Mitral valve repair device

Abstract

The present application discloses a mitral valve repair device, which includes a tissue clamping device and a control handle; the tissue clamping device includes an outer clamping arm and an inner clamping arm; the control handle includes an outer clamping arm control mechanism and an inner clamping arm control mechanism, the outer clamping arm control mechanism is used to control the opening and closing of the outer clamping arm, and the inner clamping arm control mechanism is used to control the opening and closing of the inner clamping arm relative to the outer clamping arm; the control handle is used to transport the tissue clamping device to the mitral valve via the left atrial appendage and the left atrium, and control the opening and closing of the outer clamping arm and the inner clamping arm so that the mitral valve can be clamped between the outer clamping arm and the inner clamping arm.

Description

Technical Field

[0001] The present application relates to the field of medical equipment, and in particular to a mitral valve repair device. Background Art

[0002] A valve is a membrane-like structure that can be opened and closed inside the organs of humans or certain animals. For example, each person has four valves in their heart, namely the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. Taking the mitral valve as an example, the mitral valve is located between the left atrium and the left ventricle. When the left ventricle contracts, the mitral valve acts as a check valve to tightly close the atrioventricular orifice to prevent blood from flowing back from the left ventricle into the left atrium. However, when the mitral valve is diseased, it may be difficult to close completely when the left ventricle contracts, causing the left atrium to receive a large amount of reflux blood, which may cause a sharp increase in left atrium and pulmonary venous pressure, increase the left ventricular diastolic volume load, and further lead to a series of pathological changes such as left ventricular enlargement and pulmonary hypertension, ultimately leading to clinical manifestations such as heart failure and arrhythmia, which can be life-threatening in severe cases. When repairing a diseased mitral valve, the mitral valve repair device can be used to clamp the opposite side of the mitral valve, so that the hole between the mitral valves changes from one large hole to two small holes, reducing the regurgitation area, thereby effectively preventing the occurrence of mitral valve regurgitation. Similarly, the mitral valve repair device can also be used to repair other valves such as the tricuspid valve of the heart, and the effect of reducing the regurgitation area is achieved by clamping the valve leaflets on both sides. Summary of the invention

[0003] One of the embodiments of the present application provides a mitral valve repair device, which includes a tissue clamping device and a control handle; the tissue clamping device includes an outer clamping arm and an inner clamping arm; the control handle includes an outer clamping arm control mechanism and an inner clamping arm control mechanism, the outer clamping arm control mechanism is used to control the opening and closing of the outer clamping arm, and the inner clamping arm control mechanism is used to control the opening and closing of the inner clamping arm relative to the outer clamping arm; the control handle is used to transport the tissue clamping device to the mitral valve via the left atrial appendage and the left atrium, and control the opening and closing of the outer clamping arm and the inner clamping arm so that the mitral valve can be clamped between the outer clamping arm and the inner clamping arm. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The present application will be further described in the form of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

[0005] Figure 1 is a schematic diagram of the structure of a mitral valve repair device according to some embodiments of the present application;

[0006] Figure 2is a schematic diagram of the structure of a tissue clamping device and a delivery connector according to some embodiments of the present application;

[0007] Figure 3 is a schematic structural diagram of an outer clamping arm of a tissue clamping device in an open state according to some embodiments of the present application;

[0008] Figure 4 is a schematic diagram of the structure of a conveying connection according to some embodiments of the present application;

[0009] Figure 5 is a structural schematic diagram of a tissue clamping device in a closed state according to another embodiment of the present application;

[0010] Figure 6 is a structural schematic diagram of a tissue clamping device in an open state according to another embodiment of the present application;

[0011] Figure 7 is a schematic diagram of the main structure of a curved tube according to some embodiments of the present application;

[0012] Figure 8 is a schematic diagram of a rear view structure of a curved tube according to some embodiments of the present application;

[0013] Fig. 9 is a schematic diagram of an exploded structure of a bending tube according to some embodiments of the present application;

[0014] Fig.10 is a schematic diagram of an exploded structure of a bending pipe control mechanism according to some embodiments of the present application;

[0015] Fig.11 is a schematic diagram of a partial cross-sectional structure of an outer clamp arm control mechanism according to some embodiments of the present application;

[0016] Fig.12 is a schematic diagram of the structure of a sleeve according to some embodiments of the present application;

[0017] Fig.13 is a schematic diagram of the exploded structure of the sliding part and the protective cover according to some embodiments of the present application;

[0018] Fig.14 is a structural schematic diagram of an outer clamp arm control mechanism according to another embodiment of the present application;

[0019] Fig.15 is a schematic diagram of the internal structure of an outer clamp arm control mechanism according to another embodiment of the present application;

[0020] Fig.16 is a structural schematic diagram of a thread engagement mechanism according to another embodiment of the present application;

[0021] Fig.17 is a schematic structural diagram of an engaging member of a thread engaging mechanism according to another embodiment of the present application;

[0022] Fig.18 is a schematic diagram of a partial cross-sectional structure of a sliding portion according to another embodiment of the present application;

[0023] Fig.19 is a schematic diagram of the exploded structure of a sliding part according to another embodiment of the present application;

[0024] Fig. 20 is a schematic diagram of an outer clamp arm control mechanism capable of indicating the opening and closing angle of the outer clamp arm according to some embodiments of the present application;

[0025] Fig.21 is a schematic diagram of a first indicating device according to some embodiments of the present application;

[0026] Fig. 22 is a schematic diagram of a first prompting device according to some embodiments of the present application;

[0027] Fig.23 is a partial cross-sectional structural schematic diagram of an inner clamp arm control mechanism according to some embodiments of the present application;

[0028] Fig.24 is a schematic diagram of a housing according to some embodiments of the present application;

[0029] Fig.25 is a schematic diagram of the structure of a second control unit according to some embodiments of the present application;

[0030] Fig.26 is a structural schematic diagram of a second control unit and a locking mechanism at a first viewing angle according to some embodiments of the present application;

[0031] Fig. 27 is a structural schematic diagram of a second control unit and a locking mechanism at a second viewing angle according to some embodiments of the present application;

[0032] Fig.28 is a schematic diagram of an inner clamp arm control mechanism capable of indicating the opening and closing angle of the inner clamp arm according to some embodiments of the present application;

[0033] Fig.29 is a schematic diagram of a second indicating device according to some embodiments of the present application.

[0034] In the figure: 100-mitral valve repair device; 200-tissue clamping device; 210-inner clamping arm; 211-first inner clamping arm; 213-second inner clamping arm; 215-barb; 220-outer clamping arm; 221-first outer clamping arm; 223-second outer clamping arm; 230-fixing member; 240-supporting part; 250-connecting member; 260-outer clamping plate; 261-first outer clamping plate; 263-second outer clamping plate; 270-connecting tube; 280-elastic locking member; 300-control handle; 400-outer clamping arm control mechanism; 410-sleeve ;412-first slide groove;420-first control part;421-connecting groove;429-connecting block;430-sliding part;431-outer cover;433-middle tube;434-opening;435-inner tube;437-block;438-slot;439-grip;440-driving rod;450-threaded bite mechanism;451-control button;453-first elastic member;455-bite member;456-pressing part;457-bite part;460-fixing block;470-protective cover;480-boss;500-inner clamp arm control control mechanism; 510-housing; 511-second slide; 520-second control unit; 521-pipe; 523-end cover; 530-locking mechanism; 531-second elastic member; 533-locking button; 535-locking block; 537-toothed connecting part; 600-transporting tube; 610-bending tube; 612-inner core; 614-outer tube; 616-notch; 620-bending tube control mechanism; 621-screw; 622-rotating part; 623-traction part; 625-traction rope; 627-threaded traction block; 629-bending Curved indicating device; 700-transport connecting piece; 710-main body; 720-first connecting piece; 730-second connecting piece; 740-fixed support rod; 810-first indicating device; 811-opening and closing angle mark; 821-first sensor; 823-processor; 825-display; 830-first prompting device; 831-first contact part; 833-second contact part; 835-speaker; 910-second indicating device; 911-opening and closing angle mark; 921-second sensor; 923-processor; 925-display. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical solution and advantages of the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0036] On the contrary, the present application covers any substitution, modification, equivalent method and scheme made on the essence and scope of the present application as defined by the claims. Further, in order to make the public have a better understanding of the present application, some specific details are described in detail in the detailed description of the present application below. Those skilled in the art can fully understand the present application without the description of these details.

