip at the wire hole 1213 via the operating wire, thereby flipping the capture clip.

[0047] In the embodiment, the two capture members 1200 share one capture connection part 1230, which is U-shaped and has opposite vertical parts fixedly connected to the second mounting surface of the drive connection block 2310. The capture connection part 1230 is fixedly connected to the drive connection block 2310 by hinge connection, swaging, welding, etc., so that the capture members 1200 can move axially according to the movement of the drive connection block 2310. When the drive connection block 2310 approaches the groove drive member 850 in the axial direction based on the groove drive member 850, the closure member 1100 unfolds and inverts, and the capture member 1200 also moves axially toward the groove drive member 850 as a whole. At the same time, when an inverting external force is applied to the rigid portion of the capture member 1200 in a direction toward the groove drive member 850, the capture member 1200 inverts toward the groove drive member 850, and when the appropriate leaflet contacts the deployed closure member 1100, the inverting external force on the capture member 1200 is released, and the leaflet is sandwiched between the closure member 1100 and the capture member 1200. In one embodiment, the capture member 1200 is in an open state in the natural state, and the capture member 1200 is constrained to a closed state by the operation wire 610, and when the restraining force by the operation wire 610 is released, the capture member 1200 inverts. In another embodiment, the capture member 1200 may be a flexible member, and the capture member 1200 may be inverted or captured directly by pushing the operation wire 610.

[0048] Furthermore, when the drive connection block 2310 starts to move axially away from the groove drive member 850, the closure member 1100, together with the captured leaflet and the deployed capture member 1200, reverses its closing motion, while the drive connection block 2310, together with the capture member 1200, also moves axially away from the groove drive member 850 as a whole, at which time, a relative displacement occurs between the capture member 1200 and the leaflet, or there is a tendency for a relative displacement to occur. Furthermore, since pressure is applied to the leaflet due to the elastic deformation of the capture member 1200, a frictional force is generated at the contact surface between the capture member 1200 and the leaflet, which is relatively displaced, and the direction of the frictional force applied by the capture member 1200 to the leaflet is toward the drive connection block 2310, so that the capture member has an operating characteristic like a "pull" on the leaflet. By adding a friction enhancing structure or protrusion structure, such as the capture protrusion 1212 in this embodiment, to the rigid portion of the capture member 1200, the "pulling" effect on the valve leaflet becomes more pronounced, and the connection between the valve leaflet and the fixation device in the present invention is stronger than that of the proximal element described in the background art, which can only perform an inversion movement.

[0049] Further, in this embodiment, as shown in FIG. 3, the closing clamping portion 1110 includes a free end and a connecting end connected to the closing connecting portion 1120, and the outer surface of the closing clamping portion 1110 tends to narrow inward at least partially from the connecting end to the free end. The closing clamping portion 1110 is formed in a cup mouth shape and has a recessed inner surface, so that the contact area with the leaflet can be increased when clamping the leaflet. When the closing clamping portion 1110 cooperates with the capture member 1200 to clamp and fix the leaflet, the leaflet is sandwiched between the recessed inner surface of the cup mouth structure, so that the radial displacement of the fixing device relative to the leaflet can be limited. In addition, the characteristic of the widened edge of the cup mouth structure prevents the edge of the closing clamping portion 1110 from damaging the valve. After the valve leaflets are finally seated by the fixing device, the closing clamp 1110 has a concave inner surface characteristic, so that seating holes are formed at the ends of both closing clamps, and the valve leaflets are more firmly secured in the axial direction.

[0050] Further, the structure and principle of the support mechanism 2000 will be described with reference to Fig. 3 and Fig. 8. Specifically, as described above, the support mechanism 2000 includes a fixed connection unit 2100 and a driving unit 2200 that is movable relative to the fixed connection unit 2100, and the far end of the driving unit 2200 is connected to the two closing members 1100, thereby controlling the opening and closing of the closing members 1100 when the driving unit 2200 moves relative to the fixed connection unit 2100. Specifically, the base casing further includes a base leg 2110 provided at the far end, and the groove driving member 850 is provided on the outer side of the base leg 2110. The opening and closing of the closing members 1100 is controlled by controlling the driving unit 2200 to move relative to the groove driving member 850.

