Lead ligation device and ligation method

Abstract

The invention provides a lead ligation device and ligation method.The lead ligation device comprises a clamping and binding mechanism and a handle, the clamping and binding mechanism comprises a ligation assembly and a clamping assembly which are sequentially arranged in a nested mode, and the handle comprises a pushing assembly and a thread hooking assembly; the near end of the pushing assembly is connected with the clamping assembly, the pushing assembly is arranged on the periphery of the thread hooking assembly in a sleeving mode, and the near end of the thread hooking assembly is movably connected with the ligation assembly. The operation is simple, the tissue closing rate is high, repeated positioning and capturing can be realized, and a rope releasing function is also realized.

Description

Technical Field

[0001] The invention belongs to the technical field of ligation, and relates to a lead wire ligation device and a ligation method. Background Art

[0002] For most of the vegetation or excess soft tissue in the human body, surgical removal is generally used, which usually achieves good treatment results. However, for some vegetation or soft tissue, such as some hemangiomas and left atrial appendages, which are not suitable for removal, ligation or closure is often the only treatment method. Most of the ligation or closure products on the market are surgical medical devices, which need to be operated through surgery, are more traumatic, and take a long time to recover after surgery.

[0003] With the rapid development of interventional medical technology in recent years, transcatheter products have emerged. One type is occlusion devices, such as the Watchman system, LAmbre system, and WaveCrest system. This type of product enters the left atrium through atrial septal puncture and implants the occluder at the root of the left atrial appendage. It has high requirements for the operator's operation and has the risk of causing secondary thrombosis. The other type is the clamping device, which is further divided into the clamp type and the ligation snare type. The clamp type is through epicardial intervention. The clamp is wrapped or clamped at the root of the left atrial appendage in an open state, and then the delivery device is withdrawn to close the clamp and close the left atrial appendage. The operation is relatively simple, but the shape of the clamp is fixed, and the clamping force is also certain. The left atrial appendage of a person varies greatly from person to person, so the adaptability of the clamp is poor. The ligation snare type usually includes a transepicardial snare device and a magnetic suction device for locating and capturing the left atrial appendage through atrial septal puncture. One end of the magnet passes through the inferior vena cava through the atrial septum to the inner tip of the left atrial appendage, and the other end punctures the epicardium to the outside of the left atrial appendage tip, and the left atrial appendage is captured by magnetic attraction. The snare passes through the outer magnet of the left atrial appendage to trap the left atrial appendage, and at the same time, the balloon dilatation at the inner root of the left atrial appendage pushes the line sleeve to the root of the left atrial appendage to complete the ligation and block the left atrial appendage. However, the snare and the flexible end of the handle of this system are not rigid enough, and there are safety hazards for the operation of irregular left atrial appendages. It also requires two interventions in the heart and the epicardium. The process is cumbersome and there are safety hazards. There is also a risk of secondary thrombosis. The ligation snare system also includes a transepicardial snare device and a positioning capture device, which needs to be positioned first and then the root is ligated with a snare. Summary of the invention

[0004] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a lead ligation device and a ligation method, which are simple to operate, have a built-in rope release function, avoid multiple entry and exit points, have a high tissue closure rate, can prevent thrombosis, and can repeatedly locate and capture.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] In a first aspect, the present invention provides a lead ligation device having a proximal end and a distal end, the lead ligation device comprising a clamping mechanism and a handle, the clamping mechanism comprising a ligation assembly and a clamping assembly nested in sequence, the handle comprising a pushing assembly and a wire hooking assembly, the proximal end of the pushing assembly being connected to the clamping assembly, the pushing assembly being sleeved on the outer periphery of the wire hooking assembly, and the proximal end of the wire hooking assembly being movably connected to the ligation assembly.

[0007] When the present invention is used, it is only necessary to use the hook wire component to simply pull the ligation component at one end to complete the ligation action. It has its own rope release function, avoids multiple entry and exit points, reduces risks, is safe and efficient as a whole, and will not leave anything inside the heart in the later stage. It can reduce the problems of stroke, hypertension and potential low blood pressure, improve the tissue closure rate, and prevent thrombosis.

[0008] As a preferred technical solution of the present invention, the lead ligation device also includes a connecting rod, which is movably mounted on the outer periphery of the clamping mechanism, and at least one lumen is provided in the connecting rod. The proximal end of the pushing assembly is located in the lumen and is connected to the clamping assembly, and the distal end of the connecting rod is movably connected to the handle.

[0009] Preferably, the handle further comprises a shell, the distal end of the connecting rod extends into the shell and is slidably connected to the shell, and the connecting rod moves axially toward the proximal end or the distal end of the shell so that the clamping assembly is exposed at the proximal end.

[0010] Preferably, a sliding component is slidably disposed on the housing, and the connecting rod is connected to the sliding component.

[0011] Preferably, the connecting rod and the sliding component are bonded, welded or riveted.

[0012] Preferably, the connecting rod is a rigid tube or a flexible tube.

[0013] Preferably, the connecting rod is a flexible bent pipe, and the inclination angle of the flexible bent pipe is 10 to 30°, for example, it can be 10°, 15°, 18°, 20°, 22°, 25°, 28° or 30°, but is not limited to the listed values, and other unlisted values ​​within this numerical range are also applicable.

[0014] It should be noted that the connecting rod in the present invention is used to store and expose the clamping mechanism. In minimally invasive and interventional surgeries, the connecting rod is used to push the clamping mechanism to the target tissue for ligation. In surgical operations, no connecting rod is required, and the clamping mechanism can be directly pushed to the target tissue through the pushing component of the handle.

[0015] As a preferred technical solution of the present invention, the wire hook assembly includes a traction head, a flexible hose and a distal handle. The traction head is movably connected to the ligation assembly. One end of the flexible hose is connected to the traction head, and the other end extends out of the distal end of the pushing assembly and is connected to the distal handle.

[0016] Preferably, the distal handle is located outside the housing. In the present invention, the traction head is located at the proximal end and connected to the ligation assembly, and the operator can pull the distal handle from the distal end to drive the traction head to lead the ligation assembly to move toward the distal end for tightening.

[0017] Preferably, the pushing assembly includes a clamping body fixing part and a multi-cavity fixing part, a plurality of lead-out cavities are arranged in the clamping body fixing part, the proximal end of the clamping body fixing part is connected to the clamping assembly, and the multi-cavity fixing part is sleeved on the distal end of the clamping body fixing part and is snap-connected to the shell.

[0018] Preferably, the clamping body fixing member and the multi-cavity fixing member are bonded, welded or anchored.

[0019] Preferably, the pushing assembly further comprises a guide wire flexible tube, the proximal end of which is connected to a lead-out cavity of the clamping body fixing member.

[0020] The flexible hose of the hook wire assembly in the present invention passes through a lead-out cavity of the clamp body fixing part, so that the traction head is connected to the ligation assembly at the proximal end.

[0021] As a preferred technical solution of the present invention, the clamping assembly includes a first clamping body, a second clamping body and a pulling rod, the first clamping body and the second clamping body are independently connected to the pushing assembly, the proximal end of the pulling rod is independently and movably connected to the first clamping body and the second clamping body, the distal end of the pulling rod is transmission connected to the handle, and the handle is used to drive the pulling rod to move axially toward the proximal end or toward the distal end to achieve the opening and closing of the first clamping body and the second clamping body.

[0022] Preferably, the handle also includes an active trigger, an "L"-shaped buckle and a fixed handle, one end of the "L"-shaped buckle is connected to the pull rod, and the other end is hinged to the active trigger, the active trigger is also rotatably connected to the fixed handle, and the fixed handle is fixedly connected to the shell.

[0023] The fixing connection method of the fixed handle and the shell in the present invention includes but is not limited to anchoring methods such as glue bonding, laser welding, snap fit, and thread fit.

[0024] Preferably, the movable trigger is rotatably connected to the fixed handle via a fixed rotating shaft, and the fixed rotating shaft is fixed on the housing.

[0025] Preferably, a connecting spring is provided between the bottom of the movable trigger and the bottom of the fixed handle.

