Tissue suturing device and valve repair system

Abstract

The application provides a tissue suture device and a valve repair system. The tissue suture device comprises a sheath, a clamping assembly, a puncture assembly, a catcher and a handle. The clamping assembly comprises a proximal clamping head and a distal clamping head which are relatively opened and closed. The puncture assembly comprises a puncture needle movably arranged in the proximal clamping head and a suture fixedly connected to the proximal end of the puncture needle. The catcher is movably arranged in the sheath and the proximal clamping head, and the distal end of the catcher is movably accommodated in the distal clamping head. The catcher is used for catching the puncture needle and the suture after puncturing the tissue. The handle comprises a catching linkage control module. The catching linkage control module controls the distal clamping head and the catcher to be in a linkage state connected with each other before and when the puncture needle punctures the tissue, and controls the distal clamping head and the catcher to be in an independent state disconnected after the puncture needle punctures the tissue. The catching linkage control module can ensure that the catcher reliably catches the puncture needle and the suture after puncturing the tissue.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a tissue suture device and a valve repair system. Background Technology

[0002] Heart valves, such as the mitral and tricuspid valves, are one-way valves between the atria and ventricles. Normal, healthy valves control the flow of blood from the atria to the ventricles while preventing blood from flowing from the ventricles to the atria. When the atria contract, the valves open, allowing blood to flow from the atria to the ventricles; when the ventricles contract, the valves should close to prevent blood from rushing into the atria. If the valve leaflets, chordae tendineae, annulus, or other related structures become diseased, the valves may not close completely during ventricular contraction, causing blood to flow back from the ventricles to the atria, leading to a series of pathophysiological changes.

[0003] Clinically, valvular repair techniques include chordae tendineae repair, edge-to-edge repair, and annulusoplasty. In chordae tendineae repair, sutures are implanted into the heart as artificial chordae tendineae, with one end fixed to the valve leaflet and the other end fixed to the ventricular wall or papillary muscle. In edge-to-edge repair, sutures are implanted onto adjacent valve leaflets, and by pulling the sutures, the edges of adjacent leaflets that cannot normally align are aligned. The side of the suture furthest from the valve is locked to reduce the total area of ​​the valve orifice, thereby reducing or eliminating regurgitation. In annulusoplasty, sutures are implanted into the valve annulus, and by tightening the sutures, the valve annulus is contracted, reducing the area of ​​the mitral or tricuspid valve orifice, thus reducing or eliminating regurgitation.

[0004] Implanting sutures into the aforementioned tissues requires the use of a tissue suture device. One existing tissue suture device, designed for transcatheter implantation of artificial chordae tendineae, includes a suture catcher. Because the catcher is mounted within a distal clamp, during the movement of the distal clamp, the catcher's catcher coil may become misaligned with the position on the distal clamp corresponding to the puncture needle. After the puncture needle penetrates the valve, it cannot enter the catcher coil, and the catcher coil fails to capture the suture connected to the puncture needle. Consequently, the puncture needle and suture cannot be withdrawn from the body, making subsequent suture anchoring or locking operations impossible, resulting in suture failure and the failure of the entire procedure. Summary of the Invention

[0005] To address the aforementioned technical problems, this application provides a tissue suture device and a valve repair system.

[0006] The tissue suture device provided in this application includes a sheath, a clamping assembly, a puncture assembly, a catcher, and a handle. The clamping assembly includes a proximal clamp fixedly connected to the distal end of the sheath and a distal clamp that opens and closes relative to the proximal clamp. The puncture assembly includes a puncture needle movably inserted into the proximal clamp and a suture fixedly connected to the proximal end of the puncture needle. The puncture needle is used to puncture tissue and drive the suture through the tissue. The catcher is movably inserted into the sheath and the proximal clamp, with the distal end of the catcher movably housed within the distal clamp. The catcher is used to catch the puncture needle and the suture after puncturing the tissue. The handle includes a catch-linkage control module, which controls the distal clamp and the catcher to be in a linked state of mutual connection before and during puncture, and controls the distal clamp and the catcher to be in an independent state of disconnection after puncture.

[0007] The valve repair system provided in this application includes the aforementioned tissue suture device and an adjustable curved sheath fitted over the sheath tube.

[0008] The tissue suture device and valve repair system provided in this application have a capture linkage control module on the handle. Before and during tissue puncture by the puncture needle, the capture linkage control module controls the capture device and the distal clamp to be in a linked state of mutual connection. This prevents the capture coil of the capture device from being misaligned relative to the distal clamp, ensuring that the capture device reliably captures the puncture needle and suture after tissue puncture, thus guaranteeing the smooth execution of subsequent suture anchoring or locking operations. After the puncture needle punctures the tissue, the capture linkage control module controls the distal clamp and the capture device to be in an independent state of disconnection, allowing the capture device to retract independently, thereby suturing the suture onto the tissue. Attached Figure Description

[0009] 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.

[0010] 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.

[0011] In the attached image:

[0012] Figure 1 This is a three-dimensional schematic diagram of the valve repair system according to an embodiment of this application;

[0013] Figure 2for Figure 1 A schematic diagram showing the interaction between the adjustable curved sheath and the tissue suture device.