[0051] Specifically, the fixed connection unit 2100 includes a base casing having a base cavity 2130 therein, and a base screw portion 2131 is provided inside the base cavity 2130, and the drive unit 2200 includes a drive shaft 2230 having a drive screw portion 2231 that engages with the base screw portion 2131, and the lead angle of the screw that engages with the drive screw portion 2231 is smaller than the friction angle.

[0052] In the embodiment, after the drive screw portion 2231 is engaged with the base screw portion 2131, their pitch and cross-sectional shape are the same, so that by rotating the base casing or the drive shaft 2230, the base casing and the drive shaft 2230 can move relative to each other in the axial direction. Since the helical lead angle of the helical annular groove is smaller than the friction angle between the contact surfaces of the two helical grooves, no axial displacement occurs when the base casing or the drive shaft 2230 is stopped even if an axial force is applied only to the base casing or the drive shaft 2230. Thus, a self-locking function is realized, and a leaf spring or other structure for self-locking as in the prior art is not required, and the base casing or the drive shaft 2230 can be stopped at any position by thread engagement.

[0053] The drive unit 2200 includes a drive output shaft 2210 provided at the distal end of the drive shaft 2230 and having an outer diameter smaller than that of the drive shaft 2230, and the drive connection block 2310 is provided with a connection guide hole 2311 having an inner diameter matching the drive output shaft 2210, and the drive output shaft 2210 is fitted into the connection guide hole 2311 so as to be rotatable in the axial direction. The drive unit 2200 further includes a positioning sleeve 810 provided on the distal end side of the drive connection block 2310, and the drive output shaft 2210 is inserted through the connection guide hole 2311 and then inserted into a positioning sleeve mounting hole 811 of the positioning sleeve 810, and fixedly connected to the positioning sleeve 810.

[0054] As can be seen from the above description of the structure, this embodiment discloses a dynamic fitting form between the drive output shaft 2210 and the drive connection block 2310, and the output end of the drive output shaft 2210 outputs a pushing force and a pulling force to the drive connection block 2310, thereby allowing the drive connection block 2310 to move in the axial direction, but there is a rotational movement between the drive output shaft 2210 and the base casing, while there is no rotational displacement between the drive connection block 2310 and the base casing, so the above structure can be used. The positioning sleeve 810 may be a tubular part, and both axial end faces are the end faces of the positioning sleeve 810. The positioning sleeve 810 may be fixedly connected to the output end of the drive output shaft 2210 by welding, interference fit, or mechanical connection means. In the following, as one of the mechanical connection means, a configuration is disclosed in which a positioning hole 812 of the positioning sleeve is provided radially in the positioning sleeve 810, and a positioning hole 2211 of the drive output shaft is provided radially at the engagement portion between the output end of the drive output shaft 2210 and the positioning sleeve 810, and a pin 840 is inserted into the positioning hole 812 of the positioning sleeve and the positioning hole 2211 of the drive output shaft.

[0055] The present invention further provides a system for clamping tissue, specifically, in this embodiment, a system for clamping a valve leaflet, which system includes the above-mentioned fixation device and a delivery control unit, wherein the fixation device includes a clamping mechanism 1000 for clamping tissue and a support mechanism 2000 for mounting the clamping mechanism 1000, the support mechanism 2000 including a drive unit 2200 for driving the opening and closing of the clamping mechanism 1000, and the delivery control unit includes a push shaft 600 for delivering the fixation device to a predetermined position and a clutch mechanism 3000 for detachably connecting the push shaft 600 to the fixation device.

[0056] In this embodiment, the clutch mechanism 3000 includes a control lever 3100 that is non-rotatably and axially separably connected to the drive unit 2200, and the control lever 3100 rotates to drive the axial movement of the drive unit 2200, and is configured to disengage the clutch mechanism 3000 from the fixing device when the control lever 3100 moves toward the proximal end as preset. Hereinafter, the principle of separation between the clutch mechanism 3000 and the support mechanism 2000 will be described in detail with reference to Figures 3, 8 and 10.