[0026] Preferably, a limited rotation shaft is also provided on the fixed handle to limit the rotation of the "L"-shaped buckle to prevent the clamping assembly from being over-opened.

[0027] Preferably, the pulling rod is also fixedly connected to the first clamping body and the second clamping body respectively through a fixing pin.

[0028] During the application of the present invention, the operator holds the fixed handle, and when the movable trigger is rotated in the first direction, the "L"-shaped buckle is driven to pull the pulling rod axially toward the distal end, and the first clamping body and the second clamping body at the proximal end are in an open state of a "V"-shaped, "C"-shaped or "U"-shaped acute-angle structure; when the movable trigger is rotated in the second direction, the "L"-shaped buckle is driven to push the pulling rod axially toward the proximal end, and the first clamping body and the second clamping body are in a closed state to clamp the target tissue.

[0029] Preferably, the proximal ends of the first clamping body and the second clamping body respectively transition in an arc shape toward each other.

[0030] Preferably, a surface of one side of the first clamping body and the second clamping body close to each other is independently provided with a tear-off opening, and the tear-off opening is provided with a tearable film layer.

[0031] Preferably, the outer surfaces of the first clamping body and the second clamping body are independently coated with a film layer. The film layer can be a sleeve structure, a braided structure, or a coated structure, which is not specifically limited in the present invention.

[0032] Preferably, the first clamping body and the second clamping body are independently fixedly connected to the clamping body fixing member.

[0033] In the present invention, arc-shaped limiting grooves are independently provided on the first clamping body and the second clamping body, and a rotating shaft is provided at the proximal end of the pulling rod, and the two ends of the rotating shaft extend out of the limiting grooves of the first clamping body and the second clamping body respectively to realize hinge connection. At the same time, a fixing pin is used to fix the pulling rod, the first clamping body and the second clamping body near the limiting groove.

[0034] As a preferred technical solution of the present invention, the ligation assembly includes a first multi-lumen tube, a second multi-lumen tube and a traction line. The first multi-lumen tube and the second multi-lumen tube are independently pre-loaded in the clamping assembly. The traction line is introduced by the first multi-lumen tube, and enters the second multi-lumen tube after forming a reserved knot in the first multi-lumen tube, and then extends out of the second multi-lumen tube. The hook wire assembly is used to capture the traction line extended from the second multi-lumen tube, and drive the traction line to pass through the reserved knot to move to the distal end and then tighten.

[0035] Preferably, at least two upper cavities connected to each other are provided in the first multi-lumen tube, wherein at least one upper cavity is used for introducing the traction line at the distal end, and at least one upper cavity is used for loading the reserved knot, specifically, the traction line is introduced from the distal end of one upper cavity, and enters the other upper cavity from the proximal end to form the reserved knot, and then introduced into the second multi-lumen tube.

[0036] Preferably, the surface of the upper cavity is provided with a hydrophilic coating.

[0037] Preferably, the inner surface of the second multi-lumen tube is also provided with a hydrophilic coating to facilitate the sliding of the traction wire in the second multi-lumen tube.

[0038] Preferably, the first multi-lumen tube and the second multi-lumen tube are pre-loaded independently in the first clamping body and the second clamping body respectively.

[0039] Preferably, a first lead wire opening and a second lead wire opening are independently provided on the surfaces of one side of the first multi-lumen tube and the second multi-lumen tube that are close to each other.

[0040] During the application of the present invention, as the traction head leads out the traction wire, the traction wire located in the first multi-lumen tube flows out from the first lead wire opening into the first clamping body, and then escapes from the wire-release opening of the first clamping body. The traction wire located in the second multi-lumen tube flows out from the second lead wire opening into the second clamping body, and then escapes from the wire-release opening of the second clamping body, tightening the target tissue. After the system is withdrawn, the traction wire remains on the target tissue.

[0041] Preferably, the traction head of the wire hook assembly passes through the first multi-lumen tube, extends out from the proximal end of the first multi-lumen tube, and then movably connects with the traction wire.

[0042] Preferably, the traction head is connected to the traction line by clamping, hooking, snapping or magnetic attraction.

[0043] Preferably, the ligation assembly also includes a Luer connector and a lead wire flexible tube, the Luer connector is arranged at the distal end of the handle, the proximal end of the lead wire flexible tube is connected to the first multi-lumen tube through the pushing assembly, the distal end of the lead wire flexible tube is connected to the Luer connector, the traction wire is connected by the Luer connector, and enters the first multi-lumen tube through the lead wire flexible tube.

[0044] Preferably, the proximal end of the lead wire flexible tube is connected to the lead-out cavity of the clamp body fixture. The lead wire flexible tube is connected to a lead-out cavity of the clamp body fixture, so that the traction wire can smoothly pass through the pushing component into the first multi-lumen tube. The traction wire of the present invention passes through a lead-out cavity of the clamp body fixture through the lead wire flexible tube and is then introduced into the first multi-lumen tube. When being led out, driven by the hook wire component, the traction wire passes through another lead-out cavity of the clamp body fixture again and is led out.

[0045] As a preferred technical solution of the present invention, the ligation assembly also includes an inner support tube, the proximal end of the inner support tube extends into the first multi-lumen tube, the distal end of the inner support tube is transmission-connected to the handle, the reserved knot is arranged on the outer wall of the inner support tube, and a plurality of fixed rope buckles are also arranged on the traction line in the second multi-lumen tube, and the handle is used to drive the inner support tube to disengage from the reserved knot.

[0046] Preferably, the traction head passes through the inner support tube and extends from the first multi-lumen tube, and is movably connected to the traction wire extended from the second multi-lumen tube, and driven by the distal handle, drives the traction wire to be led out of the inner support tube.

[0047] Preferably, the handle includes a toggle component, which includes a toggle block, a coupling, a connecting pin and a driving shaft. The coupling is connected to the inner support tube, one end of the toggle block is movably connected to the coupling via the connecting pin, and the other end extends out of the shell, and the toggle block is rotatably connected to the shell via the driving shaft.

[0048] Preferably, the proximal end of the inner support tube extends into the upper cavity of the first multi-lumen tube, and the distal end of the inner support tube passes through the lead-out cavity of the clamping body fixing member and is connected to the shifting component.

[0049] During the application of the present invention, after the wire hook component captures the traction wire extending from the second multi-lumen tube, it leads it out until the traction wire is completely led out. The operator shifts the shift block at the distal end to drive the coupling to move, thereby driving the inner support tube to move toward the distal end and escape from the reserved knot.

[0050] The traction line in the present invention has a first end and a second end, the first end is fixed by a Luer connector, the second end of the traction line passes through a lead wire flexible tube from an upper cavity into the first multi-lumen tube, and enters another upper cavity to form a reserved knot, and then is introduced into the second multi-lumen tube; the second end extends out of the second multi-lumen tube, and the traction head of the hook wire assembly is connected to the second end of the traction line, and under the pull of the distal handle, the second end of the traction line is driven to move toward the distal end along the inner support tube until the fixed rope buckle on the traction line passes through the reserved knot, ensuring one-way sliding, and continuing to tighten the traction line. After the ligation is completed, the Luer connector is untied, the first end of the traction line is loosened, and the system is withdrawn so that the traction line remains on the tissue.

[0051] As a preferred technical solution of the present invention, the ligation assembly also includes a tightening buckle, which is arranged in the first multi-lumen tube, and the tightening buckle is located at the proximal end of the reserved knot. The tightening buckle opens a first guide wire channel and a second guide wire channel that are connected to each other; the traction wire entering the first multi-lumen tube passes through the second guide wire channel, and after forming the reserved knot in the first multi-lumen tube, it is introduced into the second multi-lumen tube, and the hook wire assembly drives the traction wire extending from the second multi-lumen tube to pass through the first guide wire channel and the reserved knot in turn and then move toward the distal end.

[0052] Preferably, the inner wall of the first guide wire flow channel is provided with a first limiting thorn, and the tip of the first limiting thorn points to the distal end.

[0053] Preferably, the inner wall of the second guide wire flow channel is provided with a second limiting thorn, and the tip of the second limiting thorn points to the proximal end.

