Mesh sleeve apparatus for tissue ligation and ligation apparatus system

Abstract

A mesh sleeve apparatus for tissue ligation and a ligation apparatus system. The mesh sleeve apparatus for tissue ligation comprises a support module, a mesh bag, and a connection module. The support module comprises a support ring, a skirt, and at least one guide rod. The skirt covers the support ring. A proximal end and a distal end of the guide rod are provided with a first bending portion and a second bending portion, respectively. Both the first bending portion and the second bending portion are bent towards the same side of the guide rod. The first bending portion is connected to the support ring. At least one end of the mesh bag is provided with an opening, and the open end of the mesh bag is detachably connected to the support ring along a circumferential direction by means of the connection module. The mesh sleeve apparatus for tissue ligation enhances the radial support force required by the mesh bag to ensnare the target tissue during tissue ligation, preventing the mesh bag from slipping off the target tissue in the ligation process, improving the success rate of tissue ligation, and increasing the stability of the ligation apparatus system.

Description

A mesh sleeve device and ligation device system for tissue ligation Technical Field

[0001] This application belongs to the field of medical devices and relates to a mesh sleeve device and ligation device system for tissue ligation. Background Technology

[0002] Currently, the main treatment methods for tumors or soft tissues that cannot be directly removed from the human body are clipping and ligation. The devices used for clipping have a clamp-like shape and are usually manufactured through machining or injection molding. Due to their fixed shape, the clamping force is also relatively fixed. However, due to significant individual differences, these relatively fixed clips have poor adaptability, and the clamping effect is not stable. The devices used for ligation are generally divided into two categories. One type uses tools such as endoscopes or laparoscopes to provide a field of vision, and ligation is achieved by suturing or knotting with sutures. This method relies on the surgeon's skill, and the ligation effect is not stable. The other type uses a percutaneous ligation ring after locating and capturing the target tissue via transseptal puncture. However, the end of this type of device near the target tissue is often designed to be too soft, lacking sufficient support, and easily slips off the target tissue. Additionally, the connection between the ring and the pushing device can deflect, increasing the difficulty for the surgeon to retrieve the target tissue, and posing stability issues in the operation. In addition, the two types of ligation devices mentioned above are difficult to manufacture and costly. They also have multiple entry and exit points, which makes operation complicated, prone to intraoperative problems, and affects the perioperative treatment effect.

[0003] Therefore, considering both surgical convenience and ligation stability, it is necessary to develop a device system for tissue ligation that offers high support, is easy to manufacture, and can be stably released. Summary of the Invention

[0004] This application provides a netting device and ligation device system for tissue ligation, which improves the radial support force at the front end, making it more effective in opening up the space around the target tissue. Through a double-bending design, it solves the problem of front-end rotation during the capture of the target tissue. At the same time, it can also prevent the netting from slipping off the target tissue during ligation, thereby improving the success rate of tissue ligation and increasing the stability of the system.

[0005] In a first aspect, this application provides a netting device for tissue ligation, the netting device for tissue ligation comprising a support module, a net pouch, and a connecting module. The support module includes a support ring, a skirt, and at least one guide rod. The skirt covers the support ring. The proximal and distal ends of the guide rod are respectively provided with a first bend and a second bend, the first bend and the second bend bending toward the same side of the guide rod. The first bend is connected to the support ring. At least one end of the net pouch is provided with an opening, and the open end of the net pouch is detachably connected to the support ring circumferentially via the connecting module.

[0006] The netting device provided in this application utilizes a support ring to support and fix the net, increasing the radial support force required for the net to capture the target tissue during tissue ligation and solving the problem of the net slipping off the tissue during ligation. The guide rod employs a double bend to prevent the net from rotating, facilitating the capture of the target tissue. Furthermore, it uses only one channel for single entry and exit, eliminating the need to manage multiple entry and exit points and improving surgical convenience. The support ring has a constriction function, further ensuring full closure of the left atrial appendage, increasing the success rate of tissue ligation, enhancing system stability, preventing thrombosis, and reducing the risk of stroke, hypertension, and potential hypotension.

[0007] The mesh device of this application can be delivered to the vicinity of the left atrial appendage via minimally invasive (e.g., through a small incision above, below, or through the thoracic cavity, through an incision in the costal cartilage or xiphoid cartilage, through an incision below the left axilla, through a port, through the vascular system, etc.) and surgical (e.g., median sternotomy, small-incision sternotomy, thoracotomy, thoracoscopic examination, etc.) methods.

[0008] It should be noted that the shape of the support ring in this application includes all shapes formed by surrounding, and is not limited to a circle. It can also be a rectangle, an ellipse, or an irregular polygon, etc. This application does not make any specific limitation in this regard.

[0009] It should also be noted that, in this application, the proximal end refers to the end closer to the target tissue, and the distal end refers to the end of the operator.

