CN212308127U

CN212308127U - Mitral valve repair equipment

Info

Publication number: CN212308127U
Application number: CN202020770717.5U
Authority: CN
Inventors: 虞奇峰; 其他发明人请求不公开姓名
Original assignee: Shanghai Newmed Medical Co Ltd
Current assignee: Shanghai Newmed Medical Co Ltd
Priority date: 2020-05-11
Filing date: 2020-05-11
Publication date: 2021-01-08
Anticipated expiration: 2030-05-11

Abstract

A mitral valve repair device comprising a tissue clamping device and a control handle; the tissue clamping device comprises an outer clamping arm and an inner clamping arm; the control handle comprises an outer clamping arm control mechanism and an inner clamping arm control mechanism, the outer clamping arm control mechanism is used for controlling the outer clamping arm to open and close, and the inner clamping arm control mechanism is used for controlling the inner clamping arm to open and close relative to the outer clamping arm; the control handle is used for conveying the tissue clamping device to the mitral valve through the left auricle and the left atrium, and controlling 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

Mitral valve repair equipment

Technical Field

The application relates to the field of medical equipment, in particular to mitral valve repair equipment.

Background

Valves are membranous structures that can be opened and closed inside the organs of humans or some animals. For example, each individual has four valves in the heart, namely the aortic, pulmonary, mitral and tricuspid valves. Taking the mitral valve as an example, the mitral valve is located between the left atrium and the left ventricle, and when the left ventricle contracts, the mitral valve functions as a check valve to tightly close the atrioventricular orifice and prevent blood from flowing backward from the left ventricle into the left atrium. However, when the mitral valve is diseased, it may happen that the left ventricle is difficult to close completely when contracting, resulting in the left atrium receiving a large amount of blood backflow, which may result in a sharp rise in left atrium and pulmonary venous pressure, an increase in left ventricle diastolic volume load, and further a series of pathological changes such as left ventricle enlargement and pulmonary hypertension, and finally clinical manifestations such as heart failure, arrhythmia, etc., which may endanger life in severe cases. When the diseased mitral valve is repaired, the opposite sides of the mitral valve can be clamped by the mitral valve repairing equipment, so that one large hole is changed into two small holes between the valves of the mitral valve, the backflow area is reduced, and the mitral valve backflow is effectively prevented. Similarly, the mitral valve repair device can also be suitable for repairing other valves such as the tricuspid valve of the heart, and the effect of reducing the backflow area is achieved by clamping the valve leaflets on two sides.

SUMMERY OF THE UTILITY MODEL

One of the embodiments of the present application provides a mitral valve repair device comprising a tissue clamping device and a control handle; the tissue clamping device comprises an outer clamping arm and an inner clamping arm; the control handle comprises an outer clamping arm control mechanism and an inner clamping arm control mechanism, the outer clamping arm control mechanism is used for controlling the outer clamping arm to open and close, and the inner clamping arm control mechanism is used for controlling the inner clamping arm to open and close relative to the outer clamping arm; the control handle is used for conveying the tissue clamping device to the mitral valve via the left auricle and the left atrium, and controlling 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.

Drawings

The present application will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:

FIG. 1 is a schematic structural view of a mitral valve repair device according to some embodiments of the present application;

FIG. 2 is a schematic structural view of a tissue gripping device and a delivery connector according to some embodiments of the present application;

FIG. 3 is a schematic diagram illustrating the open configuration of the outer clamping arms of the tissue gripping device according to some embodiments of the present application;

FIG. 4 is a schematic illustration of a structure of a delivery connector according to some embodiments of the present application;

FIG. 5 is a schematic structural view of a tissue gripping device shown in a closed state according to another embodiment of the present application;

FIG. 6 is a schematic structural view of a tissue gripping device according to another embodiment of the present application in an open state;

FIG. 7 is a front view schematic diagram of a curved tube according to some embodiments of the present application;

FIG. 8 is a rear view schematic illustration of a curved tube according to some embodiments of the present application;

FIG. 9 is an exploded view of a curved tube according to some embodiments of the present application;

FIG. 10 is an exploded view of a bend tube control mechanism according to some embodiments of the present application;

FIG. 11 is a schematic illustration in partial cross-sectional view of an outer clamp arm control mechanism according to some embodiments of the present application;

FIG. 12 is a schematic structural view of a cannula according to some embodiments of the present application;

FIG. 13 is an exploded view of the glides and protective sleeves according to some embodiments of the present application;

FIG. 14 is a schematic structural view of an outer clamp arm control mechanism according to another embodiment of the present application;

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;

FIG. 16 is a schematic structural view of a threaded engagement mechanism according to another embodiment of the present application;

fig. 17 is a schematic structural view of a bite piece of a threaded bite mechanism according to another embodiment of the present application;

FIG. 18 is a schematic view of a partial cross-sectional structure of a sliding section according to another embodiment of the present application;

FIG. 19 is an exploded view of the slide shown in accordance with another embodiment of the present application;

FIG. 20 is a schematic view of an outer clamp arm control mechanism capable of indicating the angle of opening and closing of the outer clamp arms according to some embodiments of the present application;

FIG. 21 is a schematic view of a first indicating device according to some embodiments of the present application;

FIG. 22 is a schematic view of a first prompting device shown in accordance with some embodiments of the present application;

FIG. 23 is a schematic diagram of a partial cross-sectional configuration of an inner clamp arm control mechanism according to some embodiments of the present application;

FIG. 24 is a schematic view of a housing according to some embodiments of the present application;

FIG. 25 is a schematic structural view of a second control section according to some embodiments of the present application;

FIG. 26 is a schematic structural view of a second control and locking mechanism shown in a first perspective in accordance with some embodiments of the present application;

FIG. 27 is a schematic structural view of a second control and locking mechanism shown in a second perspective in accordance with some embodiments of the present application;

FIG. 28 is a schematic view of an inner clamp arm control mechanism capable of indicating an angle of opening and closing of an inner clamp arm according to some embodiments of the present application;

FIG. 29 is a schematic view of a second indicating device according to some embodiments of the present application.

In the figure: 100-mitral valve repair devices; 200-a tissue gripping device; 210-an inner clamping arm; 211-a first inner clip arm; 213-a second inner clip arm; 215-barbs; 220-outer clamping arm; 221-a first outer clamp arm; 223-a second outer clamp arm; 230-a fixing member; 240-a support; 250-a connector; 260-outer splints; 261-a first external splint; 263-second outer splint; 270-connecting pipe; 280-an elastic locking member; 300-a control handle; 400-outer clamp arm control mechanism; 410-a cannula; 412-a first runner; 420-a first control section; 421-connecting groove; 429-connecting block; 430-a sliding portion; 431-a housing; 433-middle cylinder; 434-opening; 435-inner tube; 437-fixture block; 438-a card slot; 439-latch; 440-a drive rod; 450-a thread engagement mechanism; 451-operation buttons; 453-a first resilient member; 455-a bite piece; 456-pressing part; 457-bite; 460-fixing block; 470-a protective sheath; 480-boss; 500-inner clamp arm control mechanism; 510-a housing; 511-a second chute; 520-a second control section; 521-a catheter; 523-end cover; 530-a locking mechanism; 531-a second elastic member; 533-lock button; 535-locking stop; 537-toothed connection; 600-a delivery pipe; 610-bending the tube; 612-an inner core; 614-outer tube; 616-a notch; 620-bend tube control mechanism; 621-screw; 622-rotating part; 623-a traction part; 625-a hauling rope; 627-a threaded traction block; 629-bend indication device; 700-a delivery connection; 710-a body; 720-a first connection tab; 730-a second connecting piece; 740-a stationary support bar; 810-a first indicating device; 811-opening and closing angle identification; 821-a first sensor; 823-processor; 825-a display; 830-a first prompting device; 831 — first contact portion; 833 — a second contact; 835-a loudspeaker; 910-a second indicating device; 911-opening and closing angle identification; 921 — a second sensor; 923-a processor; 925-display.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.

On the contrary, this application is intended to cover any alternatives, modifications, equivalents, and alternatives that may be included within the spirit and scope of the application as defined by the appended claims. Furthermore, in the following detailed description of the present application, certain specific details are set forth in order to provide a better understanding of the present application. It will be apparent to one skilled in the art that the present application may be practiced without these specific details.