[0054] Preferably, the traction wire enters from the distal end of an upper cavity of the first multi-lumen tube, passes through the second guide wire channel, and then enters the other upper cavity of the first multi-lumen tube to form the reserved knot, and is then introduced from the distal end of the first multi-lumen tube into the second multi-lumen tube, and the wire hook assembly drives the traction wire extended from the second multi-lumen tube to pass through the first guide wire channel and the reserved knot in sequence and then move toward the distal end.

[0055] During the application of the present invention, the traction line entering the first multi-lumen tube first passes through the second guide line channel of the tightening buckle, and is ensured to slide in one direction by the second limiting thorn. The traction line led out by the traction head passes through the first guide line channel of the tightening buckle, and then the traction line is passed through the reserved knot, and is ensured to slide in one direction by the first limiting thorn until it is tightened and the knot is tied.

[0056] As a preferred technical solution of the present invention, the ligation assembly further comprises a knotting rope ring, and the knotting rope ring is arranged in the first multi-lumen tube and sleeved on the outer periphery of the reserved knot.

[0057] Preferably, the traction line introduced into the first multi-lumen tube is wrapped around to form the reserved knot, then wrapped around the reserved knot for at least one circle to form the knotted rope ring and then led out into the second multi-lumen tube, and the wire hook assembly passes the traction line extending from the second multi-lumen tube through the reserved knot and moves toward the distal end, so that the knotted rope ring tightens the reserved knot.

[0058] It should be noted that the present invention has strong applicability. It can not only be used for ligating tissues, but also can be used in environments where no knotting is required. For example, after clamping the tissue, it can be used as a guiding device to wrap a traction wire around the target tissue to form a loop, and after the traction wire is withdrawn, the wire loop can be tightened or not.

[0059] In a second aspect, the present invention provides a lead ligation method, which adopts the lead ligation device described in the first aspect, and the lead ligation method includes: transporting the pushing component to the outer edge of the target tissue, releasing the clamping component to the root of the target tissue, and after capturing the target tissue, fixing the ligation component to the target tissue through the hook wire component and tightening it.

[0060] As a preferred technical solution of the present invention, the lead wire ligation method specifically includes: the wire hook assembly drives the traction wire to move, so that the fixed rope buckle passes through the reserved knot, and the toggle component is used to drive the inner support tube to move toward the distal end, so that the inner support tube is disengaged from the reserved knot, the traction wire is led out and the target tissue is tightened, and then the Luer connector is loosened and the pushing assembly is withdrawn, so that the traction wire remains on the target tissue.

[0061] Alternatively, the hook wire assembly drives the traction wire to move, so that the traction wire passes through the tightening buckle and the reserved knot in sequence, and continues to pull the traction wire to tighten the left atrial appendage to complete the knotting, then loosens the Luer connector and withdraws the pushing assembly, so that the traction wire remains on the target tissue.

[0062] Alternatively, the hook wire assembly drives the traction wire to move, passes the traction wire through the reserved knot, and continues to pull the traction wire to tighten the left atrial appendage, so that the knotted rope ring tightens the reserved knot, completes the knotting, and then loosens the Luer connector and withdraws the pushing assembly, so that the traction wire remains on the target tissue.

[0063] Compared with the prior art, the present invention has the following beneficial effects:

[0064] The present invention provides a lead wire ligation device and a ligation method, which are pre-bound with a one-way slidable reserved knot, which can only be tightened but not loosened. When used, it only needs to use a hook wire component to simply pull one end of the traction wire to complete the ligation action. It can repeatedly locate and capture, has a built-in rope release function, avoids multiple entry and exit points, reduces risks, is safe and efficient as a whole, and will not leave anything inside the heart at a later stage. It can reduce the problems of stroke, hypertension and potential hypotension, improve the tissue closure rate, and prevent thrombosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 A schematic structural diagram of a lead ligation device provided in a specific embodiment of the present invention; Figure 2 A schematic structural diagram of a connecting rod provided in a specific embodiment of the present invention; Figure 3 A schematic diagram of the structure of a line hooking assembly provided in a specific embodiment of the present invention; Figure 4 A schematic structural diagram of a clamping assembly provided in a specific embodiment of the present invention; Figure 5 A schematic diagram of the structure of a ligation assembly provided in a specific embodiment of the present invention; Figure 6 A schematic structural diagram of a clamping assembly provided in a specific embodiment of the present invention; Figure 7 A schematic structural diagram of a first clamping body and a second clamping body provided in a specific embodiment of the present invention; Figure 8 A schematic diagram of the connection between an "L"-shaped buckle and an adjustable wrench provided in a specific embodiment of the present invention;

[0066] Fig. 9 A schematic diagram of the structure of a connecting spring provided in a specific embodiment of the present invention; Fig.10 A schematic diagram of the structure of a reserved rope knot and a fixed rope buckle provided in a specific embodiment of the present invention; Fig.11 Schematic diagram of the reserved knot for fixing the rope buckle; Fig.12 A cross-sectional view of a first multi-lumen tube and a second multi-lumen tube provided for one embodiment of the present invention; Fig.13 A schematic diagram of a traction head winding provided for a specific embodiment of the present invention; Fig.14 A schematic diagram of a traction head hook connected to a traction line provided in a specific embodiment of the present invention; Fig.15 A schematic diagram of a traction head magnetically connected to a traction line provided in a specific embodiment of the present invention; Fig.16 A schematic diagram of a traction head buckle connected to a traction line provided in a specific embodiment of the present invention; Fig.17 A schematic diagram of the structure of an inner support tube provided in a specific embodiment of the present invention; Fig.18 A schematic diagram of the structure of a toggle component provided in a specific embodiment of the present invention; Fig.19 A schematic diagram of the structure of a tightening buckle provided in a specific embodiment of the present invention; Fig. 20 A schematic diagram of the structure of a tightening buckle provided in a specific embodiment of the present invention; Fig.21 A schematic diagram of the structure of a tightening buckle provided in a specific embodiment of the present invention; Fig. 22 A schematic diagram of the structure of a tightening buckle provided in a specific embodiment of the present invention; Fig.23 A schematic diagram of the structure of a knotted rope ring provided in a specific embodiment of the present invention; Fig.24 A schematic diagram of delivering the lead ligation device provided in the application example of the present invention to the left atrial appendage; Fig.25 This is a schematic diagram of the lead ligation device clamping the left atrial appendage provided in the application example of the present invention.

[0067] Among them, 1-push assembly; 2-shell; 3-hook wire assembly; 4-clamping assembly; 5-ligation assembly; 7-sliding component; 9-connecting rod; 10-traction head; 11-flexible hose; 12-distal grip; 13-first clamping body; 1311-limiting groove; 14-pull rod; 1411-extension part; 15-clamping body fixing piece; 16-multi-cavity fixing piece; 17-active trigger; 18-"L" type buckle; 19-fixed handle; 20-traction line; 21-Luer connector; 22-lead flexible tube; 23-guide wire flexible tube; 25-first multi-cavity tube; 26-second multi-cavity tube; 27-second clamping body; 30-fixing pin; 31-fixed Fixed shaft; 32-pin; 33-limiting shaft; 34-shift block; 35-coupling; 36-inner support tube; 37-connecting pin; 38-driving shaft; 2511-first upper cavity; 2512-second upper cavity; 2513-third upper cavity; 2611-first lower cavity; 2612-second lower cavity; 2613-third lower cavity; 2614-fourth lower cavity; 2615-fifth lower cavity; 2621-fixed rope buckle; 3011-reserved rope knot; 50-connecting spring; 60-tightening buckle; 61-first limiting thorn; 62-first guide wire flow channel; 63-second guide wire flow channel; 64-second limiting thorn; 70-knotted rope ring. DETAILED DESCRIPTION

[0068] It should be understood that, in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0069] It should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0070] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0071] In a specific embodiment, the present invention provides a lead ligation device, having a proximal end and a distal end, including a clamping mechanism and a handle. The clamping mechanism includes a ligation component 5 and a clamping component 4 which are nested in sequence, and the handle includes a push component 1 and a wire hooking component 3, the proximal end of the push component 1 is connected to the clamping component 4, the push component 1 is sleeved on the periphery of the wire hooking component 3, and the proximal end of the wire hooking component 3 is movably connected to the ligation component 5.