[0010] As a preferred technical solution of this application, the support ring is a single-ring structure or a multi-ring structure.

[0011] The support ring is made of shape memory metal, biocompatible malleable metal, or elastic metal.

[0012] The support ring can be an open ring structure or a closed ring structure.

[0013] The support ring is either non-stretchable or circumferentially stretchable.

[0014] The support ring of this application, serving as the main structure of the netting device, possesses strong supporting force, enabling the net to open smoothly within the body and preventing it from slipping off the target tissue after it has been secured. Compared to traditional support structures using polymer tubes or C-rings, the radial supporting force of the support ring in this application increases exponentially, which is more effective in expanding the space around the tissue. It also has a ring-contraction function to prevent unnecessary deflection during the securing process.

[0015] As a preferred technical solution of this application, the support ring is an open ring structure, and the support ring has a first end and a second end; the first end and / or the second end are bent and extended to the distal end and then bent again to form at least one of the guide rods.

[0016] The support module described in this application can adopt an integral molding structure. First, an open support ring is formed at the near end. Then, at least one end of the open end is bent once, extended to the far end, and bent a second time to form a guide rod, which effectively simplifies the structure of the support module.

[0017] As a preferred technical solution of this application, the first bending portion and the second bending portion are independently curved in an arc.

[0018] The bending angles of the first bend and the second bend may be the same or different.

[0019] The bending angle of the first bending portion is 5 to 175°, for example, it can be 5°, 10°, 15°, 20°, 30°, 40°, 45°, 60°, 80°, 90°, 100°, 120°, 130°, 150°, 170° or 175°, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0020] The bending angle of the second bending part is 5 to 90°, for example, it can be 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 60°, 70°, 80° or 90°, but it is not limited to the listed values. Other unlisted values ​​within this range are also applicable.

[0021] The guide rod is made of shape memory metal, biocompatible malleable metal, or elastic metal.

[0022] When the number of guide rods is at least two, the two adjacent guide rods are parallel to each other or intersecting side by side.

[0023] As a preferred technical solution of this application, the skirt includes a main body and a connecting part. The main body wraps around the support ring in the circumferential direction, the connecting part extends towards the net, and the surface of the connecting part is provided with at least one connecting hole in the circumferential direction.

[0024] The hem is made by sewing, knitting, weaving, or knitting.

[0025] The skirt material includes a polymer or animal pericardium.

[0026] As a preferred technical solution of this application, the connection module includes a first connection component and a second connection component.

[0027] The first connecting component detachably connects the net bag and the support module in the circumferential direction.

[0028] The second connecting component detachably connects the net bag and the support module through the connecting hole of the skirt connecting part, and the second connecting component connects at least the part of the net bag away from the guide rod to the connecting hole.

[0029] It should be noted that, in this application, the axis of the opening of the net bag is used as the dividing line. The half of the net bag closer to the guide rod is referred to as the upper half, and the half of the net bag further away from the guide rod is referred to as the lower half. The second connecting component is used to connect at least one point on the surface of the lower half of the net bag with the connecting hole, and is fixed at most along the circumference of the net bag and not beyond the corner between the lower half and the upper half.

[0030] As a preferred technical solution of this application, the first connecting component and / or the second connecting component includes at least one of threaded connectors, wedge connectors, pin connectors and key connectors.

[0031] The first connecting component and / or the second connecting component are made of silk, elastic metal wire or polymer material.

[0032] This application enables the net to be released in stages during application. After the first connecting component is disassembled and released, the second connecting component can still maintain connection with the support module, which solves the problem of the net slipping off from the target tissue during the ligation process, improves the success rate of tissue ligation, and increases the stability of the system.

[0033] As a preferred technical solution of this application, the net bag is provided with a tying and tightening rope.

[0034] The net is a three-dimensional woven body with a hollowed-out mesh, and the tying and tightening rope is crisscrossed and threaded between the hollowed-out mesh along the circumference of the opening of the net.

[0035] At least one waist tightening rope is provided along the circumference of the middle part of the net.

[0036] Both the ligation tightening rope and the waist tightening rope are unidirectional sliding.

[0037] The hollowed-out mesh can be rectangular, prismatic, or honeycomb-shaped.

[0038] In this application, the ligation and tightening cord does not need to be woven and fixed to the net bag as a whole. It only needs to cross the mesh of the net bag circumferentially at one end of the net bag opening, which reduces the tissue gap and reduces the difficulty of weaving the net bag.

[0039] Secondly, this application provides a ligation device system, which includes a delivery device and a net sleeve device for ligation as described in the first aspect, wherein the delivery device is connected to a support module of the net sleeve device.

[0040] As a preferred technical solution of this application, the conveying device includes a push guide tube, and the push guide tube is further provided with several independent cavities, which are used to movably connect the support ring, the connecting module and the net bag respectively.