[0014] Figure 3 This is a perspective view of the tissue suture device according to an embodiment of the present application;

[0015] Figure 4 This is a partial three-dimensional structural diagram showing the clamping component in the clamping state of the tissue suture device of this application.

[0016] Figure 5 An exploded perspective view of the handle in the tissue suture device of this application is provided.

[0017] Figure 6 To show an exploded perspective view of the mandrel assembly in the tissue suture device of this application;

[0018] Figure 7 To show a three-dimensional structural diagram of the handle and positioning element in the valve repair system of this application;

[0019] Figure 8 This is a three-dimensional structural diagram of the clamp control module and the puncture control module in the tissue suture device of this application;

[0020] Figure 9 This is a schematic diagram illustrating the structure of the clamp control module controlling the clamp in the tissue suture device of this application;

[0021] Figure 10 This is a schematic diagram illustrating the structure of the puncture control module in the tissue suture device of this application, which controls the puncture needle to be housed within the proximal clamp.

[0022] Figure 11 This is a schematic diagram illustrating how the puncture control module in the tissue suture device of this application controls the extension of the puncture needle from the proximal clamp.

[0023] Figure 12 This is a schematic diagram showing the mating structure between the puncture control module and the lower shell in the tissue suture device of this application;

[0024] Figure 13 This is a schematic diagram illustrating the structure of the probe control module controlling the probe in the tissue suture device of this application;

[0025] Figure 14 This is a schematic diagram illustrating how the capture linkage control module in the tissue suture device of this application controls the linkage between the capture device and the clamp push rod.

[0026] Figure 15 This is a schematic diagram illustrating how the capture linkage control module in the tissue suture device of this application controls the release of the linkage between the capture device and the clamp push rod;

[0027] Figure 16 This is a schematic diagram of the catcher and connector in the tissue suture device of this application;

[0028] Figures 17a to 17e A schematic diagram illustrating the working process of the tissue suture device of this application. Detailed Implementation

[0029] To provide a clearer understanding of the technical features, objectives, and effects of this invention, specific embodiments are now described in detail with reference to the accompanying drawings. In the following description, it should be understood that the orientations or positional relationships indicated by terms such as "front," "rear," "upper," "lower," "left," "right," "longitudinal," "horizontal," "vertical," "horizontal," "top," "bottom," "inner," "outer," "head," and "tail" are based on the orientations or positional relationships shown in the accompanying drawings, and are constructed and operated in a specific orientation. They are only for the convenience of describing this technical solution and do not indicate that the device or element referred to must have a specific orientation; therefore, they should not be construed as limitations on this invention.

[0030] It should also be noted that, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "linking," "fixing," and "setting" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. When one component is referred to as being "on" or "below" another component, the component can be located "directly" or "indirectly" on the other component, or there may be one or more intermediary components. The terms "first," "second," "third," etc., are only for the convenience of describing this technical solution and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features defined with "first," "second," "third," etc., may explicitly or implicitly include one or more features. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances.

[0031] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of the invention. However, those skilled in the art will understand that the invention can be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, structures, and methods are omitted so as not to obscure the description of the invention with unnecessary detail.

[0032] In the description of this invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction. The above definitions are for ease of expression only and should not be construed as limiting the invention.

[0033] See Figure 1 This application provides a valve repair system, including a tissue suture device 10, an adjustable curved sheath 30, a reinforcing tube 40, a positioning element 50, and a clamp 20.

[0034] Combination Figures 1 to 5 and Figure 13 The tissue suture device 10 includes a sheath 600, a clamping assembly 100, a puncture assembly 200, a catcher 300, a probe 400, and a handle 500. The proximal end of the sheath 600 is fixedly connected to the distal end of the handle 500; the clamping assembly 100 includes a proximal clamp 110 and a distal clamp 120 that opens and closes relative to the proximal clamp 110, with the proximal clamp 110 fixedly connected to the distal end of the sheath 600; the puncture assembly 200 includes a puncture needle 210, a suture 220, and a pad 230 inserted through the suture 220, with the puncture needle 210 movably inserted within the proximal clamp 110, and the suture... The puncture needle 210 is fixedly connected to the proximal end of the puncture needle 220 and is movably housed in the proximal clamp 110 and the sheath 600. The puncture needle 210 is used to puncture tissue and drive the suture 220 through the valve or other tissue. The pad 230 is movably housed in the proximal clamp 110. The catcher 300 and the probe 400 are respectively movably inserted into the sheath 600 and the proximal clamp 110. The distal end of the catcher 300 is movably housed in the distal clamp 120.

[0035] An adjustable bending sheath 30 is fitted over the sheath tube 600. A bending handle 900 is provided at the proximal end of the adjustable bending sheath 30. A reinforcing tube 40 is fixedly connected to the proximal end of the bending handle 900. The proximal end of the reinforcing tube 40 is inserted into the handle 500. The proximal end of the sheath tube 600 is movably inserted into the reinforcing tube 40. A positioning member 50 is detachably connected to the handle 500 or the reinforcing tube 40. The positioning member 50 is used to connect the reinforcing tube 40 to the handle 500 to maintain the relative position of the reinforcing tube 40 and the handle 500. By adjusting the relative position of the reinforcing tube 40 and the handle 500, the lengths of the distal end of the sheath tube 600 and the length of the clamping assembly 100 extending beyond the distal end of the adjustable bending sheath 30 can be different. A clamp 20 is used to clamp the handle 500 and the bending handle 900.