[0072] In some embodiments, the lead ligation device further comprises a connecting rod 9, which is movably sleeved on the periphery of the clamping mechanism, and has at least one lumen disposed therein, wherein the proximal end of the pushing assembly 1 is located in the lumen and connected to the clamping assembly 4, and the distal end of the connecting rod 9 is connected to the handle. Figure 1 As shown, the handle also includes a shell 2, the distal end of the connecting rod 9 extends into the shell 2 and is slidably connected to the shell 2, and the connecting rod 9 moves axially toward the proximal end or the distal end of the shell 2, so that the clamping assembly 4 is exposed at the proximal end.

[0073] Specifically, Figure 2 As shown, a sliding component 7 is slidably provided on the housing 2, and the connecting rod 9 is connected to the sliding component 7. The connecting rod 9 is bonded, welded or riveted to the sliding component 7. A first opening is provided on the housing 2 of the present invention, and the sliding component 7 extends from the first opening and is slidably connected to the housing 2 for pushing or retracting.

[0074] In some embodiments, the connecting rod 9 is a rigid tube or a flexible tube.

[0075] In some embodiments, the connecting rod 9 is a flexible curved pipe, and the inclination angle of the flexible curved pipe is 10 to 30 degrees.

[0076] like Figure 3 As shown, the hook wire assembly 3 includes a traction head 10, a flexible hose 11 and a distal handle 12. The traction head 10 is movably connected to the ligation assembly 5. One end of the flexible hose 11 is connected to the traction head 10, and the other end extends out of the distal end of the push assembly 1 and is connected to the distal handle 12. The distal handle 12 is located outside the housing 2. In the present invention, the traction head 10 is located at the proximal end and connected to the ligation assembly 5. The operator can pull the distal handle 12 from the distal end to drive the traction head 10 to lead the ligation assembly 5 to move to the distal end for tightening.

[0077] like Figure 4As shown, the pushing assembly 1 includes a clamping body fixing part 15 and a multi-cavity fixing part 16. The clamping body fixing part 15 is provided with a plurality of lead-out cavities. The proximal end of the clamping body fixing part 15 is connected to the clamping assembly 4. The multi-cavity fixing part 16 is sleeved on the distal end of the clamping body fixing part 15 and is snap-connected to the housing 2. The clamping body fixing part 15 and the multi-cavity fixing part 16 are bonded, welded or anchored. The flexible hose 11 of the hooking wire assembly 3 passes through a lead-out cavity of the clamping body fixing part 15, so that the traction head 10 is connected to the ligation assembly 5 at the proximal end.

[0078] In some embodiments, Figure 5 As shown, the pushing assembly 1 further includes a guide wire flexible tube 24 , and the proximal end of the guide wire flexible tube 24 is connected to a lead-out cavity of the clamping body fixing member 15 .

[0079] like Figure 4 , Figure 6 and Figure 7 As shown, the clamping assembly 4 includes a first clamping body 13, a second clamping body 27 and a pulling rod 14. The first clamping body 13 and the second clamping body 27 are independently connected to the pushing assembly 1, the proximal end of the pulling rod 14 is independently and movably connected to the first clamping body 13 and the second clamping body 27, and the distal end of the pulling rod 14 is transmission-connected to the handle, and the handle is used to drive the pulling rod 14 to move axially toward the proximal end or toward the distal end to realize the opening and closing of the first clamping body 13 and the second clamping body 27.

[0080] like Figure 6 and Figure 8 As shown, the handle also includes an active trigger 17, an "L"-shaped buckle 18 and a fixed handle 19. One end of the "L"-shaped buckle 18 is connected to the pulling rod 14, and the other end is hinged to the active trigger 17. Specifically, an extension portion 1411 is provided at the distal end of the pulling rod 14 for connecting the "L"-shaped buckle 18, and the "L"-shaped buckle 18 is hinged to the active trigger 17 through a pin 32. The active trigger 17 is also rotatably connected to the fixed handle 19, and the fixed handle 19 is fixedly connected to the shell 2. The pulling rod 14 is also fixedly connected to the first clamping body 13 and the second clamping body 27 respectively through a fixing pin 30. The fixed connection method of the fixed handle 19 and the shell 2 in the present invention includes but is not limited to anchoring methods such as glue bonding, laser welding, snap fit, and threaded fit. The active trigger 17 is rotatably connected to the fixed handle 19 through a fixed shaft 31, and the fixed shaft 31 is fixed to the shell 2. As shown Fig. 9 As shown, a connecting spring 50 is provided between the bottom of the movable trigger 17 and the bottom of the fixed handle 19. A limited rotation shaft 33 is also provided on the fixed handle 19 to limit the rotation of the "L"-shaped buckle 18 and prevent the clamping assembly 4 from being excessively opened.

[0081] During the application of the present invention, the operator holds the fixed handle 19, and when the movable trigger 17 is rotated along the first direction, the "L"-shaped buckle 18 is driven to pull the pulling rod 14 axially toward the distal end, and the first clamping body 13 and the second clamping body 27 at the proximal end are in an open state with acute angle structures such as "V"-shaped, "C"-shaped or "U"-shaped; when the movable trigger 17 is rotated along the second direction, the "L"-shaped buckle 18 is driven to push the pulling rod 14 axially toward the proximal end, and the first clamping body 13 and the second clamping body 27 are in a closed state to clamp the target tissue.

[0082] The proximal ends of the first clamping body 13 and the second clamping body 27 are respectively arc-shapedly transitioned in the direction of approaching each other. The surface of the side where the first clamping body 13 and the second clamping body 27 are close to each other is independently provided with a de-line opening, and the de-line opening is provided with a tearable film layer. The tearable film layer in the present invention can be torn apart, and can be a polymer material, such as PTFE (Polytetrafluoroethylene, polytetrafluoroethylene), EPTFE (Expanded Polytetrafluoroethylene), silicone or a composite material. The outer surfaces of the first clamping body 13 and the second clamping body 27 are independently coated with a thin film layer, preferably a heat shrinkable film. The thin film layer can be a sleeve structure, a braided structure, or a coating structure, and the present invention does not make specific limitations on this.

[0083] The first clamping body 13 and the second clamping body 27 are independently fixedly connected to the clamping body fixing member 15. Figure 7 As shown, the first clamping body 13 and the second clamping body 27 of the present invention are independently provided with arc-shaped limiting grooves 1311, and the proximal end of the pulling rod 14 is provided with a rotating shaft, and the two ends of the rotating shaft extend out of the limiting grooves 1311 of the first clamping body 13 and the second clamping body 27 respectively to achieve hinged connection. At the same time, near the limiting grooves 1311, the pulling rod 14, the first clamping body 13 and the second clamping body 27 are fixedly connected by a fixing pin 30. Specifically, the fixing pin 30 passes through the pulling rod 14, the first clamping body 13 and the second clamping body 27 in sequence, and its two ends are fixedly connected to the clamping body fixing member 15.

[0084] like Figure 5 , Fig.10 and Fig.11As shown, the ligation assembly 5 includes a first multi-lumen tube 25, a second multi-lumen tube 26 and a traction line 20. The first multi-lumen tube 25 and the second multi-lumen tube 26 are independently pre-loaded in the clamping assembly 4. The traction line 20 is introduced by the first multi-lumen tube 25, and forms a reserved knot 3011 in the first multi-lumen tube 25 before entering the second multi-lumen tube 26, and then extends out of the second multi-lumen tube 26. The hook assembly 3 is used to capture the traction line 20 extending from the second multi-lumen tube 26, and drive the traction line 20 to pass through the reserved knot 3011 and move to the distal end and then tighten.