The embodiment of the application relates to a mitral valve repair device and a control handle thereof. The mitral valve repair device can be used to repair a mitral valve or other valve (e.g., a tricuspid valve). The mitral valve repair device can include a tissue gripping apparatus and a control handle. The tissue gripping device may be used to grip the valve to effect repair of the valve. The control handle may be used to deliver and manipulate the tissue gripping device. In some embodiments, the tissue gripping device can reach the predetermined position through multiple paths. For example, a tissue gripping device may be delivered to the mitral valve via the femoral vein, inferior vena cava, right atrium, and left atrium to repair the mitral valve. For another example, a tissue gripping device may be delivered to the mitral valve via the left atrial appendage and the left atrium to repair the mitral valve.

FIG. 1 is a schematic structural view of a mitral valve repair device according to some embodiments of the present application; FIG. 2 is a schematic structural view of a tissue gripping device and a delivery connector according to some embodiments of the present application; FIG. 3 is a schematic diagram illustrating the open configuration of the outer clamping arms of the tissue gripping device according to some embodiments of the present application; FIG. 4 is a schematic diagram of a delivery connector according to some embodiments of the present application. As shown in fig. 1-4, mitral valve repair device 100 can include a tissue gripping apparatus 200 and a control handle 300. Tissue gripping device 200 may include outer clamp arm 220 and inner clamp arm 210; control handle 300 may correspondingly include an outer clamp arm control mechanism 400 and an inner clamp arm control mechanism 500. Outer clamp arm control mechanism 400 can be used to control the opening and closing of outer clamp arm 220 of tissue clamping device 200, and inner clamp arm control mechanism 500 can be used to control the opening and closing of inner clamp arm 210 relative to outer clamp arm 220, so that control handle 300 can enable a valve (e.g., a mitral valve) to be clamped between outer clamp arm 220 and inner clamp arm 210 by controlling the opening and closing of outer clamp arm 220 and inner clamp arm 210.

In some embodiments, mitral valve repair device 100 may include delivery tube 600; the tissue gripping device 200 is connected to the control handle 300 by a delivery tube 600. In some embodiments, the delivery tube 600 may be curved (e.g., the delivery tube 600 is made of an elastic material); the control handle 300 is capable of delivering the tissue gripping device 200 to the mitral valve via the femoral vein, inferior vena cava, right atrium, or left atrium via the flexible delivery tube 600. In some embodiments, the delivery tube 600 is inflexible (e.g., the delivery tube 600 is made of a rigid material), in which case the control handle 300 can deliver the tissue gripping device 200 through the inflexible delivery tube 600 to the mitral valve via the left atrial appendage or the left atrium. In some embodiments, to provide better maneuverability of the tissue gripping device 200 when delivering the tissue gripping device 200 to the mitral valve via the left atrial appendage and the left atrium, the delivery tube 600 may include a curved tube 610. As shown in FIG. 1, the curved tube 610 may be located at the forward end of the delivery tube 600 (i.e., the end near the tissue gripping device 200). Accordingly, the control handle 300 can include a curved tube control mechanism 620, the curved tube control mechanism 620 can be used to control the bending of the curved tube 610. Further details regarding the curved tube 610 and the curved tube control mechanism 620 can be found in relation to other embodiments of the present application (e.g., the embodiments shown in fig. 7-10). By delivering the tissue gripping device 200 to the mitral valve via the left atrial appendage and the left atrium, mitral valve repair can be performed more easily, with greater efficiency and success. In addition, the mitral valve repair device 100 can also be used for other purposes when the delivery tube 600 is not bendable or when the delivery tube 600 includes a bent tube 610. For example, the mitral valve repair device 100 can be used to perform valve repair experiments on animals (e.g., pigs).

In some embodiments, as shown in fig. 2-4, tissue gripping device 200 may include inner clamp arm 210, outer clamp arm 220, fastener 230, support 240, connector 250, and outer clamp plate 260. Wherein inner clamp arm 210 may include a first inner clamp arm 211 and a second inner clamp arm 213; outer clip arms 220 may include first outer clip arm 221 and second outer clip arm 223; the outer clamping plate 260 may include a first outer clamping plate 261 and a second outer clamping plate 263. One side of the supporting portion 240 is sequentially connected with the first outer clamping arm 221 and the first outer clamping plate 261 in a bendable manner, and the other side of the supporting portion 240 is sequentially connected with the second outer clamping arm 223 and the second outer clamping plate 263 in a bendable manner. The first outer clip arm 221 and the second outer clip arm 223 can be bent relative to the support 240 to be relatively folded, and the first outer clip arm 221 and the second outer clip arm 223 can also be bent away from the support 240 to be relatively opened. Tissue gripping device 200 as shown in FIG. 2 is in a state in which first outer clip arm 221 and second outer clip arm 223 are relatively closed; tissue gripping device 200, shown in FIG. 3, has first outer clip arm 221 and second outer clip arm 223 spread apart 180 degrees relative to one another. The relative opening angle of the first outer clamping arm 221 and the second outer clamping arm 223 can be any angle, such as 10 °, 40 °, 90 °, 120 °, 180 °, 270 °, 350 °, 360 °, and the like. In some embodiments, the outer clamp arm 220, the support portion 240, and the outer clamp plate 260 may be a unitary structure. For example, the outer clamping arms 220, the supporting portion 240 and the outer clamping plate 260 may be integrally formed by cutting and heat-treating a shape memory alloy tube. In some embodiments, as shown in fig. 2, one end (shown upper end) of the supporting portion 240 is connected (e.g., fixedly connected) to the connecting member 250, and one end (shown lower end) of the first outer clamping plate 261 and one end (shown lower end) of the second outer clamping plate 263 are respectively connected (e.g., fixedly connected) to the fixing member 230. With this arrangement, the fixing member 230 can move relative to the supporting portion 240 when the fixing member 230 moves relative to the connection member 250. When the fixing member 230 is far away from the supporting portion 240, 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 be opened relatively under the driving of the fixing member 230. In the embodiment shown in fig. 2-4, the outer clamp arm control mechanism 400 is capable of controlling the opening and closing of the outer clamp arm 220 of the tissue gripping device 200 via the drive rod 440. Specifically, one end (lower end as shown in fig. 2) of the driving rod 440 may have a screw structure by which the driving rod 440 can be detachably coupled 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 driving rod 440, so as to control the outer clamp arm 220 of the tissue clamping device 200 to open and close.

In some embodiments, first inner clamp arm 211 may be disposed on first outer clamp arm 221, second inner clamp arm 213 may be disposed on second outer clamp arm 223, first inner clamp arm 211 and second inner clamp arm 213 being openable and closable relative to first outer clamp arm 221 and second outer clamp arm 223, respectively, and enabling tissue to be clamped between first inner clamp arm 211 and first outer clamp arm 221 and between second inner clamp arm 213 and second outer clamp arm 223. In some embodiments, the inner clip arms 210 may be barbed clips. For example, barbs 215 may be mounted at the free ends of inner clip arms 210. In some embodiments, the inner and

outer clamp arms

210 and 220 may be connected by a bend (e.g., an S-bar bend) that may have a pre-formed spring-back force, such that the inner clamp arm 210 can be pressed against the outer clamp arm 220 in a natural state. In some embodiments, inner clamp arm control mechanism 500 may control opening and closing of inner clamp arm 210 relative to outer clamp arm 220 via a pull cable (not shown). For example, a pull cable may be coupled to the free end of the inner clamp arm 210. When the inner clamping arm control mechanism 500 pulls the traction cable, the inner clamping arm 210 can be opened relative to the outer clamping arm 220 under the pulling force of the traction cable; when the pull cord is released, the inner clamp arm 210 may be folded with the outer clamp arm 220 under the pre-formed spring back force of the bend. In some embodiments, the pulling cable may include steel wires, nano-wires, glass strands, or the like, which is not limited in this application.

