Tissue ligation system

Abstract

A tissue ligation system, comprising a mesh sleeve structure (2) and a ligation apparatus (1). The mesh sleeve structure (2) comprises a mesh bag (21), a root restraining sleeve (22), and a waist restraining sleeve (23). The root restraining sleeve (22) is circumferentially connected to an opening in one end of the mesh bag (21). The waist restraining sleeve (23) is circumferentially arranged along the middle of the mesh bag (21). The ligation apparatus (1) comprises a connecting rod (16) and a ligation mechanism. The ligation mechanism comprises a handle housing (11), a pushing assembly (12), a first tightening assembly (13), and a second tightening assembly (14). The first tightening assembly (13) comprises a first fixing rod (161), a first moving rod (162), and a first driving assembly. The second tightening assembly (14) comprises a second fixing rod (163), a second moving rod (164), and a second driving assembly. The root restraining sleeve (22) comprises a root tightening rope (223). Two ends of the root tightening rope (223) are connected to the first fixing rod (161) and the first moving rod (162), respectively. The first driving assembly is connected to and drives the first moving rod (162) to move, so that the root tightening rope (223) is driven to tighten. The waist restraining sleeve (23) comprises a waist tightening rope (231). Two ends of the waist tightening rope (231) are connected to the second fixing rod (163) and the second moving rod (164), respectively. The second driving assembly is connected to and drives the second moving rod (164) to move, so that the waist tightening rope (231) is driven to tighten. The system can shrink or squeeze out redundant blood in a tumor-like structure or soft tissue, thereby preventing secondary thrombus, accelerating atrophy and endothelialization, and promoting postoperative recovery.

Description

Tissue ligation system

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 7, 2023, with application number 202311666136.1. The entire contents of the above application are incorporated by reference into this application. Technical Field

[0002] The present application relates to a medical device, such as a tissue ligation system. Background Art

[0003] For most growths or excess soft tissue in the human body, surgical removal is typically performed, which generally achieves good results. However, for some growths or soft tissues, such as some hemangiomas and left atrial appendages, which are not suitable for resection, ligation or closure is often the only treatment option. Most ligation or closure products on the market are surgical medical devices that require surgical intervention, which is quite invasive and requires a long recovery time.

[0004] With the rapid development of interventional medical technology, transcatheter products have emerged. One type is the occlusion device, 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.

[0005] The other category is clipping devices, which include both clips and ligation snares. Clips, such as Atricure's AtriClip series and MediSum's E-Clip series, surgically place an open clip around or clamp the LAA root before withdrawing the delivery device to close the clip and seal the LAA. While simple to perform, the clip's shape and clamping force are fixed, and individual LAAs vary widely, making clips less adaptable. Ligation snares, such as SentreHeart's LARIAT system, consist of a transepicardial snare device and a transseptal magnetic device for locating and capturing the LAA. This system works together to ligate the LAA root, but is more complex and carries the same risk of secondary thrombosis. Another example is Aegis' Sierra system, which includes a transepicardial snare device and a positioning and capturing device, requiring initial positioning before ligating the root with the snare.

[0006] In addition, all the above-mentioned interventional ligation and sealing products, whether internal occlusion or external ligation, cannot deal with the redundant blood inside the tissue and there is a risk of thrombosis. Therefore, there is an urgent need to develop an interventional ligation and sealing product that is simple and easy to operate and can eliminate the redundant blood inside the tissue.

[0007] Summary of the Invention

[0008] A tissue ligation system comprises a net structure and a ligation device;

[0009] The net structure includes a net bag with one or both ends open and a root cuff, wherein the net bag is used to surround the target tissue, and the root cuff is circumferentially connected to the opening at one end of the net bag to tighten the root of the target tissue. In addition, at least one waist cuff is circumferentially provided at the waist of the net bag to shrink and squeeze excess blood inside the target tissue.

[0010] The ligation device comprises a connecting rod and a ligation mechanism. One end of the connecting rod is connected to the ligation mechanism, and the other end is connected to the net structure via a rope inside the rod. The ligation mechanism comprises a handle housing, a push assembly, and a tightening assembly. The push assembly and tightening assembly are nested and fixed inside the handle housing. The tightening assembly includes a first tightening assembly connected to the base sleeve and a second tightening assembly connected to the waist sleeve.

[0011] As an optional example, the pushing assembly includes an outer sheath, an inner catheter, a sliding member and a pushing button;

[0012] The outer sheath and the inner catheter are installed at the front end of the handle shell, one end of the sliding component is connected to the outer sheath, and the other end is connected to the push button. A slide rail groove is provided on the handle shell, and the push button is slidably provided in the slide rail groove.

[0013] As an optional example, the net bag is made of a woven polymer or metal material with elasticity or memory.

[0014] As an optional example, the net bag is arranged at the front end of the inner cavity of the outer sheath tube, the rear end of the outer sheath tube is connected to the front end of the sliding component, and the rear end of the sliding component is connected to the push button. The push button moves backward or forward, driving the sliding component to drive the outer sheath tube to move backward or forward, thereby releasing or retrieving the net bag.

[0015] As an optional example, the sliding member and the push button are connected via a circular shaft, the front end of the sliding member is a connecting sleeve, and the rear end is a connecting block, the connecting sleeve is connected to the rear end of the outer sheath tube, the connecting block protrudes from the surface of the connecting sleeve and forms a height difference, the bottom of the connecting block is connected to the connecting sleeve and is integrally formed, the top of the connecting block is connected to the front end of the circular shaft, and the push button is connected to the rear end of the circular shaft.