[0085] At least two upper cavities connected to each other are provided in the first multi-lumen tube 25. Among them, at least one upper cavity is used for introducing the traction line at the distal end, and at least one upper cavity is used for loading the reserved knot 3011. Specifically, the traction line 20 is introduced from the distal end of one upper cavity, and enters the other upper cavity from the proximal end to form the reserved knot 3011, and then introduced into the second multi-lumen tube 26. The surface of the upper cavity is provided with a hydrophilic coating. The inner surface of the second multi-lumen tube 26 is also provided with a hydrophilic coating to facilitate the sliding of the traction line 20 in the lower cavity.

[0086] Specifically, the first multi-lumen tube 25 and the second multi-lumen tube 26 are pre-loaded in the first clamping body 13 and the second clamping body 27, respectively. The first multi-lumen tube 25 and the second multi-lumen tube 26 are respectively close to the inner wall of the first clamping body 13 and the second clamping body 27. And the first multi-lumen tube 25 and the second multi-lumen tube 26 are respectively and independently provided with a first lead wire opening and a second lead wire opening on the surface of one side close to each other. In the application process of the present invention, as the traction head 10 leads out the traction wire 20, the traction wire 20 located in the first multi-lumen tube 25 flows out from the first lead wire opening into the first clamping body 13, and then escapes from the line-off opening of the first clamping body 13, and the traction wire 20 located in the second multi-lumen tube 26 flows out from the second lead wire opening into the second clamping body 27, and then escapes from the line-off opening of the second clamping body 27, tightening the target tissue, and after the system is withdrawn, the traction wire 20 remains on the target tissue.

[0087] Specifically, Fig.12 and Fig.13As shown, three upper cavities are arranged in the first multi-lumen tube 25, which are respectively denoted as the first upper cavity 2511, the second upper cavity 2512 and the third upper cavity 2513. Five lower cavities are arranged in sequence in parallel in the second multi-lumen tube 26, which are respectively denoted as the first lower cavity 2611, the second lower cavity 2612, the third lower cavity 2613, the fourth lower cavity 2614 and the fifth lower cavity 2615. The third upper cavity 2513 is a "C"-shaped cavity, and the opening of the "C"-shaped cavity faces the second multi-lumen tube 26. The first upper cavity 2511, the second upper cavity 2512 and the third upper cavity 2513 are interconnected, and at the same time, the first lower cavity 2611, the second lower cavity 2612, the third lower cavity 2613, the fourth lower cavity 2614 and the fifth lower cavity 2615 are interconnected. The traction line 20 at the distal end enters from the first upper cavity 2511, passes through the first upper cavity 2511, enters from the proximal end into the third upper cavity 2513 to form a reserved knot 3011, then passes through the third upper cavity 2513, enters from the proximal end of the second upper cavity 2512, and enters the second multi-lumen tube 26 after passing through the second upper cavity 2512. The traction line 20 entering the second multi-lumen tube 26 from the distal end passes through the first lower cavity 2611 and enters from the proximal end of the second lower cavity 2612, then passes through the third lower cavity 2613, the fourth lower cavity 2614 and the fifth lower cavity 2615 in sequence, and passes through the second multi-lumen tube 26 from the proximal end of the fifth lower cavity 2615. The first lower cavity 2611, the second lower cavity 2612, the third lower cavity 2613, the fourth lower cavity 2614 and the fifth lower cavity 2615 are all "C"-shaped grooves. The surfaces of the first upper cavity 2511, the second upper cavity 2512, the third upper cavity 2513, and the first lower cavity 2611, the second lower cavity 2612, the third lower cavity 2613, the fourth lower cavity 2614 and the fifth lower cavity 2615 of the present invention are all provided with a hydrophilic coating to facilitate the sliding of the traction line 20 in the cavity.

[0088] The traction head 10 and the traction line 20 are connected by clamping, hooking, snapping or magnetic attraction. That is, the present invention provides the following exemplary solutions for the connection between the traction head 10 and the traction line 20: (1) Fig.10 As shown, the traction head 10 is a clamping member that realizes the clamping function by hinged connection, and can clamp the second end of the traction line 20 for connection. (2) Fig.14 As shown, the traction head 10 is a hook structure, the second end of the traction line 20 is knotted to form a line loop, and the traction head 10 hooks the line loop for connection. (3) Fig.15 As shown, the traction head 10 is a first magnet, and a second magnet is provided at the second end of the traction line 20, and the first magnet and the second magnet are magnetically connected. (4) Fig.16As shown, the traction head 10 is a fixed buckle structure, a limiting protrusion is arranged on the outside of the fixed buckle, a buckle is arranged on the second end of the traction line 20, a limiting groove 1311 is opened on the inner wall of the buckle, and the limiting protrusion extends into the limiting groove 1311 for snap connection.

[0089] like Figure 5 As shown, the ligation assembly 5 further includes a Luer connector 21 and a lead wire flexible tube 22. The Luer connector 21 is disposed at the distal end of the handle. The proximal end of the lead wire flexible tube 22 is connected to the first multi-lumen tube 25 through the pushing assembly 1. The distal end of the lead wire flexible tube 22 is connected to the Luer connector 21. The traction wire 20 is connected by the Luer connector 21 and enters the first multi-lumen tube 25 through the lead wire flexible tube 22. The proximal end of the lead wire flexible tube 22 is connected to a lead-out cavity of the clamping body fixing member 15 of the pushing assembly 1, so that the traction wire 20 can smoothly pass through the pushing assembly 1 and enter the first multi-lumen tube 25.

[0090] In the present invention, the traction line 20 has a first end and a second end, the first end is fixed by a Luer connector 21, the traction line 20 passes through the lead wire flexible tube 22 and enters the first multi-lumen tube 25, and is sequentially wound between the first multi-lumen tube 25 and the second multi-lumen tube 26, and the second end extends out of the second multi-lumen tube 26, the traction head 10 of the hook wire assembly 3 is connected to the second end of the traction line 20, and under the pull of the distal handle 12, the second end of the traction line 20 is driven to move distally to tighten the traction line 20. After the ligation is completed, the Luer connector 21 is untied, the first end of the traction line 20 is loosened, and the system is withdrawn so that the traction line 20 remains on the tissue.

[0091] In some embodiments, Fig.17 As shown, the ligation assembly 5 also includes an inner support tube 36, the proximal end of the inner support tube 36 extends into the first multi-lumen tube 25, the distal end of the inner support tube 36 is transmission-connected to the handle, the reserved knot 3011 is arranged on the outer wall of the inner support tube 36, and a plurality of fixed rope buckles 2621 are also arranged on the traction line 20 in the second multi-lumen tube 26, the traction head 10 passes through the inner support tube 36 and extends from the first multi-lumen tube 25 to flexibly connect the traction line 20 extended from the second multi-lumen tube 26, and the handle is used to drive the inner support tube 36 to disengage from the reserved knot 3011.

[0092] like Fig.18 As shown, the handle includes a toggle component, which includes a toggle block 34, a coupling 35, a connecting pin 37 and a driving shaft 38. The coupling 35 is connected to the inner support tube 36. One end of the toggle block 34 is movably connected to the coupling 35 through the connecting pin 37, and the other end extends out of the shell 2. The toggle block 34 is rotatably connected to the shell 2 through the driving shaft 38.

[0093] Specifically, the proximal end of the inner support tube 36 extends into the third upper cavity 2513 of the first multi-lumen tube 25, and the distal end of the inner support tube 36 passes through the lead-out cavity of the clamping body fixing member 15 to connect the toggle component. The traction line 20 enters the first multi-lumen tube 25 from the distal end of the first upper cavity 2511, passes through the first upper cavity 2511, enters the third upper cavity 2513, wraps around the outer wall of the inner support tube 36 to form a reserved knot 3011, passes through the third upper cavity 2513, enters the second upper cavity 2512 from the proximal end, and then passes through the distal end and is introduced into the first lower cavity 2611 of the second multi-lumen tube 26. The fixed rope buckle 2621 is located on the traction line 20 in the first lower cavity 2611.

[0094] During the application of the present invention, after the wire hooking assembly 3 captures the traction wire 20 extending from the second multi-lumen tube 26, the operator moves the shifting block 34 at the distal end to drive the coupling 35 to move, thereby driving the inner support tube 36 to move toward the distal end and escape from the reserved knot 3011. The housing 2 of the present invention is also provided with a second opening, and the shifting block 34 extends from the second opening for shifting.