In some embodiments, the delivery tube 600 may be removably coupled to the tissue gripping device 200 via a delivery connector 700. The conveying connector 700 is provided with through holes for the driving rod 440 and the traction cable to pass through respectively. In the embodiment shown in fig. 2 and 4, the delivery connector 700 may include a main body 710, a first connector piece 720, and a second connector piece 730. Wherein, the connection part of the first connection piece 720 and the second connection piece 730 with the main body 710 can have a pre-made resilience force, and the pre-made resilience force can enable the first connection piece 720 and the second connection piece 730 to automatically open in a natural state. The middle parts of the first connecting piece 720 and the second connecting piece 730 can be further provided with a fixing support rod 740, the fixing support rod 740 is respectively perpendicular to the first connecting piece 720 and the second connecting piece 730, and the suspended end of the fixing support rod 740 is provided with a through hole for the driving rod 440 to pass through. When the delivery connector 700 is connected to the connector 250 of the tissue gripping device, the first connecting piece 720 and the second connecting piece 730 are folded toward each other and engaged with the protrusions on the connector 250, respectively. The driving rod 440 may pass through the through hole of the fixing bar 740 connected to the first connecting piece 720 and the second connecting piece 730, and the driving rod 440 may restrict the first connecting piece 720 and the second connecting piece 730 from being opened. When it is desired to disengage the delivery connector 700 from the tissue holding device 200, the drive rod 440 can be first disconnected from the tissue holding device 200 (e.g., the fastener 230) and the drive rod 440 can be withdrawn such that the drive rod 440 is disengaged from the through-holes in the fixation struts 740 that are connected to the first connector piece 720 and the second connector piece 730, such that the first connector piece 720 and the second connector piece 730 automatically open and disengage from the tabs on the connector 250. In some embodiments, the delivery connector 700 may be a one-piece structure made of shape memory alloy tubing that is cut and heat set.

In some embodiments, the tissue gripping device 200 may be in alternative configurations. For example, FIG. 5 is a schematic structural view of a closed state of a tissue gripping device according to another embodiment of the present application; FIG. 6 is a schematic structural view of a tissue gripping device according to another embodiment of the present application in an open state. In the embodiment shown in fig. 5-6, tissue gripping device 200 may include a fastener 230, an inner clamp arm 210, and an outer clamp arm 220. The inner clip arm 210 may include a first inner clip arm 211 and a second inner clip arm 213, the inner clip arm 210 is disposed on the fixing member 230, and the first inner clip arm 211 and the second inner clip arm 213 can be folded or unfolded with each other. The outer clamp arms 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 disposed on the fixing member 230, and the first outer clamp arm 221 and the second outer clamp arm 223 can be relatively folded or unfolded, and enable a valve (such as a mitral valve) to 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 the embodiment shown in fig. 5-6, the tissue gripping device 200 can further include a connecting tube 270 and a resilient latch 280. Delivery tube 600 may be removably coupled (e.g., threadably coupled) to coupling tube 270. The drive rod 440 can be directly or indirectly connected to the fixed member 230. The outer clamping arm 220 is rotatably connected with the fixing member 230 and the connecting pipe 270 through a link structure, respectively. The outer clamping arm control mechanism 400 can control the fixing member 230 to move relative to the connecting tube 270 by pushing and pulling the driving rod 440, so as to control the outer clamping arm 220 of the tissue clamping device 200 to open and close. When the outer clip arm 220 is opened and closed to a certain angle (e.g., 10 °, 90 °, 150 °, 180 °) or closed, the elastic locking member disposed on the fixing member 230 may be matched with the bayonet on the connection pipe 270, so as to form a certain resistance to the opening and closing of the outer clip arm 220. In some embodiments, the inner clamp arm 210 may be an integrally formed U-shaped structure with a pre-formed resilient force that flares outward. Inner clamp arm control mechanism 500 may control the opening and closing of inner clamp arm 210 relative to outer clamp arm 220 via a pull cable (not shown). For example, a pull cable may be coupled to the free end of the inner clamp arm 210. When the inner clamp arm control mechanism 500 pulls the traction cable, the inner clamp arm 210 can be opened relative to the outer clamp arm 220 (i.e. the first inner clamp arm 211 and the second inner clamp arm 213 are closed together) under the pulling force of the traction cable; when the pull cable is released, inner clip arms 210 may open outwardly under their pre-formed spring back force to close relative to outer clip arms 220. Specifically, the first inner clamp arm 211 and the first outer clamp arm 221 may be individually controlled to open or close with respect to the first outer clamp arm 221 and the second outer clamp arm 223, respectively.

The control handle 300 will now be described with reference to the tissue gripping device 200 shown in FIGS. 2-4. It should be noted that the control handle described in the following embodiments is for illustrative purposes only and is not limited thereto. Some or all of the structure of the control handle 300 can be adapted to other types of tissue gripping devices (e.g., the tissue gripping devices shown in fig. 5-6) as well as the tissue gripping device 200 shown in fig. 2-4.

In some embodiments, 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 gripping device 200. In some embodiments, when the delivery tube 600 includes a curved tube 610, the control handle 300 can include a curved tube control mechanism 620, the curved tube control mechanism 620 can be used to control the bending of the curved tube 610. In some embodiments, the control handle 300 may be free of the bent tube control mechanism 620 when the bent tube 610 is not included on the delivery tube 600 (e.g., when the delivery tube 600 is in a non-bendable configuration).

FIG. 7 is a front view schematic diagram of a curved tube according to some embodiments of the present application; FIG. 8 is a rear view schematic illustration of a curved tube according to some embodiments of the present application; FIG. 9 is an exploded view of a curved tube according to some embodiments of the present application. As shown in fig. 7-9, a curved tube 610 can be attached to the forward end of the delivery tube 600 (i.e., the end near the tissue gripping device 200). For example, the curved tube 610 may be coupled (e.g., laser welded) or integrally formed with the body of the delivery tube 600. The front end of the bent tube 610 may be connected to the delivery connection 700. In some embodiments, the curved tube 610 may include an inner core 612 and an outer tube 614. The outer tube 614 fits over the inner core 612. One end of the delivery connector 700 may fit over the inner core 612 and snap fit with the outer tube 614. In some embodiments, one or more through holes may be provided in inner core 612 for passing a pull cable that drives rod 440 and controls opening and closing of inner clamp arm 210.

In the embodiment shown in fig. 7-9, the curved tube 610 is provided with a plurality of notches 616 along its length. Specifically, the outer tube 614 of the bending tube 610 is provided with a plurality of notches 616. By providing a plurality of notches 616, the bending tube 610 can be made to bend easily, and can be made to bend in a particular direction. In the present embodiment, a plurality of notches 616 are opened at one side of the bending tube 610, so that the bending tube can be bent toward the opening direction of the notches. In other embodiments, the plurality of notches 616 may also be spaced on different sides of the curved tube 610, thereby enabling the curved tube 610 to bend in multiple directions. In some embodiments, the outer tube 614 of the curved tube 610 may be cut from a stainless steel tube (e.g., 316 tubing) or a resilient metal (e.g., nitinol). The inner core 612 of the curved tube 610 may be made of an elastomeric material, such as nylon, silicone, heat-shrinkable polyether block polyamide (Pebax), Polytetrafluoroethylene (PTFE) material, and the like. In some embodiments, the curved tube 610 is elastic; when no external force is applied, the bent tube 610 can maintain a cylindrical shape. Further, a polymer material layer (such as a heat-shrinkable polyether block polyamide (Pebax) material) can be further arranged on the outer surface of the bending tube 610, so that the contact of blood with the tube can be effectively reduced. In some embodiments, a plurality of notches 616 are opened at one side of the bending tube 610, and a groove may be provided at one side of the inner core 612 facing the opening direction of the notches 616, and the pulling rope 625 may be disposed in the groove. Specifically, the front end of the pull string 625 may be fixedly coupled (e.g., welded, glued, etc.) to the inner core 612 and/or the outer tube 614. The curved tube control mechanism 620 is capable of controlling the bending of the curved tube 610 via the pull line 625.