[0036] The handle 500 includes a housing 560, a spindle assembly 510, a clamp control module 520, a puncture control module 530, a probe control module 540, and a capture linkage control module 550. The spindle assembly 510 is rotatably mounted within the housing 560, with its distal end fixedly connected to the proximal end of the sheath 600. The clamp control module 520, puncture control module 530, and probe control module 540 are axially slidingly engaged with the spindle assembly 510. The capture linkage control module 550 controls the distal clamp 120 and the capture device 300 to be in a linked state before and during the puncture of the valve by the puncture needle 210, preventing misalignment of the capture coil 320 relative to the distal clamp 120 and ensuring that the puncture needle 210 can drive the suture 220 after puncturing the valve. The needle enters the capture coil 320 of the capture device 300, allowing the capture device 300 to reliably capture the puncture needle 210 and suture 220 after the valve has been punctured. This provides a foundation and guarantee for the smooth execution of subsequent suture anchoring or locking operations. After the puncture needle 210 punctures the valve, the capture linkage control module 550 controls the distal clamp 120 to be in an independent, disconnected state from the capture device 300. The capture device 300 can then retract independently, thereby capturing the portion of the puncture needle 210 connected to the suture 220 outside the body, allowing the suture 220 to be sewn onto the valve. The rotation of the spindle assembly 510 can rotate the clamping assembly 100, puncture assembly 200, probe 400, and capture device 300 relative to the outer shell 560, facilitating the adjustment of the opening of the clamping assembly 100 towards the valve without rotating the entire handle 500, thus simplifying operation.

[0037] Please see Figure 5 and Figures 7 to 10 The outer casing 560 includes an upper casing 561 and a lower casing 562 that are mated and connected to each other. A fixing frame 567 and a guide rod 568 extending axially and mounted on the fixing frame 567 are provided inside the outer casing 560. The distal ends of the upper casing 561 and the lower casing 562 are provided with external threads. A fixing member 569 is sleeved and screwed onto the external threads to fix the upper casing 561 and the lower casing 562. Figure 7 In the process, the reinforcing tube 40 passes through the fixing member 569, and the positioning member 50 is preferably a screw. The upper shell 561 of the outer shell 560 has a screw hole that mates with the screw. After the fixing member 569 is inserted into the outer shell 560, the positioning member 50 is tightened. The positioning member 50 moves toward the reinforcing tube 40 and presses the reinforcing tube 40, thereby restricting the axial movement of the reinforcing tube 40. Loosening the positioning member 50 in the opposite direction allows the reinforcing tube 40 to move axially relative to the outer shell 560.

[0038] See Figure 5 and Figure 6The spindle assembly 510 includes a short shaft 511, a long shaft 512, a separator 515, a sealing shell 513, and an inner core knob 514. The cross-sectional area of ​​the short shaft 511 in the axial direction gradually increases from the distal end to the proximal end. The proximal end of the short shaft 511 is fitted onto the distal end of the long shaft 512. The short shaft 511 and the long shaft 512 are detachably connected by multiple pins 5121. Multiple axially extending channels 5111 are spaced circumferentially on the outer surface of the short shaft 511, with each channel 5111 gradually moving away from the axis of the short shaft 511 from the distal end to the proximal end. Corresponding to each channel 5111, the long shaft 512 has axially extending cavities. The separator 515 is disposed between the short shaft 511 and the long shaft 512. Between them, the separator 515 is provided with through holes and notches corresponding to each channel 5111. When the short shaft 511 is connected to the long shaft 512, each channel 5111 on the short shaft 511 is connected to each cavity on the long shaft 512, so that the components such as the clamp push rod 130, the piercing push rod 240, the probe 400, and the capture device 300 described later can be inserted accordingly. This makes each component relatively close at the far end of the short shaft 511 to facilitate entry into the sheath 600, and relatively diffuse at the proximal end of the short shaft 511 to increase the space between them and facilitate installation onto the corresponding control module on the handle 500. The sealing shell 513 is fitted onto the short shaft 511, and the inner core knob 514 is connected to the proximal end of the long shaft 512 to prevent rotation. By rotating the inner core knob 514, the long shaft 512 and the short shaft 511 can rotate relative to the outer shell 560. When the clamping assembly 100 opens but fails to capture the leaflet, the spindle assembly 510 can be driven to rotate by rotating the inner core knob 514, thereby adjusting the opening direction of the clamping assembly 100 to capture the leaflet again.

[0039] See Figure 1 , Figure 2 , Figure 3 , Figure 5 , Figure 8 and Figure 9 The clamping assembly 100 also includes a insertion tube 150 and a guide rod 140. The distal end of the insertion tube 150 is fixedly connected to the distal clamp 120, and the proximal end of the insertion tube 150 is movably inserted into the proximal clamp 110. The catcher 300 is movably inserted into the insertion tube 150. In this embodiment, two guide rods 140 are provided, and the insertion tube 150 is disposed between the two guide rods 140. The distal end of the guide rod 140 is fixedly connected to the distal clamp 120, and the proximal end of the guide rod 140 is movably inserted into the proximal clamp 110 and fixedly connected to the distal end of the clamp push rod 130.