[0057] The support mechanism 2000 for mounting the clamping mechanism 1000 includes a fixed connection unit 2100 and a drive unit 2200 movable relative to the fixed connection unit 2100, specifically, the drive unit 2200 includes a drive shaft 2230, which includes a drive screw portion 2231 that fits with a base screw portion 2131, and the drive shaft 2230 is moved in the axial direction by a rotational motion existing between the drive output shaft 2210 and the base casing. The rotation of the drive output shaft is realized by a rotational torque by a steering lever 3100 in the clutch mechanism 3000, and the steering lever 3100 specifically includes a steering lever clutch end 3120 and a steering lever support portion 3130 that are axially separable from the drive unit 2200 and connected to the drive unit 2200 so as not to rotate relative to the drive unit 2200. Specifically, the drive unit 2200 includes a transmission lever clutch end 2220, to which a steering lever clutch end 3120 is non-rotatably connected, and when the tensile force between the steering lever clutch end 3120 and the transmission lever clutch end 2220 is greater than a predetermined value, the steering lever clutch end 3120 is disengaged from the transmission lever clutch end 2220. Here, since the helical lead angle of the helical annular groove is smaller than the friction angle between the contact surfaces of the two helical grooves, when the base casing or the drive shaft 2230 is stopped, if an axial force is applied only to the base casing or the drive shaft 2230, no axial displacement of these occurs, and therefore, when it is desired to separate the steering lever clutch end 3120 and the transmission lever clutch end 2220, they can be separated when the tensile force reaches a predetermined value by simply pulling the steering lever 3100 toward the near end in the axial direction and holding the transmission lever clutch end 2220 as it is.

[0058] Specifically, in this embodiment, a specific configuration for realizing the separation of these when a predetermined value is reached will be described below.

[0059] Either one of the steering lever clutch end 3120 and the transmission lever clutch end 2220 is provided with a deformable engagement portion 3121 made of an elastic biocompatible material such as a biocompatible polymer material, and the other is provided with a clutch connection groove 2222 provided with an engagement shaft 820 that is engaged and joined with the deformable engagement portion 3121, and the engagement shaft 820 is inserted into the coupling shaft hole 2221. Specifically, the deformable engagement portion 3121 includes an engagement port 3122 and an engagement hole 3123 that matches the engagement shaft 820 after passing through the engagement port 3122. The steering lever clutch end 3120 and the transmission lever clutch end 2220 are connected by the deformable engagement portion 3121 and the engagement shaft 820, and when the tensile force between the steering lever clutch end 3120 and the transmission lever clutch end 2220 is greater than a predetermined value, the deformable engagement portion 3121 is released from the engagement shaft 820. In this embodiment, the deformable engagement portion 3121 is provided on the steering lever clutch end 3120, and the clutch connection groove 2222 is provided on the transmission lever clutch end 2220, but the reverse is also possible.

[0060] In order to separate the outer casing of the support mechanism 2000 from the outer casing of the clutch mechanism 3000 when the steering lever clutch end 3120 and the transmission lever clutch end 2220 are separated, specifically, in this embodiment, the clutch mechanism 3000 is further provided with a connecting base 3300 detachably connected to the base clutch end 2120, and an engaging member 3200 that connects the base clutch end 2120 and the connecting base 3300. The steering lever 3100 is configured to be movable between a first position and a second position relative to the engaging member 3200, and when the steering lever 3100 moves to the proximal end in the second position, the steering lever support portion 3130 simultaneously moves the engaging member 3200 to the proximal end, thereby enabling the connecting base 3300 and the base clutch end 2120 to be separated, thereby enabling the connecting base 3300 and the base clutch end 2120 to be separated in synchronization with the separation of the steering lever clutch end 3120 and the transmission lever clutch end 2220.

[0061] Specifically, in this embodiment, the coupling base 3300 includes a coupling base connection end 3310, a coupling base clutch end 3320, and a coupling base cavity 3330 extending through the coupling base 3300, the attachment member 3200 is disposed within the coupling base cavity 3330, the coupling base clutch end 3320 is connected to the base clutch end 2120 by the attachment member 3200, and the coupling base connection end 3310 is connected to the delivery device.