FIG. 10 is an exploded view of a bend tube control mechanism according to some embodiments of the present application. In some embodiments, as shown in fig. 10, the bent tube control mechanism 620 may include a screw 621, a rotating portion 622, and a pulling portion 623; the screw 621 is in threaded connection with the traction part 623; the rotating part 622 can drive the screw 621 to rotate so as to drive the traction part 623 to move; the movement of the pulling portion 623 can control the bending of the bending tube 610. In some embodiments, the pull 623 may include a pull cord 625 and a threaded pull block 627; one end (like the tail end) of the pulling rope 625 is connected with the threaded pulling block 627, the other end (like the front end) of the pulling rope 625 is fixedly connected with the front end of the bent pipe 610, an internal thread is arranged inside the screw 621, and the threaded pulling block 627 is movably arranged inside the screw 621 and is matched with the internal thread of the screw 621. When the rotating portion 622 drives the screw 621 to rotate, the screw 621 drives the threaded traction block 627 to move in the screw 621 along the length direction, so as to realize traction or release of the traction rope 625, thereby controlling the bending of the bending tube 610. Specifically, pulling of the pull string 625 against the curved tube 610 may cause the plurality of notches 616 in the curved tube 610 to close together, thereby bending the curved tube 610. The bent tube 610 may remain bent while the threaded traction block 627 stops moving. When the threaded pull block 627 releases the pull cord 625, the curved tube 610 may relax back under its own spring force until it returns to its natural state (e.g., remains cylindrical).

In some embodiments, as shown in fig. 10, the bent tube control mechanism 620 can include a bend indicator 629. A bend indicating device 629 may be used to indicate the degree of bending of the bent tube 610. In some embodiments, the bending indicator 629 may include an indicator block which is engaged with the external threads of the screw 621 and moves with the rotation of the screw 621, and the degree of bending of the bending tube 610 is reflected by the moving position of the indicator block. In some embodiments, the movement positions of the indicator block may correspond one-to-one to the bending angle of the bent tube 610. The correspondence between the two can be determined by experiment. In some embodiments, the bending indicator 629 may further include an indicator mark, which may be disposed on a housing (e.g., a transparent housing covering the outside of the indicator block) to visually reflect the degree of bending (e.g., the bending angle) of the corresponding bent tube 610 when the indicator block is moved to a specific position.

FIG. 11 is a schematic illustration in partial cross-sectional view of an outer clamp arm control mechanism according to some embodiments of the present application; FIG. 12 is a schematic structural view of a cannula according to some embodiments of the present application; FIG. 13 is an exploded view of the glides and protective sleeves according to some embodiments of the present application; FIG. 14 is a schematic structural view of an outer clamp arm control mechanism according to another embodiment of the present application; 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; FIG. 16 is a schematic structural view of a threaded engagement mechanism according to another embodiment of the present application; fig. 17 is a schematic view of a structure of a bite piece of a threaded bite mechanism according to another embodiment of the present application. In some embodiments, as shown in fig. 11-16, the outer clamp arm control mechanism 400 can include a sleeve 410, a first control portion 420, and a slide portion 430, the slide portion 430 being disposed within the sleeve 410; the first control portion 420 can rotate to drive the sliding portion 430 to move in the sleeve 410 along the length direction of the sleeve 410 so as to control the opening and closing of the outer clamping arm 220. If one end of control handle 300 adjacent to tissue gripping device 200 is defined as a front end and the opposite end of control handle 300 is defined as a rear end, then movement of slide 430 within sleeve 410 toward the front end can be used to control the opening of outer clamping arms 220 (e.g., relative opening of first outer clamping arm 221 and second outer clamping arm 223), and movement of slide 430 toward the rear end can be used to control the closing of outer clamping arms 220.

In some embodiments, the casing 410 may have one or more interlayers, the sliding portion 430 is disposed in the interlayer of the casing 410, and the first control portion 420 can drive the sliding portion 430 to move along the length direction of the casing 410 in the casing 410. For example, the socket 410 may have a hollow cylindrical shape, which may be formed by connecting two semi-cylindrical housings, and the sliding part 430 has a cylindrical shape, and the sliding part 430 may be snapped between the two semi-cylindrical housings of the socket 410.

In some embodiments, referring to fig. 11-12, the outer circumference of the sleeve 410 may be externally threaded; the inner circumferential surface of the first control part 420 is provided with internal threads; the sleeve 410 is screw-coupled to the first control portion 420. The sleeve 410 may be provided with a first sliding groove 412 along the length direction; the sliding portion 430 passes through the first sliding groove 412 and is connected to the first control portion 420. Specifically, the sliding portion 430 may include a protruding connection block 429, the inner circumferential surface of the first control portion 420 may include a connection groove 421, and the connection block 429 may extend from the first sliding groove 412 and be clamped with the connection groove 421, so that the first control portion 420 may drive the sliding portion 430 to move along the first sliding groove 412 when rotating. In the embodiment of the present application, the sleeve 410 may include two first sliding grooves 412 respectively disposed on two sides of the sleeve 410, and two protruding connecting blocks 429 correspondingly disposed on the sliding portion 430; therefore, the stability of the first control part 420 driving the sliding part 430 to move can be ensured. In some alternative embodiments, the number of the first sliding grooves 412 may also be one, three, five, or the like.

In some embodiments, the first control part 420 may have a circular ring-shaped outer contour, and a rubber layer may be disposed on a surface of the outer contour. When the operator controls the outer arm clamp 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 the finger, so that the operator can realize accurate control. In other embodiments, the outer contour surface of the first control portion 420 may be made of a hard material such as plastic, metal, etc. without a rubber layer, and the surface thereof is provided with anti-slip patterns to increase the surface friction.

In some embodiments, as shown in fig. 11-13, the outer clamp arm control mechanism 400 can include a drive rod 440, a securing block 460, and a protective sleeve 470; the sliding portion 430 can control the opening and closing of the outer clamping arm 220 through the driving rod 440, and the rear end of the driving rod 440 is fixedly connected with the fixed block 460. Specifically, the fixing block 460 may be cylindrical, the cross-sectional diameter of the fixing block may be greater than that of the driving rod 440, and the driving rod 440 may be inserted into the fixing block 460 and fixedly connected to the fixing block 460 by means of glue joint, welding, interference connection, or the like. The protective sleeve 470 may be detachably coupled with the sliding part 430 by a screw; when the protective sleeve 470 is coupled to the sliding part 430, the protective sleeve 470 can limit the relative movement between the fixing block 460 and the sliding part 430. In some embodiments, the drive rod 440 may be made of a memory alloy (e.g., nitinol), thereby allowing the drive rod 440 to have superior tensile and compressive properties as well as superior bending properties; further, when the transfer tube 600 is bent, the outer clip arm control mechanism 400 can effectively control the opening and closing of the outer clip arm 220 by the driving lever 440.

In some embodiments, after tissue holding device 200 has been clamped, drive rod 440 needs to be separated from tissue holding device 200 and withdrawn from control handle 300 (e.g., fully or some distance). As shown in fig. 11 to 13, the protective sleeve 470 is detachably coupled to the sliding part 430 by means of screw threads. When it is desired to disengage the drive rod 440, the operator may rotate the sheath 470 away from the slide 430, then the operator may rotate the retention block 460 (i.e., rotate the drive rod 440) to disengage the drive rod 440 from the tissue gripping device, and then the operator may pull the retention block 460 to withdraw the drive rod 440 from the control handle 300.

In some embodiments, as shown in fig. 14-17, the first control portion 420 can include a threaded engagement mechanism 450. The screw engagement mechanism 450 includes a manipulation button 451, a first elastic member 453, and a pair of engagement members 455; the engaging members 455 are symmetrically arranged (e.g., centrosymmetrically) and configured to engage with the external threads of the sleeve 410 by the elastic force of the first elastic member 453; the manipulation button 451 is annularly provided outside the engaging member 455 for controlling the engaging member 455 to be disengaged from the external thread of the sleeve 410 against the elastic force of the first elastic member 453. As shown in fig. 14 to 17, the engaging member 455 may include a pressing portion 456 and an engaging portion 457, and the pressing portion 456 and the engaging portion 457 may be fixedly connected or may be an integrally molded structure. The inner circumferential surface of the engaging part 457 may be provided with a tooth-shaped structure corresponding to the external thread of the socket 410. The pair of engaging members 455 are disposed opposite to each other and surround the outer circumferential surface of the sleeve 410, and the engaging portions 457 of both the engaging members 455 can be engaged with the external threads of the sleeve 410 by the first elastic member 453. In this embodiment, the first elastic member 453 may include two springs respectively disposed at both sides of the pair of engaging members 455.