[0041] The push catheter in this application is used to deliver the mesh device to the left atrial appendage and to release and retract the mesh device after ligation.

[0042] The numerical range described in this application includes not only the point values ​​listed above, but also any point values ​​within the numerical ranges not listed above. Due to space limitations and for the sake of brevity, this application will not exhaustively list the specific point values ​​included in the range.

[0043] Compared with the prior art, the beneficial effects of this application are as follows:

[0044] This application provides a netting device and ligation device system for tissue ligation, which improves the radial support force required by the netting to capture the target tissue during the ligation process, solves the problem of the netting slipping off the target tissue during the ligation process, avoids unnecessary deflection during the capture process, can fully close the left atrial appendage, improves the success rate of tissue ligation, and increases the stability of the system. It is simple to process, has a short cycle, and reduces costs and increases efficiency. Attached Figure Description

[0045] Figure 1 is a structural schematic diagram of the mesh sleeve device for tissue ligation provided in Embodiment 1-1 of this application.

[0046] Figure 2 is a side view of the mesh sleeve device for tissue ligation provided in Embodiment 1-1 of this application.

[0047] Figure 3 is a rear view of the mesh sleeve device for tissue ligation provided in Embodiment 1-1 of this application.

[0048] Figure 4 is an enlarged view of point A in Figure 1 of this application.

[0049] Figure 5 is a schematic diagram of the skirt structure provided in Embodiment 1-1 of this application.

[0050] Figure 6 is a schematic diagram of the structure of the net bag provided in Embodiment 1-1 of this application.

[0051] Figure 7 is a schematic diagram of the support ring provided in Embodiments 1-2 of this application.

[0052] Figure 8 is a front view of the support ring provided in Embodiments 1-2 of this application.

[0053] Figure 9 is a schematic diagram of the support ring after it has been tightened and circumferentially compressed according to Embodiments 1-2 of this application.

[0054] Figure 10 is a side view of the support ring after it has been tightened and circumferentially compressed according to Embodiments 1-2 of this application.

[0055] Figure 11 is a schematic diagram of the structure of the net bag provided in Embodiments 1-3 of this application.

[0056] Figure 12 is a schematic diagram of the ligation device system provided in Embodiment 2-1 of this application.

[0057] Figure 13 is a schematic diagram of the tissue ligation process provided in Application Example 1 of this application.

[0058] Figure 14 is a schematic diagram of the tightening of the net sleeve device provided in Application Example 1 of this application.

[0059] Figure 15 is a schematic diagram of the ligation device system provided in Comparative Example 2-1 of this application.

[0060] Among them, 100-netting device; 1-support ring; 101-slide rail; 2-guide rod; 201-first bending part; 202-second bending part; 3-skirt; 301-main body; 302-connecting part; 303-connecting hole; 4-net bag; 401-tying and tightening rope; 402-waist tightening rope; 51-first connecting component; 52-second connecting component; 300-netting. Detailed Implementation

[0061] It should be understood that in the description of this application, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are used solely for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0062] It should be noted that, in the description of this application, unless otherwise expressly specified and limited, the terms "set up," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a stitched connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0063] The technical solution of this application will be further described below with reference to the accompanying drawings and specific embodiments.

[0064] In one specific embodiment, this application provides a netting device for tissue ligation, including a support module, a net, and a connecting module. The support module includes a support ring, a skirt, and at least one guide rod. The skirt covers the support ring. The proximal and distal ends of the guide rod are respectively provided with a first bend and a second bend, which bend towards the same side of the guide rod. The first bend connects to the support ring. At least one end of the net has an opening, and the open end of the net is detachably connected to the support ring circumferentially via the connecting module. The support ring supports and fixes the net circumferentially. On the one hand, it can expand the space around the target tissue so that the net can cover the target tissue. On the other hand, when the ligation line is tightened, the support ring can tighten along with the circumferential contraction, preventing the net from slipping off the target tissue. Furthermore, the bends at both ends of the guide rod constrain the free ends in multiple directions, preventing rotation of the proximal end of the net.

[0065] Specifically, the shape of the support ring includes all shapes formed by surrounding, and is not limited to a circle. It can also be a rectangle, an ellipse, or an irregular polygon, etc. This application does not make any specific limitation in this regard.

[0066] In some embodiments, the support ring is a single-ring or multi-ring structure. When the support ring adopts a multi-ring structure, it can be connected using a slide rail with an internal through-cavity. To enable the support ring to retract into the sheath and be released from the sheath into the body and open, the support ring is made of shape memory metal, biocompatible malleable metal, or elastic metal. The shape memory metal includes, but is not limited to, commonly used nickel-titanium, titanium alloy, cobalt-chromium alloy, or stainless steel. The malleable metal can be a metal frame made of biocompatible metal known to those skilled in the art or a laser-cut rigid metal tube. The elastic metal can be a flexible reed tube known to those skilled in the art, and the inner cavity of the flexible reed tube is provided with a reinforcing wire with a certain supporting force and shape memory function.