[0037] Embodiments of the present application relate to a mitral valve repair device and a control handle thereof. The mitral valve repair device can be used to repair the mitral valve or other valves (such as the tricuspid valve). The mitral valve repair device may include a tissue clamping device and a control handle. The tissue clamping device may be used to clamp the valve to repair the valve. The control handle may be used to transport and manipulate the tissue clamping device. In some embodiments, the tissue clamping device may reach a predetermined position through a variety of paths. For example, the tissue clamping device may be transported to the mitral valve via the femoral vein, the inferior vena cava, the right atrium, and the left atrium to repair the mitral valve. For another example, the tissue clamping device may be transported to the mitral valve via the left atrial appendage and the left atrium to repair the mitral valve.

[0038] Figure 1 is a schematic diagram of the structure of a mitral valve repair device according to some embodiments of the present application; Figure 2 is a schematic diagram of the structure of a tissue clamping device and a delivery connector according to some embodiments of the present application; Figure 3 is a schematic structural diagram of an outer clamping arm of a tissue clamping device in an open state according to some embodiments of the present application; Figure 4 Schematic diagram of the structure of the delivery connector according to some embodiments of the present application. Figure 1-4 As shown, the mitral valve repair device 100 may include a tissue clamping device 200 and a control handle 300. The tissue clamping device 200 may include an outer clamping arm 220 and an inner clamping arm 210; the control handle 300 may correspondingly include an outer clamping arm control mechanism 400 and an inner clamping arm control mechanism 500. The outer clamping arm control mechanism 400 can be used to control the opening and closing of the outer clamping arm 220 of the tissue clamping device 200, and the inner clamping arm control mechanism 500 can be used to control the opening and closing of the inner clamping arm 210 relative to the outer clamping arm 220, so that the control handle 300 can control the opening and closing of the outer clamping arm 220 and the inner clamping arm 210 so that the valve (such as the mitral valve) can be clamped between the outer clamping arm 220 and the inner clamping arm 210.

[0039] In some embodiments, the mitral valve repair device 100 may include a delivery tube 600; the tissue clamping device 200 is connected to the control handle 300 through the delivery tube 600. In some embodiments, the delivery tube 600 can be bent (for example, the delivery tube 600 is made of an elastic material); the control handle 300 can deliver the tissue clamping device 200 to the mitral valve via the femoral vein, the inferior vena cava, the right atrium or the left atrium through the bendable delivery tube 600. In some embodiments, the delivery tube 600 is not bendable (for example, the delivery tube 600 is made of a rigid material). In this case, the control handle 300 can deliver the tissue clamping device 200 to the mitral valve via the left atrial appendage or the left atrium through the inflexible delivery tube 600. In some embodiments, in order to make the tissue clamping device 200 more manipulable when being delivered to the mitral valve via the left atrial appendage and the left atrium, the delivery tube 600 may include a curved tube 610. Figure 1 As shown, the bending tube 610 can be located at the front end of the delivery tube 600 (i.e., one end close to the tissue clamping device 200). Accordingly, the control handle 300 can include a bending tube control mechanism 620, which can be used to control the bending of the bending tube 610. For more details about the bending tube 610 and the bending tube control mechanism 620, please refer to other embodiments of the present application (such as Figure 7-10 By delivering the tissue clamping device 200 to the mitral valve via the left atrial appendage and the left atrium, the operation of mitral valve repair can be made more convenient, and the efficiency and success rate of repair can be increased. In addition, when the delivery tube 600 is not bendable or the delivery tube 600 includes a curved tube 610, the mitral valve repair device 100 can also be used for other purposes. For example, the mitral valve repair device 100 can be used to perform valve repair experiments on animals (such as pigs).

[0040] In some embodiments, Figure 2-4 As shown, the tissue clamping device 200 may include an inner clamp arm 210, an outer clamp arm 220, a fixing member 230, a support portion 240, a connecting member 250 and an outer clamp plate 260. The inner clamp arm 210 may include a first inner clamp arm 211 and a second inner clamp arm 213; the outer clamp arm 220 may include a first outer clamp arm 221 and a second outer clamp arm 223; and the outer clamp plate 260 may include a first outer clamp plate 261 and a second outer clamp plate 263. One side of the support portion 240 is bendably connected to the first outer clamp arm 221 and the first outer clamp plate 261 in sequence, and the other side of the support portion 240 is bendably connected to the second outer clamp arm 223 and the second outer clamp plate 263 in sequence. The first outer clamp arm 221 and the second outer clamp arm 223 can be bent relative to the support portion 240 and relatively closed, and the first outer clamp arm 221 and the second outer clamp arm 223 can also be bent away from the support portion 240 and relatively open. Figure 2The tissue clamping device 200 is shown in a state where the first outer clamping arm 221 and the second outer clamping arm 223 are relatively closed; Figure 3 The tissue clamping device 200 shown is in a state where the first outer clamping arm 221 and the second outer clamping arm 223 are relatively opened to 180 degrees. The angle at which the first outer clamping arm 221 and the second outer clamping arm 223 are relatively opened can be any angle, such as 10°, 40°, 90°, 120°, 180°, 270°, 350°, 360°, etc. In some embodiments, the outer clamping arm 220, the support portion 240 and the outer clamping plate 260 can be an integrally formed structure. For example, the outer clamping arm 220, the support portion 240 and the outer clamping plate 260 can be an integrally formed structure made of shape memory alloy pipes through cutting and heat treatment. In some embodiments, as Figure 2 As shown, one end of the support portion 240 (the upper end shown in the figure) is connected to (such as fixedly connected to) the connecting member 250, and one end of the first outer clamping plate 261 (the lower end shown in the figure) and one end of the second outer clamping plate 263 (the lower end shown in the figure) are respectively connected to (such as fixedly connected to) the fixing member 230. With such an arrangement, when the fixing member 230 moves relative to the connecting member 250, the fixing member 230 can move relative to the support portion 240. When the fixing member 230 is away from the support portion 240, driven by the fixing member 230, the first outer clamping plate 261 and the second outer clamping plate 263 can respectively pull the first outer clamping arm 221 and the second outer clamping arm 223 to open relative to each other. Figure 2-4 In the embodiment shown, the outer clamp arm control mechanism 400 can control the opening and closing of the outer clamp arm 220 of the tissue clamping device 200 through the driving rod 440. Specifically, one end of the driving rod 440 (eg Figure 2 The lower end of the outer clamp arm 220 of the tissue clamping device 200 can have a threaded structure, through which the drive rod 440 can be detachably connected to the fixing member 230. The outer clamp arm control mechanism 400 can control the fixing member 230 to move relative to the connecting member 250 by pushing and pulling the drive rod 440, thereby controlling the opening and closing of the outer clamp arm 220 of the tissue clamping device 200.

[0041] In some embodiments, the first inner clamp arm 211 can be arranged on the first outer clamp arm 221, and the second inner clamp arm 213 can be arranged on the second outer clamp arm 223. The first inner clamp arm 211 and the second inner clamp arm 213 can be opened and closed relative to the first outer clamp arm 221 and the second outer clamp arm 223, respectively, and the tissue can be clamped between the first inner clamp arm 211 and the first outer clamp arm 221 and between the second inner clamp arm 213 and the second outer clamp arm 223. In some embodiments, the inner clamp arm 210 can be a barbed clamp. For example, a barb 215 can be installed at the movable end of the inner clamp arm 210. In some embodiments, the inner clamp arm 210 and the outer clamp arm 220 can be connected by a bending portion (such as an S-bar bending structure), and the bending portion can have a prefabricated resilience, so that the inner clamp arm 210 can be close to the outer clamp arm 220 in a natural state. In some embodiments, the inner clamp arm control mechanism 500 can control the opening and closing of the inner clamp arm 210 relative to the outer clamp arm 220 through a traction rope (not shown in the figure). For example, the traction rope can be connected to the movable end of the inner clamp arm 210. When the inner clamp arm control mechanism 500 pulls the traction rope, the inner clamp arm 210 can be opened relative to the outer clamp arm 220 under the tension of the traction rope; when the traction rope is relaxed, the inner clamp arm 210 can be closed with the outer clamp arm 220 under the prefabricated resilience of the bending portion. In some embodiments, the traction rope can include steel wire, nanowire or glass rope, etc., which is not limited in the present application.