In operation, an operator presses the two control buttons 451, the control buttons 451 drive the pair of engaging members 455 to move relatively and compress the first elastic member 453 to disengage the tooth-shaped structure inside the engaging members 455 from the external thread of the sleeve 410, so that the first control portion 420 and the sleeve 410 can slide relatively in the longitudinal 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 clamping arm 220. By controlling the rapid opening and closing of the outer clamp arm 220, the operator can be more flexible during surgery (such as mitral valve repair) to adapt to different surgical conditions. When the operator releases the control button, the engaging member 455 is engaged with the outer thread of the sleeve 410 again under the driving of the elastic force of the first elastic member 453, and the operator can rotate the first control portion 420 as required to perform fine adjustment of the opening and closing angle of the outer clamping arm 220 or perform the next operation. Through setting up two relative control button 451, can make the operator comparatively convenient when carrying out the control that opens and shuts fast to outer arm lock 220, can effectively avoid the operator again because the mistake touches and leads to the maloperation.

FIG. 18 is a schematic view of a partial cross-sectional structure of a sliding section according to another embodiment of the present application; fig. 19 is an exploded view schematically showing a sliding portion according to another embodiment of the present application. As shown in fig. 18 to 19, the sliding portion 430 may include an outer cover 431, a middle tube 433, and an inner tube 435; the middle barrel 433 is sleeved outside the inner pipe 435; an opening 434 is formed in the middle barrel 433, a fixture block 437 capable of extending outwards is arranged on the inner tube 435, and the fixture block 437 can penetrate through the opening 434 to be clamped with the housing 431 so as to limit the relative movement of the middle barrel 433, the inner tube 435 and the housing 431 in the length direction. The drive rod 440 may be fixedly attached to the inner tube 435. For example, one end of the drive rod 440 may be secured within the inner tube 435 by a snap fit, adhesive, interference fit, or the like. In this embodiment, the latch 437 on the inner tube 435 may have a wedge-shaped outer profile, a groove corresponding to the latch 437 may be formed on the inner wall of the housing 431, and the latch 437 passes through the opening of the middle barrel 433 and is inserted into the groove to limit the relative movement of the housing 431, the middle barrel 433, and the inner tube 435 in the longitudinal direction.

In some embodiments, the detent 437 may be pressed into the middle barrel 433. Specifically, the latch 437 may be coupled to the inner tube 435 via a bendable structure. For example, one end of the latching block 437 is connected to the outer wall of the inner tube 435 by an elastic rod, and the other end of the latching block 437 is connected to the outer wall of the inner tube 435 by an S-shaped bendable structure. For another example, one end of the latch 437 may be suspended, and only the other end is connected to the outer wall of the inner tube 435 via a bendable structure. When the latch 437 is pressed, the bent structure may be bent inward such that the latch 437 is pressed into the middle barrel 433 and separated from the opening 434. In some embodiments, the number of the latches 437 may be one or more. In this embodiment, the latch 437 can include two symmetrically disposed latches, and two openings 434 are also formed on the corresponding middle barrel 433. In some embodiments, the number of the latches 437 can also be 3, 4, or 6, and the plurality of the latches 437 can be arranged annularly along the outside of the inner tube 435 or along the length direction.

In the embodiment shown in fig. 18-19, the detent 437 is sized (e.g., wide) to fit within the opening 434, such that relative rotation between the inner tube 435 and the inner barrel 433 is limited by the engagement of the detent 437 with the opening 434. In some embodiments, the front end of the middle barrel 433 may be provided with a latch 439; a clamping groove 438 is arranged at a corresponding position of the outer cover 431 (such as the front end of the inner circumferential surface of the outer cover); the teeth 439 can be engaged with the engaging grooves 438 to limit the relative rotation between the middle barrel 433 and the outer cover 431. In some embodiments, the number of teeth 439 and slots 438 may be one or more. Preferably, the catch 439 and the catch groove 438 may be plural and arranged at equal intervals in the circumferential direction to facilitate alignment at the time of assembly. In some alternative embodiments, the arrangement of the engaging groove 438 and the engaging teeth 439 may be reversed, for example, the engaging groove is formed on the outer peripheral surface of the middle barrel 433, and the engaging teeth 439 are formed on the inner peripheral surface of the outer cover 431, which can achieve the same technical effects as the above-mentioned arrangement.

In some embodiments, the rear end of the middle barrel 433 may be provided with a boss 480, and the rear end of the inner tube 435 protrudes from the middle barrel 433. The latch 439 is disengaged from the latch groove 438 by pulling the boss 480 and/or pushing the rear end of the inner tube 435, and the latch 437 is pressed into the middle barrel 433. The boss 480 is provided to allow an operator to easily separate the middle barrel 433 from the outer cover 431, and to easily release the restriction of the relative rotation between the inner tube 435 and the middle barrel 433. After the teeth 439 are disengaged from the detents 438 and the detents 437 are pressed into the central barrel 433, the operator may rotate the inner tube 435 (i.e., rotate the drive rod 440) to disengage the drive rod 440 from the tissue holding device. The operator may then withdraw the drive rod 440 out of the control handle 300 (e.g., fully or a distance) by pulling on the inner tube 435 (or pulling on the middle and inner tubes).

In some embodiments, outer clamp arm control mechanism 400 may include a first indicator 810. The first indicating device 810 can be used for indicating the opening and closing angle of the outer clamping arm 220 according to the position of the first control part 420 and/or the sliding part 430. FIG. 20 is a schematic view of an outer clamp arm control mechanism capable of indicating the angle of opening and closing of the outer clamp arms according to some embodiments of the present application; FIG. 21 is a schematic view of a first indicating device according to some embodiments of the present application. Through setting up first indicating device 810, operating personnel can control the open angle of outer arm lock 220 more conveniently directly perceived in operation or experimentation.

In some embodiments, as shown in fig. 20, the first indicating device 810 may include one or more opening and closing angle indicators 811 disposed on the cannula 410. As shown in fig. 20, the open-close angle indicator 811 may be an indicator (e.g., an arrow) engraved or printed on the sleeve 410, and when the first control portion 420 is rotated to be aligned with the open-close angle indicator 811 (e.g., the front end of the first control portion 420 is at the position indicated by the arrow), it may indicate that the outer clip arms 220 are opened to a corresponding angle. In some embodiments, the opening and closing angle indicator 811 may also include other indicator forms. For example, the opening and closing angle indicators 811 may be graduation marks, degree values, indicating arrows of different colors, etc. engraved or printed on the sleeve 410. For another example, the opening/closing angle indicator 811 may be a paper sheet, a string, etc. that is fixedly attached (e.g., adhered) to the surface of the sleeve 410 but does not affect the rotation of the first control portion 420. In some embodiments, the plurality of opening and closing angle indicators 811 may be sequentially arranged along the length direction or the spiral direction of the sleeve 410. Each opening and closing angle indicator 811 can correspond to a specific angle (e.g., 90 degrees, 120 degrees, 180 degrees, etc.) at which outer clip arm 220 is opened. In some embodiments, the correspondence of the opening and closing angle indicator 811 to the particular angle at which the outer clamp arm 220 is open can be obtained through experimentation. In some embodiments, the installation position of each component may be adjusted according to the specific angle corresponding to the opening and closing angle identifier 811 when the outer clamp arm control mechanism 400 is installed, so that each opening and closing angle identifier 811 can correspond to the corresponding specific angle when the installation is completed.

In some embodiments, as shown in fig. 20, the first indicating 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 configured to determine the opening and closing angle of the outer clip arm 220 according to the position of the first control portion 420 and/or the sliding portion 430, and control the display 825 to display the opening and closing angle of the outer clip arm 220. In some embodiments, the display 825, the processor 823, and the first sensor 821 may be disposed directly on the control handle 300. In some alternative embodiments, the display and/or processor 823 may also be provided off of the control handle 300. For example, the first sensor 821 may have a signal connection (e.g., an electrical connection, a wireless communication connection, etc.) with the processor 823, the first sensor 821 may transmit the detected data to the processor 823, and the processor 823 may control the display 825 (e.g., a surgery monitoring display) to display the opening and closing angle of the outer clip arm 220 according to the processing result. Through adopting first sensor 821 and display 825, the angle that opens and shuts of the outer arm lock 220 of demonstration that can be more accurate can effectively avoid causing the inaccurate problem of angle reading that opens and shuts because of operating personnel's visual error.