[0095] In the present invention, the first end of the traction line 20 is fixed by the Luer connector 21, and the second end of the traction line 20 passes through the lead wire flexible tube 22 and enters the first multi-lumen tube 25 from the distal end of the first upper cavity 2511, and then passes through the first upper cavity 2511 to enter the proximal end of the third upper cavity 2513 to form a reserved knot 3011, and then passes through the third upper cavity 2513, enters the second upper cavity 2512 from the proximal end, enters the second multi-lumen tube 26, and is sequentially wound around each lower cavity of the second multi-lumen tube 26. The second end of the traction line 20 extends out of the second multi-lumen tube 26, and the traction head 10 is connected to the second end of the traction line 20. Under the pulling of the distal handle 12, the second end of the traction line 20 is driven to move distally along the inner support tube 36 until the fixed rope buckle 2621 on the traction line 20 passes through the reserved knot 3011 to ensure unidirectional sliding, and the traction line 20 continues to be tightened. After the ligation is completed, the Luer connector 21 is untied, the first end of the traction line 20 is loosened, and the system is withdrawn so that the traction line 20 remains on the tissue.

[0096] In some embodiments, the ligation assembly 5 also includes a tightening buckle 60, which is arranged in the first multi-lumen tube 25, and the tightening buckle 60 is located at the proximal end of the reserved knot 3011. The tightening buckle 60 opens a first guide wire channel 62 and a second guide wire channel 63 that are connected to each other; the traction line 20 entering the first multi-lumen tube 25 passes through the second guide wire channel 63, and after forming the reserved knot 3011 in the first multi-lumen tube 25, it is introduced into the second multi-lumen tube 26, and the hook wire assembly 3 drives the traction line 20 extending from the second multi-lumen tube 26 to pass through the first guide wire channel 62 and the reserved knot 3011 in turn and move toward the distal end.

[0097] The inner wall of the first guide wire channel 62 is provided with a first limiting thorn 61, the tip of which points to the distal end. The inner wall of the second guide wire channel 63 is provided with a second limiting thorn 64, the tip of which points to the proximal end.

[0098] During the application of the present invention, the traction line 20 introduced into the first upper cavity 2511 of the first multi-lumen tube 25 can first pass through the second guide wire channel 63, and be ensured to slide in one direction by the second limiting thorn 64, and then enter the third upper cavity 2513. After the reserved knot 3011 is formed inside, it is introduced into the second multi-lumen tube 26 from the distal end of the second upper cavity 2512 of the first multi-lumen tube 25. The traction head 10 is used to drive the traction line 20 to pass through the first guide wire channel 62 of the tightening buckle 60, and then the traction line 20 is passed out from the reserved knot 3011, and is ensured to slide in one direction by the first limiting thorn 61 until it is tightened to complete the knotting.

[0099] The present invention provides the following exemplary solutions for tightening the buckle 60: (1) Fig.19 and Fig. 20 As shown, the tightening buckle 60 is a cylindrical structure, which can be placed horizontally or vertically, and is provided with a first guide wire channel 62 and a second guide wire channel 63, and the inner walls of the first guide wire channel 62 and the second guide wire channel 63 are independently provided with a first limiting thorn 61 and a second limiting thorn 64, and the first limiting thorn 61 and the second limiting thorn 64 are directed in opposite directions, so as to ensure that the introduced traction line 20 and the led-out traction line 20 can slide independently in one direction. (2) As shown in FIG. Fig.21 As shown, the tightening buckle 60 is a clamping block structure with one end movably connected, and a first limiting thorn 61 and a second limiting thorn 64 are arranged on the inner wall thereof, and the first limiting thorn 61 and the second limiting thorn 64 are directed in opposite directions to ensure that the introduced traction line 20 and the led-out traction line 20 slide independently in one direction. (3) As shown Fig. 22As shown, the tightening buckle 60 is a crescent-shaped structure, and is provided with a first guide wire channel 62 and a second guide wire channel 63 that penetrate therethrough, and a first limiting thorn 61 and a second limiting thorn 64 are independently provided on the inner walls of the first guide wire channel 62 and the second guide wire channel 63, respectively, and the first limiting thorn 61 and the second limiting thorn 64 are directed in opposite directions, thereby ensuring that the introduced traction line 20 and the led-out traction line 20 slide independently in one direction.

[0100] In some embodiments, Fig.23 As shown, the ligation assembly 5 further includes a knotting rope ring 70, which is disposed in the first multi-lumen tube 25 and sleeved on the outer periphery of the reserved rope knot 3011. Specifically, after the traction line 20 introduced into the first multi-lumen tube 25 is wound to form the reserved rope knot 3011, it is then wound around the reserved rope knot 3011 for at least one cycle to form the knotting rope ring 70 and lead it into the second multi-lumen tube 26. The hooking wire assembly 3 passes the traction line 20 extending from the second multi-lumen tube 26 through the reserved rope knot 3011 and moves toward the distal end, so that the knotting rope ring 70 tightens the reserved rope knot 3011.

[0101] In another specific embodiment, the present invention provides a lead ligation method, which uses a lead ligation device described in a specific embodiment. The lead ligation method includes: transporting the pushing component 1 to the outer edge of the target tissue, releasing the clamping component 4 to the root of the target tissue, and after capturing the target tissue, fixing the ligation component 5 to the target tissue through the hook wire component 3 and then tightening it.

[0102] In some embodiments, the lead ligation method specifically includes: the hook wire assembly 3 drives the traction wire 20 to move, so that the fixed rope buckle 2621 passes through the reserved knot 3011, and the toggle component is used to drive the inner support tube 36 to move toward the distal end, so that the inner support tube 36 is disengaged from the reserved knot 3011, and the traction wire 20 is led out to tighten the target tissue, and then the Luer connector 21 is loosened, and the pushing assembly 1 is withdrawn, so that the traction wire 20 remains on the target tissue.

[0103] In the present invention, the ligation assembly 5 is preloaded in the clamping assembly 4 , a one-way sliding reserved knot 3011 is pre-set, and a plurality of fixed rope buckles 2621 are pre-evenly set at one end of the traction line 20 toward the second clamping body 27 . After the first clamping body 13 and the second clamping body 27 clamp the target tissue and close it, the wire hook assembly 3 passes through the reserved knot 3011 and clamps the traction line 20 extending from the second multi-lumen tube 26. The operator pulls the distal handle 12 to pull the traction line 20 out of the tearable film on the off-line opening of the second clamping body 27. After the fixed rope buckle 2621 passes through the reserved knot 3011, tighten the target tissue, push the toggle component forward, retract the inner support tube 36, and make it come out of the reserved knot 3011. Continue to pull the traction line 20 to tighten the reserved knot 3011, rotate the Luer connector 21, loosen all the lines, withdraw the lead system and withdraw the clamping assembly 4, leaving only the traction line 20 on the target tissue.

[0104] In some embodiments, the lead ligation method specifically includes: the hook wire assembly 3 drives the traction wire 20 to move, so that the traction wire 20 passes through the tightening buckle 60 and the reserved knot 3011 in sequence, and continues to pull the traction wire 20 to tighten the left atrial appendage to complete the knotting, and then loosens the Luer connector 21 and withdraws the pushing assembly 1, so that the traction wire 20 remains on the target tissue.

[0105] The lead ligation method specifically includes: the hook wire component 3 drives the traction wire 20 to move, so that the traction wire 20 passes through the reserved knot 3011, and continues to pull the traction wire 3011 to tighten the left atrial appendage, so that the knotting ring 70 tightens the reserved knot 3011, completes the knotting, and then loosens the Luer connector 21, withdraws the pushing component 1, so that the traction wire 20 remains on the target tissue.

[0106] The present invention can adopt a variety of delivery methods for the lead ligation device. For example, it can be delivered to the root of the soft tissue using a minimally invasive method (for example, through a small incision above, below or through the chest cavity, an incision in the costal cartilage or xiphoid cartilage, an incision below the left armpit, or a port, through the vascular system, etc.) or a surgical method (for example, a median sternotomy, a small incision sternotomy, a thoracotomy or a thoracoscopy, etc.).