[0067] In some embodiments, the support ring is an open or closed ring structure. The support ring is either non-stretchable or circumferentially stretchable. The support ring can be circular, rectangular, elliptical, or an irregular polygon. As the main structure of the netting device, the support ring is designed as a circumferential ring, and can be either open or closed. The size and shape of the ring can be adaptively adjusted according to the needs of those skilled in the art. The support ring can support the net to open smoothly inside the body, provide strong support for the net to capture the target tissue, and has a retraction function to prevent unnecessary deflection.

[0068] In some embodiments, the support ring is an open ring structure, having a first end and a second end; the first end and / or the second end is bent, extended distally, and then bent again to form at least one guide rod. In this application, the support ring and the guide rod can be integrally molded, with the ring band forming an open ring shape at the proximal end, at least one end of which is bent once to obtain a first bent portion, then extended distally, and subsequently bent a second time to obtain the first bent portion forming the guide rod.

[0069] For example, an elliptical open ring is formed by wrapping the ring around the proximal end, with a major axis of 5-55 mm and a minor axis of 5-25 mm. The first and second ends of the open end of the open ring structure are bent once each, with no limit on the bending angle. Then, it is extended along the distal end and bent a second time. This can satisfy the four degrees of freedom of the constraint support ring in the front, back, left, and right directions. The two bending designs can constrain six degrees of freedom in all directions, making it completely constrained and fixed.

[0070] In some embodiments, the first bend and the second bend are independently curved, and the bending angles of the first bend and the second bend may be the same or different. Specifically, the bending angle of the first bend is 5–175°. In this application, the bending angle refers to the angle between the extension line of the guide rod and the plane where the support ring is located, which can be an acute angle, a right angle, or an obtuse angle. The bending angle of the second bend is 5–90°, and in this application, the second bend refers to the angle between the extension line of the guide rod and the extension line of the second bend. This application achieves multi-directional degree of freedom constraint by adjusting the bending angles of the first bend and the second bend, avoiding the problem of rotation at the near end of the net. The guide rod is made of shape memory metal, biocompatible malleable metal, or elastic metal. The guide rod and the support ring can be made of the same material or different materials, preferably the same material. Furthermore, when there are at least two guide rods, adjacent guide rods are parallel to each other or intersecting side by side.

[0071] In some embodiments, the skirt includes a main body and a connecting part. The main body wraps around the support ring circumferentially, and the connecting part extends towards the net, with at least one connecting hole circumferentially provided on its surface. The skirt is made by sewing, knitting, weaving, or knitting. The skirt material includes a polymer or animal pericardium. Specifically, the polymer includes polyester polymers, polytetrafluoroethylene (PTFE), or expanded polytetrafluoroethylene (ePTFE). Further, the polymer can be polyethylene terephthalate. Animal pericardium includes, but is not limited to, bovine or porcine pericardium materials. The skirt material needs to have a certain degree of conformability to fit the support ring and the net respectively, and also to avoid damage to other human tissues during surgery. The connecting hole circumferentially provided in the skirt connecting part is used for suturing the support ring.

[0072] In some embodiments, the connecting module includes a first connecting component and a second connecting component. The first connecting component detachably connects the net and the support module circumferentially. The second connecting component detachably connects the net and the support module through a connecting hole in the skirt connecting portion, and the second connecting component connects at least the portion of the net surface away from the guide rod to the connecting hole. Specifically, taking the axis of the net opening as a dividing line, the half of the net closer to the guide rod is designated as the upper half, and the half away from the guide rod as the lower half. The second connecting component is used to connect at least one point on the lower half surface of the net to the connecting hole, and is fixed at most circumferentially along the net and not exceeding the corner between the lower and upper halves. This application first disassembles and retracts the first connecting component, then tightens the opening of the net, causing the net to contract towards the guide rod. By fixing the lower half of the net with the second connecting component, the net can be effectively prevented from slipping off the target tissue.

[0073] In some embodiments, the first connecting component and / or the second connecting component includes at least one of threaded couplings, wedge couplings, pin couplings, and key couplings. That is, the first or second connecting component in this application can achieve a detachable connection using any of the aforementioned couplings, or a combination of at least two couplings. Furthermore, the connection method and materials of the first and second connecting components can be the same or different; this application does not impose specific limitations in this regard. In this application, the net bag and the support module are connected by sewing, which solves the problems of difficult machining and long processing cycles, ensuring sturdiness while improving the efficiency of net bag production.