[0040] The chuck control module 520 includes an opening / closing drive wheel 521, a first slider 522, and a first drive member 523. The opening / closing drive wheel 521 is axially slidably sleeved on the long shaft 512. The proximal end of the chuck push rod 130 is fixedly connected to the opening / closing drive wheel 521. The first slider 522 is embedded in the opening / closing drive wheel 521 and slidably sleeved on the guide rod 568. The first drive member 523 is connected to the first slider 522. In this embodiment, the opening / closing drive wheel 521 has a groove on its circumference, and the first slider 522 is embedded in the groove. The first driving member 523 drives the opening and closing transmission wheel 521 to move axially toward the distal end, and the chuck push rod 130 drives the distal chuck 120 away from the proximal chuck 110, thus opening the clamping assembly 100. When the clamping assembly 100 is in the open state, the first driving member 523 is pushed toward the proximal end, and the first driving member 523 drives the opening and closing transmission wheel 521 to move axially toward the proximal end. The chuck push rod 130 drives the distal chuck 120 to move toward the proximal chuck 110, thus closing the clamping assembly 100.

[0041] See Figure 5 , Figure 8 and Figure 9Specifically, the first driving component 523 includes a first button 5231, a first abutting part 5232, a first limiting and securing part 5233, a first pin 5234, and a first elastic member 5235. The first button 5231 is connected to the first abutting part 5232, which extends axially. The first limiting and securing part 5233 is perpendicular to the first abutting part 5232. One end of the first pin 5234 is fixedly connected to the first abutting part 5232, and the other end of the first pin 5234 is movably inserted into the first slider 522. The first elastic member 5235 is sleeved on the first pin 5234 and pushes the first abutting part 5232 toward the outside of the outer shell 560. The first abutting part 5232 abuts against the outer shell 560. The outer casing 560 is provided with a first guide groove 564 extending along the axial direction and a first slot 563 communicating with the first guide groove 564. The first slot 563 is located outside the first guide groove 564. When the first elastic element 5235 pushes the first limiting safety part 5233 into the first slot 563, it restricts the first driving member 523 from moving axially. In this embodiment, the first supporting part 5232 and the first limiting safety part 5233 are in a cross shape. The upper shell 561 is provided with the first slot 563 and the first guide groove 564. The lower shell 562 is also provided with the first slot 563 and the first guide groove 564. When the first button 5231 is pressed towards the inside of the outer shell 560, the first elastic element 5235 is compressed. The first supporting part 5232 and the first limiting safety part 5233 both move towards the inside of the outer shell 560. The first limiting safety part 5233 enters the first guide groove 564 from the first slot 563. Then the first button 5231 can be moved axially to the far end to drive the first slider 522, the opening and closing transmission wheel 521 and the chuck push rod 130 to move axially to the far end, controlling the clamping assembly 100 to open. Similarly, moving the first button 5231 axially towards the proximal end drives the first slider 522, the opening / closing transmission wheel 521, and the chuck push rod 130 axially towards the proximal end, controlling the clamping assembly 100 to close until the first limit safety part 5233 re-enters the first slot 563. The first limit safety part 5233 and the first elastic element 5235 serve as a safety measure to prevent accidental operation, ensuring that the clamping assembly 100 is opened only after being delivered to the correct position by the first drive element 523.

[0042] See Figure 4 , Figure 5 , Figure 8 , Figure 10 and Figure 11 The puncture assembly 200 also includes a puncture pusher 240, which is axially movable within the sheath 600. The distal end of the puncture pusher 240 abuts against the proximal end of the puncture needle 210 within the sheath 600. In this embodiment, two puncture needles 210 are provided. After the suture 220 passes through the gasket 230, each end of the suture 220 is connected to a puncture needle 210.

[0043] The puncture control module 530 includes a puncture drive wheel 531, a second slider 532, a second drive member 533, and a third elastic member 534. The puncture drive wheel 531 is axially slidably sleeved on the long shaft 512. The proximal end of the puncture push rod 240 is fixedly connected to the puncture drive wheel 531. The second slider 532 is embedded in the puncture drive wheel 531 and slidably sleeved on the guide rod 568. The third elastic member 534 is sleeved on the guide rod 568 on the far side of the puncture drive wheel 531. The second drive member 533 is connected to the second slider 532. In this embodiment, the puncture drive wheel 531 has a groove in the circumferential direction, and the second slider 532 is embedded in the groove of the puncture drive wheel 531.

[0044] The second driving member 533 drives the puncture transmission wheel 531 to slide axially toward the distal end. The puncture push rod 240 pushes the puncture needle 210 to extend out of the proximal clamp 110 and move toward the distal clamp 120 to puncture the valve and enter the distal clamp 120. The puncture transmission wheel 531 squeezes the third elastic member 534. The third elastic member 534 is compressed. After the puncture needle 210 punctures the valve, the third elastic member 534 pushes the second slider 532 to drive the puncture push rod 240 to automatically reset, so that the operator does not need to manually withdraw the puncture push rod 240.