[0016] As an optional example, the first tightening assembly includes a first fixed rod, a first moving rod, a guide rail slider, a fixed guide rail, a threaded guide sleeve and a tail knob;

[0017] The root harness includes a root tightening rope, and two ends of the root tightening rope are respectively connected to the first fixed rod and the first movable rod, the first fixed rod is fixed to the front end of the handle shell, the first movable rod is connected to the guide rail slider, the guide rail slider is slidably arranged in the fixed guide rail, and the fixed guide rail is fixedly installed inside the handle shell through a concave-convex structure, and a threaded guide sleeve is sleeved on the outside of the fixed guide rail, the guide rail slider is provided with an external thread, and the threaded guide sleeve is provided with an internal thread, and the guide rail slider is driven to axially move in the groove on the fixed guide rail by rotating the threaded guide sleeve; the tail knob is fixedly connected to the threaded guide sleeve, and the threaded guide sleeve is driven to rotate by rotating the tail knob;

[0018] The movement of the guide rail slider drives the first moving rod to move, thereby driving the root to tighten the rope and tighten the root of the net bag.

[0019] As an optional example, the first tightening component also includes a multi-stage telescopic rod, wherein the two telescopic rods of the multi-stage telescopic rod are matched with each other in a concave-convex manner and the four degrees of freedom of the telescopic rods are restricted up, down, left and right. The telescopic rods are telescopically extended forward and backward, and the frontmost telescopic rod is connected to the guide rail slider, and the guide rail slider moves forward and backward to drive the multi-stage telescopic rods to extend and retract.

[0020] As an optional example, the fixed guide rail includes an upper fixed block and a lower fixed block, which are connected by a snap-fit ​​connection, and the front and rear ends of the upper fixed block and the lower fixed block are respectively connected to the shell in a concave-convex manner.

[0021] As an optional example, the second tightening assembly includes a second fixed rod, a second movable rod and a take-up component, the waist sleeve includes a waist tightening rope, the two ends of the waist tightening rope are respectively connected to the second fixed rod and the second movable rod, the second fixed rod is fixed to the front end of the handle shell, the second movable rod passes through the handle shell and is connected to the take-up component and the take-up component is connected to the waist tightening rope.

[0022] As an optional example, the front ends of the first and second fixed rods and the first and second movable rods are provided with threading holes and blades, and the threading holes are respectively connected to the root tightening rope and the waist tightening rope.

[0023] As an optional example, the wire-retracting component includes a Luer connector, which is connected to the rear end of the handle housing, and the waist tightening rope is connected to the Luer connector through one end connected to the second moving rod.

[0024] As an optional example, the net bag is a three-dimensional open structure with a woven polygonal structure and an internal space. The upper end of the net bag is provided with an opening or both the upper and lower ends are provided with openings, and the root sleeve is circumferentially connected to the upper end opening of the net bag.

[0025] As an optional example, the root sheath is composed of a non-completely closed cavity portion with a certain degree of rigidity, a slender connecting portion, and a root tightening rope. The non-completely closed cavity portion is a C-shaped or U-shaped hard cavity or a semi-arc-shaped cavity. One end of the slender connecting portion is connected to the middle of the cavity portion, and the other part is fixed to the front end of the inner catheter. One or more root tightening ropes extend from the upper end of the net bag and are stored inside the cavity portion of the root sheath. The root tightening rope is made of the same material as the net bag. During the tightening process, the root tightening rope extending from the upper end of the net bag gradually escapes from the cavity portion along the non-closed portion of the root sheath cavity portion.

[0026] As an optional example, the ligation device is provided with at least one lumen inside, which can be used for the fiber optic lens to enter the surgical field of view and can also be used for injecting contrast agent through the lumen.

[0027] A method of using the tissue ligation system as described above comprises the following steps:

[0028] a) The front connecting rod of the ligation device is percutaneously punctured through a catheter sheath into the body and delivered to the tumor or soft tissue to be ligated, such as a hemangioma or the left atrial appendage;

[0029] b) Move the push button and drive the outer sheath to withdraw, releasing the mesh structure;

[0030] c) Push the ligation device forward as a whole until the net bag completely covers the tumor or soft tissue, and the root of the net bag is basically flush with its root;

[0031] d) Rotate the tail knob to drive the guide rail slider and the first moving rod to retreat and tighten the rope in the root sleeve, gradually shrinking and reducing the root diameter of the tumor or soft tissue;

[0032] e) After tightening the base cuff, pull the Luer connector knob outward to tighten the waist cuff, squeezing out excess blood inside the left atrial appendage;

[0033] f) Continue tightening the root tightening rope in the root sleeve until it fully tightens the root of the tumor or soft tissue and completely seals it;

[0034] g) Rotate the ligation device as a whole, cut the rope with a blade at the front end of the connecting rod, and then withdraw the entire ligation device. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG1 is a schematic diagram of the overall structure of the tissue ligation system in this application;

[0036] FIG2 is a schematic diagram of the three-dimensional structure of the ligation device in an embodiment of the present application;

[0037] FIG3 is a schematic diagram of the exploded structure of the handle housing in an embodiment of the present application;

[0038] FIG4 is a schematic diagram showing the exploded structure of the pushing component in an embodiment of the present application;