[0042] In some embodiments, the delivery tube 600 can be detachably connected to the tissue clamping device 200 via a delivery connector 700. The delivery connector 700 is provided with through holes for the driving rod 440 and the traction rope to pass through respectively. Figure 2 and Figure 4In the illustrated embodiment, the transport connector 700 may include a main body 710, a first connector 720 and a second connector 730. The connection between the first connector 720 and the second connector 730 and the main body 710 may have a prefabricated resilience, which enables the first connector 720 and the second connector 730 to automatically open in a natural state. A fixed support rod 740 may also be provided in the middle of the first connector 720 and the second connector 730, and the fixed support rod 740 is respectively perpendicular to the first connector 720 and the second connector 730, and a through hole for the driving rod 440 to pass through is provided at one end of the fixed support rod 740 that is suspended. When the transport connector 700 is connected to the connector 250 of the tissue clamping device, the first connector 720 and the second connector 730 are relatively closed and are respectively engaged with the protrusions on the connector 250. At this time, the driving rod 440 can pass through the through hole on the fixed support rod 740 connected to the first connecting piece 720 and the second connecting piece 730, and the driving rod 440 will limit the first connecting piece 720 and the second connecting piece 730 from opening. When it is necessary to disengage the transport connector 700 from the tissue clamping device 200, the connection between the driving rod 440 and the tissue clamping device 200 (such as the fixing piece 230) can be released first and the driving rod 440 can be withdrawn, so that the driving rod 440 is disengaged from the through hole on the fixed support rod 740 connected to the first connecting piece 720 and the second connecting piece 730, so that the first connecting piece 720 and the second connecting piece 730 are automatically opened and disengaged from the clamping connection with the protrusion on the connector 250. In some embodiments, the transport connector 700 can be an integrally formed structure made of a shape memory alloy tube after cutting and heat treatment.

[0043] In some embodiments, the tissue clamping device 200 may also be in other alternative structural forms. For example, Figure 5 is a structural schematic diagram of a tissue clamping device in a closed state according to another embodiment of the present application; Figure 6 1 is a schematic structural diagram of a tissue clamping device in an open state according to another embodiment of the present application. Figure 5-6 In the illustrated embodiment, the tissue clamping device 200 may include a fixing member 230, an inner clamp arm 210, and an outer clamp arm 220. The inner clamp arm 210 may include a first inner clamp arm 211 and a second inner clamp arm 213, the inner clamp arm 210 is disposed on the fixing member 230, and the first inner clamp arm 211 and the second inner clamp arm 213 can be closed or opened with each other. The outer clamp arm 220 may include a first outer clamp arm 221 and a second outer clamp arm 223, the first outer clamp arm 221 and the second outer clamp arm 223 are both disposed on the fixing member 230, the first outer clamp arm 221 and the second outer clamp arm 223 can be relatively closed or opened, and a valve (such as a mitral valve) can be clamped between the first inner clamp arm 211 and the first outer clamp arm 221 and between the second inner clamp arm 213 and the second outer clamp arm 223.

[0044] exist Figure 5-6 In the illustrated embodiment, the tissue clamping device 200 may further include a connecting tube 270 and an elastic locking member 280. The delivery tube 600 may be detachably connected to the connecting tube 270 (e.g., threaded connection). The driving rod 440 may be directly or indirectly connected to the fixing member 230. The outer clamping arm 220 may be rotatably connected to the fixing member 230 and the connecting tube 270 through a connecting rod structure. The outer clamping arm control mechanism 400 may control the fixing member 230 to move relative to the connecting tube 270 by pushing and pulling the driving rod 440, thereby controlling the opening and closing of the outer clamping arm 220 of the tissue clamping device 200. When the outer clamping arm 220 is opened and closed to a certain angle (e.g., 10°, 90°, 150°, 180°, etc.) or closed, the elastic locking member disposed on the fixing member 230 may cooperate with the bayonet on the connecting tube 270, thereby forming a certain resistance to the opening and closing of the outer clamping arm 220. In some embodiments, the inner clamp arm 210 may be an integrally formed U-shaped structure and have a prefabricated resilience to open outward. The inner clamp arm control mechanism 500 may control the inner clamp arm 210 to open and close relative to the outer clamp arm 220 through a traction rope (not shown in the figure). For example, the traction rope may be connected to the movable end of the inner clamp arm 210. When the inner clamp arm control mechanism 500 pulls the traction rope, the inner clamp arm 210 may open relative to the outer clamp arm 220 under the tension of the traction rope (that is, the first inner clamp arm 211 and the second inner clamp arm 213 are closed together); when the traction rope is relaxed, the inner clamp arm 210 may open outward under the action of its prefabricated resilience and thus close relative to the outer clamp arm 220. Specifically, the first inner clamp arm 211 and the first outer clamp arm 221 may be controlled separately to open or close relative to the first outer clamp arm 221 and the second outer clamp arm 223, respectively.

[0045] The following will be Figure 2-4 The control handle 300 is described by taking the tissue clamping device 200 shown in the figure as an example. It should be noted that the control handle described in the following embodiments is only for illustrative purposes and does not constitute a limitation thereto. Part or all of the structure of the control handle 300 can be applied not only to Figure 2-4 The tissue clamping device 200 shown can also be applied to other types of tissue clamping devices (e.g., Figure 5-6 Tissue clamping device shown).

[0046] In some embodiments, the control handle 300 includes an outer clamp arm control mechanism 400 and an inner clamp arm control mechanism 500. The outer clamp arm control mechanism 400 is used to control the movement of the outer clamp arm 220 of the tissue clamping device 200; the inner clamp arm control mechanism 500 is used to control the movement of the inner clamp arm 210 of the tissue clamping device 200. In some embodiments, when the delivery tube 600 includes a bending tube 610, the control handle 300 may include a bending tube control mechanism 620, and the bending tube control mechanism 620 can be used to control the bending of the bending tube 610. In some embodiments, when the delivery tube 600 does not include a bending tube 610 (such as when the delivery tube 600 is a non-bendable structure), the control handle 300 may not have a bending tube control mechanism 620.

[0047] Figure 7 is a schematic diagram of the main structure of a curved tube according to some embodiments of the present application; Figure 8 is a schematic diagram of a rear view structure of a curved tube according to some embodiments of the present application; Fig. 9 Schematic diagram of the decomposition structure of the bending pipe according to some embodiments of the present application. Figure 7-9 As shown, the curved tube 610 can be connected to the front end of the delivery tube 600 (i.e., one end close to the tissue clamping device 200). For example, the curved tube 610 can be connected to the body of the delivery tube 600 (such as laser welding) or integrally formed. The front end of the curved tube 610 can be connected to the delivery connector 700. In some embodiments, the curved tube 610 can include an inner core 612 and an outer tube 614. The outer tube 614 is sleeved outside the inner core 612. One end of the delivery connector 700 can be sleeved outside the inner core 612 and snap-fitted with the outer tube 614. In some embodiments, one or more through holes can be provided inside the inner core 612 for the drive rod 440 and the traction rope that controls the opening and closing of the inner clamp arm 210 to pass through.

[0048] exist Figure 7-9In the illustrated embodiment, the bending tube 610 is provided with a plurality of notches 616 along the length direction. Specifically, a plurality of notches 616 are provided on the outer tube 614 of the bending tube 610. By providing a plurality of notches 616, the bending tube 610 can be easily bent, and the bending tube can be bent along a specific direction. In the present embodiment, a plurality of notches 616 are provided on one side of the bending tube 610, so that the bending tube can be bent in the opening direction of the notches. In other embodiments, a plurality of notches 616 can also be provided at intervals on different sides of the bending tube 610, so that the bending tube 610 can be bent in multiple directions. In some embodiments, the outer tube 614 of the bending tube 610 can be cut from a stainless steel tube (such as 316 tubing) or an elastic metal (such as nickel-titanium alloy). The inner core 612 of the bending tube 610 can be made of an elastic material (such as nylon, silicone, heat-shrinkable polyether block polyamide (Pebax), polytetrafluoroethylene (PTFE) material, etc.). In some embodiments, the curved tube 610 is elastic; when there is no external force, the curved tube 610 can maintain a cylindrical shape. Furthermore, a polymer material layer (such as a heat-shrinkable polyether block polyamide (Pebax) material) can be provided on the outer surface of the curved tube 610, so as to effectively reduce the contact of blood with the tube. In some embodiments, a plurality of notches 616 are provided on one side of the curved tube 610, and a groove can be provided on one side of the inner core 612 facing the opening direction of the notch 616, and the traction rope 625 can be provided in the groove. Specifically, the front end of the traction rope 625 can be fixedly connected to the inner core 612 and / or the outer tube 614 (such as welding, gluing, etc.). The curved tube control mechanism 620 can control the bending of the curved tube 610 through the traction rope 625.

[0049] Fig.10 is a schematic diagram of the exploded structure of the bending tube control mechanism according to some embodiments of the present application. Fig.10As shown, the bending tube control mechanism 620 may include a screw 621, a rotating part 622 and a traction part 623; the screw 621 and the traction part 623 are threadedly connected; the rotating part 622 can drive the screw 621 to rotate, thereby driving the traction part 623 to move; the movement of the traction part 623 can control the bending of the bending tube 610. In some embodiments, the traction part 623 may include a traction rope 625 and a threaded traction block 627; one end (such as the tail end) of the traction rope 625 is connected to the threaded traction block 627, and the other end (such as the front end) is fixedly connected to the front end of the bending tube 610, the screw 621 is provided with an internal thread, and the threaded traction block 627 is movably arranged inside the screw 621 and matched with the internal thread of the screw 621. When the rotating part 622 drives the screw 621 to rotate, the screw 621 drives the threaded traction block 627 to move in the length direction inside the screw 621, thereby achieving the traction or relaxation of the traction rope 625, thereby controlling the bending of the bending tube 610. Specifically, the traction of the bending tube 610 by the traction rope 625 can make the multiple notches 616 on the bending tube 610 close together, so that the bending tube 610 bends. When the threaded traction block 627 stops moving, the bending tube 610 can maintain the bending state. When the threaded traction block 627 releases the traction rope 625, the bending tube 610 can reduce the degree of bending under the action of its own elastic force until it returns to a natural state (such as maintaining a cylindrical shape).