[0045] Please see Figure 5 , Figure 10 , Figure 11 and Figure 12The second driving member 533 includes a second button 5331, a second supporting part 5332, a second limiting and securing part 5333, a second pin 5334, and a second elastic member 5335. The second button 5331 is connected to the second supporting part 5332, which extends axially. The second limiting and securing part 5333 is perpendicular to the second supporting part 5332. One end of the second pin 5334 is fixedly connected to the second supporting part 5332, and the other end of the second pin 5334 is movably inserted into the second slider 532. The second elastic member 5335 is sleeved on the second pin 5334 and pushes the second supporting part 5332 toward the outside of the outer casing 560 so that the second supporting part 5332 abuts against the outer casing 560. The outer shell 560 is provided with a second guide groove 566 extending axially and a second locking groove 565 communicating with the second guide groove 566. The second locking groove 565 is located outside the second guide groove 566. The second elastic member 5335 pushes the second limiting and securing part 5333 into the second locking groove 565 to restrict the axial movement of the second driving member 533. In this embodiment, the second supporting part 5332 and the second limiting and securing part 5333 are in a cross shape. The upper shell 561 is provided with the second locking groove 565 and the second guide groove 566, and the lower shell 562 is also provided with the second locking groove 565 and the second guide groove 566. When the second button 5331 is pressed inwards towards the outer casing 560, the second elastic element 5335 is compressed. Both the second abutting part 5332 and the second limiting safety part 5333 move towards the inner side of the outer casing 560. The second limiting safety part 5333 enters the second guide groove 566 from the second slot 565. Then, the second button 5331 can be moved axially to control the puncture push rod 240 to move distally. The puncture push rod 240 pushes the puncture needle 210 out of the proximal clamp 110 for puncture. The second limiting safety part 5333 and the second elastic element 5335 serve as a safety measure to prevent accidental operation. After confirming that the clamping assembly 100 has clamped the valve, the second driving member 533 controls the puncture needle 210 to perform the puncture.

[0046] See Figure 5 , Figure 8 and Figure 13The probe control module 540 includes a probe drive wheel 541, a third slider 542, a third drive member 543, a locking member 544, an indicator member 545, a fourth elastic member (not shown), and a fifth elastic member 546. The probe drive wheel 541 is axially slidably mounted on a long shaft 512. The proximal end of the probe 400 passes through the sheath 600 and is fixedly connected to the probe drive wheel 541. The distal end of the probe 400 is blunt. The third slider 542 is embedded in the probe drive wheel 541 and slidably mounted on a guide rod 568. The locking member 544 is disposed between the third slider 542 and the third drive member 543, connecting the third slider 542 and the third drive member 543 in a direction perpendicular to the axial direction. The fourth elastic member is compressed between the locking member 544 and the third slider 542. The locking member 544 is provided with a buckle 5441, and the outer shell 560 is provided with a locking part (not shown). The fourth elastic member pushes against the locking member 544 so that the buckle 5441 engages with the locking part, thereby restricting the third drive member 543 from controlling the probe 400 to move axially.

[0047] The indicator 545 is connected to the locking member 544 and extends axially. In this embodiment, the indicator 545 faces the distal end. The housing 560 has a graduated window corresponding to the indicator 545 to facilitate observation of the movement of the indicator 545. The fifth elastic member 546 is compressed and disposed near the third slider 542. One end of the fifth elastic member 546 pushes against the third slider 542, and the other end of the fifth elastic member 546 pushes against the fixing bracket 567. When the buckle 5441 disengages from the locking part, the fifth elastic member 546 pushes the third slider 542 to move distally.

[0048] In this application, when operating the probe 400, the third driving member 543 is first pressed towards the handle 500. The third driving member 543 drives the locking member 544 to squeeze the fourth elastic member, causing the latch 5441 of the locking member 544 to disengage from the locking part of the housing 560. The fifth elastic member 546 pushes the third slider 542 and the detection transmission wheel 541 towards the distal end. The detection transmission wheel 541 drives the probe 400 to extend out of the proximal clamp 110. The position indicated by the indicator 545 on the window is observed to determine whether the clamping assembly 100 has clamped the leaflet. After the clamping assembly 100 clamps the leaflet, the puncture needle 210 needs to puncture the valve. In order to ensure that the puncture needle 210 can puncture the valve, the probe 400 is closer to the guide rod 140 than the puncture needle 210 in the direction perpendicular to the axial direction.

[0049] Please refer to Figure 5 , Figure 8 , Figure 9 , Figure 10 , Figure 11 and Figure 12As shown in this application, the first driving member 523 is located distal to the second driving member 533, and the third driving member 543 is disposed between the first driving member 523 and the second driving member 533. Two first driving members 523 and two second driving members 533 are respectively provided. The two first driving members 523 are respectively installed on opposite sides of the opening / closing transmission wheel 521 in the axial direction, and the two second driving members 533 are respectively installed on opposite sides of the puncture transmission wheel 531 in the axial direction. The clamp control module 520, puncture control module 530, probe control module 540, and other functional modules on the handle 500 are clearly partitioned, easy to operate, and all can avoid misoperation during surgery.