[0074] In some embodiments, the first connecting component and / or the second connecting component are made of silk, elastic metal wire, or polymer materials. The polymer materials include, but are not limited to, one or more of polyoxymethylene, polytetrafluoroethylene, polyethylene, polyamide resin, and polycarbonate.

[0075] For example, in this application, the first connecting component can be a polymer fixing thread, which passes through the skirt body in a wrapping manner and circumferentially connects and fixes the support module along the opening end of the net, solving the problems of difficult processing and long cycle time, and greatly improving the efficiency of net production. In this application, the first connecting component serves as a temporary fixation and can be retracted during surgery. The second connecting component is cross-threaded on the net and passes through the connecting hole on the skirt connecting part, connecting the net to the support module. After the first connecting component is retracted, it can prevent the net from falling off the support module before ligation. The second connecting component also serves as a temporary fixation and can also be a polymer fixing thread, retractable during surgery. At the same time, during application, the first connecting component is retracted first, the net opening is tightened, and then the second connecting component is retracted. This application achieves step-by-step release through the first and second connecting components, improving system stability and shortening the implantation time.

[0076] In some embodiments, the net is provided with a ligation and tightening cord; the net is a three-dimensional woven body with a perforated mesh, and the ligation and tightening cord is crisscrossed between the perforated mesh along the circumferential direction of the net opening. One end of the ligation and tightening cord is fixed to the net, and pulling the other end causes the ligation and tightening cord to slide distally, achieving a tightening effect. Specifically, the perforated mesh is rectangular, prismatic, or honeycomb-shaped. Compared with traditional fixing methods, the tightening cord knot of this application does not need to be woven and fixed to the entire net; it only needs to cross and pass through the perforated mesh of the net at the circumferential end of the net opening, reducing tissue gaps and lowering the difficulty of net weaving. At least one waist tightening cord is provided circumferentially along the middle of the net. Both the ligation and tightening cords are unidirectionally sliding. The net is tightened and fixed outside the left atrial appendage; through two tightenings, it can more fully and securely cover the left atrial appendage. The waist tightening cord is set in the same way as the ligation and tightening cord. When ligating the left atrial appendage with a net, first tighten the ligation tightening rope until it is 90%–95% tight. Then tighten the waist tightening rope to drain blood from the left atrial appendage, preventing secondary thrombosis and promoting rapid atrial appendage shrinkage. Finally, tighten the ligation tightening rope to 100%, completely sealing the left atrial appendage. Both the ligation tightening rope and the waist tightening rope are unidirectional sliding devices, using knots or buckles for fixation, commonly used in the field. Tightening occurs through unidirectional sliding. One end of the ligation tightening rope or waist tightening rope is fixed and constrained, while the other end is pulled distally, allowing the ligation tightening rope or waist tightening rope to slide and achieve the tightening function.

[0077] In another specific embodiment, this application provides a ligation device system, which includes a delivery device and a net sleeve device for ligation as described in the specific embodiment. The delivery device is connected to a support module of the net sleeve device. The delivery device is used to deliver the net sleeve device to the left atrial appendage and to release and retract the net sleeve device after ligation. The delivery device can repeatedly capture the left atrial appendage. If the initial capture position is unsatisfactory, the delivery device can retrieve the net sleeve device and release it again at a suitable position, achieving repeated positioning and capture.

[0078] In some embodiments, the conveying device includes a push guide tube, which further comprises several independent lumens for movably connecting the support ring, the connecting module, and the net bag, respectively. The push guide tube of this application also includes necessary push handles, wires, connecting lines, and other components. This application does not impose special requirements on these components; those skilled in the art should reasonably adjust, add, or remove them according to actual production needs.

[0079] For example, the specific method of using the ligation device system provided in this application includes:

[0080] The mesh device was inserted through a minimally invasive intercostal incision using one lumen of the delivery catheter. Under DSA (Digital Subtraction Angiography) guidance, the pericardium was punctured, and the mesh device was delivered to the vicinity of the left atrial appendage. The push handle slid the support ring to the base of the left atrial appendage. First, the first connecting component was withdrawn, initially separating the mesh from the support ring. Then, the ligation cord was tightened to 90-95%, followed by tightening the waist cord to squeeze out blood from the left atrial appendage and prevent thrombosis. The ligation cord was then tightened to 100%, completely sealing the left atrial appendage. Next, the second connecting component was withdrawn, completely separating the mesh from the support ring. At this point, the entire delivery device could be removed, and excess cord cut. Finally, left atrial angiography was performed to confirm successful ligation of the left atrial appendage.