[0050] In some embodiments, Fig.10 As shown, the bending tube control mechanism 620 may include a bending indication device 629. The bending indication device 629 may be used to indicate the degree of bending of the bending tube 610. In some embodiments, the bending indication device 629 may include an indication block, which may be meshed with the external thread of the screw 621 and move with the rotation of the screw 621, and the degree of bending of the bending tube 610 may be reflected by the moving position of the indication block. In some embodiments, the moving position of the indication block may correspond to the bending angle of the bending tube 610 one by one. The corresponding relationship between the two may be determined by experiments. In some embodiments, the bending indication device 629 may also include an indication mark, which may be set on a shell (such as a transparent shell covering the outside of the indication block) to intuitively reflect the degree of bending (such as the bending angle) of the bending tube 610 corresponding to the movement of the indication block to a specific position.

[0051] Fig.11 is a schematic diagram of a partial cross-sectional structure of an outer clamp arm control mechanism according to some embodiments of the present application; Fig.12 is a schematic diagram of the structure of a sleeve according to some embodiments of the present application; Fig.13 is a schematic diagram of the exploded structure of the sliding part and the protective cover according to some embodiments of the present application; Fig.14 is a structural schematic diagram of an outer clamp arm control mechanism according to another embodiment of the present application; Fig.15is a schematic diagram of the internal structure of an outer clamp arm control mechanism according to another embodiment of the present application; Fig.16 is a structural schematic diagram of a thread engagement mechanism according to another embodiment of the present application; Fig.17 FIG. 1 is a schematic diagram of the structure of the engaging member of the thread engaging mechanism according to another embodiment of the present application. Figure 11-16 As shown, the outer clamp arm control mechanism 400 may include a sleeve 410, a first control portion 420 and a sliding portion 430, wherein the sliding portion 430 is disposed in the sleeve 410; the first control portion 420 can drive the sliding portion 430 to move in the sleeve 410 along the length direction of the sleeve 410 by rotating to control the opening and closing of the outer clamp arm 220. If the end of the control handle 300 close to the tissue clamping device 200 is defined as the front end, and the other end of the opposite control handle 300 is defined as the rear end, the sliding portion 430 moving toward the front end in the sleeve 410 can be used to control the opening of the outer clamp arm 220 (such as the relative opening of the first outer clamp arm 221 and the second outer clamp arm 223), and the sliding portion 430 moving toward the rear end can be used to control the closing of the outer clamp arm 220.

[0052] In some embodiments, the sleeve 410 may have one or more interlayers, the sliding part 430 is disposed in the interlayer of the sleeve 410, and the first control part 420 can drive the sliding part 430 to move in the sleeve 410 along the length direction of the sleeve 410. For example, the sleeve 410 may be in the shape of a hollow cylinder, which may be formed by connecting two semi-cylindrical shells, the sliding part 430 is in the shape of a cylinder, and the sliding part 430 can be clamped between the two semi-cylindrical shells of the sleeve 410.

[0053] In some embodiments, reference Figure 11-12 , the outer circumference of the sleeve 410 may be provided with an external thread; the inner circumference of the first control part 420 may be provided with an internal thread; the sleeve 410 and the first control part 420 are connected by threads. The sleeve 410 may be provided with a first slide groove 412 along the length direction; the sliding part 430 passes through the first slide groove 412 and is connected to the first control part 420. Specifically, the sliding part 430 may include a protruding connection block 429, and the inner circumference of the first control part 420 may include a connection groove 421, the connection block 429 can extend from the first slide groove 412 and be engaged with the connection groove 421, so that the first control part 420 can drive the sliding part 430 to move along the first slide groove 412 when rotating. In the embodiment of the present application, the sleeve 410 may include two first slide grooves 412, which are respectively arranged on both sides of the sleeve 410, and the sliding part 430 is correspondingly provided with two protruding connection blocks 429; thereby, the stability of the movement of the sliding part 430 driven by the first control part 420 can be ensured. In some alternative embodiments, the number of the first sliding grooves 412 may be one, three, five, etc.

[0054] In some embodiments, the first control part 420 may have a circular outer contour, and a rubber layer may be provided on the surface of the outer contour. When the operator controls the outer clamp arm 220 by rotating the first control part 420, the rubber layer can increase the friction between the first control part 420 and the palm or finger, so that the operator can achieve precise control. In other embodiments, the outer contour surface of the first control part 420 may not be provided with a rubber layer but may be made of a hard material such as plastic, metal, etc., and anti-slip grooves may be provided on its surface to increase surface friction.

[0055] In some embodiments, Figure 11-13 As shown, the outer clamp arm control mechanism 400 may include a driving rod 440, a fixing block 460 and a protective cover 470; the sliding part 430 may control the opening and closing of the outer clamp arm 220 through the driving rod 440, and the rear end of the driving rod 440 is fixedly connected to the fixing block 460. Specifically, the fixing block 460 may be cylindrical, and its cross-sectional diameter may be larger than the cross-sectional diameter of the driving rod 440. The driving rod 440 may be inserted into the fixing block 460 and fixedly connected to the fixing block 460 by means of gluing, welding or interference connection. The protective cover 470 may be detachably connected to the sliding part 430 by threads; when the protective cover 470 is connected to the sliding part 430, the protective cover 470 may limit the relative movement of the fixing block 460 and the sliding part 430. In some embodiments, the driving rod 440 can be made of a memory alloy (such as nickel-titanium alloy), so that the driving rod 440 can have better tensile and compressive resistance and better bending performance; and then when the delivery tube 600 is bent, the outer clamp arm control mechanism 400 can also effectively control the opening and closing of the outer clamp arm 220 through the driving rod 440.

[0056] In some embodiments, when the tissue clamping device 200 has completed clamping, the driving rod 440 needs to be separated from the tissue clamping device 200 and withdrawn from the control handle 300 (eg, completely withdrawn or withdrawn a certain distance). Figure 11-13 As shown, the protective cover 470 is detachably connected to the sliding portion 430 through a thread. When the driving rod 440 needs to be disengaged, the operator can rotate the protective cover 470 to disengage it from the sliding portion 430, and then the operator can rotate the fixing block 460 (i.e., rotate the driving rod 440) to separate the driving rod 440 from the tissue clamping device, and then the operator can pull the fixing block 460 to withdraw the driving rod 440 from the control handle 300.

[0057] In some embodiments, Figure 14-17As shown, the first control part 420 may include a thread engagement mechanism 450. The thread engagement mechanism 450 includes a control button 451, a first elastic member 453 and a pair of engagement members 455; the engagement members 455 are symmetrically arranged (e.g., centrally symmetrical) and are configured to engage with the external thread of the sleeve 410 through the elastic force of the first elastic member 453; the control button 451 is arranged around the outer side of the engagement member 455 to control the engagement member 455 to overcome the elastic force of the first elastic member 453 and disengage from the external thread of the sleeve 410. Figure 14-17 As shown, the bite member 455 may include a pressing portion 456 and a bite portion 457, and the pressing portion 456 and the bite portion 457 may be fixedly connected or integrally formed. The inner circumferential surface of the bite portion 457 may be provided with a tooth-shaped structure adapted to the external thread of the sleeve 410. A pair of bite members 455 are arranged oppositely and annularly arranged on the outer circumferential surface of the sleeve 410. Under the action of the first elastic member 453, the bite portions 457 of the two bite members 455 may both be engaged with the external thread of the sleeve 410. In this embodiment, the first elastic member 453 may include two springs, which are respectively arranged on both sides of the pair of bite members 455.

[0058] In actual operation, the operator presses two control buttons 451, and the control buttons 451 drive a pair of bite pieces 455 to move relative to each other and compress the first elastic member 453 so that the tooth-shaped structure inside the bite piece 455 is disengaged from the outer thread of the sleeve 410, so that the first control part 420 and the sleeve 410 can slide relative to each other in the length direction. At this time, the operator can directly drag the first control part 420 to slide on the sleeve 410, so as to realize the rapid opening and closing of the outer clamp arm 220. By controlling the rapid opening and closing of the outer clamp arm 220, the operator can operate more flexibly during surgery (such as mitral valve repair) to adapt to different surgical conditions. When the operator releases the control button, driven by the elastic force of the first elastic member 453, the bite piece 455 re-engages with the outer thread of the sleeve 410, and the operator can rotate the first control part 420 as needed to fine-tune the opening and closing angle of the outer clamp arm 220 or perform the next operation. By providing two opposite control buttons 451 , it is convenient for the operator to quickly open and close the outer clamp arm 220 , and it is also possible to effectively prevent the operator from making a wrong operation due to an accidental touch.