In some embodiments, the sleeve 410 may be provided with a first sliding groove 412 along the length direction, the sliding portion 430 passes through the first sliding groove 412 to be connected with the first control portion 420, and the first sensor 821 may include a distance measuring module. The ranging 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 portion 420; a distance between one end of the first sliding groove 412 and the sliding portion 430; a distance between one end of the first sliding groove 412 and the first control portion 420. The one or more distances may reflect the position of the first control part 420 and/or the sliding part 430. Based on the one or more distances, the processor 823 can obtain the opening and closing angle of the outer clip arm 220 and control the display 825 to display. In some embodiments, the correspondence between the position of the first control portion 420 and/or the sliding portion 430 and the opening and closing angle of the outer clip arm 220 can be obtained through experiments. The processor 823 can determine the opening and closing angle of the outer clip 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 clip arm 220. In some embodiments, the ranging module may include an ultrasonic ranging sensor, an infrared distance sensor, a hall sensor, and the like. In alternative embodiments, the first sensor 821 may detect the position of the first control portion and/or the sliding portion in other manners. For example, the first sensor 821 may determine the position of the first control portion and/or the sliding portion by monitoring the number/angle of rotation of the first control portion 420.

In some embodiments, outer clamp arm control mechanism 400 may include a first prompting device 830. The first prompting device 830 is used for prompting the outer clip 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 prompt mode can include one or more of visual, audible, and tactile.

FIG. 22 is a schematic view of a first prompting device shown in accordance with some embodiments of the present application. In some embodiments, as shown in fig. 22, the first prompting device 830 can include a first contact portion 831 and a second contact portion 833; the first contact portion 831 is provided inside the sleeve 410; the second contact portion 833 is provided outside the sliding portion 430; when the second contact portion 833 and the first contact portion 831 contact, it is prompted that the outer clip arm 220 reaches a preset opening and closing angle.

In some embodiments, the first contact portion 831 and the second contact portion 833 can contact and separate from each other during the process that the first control portion 420 rotates relative to the sleeve 410 and moves the sliding portion 430. When the first and

second contact portions

831 and 833 are in contact, the operator may be given a tactile and/or audible feedback. For example, one of the first and

second contact portions

831 and 833 may be a spring raised structure (e.g., a spring ball) and the other may be a corresponding dimple. When the first contact portion 831 and the second contact portion 833 come into contact, the spring convex structure is caught in the concave, thereby giving feedback to the operator about the click sound or the tactile sensation of the click. In some embodiments, when the first contact portion 831 and the second contact portion 833 are in contact, the opening angle of the outer clip arm 220 may be a preset opening and closing angle (e.g., 180 degrees). By giving tactile and/or audible feedback to the operator, the operator can be effectively prompted that outer clamp arm 220 has been opened to the preset angle.

In some embodiments, several first contact portions 831 may be provided along the length direction inside the sleeve 410 to prompt the operator at various angles (90 degrees, 120 degrees, 180 degrees, etc.). For example only, three first contact portions 831 may be disposed in the sleeve 410, and respectively open 90 degrees, 120 degrees and 180 degrees corresponding to the outer clip arms 220, and the three first contact portions 831 are spring protrusion structures; the second contact portion 833 of the sliding portion 430 is a dimple. In controlling the first control portion 420 to rotate about the sleeve 410 to open and close the outer clamp arm 220, the three first contact portions 831 may respectively contact the second contact portions 833 to provide three tactile and/or audible feedbacks. In some embodiments, to further distinguish between different preset positions of outer clamp arm 220 (e.g., 120 degrees and 90 degrees), the spring protrusion structure of first contact portion 831 at 120 degrees may be configured differently than at 90 degrees, so that the tactile and/or audible feedback at two locations is different, thereby better prompting the operator.

In some embodiments, the first prompting device 830 can also include a speaker 835. The first and

second contact portions

831 and 833 may include an electrical contact or a contact switch, or the like. When the first and

second contact portions

831 and 833 are in contact, the speaker 835 can play a predetermined audio (e.g., a "ticker" sound, a voice broadcast opening/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 disposed on the control handle 300, and the first prompting device 830 may transmit a contact signal to the external speaker 835 (e.g., a wireless speaker) through a signal connection (e.g., an electrical connection) to issue a prompt when the first contact portion 831 and the second contact portion 833 are in contact. In some embodiments, when the first contact portions 831 are provided, the speaker 835 may be configured to play a preset voice of a current angle, which may include a prompt message for an experiment or a surgery, etc., thereby providing a more intuitive message to the operator. In some alternative embodiments, the first prompting device 830 can further include one or more prompting components such as a light emitter, a buzzer, a vibrator, etc.

In some embodiments, the first prompting device 830 can prompt the operator with at least two of visual, tactile, and audible simultaneously to ensure the effectiveness of the reminder. For example only, the first and

second contact portions

831 and 833 may include a spring protrusion structure as an electrical contact, and when the first and

second contact portions

831 and 833 are brought into contact, the first prompting device 830 may play a preset audio through the speaker 835 and provide tactile feedback to the operator.

In some embodiments, fins may be disposed on an outer circumferential surface of the sleeve 410, and a dial block is correspondingly disposed on an inner circumferential surface of the first control portion 420, and when the first control portion 420 and the sleeve 410 rotate relatively, the dial block can dial the fins on the outer circumferential surface of the sleeve 410. The fin can be made of a metal sheet, a reed or other materials, and when the control part drives the shifting block to pass through the fin, the fin can make a sound and/or give a frustrating touch to an operator, so that the operator can be prompted to rotate the first control part 420. Through the setting of fin and shifting block, can effectively avoid operator's maloperation. In some alternative embodiments, the dial block may be disposed on the outer circumferential surface of the sleeve 410, and the fins may be disposed on the inner circumferential surface of the first control portion 420.

FIG. 23 is a schematic diagram of a partial cross-sectional configuration of an inner clamp arm control mechanism according to some embodiments of the present application; FIG. 24 is a schematic view of a housing according to some embodiments of the present application; FIG. 25 is a schematic structural view of a second control section according to some embodiments of the present application; FIG. 26 is a schematic structural view of a second control and locking mechanism shown in a first perspective in accordance with some embodiments of the present application; FIG. 27 is a schematic structural view of a second control and locking mechanism shown in a second perspective according to some embodiments of the present application. In some embodiments, as shown in fig. 23-27, inner clamp arm control mechanism 500 can include a housing 510 and a second control portion 520; the housing 510 is provided with a second chute 511; the second control portion 520 passes through the second sliding slot 511 and can move along the second sliding slot 511 to control the opening and closing of the inner clamping arm 210 relative to the outer clamping arm 220.

In some embodiments, as shown in fig. 25, the second control portion 520 may include an L-shaped conduit 521 and an end cap 523; one end of the guide pipe 521 may pass through the second sliding groove 511 and be detachably connected to the cover 523. In operation, the L-shaped conduit 521 is more easily controlled by the operator by pushing and pulling the conduit 521 at the end cap so that the second control portion 520 slides within the second chute 511. In this embodiment, the second control portion 520 may be drivingly connected to the inner clamp arm 210 via a traction cable. In one embodiment, the pull cable may pass through a through hole at the free end of the inner clamp arm 210, and both ends of the pull cable may be secured at the end cap 523. When the tissue gripping device 200 is to be separated from the control handle 300, the control handle 300 can be separated from the inner clamp arm 210 by separating the end cap 523 from the guide tube 521, releasing the fixation of the two ends of the pull cable, and withdrawing the pull cable. In some embodiments, releasing the securing of the two ends of the pull cable may include: releasing the clamping connection between the two ends of the traction rope and the end covers, releasing knots formed at the two ends of the traction rope, cutting off the traction rope and the like. In some embodiments, the pull cable may not be completely withdrawn from the control handle 300, but rather, the pull cable may be disengaged from the inner clamp arm 210.

In some embodiments, as shown in fig. 24, the second sliding slot 511 may be an elongated slot. When the end cap 523 of the second control portion 520 (or the portion of the conduit 521 extending out of the second chute) moves to the rear end (the end away from the tissue grasping device) of the second chute 511, the inner clip arm 210 may be in a folded state. In some alternative embodiments, the second chute 511 may be provided with an L-shaped profile. Specifically, a channel may be formed at the rear end of the second sliding slot 511 along a direction that is at an angle (e.g., perpendicular) to the second sliding slot 511. When the end cap 523 of the second control part 520 (or the portion of the guide pipe 521 extending out of the second sliding slot) moves to the rear end of the second sliding slot 511, the second control part 520 can be pushed and pulled laterally to enable the portion of the guide pipe 521 extending out of the second sliding slot to be clamped into the channel, so that the inner clamping arm 210 can be kept in a folded state to prevent misoperation in an operation.