[0081] Example 1-1

[0082] This embodiment provides a mesh sleeve device 100 for tissue ligation, including a support module, a mesh pocket 4, and a connecting module. As shown in Figures 1, 2, and 3, the support module includes an integrally formed support ring 1, two guide rods 2, and a skirt 3 arranged circumferentially along the support ring 1. The support ring 1 is a closed elliptical single-ring structure with a major axis of 40 mm and a minor axis of 20 mm, made of nickel-titanium metal. The two guide rods 2 are arranged parallel to each other, and the proximal and distal ends of the guide rods 2 are respectively provided with a first bending portion 201 and a second bending portion 202, which are curved towards the same side of the guide rod 2. The first bending portion 201 is connected to the support ring 1 with a bending angle of 90°, and the second bending portion 202 has a bending angle of 90°.

[0083] The skirt hem 3 is woven from hexyl phthalate fabric and includes a main body 301 and a connecting part 302. The main body 301 wraps around the support ring 1, and the connecting part 302 extends towards the net bag 4 and is sewn to the net bag 4 through a connecting module. As shown in Figure 5, the surface of the connecting part 302 of the skirt hem 3 has evenly distributed connecting holes 303 along the circumference. As shown in Figure 4, the second connecting component 52 crosses the open end of the net bag circumferentially through the hollow mesh of the net bag and passes through the connecting holes 303, connecting the skirt hem 3 and the support ring 1, so that the net bag 4 and the support ring 1 are tightly connected.

[0084] As shown in Figures 1 and 6, the net bag 4 is a three-dimensional woven body with a diamond-shaped openwork mesh, woven using oblique stitches. A tie-down cord 401 and a waist-tightening cord 402 are circumferentially arranged on the net bag 4. The tie-down cord 401 is circumferentially arranged along the open end of the net bag 4 and crosses through the openwork mesh. The waist-tightening cord 402 is located in the middle of the net bag 4 and crosses through the openwork mesh. Both the tie-down cord 401 and the waist-tightening cord 402 are unidirectionally sliding and secured with buckles.

[0085] As shown in Figures 1 and 4, the connecting module includes a first connecting component 51 and a second connecting component 52. The first connecting component 51 connects the main body 301 of the skirt edge 3 and the mesh bag 4 around the opening of the mesh bag 4 in a circumferential manner. It can be disassembled by pulling one end located in the tube cavity; the other end can be located in the same tube cavity or not. The second connecting component 52 connects the main body 301 of the skirt edge 3 and the mesh bag 4 around the opening of the lower half of the mesh bag in a circumferential manner, and passes through the connecting hole 303 on the skirt edge connecting part 302. It can be disassembled by pulling one end located in the tube cavity; the other end can be located in the same tube cavity or not. Both the first connecting component 51 and the second connecting component 52 are made of polyoxymethylene (POM), which has a low coefficient of friction.

[0086] Examples 1-2

[0087] This embodiment provides a netting device 100 for tissue ligation, which differs from Embodiment 1-1 in that, as shown in Figures 7 and 8, the support ring 1 has a double-ring structure and is connected by a slide rail 101. The remaining structure is the same as in Embodiment 1-1. In this embodiment, after the ligation tightening rope 401 is tightened, as shown in Figures 9 and 10, the support ring 1 tightens accordingly, preventing the netting 4 from slipping off the target tissue during ligation and enhancing overall stability.

[0088] Examples 1-3

[0089] This embodiment provides a netting device 100 for tissue ligation, which differs from Embodiment 1-1 in that: as shown in Figure 11, the netting 4 is a three-dimensional woven body with a rectangular hollowed-out grid, which is made of straight needle knitting, and the rest of the structure is the same as that of Embodiment 1-1.

[0090] Examples 1-4

[0091] This embodiment provides a mesh sleeve device 100 for tissue ligation, which differs from Embodiment 1-1 in that: the connecting module only includes the first connecting component 51 and does not include the second connecting component 52; the remaining structure is the same.

[0092] Same as Example 1-1.

[0093] Example 2-1

[0094] This embodiment provides a ligation device system, as shown in Figure 12, including a delivery device and a mesh sleeve device 100 for tissue ligation provided in Embodiment 1-1. The delivery device is used to deliver the mesh sleeve device 100 to the left atrial appendage and to release and retract the mesh sleeve device 100 after ligation. The structure of the mesh sleeve device 100 is similar to...

[0095] Example 1-1 is identical and will not be described again. The delivery device includes a push tube, which has at least four independent cavities inside. One cavity is used to accommodate the netting device 100, one cavity is used to embed one end of the first connecting component 51, one cavity is used to embed one end of the second connecting component 52, one cavity has a buckle for the ligation tightening rope 401 embedded in it, and one cavity has a buckle for the waist tightening rope 402 embedded in it. After the netting device 100 is released, both the support ring 1 and the net bag 4 extend out of the cavity, with at least the second bend 202 remaining inside the cavity to ensure that the netting device 100 can be smoothly withdrawn. In this embodiment, after the first connecting component 51 is withdrawn, the support ring 1 and the net bag 4 are still temporarily fixed by the second connecting component 52 to prevent the net bag 4 from falling off before ligation, achieving step-by-step release, improving the success rate of tissue ligation, and increasing the stability of the system.