[0050] Please see Figure 4 , Figure 14 , Figure 15 and Figure 16 As shown, the capture device 300 includes a drive unit 310 and a capture coil 320. The drive unit 310 includes a first tube 311 and a second tube 312. The distal end of the first tube 311 is fixedly connected to the capture coil 320, and the proximal end of the first tube 311 is fixedly connected to the distal end of the second tube 312. The first tube 311 and the second tube 312 are movably inserted into the insertion tube 150 within the sheath 600 and the proximal clamp 110. The capture coil 320 extends from the distal end of the insertion tube 150 and is movably accommodated within the distal clamp 120. In this embodiment, the first tube 311 can be made of polyimide, and the second tube 312 can be made of stainless steel. The first tube 311 can bend adaptively with the bending of the sheath 600.

[0051] The capture linkage control module 550 includes a release component 551, a bridging component 552, and a connecting component 553. The release component 551 has a disc-shaped structure, with a triangular protrusion on its proximal side for easy operation. A mounting hole 5511 with an internal thread is provided on the distal side of the release component 551. The bridging component 552 has a through hole 5521, and an external thread 5523 around the through hole that mates with the internal thread. After the second tube 312 passes through the through hole 5521, the proximal end of the second tube 312 is fixedly connected to the connecting component 553. The connector 553 can be made of metal. The connector 553 and the second tube 312 can be fixedly connected by welding or integral processing. The connector 553 is provided with at least one annular boss 5531. The annular boss 5531 is provided with an annular groove 5532. The mounting hole 5511 of the release member 551 is provided with a rib (not shown) that matches the annular groove 5532. The second tube 312 is rotatably installed in the mounting hole 5511 of the release member 551 through the connector 553. Due to the mutual cooperation between the rib and the annular groove 5532, the second tube 312 and the release member 551 are fixedly connected in the axial direction, but the second tube 312 and the release member 551 can rotate relative to each other. One end of the bridging component 552 is movably sleeved on the second tube body 312 through the through hole 5521, and the other end of the bridging component 552 is fixedly connected to the far end of the chuck push rod 130. The bridging component 552 and the release component 551 are detachably connected by the cooperation of internal and external threads.

[0052] Before the puncture needle 210 punctures the valve, the release member 551 and the bridging member 552 are connected. That is, the release member 551 is axially fixedly connected to the drive member 310 of the catcher 300, and the release member 551 is axially fixedly connected to the chuck push rod 130 through the bridging member 552. During the process of pushing the chuck push rod 130 to control the distal chuck 120 to move away from or towards the proximal chuck 110 to clamp the valve leaflet, the catcher 300 and the distal chuck 120 move synchronously. The capture coil 320 of the catcher 300 remains stationary relative to the distal chuck 120, so that the capture coil 320 can always surround the puncture needle 210 in the direction perpendicular to the axial direction. When the puncture needle 210 punctures the valve, the puncture needle 210 enters the capture coil 320. After the puncture needle 210 punctures the valve leaflet and enters the capture coil 320, the release member 551 is rotated, causing the bridging member 552 to disengage from the release member 551. Since the release member 551 is rotatably connected to the drive member 310 of the capture device 300, rotating the release member 551 will not cause the capture device 300 to rotate. Since the chuck push rod 130 is fixedly connected to the opening and closing transmission wheel 521, the chuck push rod 130 remains stationary during the rotation of the release member 551. After the bridging member 552 disengages from the release member 551, the linkage between the chuck push rod 130 and the capture device 300 is released. The release member 551 is then pulled back towards the proximal end, and the capture device 300 is driven to move towards the proximal end, thereby capturing the part of the puncture needle 210 connected to the suture 220 outside the body, so that the suture 220 is sewn onto the valve.

[0053] Please see Figures 17a to 17e , combined Figures 1 to 16 In one application scenario, the valve repair system of this application is used to treat tricuspid regurgitation, and the specific working process is as follows:

[0054] The tissue suture device 10 enters the right atrium and right ventricle via the femoral vein and inferior vena cava. The proximal clamp 110 is located on the atrial side, and the distal clamp 120 is located on the ventricular side.

[0055] With the release element 551 connected to the bridge element 552, the chuck push rod 130, and the catcher 300 in a linked state, press the first button 5231 towards the inside of the handle 500, and then push the first button 5231 towards the distal end. This causes the proximal chuck 110 and the distal chuck 120 to open relative to each other under the action of the chuck push rod 130. Adjust the orientation of the opening between the proximal chuck 110 and the distal chuck 120 using the inner core knob 514, so that the leaflets are positioned between the distal chuck 120 and the proximal chuck 110. Figure 17a As shown.

[0056] Then, pull the first button 5231 towards the proximal end, and the proximal clamp 110 and distal clamp 120 close and clamp the valve; press the third drive member 543 towards the handle 500, and after the latch 5441 of the locking member 544 disengages from the locking part of the outer shell 560, the fifth elastic member 546 pushes the third slider 542 and the detection drive wheel 541 towards the distal end. The detection drive wheel 541 drives the probe 400 to extend out of the proximal clamp 110, and the observation indicator 545... The position indicated on the window is used to determine whether the clamping assembly 100 has clamped the valve. After confirming that the valve has been effectively clamped, the probe 400 is withdrawn. By squeezing the second button 5331 towards the handle 500 and then pushing the second button 5331 distally, the puncture pusher 240 drives the puncture needle 210 to puncture from the atrial side to the ventricular side. The puncture needle 210 drives the suture 220 to puncture the valve and enter the capture coil 320 within the distal clamp 120, as shown. Figure 17b As shown; the third elastic element 534 pushes against the second slider 532, causing the puncture push rod 240 to reset.