[0039] FIG5 is a schematic diagram of the connection structure of various parts of the push component in an embodiment of the present application;

[0040] FIG6 is a schematic structural diagram of a sliding member in an embodiment of the present application;

[0041] FIG7 is a schematic diagram of the exploded structure of the first tightening assembly in an embodiment of the present application;

[0042] FIG8 is a cross-sectional structural diagram of the working principle of the first tightening assembly in an embodiment of the present application;

[0043] FIG9 is a schematic structural diagram of a second tightening assembly in an embodiment of the present application;

[0044] FIG10 is a schematic structural diagram of the front end portion of each metal rod in an embodiment of the present application;

[0045] FIG11 is a schematic diagram of the overall exploded structure of the ligation device according to an embodiment of the present application;

[0046] FIG12 is a schematic diagram of a mesh sleeve structure with one end open in an embodiment of the present application;

[0047] FIG13 is a schematic diagram of a mesh sleeve structure with openings at both ends in an embodiment of the present application;

[0048] 14A, 14B and 14C are schematic diagrams of the net bag structure in different states according to an embodiment of the present application;

[0049] FIG15 is a schematic diagram of the connection relationship between the harness and the net bag in an embodiment of the present application;

[0050] FIG16 is a schematic diagram of the working state of the tissue ligation system according to an embodiment of the present application;

[0051] FIG17 is a schematic diagram showing the working principle of the mesh structure for ligating tissue in an embodiment of the present application;

[0052] FIG. 18 is a schematic diagram showing steps for using the tissue ligation system according to an embodiment of the present application.

[0053] In the picture:

[0054] 1. Ligation device;

[0055] 11. Handle housing; 111. Upper housing; 112. Lower housing; 113. Buckle; 114. Slot; 115. Slide rail slot; 116. Limit slot;

[0056] 12. Push assembly; 121. Outer sheath; 122. Sliding member; 1221. Connecting sleeve; 1222. Connecting block; 1223. Round shaft; 123. Push button; 124. Inner catheter; 1241. Lead hole;

[0057] 13. First tightening assembly; 131. Guide rail slider; 1311. External thread; 132. First telescopic rod; 133. Second telescopic rod; 134. Third telescopic rod; 135. Fourth telescopic rod; 136. Fixed guide rail; 1361. Upper fixing block; 1362. Lower fixing block; 1363. Groove; 137. Threaded guide sleeve; 1371. Internal thread; 138. Tail knob;

[0058] 14. Second tightening assembly; 141. Luer connector; 1411. Tail knob;

[0059] 15. Plug;

[0060] 16. Connecting rod; 161. First fixed rod; 162. First movable rod; 163. Second fixed rod; 164. Second movable rod; 165. Threading hole; 166. Blade;

[0061] 2. Net structure;

[0062] 21. Net bag; 211. Rope ring;

[0063] 22. Root cuff; 221. Cavity portion; 222. Slender connecting portion; 223. Root tightening rope; 23. Waist cuff; 231. Waist tightening rope;

[0064] 24. Front opening;

[0065] 25. Rear end opening;

[0066] 3. Heart;

[0067] 31. Left atrial appendage. DETAILED DESCRIPTION

[0068] The embodiments of the present application are described in detail below, and examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application, and should not be understood as limiting the present application.

[0069] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise" and "counterclockwise" indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply 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 limiting the present application. In addition, the terms "first" and "second" are used for descriptive purposes only 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" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present application, "multiple" means two or more, unless otherwise clearly and specifically defined.

[0070] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "installed," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections, electrical connections, or mutual communication; they can refer to direct connections or indirect connections through an intermediate medium; they can refer to internal communication between two components or the interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0071] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0072] The disclosure below provides many different embodiments or examples for realizing different structures of the present application. In order to simplify the disclosure of the present application, the components and settings of specific examples are described below. Of course, they are merely examples and are not intended to limit the present application. In addition, the present application may repeat reference numbers and / or reference letters in different examples, and such repetition is for the purpose of simplicity and clarity, and does not itself indicate the relationship between the various embodiments and / or settings discussed. In addition, the present application provides examples of various specific processes and materials, but those of ordinary skill in the art will appreciate the application of other processes and / or the use of other materials.

[0073] The following embodiments of the present application illustrate the application device in a form suitable for ligating the left atrial appendage 31 of a human heart 3 (see Figure 17). It should be understood that the following embodiments discuss the use on the left atrial appendage 31. However, unless otherwise specified, variations of the systems, devices and methods are not limited to use on the ligation of the left atrial appendage 31. On the contrary, the present application can be used for ligating any tumor or soft tissue in the body. At the same time, the present application can be applicable in different parts of the human body similar to the left atrial appendage 31. In addition, the present application can be used in various processes in which the benefits of the method and / or device are expected.

[0074] Unless otherwise specified, all technical and scientific terms used in this application shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It should also be understood that terms defined in commonly used dictionaries should be interpreted as having the meaning consistent with their context in the relevant art and should not be interpreted as idealized or overly formal unless explicitly defined.

[0075] For the sake of convenience of description, the "front end" in this application refers to the end away from the operator, the "rear end" in this application refers to the end close to the operator, the "front end" of the tissue in this application refers to the end close to the ligation device 1, the "root" of the tissue refers to the end away from the ligation device 1, the "waist" or "middle" of the tissue refers to all areas between the front end and the root of the tissue, and the "waist" or "middle" of the net bag 21 (see Figure 12) refers to all areas between the two ends of the net bag 21.