[0107] Application Example 1

[0108] This application example uses a lead ligation device to ligate the left atrial appendage, which specifically includes the following steps:

[0109] (1) Use a multi-lumen tube puncture sheath to puncture a cavity of the epicardium, and insert the coronary endoscope 2 mm into the pericardial layer to observe the front end of the chicken-wing-shaped left atrial appendage. In the above multi-lumen tube, contrast agent can also be injected into any cavity to assist in determining the position of the endoscope and the left atrial appendage;

[0110] (2) Fig.24 As shown, a catheter sheath-cavity pericardial approach is used to deliver the lead ligation device, which reaches the front end of the left atrial appendage under direct endoscope vision and captures the left atrial appendage;

[0111] (3) Fig.25 As shown, the sliding member 7 is moved distally to drive the connecting rod 9 to withdraw, the clamping assembly 4 is released to the outer edge of the left atrial appendage root, the movable trigger 17 is opened and pushed forward as a whole, and the first clamping body 13 and the second clamping body 27 are used to clamp the atrial appendage root and then closed;

[0112] (4) Pull the traction line 20 in the second multi-lumen tube 26 below into the first multi-lumen tube 25 above through the traction head 10, so that the fixed buckle rope passes through the reserved knot 3011 until the traction line 20 is completely pulled out, pull the traction line 20 to tighten the left atrial appendage, use the toggle component to drive the inner support tube 36 to move toward the distal end to remove the inner support tube 36 from the reserved knot 3011, then tighten the reserved knot 3011, release one end of the traction line 20 with the right-handed Luer connector 21, and leave the other end at the distal end of the second multi-lumen tube 26, then withdraw the lead ligation device as a whole, and leave the traction line 20 on the left atrial appendage;

[0113] (5) The left atrial appendage can be captured repeatedly. When the first capture position is not good, the sliding component 7 is pushed proximally, the clamping assembly 4 is retracted, and the clamping assembly 4 is released again at a suitable position. After the ligation is successful, the excess thread is cut off and the final left atrial angiography is performed to verify the successful ligation of the left atrial appendage.

[0114] Application Example 2

[0115] This application example uses a lead ligation device to ligate the left atrial appendage, which specifically includes the following steps:

[0116] (1) Use a multi-lumen tube puncture sheath to puncture a cavity of the epicardium, and insert the coronary endoscope 2 mm into the pericardial layer to observe the front end of the chicken-wing-shaped left atrial appendage. In the above multi-lumen tube, contrast agent can also be injected into any cavity to assist in determining the position of the endoscope and the left atrial appendage;

[0117] (2) Using a catheter sheath-lumen pericardial approach, the lead ligation device is delivered to the front end of the left atrial appendage under direct endoscope vision to capture the left atrial appendage;

[0118] (3) Move the sliding member 7 to the distal end to drive the connecting rod 9 to withdraw, release the clamping assembly 4 to the outer edge of the left atrial appendage root, open the movable trigger 17 and push it forward as a whole, and use the first clamping body 13 and the second clamping body 27 to clamp the atrial appendage root and then close it;

[0119] (4) Pull the traction wire 20 in the second multi-lumen tube 26 below into the first multi-lumen tube 25 above through the traction head 10, so that the traction wire 20 passes through the tightening buckle 60 and the reserved knot 3011 in sequence until the traction wire 20 is completely pulled out, and the traction wire 20 is pulled to tighten the left atrial appendage to complete the knotting. The right-handed Luer connector 21 releases one end of the traction wire 20, and the other end is at the distal end of the second multi-lumen tube 26. Then, the lead ligation device is withdrawn as a whole, and the traction wire 20 is left on the left atrial appendage;

[0120] (5) The left atrial appendage can be captured repeatedly. When the first capture position is not good, the sliding component 7 is pushed proximally, the clamping assembly 4 is retracted, and the clamping assembly 4 is released again at a suitable position. After the ligation is successful, the excess thread is cut off and the final left atrial angiography is performed to verify the successful ligation of the left atrial appendage.

[0121] Application Example 3

[0122] This application example uses a lead ligation device to ligate the left atrial appendage, which specifically includes the following steps:

[0123] (1) Use a multi-lumen tube puncture sheath to puncture a cavity of the epicardium, and insert the coronary endoscope 2 mm into the pericardial layer to observe the front end of the chicken-wing-shaped left atrial appendage. In the above multi-lumen tube, contrast agent can also be injected into any cavity to assist in determining the position of the endoscope and the left atrial appendage;

[0124] (2) Using a catheter sheath-lumen pericardial approach, the lead ligation device is delivered to the front end of the left atrial appendage under direct endoscope vision to capture the left atrial appendage;

[0125] (3) Move the sliding member 7 to the distal end to drive the connecting rod 9 to withdraw, release the clamping assembly 4 to the outer edge of the left atrial appendage root, open the movable trigger 17 and push it forward as a whole, and use the first clamping body 13 and the second clamping body 27 to clamp the atrial appendage root and then close it;

[0126] (4) Pull the traction wire 20 in the second multi-lumen tube 26 below into the first multi-lumen tube 25 above through the traction head 10, so that the traction wire 20 passes through the reserved knot 3011 until the traction wire 20 is completely pulled out, pull the traction wire 20 to tighten the left atrial appendage, and tighten the reserved knot 3011 with the knotting ring 70 sleeved on the outer periphery of the reserved knot 3011 to complete the knotting. The right-handed Luer connector 21 releases one end of the traction wire 20, and the other end is at the distal end of the second multi-lumen tube 26. Then, the lead ligation device is withdrawn as a whole, leaving the traction wire 20 on the left atrial appendage;

[0127] (5) The left atrial appendage can be captured repeatedly. When the first capture position is not good, the sliding component 7 is pushed proximally, the clamping assembly 4 is retracted, and the clamping assembly 4 is released again at a suitable position. After the ligation is successful, the excess thread is cut off and the final left atrial angiography is performed to verify the successful ligation of the left atrial appendage.

[0128] The present invention has a single entry and exit, does not need to enter the circulation, and does not need to manage two entry and exit points, which shortens the implantation time. No device is left in the left atrial appendage, which can reduce the problems of stroke, hypertension and potential hypotension, and has a higher left atrial appendage closure rate, which can prevent thrombosis.

[0129] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. A lead ligation device having a proximal end and a distal end, It is characterized in that The lead ligation device includes a clamping mechanism and a handle, the clamping mechanism includes a ligation component and a clamping component which are nested in sequence, the handle includes a pushing component and a wire hooking component, the proximal end of the pushing component is connected to the clamping component, the pushing component is sleeved on the outer periphery of the wire hooking component, and the proximal end of the wire hooking component is movably connected to the ligation component.

2. The lead ligation device according to claim 1, It is characterized in that The lead ligation device further comprises a connecting rod, which is movably sleeved on the outer periphery of the clamping mechanism, wherein at least one lumen is arranged in the connecting rod, wherein the proximal end of the pushing assembly is located in the lumen and connected to the clamping assembly, and the distal end of the connecting rod is movably connected to the handle; Preferably, the handle further comprises a housing, the distal end of the connecting rod extends into the housing and is slidably connected to the housing, and the connecting rod moves axially toward the proximal end or the distal end of the housing so that the clamping assembly is exposed at the proximal end; Preferably, a sliding component is slidably provided on the housing, and the connecting rod is connected to the sliding component; Preferably, the connecting rod and the sliding component are bonded, welded or riveted; Preferably, the connecting rod is a rigid tube or a flexible tube; Preferably, the connecting rod is a flexible curved pipe, and the inclination angle of the flexible curved pipe is 10 to 30 degrees.