[0059] Fig.18 is a schematic diagram of a partial cross-sectional structure of a sliding portion according to another embodiment of the present application; Fig.19 FIG. 1 is a schematic diagram of the exploded structure of a sliding part according to another embodiment of the present application. Figure 18-19As shown, the sliding part 430 may include an outer cover 431, a middle tube 433 and an inner tube 435; the middle tube 433 is sleeved outside the inner tube 435; the middle tube 433 is provided with an opening 434, and the inner tube 435 is provided with a block 437 that can extend outward, and the block 437 can pass through the opening 434 and engage with the outer cover 431 to limit the relative movement of the middle tube 433, the inner tube 435 and the outer cover 431 in the length direction. The driving rod 440 can be fixedly connected to the inner tube 435. For example, one end of the driving rod 440 can be fixed in the inner tube 435 by means of clamping, gluing, interference connection, etc. In this embodiment, the block 437 on the inner tube 435 may have a wedge-shaped outer profile, and a groove adapted to the block 437 may be opened on the inner wall of the outer cover 431. The block 437 passes through the opening of the middle tube 433 and is embedded in the groove to limit the relative movement of the outer cover 431, the middle tube 433 and the inner tube 435 in the length direction.

[0060] In some embodiments, the block 437 can be pressed into the middle tube 433. Specifically, the block 437 can be connected to the inner tube 435 through a bendable structure. For example, one end of the block 437 is connected to the outer wall of the inner tube 435 through an elastic rod, and the other end of the block 437 is connected to the outer wall of the inner tube 435 through an "S"-shaped bendable structure. For another example, one end of the block 437 can be suspended, and only the other end is connected to the outer wall of the inner tube 435 through a bendable structure. When the block 437 is subjected to an extrusion force, the bending structure can bend inward so that the block 437 is pressed into the middle tube 433 and disengaged from the opening 434. In some embodiments, the number of the block 437 can be one or more. In this embodiment, the block 437 can include two symmetrically arranged, and two openings 434 are also provided on the corresponding middle tube 433. In some embodiments, the number of the blocks 437 may be 3, 4, or 6, etc., and the multiple blocks 437 may be arranged in a ring shape along the outer side of the inner tube 435 or along the length direction.

[0061] exist Figure 18-19In the illustrated embodiment, the size (e.g., width) of the block 437 can match the opening 434, so that the relative rotation between the inner tube 435 and the middle tube 433 can be limited by the engagement of the block 437 with the opening 434. In some embodiments, the front end of the middle tube 433 can be provided with a latching tooth 439; the corresponding position of the outer cover 431 (e.g., the front end of the inner circumferential surface of the outer cover) is provided with a latching groove 438; the latching tooth 439 can be engaged with the latching groove 438 to limit the relative rotation of the middle tube 433 and the outer cover 431. In some embodiments, the number of the latching tooth 439 and the latching groove 438 can be one or more. Preferably, the latching tooth 439 and the latching groove 438 can be multiple, and are arranged at equal intervals along the circumferential direction to facilitate alignment during assembly. In some alternative embodiments, the arrangement of the above-mentioned slot 438 and the latch tooth 439 can be reversed. For example, the slot is opened on the outer circumference of the middle tube 433, and the latch tooth 439 is arranged on the inner circumference of the outer cover 431. This arrangement can achieve the same technical effect as the above-mentioned method.

[0062] In some embodiments, the rear end of the middle tube 433 may be provided with a boss 480, and the rear end of the inner tube 435 extends out from the middle tube 433. By pulling the boss 480 and / or pushing the rear end of the inner tube 435, the latch 439 can be disengaged from the slot 438, and the block 437 can be pressed into the middle tube 433. By setting the boss 480, the operator can conveniently separate the middle tube 433 from the outer cover 431, and can conveniently release the restriction on the relative rotation between the inner tube 435 and the middle tube 433. When the latch 439 is disengaged from the slot 438 and the block 437 is pressed into the middle tube 433, the operator can rotate the inner tube 435 (that is, rotate the drive rod 440) to separate the drive rod 440 from the tissue clamping device. Then the operator can pull the inner tube 435 (or pull the middle tube and the inner tube) to withdraw the drive rod 440 from the control handle 300 (such as withdrawing it completely or withdrawing it a certain distance).

[0063] In some embodiments, the outer clamp arm control mechanism 400 may include a first indicator device 810. The first indicator device 810 may be used to indicate the opening and closing angle of the outer clamp arm 220 according to the position of the first control part 420 and / or the sliding part 430. Fig. 20 is a schematic diagram of an outer clamp arm control mechanism capable of indicating the opening and closing angle of the outer clamp arm according to some embodiments of the present application; Fig.21 810 is a schematic diagram of a first indicator device according to some embodiments of the present application. By providing the first indicator device 810, the operator can more conveniently and intuitively control the opening angle of the outer clamp arm 220 during surgery or experiment.

[0064] In some embodiments, Fig. 20 As shown, the first indicator device 810 may include one or more opening and closing angle marks 811 disposed on the sleeve 410. Fig. 20 As shown, the opening and closing angle mark 811 can be a mark (such as an arrow) engraved or printed on the sleeve 410. When the first control part 420 rotates to align with the opening and closing angle mark 811 (such as the front end of the first control part 420 is at the position indicated by the arrow), it can indicate that the outer clamp arm 220 is opened to the corresponding angle. In some embodiments, the opening and closing angle mark 811 can also include other marking forms. For example, the opening and closing angle mark 811 can be a scale line, a degree value, an indicating arrow of different colors, etc. engraved or printed on the sleeve 410. For another example, the opening and closing angle mark 811 can be a piece of paper, a string, etc. that is fixed (such as bonded) on the surface of the sleeve 410 but does not affect the rotation of the first control part 420. In some embodiments, multiple opening and closing angle marks 811 can be arranged in sequence along the length direction or spiral direction of the sleeve 410. Each opening and closing angle mark 811 can correspond to a specific angle (such as 90 degrees, 120 degrees, 180 degrees, etc.) opened by an outer clamp arm 220. In some embodiments, the correspondence between the opening and closing angle mark 811 and the specific angle of the outer clamp arm 220 can be obtained through experiments. In some embodiments, when installing the outer clamp arm control mechanism 400, the installation positions of the components can be adjusted according to the specific angle corresponding to the opening and closing angle mark 811, so that each opening and closing angle mark 811 can correspond to the corresponding specific angle when the installation is completed.

[0065] In some embodiments, Fig. 20 As shown, the first indication device 810 may include a processor 823, a display 825, and a first sensor 821. The first sensor 821 may be used to detect the position of the first control part 420 and / or the sliding part 430; the processor 823 may be used to determine the opening and closing angle of the outer clamp arm 220 according to the position of the first control part 420 and / or the sliding part 430, and control the display 825 to display the opening and closing angle of the outer clamp arm 220. In some embodiments, the display 825, the processor 823, and the first sensor 821 may be directly disposed on the control handle 300. In some alternative embodiments, the display and / or the processor 823 may also be disposed away from the control handle 300. For example, the first sensor 821 may have a signal connection (such as an electrical connection, a wireless communication connection, etc.) with the processor 823, the first sensor 821 may send the detected data to the processor 823, and the processor 823 may control the display 825 (such as a surgical monitoring display) to display the opening and closing angle of the outer clamp arm 220 according to the processing result. By using the first sensor 821 and the display 825, the opening and closing angle of the outer clamping arm 220 can be displayed more accurately, which can effectively avoid the problem of inaccurate reading of the opening and closing angle due to the visual error of the operator.