[0062] The main body of the base clutch end 2120 is an extension of the tubular structure of the base, and the connecting base clutch end 3320 can be fitted onto the base clutch end 2120 or inserted into the base clutch end 2120, and the contact surfaces of the two clutch ends are respectively called the base mating surface and the connecting base mating surface, and the base mating surface has a base engagement hole 2121 formed radially, and the connecting base mating surface corresponding to the base mating surface has a connecting base engagement hole 3321 formed radially in the same direction, the connecting base clutch end 3320 has a connecting base engagement hole 3321 formed therein, and the base clutch end 2120 has a base engagement hole 2121 corresponding to the connecting base engagement hole 3321. The attachment member 3200 includes an engagement portion 3220 that is inserted simultaneously through the connecting base engagement hole 3321 and the base engagement hole 2121 to fix the connecting base 3300 and the base clutch end 2120 relative to each other, and the engagement portion 3220 is configured to disengage from the connecting base engagement hole 3321 and / or the base engagement hole 2121 when the attachment member 3200 moves toward the proximal end relative to the connecting base 3300, thereby enabling the connecting base 3300 and the base clutch end 2120 to be separated.

[0063] The engaging portion 3220 is made of a flexible material, so that when the fastening member 3200 moves proximally relative to the connecting base 3300, the engaging portion 3320 deforms, so that the engaging portion can directly disengage from the connecting base engaging hole 3321 and the base engaging hole 2121, and the engaging portion does not recover and prevent effective separation. The material of the engaging portion 3220 is made of a biocompatible plastic or metal that cannot recover after being bent.

[0064] Further, in this embodiment, the engaging member 3200 includes the engaging claw ring 3230 and the engaging claw connecting rods 3210, the number of which is the same as the number of the engaging parts 3220, which connect the engaging parts 3220 and the engaging claw ring 3230, and the engaging claw ring 3230 is provided with a ring hole. The number of the engaging claw connecting rods 3210 is 3 to 6, and they are evenly distributed and connected to the side of the engaging claw ring 3230. Preferably, the number of the engaging claw connecting rods 3210 is three. The radial surface of the shaft-shaped or rod-shaped steering lever support part 3130 limits the movement of the engaging part 3220 toward the center, thereby preventing the engaging part 3220 from unintentionally escaping from the base engaging hole 2121 and the connecting base engaging hole 3321, and the connected state between the base clutch end 2120 and the connecting base 3300 can be maintained.

[0065] The steering lever 3100 further includes a steering lever connection end 3110 connected to a proximal end of the steering lever support part 3130, the proximal end of which is inserted through a ring hole and then connected to a drive source, and the outer diameter of the proximal end of the steering lever support part 3130 is larger than the inner diameter of the ring hole.

[0066] The length of the steering lever support part 3130 is smaller than the length of the engagement claw connecting rod 3210, and the outer diameter of the steering lever support part 3130 is configured such that when the steering lever support part 3130 is positioned in the connecting base engagement hole 3321, the outer surface of the steering lever support part 3130 prevents the engagement part 3220 from disengaging from the connecting base engagement hole 3321 and the base engagement hole 2121, and therefore the engagement part 3220 deforms only when the steering lever support part 3130 contacts the engagement claw ring 3230 and moves further toward the near end.

[0067] Based on the above structure, when attempting to separate the base clutch end 2120 and the connecting base 3300, the steering lever moves toward the engagement claw ring 3230 due to the action of an axial force, and as the engagement claw ring 3230 is pushed by the steering lever, the steering lever support portion 3130 also disengages from the engagement portion 3220, and there is no longer any restriction on the radial movement of the engagement portion 3220. If the external force is sufficient, the engagement portion 3220 can be pulled out of the base engagement hole 2121 and the connecting base engagement hole 3321, and the base clutch end 2120 and the connecting base 3300 can be separated.