[0096] Example 2-2

[0097] This embodiment provides a ligation device system, which differs from Embodiment 2-1 in that the net sleeve device 100 is the same as the net sleeve device 100 for tissue ligation provided in Embodiments 1-4, while the rest of the structure is the same as in Embodiment 2-1.

[0098] Application Example 1

[0099] This application example uses the ligation device system of Example 2-1 to ligate a chicken-wing shaped left atrial appendage, specifically including the following steps, as shown in Figures 13 and 14:

[0100] Using a pericardiocentesis needle, the epicardium is punctured, and a 0.18mm guidewire is inserted into the pericardial layer. A dilator sheath is used to widen the passage, separating pericardial adhesions. Contrast agent is injected to determine the location of the left atrial appendage. The catheter sheath is advanced to the anterior end of the left atrial appendage, and the mesh device 100 is then inserted through a lumen of the advancement catheter to puncture the pericardium. Under DSA guidance, it reaches the anterior end of the left atrial appendage, where the mesh 4 captures the left atrial appendage. The advancement handle slides the support ring 1 to the base of the left atrial appendage to begin tightening the mesh 4. First, the first connecting assembly 51 is withdrawn to initially separate the mesh 4 from the support ring 1. Then, the ligation tightening cord 401 is tightened to 90-95%, followed by tightening the waist tightening cord 402 to drain blood from the left atrial appendage and prevent secondary thrombosis. Finally, the ligation tightening cord 401 is tightened to 100%, completely closing the left atrial appendage. Then retract the second connecting component 52 to completely separate the net 4 from the support ring 1. At this point, the entire delivery device can be removed, and excess wires can be cut. Finally, perform left atrial angiography to verify successful ligation of the left atrial appendage.

[0101] In this application example, the support ring 1 supports the space around the target tissue, allowing the net 4 to accurately enclose the target tissue. The support ring 1 has a shrinking function and provides a large radial support force, preventing the net 4 from slipping off the tissue during ligation and enhancing overall stability. Meanwhile, the guide rod 2 employs a double-bending design to prevent the net from rotating, facilitating tissue capture. Furthermore, after enclosing the target tissue, even after retracting the first connecting component 51, the support ring 1 and the net 4 can still be temporarily fixed via the second connecting component 52, preventing the net 4 from falling off before ligation. This step-by-step release improves the success rate of tissue ligation.

[0102] Application Example 2

[0103] This application example uses the ligation device system of Example 2-2 to perform ligation on a chicken-wing shaped left atrial appendage, specifically including the following steps:

[0104] Using a pericardiocentesis needle, the epicardium is punctured, and a 0.18mm guidewire is inserted into the pericardial layer. The passage is widened with a dilator sheath, pericardial adhesions are separated, and contrast agent is injected to determine the location of the left atrial appendage. The catheter sheath is advanced to the anterior end of the left atrial appendage, and the mesh device 100 is then guided through a lumen of the advancement catheter to the anterior end of the left atrial appendage under DSA guidance. The mesh 4 captures the left atrial appendage. The advancement handle slides the support ring 1 to the root of the left atrial appendage to begin tightening the mesh 4. The first connecting assembly 51 is withdrawn, separating the mesh 4 from the support ring 1, and the ligation tightening cord 401 is tightened to 100%, completely sealing the left atrial appendage. The entire delivery device is then withdrawn, and excess cord is cut. Finally, left atrial angiography is performed to verify successful ligation of the left atrial appendage.

[0105] In this application example, after capturing the left atrial appendage, the first connecting component 51 is withdrawn, causing the net 4 to lose its temporary fixing point, making it prone to slippage and reducing the success rate of tissue ligation.

[0106] Comparative Example 1-1

[0107] This comparative example provides a netting 300 for tissue ligation, which differs from Example 1-1 in the structure of the support module. The support module of this comparative example does not have a support ring or skirt, and the two ends of the guide rod do not have a first bend and a second bend. The netting is directly fixed to the guide rod by a ligation tightening rope; the remaining structure is the same as in Example 1-1.

[0108] Comparative Example 2-1

[0109] This comparative example provides a ligation device system, as shown in Figure 15, including a delivery device and a mesh sleeve 300 for tissue ligation provided in Comparative Example 1-1. The delivery device is used to deliver the mesh sleeve 300 to the left atrial appendage and to release and retract the mesh sleeve 300 after ligation. The structure of the mesh sleeve 300 is exactly the same as that of Comparative Example 1-1 and will not be described further here. The delivery device includes a pusher tube, which has at least four independent lumens inside. One lumen is used to accommodate the mesh sleeve 300, one lumen has a pre-embedded buckle for ligation tightening cord, and one lumen has a pre-embedded buckle for waist tightening cord.