[0076] The left atrial appendage (LAA) is a crucial structure within the heart that is often associated with heart disease and stroke. When excess blood accumulates within the LAA, it can lead to thrombosis, increasing the risk of stroke. Therefore, developing an effective method to ligate the LAA and remove excess blood is of great clinical significance.

[0077] In response to the problem that conventional interventional tissue ligation devices have the risk of causing secondary thrombosis, or require auxiliary instruments or systems to first locate and then ligate, which is cumbersome and time-consuming, this application designs a tissue ligation system that does not require intracardiac atrial septal puncture or additional instruments to locate and capture tissue, making operation simpler. The tissue ligation system can squeeze excess blood inside the tissue while ligating the tissue root, accelerate tissue atrophy and endothelialization, and promote postoperative recovery.

[0078] The technical solution of this application is described below with reference to the accompanying drawings and through specific implementation methods.

[0079] In one embodiment provided herein, a tissue ligation system is an innovative implantable medical device for addressing heart 3-related diseases. Specifically, it is a device for ligating a tumor or soft tissue in the body, such as the left atrial appendage, and draining excess blood therefrom. For example, it is used to address problems within the left atrial appendage 31 to reduce or prevent the accumulation of excess blood. The system includes a mesh structure 2, a ligation device 1 (see FIG1 ), and corresponding components, and can be used through specific steps. This embodiment will introduce the components, usage methods, and features of the system.

[0080] Ligation system:

[0081] 1 , the tissue ligation system includes a mesh structure 2 and a ligation device 1 , wherein the mesh structure 2 serves as a tightening component for enclosing and ligating the left atrial appendage 31 and displacing redundant blood inside the left atrial appendage 31 .

[0082] The ligation device 1 is used to release the mesh structure 2 and transport it to the outer edge of the left atrial appendage 31 and tighten the mesh structure 2.

[0083] Regarding the ligation device 1, referring to FIG2 , the ligation device 1 of the present application comprises a handle housing 11, a push assembly 12, a first tightening assembly 13, and a second tightening assembly 14. The push assembly 12 is used to release the mesh structure 2 and deliver it to the left atrial appendage 31; the first tightening assembly 13 is connected to and tightens the root tightening rope 223 within the cavity 221 of the root sheath 22 of the mesh structure 2; and the second tightening assembly 14 is connected to and tightens the waist tightening rope 231 of the waist sheath 23 of the mesh structure 2.

[0084] Regarding the handle housing 11, referring to Figure 3, the handle housing 11 is the main external part of the ligation device 1, which protects and secures other components and facilitates the operator's grip. The handle housing 11 is composed of an upper shell 111 and a lower shell 112. The upper shell 111 is provided with multiple handle slots 114 on both sides of the edge, and the lower shell 112 is provided with handle clips 113 on both sides of the edge corresponding to the number and position of the handle slots 114. The two are detachably connected via the clips 113 and the slots 114. A strip-shaped slide groove 115 is provided on the surface of the lower shell 112 for guiding and limiting the pushing assembly 12. At the same time, a limiting groove 116 is provided at the front end of the handle housing 11 for fixing the fixed guide rail 136 of the first tightening assembly 13 described below.

[0085] Regarding the pushing assembly 12, referring to Figure 4, the pushing assembly 12 includes an outer sheath 121, a sliding member 122 and a pushing button 123. The outer sheath 121 is connected to the front end of the handle housing 11, and the net bag 21 is arranged at the front end of the inner cavity of the outer sheath 121. An inner catheter 124 is provided inside the outer sheath 121. The inner catheter 124 serves as a guiding structure when the outer sheath 121 moves, and the inner catheter 124 is fixed to the front end of the handle housing 11. The rear end of the outer sheath 121 is connected to the front end of the sliding member 122, and the rear end of the sliding member 122 is connected to the pushing button 123. The pushing button 123 can slide in the button slide groove of the handle housing 11. Through the forward and backward movement of the push button 123, the sliding member 122 moves the outer sheath 121 forward or backward, thereby releasing or retrieving the net bag 21. The outer sheath 121 and the sliding member 122 are fixed at the front end of the handle housing 11. The fixing method can be fixed by welding. Optionally, the outer sheath 121 is rigid or flexible, with a rigid or flexible angle pre-bend, or a flexible controllable bend. The front end opening of the outer sheath 121 is blocked by a plug 15. Optionally, the plug 15 adopts a transfer interface protective head (Transfer Interface Protector, TIP). In this embodiment, the front end opening of the outer sheath 121 is blocked by the TIP head before it is not working.

[0086] 5 and 6 , the push button 123 and the sliding member 122 are connected via a circular shaft 1223 , such as by gluing, welding, or other anchoring methods. In this embodiment, the sliding member 122 has a connecting sleeve 1221 at its front end and a connecting block 1222 at its rear end. The connecting sleeve 1221 is connected to the rear end of the push tube. The connecting block 1222 protrudes from the surface of the connecting sleeve 1221 to form a height difference. The bottom of the connecting block 1222 is connected to the connecting sleeve 1221 and is integrally formed. The top of the connecting block 1222 is connected to the front end of the circular shaft 1223 , and the push button 123 is connected to the rear end of the circular shaft 1223 .