[0066] In some embodiments, the sleeve 410 may be provided with a first slide groove 412 along the length direction, and the sliding part 430 passes through the first slide groove 412 to connect with the first control part 420, and the first sensor 821 may include a distance measurement module. The distance measurement module may be used to detect one or more of the following: the distance between one end of the sleeve 410 and the sliding part 430; the distance between one end of the sleeve 410 and the first control part 420; the distance between one end of the first slide groove 412 and the sliding part 430; the distance between one end of the first slide groove 412 and the first control part 420. The above one or more distances may reflect the position of the first control part 420 and / or the sliding part 430. Based on the above one or more distances, the processor 823 may obtain the opening and closing angle of the outer clamp arm 220 and control the display 825 to display. In some embodiments, the corresponding relationship between the position of the first control part 420 and / or the sliding part 430 and the opening and closing angle of the outer clamp arm 220 may be obtained through experiments. The processor 823 can determine the opening and closing angle of the outer clamp arm 220 based on the position of the first control part and / or the sliding part, and by using the corresponding relationship between the position of the first control part and / or the sliding part and the opening and closing angle of the outer clamp arm 220. In some embodiments, the distance measurement module can include an ultrasonic distance measurement sensor, an infrared distance sensor, a Hall sensor, etc. In some alternative embodiments, the first sensor 821 can also detect the position of the first control part and / or the sliding part in other ways. For example, the first sensor 821 can determine the position of the first control part and / or the sliding part by monitoring the number of turns / angles rotated by the first control part 420.

[0067] In some embodiments, the outer clamp arm control mechanism 400 may include a first prompting device 830. The first prompting device 830 is used to prompt the outer clamp arm 220 to reach a preset opening and closing angle. Specifically, the first prompting device 830 can give the operator a prompt at a specific angle (90 degrees, 120 degrees, 180 degrees, etc.), and the prompting method can include one or more combinations of visual, auditory or tactile.

[0068] Fig. 22 is a schematic diagram of a first prompting device according to some embodiments of the present application. Fig. 22 As shown, the first prompting device 830 may include a first contact portion 831 and a second contact portion 833; the first contact portion 831 is arranged on the inner side of the sleeve 410; the second contact portion 833 is arranged on the outer side of the sliding portion 430; when the second contact portion 833 and the first contact portion 831 are in contact, the outer clamping arm 220 is prompted to reach a preset opening and closing angle.

[0069] In some embodiments, during the process that the first control part 420 rotates relative to the sleeve 410 and drives the sliding part 430 to move, the first contact part 831 and the second contact part 833 can contact and separate from each other. When the first contact part 831 and the second contact part 833 are in contact, a tactile and / or auditory feedback can be given to the operator. For example, one of the first contact part 831 and the second contact part 833 can be a spring protrusion structure (such as a spring bead), and the other can be a corresponding pit. When the first contact part 831 and the second contact part 833 are in contact, the spring protrusion structure can be stuck in the pit, thereby giving the operator feedback of a snapping sound or a snapping tactile feeling. In some embodiments, when the first contact part 831 and the second contact part 833 are in contact, the opening angle of the outer clamp arm 220 can be a preset opening and closing angle (such as 180 degrees). By giving the operator tactile and / or auditory feedback, the operator can be effectively prompted that the outer clamp arm 220 has been opened to the preset angle.

[0070] In some embodiments, a plurality of first contact portions 831 may be provided in the sleeve 410 along the length direction to prompt the operator at multiple angles (90 degrees, 120 degrees, 180 degrees, etc.). As an example only, three first contact portions 831 may be provided in the sleeve 410, corresponding to the outer clamp arm 220 opening 90 degrees, 120 degrees and 180 degrees, respectively, and the three first contact portions 831 are spring protrusion structures; the second contact portion 833 on the sliding portion 430 is a pit. In the process of controlling the first control portion 420 to rotate around the sleeve 410 to open and close the outer clamp arm 220, the three first contact portions 831 may contact the second contact portion 833 respectively to provide three tactile and / or auditory feedbacks. In some embodiments, in order to further distinguish the outer clamp arm 220 in different preset positions (such as the 120 degree position and the 90 degree position), the spring protrusion structure of the first contact portion 831 at 120 degrees can be set to be different from that at 90 degrees, so that the tactile and / or auditory feedback at the two locations are different, thereby being able to better prompt the operator.

[0071] In some embodiments, the first prompt device 830 may further include a speaker 835. The first contact portion 831 and the second contact portion 833 may include an electrical contact or a contact switch, etc. When the first contact portion 831 and the second contact portion 833 are in contact, the speaker 835 may play a preset audio (such as a "beep" sound, a voice broadcast of the opening and closing angle, etc.). In some embodiments, the speaker 835 may be provided on the control handle 300. In some alternative embodiments, the speaker 835 may not be provided on the control handle 300. When the first contact portion 831 and the second contact portion 833 are in contact, the first prompt device 830 may transmit the contact signal to an external speaker 835 (such as a wireless speaker) through a signal connection (such as an electrical connection) to issue a prompt. In some embodiments, when a plurality of first contact portions 831 are provided, the speaker 835 may be configured to play a preset voice of the current angle, and the preset voice may include prompt information for experiments or surgeries, etc., so as to provide more intuitive information to the operator. In some alternative embodiments, the first prompt device 830 may further include one or more prompt components such as a light emitter, a buzzer, and a vibrator.

[0072] In some embodiments, the first prompting device 830 can simultaneously use at least two of vision, touch and hearing to prompt the operator to ensure the reminder effect. As an example only, the first contact portion 831 or the second contact portion 833 may include a spring protrusion structure as an electrical contact. When the first contact portion 831 and the second contact portion 833 are in contact, the first prompting device 830 can play a preset audio through the speaker 835 and provide tactile feedback to the operator.

[0073] In some embodiments, a fin may be provided on the outer circumference of the sleeve 410, and a dial block may be correspondingly provided on the inner circumference of the first control part 420. When the first control part 420 and the sleeve 410 rotate relative to each other, the dial block may move the fin on the outer circumference of the sleeve 410. The fin may be made of a metal sheet, a reed, or other materials. When the control part drives the dial block to pass through the fin, a sound may be emitted and / or a sense of frustration may be given to the operator, thereby prompting the operator to rotate the first control part 420. By providing the fin and the dial block, the operator may effectively avoid misoperation. In some alternative embodiments, a dial block may also be provided on the outer circumference of the sleeve 410, and a fin may be correspondingly provided on the inner circumference of the first control part 420.

[0074] Fig.23 is a partial cross-sectional structural schematic diagram of an inner clamp arm control mechanism according to some embodiments of the present application; Fig.24 is a schematic diagram of a housing according to some embodiments of the present application; Fig.25 is a schematic diagram of the structure of a second control unit according to some embodiments of the present application; Fig.26is a structural schematic diagram of a second control unit and a locking mechanism at a first viewing angle according to some embodiments of the present application; Fig. 27 is a schematic diagram of the structure of the second control unit and the locking mechanism at a second viewing angle according to some embodiments of the present application. Figure 23-27 As shown, the inner clamp arm control mechanism 500 may include a shell 510 and a second control part 520; a second slide groove 511 is opened on the shell 510; the second control part 520 passes through the second slide groove 511 and can move along the second slide groove 511 to control the opening and closing of the inner clamp arm 210 relative to the outer clamp arm 220.

[0075] In some embodiments, Fig.25 As shown, the second control part 520 may include an L-shaped catheter 521 and an end cap 523; one end of the catheter 521 may pass through the second slide groove 511 and be detachably connected to the end cap 523. During operation, the second control part 520 may slide in the second slide groove 511 by pushing and pulling the catheter 521 at the end cap, and the L-shaped catheter 521 is more convenient for the operator to control. In this embodiment, the second control part 520 may be connected to the inner clamp arm 210 through a traction rope. In a specific embodiment, the traction rope may pass through the through hole at the movable end of the inner clamp arm 210, and the two ends of the traction rope may be fixed at the end cap 523. When it is necessary to separate the tissue clamping device 200 from the control handle 300, the end cap 523 may be separated from the catheter 521, and the two ends of the traction rope may be released and the traction rope may be pulled out, so that the control handle 300 may be separated from the inner clamp arm 210. In some embodiments, releasing the two ends of the traction rope may include: releasing the clamping connection between the two ends of the traction rope and the end cap, untying the knot formed by the two ends of the traction rope, cutting the traction rope, etc. In some embodiments, the traction rope may not be completely pulled out of the control handle 300 , but the traction rope may be separated from the inner clamp arm 210 .

[0076] In some embodiments, Fig.24 As shown, the second chute 511 can be arranged in a long strip shape. When the end cap 523 of the second control part 520 (or the part of the catheter 521 extending out of the second chute) moves to the rear end of the second chute 511 (the end away from the tissue clamping device), the inner clamp arm 210 can be in a retracted state. In some alternative embodiments, the second chute 511 can have an L-shaped profile. Specifically, a channel can be opened at the rear end of the second chute 511 in a direction at a certain angle (such as vertical) to the second chute 511. When the end cap 523 of the second control part 520 (or the part of the catheter 521 extending out of the second chute) moves to the rear end of the second chute 511, the second control part 520 can be pushed and pulled laterally so that the part of the catheter 521 extending out of the second chute is stuck in the channel, so that the inner clamp arm 210 can be kept in a retracted state to avoid misoperation during surgery.