[0057] Then, the release element 551 is rotated to disengage it from the bridging element 552. The release element 551 is then retracted proximally, and the capture coil 320 gradually tightens and pulls the puncture needle 210 and suture 220 sequentially into the insertion tube 150 and sheath 600, until the portion of the puncture needle 210 connected to the suture 220 is withdrawn from the body. Figure 17c and Figure 17d As shown.

[0058] like Figure 17e As shown, the portion of suture 220 away from puncture needle 210 and pad 230 are brought out from proximal clamp 110, so that pad 230 contacts the side of valve near the atrium, and the tissue suture device 10 is withdrawn; finally, suture 220 is fixed to the ventricular wall or papillary muscle by anchoring and excess suture 220 is cut, thus completing the implantation of artificial chordae tendineae.

[0059] In one application scenario, the tissue suture device of this application can be implanted into the tricuspid valve via a catheter, and can also enter the right atrium and right ventricle via the superior vena cava.

[0060] In one application scenario, the tissue suture device of this application can be implanted into the mitral valve via a catheter, allowing the artificial chordae tendineae to enter the left atrium and left ventricle through the superior femoral vein, inferior vena cava, and right atrium; it can also enter the left atrium and left ventricle through the superior vena cava and right atrium to reach the mitral valve and suture 220 onto the valve.

[0061] Understandably, the suture device of this application can suture 220 onto each leaflet of the tricuspid or mitral valve, and then lock all sutures 220 with a locking device and cut off the excess sutures to perform edge-to-edge repair of the tricuspid or mitral valve.

[0062] Understandably, in addition to the leaflet tissue of the mitral or tricuspid valve, the tissue suture device of this application can also be used to implant sutures into the papillary muscles of the mitral or tricuspid valve.

[0063] For example, the tissue suture device 10 can enter the left ventricle (e.g., via the femoral artery or aortic arch) or right ventricle through various feasible routes. The proximal clamp 110 and distal clamp 120 clamp the papillary muscle. The puncture needle 210 drives the suture 220 to puncture the papillary muscle and enter the capture coil 320 within the distal clamp 120. Then, the release member 551 is rotated to disengage it from the bridging member 552. The release member 551 is then retracted proximally, and the capture coil... 320 Gradually tighten and pull the puncture needle 210 and suture 220 sequentially into the insertion tube 150 and sheath 600 until the portion of the puncture needle 210 connected to the suture 220 is withdrawn from the body, allowing the portion of the suture 220 away from the puncture needle 210 and the pad 230 to be pulled out from the proximal clamp 110 and sutured onto the papillary muscle; after withdrawing the tissue suture device 10, the suture 220 and puncture needle 210 can be reattached to the tissue suture device 10, and the process can be repeated. Figures 17a to 17d The steps described above allow the suture 220 to pass through the leaflet. Afterwards, the suture 220 is locked and any excess suture 220 is cut, thus completing the implantation of the artificial tendineae. Alternatively, two sets of tissue suture devices 10 can be used to implant the suture 220 into the papillary muscle and leaflet respectively. Finally, the corresponding two sets of sutures 220 are locked and any excess suture 220 is cut, also completing the implantation of the artificial tendineae.

[0064] It is understood that the tissue suture device of this application can also be used to suture sutures to tissues such as valve annulus, apex of heart or ventricular wall, as long as the proximal clamp 110 and the distal clamp 120 clamp the valve annulus or other tissues through feasible interventional approaches.

[0065] It is understood that the above embodiments only illustrate preferred embodiments of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can freely combine the above technical features without departing from the concept of the present invention, and can also make several modifications and improvements, all of which fall within the protection scope of the present invention. Therefore, all equivalent transformations and modifications made with respect to the scope of the claims of the present invention should fall within the scope of the claims of the present invention.

Claims

1. A tissue suture device, characterized by, The device comprises a sheath, a clamping assembly, a puncture assembly, a catcher and a handle. The clamping assembly comprises a proximal clamping head fixedly connected with the distal end of the sheath and a distal clamping head which is opened and closed relative to the proximal clamping head. The puncture assembly comprises a puncture needle movably arranged in the proximal clamping head and a suture fixedly connected with the proximal end of the puncture needle, the puncture needle being used for puncturing tissue and leading the suture through the tissue. The catcher is movably arranged in the sheath and the proximal clamping head, the distal end of the catcher being movably arranged in the distal clamping head, the catcher being used for catching the puncture needle and the suture after puncturing the tissue. The handle comprises a catching linkage control module, the catching linkage control module controlling the distal clamping head and the catcher to be in a linkage state before and during the puncture needle puncturing the tissue and controlling the distal clamping head and the catcher to be in an independent state after the puncture needle puncturing the tissue. The clamping assembly further comprises a clamping push rod movably arranged in the proximal clamping head, the distal end of the clamping push rod being fixedly connected with the distal clamping head; the catcher comprises a driving member movably arranged in the sheath and the proximal clamping head and a catching coil fixedly connected with the distal end of the driving member, the catching coil being movably arranged in the distal clamping head. The catching linkage control module comprises a release member and a bridging member; the release member is fixedly connected with the driving member in the axial direction and rotationally connected with the driving member; one end of the bridging member is fixedly connected with the clamping push rod, the other end of the bridging member is slidably sleeved on the driving member, and the other end of the bridging member is screwed with the release member to form a detachable connection. When the release member and the bridging member are in the connected state, the catcher and the distal clamping head are synchronously linked, and the catching coil remains stationary relative to the distal clamping head; after the bridging member and the release member are disengaged, the linkage is released, and the catcher can be independently withdrawn.