[0068] The above embodiment will be further described. The connecting base clutch end 3320 is fitted on the base clutch end 2120, and as shown in Fig. 11, the fastening member 3200 includes an operating wire limiting groove 3322, and an expansion part is formed at the tip of the operating wire 610 that controls the opening and closing of the capturing member 1200 of the clamping mechanism 1000 in the delivery control unit, and the expansion part is disposed in the base end hole 2122, and its minimum size is larger than the size of the operating wire limiting groove 3322 and smaller than the size of the base end hole 2122. When the connecting base 3300 is connected to the base clutch end 2120, the operating wire limiting groove 3322 prevents the operating wire 610 from being separated.

[0069] In one embodiment, a passage is provided within the steering lever 3100 that passes from its near end to the steering lever clutch end 3120 to communicate between them. In this application, instead of using a solid steering lever that is connected with a screw as in the prior art, the connection is made by fitting the clutch connection groove 2222 into the deformable engagement portion 3121. Therefore, the steering lever may be hollow and provided with a flexible shaft for controlling the direction, thereby eliminating the need for an external operating structure for controlling bending.

[0070] With reference to the structure described in detail in this embodiment, the method of operation of the tissue clamping system of the present application will now be described using mitral valve repair as an example.

[0071] Step 1: The push shaft 600 pushes the fixation device connected thereto from the left atrium and delivers it to the left ventricle through the mitral valve. At this time, the closing member 1100 of the clamping mechanism 1000 is in a closed state as shown in FIG. 12(a).

[0072] Step 2: The relative position of the fixing device of the valve leaflet and the mitral valve is adjusted by the pushing shaft 600, and the two closing members 1100 of the fixing device are respectively brought close to the anterior leaflet and the posterior leaflet of the mitral valve. Next, the driving shaft 2230 is rotated, and the driving connection block 2310 is moved to the distal end by the engagement between the base screw portion 2131 and the driving screw portion 2231. When the driving connection block 2310 approaches the groove driving member 850 in the axial direction based on the groove driving member 850, the closing member 1100 is deployed and inverted, and then the driving connection block 2310 is rotated. 12(b) and (c), the closing member may be further inverted to the state shown in Fig. 12(d), at which time the distance between the ends of the two closing members 1100 is maximized and the angle between the two closing clamps 1110 is 180°, after which the closing member may be further inverted and deployed to the obtuse angle shown in Fig. 13(a), which can be applied when the positioning is not accurate or it is necessary to pull the fixation device out of the heart due to some other circumstances. Since the angle between the two closing clamps 1110 is an obtuse angle, the contact surface with the tissue tends to be inclined outward during the pulling process, and the tissue does not get caught, allowing the device to be pulled out smoothly and safely.

[0073] Step 3: After the valve leaflets are captured by the two closure members 1100, the operating wire 610 is controlled to flip the capture member 1200 toward the closure clamping portion 1110, and the valve leaflets are clamped between the closure member 1100 and the capture member 1200, as shown in FIG. 13(b).

[0074] Step 4: When the drive connection block 2310 starts to move axially away from the groove drive member 850, the closure member 1100 closes and inverts together with the captured leaflet and the deployed capture member 1200, while the drive connection block 2310 also moves axially together with the capture member 1200 as a whole away from the groove drive member 850, to the state shown in Fig. 13(c) and (d), where a relative displacement occurs between the capture member 1200 and the leaflet or there is a tendency for a relative displacement. Furthermore, since a pressure due to the elastic deformation of the capture member 1200 is applied to the leaflet, a frictional force is generated at the contact surface between the capture member 1200 and the leaflet, which is relatively displaced, and the direction of the frictional force of the capture member 1200 on the leaflet is toward the drive connection block 2310, so that the capture member has an operating characteristic like "pulling" on the leaflet.

[0075] When the tissue clamping system of the present application is used to repair a heart valve, the closing jaws have a pulling effect toward the distal end, giving the closing process a "meshing"-like operating characteristic, firmly clamping the tissue and providing a "pulling" effect on the leaflets clamped by the closing jaws. When actuated in combination with a guide groove having a non-linear portion, the opening angle and capture distance of the closing member can be increased, making it easier to capture the leaflets, making a larger contact area with the leaflets, and more securely capturing the leaflets.

[0076] The orientation terms such as front, back, top, bottom, etc. used in this specification are defined by the positions of parts in the drawings and the positions of parts relative to each other, and are merely intended to describe the technical solutions more clearly and conveniently. It should be understood that the use of said orientation terms does not limit the scope of the claims of this application.