[0077] In this embodiment, second slide grooves 511 may be respectively provided on both sides of the shell 510, and the second control unit 520 includes a first sub-control unit for controlling the first inner clamp arm 211 and a second sub-control unit for controlling the second inner clamp arm 213. The first sub-control unit and the second sub-control unit may correspond to separate traction ropes, respectively. In some embodiments, the second control unit 520 may be configured to be linked or split according to actual needs, so as to accurately control the inner clamp arm 210 according to the needs of experiments or surgeries. For example, during the mitral valve repair process, the first inner clamp arm 211 may be controlled to clamp one side of the mitral valve and then the second inner clamp arm 213 may be controlled to clamp the other side of the mitral valve. For another example, the second control unit 520 may simultaneously control the first inner clamp arm 211 and the second inner clamp arm 213 to clamp the mitral valve.

[0078] In some embodiments, one end of the housing 510 can be connected to (or integrally formed with) the sleeve 410, and the central axes of the housing 510 and the sleeve 410 coincide, so that the control handle 300 is more compact and easier to operate. For example, the housing 510 can be disposed at one end of the sleeve 410 close to the tissue clamping device 200, and the outer clamping arm 220 can be configured to be in the maximum open state when the first control portion 420 abuts against the rear end of the housing 510. In some alternative embodiments, the housing 510 can also be disposed at one end of the sleeve 410 away from the tissue clamping device 200.

[0079] In some embodiments, Figure 23-27 As shown, the inner clamp arm control mechanism 500 may include a locking mechanism 530; the locking mechanism 530 includes a second elastic member 531, a locking button 533 and a locking stopper 535. The second control portion 520 may also include a toothed connection portion 537. The locking button 533 is used to control the locking stopper 535 to overcome the elastic force of the second elastic member 531 to move so as to release the restriction of the locking stopper 535 on the toothed connection portion 537.

[0080] like Figure 23-27As shown, in this embodiment, the locking mechanism 530 includes a group of relatively arranged locking blocks 535, and the first sub-control part and the second sub-control part can respectively include corresponding toothed connecting parts 537. Specifically, the toothed connecting part 537 can be connected to the conduit 521 of the first sub-control part or the second sub-control part or integrally formed. A group of relatively arranged locking blocks 535 can be used to limit the movement of the first sub-control part and the second sub-control part under the elastic force of the second elastic member 531. For example, the locking block 535 corresponding to the first sub-control part can be clamped into the toothed connecting part 537 corresponding to the first sub-control part under the elastic force of the second elastic member 531. The locking block 535 corresponding to the second sub-control part can be clamped into the toothed connecting part 537 corresponding to the second sub-control part under the elastic force of the second elastic member 531. The second elastic member 531 can be two springs in this embodiment. The locking button 533 can include two, respectively connected to the two locking blocks 535. The locking button 533 can be exposed from the housing 510. Taking the operation of the first sub-control part as an example, when the locking button 533 corresponding to the first sub-control part is pressed, the locking button 533 drives the locking block 535 to overcome the elastic force of the second elastic member 531 and thus disengage from the toothed connection part 537, and the operator can push and pull the first sub-control part (such as the conduit 521 of the first sub-control part) to slide in the second slide groove 511 to control the opening and closing of the first inner clamp arm 211. When the operator releases the locking button 533, driven by the elastic force of the second elastic member 531, the locking block 535 can be re-engaged in the toothed connection part 537 to restrict the movement of the toothed connection part 537 (i.e., the movement of the conduit 521). The operation of the second sub-control part is similar to that of the first sub-control part, and will not be described in detail here.

[0081] In some embodiments, since there are two lock buttons 533, in order to facilitate identification by the operator, a mark can be added to the lock button 533. The mark can be "left", "right", "L", "R" or an arrow, etc.

[0082] In some embodiments, the inner clamp arm control mechanism 500 may include a second indicator 910. The second indicator 910 may be used to indicate the opening and closing angle of the inner clamp arm 210 according to the position of the second control part 520. Fig.28 is a schematic diagram of an inner clamp arm control mechanism capable of indicating the opening and closing angle of the inner clamp arm according to some embodiments of the present application; Fig.29 9 is a schematic diagram of a second indicator device according to some embodiments of the present application. By providing the second indicator device 910, the operator can more conveniently and intuitively control the opening angle of the inner clamp arm 210 during surgery or experiment.

[0083] In some embodiments, the opening and closing angle of the inner clamp arm 210 may be the opening and closing angle of the inner clamp arm 210 relative to the closed state. Figure 2-3 In the embodiment shown, Figure 2 is a schematic diagram of the inner clamp arm 210 in a retracted state; the opening and closing angle of the inner clamp arm 210 relative to the retracted state can be understood as the opening and closing angle of the inner clamp arm relative to the support portion 240. For example, in Figure 6 In the illustrated embodiment, the inner clamp arm 210 is in a retracted state, and the opening and closing angle of the inner clamp arm 210 relative to the retracted state can be understood as the opening and closing angle of the inner clamp arm relative to the connecting tube 270. In some alternative embodiments, the opening and closing angle of the inner clamp arm 210 can also be the angle between the two inner clamp arms.

[0084] In some embodiments, Fig.28 As shown, the second indicator device 910 may include one or more opening and closing angle marks 911 disposed on the housing 510. Fig.28 As shown, the opening and closing angle mark 911 can be a mark (such as an arrow) printed on the housing 510. When the second control part 520 (such as the part of the conduit 521 extending out of the second slide slot) moves to align with the opening and closing angle mark 911, it can indicate that the inner clamp arm 210 is opened to the corresponding angle. In some embodiments, the opening and closing angle mark 911 can also include other marking forms. For example, the opening and closing angle mark 911 can be a scale line, a degree value, an indicating arrow of different colors printed or engraved on the housing 510. In some embodiments, a plurality of opening and closing angle marks 911 can be arranged in sequence along the length direction of the housing 510. Each opening and closing angle mark 911 can correspond to a specific angle (such as 0 degrees, 30 degrees, 60 degrees, 90 degrees, etc.) of the inner clamp arm 210. In some embodiments, the corresponding relationship between the opening and closing angle mark 911 and the specific angle of the inner clamp arm 210 can be obtained by experiment. In some embodiments, when installing the inner clamp arm control mechanism 500, the installation positions of the components can be adjusted according to the specific angles that the opening and closing angle marks 911 should correspond to, so that each opening and closing angle mark 911 can correspond to the corresponding specific angle when the installation is completed.

[0085] In some embodiments, Fig.29As shown, the second indicating device 910 may include a processor 923, a display 925, and a second sensor 921. The second sensor 921 may be used to detect the position of the second control unit 520; the processor 923 is used to determine the opening and closing angle of the inner clamp arm 210 according to the position of the second control unit 520, and control the display 925 to display the opening and closing angle of the inner clamp arm 210. In some embodiments, the display 925, the processor 923, and the first sensor 921 may be directly disposed on the control handle 300. In some alternative embodiments, the display 925 and / or the processor 923 may also be disposed away from the control handle 300. For example, the second sensor 921 may have a signal connection (such as an electrical connection, a wireless communication connection, etc.) with the processor 923, the second sensor 921 may send the detected data to the processor 923, and the processor 923 may control the display 925 (such as a surgical monitoring display) to display the opening and closing angle of the inner clamp arm 210 according to the processing result. By using the second sensor 921 and the display 925, the opening and closing angle of the inner clamp arm 210 can be displayed more accurately, which can effectively avoid the problem of inaccurate reading of the opening and closing angle due to the operator's visual error. In some embodiments, the outer clamp arm control mechanism 400 and the inner clamp arm control mechanism 500 can use the same processor and / or the same display.

[0086] In some embodiments, the second sensor 921 may include a distance measurement module. The distance measurement module may be used to detect the distance between one end of the second chute 511 and the second control unit 520 (such as the portion of the conduit 521 extending out of the second chute). The distance may reflect the position of the second control unit 520. In some embodiments, the correspondence between the position of the second control unit 520 and the opening and closing angle of the inner clamp arm 210 may be obtained through experiments. The processor 923 may determine the opening and closing angle of the inner clamp arm 210 based on the position of the second control unit 520 and the correspondence between the position of the second control unit 520 and the opening and closing angle of the inner clamp arm 210. In some embodiments, the distance measurement module may include an ultrasonic distance measurement sensor, an infrared distance sensor, a Hall sensor, and the like.