2. The tissue suture device of claim 1, wherein, The handle further comprises a housing and a mandrel assembly rotationally connected with the housing, the distal end of the mandrel assembly being connected with the proximal end of the sheath, the clamping push rod and the driving member being movably arranged on the mandrel assembly, the mandrel assembly being used for driving the clamping assembly, the puncture assembly and the catcher to rotate relative to the housing.

3. The tissue suture device of claim 2, wherein, The mandrel assembly comprises a short shaft and a long shaft detachably connected with the proximal end of the short shaft; the cross-sectional area of the short shaft gradually increases from the distal end to the proximal end in the direction perpendicular to the axial direction, and a plurality of channels extending in the axial direction are formed on the short shaft at intervals; the long shaft is provided with cavities extending in the axial direction and communicating with the corresponding channels.

4. The tissue suture device of claim 3, wherein, The handle further comprises a clamping control module, the clamping control module comprising an opening and closing transmission wheel, a first sliding block and a first driving member. The opening and closing transmission wheel is axially slidably sleeved on the long shaft, the proximal end of the clamping push rod being fixedly connected with the opening and closing transmission wheel; the first sliding block is embedded on the opening and closing transmission wheel; the first driving member is connected with the first sliding block to drive the first sliding block to move in the axial direction.

5. The tissue suture device of claim 4, wherein, The first driving member comprises a first limiting safety part, the shell is provided with a first guide sliding groove extending along the axial direction and a first clamping groove communicated with the first guide sliding groove, when the first limiting safety part enters the first clamping groove, the first driving member is limited to move along the axial direction.

6. The tissue suture device of claim 3, wherein, The puncture assembly further comprises a puncture push rod movably arranged in the sheath and abutting against the proximal end of the puncture needle; The handle further comprises a puncture control module, the puncture control module comprises a puncture transmission wheel, a second sliding block and a second driving member; the puncture transmission wheel is axially slidably sleeved on the long shaft, the proximal end of the puncture push rod is fixedly connected with the puncture transmission wheel; the second sliding block is embedded on the puncture transmission wheel; the second driving member is connected with the second sliding block to drive the second sliding block to move along the axial direction.

7. The tissue suture device of claim 6, wherein, The second driving member comprises a second limiting safety part, the shell is provided with a second guide sliding groove extending along the axial direction and a second clamping groove communicated with the second guide sliding groove, when the second limiting safety part enters the second clamping groove, the second driving member is limited to move along the axial direction.

8. The tissue suture device of claim 6, wherein, The shell is provided with a fixing frame and a guide rod mounted on the fixing frame and extending along the axial direction, the second sliding block is slidably sleeved on the guide rod; a resilient member is sleeved on the guide rod distally to the second sliding block; during the process that the puncture needle punctures the tissue, the second sliding block drives the puncture push rod to move along the axial direction to the distal end and press the resilient member, after the puncture needle punctures the tissue, the resilient member pushes the second sliding block to drive the puncture push rod to reset.

9. The tissue suture device of claim 3, wherein, The tissue suture device further comprises a probe movably arranged in the proximal clamping head and the sheath; The handle further comprises a probe control module, the probe control module comprises a detection transmission wheel, a third sliding block and a third driving member; The detection transmission wheel is axially slidably sleeved on the long shaft, the proximal end of the probe is fixedly connected with the detection transmission wheel; the third sliding block is embedded on the detection transmission wheel; the third driving member is connected with the third sliding block to drive the third sliding block to move along the axial direction.

10. The tissue suture device of claim 9, wherein, The probe control module further comprises a locking member and a resilient member, the locking member is connected with the third sliding block and the third driving member in a direction perpendicular to the axial direction, the locking member is provided with a buckle; the resilient member is compressed between the locking member and the third sliding block, the resilient member pushes the locking member so that the buckle cooperates with a locking part provided on the shell to limit the probe to move along the axial direction; another resilient member is provided on the proximal side of the third sliding block; when the buckle cooperates with the locking part, the other resilient member is compressed; after the buckle is disengaged from the locking part, the other resilient member pushes the third sliding block to move along the axial direction to the distal end.

11. A valve repair system, characterized in that, The tissue suture device comprises the tissue suture device and an adjustable bending sheath sleeved outside the sheath.

12. The valve repair system of Ciaim 11, wherein, The proximal end of the adjustable bending sheath is provided with a bending handle, the proximal end of the bending handle is fixedly connected with a reinforcing tube sleeved outside the sheath tube, and the proximal end of the reinforcing tube is movably inserted into the handle.

13. The valve repair system of Ciaim 12, wherein, The valve repair system further comprises a positioning member which is detachably connected with the handle or the reinforcing tube and is used for keeping the relative position of the reinforcing tube and the handle. The valve repair system further comprises a clamp which clamps the handle and the bending handle.

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