In this embodiment, the two sides of the housing 510 may be respectively provided with a second sliding slot 511, and the second control portion 520 includes a first sub-control portion for controlling the first inner clamping arm 211 and a second sub-control portion for controlling the second inner clamping arm 213. The first sub-control part and the second sub-control part may correspond to separate traction ropes, respectively. In some embodiments, second control portion 520 may be configured to be coupled or decoupled according to actual needs, so as to accurately control inner clamping arm 210 according to experimental or surgical needs. For example, in the mitral valve repair process, the first inner clamping arm 211 can be controlled to clamp one side of the mitral valve, and then the second inner clamping arm 213 can be controlled to clamp the other side of the mitral valve. For another example, the second control portion 520 may control the first inner clamp arm 211 and the second inner clamp arm 213 to clamp the mitral valve at the same time.

In some embodiments, one end of the housing 510 may be connected to (or integrally formed with) the cannula 410, and the central axes of the housing 510 and the cannula 410 coincide, making the control handle 300 more compact and easier to manipulate. For example, housing 510 may be disposed at an end of cannula 410 proximate to tissue gripping device 200, and outer clip arms 220 may be configured to be in a maximum open state when first control portion 420 abuts a rear end of housing 510. In some alternative embodiments, the housing 510 may also be provided at the end of the cannula 410 distal to the tissue gripping device 200.

In some embodiments, as shown in fig. 23-27, the inner clamp arm control mechanism 500 can 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 further include a tooth shaped connection portion 537. The locking button 533 serves to control the locking stopper 535 to move against the elastic force of the second elastic member 531 to release the locking stopper 535 from restraining the tooth-shaped connection portion 537.

As shown in fig. 23-27, in the present embodiment, the locking mechanism 530 includes a set of oppositely disposed locking stops 535, and the first and second sub-controls may each include a corresponding tooth attachment portion 537. Specifically, the tooth shape connection portion 537 may be connected to or integrally formed with the conduit 521 of the first sub-control portion or the second sub-control portion. A set of oppositely disposed locking stops 535 may be used to limit the movement of the first and second sub-control parts, respectively, under the elastic force of the second elastic member 531. For example, the locking stopper 535 corresponding to the first sub-control portion may be caught in the tooth-shaped connection portion 537 corresponding to the first sub-control portion by the elastic force of the second elastic member 531. The locking stopper 535 corresponding to the second sub-control portion can be engaged with the tooth-shaped connection portion 537 corresponding to the second sub-control portion by the elastic force of the second elastic member 531. The second elastic member 531 may be two springs in this embodiment. The locking button 533 may include two, which are respectively connected to the two locking stoppers 535. The locking button 533 may be exposed from the housing 510. Taking the operation of the first sub-control portion as an example, when the locking button 533 corresponding to the first sub-control portion is pressed, the locking button 533 drives the locking stopper 535 to overcome the elastic force of the second elastic member 531 so as to disengage from the tooth-shaped connecting portion 537, and the operator can push and pull the first sub-control portion (e.g. the conduit 521 of the first sub-control portion) to slide in the second sliding slot 511 to control the opening and closing of the first inner clipping arm 211. When the operator releases the locking button 533, the locking stopper 535 may be re-inserted into the tooth-shaped connection portion 537 by the elastic force of the second elastic member 531, so as to limit the movement of the tooth-shaped connection portion 537 (i.e., the movement of the guide pipe 521). The operation of the second sub-control part is similar to that of the first sub-control part, and is not described in detail herein.

In some embodiments, since two locking buttons 533 are provided, a mark may be added to the locking buttons 533 for easy recognition by the operator. The indicia may be "left", "right", "L", "R", or an arrow, etc.

In some embodiments, the inner clamp arm control mechanism 500 may include a second indicator 910. The second indicating device 910 can be used for indicating the opening and closing angle of the inner clamping arm 210 according to the position of the second control part 520. FIG. 28 is a schematic view of an inner clamp arm control mechanism capable of indicating an angle of opening and closing of an inner clamp arm according to some embodiments of the present application; FIG. 29 is a schematic view of a second indicating device according to some embodiments of the present application. By arranging the second indicating device 910, an operator can more conveniently and intuitively control the opening angle of the inner clamping arm 210 in the process of an operation or experiment.

In some embodiments, the opening and closing angle of inner clamp arm 210 may be the opening and closing angle of inner clamp arm 210 relative to a collapsed state. For example, in the embodiment shown in FIGS. 2-3, FIG. 2 is a schematic view of inner clamp arm 210 in a collapsed state; the opening and closing angle of the inner clip arm 210 relative to the closed state can be understood as the opening and closing angle of the inner clip arm relative to the support 240. For another example, in the embodiment shown in fig. 6, the inner clip arm 210 is in a folded state, and the opening and closing angle of the inner clip arm 210 relative to the folded state can be understood as the opening and closing angle of the inner clip arm relative to the connecting pipe 270. In some alternative embodiments, the opening and closing angle of inner clamp arm 210 may also be an angle at which the two inner clamp arms open relative to each other.

In some embodiments, as shown in fig. 28, the second indicating device 910 may include one or more opening and closing angle indicators 911 provided on the housing 510. As shown in fig. 28, the opening and closing angle indicator 911 may be an indicator (such as an arrow) printed on the housing 510, and when the second control part 520 (such as a portion of the conduit 521 extending out of the second chute) moves to be aligned with the opening and closing angle indicator 911, it may indicate that the inner clamping arms 210 are opened to a corresponding angle. In some embodiments, the opening and closing angle indicator 911 may also include other indicator modalities. For example, the opening and closing angle indicator 911 may be a graduation mark, a degree value, an indication arrow with different colors, etc. printed or engraved on the housing 510. In some embodiments, a plurality of opening and closing angle indicators 911 may be sequentially disposed along the length direction of the housing 510. Each opening and closing angle indicator 911 may correspond to a specific opening angle (e.g., 0 degree, 30 degrees, 60 degrees, 90 degrees, etc.) of one inner clip arm 210. In some embodiments, the correspondence between the opening and closing angle indicator 911 and the specific angle at which the inner clamp arm 210 is opened can be obtained through experiments. In some embodiments, the installation position of each component may be adjusted according to a specific angle that the opening and closing angle indicator 911 should correspond to when the inner clamp arm control mechanism 500 is installed, so that each opening and closing angle indicator 911 can correspond to a corresponding specific angle when the installation is completed.

In some embodiments, as shown in fig. 29, the second indication 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 part 520; the processor 923 is configured to determine an opening and closing angle of the inner clamping arm 210 according to the position of the second control portion 520, and control the display 925 to display the opening and closing angle of the inner clamping arm 210. In some embodiments, the display 925, the processor 923 and the first sensor 921 can be provided directly on the control handle 300. In some alternative embodiments, the display 925 and/or the processor 923 may also be provided separate from the control handle 300. For example, the second sensor 921 may have a signal connection (e.g., 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 (e.g., a surgery monitoring display) to display the opening and closing angle of the inner clamping arm 210 according to the processing result. Through adopting second sensor 921 and display 925, arm lock 210 angle that opens and shuts in demonstration that can be more accurate can effectively avoid causing the inaccurate problem of angle reading that opens and shuts because of operating personnel's visual error. In some embodiments, outer clamp arm control mechanism 400 and inner clamp arm control mechanism 500 may use the same processor and/or the same display.

In some embodiments, the second sensor 921 may comprise a ranging module. The distance measuring module may be used to detect a distance between an end of the second chute 511 and the second control part 520 (e.g., a portion of the conduit 521 extending out of the second chute). The distance may reflect the position of the second control part 520. In some embodiments, the correspondence between the position of the second control portion 520 and the opening and closing angle of the inner clip arm 210 can 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 portion 520 and the corresponding relationship between the position of the second control portion 520 and the opening and closing angle of the inner clamp arm 210. In some embodiments, the ranging module may include an ultrasonic ranging sensor, an infrared distance sensor, a hall sensor, and the like.