[0087] Regarding the connecting rod 16, in the embodiments of the present application, referring to Figures 10 and 11, both ends of the root tightening rope 223 of the root harness 22 and both ends of the waist tightening rope 231 of the waist harness 23 are respectively connected to the connecting rod 16. In some embodiments, the connection method can be a rope and ring knot fixation, a buckle fixation, or other anchoring method. In some embodiments, the end of the connecting rod 16 connected to the mesh structure 2 can be pre-bent at a certain angle, with the angle range of 0-90 degrees. In this embodiment, the connecting rod 16 is four metal rods, including two fixed metal connecting rods 16, a first fixed rod 161 and a second fixed rod 163, and the other two movable metal connecting rods 16, a first movable rod 162 and a second movable rod 164. The two fixed metal connecting rods 16 are fixedly connected to the inner catheter 124 inside the outer sheath 121. The front end of each connecting rod 16 is provided with a threading hole 165 and the middle position of each threading hole 165 is provided with a blade 166. The four threading holes 165 are sharpened in the left and right quarters and a thin layer of medical wax is applied to the edge to prevent the rope of the sheath from being cut.

[0088] Regarding the first tightening assembly 13 , referring to FIG. 7 , the first tightening assembly 13 includes a first fixed rod 161 , a first movable rod 162 , a guide rail slider 131 , a fixed guide rail 136 , a threaded guide sleeve 137 , and a tail knob 138 .

[0089] The two ends of the root sleeve 22 are respectively connected to the first fixed rod 161 and the first movable rod 162. The first fixed rod 161 is fixed in the inner guide tube 124 at the front end of the handle housing 11. The first movable rod 162 is connected to the guide rail slider 131. The fixed guide rail 136 is usually fixedly installed inside the handle housing 11. Specifically, the fixed guide rail 136 is fixedly connected to the handle housing 11. As some embodiments, the two can be glued, screwed, or fixed with a buckle. In the embodiment of the present application, a buckle 113 is used to constrain the fixed guide rail 136 and the handle housing 11. A limiting groove 116 is provided at the front end of the handle housing 11. The limiting groove 116 constrains the four degrees of freedom of the fixed guide rail 136, namely, up, down, front, and back. The concave-convex structure constrains the left and right degrees of freedom from rotation. The guide rail slider 131 is provided with external threads 1311 on the upper and lower sides and protrusions on the left and right sides. The guide rail slider 131 can slide within the grooves 1363 on both sides of the fixed guide rail 136 through the protrusions on the left and right sides. The fixed guide rail 136 is externally sleeved with a threaded guide sleeve 137, allowing the two to rotate relative to each other. Referring to Figure 8, the guide rail slider 131 is provided with external threads 1311 on the upper and lower sides, and the threaded guide sleeve 137 is provided with an internal thread 1371. When the threaded guide sleeve 137 rotates, the guide rail slider 131 does not rotate with it. The guide rail slider 131 can only move axially within the grooves 1363 on both sides of the fixed guide rail 136. The movement of the guide rail slider 131 drives the first movable rod 162 to move. The movement of the first movable rod 162 tightens one end of the root tightening rope 223 of the root sleeve 22, and together with the other end, tightens the front opening 24 of the net bag 21. At the same time, the tail knob 138 and the threaded guide sleeve 137 are fixedly connected in cooperation. Optionally, the two can be glued, screwed, or fixed by buckles. In this embodiment, the tail knob 138 and the threaded guide sleeve 137 are connected in a concave-convex manner to constrain the four degrees of freedom of front, back, up, and down.

[0090] In addition, a multi-stage telescopic rod is also connected to the rear end of the guide rail slider 131, and the multi-stage telescopic rod includes a first telescopic rod 132 located at the front stage, a second telescopic rod 133 and a third telescopic rod 134 in the middle, and a fourth telescopic rod 135 located at the rear stage. The multi-stage telescopic rod can play a role in assisting the movement of the guiding and limiting guide rail slider 131.

[0091] In certain embodiments, the four rods of the multi-stage telescopic rod are connected by a mating mechanism. When two rods are connected, the four degrees of freedom (up, down, left, and right) are restricted, leaving only two degrees of freedom (forward, backward). Optionally, the rods are radially mated by concave and convex structures at the front and rear ends to prevent relative rotation.

[0092] As some embodiments, the fixed guide rail 136 includes an upper fixing block 1361 and a lower fixing block 1362 , and the upper fixing block 1361 and the lower fixing block 1362 are detachably connected.

[0093] Regarding the second tightening assembly 14, referring to Figure 9, the second tightening assembly 14 includes a second fixed rod 163, a second movable rod 164 and a take-up component. The two ends of the waist tightening rope 231 of the waist sleeve 23 are respectively connected to the second fixed rod 163 and the second movable rod 164. The second fixed rod 163 is fixed in the inner guide tube 124 at the front end of the handle shell 11. The second movable rod 164 passes through the inner guide tube 124, the guide rail slider 131, and the multi-stage telescopic rod in sequence and is connected to the take-up component, and the take-up component is connected to the waist tightening rope 231 of the waist sleeve 23. In this embodiment, the second tightening component adopts a Luer connector 141, which is connected to the tail end of the handle housing 11. One end of the waist tightening rope 231 is connected to the Luer connector 141 through the second movable rod 164. The Luer connector 141 can temporarily fix the waist tightening rope 231. At the same time, a tail end knob 1411 is provided at the tail end of the Luer connector 141. When the tail end knob 1411 is pulled outward, the tail end knob 1411 drives the second movable rod 164 and the waist tightening rope 231 to tighten, thereby tightening the waist of the net bag 21.