[0087] In some embodiments, the opening and closing angle of the inner clamp arm 210 can be the opening and closing angle of the inner clamp arm 210 relative to the outer clamp arm 220. It is understandable that the opening and closing angle of the inner clamp arm 210 relative to the outer clamp arm 220 cannot be directly indicated in some embodiments, and it can be calculated by the opening and closing angle of the inner clamp arm 210 itself and the opening and closing angle of the outer clamp arm 220. In some embodiments, the second indicating device 910 can be used to indicate the opening and closing angle of the inner clamp arm 210 according to the position of the second control part 520 and the opening and closing angle of the outer clamp arm 220; wherein the opening and closing angle of the outer clamp arm 220 is determined by the outer clamp arm control mechanism 400. In some embodiments, as Fig.29As shown, the second indicating device 910 includes a processor 923, a display 925 and a second sensor 921; the second sensor 921 is used to detect the position of the second control part 520; the processor 923 can be used to determine the opening and closing angle of the inner clamp arm 210 according to the position of the second control part 520 and the opening and closing angle of the outer clamp arm 220, and control the display 925 to display the opening and closing angle of the inner clamp arm 210 (relative to the opening and closing angle of the outer clamp arm 220). For example, the processor 923 can obtain the opening and closing angle of the outer clamp arm 220 from the processor 823. For another example, the processor 923 can obtain the opening and closing angle of the outer clamp arm 220 according to the data detected by the first sensor 821. In the embodiment of the present application, the opening and closing angle of the outer clamp arm 220 can be understood as the angle between the two outer clamp arms; the processor 923 can determine the opening and closing angle of a certain inner clamp arm (such as the first inner clamp arm 211 or the second inner clamp arm 213) relative to the retracted state according to the position of the second control part 520. On this basis, the processor 923 can calculate the opening and closing angle of the inner clamp arm relative to the outer clamp arm 220 through arithmetic operation. For example, the processor 923 obtains the opening and closing angle of the outer clamp arm 220 from the outer clamp arm control mechanism 400 as 180 degrees, and the processor 923 obtains the opening and closing angle of the first inner clamp arm 211 relative to the retracted state as 30 degrees based on the information fed back by the second sensor 921 (the position of the second control unit 520), then the processor 923 can determine that the opening and closing angle of the first inner clamp arm 211 relative to the outer clamp arm is (180÷2)-30=60 degrees. It is worth noting that in some embodiments, when the opening and closing angle of a certain inner clamp arm relative to the retracted state is greater than half of the opening and closing angle of the outer clamp arm 220, it means that the inner clamp arm is closed relative to the outer clamp arm 220, and the traction rope corresponding to the inner clamp arm is in a relaxed state.

[0088] In some embodiments, the inner clamp arm control mechanism 500 may include a second prompting device. The second prompting device may be used to prompt the inner clamp arm 210 to reach a preset opening and closing angle. Specifically, the preset opening and closing angle may be a preset opening and closing angle of the inner clamp arm 210 relative to the retracted state, or an opening and closing angle of the inner clamp arm 210 relative to the outer clamp arm 220. In some embodiments, the second prompting device may give an operator a prompt at a specific angle (such as 0 degrees, 30 degrees, 60 degrees, 90 degrees, etc.), and the prompting method may include a combination of one or more visual, auditory or tactile. By giving the operator visual, auditory and / or tactile feedback, the operator can be effectively prompted that the inner clamp arm 210 has reached the preset opening and closing angle.

[0089] In some embodiments, the second prompting device may include a first contact portion and a second contact portion similar to the first prompting device 830, the first contact portion may be arranged on the outer peripheral surface of the second control portion, and the second contact portion may be arranged inside the shell. When the second contact portion contacts the first contact portion, the second prompting device may prompt that the outer clamping arm 220 reaches a preset opening and closing angle. In some embodiments, the second prompting device may include a prompting component. The prompting component may include but is not limited to a combination of one or more of a speaker, a light emitter, a buzzer, a vibrator, etc. In some embodiments, the prompting component may be controlled by the processor 923. When the processor 923 detects that the inner clamping arm 210 reaches a preset opening and closing angle, the processor may control the prompting component to issue a prompt.

[0090] In some embodiments, the second control unit 520 may include a first sub-control unit and a second sub-control unit for controlling the opening and closing of the first inner clamp arm 211 and the second inner clamp arm 213. The second indication device 910 may include a first sub-indication device and a second sub-indication device for indicating the opening and closing angles of the first inner clamp arm 211 and the second inner clamp arm 213. The second prompting device may include a first sub-prompting device and a second sub-prompting device for prompting the first inner clamp arm 211 and the second inner clamp arm 213 to reach a preset opening and closing angle.

[0091] The beneficial effects that may be brought about by the embodiments of the present application include but are not limited to: (1) being able to precisely control the outer clamp arm and / or inner clamp arm of the tissue clamp device; (2) being able to quickly control the outer clamp arm of the tissue clamp device; (3) being able to conveniently detach the control handle from the tissue clamp device; (4) being able to make the operation of mitral valve repair more convenient, and the efficiency and success rate of repair higher; (5) being able to quickly and intuitively obtain the opening and closing angles of the outer clamp arm and / or inner clamp arm; (6) being able to prevent misoperation in multiple links. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other possible beneficial effects.

[0092] The above are only preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A mitral valve repair device, characterized in that: It includes a delivery tube, a tissue clamping device and a control handle; the tissue clamping device is connected to the control handle through the delivery tube; The tissue clamping device comprises a fixing member, an outer clamping arm and an inner clamping arm; The control handle comprises an outer clamp arm control mechanism and an inner clamp arm control mechanism, wherein the outer clamp arm control mechanism is used to control the opening and closing of the outer clamp arm, and the inner clamp arm control mechanism is used to control the opening and closing of the inner clamp arm relative to the outer clamp arm; The outer clamp arm control mechanism comprises a sleeve, a first control part and a sliding part, wherein the sliding part is arranged in the sleeve; the first control part can drive the sliding part to move in the sleeve along the length direction of the sleeve by rotating to control the opening and closing of the outer clamp arm; The inner clamp arm control mechanism comprises a housing and a second control part; the housing is provided with a second slide slot; the second control part passes through the second slide slot and can move along the second slide slot to control the inner clamp arm to open and close relative to the outer clamp arm; The inner clamp arm control mechanism further includes a locking mechanism; the locking mechanism includes a second elastic member, a locking button and a locking block; the second control portion further includes a toothed connection portion; the locking button is used to control the locking block to overcome the elastic force of the second elastic member and move to release the restriction of the locking block on the toothed connection portion; The control handle is used to deliver the tissue clamping device to the mitral valve via the left atrial appendage and the left atrium, and to control the opening and closing of the outer clamping arm and the inner clamping arm so that the mitral valve can be clamped between the outer clamping arm and the inner clamping arm.

2. The mitral valve repair device according to claim 1, characterized in that: The delivery tube is not bendable.

3. The mitral valve repair device according to claim 1, characterized in that: The delivery tube includes a bending tube, and the control handle also includes a bending tube control mechanism; The bending tube control mechanism is used to control the bending of the bending tube.

4. The mitral valve repair device according to claim 3, characterized in that: The curved tube is provided with a plurality of notches along the length direction; The bending tube control mechanism includes a traction part, and the bending tube control mechanism can control the opening and closing of the plurality of notches through the traction part, thereby controlling the bending of the bending tube.

5. The mitral valve repair device according to claim 1, characterized in that: The outer circumference of the sleeve is provided with an external thread; the inner circumference of the first control part is provided with an internal thread; the sleeve is connected to the first control part through threads; the sleeve is provided with a first slide groove along the length direction; the sliding part passes through the first slide groove and is connected to the first control part.

6. The mitral valve repair device according to claim 1, characterized in that: The first control part includes a threaded engagement mechanism; the threaded engagement mechanism includes a control button, a first elastic member and a pair of engagement members; the engagement members are symmetrically arranged and are configured to engage with the external thread of the sleeve through the elastic force of the first elastic member; the control button is arranged around the outside of the engagement member for controlling the engagement member to overcome the elastic force of the first elastic member and disengage from the external thread of the sleeve.

7. The mitral valve repair device according to claim 1, characterized in that: The sliding part includes an outer cover, a middle tube and an inner tube; the middle tube is sleeved outside the inner tube; the middle tube is provided with an opening, and the inner tube is provided with a block that can extend outward, and the block can pass through the opening and engage with the outer cover to limit the relative movement of the middle tube, the inner tube and the outer cover in the length direction.

8. The mitral valve repair device according to claim 1, characterized in that: The outer clamp arm control mechanism further includes a driving rod, a fixing block and a protective sleeve; the sliding part controls the opening and closing of the outer clamp arm through the driving rod; the rear end of the driving rod is fixedly connected to the fixing block; the protective sleeve is detachably connected to the sliding part through a thread; When the protective cover is connected to the sliding part, the protective cover can limit the relative movement between the fixing block and the sliding part.

9. The mitral valve repair device according to claim 1, characterized in that: The second control part includes an L-shaped conduit and an end cover; one end of the conduit passes through the second slide groove and is detachably connected to the end cover.

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