[0110] Comparative Application Example 1

[0111] This comparative application example uses the ligation device system of Comparative Example 2-1 to ligate a chicken-wing shaped left atrial appendage, specifically including the following steps:

[0112] Using a pericardiocentesis needle, the epicardium is punctured, and a 0.18mm guidewire is inserted into the pericardial layer. The pathway is widened with a dilator sheath, pericardial adhesions are separated, and contrast agent is injected to determine the location of the left atrial appendage. The catheter sheath is then advanced to the anterior end of the left atrial appendage. A mesh 300 is then inserted through a lumen in the catheter via the pericardial approach, and DSA is used to reach the anterior end of the left atrial appendage. The mesh 4 captures the left atrial appendage. The ligation cord is tightened to 100% using the push handle, completely occluding the left atrial appendage. The delivery device is withdrawn, excess cord is cut, and finally, left atrial angiography is performed to verify successful ligation of the left atrial appendage.

[0113] In this comparative application example, after the net reached the front of the left atrial appendage, it was difficult to capture the left atrial appendage because it failed to fully support the space around the left atrial appendage. In addition, the support at the opening end of the net was low, making it easy to slip off, resulting in unsuccessful ligation.

[0114] The applicant declares that the above description is only a specific implementation of this application, but the protection scope of this application is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application fall within the protection and disclosure scope of this application.

Claims

1. A netting device for tissue ligation, comprising a support module, a net pouch, and a connecting module, wherein the support module includes a support ring, a skirt, and at least one guide rod, the skirt covering the support ring, the guide rod having a first bend and a second bend at its proximal and distal ends, respectively, the first bend and the second bend bending toward the same side of the guide rod, the first bend being connected to the support ring; the net pouch having an opening at at least one end, the opening of the net pouch being detachably connected to the support ring circumferentially via the connecting module.

2. The mesh sleeve device for tissue ligation according to claim 1, wherein, The support ring can be a single-ring structure or a multi-ring structure; The support ring is made of shape memory metal, biocompatible malleable metal, or elastic metal. The support ring is an open ring structure or a closed ring structure; The support ring is either non-stretchable or circumferentially stretchable.

3. The mesh sleeve device for tissue ligation according to claim 2, wherein, The support ring is an open ring structure, and the support ring has a first end and a second end; The first end and / or the second end are bent and extended distally before being bent again to form at least one of the guide rods.

4. The mesh sleeve device for tissue ligation according to claim 1, wherein, The first bend and the second bend are independently curved. The bending angles of the first bend and the second bend may be the same or different. The bending angle of the first bend is 5 to 175°; The bending angle of the second bend is 5 to 90°; The guide rod is made of shape memory metal, biocompatible malleable metal, or elastic metal. When the number of guide rods is at least two, the two adjacent guide rods are parallel to each other or intersecting side by side.

5. The mesh sleeve device for tissue ligation according to claim 1, wherein, The skirt includes a main body and a connecting part. The main body wraps around the support ring in the circumferential direction. The connecting part extends towards the net bag, and at least one connecting hole is provided on the surface of the connecting part in the circumferential direction. The hem is made by sewing, knitting, weaving or knitting; The skirt material includes a polymer or animal pericardium.

6. The mesh sleeve device for tissue ligation according to claim 5, wherein, The connection module includes a first connection component and a second connection component; The first connecting component detachably connects the net and the support module in the circumferential direction; The second connecting component detachably connects the net bag and the support module through the connecting hole of the skirt connecting part, and the second connecting component connects at least the part of the net bag away from the guide rod to the connecting hole.

7. The mesh sleeve device for tissue ligation according to claim 6, wherein, The first connecting assembly and / or the second connecting assembly includes at least one of threaded couplings, wedge couplings, pin couplings, and key couplings; The first connecting component and / or the second connecting component are made of silk, elastic metal wire or polymer material.

8. The mesh sleeve device for tissue ligation according to claim 1, wherein, The net bag is equipped with a tying and tightening rope; The net is a three-dimensional woven body with a hollow mesh, and the tying and tightening rope is crisscrossed and passed between the hollow mesh along the circumferential direction of the opening of the net; At least one waist tightening rope is provided circumferentially along the middle of the net bag; Both the ligation tightening rope and the waist tightening rope are unidirectional sliding. The hollowed-out mesh can be rectangular, prismatic, or honeycomb-shaped.

9. A ligation device system comprising a delivery device and a mesh sleeve device for tissue ligation as described in any one of claims 1-8, said delivery device being connected to a support module of the mesh sleeve device.

10. The ligation device system according to claim 9, wherein, The conveying device includes a push guide tube, which is further provided with several independent cavities. The several cavities are used to movably connect the support ring, the connecting module and the net bag respectively.

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