[0094] Regarding the mesh structure 2, referring to Figure 12, the mesh structure 2 includes a mesh bag 21 and a sleeve, wherein the sleeve includes a root sleeve 22 and a waist sleeve 23. The root sleeve 22 is connected to the front end opening 24 of the mesh bag 21 and is used to tighten the front end opening 24 of the mesh bag 21 to ligate the left atrial appendage 31. The waist sleeve 23 is connected to the waist of the mesh bag 21 and is used to tighten the waist of the mesh bag 21 to squeeze the waist and front end of the left atrial appendage 31.

[0095] The mesh structure 2 will be described below.

[0096] The net bag 21 is a woven polygonal structure with a three-dimensional open structure with an internal space. As some embodiments, referring to Figures 12-13, the open structure can be open at one end or at both ends, that is, it includes both a front opening 24 and a rear opening 25. The front end represents the end connected to the root sheath 22, and the rear end represents the end not connected to the root sheath 22. The net bag structure 2 is tightened and fixed on the outside of the left atrial appendage 31 in two steps. The polygonal structure of the net bag 21 can increase friction and make it easier to wrap around the left atrial appendage 31. In this embodiment, the front end opening 24 of the net bag 21 is provided with a root sleeve 22. Specifically, the root sleeve 22 is composed of a non-completely closed cavity portion 221 with a certain rigidity and a slender connecting portion 222, wherein the non-completely closed cavity portion 221 is a C-shaped or U-shaped hard cavity or a semi-arc cavity. The hard cavity can ensure that the root sleeve 22 is convenient for sheathing the left atrial appendage 31. One end of the slender connecting portion 222 of the root sleeve 22 is connected to the cavity portion 221. The slender connecting portion 222 is connected to the middle portion of the inner tube 124, and the other end is connected to the guide hole 1241 in the inner tube 124. The slender connecting portion 222 is a slender tube that is used to rigidly connect the mesh structure 2 and the ligation device 1. One or more root tightening ropes 223 extend from the front end of the mesh bag 21 and are stored within the cavity 221 of the root sleeve 22. A slit is provided on the side of the cavity 221 to allow the root tightening ropes 223 to be released during tensioning. In this embodiment, the mesh bag 21 measures 5.5 cm in the major axis and 3 cm in the minor axis. It is made of a memory alloy material with a certain degree of rigidity, such as nickel-titanium alloy.

[0097] Referring to Figure 14 , the front opening 24 of the net bag 21 is pushed toward the base of the left atrial appendage 31. Figure 14A shows the net bag 21 encircling the base of the left atrial appendage 31, while Figures 14B and 14C respectively illustrate the range of angles within which the net bag 21 can move. Optionally, the front opening 24 and the lower end surface of the left atrial appendage 31 may form an acute angle, a right angle, or an obtuse angle.

[0098] In this embodiment, a circle of rope rings 211 are provided along the circumferential direction of the front end opening 24 of the net bag 21 . The rope rings 211 and the net bag 21 are woven into an integral structure, wherein the root tightening ropes 223 pass through the rope rings 211 one by one and are stored in the cavity part 221 .

[0099] The structure of the waist cuff 23 is different from that of the root cuff 22. The waist cuff 23 does not contain a hard cavity. The waist cuff 23 is composed of a waist tightening rope 231 and a plurality of rope rings 211 woven around the waist of the net bag 21. The material of the waist tightening rope 231 of the waist cuff 23 is also consistent with the material used for weaving the net bag 21. Referring to Figure 15, the root and waist of the net bag 21 are woven with a plurality of rope rings 211, and the tightening ropes of the root cuff 22 and the waist cuff 23 are connected to the net bag 21 by passing through the rope rings 211. Optionally, there is no limit to the number of waist cuffs 23 as long as conditions permit. The more waist cuffs 23 there are, the better the tightening effect of the left atrial appendage 31, and it is easier to discharge internal blood.

[0100] In certain embodiments, the tightening cords of both the base cuff 22 and the waist cuff 23 are constructed of soft cords made of polymer or metal, such as high molecular weight polyethylene, nickel titanium, or other materials. The waist tightening cord 231 of the waist cuff 23 constrains its freedom in six directions through torsional friction. When the waist tightening cord 231 of the waist cuff 23 is released, it is twisted again to release the freedom, achieving a temporary fixation. Rotating the Luer connector 141 temporarily secures the waist tightening cord 231.

[0101] The tissue ligation system provided by the present invention can not only ligate tumors or soft tissues in the body, but also shrink or squeeze out redundant blood inside the tumors or soft tissues, prevent secondary thrombosis, accelerate their atrophy and endothelialization, and promote postoperative recovery.