[0077] Unless inconsistent, the features in the above embodiments and embodiments herein may be combined with each other.

[0078] The above disclosure is merely a preferred embodiment of the present invention, and does not limit the scope of the claims of the present invention. Therefore, the same variations based on the claims of the present invention are also intended to be included in the scope of the present invention.

Claims

1. 1. A fixation device for clamping tissue, comprising: A support mechanism (2000) including a fixed connection unit (2100) and a drive unit (2200) movable relative to the fixed connection unit (2100); A clamping mechanism (1000) including a pair of closure members (1100) and a pair of capture members (1200) provided corresponding to the closure members (1100), respectively, wherein the closure members (1100) include a clamping mechanism (1000) including a closure connection portion (1120) provided with a guide groove (1121) and a closure clamping portion (1110) that cooperates with the capture members (1200) to clamp tissue; A fixing device characterized in that the fixed connection unit (2100) is provided with a groove driving member (850) at least a portion of which is located within the guide groove (1121), the guide groove (1121) including at least one non-linearly extending portion, and the driving unit (2200) connects the two closing connection portions (1120) and is configured to drive the two closing clamping portions (1110) to move closer to or farther apart relative to each other when the driving unit (2200) moves relative to the fixed connection unit (2100), by the groove driving member (850) sliding relatively within the guide groove (1121).

2. 2. The fixation device for clamping tissue according to claim 1, characterized in that the closure connection (1120) is rotatably connected to the drive unit (2200), the connection site being on a side closer to the distal end of the closure connection (1120).

3. A fixation device for clamping tissue as described in claim 1, characterized in that the non-linearly extending portion is an arc-shaped extending portion, and a connection site between the closed connection portion (1120) and the drive unit (2200) is on the centripetal side of the arc-shaped extending portion of the closed connection portion.

4. A fixation device for clamping tissue as described in any one of claims 1 to 3, characterized in that the guide groove (1121) includes at least two guide grooves that are in communication with each other, and the curvature of the first guide groove is greater than the curvature of the second guide groove.

5. 5. The fixation device for clamping tissue according to claim 4, further comprising a third guide groove communicating with the second guide groove and having a curvature larger than that of the second guide groove, the second guide groove being located between the first guide groove and the third guide groove.

6. The drive unit (2200) includes a drive connection block (2310) having first and second mounting surfaces on its sides that are perpendicular to each other; The drive connection block (2310) is connected to the closure connection portion (1120) by a closure member fitting portion (2320) provided on the first mounting surface, 2. The fixation device for clamping tissue according to claim 1, characterized in that the capture member (1200) includes a rigid capture portion (1210), a flexible connection portion (1220), and a capture connection portion (1230), the flexible connection portion (1220) being located between the rigid capture portion (1210) and the capture connection portion (1230), and the second mounting surface being fixedly connected to the capture connection portion (1230).

7. The fixation device for clamping tissue according to claim 6, characterized in that the rigid capture portion (1210) includes a rigid surface (1211) and a capture protrusion (1212) provided on the outside of the rigid surface, the rigid surface (1211) being uniform in thickness and curved.

8. The fixation device for clamping tissue according to claim 1, characterized in that the closing clamping portion (1110) has a free end and a connecting end connected to the closing connecting portion (1120), and an outer surface of the closing clamping portion (1110) tends to narrow inward at least partially in a direction from the connecting end toward the free end.

9. The fixation device for clamping tissue as described in claim 1, characterized in that the fixed connection unit (2100) includes a base casing having a base cavity (2130) therein, the base cavity (2130) having a base screw portion (2131) therein, the drive unit (2200) includes a drive shaft (2230) having a drive screw portion (2231) that engages with the base screw portion (2131), and the base screw portion (2131) has a screw lead angle that engages with the drive screw portion (2231) that is smaller than the friction angle.

10. The fixation device for clamping tissue as described in claim 9, characterized in that the base casing further includes a base leg (2110) provided at a distal end, and the groove driving member (850) is provided outside the base leg (2110).

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