In some embodiments, the opening and closing angle of inner clamp arm 210 may be the opening and closing angle of inner clamp arm 210 relative to outer clamp arm 220. It is understood 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 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 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 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 shown in fig. 29, 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 configured to determine an opening and closing angle of the inner clamping arm 210 according to the position of the second control portion 520 and the opening and closing angle of the outer clamping arm 220, and control the display 925 to display the opening and closing angle of the inner clamping arm 210 (relative to the opening and closing angle of the outer clamping arm 220). For example, processor 923 may obtain the opening and closing angle of outer clamp arm 220 from processor 823. For another example, the processor 923 may 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 clamping arm 220 can be understood as an angle at which two outer clamping arms open each other; the processor 923 can determine the opening and closing angle of a certain inner clamping arm (e.g., the first inner clamping arm 211 or the second inner clamping arm 213) relative to the closed state according to the position of the second control portion 520. In addition, the processor 923 may calculate the opening and closing angle of the inner clamp arm with respect to the outer clamp arm 220 through arithmetic operations. For example, if the processor 923 obtains that the opening and closing angle of the outer arm 220 obtained from the outer arm control mechanism 400 is 180 degrees, and the processor 923 obtains that the opening and closing angle of the first inner arm 211 with respect to the closed state is 30 degrees from the information fed back by the second sensor 921 (the position of the second control unit 520), the processor 923 may determine that the opening and closing angle of the first inner arm 211 with respect to the outer arm is (180 ÷ 2) — 30 ═ 60 degrees. It should be noted that, in some embodiments, when the opening and closing angle of an inner clip arm relative to the closed state is greater than half of the opening and closing angle of the outer clip arm 220, it means that the inner clip arm is closed relative to the outer clip arm 220, and the corresponding pulling cable of the inner clip arm is in a slack state.

In some embodiments, inner clamp arm control mechanism 500 may include a second prompting device. The second prompting device can be used for prompting that the inner clamping arm 210 reaches a preset opening and closing angle. Specifically, the preset opening and closing angle may be a preset opening and closing angle of the inner clamping arm 210 relative to a folded state, or an opening and closing angle of the inner clamping arm 210 relative to the outer clamping arm 220. In some embodiments, the second prompting device may give the operator a prompt at a specific angle (e.g., 0 degrees, 30 degrees, 60 degrees, 90 degrees, etc.), and the manner of the prompt may include one or more of visual, audible, or tactile, among others. By giving visual, auditory and/or tactile feedback to the operator, the operator can be effectively prompted that the inner clamping arm 210 has reached the preset opening and closing angle.

In some embodiments, the second prompting device can include a first contact portion and a second contact portion similar to the first prompting device 830, the first contact portion can be disposed on an outer peripheral surface of the second control portion, and the second contact portion can be disposed inside the housing. When the second contact portion contacts with the first contact portion, the second prompting device can prompt the outer clamping arm 220 to reach 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, one or more of a speaker, a light emitter, a buzzer, a vibrator, and the like in combination. 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 the preset opening and closing angle, the processor can control the prompting component to send a prompt.

In some embodiments, the second control portion 520 may include a first sub-control portion and a second sub-control portion for controlling the opening and closing of the first inner clamp arm 211 and the second inner clamp arm 213, respectively. The second indicating device 910 may include a first sub-indicating device and a second sub-indicating device for indicating the opening and closing angles of the first inner clamp arm 211 and the second inner clamp arm 213, respectively. The second prompting device may include a first sub-prompting device and a second sub-prompting device for prompting that the first inner clamping arm 211 and the second inner clamping arm 213 reach a preset opening and closing angle, respectively.

The beneficial effects that may be brought by the embodiments of the present application include, but are not limited to: (1) the outer clamping arm and/or the inner clamping arm of the tissue clamping device can be accurately controlled; (2) the outer clamping arm of the tissue clamping device can be rapidly controlled; (3) the control handle can be conveniently separated from the tissue clamping device; (4) the mitral valve repair operation can be more convenient, and the repair efficiency and success rate are higher; (5) the opening and closing angle of the outer clamping arm and/or the inner clamping arm can be rapidly and intuitively obtained; (6) it is possible to prevent the occurrence of erroneous operation in a plurality of links. It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.

The present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed.

Claims

1. A mitral valve repair device comprising a tissue gripping device and a control handle;

the tissue clamping device comprises an outer clamping arm and an inner clamping arm;

the control handle comprises an outer clamping arm control mechanism and an inner clamping arm control mechanism, the outer clamping arm control mechanism is used for controlling the outer clamping arm to open and close, and the inner clamping arm control mechanism is used for controlling the inner clamping arm to open and close relative to the outer clamping arm;

the control handle is used for conveying the tissue clamping device to the mitral valve via the left auricle and the left atrium, and controlling 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 of claim 1, wherein: the device also comprises a conveying pipe; the tissue gripping device is connected to the control handle through the delivery tube.

3. The mitral valve repair device of claim 2, wherein: the delivery tube is inflexible.

4. The mitral valve repair device of claim 2, wherein: the delivery pipe comprises a bent pipe, and the control handle further comprises a bent pipe control mechanism;

the bending pipe control mechanism is used for controlling the bending of the bending pipe.

5. The mitral valve repair device of claim 4, wherein: the bending pipe is provided with a plurality of gaps along the length direction;

the bending pipe control mechanism comprises a traction part, and the bending pipe control mechanism can control the opening and closing of the plurality of gaps through the traction part so as to control the bending of the bending pipe.

6. The mitral valve repair device according to any one of claims 2-5, wherein: the outer clamping arm control mechanism comprises a sleeve, a first control part and a sliding part, and 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 through rotation so as to control the opening and closing of the outer clamping arm;

the inner clamping arm control mechanism comprises a shell and a second control part; the shell is provided with a second sliding chute; the second control part penetrates through the second sliding groove and can move along the second sliding groove to control the inner clamping arm to open and close relative to the outer clamping arm.

7. The mitral valve repair device of claim 6, wherein: the outer peripheral surface of the sleeve is provided with an external thread; the inner circumferential surface of the first control part is provided with an internal thread; the sleeve is connected with the first control part through threads; the sleeve is provided with a first sliding chute along the length direction; the sliding part penetrates through the first sliding groove and is connected with the first control part.

8. The mitral valve repair device of claim 7, wherein: the first control portion comprises a threaded engagement mechanism; the thread engagement mechanism comprises a control button, a first elastic piece and a pair of engagement pieces; the engaging pieces are symmetrically arranged and are configured to be engaged with the external threads of the sleeve by the elastic force of the first elastic piece; the control button is arranged on the outer side of the occluding part in a surrounding mode and used for controlling the occluding part to overcome the elastic force of the first elastic part to be separated from the external thread of the sleeve.

9. The mitral valve repair device of claim 6, wherein: the sliding part comprises an outer cover, a middle cylinder and an inner pipe; the middle cylinder is sleeved outside the inner pipe; the middle cylinder is provided with an opening, the inner tube is provided with a clamping block capable of extending outwards, and the clamping block can penetrate through the opening and be clamped with the outer cover to limit the relative movement of the middle cylinder, the inner tube and the outer cover in the length direction.

10. The mitral valve repair device of claim 6, wherein: the outer clamping arm control mechanism further comprises a driving rod, a fixing block and a protective sleeve; the sliding part controls the outer clamping arm to open and close through the driving rod; the rear end of the driving rod is fixedly connected with the fixed block; the protective sleeve is detachably connected with the sliding part through threads;

when the protective sleeve is connected with the sliding part, the protective sleeve can limit the relative movement of the fixed block and the sliding part.

11. The mitral valve repair device of claim 6, wherein: the second control part comprises an L-shaped conduit and an end cover; one end of the guide pipe penetrates through the second sliding groove and is detachably connected with the end cover.

12. The mitral valve repair device of claim 6, wherein: the inner clamping arm control mechanism also comprises a locking mechanism; the locking mechanism comprises a second elastic piece, a locking button and a locking stop block; the second control part also comprises a tooth-shaped connecting part; the locking button is used for controlling the locking stop block to move against the elastic force of the second elastic piece so as to release the limitation of the locking stop block on the tooth-shaped connecting part.