[0102] 18 , the present application provides a method for using the tissue ligation system as described above, comprising the following steps:

[0103] a) The front connecting rod 16 of the ligation device 1 is percutaneously punctured through the catheter sheath into the body and delivered to the tumor or soft tissue to be ligated, such as a hemangioma or the left atrial appendage;

[0104] b) moving the push button 123 and driving the outer sheath 121 to retreat, releasing the mesh structure 2;

[0105] c) Push the ligation device 1 forward as a whole until the net bag 21 completely covers the tumor or soft tissue, and the cavity portion 221 of the root sheath 22 is substantially flush with its root;

[0106] d) Rotating the tail knob 138 drives the guide rail slider 131 and the first moving rod 162 to retreat and tighten the root tightening rope 223 in the cavity portion 221, gradually shrinking and reducing the root diameter of the tumor or soft tissue;

[0107] e) After the root tightening rope 223 of the root cuff 22 is partially tightened, the tail end knob 1411 of the Luer connector 141 is pulled outward to tighten the waist tightening rope 231 of the waist cuff 23, thereby squeezing the redundant blood inside the left atrial appendage 31;

[0108] f) Continue tightening the root tightening rope 223 in the cavity portion 221 of the root sheath 22 until it fully tightens the root of the tumor or soft tissue and completely seals it;

[0109] g) Rotate the ligation device 1 as a whole, cut the root tightening rope 223 and the waist tightening rope 231 with the front edge 166 of the connecting rod 16, and then withdraw the entire ligation device.

[0110] During operation of the ligation system of the present application, when the net bag 21 ligates the left atrial appendage 31, the rope of the root cuff 22 is first tightened. After the rope of the root cuff 22 is tightened to 90% to 95%, the rope of the waist cuff 23 is tightened to discharge the blood inside the left atrial appendage 31, prevent secondary thrombosis, and help the left atrial appendage 31 to shrink rapidly. Then, the rope of the root cuff 22 is tightened to 100%, completely blocking the left atrial appendage 31. The tightening method of the rope can optionally be tightened and fixed in the form of a one-way tie, knotted or fixed with a slide buckle, including but not limited to a sliding tightening method. In the embodiment of the present application, the rope is braided into a one-way sliding knot. One end of the rope is fixed and constrained, and the other end can be pulled to slide toward the distal end to achieve the tightening function. Optionally, the exposed external rope is coated with a reinforcement layer. Optionally, the coating method can be a sleeve, or braided or coated, including but not limited to a covering molding method. Optionally, the reinforcing layer may be made of a polymer material such as PTFE, EPTFE, silicone, or a composite material such as nickel titanium or stainless steel. Optionally, the cavity portion 221 in the present application may be coated with a hydrophilic coating inside or outside to facilitate the rope sliding.

[0111] With reference to FIG16 and FIG17, the specific implementation method of the delivery system of the present application in surgery is as follows: the present application is suitable for minimally invasive methods, for example, through a small incision above, below or through the chest cavity, through an incision in the costal cartilage or xiphoid cartilage, through an incision below the left armpit, through a port, through the vascular system, etc., or surgical methods, for example, median sternotomy, small incision sternotomy, thoracotomy, thoracoscopy, etc. to advance to the left atrial appendage 31. In this embodiment, a multi-lumen puncture sheath is used to puncture the epicardium-cavity to allow the coronary endoscope to enter the pericardial layer 2mm from the outer cavity to observe the front end of the chicken-wing-shaped left atrial appendage 31. In the multi-lumen tube, there can also be a lumen in which an injectable contrast agent can be used to help the doctor determine the position of the endoscope and the left atrial appendage 31. The left atrial appendage 31 ligation system of the present application is then passed through the catheter sheath-cavity pericardial approach, and the endoscope reaches the front end of the left atrial appendage 31 under direct vision to capture the left atrial appendage 31. Move the push button 123 backward, retract the outer sheath 121, release the net bag 21 that was previously stored in the outer sheath 121, and reach the outer edge of the left atrial appendage 31. Push the handle forward as a whole, and the net bag 21 slides forward along the outer edge of the lower end of the left atrial appendage 31. The root of the net bag 21 hooks the front end of the outer edge of the left atrial appendage 31, and the hard cavity part 221 where the root tightening rope 223 of the root sleeve 22 is located slides to the root of the left atrial appendage 31 and begins to tighten the root of the net bag 21, and then tightens the waist tightening rope 231 of the waist sleeve 23 of the net bag 21. This system can repeatedly capture the left atrial appendage 31. If the first capture position is not good, slide the push button 123 upward to retract the net sleeve structure 2, select a suitable position to release the net bag 21 again. Rotate the tail knob 138 and the tail end knob 1411 to tighten the rope, thereby closing the left atrial appendage 31. The handle is slowly rotated, and the left and right edges 166 of the threading holes 165 of the connecting rod 16 cut one end of the ligature. The system can now be withdrawn and the excess ligature cut. A final left atrial angiography is performed to verify that the left atrial appendage 31 has been successfully ligated.

[0112] The left atrial appendage 31 ligation system of this embodiment has multiple features:

[0113] One-way sliding knot: The rope adopts a one-way sliding knot, which can only be tightened but not loosened, making the operation more convenient and ensuring high safety.

[0114] Polygonal mesh structure 2: The mesh bag 21 adopts a polygonal structure, which increases friction and makes it easier for doctors to wrap around the left atrial appendage 31.

[0115] Cord release function: The system has a cord release function that can be achieved by simply rotating the device, avoiding multiple surgical entry and exit points and multiple surgical instruments, and reducing surgical risks.

[0116] Repositionable capture: The system can repeatedly capture the left atrial appendage 31. If the first capture position is not good, the doctor can select a suitable position to release the mesh again.

[0117] The left atrial appendage 31 ligation system has several significant advantages in clinical application:

[0118] Single access and exit: No need to access circulation or manage multiple access points, reducing the complexity of the procedure.