3. The lead ligation device according to claim 1 or 2, It is characterized in that The hook wire assembly comprises a traction head, a flexible hose and a distal handle, wherein the traction head is movably connected to the ligation assembly, one end of the flexible hose is connected to the traction head, and the other end extends out of the distal end of the push assembly and is connected to the distal handle; Preferably, the distal grip is located outside the housing; Preferably, the pushing assembly comprises a clamping body fixing part and a multi-cavity fixing part, the clamping body fixing part is provided with a plurality of lead-out cavities, the proximal end of the clamping body fixing part is connected to the clamping assembly, and the multi-cavity fixing part is sleeved on the distal end of the clamping body fixing part and is snap-connected to the housing; Preferably, the clamping body fixing member and the multi-cavity fixing member are bonded, welded or anchored; Preferably, the pushing assembly further comprises a guide wire flexible tube, the proximal end of which is connected to a lead-out cavity of the clamping body fixing member.

4. The lead ligation device according to any one of claims 1 to 3, It is characterized in that The clamping assembly comprises a first clamping body, a second clamping body and a pulling rod, the first clamping body and the second clamping body are independently connected to the pushing assembly, the proximal end of the pulling rod is independently and movably connected to the first clamping body and the second clamping body, the distal end of the pulling rod is transmission-connected to the handle, and the handle is used to drive the pulling rod to move axially toward the proximal end or toward the distal end to realize the opening and closing of the first clamping body and the second clamping body; Preferably, the handle further comprises an active trigger, an "L"-shaped buckle and a fixed handle, one end of the "L"-shaped buckle is connected to the pulling rod, and the other end is hinged to the active trigger, the active trigger is also rotatably connected to the fixed handle, and the fixed handle is fixedly connected to the housing; Preferably, the movable trigger is rotatably connected to the fixed handle via a fixed rotating shaft, and the fixed rotating shaft is fixed on the housing; Preferably, a connecting spring is provided between the bottom of the movable trigger and the bottom of the fixed handle; Preferably, a limited rotation shaft is also provided on the fixed handle; Preferably, the pulling rod is also fixedly connected to the first clamping body and the second clamping body respectively through a fixing pin; Preferably, the proximal ends of the first clamping body and the second clamping body respectively transition in an arc shape toward a direction approaching each other; Preferably, a surface of one side of the first clamping body and the second clamping body close to each other is independently provided with a tear-off opening, and the tear-off opening is provided with a tearable film layer; Preferably, the outer surfaces of the first clamping body and the second clamping body are independently coated with a film layer; Preferably, the first clamping body and the second clamping body are independently fixedly connected to the clamping body fixing member.

5. The lead ligation device according to any one of claims 1 to 4, It is characterized in that The ligation assembly includes a first multi-lumen tube, a second multi-lumen tube and a traction line. The first multi-lumen tube and the second multi-lumen tube are independently pre-loaded in the clamping assembly. The traction line is introduced from the first multi-lumen tube, and enters the second multi-lumen tube after forming a reserved knot in the first multi-lumen tube, and then extends out of the second multi-lumen tube. The hook assembly is used to capture the traction line extended from the second multi-lumen tube, and drive the traction line to pass through the reserved knot to move to the distal end and then tighten. Preferably, at least two upper cavities communicating with each other are provided in the first multi-lumen tube; Preferably, the surface of the upper cavity is provided with a hydrophilic coating; Preferably, the first multi-lumen tube and the second multi-lumen tube are pre-loaded independently in the first clamping body and the second clamping body respectively; Preferably, the first lead wire opening and the second lead wire opening are independently provided on the surfaces of the first multi-lumen tube and the second multi-lumen tube on one side close to each other; Preferably, the traction head of the hook wire assembly passes through the first multi-lumen tube, extends out from the proximal end of the first multi-lumen tube, and then movably connects to the traction wire; Preferably, the traction head is connected to the traction line by clamping, hooking, snapping or magnetic attraction; Preferably, the ligation assembly further comprises a Luer connector and a lead wire flexible tube, the Luer connector is arranged at the distal end of the handle, the proximal end of the lead wire flexible tube is connected to the first multi-lumen tube through the pushing assembly, the distal end of the lead wire flexible tube is connected to the Luer connector, the traction wire is connected by the Luer connector, and enters the first multi-lumen tube through the lead wire flexible tube; Preferably, the proximal end of the lead wire flexible tube is connected to the lead-out cavity of the clamp body fixing member.

6. The lead ligation device according to claim 5, It is characterized in that The ligation assembly also includes an inner support tube, the proximal end of the inner support tube extends into the first multi-lumen tube, the distal end of the inner support tube is transmission-connected to the handle, the reserved knot is arranged on the outer wall of the inner support tube, a plurality of fixed rope buckles are also arranged on the traction line in the second multi-lumen tube, and the handle is used to drive the inner support tube to escape from the reserved knot; Preferably, the traction head passes through the inner support tube and extends out of the first multi-lumen tube, and is movably connected to the traction line extending from the second multi-lumen tube, and driven by the distal handle to drive the traction line to be led out of the inner support tube; Preferably, the handle includes a toggle component, which includes a toggle block, a coupling, a connecting pin and a driving shaft, the coupling is connected to the inner support tube, one end of the toggle block is movably connected to the coupling through the connecting pin, and the other end extends out of the housing, and the toggle block is rotatably connected to the housing through the driving shaft; Preferably, the proximal end of the inner support tube extends into the upper cavity of the first multi-lumen tube, and the distal end of the inner support tube passes through the lead-out cavity of the clamping body fixing member and is connected to the shifting component.

7. The lead ligation device according to claim 5, It is characterized in that The ligation assembly further comprises a tightening buckle, which is arranged in the first multi-lumen tube, the tightening buckle is located at the proximal end of the reserved knot, and the tightening buckle opens a first guide wire flow channel and a second guide wire flow channel that are connected; The traction wire entering the first multi-lumen tube passes through the second guide wire flow channel, forms the reserved knot in the first multi-lumen tube, and is then introduced into the second multi-lumen tube. The hook wire assembly drives the traction wire extending from the second multi-lumen tube to pass through the first guide wire flow channel and the reserved knot in sequence and then move toward the distal end. Preferably, the inner wall of the first guide wire flow channel is provided with a first limiting thorn, and the tip of the first limiting thorn points to the distal end; Preferably, the inner wall of the second guide wire flow channel is provided with a second limiting thorn, and the tip of the second limiting thorn points to the proximal end.

8. The lead ligation device according to claim 5, It is characterized in that The ligation assembly further comprises a knotting rope ring, which is arranged in the first multi-lumen tube and sleeved on the outer periphery of the reserved rope knot; Preferably, the traction line introduced into the first multi-lumen tube is wrapped around to form the reserved knot, then wrapped around the reserved knot for at least one circle to form the knotted rope ring and then led out into the second multi-lumen tube, and the wire hook assembly passes the traction line extending from the second multi-lumen tube through the reserved knot and moves toward the distal end, so that the knotted rope ring tightens the reserved knot.

9. A lead ligation method, It is characterized in that The lead ligation method adopts the lead ligation device according to any one of claims 1 to 8, and the lead ligation method comprises: The pushing component is transported to the outer edge of the target tissue, the clamping component is released to the root of the target tissue, and after the target tissue is captured, the ligation component is fixed to the target tissue by the hook wire component and then tightened.

10. The lead ligation method according to claim 9, It is characterized in that The lead ligation method specifically comprises: The hook wire assembly drives the traction wire to move, so that the fixed rope buckle passes through the reserved rope knot, and the inner support tube is driven to move toward the distal end by the toggle component, so that the inner support tube is disengaged from the reserved rope knot, the traction wire is led out and the target tissue is tightened, and then the Luer connector is loosened and the pushing assembly is withdrawn, so that the traction wire remains on the target tissue; Alternatively, the hook wire assembly drives the traction wire to move, so that the traction wire passes through the tightening buckle and the reserved knot in sequence, and continues to pull the traction wire to tighten the left atrial appendage to complete the knotting, then loosens the Luer connector and withdraws the pushing assembly, so that the traction wire remains on the target tissue; Alternatively, the hook wire assembly drives the traction wire to move, passes the traction wire through the reserved knot, and continues to pull the traction wire to tighten the left atrial appendage, so that the knotted rope ring tightens the reserved knot, completes the knotting, and then loosens the Luer connector and withdraws the pushing assembly, so that the traction wire remains on the target tissue.

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