[0119] Minimum implantation time: The system is relatively simple to operate, making the surgical procedure more efficient.

[0120] Safety: No device is left in the left atrial appendage 31, reducing the risk of potential complications.

[0121] High efficiency: The left atrial appendage 31 closure rate is higher, which helps prevent the formation of blood clots.

[0122] The beneficial effects of this application are:

[0123] (1) The tissue ligation system provided by the present application is different from conventional ligation devices that can only ligate tissue. The present application can deliver the mesh structure to the left atrial appendage and tighten it step by step through the ligation device, tightening the upper end and waist of the mesh bag respectively. The mesh structure can not only surround and ligate tissue, but also squeeze out redundant blood inside the tissue, prevent secondary thrombosis, accelerate tissue atrophy, and promote postoperative recovery;

[0124] (2) The tissue ligation system provided by the present application can achieve double tightening of the tissue by only using a single delivery device for single entry and exit, and can achieve occlusion without leaving any device in the tissue, which is safe and reliable;

[0125] (3) Through this application, the tissue ligation system has a built-in rope release function. By simply rotating the handle as a whole, the rope can be cut through the blade at the front end of the rod, thereby achieving rope release, avoiding multiple surgical entry and exit points and multiple surgical instruments, and reducing surgical risks;

[0126] (4) Through this application, the net bag is designed into a woven polygonal structure with a three-dimensional opening structure with an internal space, which can increase friction and make it easier to trap tissue;

[0127] (5) The tissue ligation system provided by the present application can repeatedly capture tissue, and the mesh structure can be retracted by sliding the push button upward.

[0128] Throughout this specification, reference to the terms "certain embodiments," "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" means that a specific feature, structure, material, or characteristic described in conjunction with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the exemplary descriptions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0129] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the described features. In the description of the present invention, "plurality" means at least two, for example, two or three, unless otherwise specifically defined.

Claims

1. A tissue ligation system, comprising a mesh structure and a ligation device; The net sleeve structure includes a net bag, a root sleeve, and a waist sleeve, wherein the root sleeve is circumferentially connected to an opening at one end of the net bag; a plurality of independent small rings are arranged in one or more circles in the middle of the net bag, which are used to add one or more waist sleeves, and the waist sleeves are arranged along the circumference of the net bag through the independent small rings; The ligation device comprises a connecting rod and a ligation mechanism, one end of the connecting rod is connected to the ligation mechanism, and the other end is connected to the net structure through a tie rope inside the rod; The ligation mechanism comprises a handle shell, a pushing assembly, a first tightening assembly and a second tightening assembly installed on the handle shell; The pushing component is connected to the mesh structure and is used to release the mesh structure and transport it to the left atrial appendage; The first tightening assembly includes a first fixed rod, a first moving rod and a first driving assembly, and the second tightening assembly includes a second fixed rod, a second moving rod and a second driving assembly; The root tie sleeve includes a root tightening rope, the two ends of which are respectively connected to the first fixed rod and the first movable rod, and the first driving assembly is connected to and drives the first movable rod to move, thereby driving the root tightening rope to tighten; The waist cinch includes a waist tightening rope, the two ends of which are respectively connected to the second fixed rod and the second movable rod, and the second driving assembly is connected to and drives the second movable rod to move, thereby driving the waist tightening rope to tighten.

2. The tissue ligation system according to claim 1, wherein: The first driving assembly includes a guide rail slider, a fixed guide rail, a threaded guide sleeve and a tail knob; The first fixed rod is fixed to the front end of the handle shell, the first movable rod is connected to the guide rail slider, the guide rail slider is slidably arranged in the fixed guide rail, the fixed guide rail is fixedly installed in the handle shell through a concave-convex structure, the outside of the fixed guide rail is sleeved with a threaded guide sleeve, the guide rail slider is provided with an external thread, and the threaded guide sleeve is provided with an internal thread, and the guide rail slider is driven to move axially in the groove on the fixed guide rail by rotating the threaded guide sleeve; the tail knob is fixedly connected to the threaded guide sleeve, and the rotation of the tail knob drives the threaded guide sleeve to rotate; the movement of the guide rail slider drives the first movable rod to move, and then drives the root to tighten the rope and tighten the root of the net bag.

3. The tissue ligation system according to claim 1, wherein: The second driving assembly includes a Luer connector and a tail knob, the second fixing rod is fixed to the front end of the handle housing, the second moving rod passes through the handle housing and is connected to the Luer connector, and the Luer connector is connected to the waist tightening rope; The tail end of the Luer connector is provided with a tail end knob, which is connected to the second moving rod. Pulling the tail end knob drives the second moving rod and the waist tightening rope to tighten, thereby realizing the waist of the net bag. Tighten.

4. The tissue ligation system according to claim 1, wherein: The net bag is a three-dimensional structure formed by cross-weaving multiple ropes or silk threads and having an internal space. One end is open and circumferentially connected to the root sleeve, and the other end is closed or open. The net bag is woven from a polymer or metal material with elasticity or memory.

5. The tissue ligation system according to claim 1, wherein: The root bundle is an elastic hollow tube, and the hollow tube is made of a polymer or metal material with elasticity or memory.

6. The tissue ligation system according to claim 1, wherein: One end of the connecting rod connected to the mesh structure can be pre-bent into a certain angle, and the angle range is 0-90 degrees.

7. The tissue ligation system according to claim 1, wherein: At least one lumen is disposed inside the connecting rod.

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